Laser 3D micro-manufacturing

NASA Astrophysics Data System (ADS)

Piqué, Alberto; Auyeung, Raymond C. Y.; Kim, Heungsoo; Charipar, Nicholas A.; Mathews, Scott A.

2016-06-01

Laser-based materials processing techniques are gaining widespread use in micro-manufacturing applications. The use of laser microfabrication techniques enables the processing of micro- and nanostructures from a wide range of materials and geometries without the need for masking and etching steps commonly associated with photolithography. This review aims to describe the broad applications space covered by laser-based micro- and nanoprocessing techniques and the benefits offered by the use of lasers in micro-manufacturing processes. Given their non-lithographic nature, these processes are also referred to as laser direct-write and constitute some of the earliest demonstrations of 3D printing or additive manufacturing at the microscale. As this review will show, the use of lasers enables precise control of the various types of processing steps—from subtractive to additive—over a wide range of scales with an extensive materials palette. Overall, laser-based direct-write techniques offer multiple modes of operation including the removal (via ablative processes) and addition (via photopolymerization or printing) of most classes of materials using the same equipment in many cases. The versatility provided by these multi-function, multi-material and multi-scale laser micro-manufacturing processes cannot be matched by photolithography nor with other direct-write microfabrication techniques and offer unique opportunities for current and future 3D micro-manufacturing applications.

Manufacturing process and material selection in concurrent collaborative design of MEMS devices

NASA Astrophysics Data System (ADS)

Zha, Xuan F.; Du, H.

2003-09-01

In this paper we present knowledge of an intensive approach and system for selecting suitable manufacturing processes and materials for microelectromechanical systems (MEMS) devices in concurrent collaborative design environment. In the paper, fundamental issues on MEMS manufacturing process and material selection such as concurrent design framework, manufacturing process and material hierarchies, and selection strategy are first addressed. Then, a fuzzy decision support scheme for a multi-criteria decision-making problem is proposed for estimating, ranking and selecting possible manufacturing processes, materials and their combinations. A Web-based prototype advisory system for the MEMS manufacturing process and material selection, WebMEMS-MASS, is developed based on the client-knowledge server architecture and framework to help the designer find good processes and materials for MEMS devices. The system, as one of the important parts of an advanced simulation and modeling tool for MEMS design, is a concept level process and material selection tool, which can be used as a standalone application or a Java applet via the Web. The running sessions of the system are inter-linked with webpages of tutorials and reference pages to explain the facets, fabrication processes and material choices, and calculations and reasoning in selection are performed using process capability and material property data from a remote Web-based database and interactive knowledge base that can be maintained and updated via the Internet. The use of the developed system including operation scenario, use support, and integration with an MEMS collaborative design system is presented. Finally, an illustration example is provided.

An Overview of Cloud Implementation in the Manufacturing Process Life Cycle

NASA Astrophysics Data System (ADS)

Kassim, Noordiana; Yusof, Yusri; Hakim Mohamad, Mahmod Abd; Omar, Abdul Halim; Roslan, Rosfuzah; Aryanie Bahrudin, Ida; Ali, Mohd Hatta Mohamed

2017-08-01

The advancement of information and communication technology (ICT) has changed the structure and functions of various sectors and it has also started to play a significant role in modern manufacturing in terms of computerized machining and cloud manufacturing. It is important for industries to keep up with the current trend of ICT for them to be able survive and be competitive. Cloud manufacturing is an approach that wanted to realize a real-world manufacturing processes that will apply the basic concept from the field of Cloud computing to the manufacturing domain called Cloud-based manufacturing (CBM) or cloud manufacturing (CM). Cloud manufacturing has been recognized as a new paradigm for manufacturing businesses. In cloud manufacturing, manufacturing companies need to support flexible and scalable business processes in the shop floor as well as the software itself. This paper provides an insight or overview on the implementation of cloud manufacturing in the modern manufacturing processes and at the same times analyses the requirements needed regarding process enactment for Cloud manufacturing and at the same time proposing a STEP-NC concept that can function as a tool to support the cloud manufacturing concept.

3D model of filler melting with micro-beam plasma arc based on additive manufacturing technology

NASA Astrophysics Data System (ADS)

Chen, Weilin; Yang, Tao; Yang, Ruixin

2017-07-01

Additive manufacturing technology is a systematic process based on discrete-accumulation principle, which is derived by the dimension of parts. Aiming at the dimension mathematical model and slicing problems in additive manufacturing process, the constitutive relations between micro-beam plasma welding parameters and the dimension of part were investigated. The slicing algorithm and slicing were also studied based on the dimension characteristics. By using the direct slicing algorithm according to the geometric characteristics of model, a hollow thin-wall spherical part was fabricated by 3D additive manufacturing technology using micro-beam plasma.

Integrated Dynamic Process Planning and Scheduling in Flexible Manufacturing Systems via Autonomous Agents

NASA Astrophysics Data System (ADS)

Nejad, Hossein Tehrani Nik; Sugimura, Nobuhiro; Iwamura, Koji; Tanimizu, Yoshitaka

Process planning and scheduling are important manufacturing planning activities which deal with resource utilization and time span of manufacturing operations. The process plans and the schedules generated in the planning phase shall be modified in the execution phase due to the disturbances in the manufacturing systems. This paper deals with a multi-agent architecture of an integrated and dynamic system for process planning and scheduling for multi jobs. A negotiation protocol is discussed, in this paper, to generate the process plans and the schedules of the manufacturing resources and the individual jobs, dynamically and incrementally, based on the alternative manufacturing processes. The alternative manufacturing processes are presented by the process plan networks discussed in the previous paper, and the suitable process plans and schedules are searched and generated to cope with both the dynamic status and the disturbances of the manufacturing systems. We initiatively combine the heuristic search algorithms of the process plan networks with the negotiation protocols, in order to generate suitable process plans and schedules in the dynamic manufacturing environment. A simulation software has been developed to carry out case studies, aimed at verifying the performance of the proposed multi-agent architecture.

Holistic Context-Sensitivity for Run-Time Optimization of Flexible Manufacturing Systems.

PubMed

Scholze, Sebastian; Barata, Jose; Stokic, Dragan

2017-02-24

Highly flexible manufacturing systems require continuous run-time (self-) optimization of processes with respect to diverse parameters, e.g., efficiency, availability, energy consumption etc. A promising approach for achieving (self-) optimization in manufacturing systems is the usage of the context sensitivity approach based on data streaming from high amount of sensors and other data sources. Cyber-physical systems play an important role as sources of information to achieve context sensitivity. Cyber-physical systems can be seen as complex intelligent sensors providing data needed to identify the current context under which the manufacturing system is operating. In this paper, it is demonstrated how context sensitivity can be used to realize a holistic solution for (self-) optimization of discrete flexible manufacturing systems, by making use of cyber-physical systems integrated in manufacturing systems/processes. A generic approach for context sensitivity, based on self-learning algorithms, is proposed aiming at a various manufacturing systems. The new solution encompasses run-time context extractor and optimizer. Based on the self-learning module both context extraction and optimizer are continuously learning and improving their performance. The solution is following Service Oriented Architecture principles. The generic solution is developed and then applied to two very different manufacturing processes.

Holistic Context-Sensitivity for Run-Time Optimization of Flexible Manufacturing Systems

PubMed Central

Scholze, Sebastian; Barata, Jose; Stokic, Dragan

2017-01-01

Highly flexible manufacturing systems require continuous run-time (self-) optimization of processes with respect to diverse parameters, e.g., efficiency, availability, energy consumption etc. A promising approach for achieving (self-) optimization in manufacturing systems is the usage of the context sensitivity approach based on data streaming from high amount of sensors and other data sources. Cyber-physical systems play an important role as sources of information to achieve context sensitivity. Cyber-physical systems can be seen as complex intelligent sensors providing data needed to identify the current context under which the manufacturing system is operating. In this paper, it is demonstrated how context sensitivity can be used to realize a holistic solution for (self-) optimization of discrete flexible manufacturing systems, by making use of cyber-physical systems integrated in manufacturing systems/processes. A generic approach for context sensitivity, based on self-learning algorithms, is proposed aiming at a various manufacturing systems. The new solution encompasses run-time context extractor and optimizer. Based on the self-learning module both context extraction and optimizer are continuously learning and improving their performance. The solution is following Service Oriented Architecture principles. The generic solution is developed and then applied to two very different manufacturing processes. PMID:28245564

UOE Pipe Manufacturing Process Simulation: Equipment Designing and Construction

NASA Astrophysics Data System (ADS)

Delistoian, Dmitri; Chirchor, Mihael

2017-12-01

UOE pipe manufacturing process influence directly on pipeline resilience and operation capacity. At present most spreaded pipe manufacturing method is UOE. This method is based on cold forming. After each technological step appears a certain stress and strain level. For pipe stress strain study is designed and constructed special equipment that simulate entire technological process.UOE pipe equipment is dedicated for manufacturing of longitudinally submerged arc welded DN 400 (16 inch) steel pipe.

A Framework for Preliminary Design of Aircraft Structures Based on Process Information. Part 1

NASA Technical Reports Server (NTRS)

Rais-Rohani, Masoud

1998-01-01

This report discusses the general framework and development of a computational tool for preliminary design of aircraft structures based on process information. The described methodology is suitable for multidisciplinary design optimization (MDO) activities associated with integrated product and process development (IPPD). The framework consists of three parts: (1) product and process definitions; (2) engineering synthesis, and (3) optimization. The product and process definitions are part of input information provided by the design team. The backbone of the system is its ability to analyze a given structural design for performance as well as manufacturability and cost assessment. The system uses a database on material systems and manufacturing processes. Based on the identified set of design variables and an objective function, the system is capable of performing optimization subject to manufacturability, cost, and performance constraints. The accuracy of the manufacturability measures and cost models discussed here depend largely on the available data on specific methods of manufacture and assembly and associated labor requirements. As such, our focus in this research has been on the methodology itself and not so much on its accurate implementation in an industrial setting. A three-tier approach is presented for an IPPD-MDO based design of aircraft structures. The variable-complexity cost estimation methodology and an approach for integrating manufacturing cost assessment into design process are also discussed. This report is presented in two parts. In the first part, the design methodology is presented, and the computational design tool is described. In the second part, a prototype model of the preliminary design Tool for Aircraft Structures based on Process Information (TASPI) is described. Part two also contains an example problem that applies the methodology described here for evaluation of six different design concepts for a wing spar.

78 FR 17142 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-20

... Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food; Correction AGENCY... manufacturing, packing, or holding human food (CGMPs) to modernize it and to add requirements for domestic and... ``food-production purposes (i.e., manufacturing, processing, packing, and holding) to consistently use...

Data quality and processing for decision making: divergence between corporate strategy and manufacturing processes

NASA Astrophysics Data System (ADS)

McNeil, Ronald D.; Miele, Renato; Shaul, Dennis

2000-10-01

Information technology is driving improvements in manufacturing systems. Results are higher productivity and quality. However, corporate strategy is driven by a number of factors and includes data and pressure from multiple stakeholders, which includes employees, managers, executives, stockholders, boards, suppliers and customers. It is also driven by information about competitors and emerging technology. Much information is based on processing of data and the resulting biases of the processors. Thus, stakeholders can base inputs on faulty perceptions, which are not reality based. Prior to processing, data used may be inaccurate. Sources of data and information may include demographic reports, statistical analyses, intelligence reports (e.g., marketing data), technology and primary data collection. The reliability and validity of data as well as the management of sources and information is critical element to strategy formulation. The paper explores data collection, processing and analyses from secondary and primary sources, information generation and report presentation for strategy formulation and contrast this with data and information utilized to drive internal process such as manufacturing. The hypothesis is that internal process, such as manufacturing, are subordinate to corporate strategies. The impact of possible divergence in quality of decisions at the corporate level on IT driven, quality-manufacturing processes based on measurable outcomes is significant. Recommendations for IT improvements at the corporate strategy level are given.

Technology CAD for integrated circuit fabrication technology development and technology transfer

NASA Astrophysics Data System (ADS)

Saha, Samar

2003-07-01

In this paper systematic simulation-based methodologies for integrated circuit (IC) manufacturing technology development and technology transfer are presented. In technology development, technology computer-aided design (TCAD) tools are used to optimize the device and process parameters to develop a new generation of IC manufacturing technology by reverse engineering from the target product specifications. While in technology transfer to manufacturing co-location, TCAD is used for process centering with respect to high-volume manufacturing equipment of the target manufacturing equipment of the target manufacturing facility. A quantitative model is developed to demonstrate the potential benefits of the simulation-based methodology in reducing the cycle time and cost of typical technology development and technology transfer projects over the traditional practices. The strategy for predictive simulation to improve the effectiveness of a TCAD-based project, is also discussed.

Method for distributed agent-based non-expert simulation of manufacturing process behavior

DOEpatents

Ivezic, Nenad; Potok, Thomas E.

2004-11-30

A method for distributed agent based non-expert simulation of manufacturing process behavior on a single-processor computer comprises the steps of: object modeling a manufacturing technique having a plurality of processes; associating a distributed agent with each the process; and, programming each the agent to respond to discrete events corresponding to the manufacturing technique, wherein each discrete event triggers a programmed response. The method can further comprise the step of transmitting the discrete events to each agent in a message loop. In addition, the programming step comprises the step of conditioning each agent to respond to a discrete event selected from the group consisting of a clock tick message, a resources received message, and a request for output production message.

Economic assessment of single-walled carbon nanotube processes

NASA Astrophysics Data System (ADS)

Isaacs, J. A.; Tanwani, A.; Healy, M. L.; Dahlben, L. J.

2010-02-01

The carbon nanotube market is steadily growing and projected to reach 1.9 billion by 2010. This study examines the economics of manufacturing single-walled carbon nanotubes (SWNT) using process-based cost models developed for arc, CVD, and HiPco processes. Using assumed input parameters, manufacturing costs are calculated for 1 g SWNT for arc, CVD, and HiPco, totaling 1,906, 1,706, and 485, respectively. For each SWNT process, the synthesis and filtration steps showed the highest costs, with direct labor as a primary cost driver. Reductions in production costs are calculated for increased working hours per day and for increased synthesis reaction yield (SRY) in each process. The process-based cost models offer a means for exploring opportunities for cost reductions, and provide a structured system for comparisons among alternative SWNT manufacturing processes. Further, the models can be used to comprehensively evaluate additional scenarios on the economics of environmental, health, and safety best manufacturing practices.

Simulation based optimization on automated fibre placement process

NASA Astrophysics Data System (ADS)

Lei, Shi

2018-02-01

In this paper, a software simulation (Autodesk TruPlan & TruFiber) based method is proposed to optimize the automate fibre placement (AFP) process. Different types of manufacturability analysis are introduced to predict potential defects. Advanced fibre path generation algorithms are compared with respect to geometrically different parts. Major manufacturing data have been taken into consideration prior to the tool paths generation to achieve high success rate of manufacturing.

Mining manufacturing data for discovery of high productivity process characteristics.

PubMed

Charaniya, Salim; Le, Huong; Rangwala, Huzefa; Mills, Keri; Johnson, Kevin; Karypis, George; Hu, Wei-Shou

2010-06-01

Modern manufacturing facilities for bioproducts are highly automated with advanced process monitoring and data archiving systems. The time dynamics of hundreds of process parameters and outcome variables over a large number of production runs are archived in the data warehouse. This vast amount of data is a vital resource to comprehend the complex characteristics of bioprocesses and enhance production robustness. Cell culture process data from 108 'trains' comprising production as well as inoculum bioreactors from Genentech's manufacturing facility were investigated. Each run constitutes over one-hundred on-line and off-line temporal parameters. A kernel-based approach combined with a maximum margin-based support vector regression algorithm was used to integrate all the process parameters and develop predictive models for a key cell culture performance parameter. The model was also used to identify and rank process parameters according to their relevance in predicting process outcome. Evaluation of cell culture stage-specific models indicates that production performance can be reliably predicted days prior to harvest. Strong associations between several temporal parameters at various manufacturing stages and final process outcome were uncovered. This model-based data mining represents an important step forward in establishing a process data-driven knowledge discovery in bioprocesses. Implementation of this methodology on the manufacturing floor can facilitate a real-time decision making process and thereby improve the robustness of large scale bioprocesses. 2010 Elsevier B.V. All rights reserved.

Additive Manufacturing Design Considerations for Liquid Engine Components

NASA Technical Reports Server (NTRS)

Whitten, Dave; Hissam, Andy; Baker, Kevin; Rice, Darron

2014-01-01

The Marshall Space Flight Center's Propulsion Systems Department has gained significant experience in the last year designing, building, and testing liquid engine components using additive manufacturing. The department has developed valve, duct, turbo-machinery, and combustion device components using this technology. Many valuable lessons were learned during this process. These lessons will be the focus of this presentation. We will present criteria for selecting part candidates for additive manufacturing. Some part characteristics are 'tailor made' for this process. Selecting the right parts for the process is the first step to maximizing productivity gains. We will also present specific lessons we learned about feature geometry that can and cannot be produced using additive manufacturing machines. Most liquid engine components were made using a two-step process. The base part was made using additive manufacturing and then traditional machining processes were used to produce the final part. The presentation will describe design accommodations needed to make the base part and lessons we learned about which features could be built directly and which require the final machine process. Tolerance capabilities, surface finish, and material thickness allowances will also be covered. Additive Manufacturing can produce internal passages that cannot be made using traditional approaches. It can also eliminate a significant amount of manpower by reducing part count and leveraging model-based design and analysis techniques. Information will be shared about performance enhancements and design efficiencies we experienced for certain categories of engine parts.

A new chapter in pharmaceutical manufacturing: 3D-printed drug products.

PubMed

Norman, James; Madurawe, Rapti D; Moore, Christine M V; Khan, Mansoor A; Khairuzzaman, Akm

2017-01-01

FDA recently approved a 3D-printed drug product in August 2015, which is indicative of a new chapter for pharmaceutical manufacturing. This review article summarizes progress with 3D printed drug products and discusses process development for solid oral dosage forms. 3D printing is a layer-by-layer process capable of producing 3D drug products from digital designs. Traditional pharmaceutical processes, such as tablet compression, have been used for decades with established regulatory pathways. These processes are well understood, but antiquated in terms of process capability and manufacturing flexibility. 3D printing, as a platform technology, has competitive advantages for complex products, personalized products, and products made on-demand. These advantages create opportunities for improving the safety, efficacy, and accessibility of medicines. Although 3D printing differs from traditional manufacturing processes for solid oral dosage forms, risk-based process development is feasible. This review highlights how product and process understanding can facilitate the development of a control strategy for different 3D printing methods. Overall, the authors believe that the recent approval of a 3D printed drug product will stimulate continual innovation in pharmaceutical manufacturing technology. FDA encourages the development of advanced manufacturing technologies, including 3D-printing, using science- and risk-based approaches. Published by Elsevier B.V.

Integration Framework of Process Planning based on Resource Independent Operation Summary to Support Collaborative Manufacturing

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kulvatunyou, Boonserm; Wysk, Richard A.; Cho, Hyunbo

2004-06-01

In today's global manufacturing environment, manufacturing functions are distributed as never before. Design, engineering, fabrication, and assembly of new products are done routinely in many different enterprises scattered around the world. Successful business transactions require the sharing of design and engineering data on an unprecedented scale. This paper describes a framework that facilitates the collaboration of engineering tasks, particularly process planning and analysis, to support such globalized manufacturing activities. The information models of data and the software components that integrate those information models are described. The integration framework uses an Integrated Product and Process Data (IPPD) representation called a Resourcemore » Independent Operation Summary (RIOS) to facilitate the communication of business and manufacturing requirements. Hierarchical process modeling, process planning decomposition and an augmented AND/OR directed graph are used in this representation. The Resource Specific Process Planning (RSPP) module assigns required equipment and tools, selects process parameters, and determines manufacturing costs based on two-level hierarchical RIOS data. The shop floor knowledge (resource and process knowledge) and a hybrid approach (heuristic and linear programming) to linearize the AND/OR graph provide the basis for the planning. Finally, a prototype system is developed and demonstrated with an exemplary part. Java and XML (Extensible Markup Language) are used to ensure software and information portability.« less

MANTECH project book

NASA Astrophysics Data System (ADS)

The effective integration of processes, systems, and procedures used in the production of aerospace systems using computer technology is managed by the Integration Technology Division (MTI). Under its auspices are the Information Management Branch, which is actively involved with information management, information sciences and integration, and the Implementation Branch, whose technology areas include computer integrated manufacturing, engineering design, operations research, and material handling and assembly. The Integration Technology Division combines design, manufacturing, and supportability functions within the same organization. The Processing and Fabrication Division manages programs to improve structural and nonstructural materials processing and fabrication. Within this division, the Metals Branch directs the manufacturing methods program for metals and metal matrix composites processing and fabrication. The Nonmetals Branch directs the manufacturing methods programs, which include all manufacturing processes for producing and utilizing propellants, plastics, resins, fibers, composites, fluid elastomers, ceramics, glasses, and coatings. The objective of the Industrial Base Analysis Division is to act as focal point for the USAF industrial base program for productivity, responsiveness, and preparedness planning.

Dendritic cells for active immunotherapy: optimizing design and manufacture in order to develop commercially and clinically viable products.

PubMed

Nicolette, C A; Healey, D; Tcherepanova, I; Whelton, P; Monesmith, T; Coombs, L; Finke, L H; Whiteside, T; Miesowicz, F

2007-09-27

Dendritic cell (DC) active immunotherapy is potentially efficacious in a broad array of malignant disease settings. However, challenges remain in optimizing DC-based therapy for maximum clinical efficacy within manufacturing processes that permit quality control and scale-up of consistent products. In this review we discuss the critical issues that must be addressed in order to optimize DC-based product design and manufacture, and highlight the DC based platforms currently addressing these issues. Variables in DC-based product design include the type of antigenic payload used, DC maturation steps and activation processes, and functional assays. Issues to consider in development include: (a) minimizing the invasiveness of patient biological material collection; (b) minimizing handling and manipulations of tissue at the clinical site; (c) centralized product manufacturing and standardized processing and capacity for commercial-scale production; (d) rapid product release turnaround time; (e) the ability to manufacture sufficient product from limited starting material; and (f) standardized release criteria for DC phenotype and function. Improvements in the design and manufacture of DC products have resulted in a handful of promising leads currently in clinical development.

Manufacturing a Porous Structure According to the Process Parameters of Functional 3D Porous Polymer Printing Technology Based on a Chemical Blowing Agent

NASA Astrophysics Data System (ADS)

Yoo, C. J.; Shin, B. S.; Kang, B. S.; Yun, D. H.; You, D. B.; Hong, S. M.

2017-09-01

In this paper, we propose a new porous polymer printing technology based on CBA(chemical blowing agent), and describe the optimization process according to the process parameters. By mixing polypropylene (PP) and CBA, a hybrid CBA filament was manufactured; the diameter of the filament ranged between 1.60 mm and 1.75 mm. A porous polymer structure was manufactured based on the traditional fused deposition modelling (FDM) method. The process parameters of the three-dimensional (3D) porous polymer printing (PPP) process included nozzle temperature, printing speed, and CBA density. Porosity increase with an increase in nozzle temperature and CBA density. On the contrary, porosity increase with a decrease in the printing speed. For porous structures, it has excellent mechanical properties. We manufactured a simple shape in 3D using 3D PPP technology. In the future, we will study the excellent mechanical properties of 3D PPP technology and apply them to various safety fields.

Laser polishing of additive manufactured Ti alloys

NASA Astrophysics Data System (ADS)

Ma, C. P.; Guan, Y. C.; Zhou, W.

2017-06-01

Laser-based additive manufacturing has attracted much attention as a promising 3D printing method for metallic components in recent years. However, surface roughness of additive manufactured components has been considered as a challenge to achieve high performance. In this work, we demonstrate the capability of fiber laser in polishing rough surface of additive manufactured Ti-based alloys as Ti-6Al-4V and TC11. Both as-received surface and laser-polished surfaces as well as cross-section subsurfaces were analyzed carefully by White-Light Interference, Confocal Microscope, Focus Ion Beam, Scanning Electron Microscopy, Energy Dispersive Spectrometer, and X-ray Diffraction. Results revealed that as-received Ti-based alloys with surface roughness more than 5 μm could be reduce to less than 1 μm through laser polishing process. Moreover, microstructure, microhardness and wear resistance of laser-polished zone was investigated in order to examine the thermal effect of laser polishing processing on the substrate of additive manufactured Ti alloys. This proof-of-concept process has the potential to effectively improve the surface roughness of additive manufactured metallic alloy by local polishing method without damage to the substrate.

Biocompatibility of hydroxyapatite scaffolds processed by lithography-based additive manufacturing.

PubMed

Tesavibul, Passakorn; Chantaweroad, Surapol; Laohaprapanon, Apinya; Channasanon, Somruethai; Uppanan, Paweena; Tanodekaew, Siriporn; Chalermkarnnon, Prasert; Sitthiseripratip, Kriskrai

2015-01-01

The fabrication of hydroxyapatite scaffolds for bone tissue engineering applications by using lithography-based additive manufacturing techniques has been introduced due to the abilities to control porous structures with suitable resolutions. In this research, the use of hydroxyapatite cellular structures, which are processed by lithography-based additive manufacturing machine, as a bone tissue engineering scaffold was investigated. The utilization of digital light processing system for additive manufacturing machine in laboratory scale was performed in order to fabricate the hydroxyapatite scaffold, of which biocompatibilities were eventually evaluated by direct contact and cell-culturing tests. In addition, the density and compressive strength of the scaffolds were also characterized. The results show that the hydroxyapatite scaffold at 77% of porosity with 91% of theoretical density and 0.36 MPa of the compressive strength are able to be processed. In comparison with a conventionally sintered hydroxyapatite, the scaffold did not present any cytotoxic signs while the viability of cells at 95.1% was reported. After 14 days of cell-culturing tests, the scaffold was able to be attached by pre-osteoblasts (MC3T3-E1) leading to cell proliferation and differentiation. The hydroxyapatite scaffold for bone tissue engineering was able to be processed by the lithography-based additive manufacturing machine while the biocompatibilities were also confirmed.

Manufacturing with the Sun

NASA Astrophysics Data System (ADS)

Murphy, L. M.; Hauser, S. G.; Clyne, R. J.

1992-05-01

Concentrated solar radiation is now a viable alternative energy source for many advanced manufacturing processes. Researchers at the National Renewable Energy Laboratory (NREL) have demonstrated the feasibility of processes such as solar-induced surface transformation of materials (SISTM), solar-based manufacturing, and solar-pumped lasers. Researchers are also using sunlight to decontaminate water and soils polluted with organic compounds; these techniques could provide manufacturers with innovative alternatives to traditional methods of waste management. The solar technology that is now being integrated into today's manufacturing processes offers even greater potential for tomorrow, especially as applied to the radiation-abundant environment available in space and on the lunar surface.

Manufacturing with the Sun

NASA Astrophysics Data System (ADS)

Murphy, Lawrence M.; Hauser, Steven G.; Clyne, Richard J.

1991-12-01

Concentrated solar radiation is now a viable alternative source for many advanced manufacturing processes. Researchers at the National Renewable Energy Laboratory (NREL) have demonstrated the feasibility of processes such as solar induced surface transformation of materials (SISTM), solar based manufacturing, and solar pumped lasers. Researchers are also using sunlight to decontaminate water and soils polluted with organic compounds; these techniques could provide manufacturers with innovative alternatives to traditional methods of waste management. The solar technology that is now being integrated into today's manufacturing processes offer greater potential for tomorrow, especially as applied to the radiation abundant environment available in space and on the lunar surface.

Manufacturing with the Sun

NASA Technical Reports Server (NTRS)

Murphy, Lawrence M.; Hauser, Steven G.; Clyne, Richard J.

1991-01-01

Concentrated solar radiation is now a viable alternative source for many advanced manufacturing processes. Researchers at the National Renewable Energy Laboratory (NREL) have demonstrated the feasibility of processes such as solar induced surface transformation of materials (SISTM), solar based manufacturing, and solar pumped lasers. Researchers are also using sunlight to decontaminate water and soils polluted with organic compounds; these techniques could provide manufacturers with innovative alternatives to traditional methods of waste management. The solar technology that is now being integrated into today's manufacturing processes offer greater potential for tomorrow, especially as applied to the radiation abundant environment available in space and on the lunar surface.

Mechanical properties of sheet metal components with local reinforcement produced by additive manufacturing

NASA Astrophysics Data System (ADS)

Ünsal, Ismail; Hama-Saleh, R.; Sviridov, Alexander; Bambach, Markus; Weisheit, A.; Schleifenbaum, J. H.

2018-05-01

New technological challenges like electro-mobility pose an increasing demand for cost-efficient processes for the production of product variants. This demand opens the possibility to combine established die-based manufacturing methods and innovative, dieless technologies like additive manufacturing [1, 2]. In this context, additive manufacturing technologies allow for the weight-efficient local reinforcement of parts before and after forming, enabling manufacturers to produce product variants from series parts [3]. Previous work by the authors shows that the optimal shape of the reinforcing structure can be determined using sizing optimization. Sheet metal parts can then be reinforced using laser metal deposition. The material used is a pearlite-reduced, micro-alloyed steel (ZE 630). The aim of this paper is to determine the effect of the additive manufacturing process on the material behavior and the mechanical properties of the base material and the resulting composite material. The parameters of the AM process are optimized to reach similar material properties in the base material and the build-up volume. A metallographic analysis of the parts is presented, where the additive layers, the base material and also the bonding between the additive layers and the base material are analyzed. The paper shows the feasibility of the approach and details the resulting mechanical properties and performance.

Ramp Technology and Intelligent Processing in Small Manufacturing

NASA Technical Reports Server (NTRS)

Rentz, Richard E.

1992-01-01

To address the issues of excessive inventories and increasing procurement lead times, the Navy is actively pursuing flexible computer integrated manufacturing (FCIM) technologies, integrated by communication networks to respond rapidly to its requirements for parts. The Rapid Acquisition of Manufactured Parts (RAMP) program, initiated in 1986, is an integral part of this effort. The RAMP program's goal is to reduce the current average production lead times experienced by the Navy's inventory control points by a factor of 90 percent. The manufacturing engineering component of the RAMP architecture utilizes an intelligent processing technology built around a knowledge-based shell provided by ICAD, Inc. Rules and data bases in the software simulate an expert manufacturing planner's knowledge of shop processes and equipment. This expert system can use Product Data Exchange using STEP (PDES) data to determine what features the required part has, what material is required to manufacture it, what machines and tools are needed, and how the part should be held (fixtured) for machining, among other factors. The program's rule base then indicates, for example, how to make each feature, in what order to make it, and to which machines on the shop floor the part should be routed for processing. This information becomes part of the shop work order. The process planning function under RAMP greatly reduces the time and effort required to complete a process plan. Since the PDES file that drives the intelligent processing is 100 percent complete and accurate to start with, the potential for costly errors is greatly diminished.

Ramp technology and intelligent processing in small manufacturing

NASA Astrophysics Data System (ADS)

Rentz, Richard E.

1992-04-01

To address the issues of excessive inventories and increasing procurement lead times, the Navy is actively pursuing flexible computer integrated manufacturing (FCIM) technologies, integrated by communication networks to respond rapidly to its requirements for parts. The Rapid Acquisition of Manufactured Parts (RAMP) program, initiated in 1986, is an integral part of this effort. The RAMP program's goal is to reduce the current average production lead times experienced by the Navy's inventory control points by a factor of 90 percent. The manufacturing engineering component of the RAMP architecture utilizes an intelligent processing technology built around a knowledge-based shell provided by ICAD, Inc. Rules and data bases in the software simulate an expert manufacturing planner's knowledge of shop processes and equipment. This expert system can use Product Data Exchange using STEP (PDES) data to determine what features the required part has, what material is required to manufacture it, what machines and tools are needed, and how the part should be held (fixtured) for machining, among other factors. The program's rule base then indicates, for example, how to make each feature, in what order to make it, and to which machines on the shop floor the part should be routed for processing. This information becomes part of the shop work order. The process planning function under RAMP greatly reduces the time and effort required to complete a process plan. Since the PDES file that drives the intelligent processing is 100 percent complete and accurate to start with, the potential for costly errors is greatly diminished.

Process-based tolerance assessment of connecting rod machining process

NASA Astrophysics Data System (ADS)

Sharma, G. V. S. S.; Rao, P. Srinivasa; Surendra Babu, B.

2016-06-01

Process tolerancing based on the process capability studies is the optimistic and pragmatic approach of determining the manufacturing process tolerances. On adopting the define-measure-analyze-improve-control approach, the process potential capability index ( C p) and the process performance capability index ( C pk) values of identified process characteristics of connecting rod machining process are achieved to be greater than the industry benchmark of 1.33, i.e., four sigma level. The tolerance chain diagram methodology is applied to the connecting rod in order to verify the manufacturing process tolerances at various operations of the connecting rod manufacturing process. This paper bridges the gap between the existing dimensional tolerances obtained via tolerance charting and process capability studies of the connecting rod component. Finally, the process tolerancing comparison has been done by adopting a tolerance capability expert software.

Knowledge-Based Manufacturing and Structural Design for a High Speed Civil Transport

NASA Technical Reports Server (NTRS)

Marx, William J.; Mavris, Dimitri N.; Schrage, Daniel P.

1994-01-01

The aerospace industry is currently addressing the problem of integrating manufacturing and design. To address the difficulties associated with using many conventional procedural techniques and algorithms, one feasible way to integrate the two concepts is with the development of an appropriate Knowledge-Based System (KBS). The authors present their reasons for selecting a KBS to integrate design and manufacturing. A methodology for an aircraft producibility assessment is proposed, utilizing a KBS for manufacturing process selection, that addresses both procedural and heuristic aspects of designing and manufacturing of a High Speed Civil Transport (HSCT) wing. A cost model is discussed that would allow system level trades utilizing information describing the material characteristics as well as the manufacturing process selections. Statements of future work conclude the paper.

Article and process for producing an article

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lacy, Benjamin Paul; Jacala, Ariel Caesar Prepena; Kottilingam, Srikanth Chandrudu

An article and a process of producing an article are provided. The article includes a base material, a cooling feature arrangement positioned on the base material, the cooling feature arrangement including an additive-structured material, and a cover material. The cooling feature arrangement is between the base material and the cover material. The process of producing the article includes manufacturing a cooling feature arrangement by an additive manufacturing technique, and then positioning the cooling feature arrangement between a base material and a cover material.

3D Printing, Additive Manufacturing, and Solid Freeform Fabrication: The Technologies of the Past, Present and Future

NASA Astrophysics Data System (ADS)

Beaman, Joseph

2015-03-01

Starting in the late 1980's, several new technologies were created that have the potential to revolutionize manufacturing. These technologies are, for the most part, additive processes that build up parts layer by layer. In addition, the processes that are being touted for hard-core manufacturing are primarily laser or e-beam based processes. This presentation gives a brief history of Additive Manufacturing and gives an assessment for these technologies. These technologies initially grew out of a commercial need for rapid prototyping. This market has a different requirement for process and quality control than traditional manufacturing. The relatively poor process control of the existing commercial Additive Manufacturing equipment is a vestige of this history. This presentation discusses this history and improvements in quality over time. The emphasis will be on Additive Manufacturing processes that are being considered for direct manufacturing, which is a different market than the 3D Printing ``Makerbot'' market. Topics discussed include past and present machine sensors, materials, and operational methods that were used in the past and those that are used today to create manufactured parts. Finally, a discussion of new methods and future directions of AM is presented.

Computer-Based Automation of Discrete Product Manufacture: A preliminary Discussion of Feasibility and Impact

DTIC Science & Technology

1974-07-01

automated manufacturing processes and a rough technoeconomic evaluation of those concepts. Our evaluation is largely based on estimates; therefore, the...must be subjected to thorough analysis and experimental verification before they can be considered definitive. They are being published at this time...hardware and sensor technology, manufacturing engineering, automation, and economic analysis . Members of this team inspected over thirty manufacturing

An Overview of Ni Base Additive Fabrication Technologies for Aerospace Applications (Preprint)

DTIC Science & Technology

2011-03-01

fusion welding processes that have the ability to add filler material can be used as additive manufacturing processes . The majority of the work in the...Laser Additive Manufacturing (LAM) The LAM process uses a conventional laser welding heat source (CO2 or solid state laser) combined with a...wrought properties. The LAM process typically has a lower deposition rate (0.5 – 10 lbs/hr) compared to EB, PTA or TIG based processes , although as

On-line application of near-infrared spectroscopy for monitoring water levels in parts per million in a manufacturing-scale distillation process.

PubMed

Lambertus, Gordon; Shi, Zhenqi; Forbes, Robert; Kramer, Timothy T; Doherty, Steven; Hermiller, James; Scully, Norma; Wong, Sze Wing; LaPack, Mark

2014-01-01

An on-line analytical method based on transmission near-infrared spectroscopy (NIRS) for the quantitative determination of water concentrations (in parts per million) was developed and applied to the manufacture of a pharmaceutical intermediate. Calibration models for water analysis, built at the development site and applied at the manufacturing site, were successfully demonstrated during six manufacturing runs at a 250-gallon scale. The water measurements will be used as a forward-processing control point following distillation of a toluene product solution prior to use in a Grignard reaction. The most significant impact of using this NIRS-based process analytical technology (PAT) to replace off-line measurements is the significant reduction in the risk of operator exposure through the elimination of sampling of a severely lachrymatory and mutagenic compound. The work described in this report illustrates the development effort from proof-of-concept phase to manufacturing implementation.

Feedstock powder processing research needs for additive manufacturing development

DOE PAGES

Anderson, Iver E.; White, Emma M. H.; Dehoff, Ryan

2018-02-01

Additive manufacturing (AM) promises to redesign traditional manufacturing by enabling the ultimate in agility for rapid component design changes in commercial products and for fabricating complex integrated parts. Here, by significantly increasing quality and yield of metallic alloy powders, the pace for design, development, and deployment of the most promising AM approaches can be greatly accelerated, resulting in rapid commercialization of these advanced manufacturing methods. By successful completion of a critical suite of processing research tasks that are intended to greatly enhance gas atomized powder quality and the precision and efficiency of powder production, researchers can help promote continued rapidmore » growth of AM. Finally, other powder-based or spray-based advanced manufacturing methods could also benefit from these research outcomes, promoting the next wave of sustainable manufacturing technologies for conventional and advanced materials.« less

Feedstock powder processing research needs for additive manufacturing development

DOE Office of Scientific and Technical Information (OSTI.GOV)

Anderson, Iver E.; White, Emma M. H.; Dehoff, Ryan

Additive manufacturing (AM) promises to redesign traditional manufacturing by enabling the ultimate in agility for rapid component design changes in commercial products and for fabricating complex integrated parts. Here, by significantly increasing quality and yield of metallic alloy powders, the pace for design, development, and deployment of the most promising AM approaches can be greatly accelerated, resulting in rapid commercialization of these advanced manufacturing methods. By successful completion of a critical suite of processing research tasks that are intended to greatly enhance gas atomized powder quality and the precision and efficiency of powder production, researchers can help promote continued rapidmore » growth of AM. Finally, other powder-based or spray-based advanced manufacturing methods could also benefit from these research outcomes, promoting the next wave of sustainable manufacturing technologies for conventional and advanced materials.« less

All-inkjet-printed thin-film transistors: manufacturing process reliability by root cause analysis.

PubMed

Sowade, Enrico; Ramon, Eloi; Mitra, Kalyan Yoti; Martínez-Domingo, Carme; Pedró, Marta; Pallarès, Jofre; Loffredo, Fausta; Villani, Fulvia; Gomes, Henrique L; Terés, Lluís; Baumann, Reinhard R

2016-09-21

We report on the detailed electrical investigation of all-inkjet-printed thin-film transistor (TFT) arrays focusing on TFT failures and their origins. The TFT arrays were manufactured on flexible polymer substrates in ambient condition without the need for cleanroom environment or inert atmosphere and at a maximum temperature of 150 °C. Alternative manufacturing processes for electronic devices such as inkjet printing suffer from lower accuracy compared to traditional microelectronic manufacturing methods. Furthermore, usually printing methods do not allow the manufacturing of electronic devices with high yield (high number of functional devices). In general, the manufacturing yield is much lower compared to the established conventional manufacturing methods based on lithography. Thus, the focus of this contribution is set on a comprehensive analysis of defective TFTs printed by inkjet technology. Based on root cause analysis, we present the defects by developing failure categories and discuss the reasons for the defects. This procedure identifies failure origins and allows the optimization of the manufacturing resulting finally to a yield improvement.

Volatile organic compound (VOC) emissions during malting and beer manufacture

NASA Astrophysics Data System (ADS)

Gibson, Nigel B.; Costigan, Gavin T.; Swannell, Richard P. J.; Woodfield, Michael J.

Estimates have been made of the amounts of volatile organic compounds (VOCs) released during different stages of beer manufacture. The estimates are based on recent measurements and plant specification data supplied by manufacturers. Data were obtained for three main manufacturing processes (malting, wort processing and fermentation) for three commercial beer types. Some data on the speciation of emitted compounds have been obtained. Based on these measurements, an estimate of the total unabated VOC emission. from the U.K. brewing industry was calculated as 3.5 kta -1, over 95% of which was generated during barley malting. This value does not include any correction for air pollution control.

A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms.

PubMed

Leane, Michael; Pitt, Kendal; Reynolds, Gavin

2015-01-01

This paper proposes the development of a drug product Manufacturing Classification System (MCS) based on processing route. It summarizes conclusions from a dedicated APS conference and subsequent discussion within APS focus groups and the MCS working party. The MCS is intended as a tool for pharmaceutical scientists to rank the feasibility of different processing routes for the manufacture of oral solid dosage forms, based on selected properties of the API and the needs of the formulation. It has many applications in pharmaceutical development, in particular, it will provide a common understanding of risk by defining what the "right particles" are, enable the selection of the best process, and aid subsequent transfer to manufacturing. The ultimate aim is one of prediction of product developability and processability based upon previous experience. This paper is intended to stimulate contribution from a broad range of stakeholders to develop the MCS concept further and apply it to practice. In particular, opinions are sought on what API properties are important when selecting or modifying materials to enable an efficient and robust pharmaceutical manufacturing process. Feedback can be given by replying to our dedicated e-mail address (mcs@apsgb.org); completing the survey on our LinkedIn site; or by attending one of our planned conference roundtable sessions.

Automated manufacturing process for DEAP stack-actuators

NASA Astrophysics Data System (ADS)

Tepel, Dominik; Hoffstadt, Thorben; Maas, Jürgen

2014-03-01

Dielectric elastomers (DE) are thin polymer films belonging to the class of electroactive polymers (EAP), which are coated with compliant and conductive electrodes on each side. Due to the influence of an electrical field, dielectric elastomers perform a large amount of deformation. In this contribution a manufacturing process of automated fabricated stack-actuators based on dielectric electroactive polymers (DEAP) are presented. First of all the specific design of the considered stack-actuator is explained and afterwards the development, construction and realization of an automated manufacturing process is presented in detail. By applying this automated process, stack-actuators with reproducible and homogeneous properties can be manufactured. Finally, first DEAP actuator modules fabricated by the mentioned process are validated experimentally.

Space Manufacturing: The Next Great Challenge

NASA Technical Reports Server (NTRS)

Whitaker, Ann F.; Curreri, Peter; Sharpe, Jonathan B.; Colberg, Wendell R.; Vickers, John H.

1998-01-01

Space manufacturing encompasses the research, development and manufacture necessary for the production of any product to be used in near zero gravity, and the production of spacecraft required for transporting research or production devices to space. Manufacturing for space, and manufacturing in space will require significant breakthroughs in materials and manufacturing technology, as well as in equipment designs. This report reviews some of the current initiatives in achieving space manufacturing. The first initiative deals with materials processing in space, e.g., processing non-terrestrial and terrestrial materials, especially metals. Some of the ramifications of the United States Microgravity Payloads fourth (USMP-4) mission are discussed. Some problems in non-terrestrial materials processing are mentioned. The second initiative is structures processing in space. In order to accomplish this, the International Space Welding Experiment was designed to demonstrate welding technology in near-zero gravity. The third initiative is advancements in earth-based manufacturing technologies necessary to achieve low cost access to space. The advancements discussed include development of lightweight material having high specific strength, and automated fabrication and manufacturing methods for these materials.

Production process stability - core assumption of INDUSTRY 4.0 concept

NASA Astrophysics Data System (ADS)

Chromjakova, F.; Bobak, R.; Hrusecka, D.

2017-06-01

Today’s industrial enterprises are confronted by implementation of INDUSTRY 4.0 concept with basic problem - stabilised manufacturing and supporting processes. Through this phenomenon of stabilisation, they will achieve positive digital management of both processes and continuously throughput. There is required structural stability of horizontal (business) and vertical (digitized) manufacturing processes, supported through digitalised technologies of INDUSTRY 4.0 concept. Results presented in this paper based on the research results and survey realised in more industrial companies. Following will described basic model for structural process stabilisation in manufacturing environment.

Development of a Design Supporting System for Nano-Materials based on a Framework for Integrated Knowledge of Functioning-Manufacturing Process

NASA Astrophysics Data System (ADS)

Tarumi, Shinya; Kozaki, Kouji; Kitamura, Yoshinobu; Mizoguchi, Riichiro

In the recent materials research, much work aims at realization of ``functional materials'' by changing structure and/or manufacturing process with nanotechnology. However, knowledge about the relationship among function, structure and manufacturing process is not well organized. So, material designers have to consider a lot of things at the same time. It would be very helpful for them to support their design process by a computer system. In this article, we discuss a conceptual design supporting system for nano-materials. Firstly, we consider a framework for representing functional structures and manufacturing processes of nano-materials with relationships among them. We expand our former framework for representing functional knowledge based on our investigation through discussion with experts of nano-materials. The extended framework has two features: 1) it represents functional structures and manufacturing processes comprehensively, 2) it expresses parameters of function and ways with their dependencies because they are important for material design. Next, we describe a conceptual design support system we developed based on the framework with its functionalities. Lastly, we evaluate the utility of our system in terms of functionality for design supports. For this purpose, we tried to represent two real examples of material design. And then we did an evaluation experiment on conceptual design of material using our system with the collaboration of domain experts.

Dropwise additive manufacturing of pharmaceutical products for melt-based dosage forms.

PubMed

Içten, Elçin; Giridhar, Arun; Taylor, Lynne S; Nagy, Zoltan K; Reklaitis, Gintaras V

2015-05-01

The US Food and Drug Administration introduced the quality by design approach and process analytical technology guidance to encourage innovation and efficiency in pharmaceutical development, manufacturing, and quality assurance. As part of this renewed emphasis on the improvement of manufacturing, the pharmaceutical industry has begun to develop more efficient production processes with more intensive use of online measurement and sensing, real-time quality control, and process control tools. Here, we present dropwise additive manufacturing of pharmaceutical products (DAMPP) as an alternative to conventional pharmaceutical manufacturing methods. This mini-manufacturing process for the production of pharmaceuticals utilizes drop on demand printing technology for automated and controlled deposition of melt-based formulations onto edible substrates. The advantages of drop-on-demand technology, including reproducible production of small droplets, adjustable drop sizing, high placement accuracy, and flexible use of different formulations, enable production of individualized dosing even for low-dose and high-potency drugs. In this work, DAMPP is used to produce solid oral dosage forms from hot melts of an active pharmaceutical ingredient and a polymer. The dosage forms are analyzed to show the reproducibility of dosing and the dissolution behavior of different formulations. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

Industrial based volume manufacturing of lightweight aluminium alloy panel components with high-strength and complex-shape for car body and chassis structures

NASA Astrophysics Data System (ADS)

Anyasodor, Gerald; Koroschetz, Christian

2017-09-01

To achieve the high volume manufacture of lightweight passenger cars at economic cost as required in the automotive industry, low density materials and new process route will be needed. While high strength aluminium alloy grades: AA7075 and AA6082 may provide the alternative material solution, hot stamping process used for high-strength and ultrahigh strength steels such as boron steel 22mnb5 can enable the volume manufacture of panel components with high-strength and complex-shape for car body and chassis structures. These aluminium alloy grades can be used to manufacture panel components with possible yield strengths ≥ 500 MPa. Due to the differences in material behaviors, hot stamping process of 22mnb5 cannot be directly applied to high strength aluminium alloy grades. Despite recorded successes in laboratories, researches and niche hot forming processes of high strength aluminium alloy grades, not much have been achieved for adequate and efficient volume manufacturing system applicable in the automotive industry. Due to lack of such system and based on expert knowledge in hot stamping production-line, AP&T presents in this paper a hot stamping processing route for high strength aluminium alloys been suitable for production-line development and volume manufacturing.

Selective laser melting of Inconel super alloy-a review

NASA Astrophysics Data System (ADS)

Karia, M. C.; Popat, M. A.; Sangani, K. B.

2017-07-01

Additive manufacturing is a relatively young technology that uses the principle of layer by layer addition of material in solid, liquid or powder form to develop a component or product. The quality of additive manufactured part is one of the challenges to be addressed. Researchers are continuously working at various levels of additive manufacturing technologies. One of the significant powder bed processes for met als is Selective Laser Melting (SLM). Laser based processes are finding more attention of researchers and industrial world. The potential of this technique is yet to be fully explored. Due to very high strength and creep resistance Inconel is extensively used nickel based super alloy for manufacturing components for aerospace, automobile and nuclear industries. Due to law content of Aluminum and Titanium, it exhibits good fabricability too. Therefore the alloy is ideally suitable for selective laser melting to manufacture intricate components with high strength requirements. The selection of suitable process for manufacturing for a specific component depends on geometrical complexity, production quantity, and cost and required strength. There are numerous researchers working on various aspects like metallurgical and micro structural investigations and mechanical properties, geometrical accuracy, effects of process parameters and its optimization and mathematical modeling etc. The present paper represents a comprehensive overview of selective laser melting process for Inconel group of alloys.

A factory concept for processing and manufacturing with lunar material

NASA Technical Reports Server (NTRS)

Driggers, G. W.

1977-01-01

A conceptual design for an orbital factory sized to process 1.5 million metric tons per year of raw lunar fines into 0.3 million metric tons of manufacturing materials is presented. A conservative approach involving application of present earth-based technology leads to a design devoid of new inventions. Earth based counterparts to the factory machinery were used to generate subsystem masses and lumped parameters for volume and mass estimates. The results are considered to be conservative since technologies more advanced than those assumed are presently available in many areas. Some attributes of potential space processing technologies applied to material refinement and component manufacture are discussed.

Transforming nanomedicine manufacturing toward Quality by Design and microfluidics.

PubMed

Colombo, Stefano; Beck-Broichsitter, Moritz; Bøtker, Johan Peter; Malmsten, Martin; Rantanen, Jukka; Bohr, Adam

2018-04-05

Nanopharmaceuticals aim at translating the unique features of nano-scale materials into therapeutic products and consequently their development relies critically on the progression in manufacturing technology to allow scalable processes complying with process economy and quality assurance. The relatively high failure rate in translational nanopharmaceutical research and development, with respect to new products on the market, is at least partly due to immature bottom-up manufacturing development and resulting sub-optimal control of quality attributes in nanopharmaceuticals. Recently, quality-oriented manufacturing of pharmaceuticals has undergone an unprecedented change toward process and product development interaction. In this context, Quality by Design (QbD) aims to integrate product and process development resulting in an increased number of product applications to regulatory agencies and stronger proprietary defense strategies of process-based products. Although QbD can be applied to essentially any production approach, microfluidic production offers particular opportunities for QbD-based manufacturing of nanopharmaceuticals. Microfluidics provides unique design flexibility, process control and parameter predictability, and also offers ample opportunities for modular production setups, allowing process feedback for continuously operating production and process control. The present review aims at outlining emerging opportunities in the synergistic implementation of QbD strategies and microfluidic production in contemporary development and manufacturing of nanopharmaceuticals. In doing so, aspects of design and development, but also technology management, are reviewed, as is the strategic role of these tools for aligning nanopharmaceutical innovation, development, and advanced industrialization in the broader pharmaceutical field. Copyright © 2018 Elsevier B.V. All rights reserved.

Additive Manufacturing of Nickel Superalloys: Opportunities for Innovation and Challenges Related to Qualification

NASA Astrophysics Data System (ADS)

Babu, S. S.; Raghavan, N.; Raplee, J.; Foster, S. J.; Frederick, C.; Haines, M.; Dinwiddie, R.; Kirka, M. K.; Plotkowski, A.; Lee, Y.; Dehoff, R. R.

2018-06-01

Innovative designs for turbines can be achieved by advances in nickel-based superalloys and manufacturing methods, including the adoption of additive manufacturing. In this regard, selective electron beam melting (SEBM) and selective laser melting (SLM) of nickel-based superalloys do provide distinct advantages. Furthermore, the direct energy deposition (DED) processes can be used for repair and reclamation of nickel alloy components. The current paper explores opportunities for innovation and qualification challenges with respect to deployment of AM as a disruptive manufacturing technology. In the first part of the paper, fundamental correlations of processing parameters to defect tendency and microstructure evolution will be explored using DED process. In the second part of the paper, opportunities for innovation in terms of site-specific control of microstructure during processing will be discussed. In the third part of the paper, challenges in qualification of AM parts for service will be discussed and potential methods to alleviate these issues through in situ process monitoring, and big data analytics are proposed.

Scale-up of 2G wire manufacturing at American Superconductor Corporation

NASA Astrophysics Data System (ADS)

Fleshler, S.; Buczek, D.; Carter, B.; Cedrone, P.; DeMoranville, K.; Gannon, J.; Inch, J.; Li, X.; Lynch, J.; Otto, A.; Podtburg, E.; Roy, D.; Rupich, M.; Sathyamurthy, S.; Schreiber, J.; Thieme, C.; Thompson, E.; Tucker, D.; Nagashima, K.; Ogata, M.

2009-10-01

American Superconductor Corporation (AMSC) has developed the base technology and a manufacturing line for initial volume production of low-cost second generation high temperature superconductor (2G HTS) wire for commercial and military applications. The manufacturing line is based on reel-to-reel processing of wide HTS strips using rolling assisted bi-axially textured substrate (RABiTS™) for the template and Metal Organic Deposition (MOD) for the HTS layer. AMSC’s wide strip process is a low cost manufacturing technology since multiple wires are produced in a single manufacturing pass by slitting the wide strip to narrower width in the last stage of the manufacturing process. Industry standard 4.4 mm wide wires are produced by laminating metallic foils, such as copper, stainless steel or any other material, to the HTS insert wire, and are chosen to tailor the electrical, thermal and mechanical properties of the wire for specific applications. The laminated, 4.4 mm wide wires are known as “344 superconductors.” In this paper, we summarize the status of AMSC’s manufacturing capability, the performance of the wire presently being produced, as well as the cost and technical advantages of AMSC’s manufacturing approach. In addition, future direction for research and development to improve electrical performance is presented.

Additive Manufacturing in Production: A Study Case Applying Technical Requirements

NASA Astrophysics Data System (ADS)

Ituarte, Iñigo Flores; Coatanea, Eric; Salmi, Mika; Tuomi, Jukka; Partanen, Jouni

Additive manufacturing (AM) is expanding the manufacturing capabilities. However, quality of AM produced parts is dependent on a number of machine, geometry and process parameters. The variability of these parameters affects the manufacturing drastically and therefore standardized processes and harmonized methodologies need to be developed to characterize the technology for end use applications and enable the technology for manufacturing. This research proposes a composite methodology integrating Taguchi Design of Experiments, multi-objective optimization and statistical process control, to optimize the manufacturing process and fulfil multiple requirements imposed to an arbitrary geometry. The proposed methodology aims to characterize AM technology depending upon manufacturing process variables as well as to perform a comparative assessment of three AM technologies (Selective Laser Sintering, Laser Stereolithography and Polyjet). Results indicate that only one machine, laser-based Stereolithography, was feasible to fulfil simultaneously macro and micro level geometrical requirements but mechanical properties were not at required level. Future research will study a single AM system at the time to characterize AM machine technical capabilities and stimulate pre-normative initiatives of the technology for end use applications.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tate, John G.; Richardson, Bradley S.; Love, Lonnie J.

ORNL worked with the Schaeffler Group USA to explore additive manufacturing techniques that might be appropriate for prototyping of bearing cages. Multiple additive manufacturing techniques were investigated, including e-beam, binder jet and multiple laser based processes. The binder jet process worked best for the thin, detailed cages printed.

Application of agent-based system for bioprocess description and process improvement.

PubMed

Gao, Ying; Kipling, Katie; Glassey, Jarka; Willis, Mark; Montague, Gary; Zhou, Yuhong; Titchener-Hooker, Nigel J

2010-01-01

Modeling plays an important role in bioprocess development for design and scale-up. Predictive models can also be used in biopharmaceutical manufacturing to assist decision-making either to maintain process consistency or to identify optimal operating conditions. To predict the whole bioprocess performance, the strong interactions present in a processing sequence must be adequately modeled. Traditionally, bioprocess modeling considers process units separately, which makes it difficult to capture the interactions between units. In this work, a systematic framework is developed to analyze the bioprocesses based on a whole process understanding and considering the interactions between process operations. An agent-based approach is adopted to provide a flexible infrastructure for the necessary integration of process models. This enables the prediction of overall process behavior, which can then be applied during process development or once manufacturing has commenced, in both cases leading to the capacity for fast evaluation of process improvement options. The multi-agent system comprises a process knowledge base, process models, and a group of functional agents. In this system, agent components co-operate with each other in performing their tasks. These include the description of the whole process behavior, evaluating process operating conditions, monitoring of the operating processes, predicting critical process performance, and providing guidance to decision-making when coping with process deviations. During process development, the system can be used to evaluate the design space for process operation. During manufacture, the system can be applied to identify abnormal process operation events and then to provide suggestions as to how best to cope with the deviations. In all cases, the function of the system is to ensure an efficient manufacturing process. The implementation of the agent-based approach is illustrated via selected application scenarios, which demonstrate how such a framework may enable the better integration of process operations by providing a plant-wide process description to facilitate process improvement. Copyright 2009 American Institute of Chemical Engineers

All-inkjet-printed thin-film transistors: manufacturing process reliability by root cause analysis

PubMed Central

Sowade, Enrico; Ramon, Eloi; Mitra, Kalyan Yoti; Martínez-Domingo, Carme; Pedró, Marta; Pallarès, Jofre; Loffredo, Fausta; Villani, Fulvia; Gomes, Henrique L.; Terés, Lluís; Baumann, Reinhard R.

2016-01-01

We report on the detailed electrical investigation of all-inkjet-printed thin-film transistor (TFT) arrays focusing on TFT failures and their origins. The TFT arrays were manufactured on flexible polymer substrates in ambient condition without the need for cleanroom environment or inert atmosphere and at a maximum temperature of 150 °C. Alternative manufacturing processes for electronic devices such as inkjet printing suffer from lower accuracy compared to traditional microelectronic manufacturing methods. Furthermore, usually printing methods do not allow the manufacturing of electronic devices with high yield (high number of functional devices). In general, the manufacturing yield is much lower compared to the established conventional manufacturing methods based on lithography. Thus, the focus of this contribution is set on a comprehensive analysis of defective TFTs printed by inkjet technology. Based on root cause analysis, we present the defects by developing failure categories and discuss the reasons for the defects. This procedure identifies failure origins and allows the optimization of the manufacturing resulting finally to a yield improvement. PMID:27649784

RTD-based Material Tracking in a Fully-Continuous Dry Granulation Tableting Line.

PubMed

Martinetz, M C; Karttunen, A-P; Sacher, S; Wahl, P; Ketolainen, J; Khinast, J G; Korhonen, O

2018-06-06

Continuous manufacturing (CM) offers quality and cost-effectiveness benefits over currently dominating batch processing. One challenge that needs to be addressed when implementing CM is traceability of materials through the process, which is needed for the batch/lot definition and control strategy. In this work the residence time distributions (RTD) of single unit operations (blender, roller compactor and tablet press) of a continuous dry granulation tableting line were captured with NIR based methods at selected mass flow rates to create training data. RTD models for continuous operated unit operations and the entire line were developed based on transfer functions. For semi-continuously operated bucket conveyor and pneumatic transport an assumption based the operation frequency was used. For validation of the parametrized process model, a pre-defined API step change and its propagation through the manufacturing line was computed and compared to multi-scale experimental runs conducted with the fully assembled continuous operated manufacturing line. This novel approach showed a very good prediction power at the selected mass flow rates for a complete continuous dry granulation line. Furthermore, it shows and proves the capabilities of process simulation as a tool to support development and control of pharmaceutical manufacturing processes. Copyright © 2018. Published by Elsevier B.V.

A Search Algorithm for Generating Alternative Process Plans in Flexible Manufacturing System

NASA Astrophysics Data System (ADS)

Tehrani, Hossein; Sugimura, Nobuhiro; Tanimizu, Yoshitaka; Iwamura, Koji

Capabilities and complexity of manufacturing systems are increasing and striving for an integrated manufacturing environment. Availability of alternative process plans is a key factor for integration of design, process planning and scheduling. This paper describes an algorithm for generation of alternative process plans by extending the existing framework of the process plan networks. A class diagram is introduced for generating process plans and process plan networks from the viewpoint of the integrated process planning and scheduling systems. An incomplete search algorithm is developed for generating and searching the process plan networks. The benefit of this algorithm is that the whole process plan network does not have to be generated before the search algorithm starts. This algorithm is applicable to large and enormous process plan networks and also to search wide areas of the network based on the user requirement. The algorithm can generate alternative process plans and to select a suitable one based on the objective functions.

Identifying Critical Manufacturing Technologies Required for Transforming the Army Industrial Base

DTIC Science & Technology

2014-04-01

mechanism, 1 = least common mechanism)? ................................................................... 29 Figure 5 – Which Technology “ Test Beds...facilities, produce new designs , and incorporate efficient manufacturing processes. The value and continued success of the Army Industrial Base depends on...in materiel supplies to troops. Specific programs, described in AR 700-09, that are designed to transition manufacturing technology into the Army

Issues in nanocomposite ceramic engineering: focus on processing and properties of alumina-based composites.

PubMed

Palmero, Paola; Kern, Frank; Sommer, Frank; Lombardi, Mariangela; Gadow, Rainer; Montanaro, Laura

2014-12-30

Ceramic nanocomposites, containing at least one phase in the nanometric dimension, have received special interest in recent years. They have, in fact, demonstrated increased performance, reliability and lifetime with respect to monolithic ceramics. However, a successful approach to the production of tailored composite nanostructures requires the development of innovative concepts at each step of manufacturing, from the synthesis of composite nanopowders, to their processing and sintering.This review aims to deepen understanding of some of the critical issues associated with the manufacturing of nanocomposite ceramics, focusing on alumina-based composite systems. Two case studies are presented and briefly discussed. The former illustrates the benefits, in terms of sintered microstructure and related mechanical properties, resulting from the application of an engineering approach to a laboratory-scale protocol for the elaboration of nanocomposites in the system alumina-ZrO2-YAG (yttrium aluminium garnet). The latter illustrates the manufacturing of alumina-based composites for large-scale applications such as cutting tools, carried out by an injection molding process. The need for an engineering approach to be applied in all processing steps is demonstrated also in this second case study, where a tailored manufacturing process is required to obtain the desired results.

CIMOSA process classification for business process mapping in non-manufacturing firms: A case study

NASA Astrophysics Data System (ADS)

Latiffianti, Effi; Siswanto, Nurhadi; Wiratno, Stefanus Eko; Saputra, Yudha Andrian

2017-11-01

A business process mapping is one important means to enable an enterprise to effectively manage the value chain. One of widely used approaches to classify business process for mapping purpose is Computer Integrated Manufacturing System Open Architecture (CIMOSA). CIMOSA was initially designed for Computer Integrated Manufacturing (CIM) system based enterprises. This paper aims to analyze the use of CIMOSA process classification for business process mapping in the firms that do not fall within the area of CIM. Three firms of different business area that have used CIMOSA process classification were observed: an airline firm, a marketing and trading firm for oil and gas products, and an industrial estate management firm. The result of the research has shown that CIMOSA can be used in non-manufacturing firms with some adjustment. The adjustment includes addition, reduction, or modification of some processes suggested by CIMOSA process classification as evidenced by the case studies.

Monitoring the progression of calcium and protein solubilisation as affected by calcium chelators during small-scale manufacture of casein-based food matrices.

PubMed

McIntyre, Irene; O'Sullivan, Michael; O'Riordan, Dolores

2017-12-15

Calcium and protein solubilisation during small-scale manufacture of semi-solid casein-based food matrices was investigated and found to be very different in the presence or absence of calcium chelating salts. Calcium concentrations in the dispersed phase increased and calcium-ion activity (A Ca ++ ) decreased during manufacture of the matrices containing calcium chelating salts; with ∼23% of total calcium solubilised by the end of manufacture. In the absence of calcium chelating salts, these concentrations were significantly lower at equivalent processing times and remained unchanged as did A Ca ++ , throughout manufacture. The protein content of the dispersed phase was low (≤3% of total protein), but was significantly higher for matrices containing calcium chelating salts. This study elucidates the critical role of calcium chelating salts in modulating casein hydration and dispersion and gives an indication of the levels of soluble calcium and protein required to allow matrix formation during manufacture of casein-based food structures e.g. processed and analogue cheese. Copyright © 2017 Elsevier Ltd. All rights reserved.

The Future of Pharmaceutical Manufacturing Sciences

PubMed Central

2015-01-01

The entire pharmaceutical sector is in an urgent need of both innovative technological solutions and fundamental scientific work, enabling the production of highly engineered drug products. Commercial‐scale manufacturing of complex drug delivery systems (DDSs) using the existing technologies is challenging. This review covers important elements of manufacturing sciences, beginning with risk management strategies and design of experiments (DoE) techniques. Experimental techniques should, where possible, be supported by computational approaches. With that regard, state‐of‐art mechanistic process modeling techniques are described in detail. Implementation of materials science tools paves the way to molecular‐based processing of future DDSs. A snapshot of some of the existing tools is presented. Additionally, general engineering principles are discussed covering process measurement and process control solutions. Last part of the review addresses future manufacturing solutions, covering continuous processing and, specifically, hot‐melt processing and printing‐based technologies. Finally, challenges related to implementing these technologies as a part of future health care systems are discussed. © 2015 The Authors. Journal of Pharmaceutical Sciences published by Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:3612–3638, 2015 PMID:26280993

The Future of Pharmaceutical Manufacturing Sciences.

PubMed

Rantanen, Jukka; Khinast, Johannes

2015-11-01

The entire pharmaceutical sector is in an urgent need of both innovative technological solutions and fundamental scientific work, enabling the production of highly engineered drug products. Commercial-scale manufacturing of complex drug delivery systems (DDSs) using the existing technologies is challenging. This review covers important elements of manufacturing sciences, beginning with risk management strategies and design of experiments (DoE) techniques. Experimental techniques should, where possible, be supported by computational approaches. With that regard, state-of-art mechanistic process modeling techniques are described in detail. Implementation of materials science tools paves the way to molecular-based processing of future DDSs. A snapshot of some of the existing tools is presented. Additionally, general engineering principles are discussed covering process measurement and process control solutions. Last part of the review addresses future manufacturing solutions, covering continuous processing and, specifically, hot-melt processing and printing-based technologies. Finally, challenges related to implementing these technologies as a part of future health care systems are discussed. © 2015 The Authors. Journal of Pharmaceutical Sciences published by Wiley Periodicals, Inc. and the American Pharmacists Association.

Manufacture and quality control of interconnecting wire hardnesses, Volume 1

NASA Technical Reports Server (NTRS)

1972-01-01

A standard is presented for manufacture, installation, and quality control of eight types of interconnecting wire harnesses. The processes, process controls, and inspection and test requirements reflected are based on acknowledgment of harness design requirements, acknowledgment of harness installation requirements, identification of the various parts, materials, etc., utilized in harness manufacture, and formulation of a typical manufacturing flow diagram for identification of each manufacturing and quality control process, operation, inspection, and test. The document covers interconnecting wire harnesses defined in the design standard, including type 1, enclosed in fluorocarbon elastomer convolute, tubing; type 2, enclosed in TFE convolute tubing lines with fiberglass braid; type 3, enclosed in TFE convolute tubing; and type 5, combination of types 3 and 4. Knowledge gained through experience on the Saturn 5 program coupled with recent advances in techniques, materials, and processes was incorporated.

Pharmaceutical quality by design: product and process development, understanding, and control.

PubMed

Yu, Lawrence X

2008-04-01

The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and describe how it can be used to ensure pharmaceutical quality. The QbD was described and some of its elements identified. Process parameters and quality attributes were identified for each unit operation during manufacture of solid oral dosage forms. The use of QbD was contrasted with the evaluation of product quality by testing alone. The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include: Defining target product quality profile; Designing product and manufacturing processes; Identifying critical quality attributes, process parameters, and sources of variability; Controlling manufacturing processes to produce consistent quality over time. Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality. Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.

Q-marker based strategy for CMC research of Chinese medicine: A case study of Panax Notoginseng saponins.

PubMed

Zhong, Yi; Zhu, Jieqiang; Yang, Zhenzhong; Shao, Qing; Fan, Xiaohui; Cheng, Yiyu

2018-01-31

To ensure pharmaceutical quality, chemistry, manufacturing and control (CMC) research is essential. However, due to the inherent complexity of Chinese medicine (CM), CMC study of CM remains a great challenge for academia, industry, and regulatory agencies. Recently, quality-marker (Q-marker) was proposed to establish quality standards or quality analysis approaches of Chinese medicine, which sheds a light on Chinese medicine's CMC study. Here manufacture processes of Panax Notoginseng Saponins (PNS) is taken as a case study and the present work is to establish a Q-marker based research strategy for CMC of Chinese medicine. The Q-markers of Panax Notoginseng Saponins (PNS) is selected and established by integrating chemical profile with pharmacological activities. Then, the key processes of PNS manufacturing are identified by material flow analysis. Furthermore, modeling algorithms are employed to explore the relationship between Q-markers and critical process parameters (CPPs) of the key processes. At last, CPPs of the key processes are optimized in order to improving the process efficiency. Among the 97 identified compounds, Notoginsenoside R 1 , ginsenoside Rg 1 , Re, Rb 1 and Rd are selected as the Q-markers of PNS. Our analysis on PNS manufacturing show the extraction process and column chromatography process are the key processes. With the CPPs of each process as the inputs and Q-markers' contents as the outputs, two process prediction models are built separately for the extraction process and column chromatography process of Panax notoginseng, which both possess good prediction ability. Based on the efficiency models of extraction process and column chromatography process we constructed, the optimal CPPs of both processes are calculated. Our results show that the Q-markers derived from CMC research strategy can be applied to analyze the manufacturing processes of Chinese medicine to assure product's quality and promote key processes' efficiency simultaneously. Copyright © 2018 Elsevier GmbH. All rights reserved.

Integrated control system for electron beam processes

NASA Astrophysics Data System (ADS)

Koleva, L.; Koleva, E.; Batchkova, I.; Mladenov, G.

2018-03-01

The ISO/IEC 62264 standard is widely used for integration of the business systems of a manufacturer with the corresponding manufacturing control systems based on hierarchical equipment models, functional data and manufacturing operations activity models. In order to achieve the integration of control systems, formal object communication models must be developed, together with manufacturing operations activity models, which coordinate the integration between different levels of control. In this article, the development of integrated control system for electron beam welding process is presented as part of a fully integrated control system of an electron beam plant, including also other additional processes: surface modification, electron beam evaporation, selective melting and electron beam diagnostics.

Predictive modeling, simulation, and optimization of laser processing techniques: UV nanosecond-pulsed laser micromachining of polymers and selective laser melting of powder metals

NASA Astrophysics Data System (ADS)

Criales Escobar, Luis Ernesto

One of the most frequently evolving areas of research is the utilization of lasers for micro-manufacturing and additive manufacturing purposes. The use of laser beam as a tool for manufacturing arises from the need for flexible and rapid manufacturing at a low-to-mid cost. Laser micro-machining provides an advantage over mechanical micro-machining due to the faster production times of large batch sizes and the high costs associated with specific tools. Laser based additive manufacturing enables processing of powder metals for direct and rapid fabrication of products. Therefore, laser processing can be viewed as a fast, flexible, and cost-effective approach compared to traditional manufacturing processes. Two types of laser processing techniques are studied: laser ablation of polymers for micro-channel fabrication and selective laser melting of metal powders. Initially, a feasibility study for laser-based micro-channel fabrication of poly(dimethylsiloxane) (PDMS) via experimentation is presented. In particular, the effectiveness of utilizing a nanosecond-pulsed laser as the energy source for laser ablation is studied. The results are analyzed statistically and a relationship between process parameters and micro-channel dimensions is established. Additionally, a process model is introduced for predicting channel depth. Model outputs are compared and analyzed to experimental results. The second part of this research focuses on a physics-based FEM approach for predicting the temperature profile and melt pool geometry in selective laser melting (SLM) of metal powders. Temperature profiles are calculated for a moving laser heat source to understand the temperature rise due to heating during SLM. Based on the predicted temperature distributions, melt pool geometry, i.e. the locations at which melting of the powder material occurs, is determined. Simulation results are compared against data obtained from experimental Inconel 625 test coupons fabricated at the National Institute for Standards & Technology via response surface methodology techniques. The main goal of this research is to develop a comprehensive predictive model with which the effect of powder material properties and laser process parameters on the built quality and integrity of SLM-produced parts can be better understood. By optimizing process parameters, SLM as an additive manufacturing technique is not only possible, but also practical and reproducible.

Designing an in-situ ultrasonic nondestructive evaluation system for ultrasonic additive manufacturing

NASA Astrophysics Data System (ADS)

Nadimpalli, Venkata K.; Nagy, Peter B.

2018-04-01

Ultrasonic Additive Manufacturing (UAM) is a solid-state layer by layer manufacturing process that utilizes vibration induced plastic deformation to form a metallurgical bond between a thin layer and an existing base structure. Due to the vibration based bonding mechanism, the quality of components at each layer depends on the geometry of the structure. In-situ monitoring during and between UAM manufacturing steps offers the potential for closed-loop control to optimize process parameters and to repair existing defects. One interface that is most prone to delamination is the base/build interface and often UAM component height and quality are limited by failure at the base/build interface. Low manufacturing temperatures and favorable orientation of typical interface defects in UAM make ultrasonic NDE an attractive candidate for online monitoring. Two approaches for in-situ NDE are discussed and the design of the monitoring system optimized so that the quality of UAM components is not affected by the addition of the NDE setup. Preliminary results from in-situ ultrasonic NDE indicate the potential to be utilized for online qualification, closed-loop control and offline certification of UAM components.

A PetriNet-Based Approach for Supporting Traceability in Cyber-Physical Manufacturing Systems

PubMed Central

Huang, Jiwei; Zhu, Yeping; Cheng, Bo; Lin, Chuang; Chen, Junliang

2016-01-01

With the growing popularity of complex dynamic activities in manufacturing processes, traceability of the entire life of every product has drawn significant attention especially for food, clinical materials, and similar items. This paper studies the traceability issue in cyber-physical manufacturing systems from a theoretical viewpoint. Petri net models are generalized for formulating dynamic manufacturing processes, based on which a detailed approach for enabling traceability analysis is presented. Models as well as algorithms are carefully designed, which can trace back the lifecycle of a possibly contaminated item. A practical prototype system for supporting traceability is designed, and a real-life case study of a quality control system for bee products is presented to validate the effectiveness of the approach. PMID:26999141

A PetriNet-Based Approach for Supporting Traceability in Cyber-Physical Manufacturing Systems.

PubMed

Huang, Jiwei; Zhu, Yeping; Cheng, Bo; Lin, Chuang; Chen, Junliang

2016-03-17

With the growing popularity of complex dynamic activities in manufacturing processes, traceability of the entire life of every product has drawn significant attention especially for food, clinical materials, and similar items. This paper studies the traceability issue in cyber-physical manufacturing systems from a theoretical viewpoint. Petri net models are generalized for formulating dynamic manufacturing processes, based on which a detailed approach for enabling traceability analysis is presented. Models as well as algorithms are carefully designed, which can trace back the lifecycle of a possibly contaminated item. A practical prototype system for supporting traceability is designed, and a real-life case study of a quality control system for bee products is presented to validate the effectiveness of the approach.

Robot-based additive manufacturing for flexible die-modelling in incremental sheet forming

NASA Astrophysics Data System (ADS)

Rieger, Michael; Störkle, Denis Daniel; Thyssen, Lars; Kuhlenkötter, Bernd

2017-10-01

The paper describes the application concept of additive manufactured dies to support the robot-based incremental sheet metal forming process (`Roboforming') for the production of sheet metal components in small batch sizes. Compared to the dieless kinematic-based generation of a shape by means of two cooperating industrial robots, the supporting robot models a die on the back of the metal sheet by using the robot-based fused layer manufacturing process (FLM). This tool chain is software-defined and preserves the high geometrical form flexibility of Roboforming while flexibly generating support structures adapted to the final part's geometry. Test series serve to confirm the feasibility of the concept by investigating the process challenges of the adhesion to the sheet surface and the general stability as well as the influence on the geometric accuracy compared to the well-known forming strategies.

Manufacturing of embedded multimode waveguides by reactive lamination of cyclic olefin polymer and polymethylmethacrylate

NASA Astrophysics Data System (ADS)

Kelb, Christian; Rother, Raimund; Schuler, Anne-Katrin; Hinkelmann, Moritz; Rahlves, Maik; Prucker, Oswald; Müller, Claas; Rühe, Jürgen; Reithmeier, Eduard; Roth, Bernhard

2016-03-01

We demonstrate the manufacturing of embedded multimode optical waveguides through linking of polymethylmethacrylate (PMMA) foils and cyclic olefin polymer (COP) filaments based on a lamination process. Since the two polymeric materials cannot be fused together through interdiffusion of polymer chains, we utilize a reactive lamination agent based on PMMA copolymers containing photoreactive 2-acryloyloxyanthraquinone units, which allows the creation of monolithic PMMA-COP substrates through C-H insertion reactions across the interface between the two materials. We elucidate the lamination process and evaluate the chemical link between filament and foils by carrying out extraction tests with a custom-built tensile testing machine. We also show attenuation measurements of the manufactured waveguides for different manufacturing parameters. The lamination process is in particular suited for large-scale and low-cost fabrication of board-level devices with optical waveguides or other micro-optical structures, e.g., optofluidic devices.

Tribology symposium -- 1994. PD-Volume 61

DOE Office of Scientific and Technical Information (OSTI.GOV)

Masudi, H.

This year marks the first Tribology Symposium within the Energy-Sources Technology Conference, sponsored by the ASME Petroleum Division. The program was divided into five sessions: Tribology in High Technology, a historical discussion of some watershed events in tribology; Research/Development, design, research and development on modern manufacturing; Tribology in Manufacturing, the impact of tribology on modern manufacturing; Design/Design Representation, aspects of design related to tribological systems; and Failure Analysis, an analysis of failure, failure detection, and failure monitoring as relating to manufacturing processes. Eleven papers have been processed separately for inclusion on the data base.

Framework for Sustainability Performance Assessment for Manufacturing Processes- A Review

NASA Astrophysics Data System (ADS)

Singh, K.; Sultan, I.

2017-07-01

Manufacturing industries are facing tough competition due to increasing raw material cost and depleting natural resources. There is great pressure on the industry to produce environmental friendly products using environmental friendly processes. To address these issues modern manufacturing industries are focusing on sustainable manufacturing. To develop more sustainable societies, industries need to better understand how to respond to environmental, economic and social challenges. This paper proposed some framework and tools that accelerate the transition towards a sustainable system. The developed framework will be beneficial for sustainability assessment comparing different plans alongside material properties, ultimately helping the manufacturing industries to reduce the carbon emissions and material waste, besides improving energy efficiency. It is expected that this would be highly beneficial for determination of environmental impact of a process at early design stages. Therefore, it would greatly help the manufacturing industries for selection of process plan based on sustainable indices. Overall objective of this paper would have good impact on reducing air emissions and protecting environment. We expect this work to contribute to the development of a standard reference methodology to help further sustainability in the manufacturing sector.

Discrete State Change Model of Manufacturing Quality to Aid Assembly Process Design

NASA Astrophysics Data System (ADS)

Koga, Tsuyoshi; Aoyama, Kazuhiro

This paper proposes a representation model of the quality state change in an assembly process that can be used in a computer-aided process design system. In order to formalize the state change of the manufacturing quality in the assembly process, the functions, operations, and quality changes in the assembly process are represented as a network model that can simulate discrete events. This paper also develops a design method for the assembly process. The design method calculates the space of quality state change and outputs a better assembly process (better operations and better sequences) that can be used to obtain the intended quality state of the final product. A computational redesigning algorithm of the assembly process that considers the manufacturing quality is developed. The proposed method can be used to design an improved manufacturing process by simulating the quality state change. A prototype system for planning an assembly process is implemented and applied to the design of an auto-breaker assembly process. The result of the design example indicates that the proposed assembly process planning method outputs a better manufacturing scenario based on the simulation of the quality state change.

Manufacturing of Smart Structures Using Fiber Placement Manufacturing Processes

NASA Technical Reports Server (NTRS)

Thomas, Matthew M.; Glowasky, Robert A.; McIlroy, Bruce E.; Story, Todd A.

1996-01-01

Smart structures research and development, with the ultimate aim of rapid commercial and military production of these structures, are at the forefront of the Synthesis and Processing of Intelligent Cost-Effective Structures (SPICES) program. As part of this ARPA-sponsored program, MDA-E is using fiber placement processes to manufacture integrated smart structure systems. These systems comprise advanced composite structures with embedded fiber optic sensors, shape memory alloys, piezoelectric actuators, and miniature accelerometers. Cost-effective approaches and solutions to smart material synthesis in the fiber-placement process, based upon integrated product development, are discussed herein.

Information flow analysis and Petri-net-based modeling for welding flexible manufacturing cell

NASA Astrophysics Data System (ADS)

Qiu, T.; Chen, Shanben; Wang, Y. T.; Wu, Lin

2000-10-01

Due to the development of advanced manufacturing technology and the introduction of Smart-Manufacturing notion in the field of modern industrial production, welding flexible manufacturing system (WFMS) using robot technology has become the inevitable developing direction on welding automation. In WFMS process, the flexibility for different welding products and the realizing on corresponding welding parameters control are the guarantees for welding quality. Based on a new intelligent arc-welding flexible manufacturing cell (WFMC), the system structure and control policies are studied in this paper. Aiming at the different information flows among every subsystem and central monitoring computer in this WFMC, Petri net theory is introduced into the process of welding manufacturing. With its help, a discrete control model of WFMC has been constructed, in which the system status is regarded as place and the control process is regarded as transition. Moreover, grounded on automation Petri net principle, the judging and utilizing of information obtained from welding sensors are imported into net structure, which extends the traditional Petri net concepts. The control model and policies researched in this paper have established foundation for further intelligent real-time control on WFMC and WFMS.

7 CFR 52.82 - Basis of survey and plant inspection.

Code of Federal Regulations, 2012 CFR

2012-01-01

... inspection. The plant survey and inspection will be based on the Regulations issued under the Federal Food, Drug, and Cosmetic Act—Human Foods; Good Manufacturing Practice (Sanitation) in Manufacture, Processing... PROCESSED FOOD PRODUCTS 1 Regulations Governing Inspection and Certification Requirements for Plants to Be...

Using Residence Time Distributions (RTDs) to Address the Traceability of Raw Materials in Continuous Pharmaceutical Manufacturing.

PubMed

Engisch, William; Muzzio, Fernando

Continuous processing in pharmaceutical manufacturing is a relatively new approach that has generated significant attention. While it has been used for decades in other industries, showing significant advantages, the pharmaceutical industry has been slow in its adoption of continuous processing, primarily due to regulatory uncertainty. This paper aims to help address these concerns by introducing methods for batch definition, raw material traceability, and sensor frequency determination. All of the methods are based on established engineering and mathematical principles, especially the residence time distribution (RTD). This paper introduces a risk-based approach to address content uniformity challenges of continuous manufacturing. All of the detailed methods are discussed using a direct compaction manufacturing line as the main example, but the techniques can easily be applied to other continuous manufacturing methods such as wet and dry granulation, hot melt extrusion, capsule filling, etc.

The Economics of Big Area Addtiive Manufacturing

DOE Office of Scientific and Technical Information (OSTI.GOV)

Post, Brian; Lloyd, Peter D; Lindahl, John

Case studies on the economics of Additive Manufacturing (AM) suggest that processing time is the dominant cost in manufacturing. Most additive processes have similar performance metrics: small part sizes, low production rates and expensive feedstocks. Big Area Additive Manufacturing is based on transitioning polymer extrusion technology from a wire to a pellet feedstock. Utilizing pellets significantly increases deposition speed and lowers material cost by utilizing low cost injection molding feedstock. The use of carbon fiber reinforced polymers eliminates the need for a heated chamber, significantly reducing machine power requirements and size constraints. We hypothesize that the increase in productivity coupledmore » with decrease in feedstock and energy costs will enable AM to become more competitive with conventional manufacturing processes for many applications. As a test case, we compare the cost of using traditional fused deposition modeling (FDM) with BAAM for additively manufacturing composite tooling.« less

Economics of polysilicon process: A view from Japan

NASA Technical Reports Server (NTRS)

Shimizu, Y.

1986-01-01

The production process of solar grade silicon (SOG-Si) through trichlorosilane (TCS) was researched in a program sponsored by New Energy Development Organization (NEDO). The NEDO process consists of the following two steps: TCS production from by-product silicon tetrachloride (STC) and SOG-Si formation from TCS using a fluidized bed reactor. Based on the data obtained during the research program, the manufacturing cost of the NEDO process and other polysilicon manufacturing processes were compared. The manufacturing cost was calculated on the basis of 1000 tons/year production. The cost estimate showed that the cost of producing silicon by all of the new processes is less than the cost by the conventional Siemens process. Using a new process, the cost of producing semiconductor grade silicon was found to be virtually the same with any to the TCS, diclorosilane, and monosilane processes when by-products were recycled. The SOG-Si manufacturing processes using the fluidized bed reactor, which needs further development, shows a greater probablility of cost reduction than the filament processes.

Surface texture and hardness of dental alloys processed by alternative technologies

NASA Astrophysics Data System (ADS)

Porojan, Liliana; Savencu, Cristina E.; Topală, Florin I.; Porojan, Sorin D.

2017-08-01

Technological developments have led to the implementation of novel digitalized manufacturing methods for the production of metallic structures in prosthetic dentistry. These technologies can be classified as based on subtractive manufacturing, assisted by computer-aided design/computer-aided manufacturing (CAD/CAM) systems, or on additive manufacturing (AM), such as the recently developed laser-based methods. The aim of the study was to assess the surface texture and hardness of metallic structures for dental restorations obtained by alternative technologies: conventional casting (CST), computerized milling (MIL), AM power bed fusion methods, respective selective laser melting (SLM) and selective laser sintering (SLS). For the experimental analyses metallic specimens made of Co-Cr dental alloys were prepared as indicated by the manufacturers. The specimen structure at the macro level was observed by an optical microscope and micro-hardness was measured in all substrates. Metallic frameworks obtained by AM are characterized by increased hardness, depending also on the surface processing. The formation of microstructural defects can be better controlled and avoided during SLM and MIL process. Application of power bed fusion techniques, like SLS and SLM, is currently a challenge in dental alloys processing.

Primary Manufacturing Processes for Fiber Reinforced Composites: History, Development & Future Research Trends

NASA Astrophysics Data System (ADS)

Tapan Bhatt, Alpa; Gohil, Piyush P.; Chaudhary, Vijaykumar

2018-03-01

Composite Materials are becoming more popular gradually replacing traditional material with extra strength, lighter weight and superior property. The world is exploring use of fiber reinforced composites in all application which includes air, land and water transport, construction industry, toys, instrumentation, medicine and the list is endless. Based on application and reinforcement used, there are many ways to manufactures parts with fiber reinforced composites. In this paper various manufacturing processes have been discussed at length, to make fiber reinforced composites components. The authors have endeavored to include all the processes available recently in composite industry. Paper first highlights history of fiber reinforced composites manufacturing, and then the comparison of different manufacturing process to build composites have been discussed, to give clear understanding on, which process should be selected, based on reinforcement, matrix and application. All though, there are several advantages to use such fiber reinforcement composites, still industries have not grown at par and there is a lot of scope to improve these industries. At last, where India stands today, what are the challenges in market has been highlighted and future market and research trend of exploring such composite industries have been discussed. This work is carried out as a part of research project sanctioned by GUJCOST, Gandhinagar.

Composite fuselage crown panel manufacturing technology

NASA Technical Reports Server (NTRS)

Willden, Kurtis; Metschan, S.; Grant, C.; Brown, T.

1992-01-01

Commercial fuselage structures contain significant challenges in attempting to save manufacturing costs with advanced composite technology. Assembly issues, materials costs, and fabrication of elements with complex geometry are each expected to drive the cost of composite fuselage structure. Key technologies, such as large crown panel fabrication, were pursued for low cost. An intricate bond panel design and manufacturing concept were selected based on the efforts of the Design Build Team. The manufacturing processes selected for the intricate bond design include multiple large panel fabrication with Advanced Tow Placement (ATP) process, innovative cure tooling concepts, resin transfer molding of long fuselage frames, and use of low cost materials forms. The process optimization for final design/manufacturing configuration included factory simulations and hardware demonstrations. These efforts and other optimization tasks were instrumental in reducing costs by 18 pct. and weight by 45 pct. relative to an aluminum baseline. The qualitative and quantitative results of the manufacturing demonstrations were used to assess manufacturing risks and technology readiness.

Composite fuselage crown panel manufacturing technology

NASA Technical Reports Server (NTRS)

Willden, Kurtis; Metschan, S.; Grant, C.; Brown, T.

1992-01-01

Commercial fuselage structures contain significant challenges in attempting to save manufacturing costs with advanced composite technology. Assembly issues, material costs, and fabrication of elements with complex geometry are each expected to drive the cost of composite fuselage structures. Boeing's efforts under the NASA ACT program have pursued key technologies for low-cost, large crown panel fabrication. An intricate bond panel design and manufacturing concepts were selected based on the efforts of the Design Build Team (DBT). The manufacturing processes selected for the intricate bond design include multiple large panel fabrication with the Advanced Tow Placement (ATP) process, innovative cure tooling concepts, resin transfer molding of long fuselage frames, and utilization of low-cost material forms. The process optimization for final design/manufacturing configuration included factory simulations and hardware demonstrations. These efforts and other optimization tasks were instrumental in reducing cost by 18 percent and weight by 45 percent relative to an aluminum baseline. The qualitative and quantitative results of the manufacturing demonstrations were used to assess manufacturing risks and technology readiness.

Development of Probabilistic Structural Analysis Integrated with Manufacturing Processes

NASA Technical Reports Server (NTRS)

Pai, Shantaram S.; Nagpal, Vinod K.

2007-01-01

An effort has been initiated to integrate manufacturing process simulations with probabilistic structural analyses in order to capture the important impacts of manufacturing uncertainties on component stress levels and life. Two physics-based manufacturing process models (one for powdered metal forging and the other for annular deformation resistance welding) have been linked to the NESSUS structural analysis code. This paper describes the methodology developed to perform this integration including several examples. Although this effort is still underway, particularly for full integration of a probabilistic analysis, the progress to date has been encouraging and a software interface that implements the methodology has been developed. The purpose of this paper is to report this preliminary development.

Computational modeling of residual stress formation during the electron beam melting process for Inconel 718

DOE PAGES

Prabhakar, P.; Sames, William J.; Dehoff, Ryan R.; ...

2015-03-28

Here, a computational modeling approach to simulate residual stress formation during the electron beam melting (EBM) process within the additive manufacturing (AM) technologies for Inconel 718 is presented in this paper. The EBM process has demonstrated a high potential to fabricate components with complex geometries, but the resulting components are influenced by the thermal cycles observed during the manufacturing process. When processing nickel based superalloys, very high temperatures (approx. 1000 °C) are observed in the powder bed, base plate, and build. These high temperatures, when combined with substrate adherence, can result in warping of the base plate and affect themore » final component by causing defects. It is important to have an understanding of the thermo-mechanical response of the entire system, that is, its mechanical behavior towards thermal loading occurring during the EBM process prior to manufacturing a component. Therefore, computational models to predict the response of the system during the EBM process will aid in eliminating the undesired process conditions, a priori, in order to fabricate the optimum component. Such a comprehensive computational modeling approach is demonstrated to analyze warping of the base plate, stress and plastic strain accumulation within the material, and thermal cycles in the system during different stages of the EBM process.« less

POLLUTION BALANCE: A NEW METHODOLOGY FOR MINIMIZING WASTE PRODUCTION IN MANUFACTURING PROCESSES.

EPA Science Inventory

A new methodolgy based on a generic pollution balance equation, has been developed for minimizing waste production in manufacturing processes. A "pollution index," defined as the mass of waste produced per unit mass of a product, has been introduced to provide a quantitative meas...

In-Space Manufacturing (ISM): Pioneering Space Exploration

NASA Technical Reports Server (NTRS)

Werkheiser, Niki

2015-01-01

ISM Objective: Develop and enable the manufacturing technologies and processes required to provide on-demand, sustainable operations for Exploration Missions. This includes development of the desired capabilities, as well as the required processes for the certification, characterization & verification that will enable these capabilities to become institutionalized via ground-based and ISS demonstrations.

Roll-to-Roll Advanced Materials Manufacturing DOE Lab Consortium - FY16 Annual Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Daniel, Claus; Wood, III, David L.; Krumdick, Gregory

2016-12-01

A DOE laboratory consortium comprised of ORNL, ANL, NREL and LBNL, coordinating with Kodak’s Eastman Business Park (Kodak) and other selected industry partners, was formed to address enhancing battery electrode performance and R2R manufacturing challenges. The objective of the FY 2016 seed project was to develop a materials genome synthesis process amenable to R2R manufacturing and to provide modeling, simulation, processing, and manufacturing techniques that demonstrate the feasibility of process controls and scale-up potential for improved battery electrodes. The research efforts were to predict and measure changes and results in electrode morphology and performance based on process condition changes; tomore » evaluate mixed, active, particle size deposition and drying for novel electrode materials; and to model various process condition changes and the resulting morphology and electrode performance.« less

Recent progress in continuous and semi-continuous processing of solid oral dosage forms: a review.

PubMed

Teżyk, Michał; Milanowski, Bartłomiej; Ernst, Andrzej; Lulek, Janina

2016-08-01

Continuous processing is an innovative production concept well known and successfully used in other industries for many years. The modern pharmaceutical industry is facing the challenge of transition from a traditional manufacturing approach based on batch-wise production to a continuous manufacturing model. The aim of this article is to present technological progress in manufacturing based on continuous and semi-continuous processing of the solid oral dosage forms. Single unit processes possessing an alternative processing pathway to batch-wise technology or, with some modification, an altered approach that may run continuously, and are thus able to seamlessly switch to continuous manufacturing are briefly presented. Furthermore, the concept of semi-continuous processing is discussed. Subsequently, more sophisticated production systems created by coupling single unit processes and comprising all the steps of production, from powder to final dosage form, were reviewed. Finally, attempts of end-to-end production approach, meaning the linking of continuous synthesis of API from intermediates with the production of final dosage form, are described. There are a growing number of scientific articles showing an increasing interest in changing the approach to the production of pharmaceuticals in recent years. Numerous scientific publications are a source of information on the progress of knowledge and achievements of continuous processing. These works often deal with issues of how to modify or replace the unit processes in order to enable seamlessly switching them into continuous processing. A growing number of research papers concentrate on integrated continuous manufacturing lines in which the production concept of "from powder to tablet" is realized. Four main domains are under investigation: influence of process parameters on intermediates or final dosage forms properties, implementation of process analytical tools, control-managing system responsible for keeping continuous materials flow through the whole manufacturing process and the development of new computational methods to assess or simulate these new manufacturing techniques. The attempt to connect the primary and secondary production steps proves that development of continuously operating lines is possible. A mind-set change is needed to be able to face, and fully assess, the advantages and disadvantages of switching from batch to continuous mode production.

Additive manufacturing of reflective optics: evaluating finishing methods

NASA Astrophysics Data System (ADS)

Leuteritz, G.; Lachmayer, R.

2018-02-01

Individually shaped light distributions become more and more important in lighting technologies and thus the importance of additively manufactured reflectors increases significantly. The vast field of applications ranges from automotive lighting to medical imaging and bolsters the statement. However, the surfaces of additively manufactured reflectors suffer from insufficient optical properties even when manufactured using optimized process parameters for the Selective Laser Melting (SLM) process. Therefore post-process treatments of reflectors are necessary in order to further enhance their optical quality. This work concentrates on the effectiveness of post-process procedures for reflective optics. Based on already optimized aluminum reflectors, which are manufactured with a SLM machine, the parts are differently machined after the SLM process. Selected finishing methods like laser polishing, sputtering or sand blasting are applied and their effects quantified and compared. The post-process procedures are investigated on their impact on surface roughness and reflectance as well as geometrical precision. For each finishing method a demonstrator will be created and compared to a fully milled sample and among themselves. Ultimately, guidelines are developed in order to figure out the optimal treatment of additively manufactured reflectors regarding their optical and geometrical properties. Simulations of the light distributions will be validated with the developed demonstrators.

Relational-database model for improving quality assurance and process control in a composite manufacturing environment

NASA Astrophysics Data System (ADS)

Gentry, Jeffery D.

2000-05-01

A relational database is a powerful tool for collecting and analyzing the vast amounts of inner-related data associated with the manufacture of composite materials. A relational database contains many individual database tables that store data that are related in some fashion. Manufacturing process variables as well as quality assurance measurements can be collected and stored in database tables indexed according to lot numbers, part type or individual serial numbers. Relationships between manufacturing process and product quality can then be correlated over a wide range of product types and process variations. This paper presents details on how relational databases are used to collect, store, and analyze process variables and quality assurance data associated with the manufacture of advanced composite materials. Important considerations are covered including how the various types of data are organized and how relationships between the data are defined. Employing relational database techniques to establish correlative relationships between process variables and quality assurance measurements is then explored. Finally, the benefits of database techniques such as data warehousing, data mining and web based client/server architectures are discussed in the context of composite material manufacturing.

Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice: September 26-27, 2016, International Symposium on the Continuous Manufacturing of Pharmaceuticals.

PubMed

Nasr, Moheb M; Krumme, Markus; Matsuda, Yoshihiro; Trout, Bernhardt L; Badman, Clive; Mascia, Salvatore; Cooney, Charles L; Jensen, Keith D; Florence, Alastair; Johnston, Craig; Konstantinov, Konstantin; Lee, Sau L

2017-11-01

Continuous manufacturing plays a key role in enabling the modernization of pharmaceutical manufacturing. The fate of this emerging technology will rely, in large part, on the regulatory implementation of this novel technology. This paper, which is based on the 2nd International Symposium on the Continuous Manufacturing of Pharmaceuticals, describes not only the advances that have taken place since the first International Symposium on Continuous Manufacturing of Pharmaceuticals in 2014, but the regulatory landscape that exists today. Key regulatory concepts including quality risk management, batch definition, control strategy, process monitoring and control, real-time release testing, data processing and management, and process validation/verification are outlined. Support from regulatory agencies, particularly in the form of the harmonization of regulatory expectations, will be crucial to the successful implementation of continuous manufacturing. Collaborative efforts, among academia, industry, and regulatory agencies, are the optimal solution for ensuring a solid future for this promising manufacturing technology. Copyright © 2017 American Pharmacists Association®. All rights reserved.

Using Module-Based Learning Methods to Introduce Sustainable Manufacturing in Engineering Curriculum

ERIC Educational Resources Information Center

Sengupta, Debalina; Huang, Yinlun; Davidson, Cliff I.; Edgar, Thomas F.; Eden, Mario R.; El-Halwagi, Mahmoud M.

2017-01-01

Purpose: Sustainable manufacturing may be defined as the creation of manufactured products that use processes that are non-polluting, conserve energy and natural resources, and are economically sound and safe for employees, communities and consumers. Recently, there have been several industrial and governmental endeavors to launch sustainable…

Process Analytical Technology (PAT): batch-to-batch reproducibility of fermentation processes by robust process operational design and control.

PubMed

Gnoth, S; Jenzsch, M; Simutis, R; Lübbert, A

2007-10-31

The Process Analytical Technology (PAT) initiative of the FDA is a reaction on the increasing discrepancy between current possibilities in process supervision and control of pharmaceutical production processes and its current application in industrial manufacturing processes. With rigid approval practices based on standard operational procedures, adaptations of production reactors towards the state of the art were more or less inhibited for long years. Now PAT paves the way for continuous process and product improvements through improved process supervision based on knowledge-based data analysis, "Quality-by-Design"-concepts, and, finally, through feedback control. Examples of up-to-date implementations of this concept are presented. They are taken from one key group of processes in recombinant pharmaceutical protein manufacturing, the cultivations of genetically modified Escherichia coli bacteria.

Quality Risk Management: Putting GMP Controls First.

PubMed

O'Donnell, Kevin; Greene, Anne; Zwitkovits, Michael; Calnan, Nuala

2012-01-01

This paper presents a practical way in which current approaches to quality risk management (QRM) may be improved, such that they better support qualification, validation programs, and change control proposals at manufacturing sites. The paper is focused on the treatment of good manufacturing practice (GMP) controls during QRM exercises. It specifically addresses why it is important to evaluate and classify such controls in terms of how they affect the severity, probability of occurrence, and detection ratings that may be assigned to potential failure modes or negative events. It also presents a QRM process that is designed to directly link the outputs of risk assessments and risk control activities with qualification and validation protocols in the GMP environment. This paper concerns the need for improvement in the use of risk-based principles and tools when working to ensure that the manufacturing processes used to produce medicines, and their related equipment, are appropriate. Manufacturing processes need to be validated (or proven) to demonstrate that they can produce a medicine of the required quality. The items of equipment used in such processes need to be qualified, in order to prove that they are fit for their intended use. Quality risk management (QRM) tools can be used to support such qualification and validation activities, but their use should be science-based and subject to as little subjectivity and uncertainty as possible. When changes are proposed to manufacturing processes, equipment, or related activities, they also need careful evaluation to ensure that any risks present are managed effectively. This paper presents a practical approach to how QRM may be improved so that it better supports qualification, validation programs, and change control proposals in a more scientific way. This improved approach is based on the treatment of what are called good manufacturing process (GMP) controls during those QRM exercises. A GMP control can be considered to be any control that is put in place to assure product quality and regulatory compliance. This improved approach is also based on how the detectability of risks is assessed. This is important because when producing medicines, it is not always good practice to place a high reliance upon detection-type controls in the absence of an adequate level of assurance in the manufacturing process that leads to the finished medicine.

Total Quality Management in Space Shuttle Main Engine manufacturing

NASA Technical Reports Server (NTRS)

Ding, J.

1992-01-01

The Total Quality Management (TQM) philosophy developed in the Marshall Space Flight Center (MSFC) is briefly reviewed and the ongoing TQM implementation effort which is being pursued through the continuous improvement (CI) process is discussed. TQM is based on organizational excellence which integrates the new supportive culture with the technical tools necessary to identify, assess, and correct manufacturing processes. Particular attention is given to the prime contractor's change to the organizational excellence management philosophy in SSME manufacturing facilities.

High-throughput manufacturing of size-tuned liposomes by a new microfluidics method using enhanced statistical tools for characterization.

PubMed

Kastner, Elisabeth; Kaur, Randip; Lowry, Deborah; Moghaddam, Behfar; Wilkinson, Alexander; Perrie, Yvonne

2014-12-30

Microfluidics has recently emerged as a new method of manufacturing liposomes, which allows for reproducible mixing in miliseconds on the nanoliter scale. Here we investigate microfluidics-based manufacturing of liposomes. The aim of these studies was to assess the parameters in a microfluidic process by varying the total flow rate (TFR) and the flow rate ratio (FRR) of the solvent and aqueous phases. Design of experiment and multivariate data analysis were used for increased process understanding and development of predictive and correlative models. High FRR lead to the bottom-up synthesis of liposomes, with a strong correlation with vesicle size, demonstrating the ability to in-process control liposomes size; the resulting liposome size correlated with the FRR in the microfluidics process, with liposomes of 50 nm being reproducibly manufactured. Furthermore, we demonstrate the potential of a high throughput manufacturing of liposomes using microfluidics with a four-fold increase in the volumetric flow rate, maintaining liposome characteristics. The efficacy of these liposomes was demonstrated in transfection studies and was modelled using predictive modeling. Mathematical modelling identified FRR as the key variable in the microfluidic process, with the highest impact on liposome size, polydispersity and transfection efficiency. This study demonstrates microfluidics as a robust and high-throughput method for the scalable and highly reproducible manufacture of size-controlled liposomes. Furthermore, the application of statistically based process control increases understanding and allows for the generation of a design-space for controlled particle characteristics. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

Quality cell therapy manufacturing by design.

PubMed

Lipsitz, Yonatan Y; Timmins, Nicholas E; Zandstra, Peter W

2016-04-01

Transplantation of live cells as therapeutic agents is poised to offer new treatment options for a wide range of acute and chronic diseases. However, the biological complexity of cells has hampered the translation of laboratory-scale experiments into industrial processes for reliable, cost-effective manufacturing of cell-based therapies. We argue here that a solution to this challenge is to design cell manufacturing processes according to quality-by-design (QbD) principles. QbD integrates scientific knowledge and risk analysis into manufacturing process development and is already being adopted by the biopharmaceutical industry. Many opportunities to incorporate QbD into cell therapy manufacturing exist, although further technology development is required for full implementation. Linking measurable molecular and cellular characteristics of a cell population to final product quality through QbD is a crucial step in realizing the potential for cell therapies to transform healthcare.

The Development of Model for Measuring Railway Wheels Manufacturing Readiness Level

NASA Astrophysics Data System (ADS)

Inrawan Wiratmadja, Iwan; Mufid, Anas

2016-02-01

In an effort to grow the railway wheel industry in Indonesia and reduce the dependence on imports, Metal Industries Development Center (MIDC) makes the implementation of the railway wheel manufacturing technology in Indonesia. MIDC is an institution based on research and development having a task to research the production of railway wheels prototype and acts as a supervisor to the industry in Indonesia, for implementing the railway wheel manufacturing technology. The process of implementing manufacturing technology requires a lot of resources. Therefore it is necessary to measure the manufacturing readiness process. Measurement of railway wheels manufacturing readiness was in this study done using the manufacturing readiness level (MRL) model from the United States Department of Defense. MRL consists of 10 manufacturing readiness levels described by 90 criteria and 184 sub-criteria. To get a manufacturing readiness measurement instrument that is good and accurate, the development process involved experts through expert judgment method and validated with a content validity ratio (CVR). Measurement instrument developed in this study consist of 448 indicators. The measurement results show that MIDC's railway wheels manufacturing readiness is at the level 4. This shows that there is a gap between the current level of manufacturing readiness owned by MIDC and manufacturing readiness levels required to achieve the program objectives, which is level 5. To achieve the program objectives at level 5, a number of actions were required to be done by MIDC. Indicators that must be improved to be able to achieve level 5 are indicators related to the cost and financing, process capability and control, quality management, workers, and manufacturing management criteria.

Additive Manufacturing of Single-Crystal Superalloy CMSX-4 Through Scanning Laser Epitaxy: Computational Modeling, Experimental Process Development, and Process Parameter Optimization

NASA Astrophysics Data System (ADS)

Basak, Amrita; Acharya, Ranadip; Das, Suman

2016-08-01

This paper focuses on additive manufacturing (AM) of single-crystal (SX) nickel-based superalloy CMSX-4 through scanning laser epitaxy (SLE). SLE, a powder bed fusion-based AM process was explored for the purpose of producing crack-free, dense deposits of CMSX-4 on top of similar chemistry investment-cast substrates. Optical microscopy and scanning electron microscopy (SEM) investigations revealed the presence of dendritic microstructures that consisted of fine γ' precipitates within the γ matrix in the deposit region. Computational fluid dynamics (CFD)-based process modeling, statistical design of experiments (DoE), and microstructural characterization techniques were combined to produce metallurgically bonded single-crystal deposits of more than 500 μm height in a single pass along the entire length of the substrate. A customized quantitative metallography based image analysis technique was employed for automatic extraction of various deposit quality metrics from the digital cross-sectional micrographs. The processing parameters were varied, and optimal processing windows were identified to obtain good quality deposits. The results reported here represent one of the few successes obtained in producing single-crystal epitaxial deposits through a powder bed fusion-based metal AM process and thus demonstrate the potential of SLE to repair and manufacture single-crystal hot section components of gas turbine systems from nickel-based superalloy powders.

Development of hybrid lifecycle cost estimating tool (HLCET) for manufacturing influenced design tradeoff

NASA Astrophysics Data System (ADS)

Sirirojvisuth, Apinut

In complex aerospace system design, making an effective design decision requires multidisciplinary knowledge from both product and process perspectives. Integrating manufacturing considerations into the design process is most valuable during the early design stages since designers have more freedom to integrate new ideas when changes are relatively inexpensive in terms of time and effort. Several metrics related to manufacturability are cost, time, and manufacturing readiness level (MRL). Yet, there is a lack of structured methodology that quantifies how changes in the design decisions impact these metrics. As a result, a new set of integrated cost analysis tools are proposed in this study to quantify the impacts. Equally important is the capability to integrate this new cost tool into the existing design methodologies without sacrificing agility and flexibility required during the early design phases. To demonstrate the applicability of this concept, a ModelCenter environment is used to develop software architecture that represents Integrated Product and Process Development (IPPD) methodology used in several aerospace systems designs. The environment seamlessly integrates product and process analysis tools and makes effective transition from one design phase to the other while retaining knowledge gained a priori. Then, an advanced cost estimating tool called Hybrid Lifecycle Cost Estimating Tool (HLCET), a hybrid combination of weight-, process-, and activity-based estimating techniques, is integrated with the design framework. A new weight-based lifecycle cost model is created based on Tailored Cost Model (TCM) equations [3]. This lifecycle cost tool estimates the program cost based on vehicle component weights and programmatic assumptions. Additional high fidelity cost tools like process-based and activity-based cost analysis methods can be used to modify the baseline TCM result as more knowledge is accumulated over design iterations. Therefore, with this concept, the additional manufacturing knowledge can be used to identify a more accurate lifecycle cost and facilitate higher fidelity tradeoffs during conceptual and preliminary design. Advanced Composite Cost Estimating Model (ACCEM) is employed as a process-based cost component to replace the original TCM result of the composite part production cost. The reason for the replacement is that TCM estimates production costs from part weights as a result of subtractive manufacturing of metallic origin such as casting, forging, and machining processes. A complexity factor can sometimes be adjusted to reflect different types of metal and machine settings. The TCM assumption, however, gives erroneous results when applied to additive processes like those of composite manufacturing. Another innovative aspect of this research is the introduction of a work measurement technique called Maynard Operation Sequence Technique (MOST) to be used, similarly to Activity-Based Costing (ABC) approach, to estimate manufacturing time of a part by virtue of breaking down the operations occurred during its production. ABC allows a realistic determination of cost incurred in each activity, as opposed to using a traditional method of time estimation by analogy or using response surface equations from historical process data. The MOST concept provides a tailored study of an individual process typically required for a new, innovative design. Nevertheless, the MOST idea has some challenges, one of which is its requirement to build a new process from ground up. The process development requires a Subject Matter Expertise (SME) in manufacturing method of the particular design. The SME must have also a comprehensive understanding of the MOST system so that the correct parameters are chosen. In practice, these knowledge requirements may demand people from outside of the design discipline and a priori training of MOST. To relieve the constraint, this study includes an entirely new sub-system architecture that comprises 1) a knowledge-based system to provide the required knowledge during the process selection; and 2) a new user-interface to guide the parameter selection when building the process using MOST. Also included in this study is the demonstration of how the HLCET and its constituents can be integrated with a Georgia Tech' Integrated Product and Process Development (IPPD) methodology. The applicability of this work will be shown through a complex aerospace design example to gain insights into how manufacturing knowledge helps make better design decisions during the early stages. The setup process is explained with an example of its utility demonstrated in a hypothetical fighter aircraft wing redesign. The evaluation of the system effectiveness against existing methodologies is illustrated to conclude the thesis.

Validation of column-based chromatography processes for the purification of proteins. Technical report No. 14.

PubMed

2008-01-01

PDA Technical Report No. 14 has been written to provide current best practices, such as application of risk-based decision making, based in sound science to provide a foundation for the validation of column-based chromatography processes and to expand upon information provided in Technical Report No. 42, Process Validation of Protein Manufacturing. The intent of this technical report is to provide an integrated validation life-cycle approach that begins with the use of process development data for the definition of operational parameters as a basis for validation, confirmation, and/or minor adjustment to these parameters at manufacturing scale during production of conformance batches and maintenance of the validated state throughout the product's life cycle.

Virtual manufacturing in reality

NASA Astrophysics Data System (ADS)

Papstel, Jyri; Saks, Alo

2000-10-01

SMEs play an important role in manufacturing industry. But from time to time there is a shortage in resources to complete the particular order in time. Number of systems is introduced to produce digital information in order to support product and process development activities. Main problem is lack of opportunity for direct data transition within design system modules when needed temporary extension of design capacity (virtuality) or to implement integrated concurrent product development principles. The planning experience in the field is weakly used as well. The concept of virtual manufacturing is a supporting idea to solve this problem. At the same time a number of practical problems should be solved like information conformity, data transfer, unified technological concepts acceptation etc. In the present paper the proposed ways to solve the practical problems of virtual manufacturing are described. General objective is to introduce the knowledge-based CAPP system as missing module for Virtual Manufacturing in the selected product domain. Surface-centered planning concept based on STEP- based modeling principles, and knowledge-based process planning methodology will be used to gain the objectives. As a result the planning module supplied by design data with direct access, and supporting advising environment is expected. Mould producing SME would be as test basis.

Testing single point incremental forming molds for thermoforming operations

NASA Astrophysics Data System (ADS)

Afonso, Daniel; de Sousa, Ricardo Alves; Torcato, Ricardo

2016-10-01

Low pressure polymer processing processes as thermoforming or rotational molding use much simpler molds then high pressure processes like injection. However, despite the low forces involved with the process, molds manufacturing for this operations is still a very material, energy and time consuming operation. The goal of the research is to develop and validate a method for manufacturing plastically formed sheets metal molds by single point incremental forming (SPIF) operation for thermoforming operation. Stewart platform based SPIF machines allow the forming of thick metal sheets, granting the required structural stiffness for the mold surface, and keeping the short lead time manufacture and low thermal inertia.

The Effect of Ultrasonic Additive Manufacturing on Integrated Printed Electronic Conductors

NASA Astrophysics Data System (ADS)

Bournias-Varotsis, Alkaios; Wang, Shanda; Hutt, David; Engstrøm, Daniel S.

2018-07-01

Ultrasonic additive manufacturing (UAM) is a low temperature manufacturing method capable of embedding printed electronics in metal components. The effect of UAM processing on the resistivity of conductive tracks printed with five different conductive pastes based on silver, copper or carbon flakes/particles in either a thermoplastic or thermoset filler binder are investigated. For all but the carbon-based paste, the resistivity changed linearly with the UAM energy input. After UAM processing, a resistivity increase of more than 150 times was recorded for the copper based thermoset paste. The silver based pastes showed a resistivity increase of between 1.1 and 50 times from their initial values. The carbon-based paste showed no change in resistivity after UAM processing. Focussed ion beam microstructure analysis of the printed conductive tracks before and after UAM processing showed that the silver particles and flakes in at least one of the pastes partly dislodged from their thermoset filler creating voids, thereby increasing the resistivity, whereas the silver flakes in a thermoplastic filler did not dislodge due to material flow of the polymer binder. The lowest resistivity (8 × 10-5 Ω cm) after UAM processing was achieved for a thermoplastic paste with silver flakes at low UAM processing energy.

The Effect of Ultrasonic Additive Manufacturing on Integrated Printed Electronic Conductors

NASA Astrophysics Data System (ADS)

Bournias-Varotsis, Alkaios; Wang, Shanda; Hutt, David; Engstrøm, Daniel S.

2018-03-01

Ultrasonic additive manufacturing (UAM) is a low temperature manufacturing method capable of embedding printed electronics in metal components. The effect of UAM processing on the resistivity of conductive tracks printed with five different conductive pastes based on silver, copper or carbon flakes/particles in either a thermoplastic or thermoset filler binder are investigated. For all but the carbon-based paste, the resistivity changed linearly with the UAM energy input. After UAM processing, a resistivity increase of more than 150 times was recorded for the copper based thermoset paste. The silver based pastes showed a resistivity increase of between 1.1 and 50 times from their initial values. The carbon-based paste showed no change in resistivity after UAM processing. Focussed ion beam microstructure analysis of the printed conductive tracks before and after UAM processing showed that the silver particles and flakes in at least one of the pastes partly dislodged from their thermoset filler creating voids, thereby increasing the resistivity, whereas the silver flakes in a thermoplastic filler did not dislodge due to material flow of the polymer binder. The lowest resistivity (8 × 10-5 Ω cm) after UAM processing was achieved for a thermoplastic paste with silver flakes at low UAM processing energy.

Technological progress and challenges towards cGMP manufacturing of human pluripotent stem cells based therapeutic products for allogeneic and autologous cell therapies.

PubMed

Abbasalizadeh, Saeed; Baharvand, Hossein

2013-12-01

Recent technological advances in the generation, characterization, and bioprocessing of human pluripotent stem cells (hPSCs) have created new hope for their use as a source for production of cell-based therapeutic products. To date, a few clinical trials that have used therapeutic cells derived from hESCs have been approved by the Food and Drug Administration (FDA), but numerous new hPSC-based cell therapy products are under various stages of development in cell therapy-specialized companies and their future market is estimated to be very promising. However, the multitude of critical challenges regarding different aspects of hPSC-based therapeutic product manufacturing and their therapies have made progress for the introduction of new products and clinical applications very slow. These challenges include scientific, technological, clinical, policy, and financial aspects. The technological aspects of manufacturing hPSC-based therapeutic products for allogeneic and autologous cell therapies according to good manufacturing practice (cGMP) quality requirements is one of the most important challenging and emerging topics in the development of new hPSCs for clinical use. In this review, we describe main critical challenges and highlight a series of technological advances in all aspects of hPSC-based therapeutic product manufacturing including clinical grade cell line development, large-scale banking, upstream processing, downstream processing, and quality assessment of final cell therapeutic products that have brought hPSCs closer to clinical application and commercial cGMP manufacturing. © 2013.

Sustainability Characterization for Additive Manufacturing.

PubMed

Mani, Mahesh; Lyons, Kevin W; Gupta, S K

2014-01-01

Additive manufacturing (AM) has the potential to create geometrically complex parts that require a high degree of customization, using less material and producing less waste. Recent studies have shown that AM can be an economically viable option for use by the industry, yet there are some inherent challenges associated with AM for wider acceptance. The lack of standards in AM impedes its use for parts production since industries primarily depend on established standards in processes and material selection to ensure the consistency and quality. Inability to compare AM performance against traditional manufacturing methods can be a barrier for implementing AM processes. AM process sustainability has become a driver due to growing environmental concerns for manufacturing. This has reinforced the importance to understand and characterize AM processes for sustainability. Process characterization for sustainability will help close the gaps for comparing AM performance to traditional manufacturing methods. Based on a literature review, this paper first examines the potential environmental impacts of AM. A methodology for sustainability characterization of AM is then proposed to serve as a resource for the community to benchmark AM processes for sustainability. Next, research perspectives are discussed along with relevant standardization efforts.

Structural design of composite rotor blades with consideration of manufacturability, durability, and manufacturing uncertainties

NASA Astrophysics Data System (ADS)

Li, Leihong

A modular structural design methodology for composite blades is developed. This design method can be used to design composite rotor blades with sophisticate geometric cross-sections. This design method hierarchically decomposed the highly-coupled interdisciplinary rotor analysis into global and local levels. In the global level, aeroelastic response analysis and rotor trim are conduced based on multi-body dynamic models. In the local level, variational asymptotic beam sectional analysis methods are used for the equivalent one-dimensional beam properties. Compared with traditional design methodology, the proposed method is more efficient and accurate. Then, the proposed method is used to study three different design problems that have not been investigated before. The first is to add manufacturing constraints into design optimization. The introduction of manufacturing constraints complicates the optimization process. However, the design with manufacturing constraints benefits the manufacturing process and reduces the risk of violating major performance constraints. Next, a new design procedure for structural design against fatigue failure is proposed. This procedure combines the fatigue analysis with the optimization process. The durability or fatigue analysis employs a strength-based model. The design is subject to stiffness, frequency, and durability constraints. Finally, the manufacturing uncertainty impacts on rotor blade aeroelastic behavior are investigated, and a probabilistic design method is proposed to control the impacts of uncertainty on blade structural performance. The uncertainty factors include dimensions, shapes, material properties, and service loads.

Process-based Cost Estimation for Ramjet/Scramjet Engines

NASA Technical Reports Server (NTRS)

Singh, Brijendra; Torres, Felix; Nesman, Miles; Reynolds, John

2003-01-01

Process-based cost estimation plays a key role in effecting cultural change that integrates distributed science, technology and engineering teams to rapidly create innovative and affordable products. Working together, NASA Glenn Research Center and Boeing Canoga Park have developed a methodology of process-based cost estimation bridging the methodologies of high-level parametric models and detailed bottoms-up estimation. The NASA GRC/Boeing CP process-based cost model provides a probabilistic structure of layered cost drivers. High-level inputs characterize mission requirements, system performance, and relevant economic factors. Design alternatives are extracted from a standard, product-specific work breakdown structure to pre-load lower-level cost driver inputs and generate the cost-risk analysis. As product design progresses and matures the lower level more detailed cost drivers can be re-accessed and the projected variation of input values narrowed, thereby generating a progressively more accurate estimate of cost-risk. Incorporated into the process-based cost model are techniques for decision analysis, specifically, the analytic hierarchy process (AHP) and functional utility analysis. Design alternatives may then be evaluated not just on cost-risk, but also user defined performance and schedule criteria. This implementation of full-trade study support contributes significantly to the realization of the integrated development environment. The process-based cost estimation model generates development and manufacturing cost estimates. The development team plans to expand the manufacturing process base from approximately 80 manufacturing processes to over 250 processes. Operation and support cost modeling is also envisioned. Process-based estimation considers the materials, resources, and processes in establishing cost-risk and rather depending on weight as an input, actually estimates weight along with cost and schedule.

Manufacturing process modeling for composite materials and structures, Sandia blade reliability collaborative

DOE Office of Scientific and Technical Information (OSTI.GOV)

Guest, Daniel A.; Cairns, Douglas S.

2014-02-01

The increased use and interest in wind energy over the last few years has necessitated an increase in the manufacturing of wind turbine blades. This increase in manufacturing has in many ways out stepped the current understanding of not only the materials used but also the manufacturing methods used to construct composite laminates. The goal of this study is to develop a list of process parameters which influence the quality of composite laminates manufactured using vacuum assisted resin transfer molding and to evaluate how they influence laminate quality. Known to be primary factors for the manufacturing process are resin flowmore » rate and vacuum pressure. An incorrect balance of these parameters will often cause porosity or voids in laminates that ultimately degrade the strength of the composite. Fiber waviness has also been seen as a major contributor to failures in wind turbine blades and is often the effect of mishandling during the lay-up process. Based on laboratory tests conducted, a relationship between these parameters and laminate quality has been established which will be a valuable tool in developing best practices and standard procedures for the manufacture of wind turbine blade composites.« less

Integrating artificial and human intelligence into tablet production process.

PubMed

Gams, Matjaž; Horvat, Matej; Ožek, Matej; Luštrek, Mitja; Gradišek, Anton

2014-12-01

We developed a new machine learning-based method in order to facilitate the manufacturing processes of pharmaceutical products, such as tablets, in accordance with the Process Analytical Technology (PAT) and Quality by Design (QbD) initiatives. Our approach combines the data, available from prior production runs, with machine learning algorithms that are assisted by a human operator with expert knowledge of the production process. The process parameters encompass those that relate to the attributes of the precursor raw materials and those that relate to the manufacturing process itself. During manufacturing, our method allows production operator to inspect the impacts of various settings of process parameters within their proven acceptable range with the purpose of choosing the most promising values in advance of the actual batch manufacture. The interaction between the human operator and the artificial intelligence system provides improved performance and quality. We successfully implemented the method on data provided by a pharmaceutical company for a particular product, a tablet, under development. We tested the accuracy of the method in comparison with some other machine learning approaches. The method is especially suitable for analyzing manufacturing processes characterized by a limited amount of data.

Cleaning Process Development for Metallic Additively Manufactured Parts

NASA Technical Reports Server (NTRS)

Tramel, Terri L.; Welker, Roger; Lowery, Niki; Mitchell, Mark

2014-01-01

Additive Manufacturing of metallic components for aerospace applications offers many advantages over traditional manufacturing techniques. As a new technology, many aspects of its widespread utilization remain open to investigation. Among these are the cleaning processes that can be used for post finishing of parts and measurements to verify effectiveness of the cleaning processes. Many cleaning and drying processes and measurement methods that have been used for parts manufactured using conventional techniques are candidates that may be considered for cleaning and verification of additively manufactured parts. Among these are vapor degreasing, ultrasonic immersion and spray cleaning, followed by hot air drying, vacuum baking and solvent displacement drying. Differences in porosity, density, and surface finish of additively manufactured versus conventionally manufactured parts may introduce new considerations in the selection of cleaning and drying processes or the method used to verify their effectiveness. This presentation will review the relative strengths and weaknesses of different candidate cleaning and drying processes as they may apply to additively manufactured metal parts for aerospace applications. An ultrasonic cleaning technique for exploring the cleanability of parts will be presented along with an example using additively manufactured Inconel 718 test specimens to illustrate its use. The data analysis shows that this ultrasonic cleaning approach results in a well-behaved ultrasonic cleaning/extraction behavior. That is, it does not show signs of accelerated cavitation erosion of the base material, which was later confirmed by neutron imaging. In addition, the analysis indicated that complete cleaning would be achieved by ultrasonic immersion cleaning at approximately 5 minutes, which was verified by subsequent cleaning of additional parts.

Process Development for the Design and Manufacturing of Personalizable Mouth Sticks.

PubMed

Berger, Veronika M; Pölzer, Stephan; Nussbaum, Gerhard; Ernst, Waltraud; Major, Zoltan

2017-01-01

To increase the independence of people with reduced hand/arm functionality, a process to generate personalizable mouth sticks was developed based on the participatory design principle. In a web tool, anybody can choose the geometry and the materials of their mouth piece, stick and tip. Manufacturing techniques (e.g. 3D printing) and materials used in the process are discussed and evaluated.

Pyrotechnic hazards classification and evaluation program. Phase 2, segment 3: Test plan for determining hazards associated with pyrotechnic manufacturing processes

NASA Technical Reports Server (NTRS)

1971-01-01

A comprehensive test plan for determining the hazards associated with pyrotechnic manufacturing processes is presented. The rationale for each test is based on a systematic analysis of historical accounts of accidents and a detailed study of the characteristics of each manufacturing process. The most hazardous manufacturing operations have been determined to be pressing, mixing, reaming, and filling. The hazard potential of a given situation is evaluated in terms of the probabilities of initiation, communication, and transition to detonation (ICT). The characteristics which affect the ICT probabilities include the ignition mechanisms which are present either in normal or abnormal operation, the condition and properties of the pyrotechnic material, and the configuration of the processing equipment. Analytic expressions are derived which describe the physical conditions of the system, thus permitting a variety of processes to be evaluated in terms of a small number of experiments.

Rheology as a tool for evaluation of melt processability of innovative dosage forms.

PubMed

Aho, Johanna; Boetker, Johan P; Baldursdottir, Stefania; Rantanen, Jukka

2015-10-30

Future manufacturing of pharmaceuticals will involve innovative use of polymeric excipients. Hot melt extrusion (HME) is an already established manufacturing technique and several products based on HME are on the market. Additionally, processing based on, e.g., HME or three dimensional (3D) printing, will have an increasingly important role when designing products for flexible dosing, since dosage forms based on compacting of a given powder mixture do not enable manufacturing of optimal pharmaceutical products for personalized treatments. The melt processability of polymers and API-polymer mixtures is highly dependent on the rheological properties of these systems, and rheological measurements should be considered as a more central part of the material characterization tool box when selecting suitable candidates for melt processing by, e.g., HME or 3D printing. The polymer processing industry offers established platforms, methods, and models for rheological characterization, and they can often be readily applied in the field of pharmaceutical manufacturing. Thoroughly measured and calculated rheological parameters together with thermal and mechanical material data are needed for the process simulations which are also becoming increasingly important. The authors aim to give an overview to the basics of rheology and summarize examples of the studies where rheology has been utilized in setting up or evaluating extrusion processes. Furthermore, examples of different experimental set-ups available for rheological measurements are presented, discussing each of their typical application area, advantages and limitations. Copyright © 2015 Elsevier B.V. All rights reserved.

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

This factsheet describes a project that developed and demonstrated a new manufacturing-informed design framework that utilizes advanced multi-scale, physics-based process modeling to dramatically improve manufacturing productivity and quality in machining operations while reducing the cost of machined components.

Undergraduate Quality Management Project: Motorcycle Manufacturer Vendor Rating System

ERIC Educational Resources Information Center

Baker, James; McHaney, Roger

2009-01-01

A major motorcycle vendor, based in the U.S. Midwest, is the world's largest custom V-Twin motorcycle manufacturer and domestically the second largest motorcycle manufacturer behind Harley-Davidson. This project describes the process used used by a K-State undergraduate distance learning student to design and develop the initial version of a…

Evaluation of RFID for Information Visibility Based Job-Shop Scheduling in Lean Manufacturing Environments

ERIC Educational Resources Information Center

Chongwatpol, Jongsawas

2012-01-01

This dissertation investigates the impact of radio frequency identification (RFID) in manufacturing. Two simulation studies of an organization that is considering implementing RFID on a production line are conducted. First, we investigate whether addition of RFID technologies in the manufacturing process can complement Lean initiatives.…

Process Modeling and Validation for Metal Big Area Additive Manufacturing

DOE Office of Scientific and Technical Information (OSTI.GOV)

Simunovic, Srdjan; Nycz, Andrzej; Noakes, Mark W.

Metal Big Area Additive Manufacturing (mBAAM) is a new additive manufacturing (AM) technology based on the metal arc welding. A continuously fed metal wire is melted by an electric arc that forms between the wire and the substrate, and deposited in the form of a bead of molten metal along the predetermined path. Objects are manufactured one layer at a time starting from the base plate. The final properties of the manufactured object are dependent on its geometry and the metal deposition path, in addition to depending on the basic welding process parameters. Computational modeling can be used to acceleratemore » the development of the mBAAM technology as well as a design and optimization tool for the actual manufacturing process. We have developed a finite element method simulation framework for mBAAM using the new features of software ABAQUS. The computational simulation of material deposition with heat transfer is performed first, followed by the structural analysis based on the temperature history for predicting the final deformation and stress state. In this formulation, we assume that two physics phenomena are coupled in only one direction, i.e. the temperatures are driving the deformation and internal stresses, but their feedback on the temperatures is negligible. The experiment instrumentation (measurement types, sensor types, sensor locations, sensor placements, measurement intervals) and the measurements are presented. The temperatures and distortions from the simulations show good correlation with experimental measurements. Ongoing modeling work is also briefly discussed.« less

Recent developments in turbomachinery component materials and manufacturing challenges for aero engine applications

NASA Astrophysics Data System (ADS)

Srinivas, G.; Raghunandana, K.; Satish Shenoy, B.

2018-02-01

In the recent years the development of turbomachinery materials performance enhancement plays a vital role especially in aircraft air breathing engines like turbojet engine, turboprop engine, turboshaft engine and turbofan engines. Especially the transonic flow engines required highly sophisticated materials where it can sustain the entire thrust which can create by the engine. The main objective of this paper is to give an overview of the present cost-effective and technological capabilities process for turbomachinery component materials. Especially the main focus is given to study the Electro physical, Photonic additive removal process and Electro chemical process for turbomachinery parts manufacture. The aeronautical propulsion based technologies are reviewed thoroughly where in surface reliability, geometrical precession, and material removal and highly strengthened composite material deposition rates usually difficult to cut dedicated steels, Titanium and Nickel based alloys. In this paper the past aeronautical and propulsion mechanical based manufacturing technologies, current sophisticated technologies and also future challenging material processing techniques are covered. The paper also focuses on the brief description of turbomachinery components of shaping process and coating in aeromechanical applications.

Microeconomics of process control in semiconductor manufacturing

NASA Astrophysics Data System (ADS)

Monahan, Kevin M.

2003-06-01

Process window control enables accelerated design-rule shrinks for both logic and memory manufacturers, but simple microeconomic models that directly link the effects of process window control to maximum profitability are rare. In this work, we derive these links using a simplified model for the maximum rate of profit generated by the semiconductor manufacturing process. We show that the ability of process window control to achieve these economic objectives may be limited by variability in the larger manufacturing context, including measurement delays and process variation at the lot, wafer, x-wafer, x-field, and x-chip levels. We conclude that x-wafer and x-field CD control strategies will be critical enablers of density, performance and optimum profitability at the 90 and 65nm technology nodes. These analyses correlate well with actual factory data and often identify millions of dollars in potential incremental revenue and cost savings. As an example, we show that a scatterometry-based CD Process Window Monitor is an economically justified, enabling technology for the 65nm node.

Manufacturing Demonstration Facility: Roll-to-Roll Processing

DOE Office of Scientific and Technical Information (OSTI.GOV)

Datskos, Panos G; Joshi, Pooran C; List III, Frederick Alyious

This Manufacturing Demonstration Facility (MDF)e roll-to-roll processing effort described in this report provided an excellent opportunity to investigate a number of advanced manufacturing approaches to achieve a path for low cost devices and sensors. Critical to this effort is the ability to deposit thin films at low temperatures using nanomaterials derived from nanofermentation. The overarching goal of this project was to develop roll-to-roll manufacturing processes of thin film deposition on low-cost flexible substrates for electronics and sensor applications. This project utilized ORNL s unique Pulse Thermal Processing (PTP) technologies coupled with non-vacuum low temperature deposition techniques, ORNL s clean roommore » facility, slot dye coating, drop casting, spin coating, screen printing and several other equipment including a Dimatix ink jet printer and a large-scale Kyocera ink jet printer. The roll-to-roll processing project had three main tasks: 1) develop and demonstrate zinc-Zn based opto-electronic sensors using low cost nanoparticulate structures manufactured in a related MDF Project using nanofermentation techniques, 2) evaluate the use of silver based conductive inks developed by project partner NovaCentrix for electronic device fabrication, and 3) demonstrate a suite of low cost printed sensors developed using non-vacuum deposition techniques which involved the integration of metal and semiconductor layers to establish a diverse sensor platform technology.« less

A methodology toward manufacturing grid-based virtual enterprise operation platform

NASA Astrophysics Data System (ADS)

Tan, Wenan; Xu, Yicheng; Xu, Wei; Xu, Lida; Zhao, Xianhua; Wang, Li; Fu, Liuliu

2010-08-01

Virtual enterprises (VEs) have become one of main types of organisations in the manufacturing sector through which the consortium companies organise their manufacturing activities. To be competitive, a VE relies on the complementary core competences among members through resource sharing and agile manufacturing capacity. Manufacturing grid (M-Grid) is a platform in which the production resources can be shared. In this article, an M-Grid-based VE operation platform (MGVEOP) is presented as it enables the sharing of production resources among geographically distributed enterprises. The performance management system of the MGVEOP is based on the balanced scorecard and has the capacity of self-learning. The study shows that a MGVEOP can make a semi-automated process possible for a VE, and the proposed MGVEOP is efficient and agile.

A methodology for Manufacturing Execution Systems (MES) implementation

NASA Astrophysics Data System (ADS)

Govindaraju, Rajesri; Putra, Krisna

2016-02-01

Manufacturing execution system is information systems (IS) application that bridges the gap between IS at the top level, namely enterprise resource planning (ERP), and IS at the lower levels, namely the automation systems. MES provides a media for optimizing the manufacturing process as a whole in a real time basis. By the use of MES in combination with the implementation of ERP and other automation systems, a manufacturing company is expected to have high competitiveness. In implementing MES, functional integration -making all the components of the manufacturing system able to work well together, is the most difficult challenge. For this, there has been an industry standard that specifies the sub-systems of a manufacturing execution systems and defines the boundaries between ERP systems, MES, and other automation systems. The standard is known as ISA-95. Although the advantages from the use of MES have been stated in some studies, not much research being done on how to implement MES effectively. The purpose of this study is to develop a methodology describing how MES implementation project should be managed, utilising the support of ISA- 95 reference model in the system development process. A proposed methodology was developed based on a general IS development methodology. The developed methodology were then revisited based on the understanding about the specific charateristics of MES implementation project found in an Indonesian steel manufacturing company implementation case. The case study highlighted the importance of applying an effective requirement elicitation method during innitial system assessment process, managing system interfaces and labor division in the design process, and performing a pilot deployment before putting the whole system into operation.

Integrating post-manufacturing issues into design and manufacturing decisions

NASA Technical Reports Server (NTRS)

Eubanks, Charles F.

1996-01-01

An investigation is conducted on research into some of the fundamental issues underlying the design for manufacturing, service and recycling that affect engineering decisions early in the conceptual design phase of mechanical systems. The investigation focuses on a system-based approach to material selection, manufacturing methods and assembly processes related to overall product requirements, performance and life-cycle costs. Particular emphasis is placed on concurrent engineering decision support for post-manufacturing issues such as serviceability, recyclability, and product retirement.

Post-processing of 3D-printed parts using femtosecond and picosecond laser radiation

NASA Astrophysics Data System (ADS)

Mingareev, Ilya; Gehlich, Nils; Bonhoff, Tobias; Meiners, Wilhelm; Kelbassa, Ingomar; Biermann, Tim; Richardson, Martin C.

2014-03-01

Additive manufacturing, also known as 3D-printing, is a near-net shape manufacturing approach, delivering part geometry that can be considerably affected by various process conditions, heat-induced distortions, solidified melt droplets, partially fused powders, and surface modifications induced by the manufacturing tool motion and processing strategy. High-repetition rate femtosecond and picosecond laser radiation was utilized to improve surface quality of metal parts manufactured by laser additive techniques. Different laser scanning approaches were utilized to increase the ablation efficiency and to reduce the surface roughness while preserving the initial part geometry. We studied post-processing of 3D-shaped parts made of Nickel- and Titanium-base alloys by utilizing Selective Laser Melting (SLM) and Laser Metal Deposition (LMD) as additive manufacturing techniques. Process parameters such as the pulse energy, the number of layers and their spatial separation were varied. Surface processing in several layers was necessary to remove the excessive material, such as individual powder particles, and to reduce the average surface roughness from asdeposited 22-45 μm to a few microns. Due to the ultrafast laser-processing regime and the small heat-affected zone induced in materials, this novel integrated manufacturing approach can be used to post-process parts made of thermally and mechanically sensitive materials, and to attain complex designed shapes with micrometer precision.

Method for automatically evaluating a transition from a batch manufacturing technique to a lean manufacturing technique

DOEpatents

Ivezic, Nenad; Potok, Thomas E.

2003-09-30

A method for automatically evaluating a manufacturing technique comprises the steps of: receiving from a user manufacturing process step parameters characterizing a manufacturing process; accepting from the user a selection for an analysis of a particular lean manufacturing technique; automatically compiling process step data for each process step in the manufacturing process; automatically calculating process metrics from a summation of the compiled process step data for each process step; and, presenting the automatically calculated process metrics to the user. A method for evaluating a transition from a batch manufacturing technique to a lean manufacturing technique can comprise the steps of: collecting manufacturing process step characterization parameters; selecting a lean manufacturing technique for analysis; communicating the selected lean manufacturing technique and the manufacturing process step characterization parameters to an automatic manufacturing technique evaluation engine having a mathematical model for generating manufacturing technique evaluation data; and, using the lean manufacturing technique evaluation data to determine whether to transition from an existing manufacturing technique to the selected lean manufacturing technique.

Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use.

PubMed

Salmikangas, Paula; Menezes-Ferreira, Margarida; Reischl, Ilona; Tsiftsoglou, Asterios; Kyselovic, Jan; Borg, John Joseph; Ruiz, Sol; Flory, Egbert; Trouvin, Jean-Hugues; Celis, Patrick; Ancans, Janis; Timon, Marcos; Pante, Guido; Sladowski, Dariusz; Lipnik-Stangelj, Metoda; Schneider, Christian K

2015-01-01

During the past decade, a large number of cell-based medicinal products have been tested in clinical trials for the treatment of various diseases and tissue defects. However, licensed products and those approaching marketing authorization are still few. One major area of challenge is the manufacturing and quality development of these complex products, for which significant manipulation of cells might be required. While the paradigms of quality, safety and efficacy must apply also to these innovative products, their demonstration may be demanding. Demonstration of comparability between production processes and batches may be difficult for cell-based medicinal products. Thus, the development should be built around a well-controlled manufacturing process and a qualified product to guarantee reproducible data from nonclinical and clinical studies.

Numerical simulation of residual stress in laser based additive manufacturing process

NASA Astrophysics Data System (ADS)

Kalyan Panda, Bibhu; Sahoo, Seshadev

2018-03-01

Minimizing the residual stress build-up in metal-based additive manufacturing plays a pivotal role in selecting a particular material and technique for making an industrial part. In beam-based additive manufacturing, although a great deal of effort has been made to minimize the residual stresses, it is still elusive how to do so by simply optimizing the processing parameters, such as beam size, beam power, and scan speed. Amid different types of additive manufacturing processes, Direct Metal Laser Sintering (DMLS) process uses a high-power laser to melt and sinter layers of metal powder. The rapid solidification and heat transfer on powder bed endows a high cooling rate which leads to the build-up of residual stresses, that will affect the mechanical properties of the build parts. In the present work, the authors develop a numerical thermo-mechanical model for the measurement of residual stress in the AlSi10Mg build samples by using finite element method. Transient temperature distribution in the powder bed was assessed using the coupled thermal to structural model. Subsequently, the residual stresses were estimated with varying laser power. From the simulation result, it found that the melt pool dimensions increase with increasing the laser power and the magnitude of residual stresses in the built part increases.

Towards automatic planning for manufacturing generative processes

DOE Office of Scientific and Technical Information (OSTI.GOV)

CALTON,TERRI L.

2000-05-24

Generative process planning describes methods process engineers use to modify manufacturing/process plans after designs are complete. A completed design may be the result from the introduction of a new product based on an old design, an assembly upgrade, or modified product designs used for a family of similar products. An engineer designs an assembly and then creates plans capturing manufacturing processes, including assembly sequences, component joining methods, part costs, labor costs, etc. When new products originate as a result of an upgrade, component geometry may change, and/or additional components and subassemblies may be added to or are omitted from themore » original design. As a result process engineers are forced to create new plans. This is further complicated by the fact that the process engineer is forced to manually generate these plans for each product upgrade. To generate new assembly plans for product upgrades, engineers must manually re-specify the manufacturing plan selection criteria and re-run the planners. To remedy this problem, special-purpose assembly planning algorithms have been developed to automatically recognize design modifications and automatically apply previously defined manufacturing plan selection criteria and constraints.« less

Integrated manufacturing approach to attain benchmark team performance

NASA Astrophysics Data System (ADS)

Chen, Shau-Ron; Nguyen, Andrew; Naguib, Hussein

1994-09-01

A Self-Directed Work Team (SDWT) was developed to transfer a polyimide process module from the research laboratory to our wafer fab facility for applications in IC specialty devices. The SDWT implemented processes and tools based on the integration of five manufacturing strategies for continuous improvement. These were: Leadership Through Quality (LTQ), Total Productive Maintenance (TMP), Cycle Time Management (CTM), Activity-Based Costing (ABC), and Total Employee Involvement (TEI). Utilizing these management techniques simultaneously, the team achieved six sigma control of all critical parameters, increased Overall Equipment Effectiveness (OEE) from 20% to 90%, reduced cycle time by 95%, cut polyimide manufacturing cost by 70%, and improved its overall team member skill level by 33%.

A study of internal structure in components made by additive manufacturing process using 3 D X-ray tomography

NASA Astrophysics Data System (ADS)

Raguvarun, K.; Balasubramaniam, Krishnan; Rajagopal, Prabhu; Palanisamy, Suresh; Nagarajah, Romesh; Hoye, Nicholas; Curiri, Dominic; Kapoor, Ajay

2015-03-01

Additive manufacturing methods are gaining increasing popularity for rapidly and efficiently manufacturing parts and components in the industrial context, as well as for domestic applications. However, except when used for prototyping or rapid visualization of components, industries are concerned with the load carrying capacity and strength achievable by additive manufactured parts. In this paper, the wire-arc additive manufacturing (AM) process based on gas tungsten arc welding (GTAW) has been examined for the internal structure and constitution of components generated by the process. High-resolution 3D X-ray tomography is used to gain cut-views through wedge-shaped parts created using this GTAW additive manufacturing process with titanium alloy materials. In this work, two different control conditions for the GTAW process are considered. The studies reveal clusters of porosities, located in periodic spatial intervals along the sample cross-section. Such internal defects can have a detrimental effect on the strength of the resulting AM components, as shown in destructive testing studies. Closer examination of this phenomenon shows that defect clusters are preferentially located at GTAW traversal path intervals. These results highlight the strong need for enhanced control of process parameters in ensuring components with minimal defects and higher strength.

Integrated Glass Coating Manufacturing Line

DOE Office of Scientific and Technical Information (OSTI.GOV)

Brophy, Brenor

2015-09-30

This project aims to enable US module manufacturers to coat glass with Enki’s state of the art tunable functionalized AR coatings at the lowest possible cost and highest possible performance by encapsulating Enki’s coating process in an integrated tool that facilitates effective process improvement through metrology and data analysis for greater quality and performance while reducing footprint, operating and capital costs. The Phase 1 objective was a fully designed manufacturing line, including fully specified equipment ready for issue of purchase requisitions; a detailed economic justification based on market prices at the end of Phase 1 and projected manufacturing costs andmore » a detailed deployment plan for the equipment.« less

U.S. Wind Energy Manufacturing and Supply Chain: A Competitiveness Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fullenkamp, Patrick H; Holody, Diane S

The goal of the project was to develop a greater understanding of the key factors determining wind energy component manufacturing costs and pricing on a global basis in order to enhance the competitiveness of U.S. manufacturers, and to reduce installed systems cost. Multiple stakeholders including DOE, turbine OEMs, and large component manufactures will all benefit by better understanding the factors determining domestic competitiveness in the emerging offshore and next generation land-based wind industries. Major objectives of this project were to: 1. Carry out global cost and process comparisons for 5MW jacket foundations, blades, towers, and permanent magnet generators; 2. Assessmore » U.S. manufacturers’ competitiveness and potential for cost reduction; 3. Facilitate informed decision-making on investments in U.S. manufacturing; 4. Develop an industry scorecard representing the readiness of the U.S. manufacturers’ to produce components for the next generations of wind turbines, nominally 3MW land-based and 5MW offshore; 5. Disseminate results through the GLWN Wind Supply Chain GIS Map, a free website that is the most comprehensive public database of U.S. wind energy suppliers; 6. Identify areas and develop recommendations to DOE on potential R&D areas to target for increasing domestic manufacturing competitiveness, per DOE’s Clean Energy Manufacturing Initiative (CEMI). Lists of Deliverables 1. Cost Breakdown Competitive Analyses of four product categories: tower, jacket foundation, blade, and permanent magnet (PM) generator. The cost breakdown for each component includes a complete Bill of Materials with net weights; general process steps for labor; and burden adjusted by each manufacturer for their process categories of SGA (sales general and administrative), engineering, logistics cost to a common U.S. port, and profit. 2. Value Stream Map Competitiveness Analysis: A tool that illustrates both information and material flow from the point of getting a customer order at the manufacturing plant; to the orders being forwarded by the manufacturing plant to the material suppliers; to the material being received at the manufacturing plant and processed through the system; to the final product being shipped to the Customer. 3. Competitiveness Scorecard: GLWN developed a Wind Industry Supply Chain Scorecard that reflects U.S. component manufacturers’ readiness to supply the next generation wind turbines, 3MW and 5MW, for land-based and offshore applications. 4. Wind Supply Chain Database & Map: Expand the current GLWN GIS Wind Supply Chain Map to include offshore elements. This is an on-line, free access, wind supply chain map that provides a platform for identifying active and emerging suppliers for the land-based and offshore wind industry, including turbine component manufacturers and wind farm construction service suppliers.« less

Tracking the course of the manufacturing process in selective laser melting

NASA Astrophysics Data System (ADS)

Thombansen, U.; Gatej, A.; Pereira, M.

2014-02-01

An innovative optical train for a selective laser melting based manufacturing system (SLM) has been designed under the objective to track the course of the SLM process. In this, the thermal emission from the melt pool and the geometric properties of the interaction zone are addressed by applying a pyrometer and a camera system respectively. The optical system is designed such that all three radiations from processing laser, thermal emission and camera image are coupled coaxially and that they propagate on the same optical axis. As standard f-theta lenses for high power applications inevitably lead to aberrations and divergent optical axes for increasing deflection angles in combination with multiple wavelengths, a pre-focus system is used to implement a focusing unit which shapes the beam prior to passing the scanner. The sensor system records synchronously the current position of the laser beam, the current emission from the melt pool and an image of the interaction zone. Acquired data of the thermal emission is being visualized after processing which allows an instant evaluation of the course of the process at any position of each layer. As such, it provides a fully detailed history of the product This basic work realizes a first step towards self-optimization of the manufacturing process by providing information about quality relevant events during manufacture. The deviation from the planned course of the manufacturing process to the actual course of the manufacturing process can be used to adapt the manufacturing strategy from one layer to the next. In the current state, the system can be used to facilitate the setup of the manufacturing system as it allows identification of false machine settings without having to analyze the work piece.

Technological innovation capability in Malaysian-owned resource-based manufacturing companies: Early findings

NASA Astrophysics Data System (ADS)

Razali, Nur Fhathyhah; Mohd Suradi, Nur Riza; Ahmad Shahabuddin, Faridatul Azna; Ismail, Wan Rosmanira; Abidin, Norkisme Zainal; Ahmad, Nor Amalina; Mustafa, Zainol

2013-04-01

This study aims to identify the determinants of technological innovation capability of Malaysian-owned companies in the resources-based manufacturing, to identify the relationship between technological innovation capability (TIC) and technological innovation performance (TIP) for the resource-based manufacturing. Furthermore, this study also aims to identify innovation capability factors that need more emphasis and improvements from the respective authority. The scope of the study covers four industries which are petrochemical industries, pharmaceutical industries, palm oil-based industries and food processing industries which are located in the state of Selangor. Descriptive analysis, correlation analysis and performance capability analysis were used in this study. It was found that, technological innovation capabilities (TIC) for companies in the resource-based manufacturing are moderate. Factors such as policies capability, human resources capability and facilities capability have a positive relationship with the performance of technological innovation (TIP). These findings will help the government in making decisions and better implementation of policies to strengthen the competitiveness of the company, particularly in resource-based manufacturing.

Effects of build parameters on linear wear loss in plastic part produced by fused deposition modeling

NASA Astrophysics Data System (ADS)

Mohamed, Omar Ahmed; Masood, Syed Hasan; Bhowmik, Jahar Lal

2017-07-01

Fused Deposition Modeling (FDM) is one of the prominent additive manufacturing technologies for producing polymer products. FDM is a complex additive manufacturing process that can be influenced by many process conditions. The industrial demands required from the FDM process are increasing with higher level product functionality and properties. The functionality and performance of FDM manufactured parts are greatly influenced by the combination of many various FDM process parameters. Designers and researchers always pay attention to study the effects of FDM process parameters on different product functionalities and properties such as mechanical strength, surface quality, dimensional accuracy, build time and material consumption. However, very limited studies have been carried out to investigate and optimize the effect of FDM build parameters on wear performance. This study focuses on the effect of different build parameters on micro-structural and wear performance of FDM specimens using definitive screening design based quadratic model. This would reduce the cost and effort of additive manufacturing engineer to have a systematic approachto make decision among the manufacturing parameters to achieve the desired product quality.

Materials, Processes and Manufacturing in Ares 1 Upper Stage: Integration with Systems Design and Development

NASA Technical Reports Server (NTRS)

Bhat, Biliyar N.

2008-01-01

Ares I Crew Launch Vehicle Upper Stage is designed and developed based on sound systems engineering principles. Systems Engineering starts with Concept of Operations and Mission requirements, which in turn determine the launch system architecture and its performance requirements. The Ares I-Upper Stage is designed and developed to meet these requirements. Designers depend on the support from materials, processes and manufacturing during the design, development and verification of subsystems and components. The requirements relative to reliability, safety, operability and availability are also dependent on materials availability, characterization, process maturation and vendor support. This paper discusses the roles and responsibilities of materials and manufacturing engineering during the various phases of Ares IUS development, including design and analysis, hardware development, test and verification. Emphasis is placed how materials, processes and manufacturing support is integrated over the Upper Stage Project, both horizontally and vertically. In addition, the paper describes the approach used to ensure compliance with materials, processes, and manufacturing requirements during the project cycle, with focus on hardware systems design and development.

Polyoxylglycerides and glycerides: effects of manufacturing parameters on API stability, excipient functionality and processing.

PubMed

Jannin, Vincent; Rodier, Jean-David; Musakhanian, Jasmine

2014-05-15

Lipid-based formulations are a viable option to address modern drug delivery challenges such as increasing the oral bioavailability of poorly water-soluble active pharmaceutical ingredients (APIs), or sustaining the drug release of molecules intended for chronic diseases. Esters of fatty acids and glycerol (glycerides) and polyethylene-glycols (polyoxylglycerides) are two main classes of lipid-based excipients used by oral, dermal, rectal, vaginal or parenteral routes. These lipid-based materials are more and more commonly used in pharmaceutical drug products but there is still a lack of understanding of how the manufacturing processes, processing aids, or additives can impact the chemical stability of APIs within the drug product. In that regard, this review summarizes the key parameters to look at when formulating with lipid-based excipients in order to anticipate a possible impact on drug stability or variation of excipient functionality. The introduction presents the chemistry of natural lipids, fatty acids and their properties in relation to the extraction and refinement processes. Then, the key parameters during the manufacturing process influencing the quality of lipid-based excipients are provided. Finally, their critical characteristics are discussed in relation with their intended functionality and ability to interact with APIs and others excipients within the formulation. Copyright © 2014. Published by Elsevier B.V.

Highly Manufacturable Deep (Sub-Millimeter) Etching Enabled High Aspect Ratio Complex Geometry Lego-Like Silicon Electronics.

PubMed

Ghoneim, Mohamed Tarek; Hussain, Muhammad Mustafa

2017-04-01

A highly manufacturable deep reactive ion etching based process involving a hybrid soft/hard mask process technology shows high aspect ratio complex geometry Lego-like silicon electronics formation enabling free-form (physically flexible, stretchable, and reconfigurable) electronic systems. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

40 CFR 761.185 - Certification program and retention of records by importers and persons generating PCBs in...

Code of Federal Regulations, 2010 CFR

2010-07-01

... manufacturing processes in which PCBs are generated when the PCB level in products leaving any manufacturing... imported products when the PCB concentration of products being imported is greater than 2 µg/g for any... process waste disposal. (2) Whether determinations of compliance are based on actual monitoring of PCB...

Pattern database applications from design to manufacturing

NASA Astrophysics Data System (ADS)

Zhuang, Linda; Zhu, Annie; Zhang, Yifan; Sweis, Jason; Lai, Ya-Chieh

2017-03-01

Pattern-based approaches are becoming more common and popular as the industry moves to advanced technology nodes. At the beginning of a new technology node, a library of process weak point patterns for physical and electrical verification are starting to build up and used to prevent known hotspots from re-occurring on new designs. Then the pattern set is expanded to create test keys for process development in order to verify the manufacturing capability and precheck new tape-out designs for any potential yield detractors. With the database growing, the adoption of pattern-based approaches has expanded from design flows to technology development and then needed for mass-production purposes. This paper will present the complete downstream working flows of a design pattern database(PDB). This pattern-based data analysis flow covers different applications across different functional teams from generating enhancement kits to improving design manufacturability, populating new testing design data based on previous-learning, generating analysis data to improve mass-production efficiency and manufacturing equipment in-line control to check machine status consistency across different fab sites.

Lubricant base oil and wax processing. [Glossary included

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sequeira, A. Jr.

1994-01-01

This book provides state-of-the-art information on all processes currently used to manufacture lubricant base oils and waxes. It furnishes helpful lists of conversion factors, construction cost data, and process licensors, as well as a glossary of essential petroleum processing terms.

Assembly processes comparison for a miniaturized laser used for the Exomars European Space Agency mission

NASA Astrophysics Data System (ADS)

Ribes-Pleguezuelo, Pol; Inza, Andoni Moral; Basset, Marta Gilaberte; Rodríguez, Pablo; Rodríguez, Gemma; Laudisio, Marco; Galan, Miguel; Hornaff, Marcel; Beckert, Erik; Eberhardt, Ramona; Tünnermann, Andreas

2016-11-01

A miniaturized diode-pumped solid-state laser (DPSSL) designed as part of the Raman laser spectrometer (RLS) instrument for the European Space Agency (ESA) Exomars mission 2020 is assembled and tested for the mission purpose and requirements. Two different processes were tried for the laser assembling: one based on adhesives, following traditional laser manufacturing processes; another based on a low-stress and organic-free soldering technique called solderjet bumping technology. The manufactured devices were tested for the processes validation by passing mechanical, thermal cycles, radiation, and optical functional tests. The comparison analysis showed a device improvement in terms of reliability of the optical performances from the soldered to the assembled by adhesive-based means.

Lasers in Materials Processing

NASA Astrophysics Data System (ADS)

Kukreja, L. M.; Paul, C. P.; Kumar, Atul; Kaul, R.; Ganesh, P.; Rao, B. T.

Laser is undoubtedly one of the most important inventions of the twentieth century. Today, it is widely deployed for a cornucopia of applications including materials processing. Different lasers such as CO2, Nd:YAG, excimer, copper vapor, diode, fiber lasers, etc., are being used extensively for various materials processing applications like cutting, welding, brazing, surface treatment, peening, and rapid manufacturing by adopting conventional and unconventional routes with unprecedented precision. In view of its potential for providing solution to the emerging problems of the industrial materials processing and manufacturing technologies, a comprehensive program on laser materials processing and allied technologies was initiated at our laboratory. A novel feature-based design and additive manufacturing technologies facilitated the laser rapid manufacturing of complex engineering components with superior performance. This technology is being extended for the fabrication of anatomically shaped prosthetics with internal heterogeneous architectures. Laser peening of spring steels brought significant improvement in its fatigue life. Laser surface treatments resulted in enhanced intergranular corrosion resistance of AISI 316(N) and 304 stainless steel. Parametric dependence of laser welding of dissimilar materials, AISI 316M stainless steel with alloy D9, was established for avoiding cracks under optimum processing conditions. In the domain of laser cutting and piercing, the development of a power ramped pulsed mode with high pulse repetition frequency and low duty cycle scheme could produce highly circular, narrow holes with minimum spattered pierced holes. A review of these experimental and some theoretical studies is presented and discussed in this chapter. These studies have provided deeper insight of fascinating laser-based materials processing application for industrial manufacturing technologies.

Preliminary Investigation of Keyhole Phenomena during Single Layer Fabrication in Laser Additive Manufacturing of Stainless Steel

NASA Astrophysics Data System (ADS)

Matilainen, Ville-Pekka; Piili, Heidi; Salminen, Antti; Nyrhilä, Olli

Laser additive manufacturing (LAM) is a fabrication technology that enables production of complex parts from metallic materials with mechanical properties comparable to conventionally manufactured parts. In the LAM process, parts are manufactured by melting metallic powder layer-by-layer with a laser beam. This manufacturing technology is nowadays called powder bed fusion (PBF) according to the ASTM F2792-12a standard. This strategy involves several different independent and dependent thermal cycles, all of which have an influence on the final properties of the manufactured part. The quality of PBF parts depends strongly on the characteristics of each single laser-melted track and each single layer. This study consequently concentrates on investigating the effects of process parameters such as laser power on single track and layer formation and laser-material interaction phenomena occurring during the PBF process. Experimental tests were done with two different machines: a modified research machine based on an EOS EOSINT M-series system and an EOS EOSINT M280 system. The material used was EOS stainless steel 17-4 PH. Process monitoring was done with an active illuminated high speed camera system. After microscopy analysis, it was concluded that a keyhole can form during laser additive manufacturing of stainless steel. It was noted that heat input has an important effect on the likelihood of keyhole formation. The threshold intensity value for keyhole formation of 106 W/cm2 was exceeded in all manufactured single tracks. Laser interaction time was found to have an effect on penetration depth and keyhole formation, since the penetration depth increased with increased laser interaction time. It was also concluded that active illuminated high speed camera systems are suitable for monitoring of the manufacturing process and facilitate process control.

Agent-based services for B2B electronic commerce

NASA Astrophysics Data System (ADS)

Fong, Elizabeth; Ivezic, Nenad; Rhodes, Tom; Peng, Yun

2000-12-01

The potential of agent-based systems has not been realized yet, in part, because of the lack of understanding of how the agent technology supports industrial needs and emerging standards. The area of business-to-business electronic commerce (b2b e-commerce) is one of the most rapidly developing sectors of industry with huge impact on manufacturing practices. In this paper, we investigate the current state of agent technology and the feasibility of applying agent-based computing to b2b e-commerce in the circuit board manufacturing sector. We identify critical tasks and opportunities in the b2b e-commerce area where agent-based services can best be deployed. We describe an implemented agent-based prototype system to facilitate the bidding process for printed circuit board manufacturing and assembly. These activities are taking place within the Internet Commerce for Manufacturing (ICM) project, the NIST- sponsored project working with industry to create an environment where small manufacturers of mechanical and electronic components may participate competitively in virtual enterprises that manufacture printed circuit assemblies.

System-wide hybrid MPC-PID control of a continuous pharmaceutical tablet manufacturing process via direct compaction.

PubMed

Singh, Ravendra; Ierapetritou, Marianthi; Ramachandran, Rohit

2013-11-01

The next generation of QbD based pharmaceutical products will be manufactured through continuous processing. This will allow the integration of online/inline monitoring tools, coupled with an efficient advanced model-based feedback control systems, to achieve precise control of process variables, so that the predefined product quality can be achieved consistently. The direct compaction process considered in this study is highly interactive and involves time delays for a number of process variables due to sensor placements, process equipment dimensions, and the flow characteristics of the solid material. A simple feedback regulatory control system (e.g., PI(D)) by itself may not be sufficient to achieve the tight process control that is mandated by regulatory authorities. The process presented herein comprises of coupled dynamics involving slow and fast responses, indicating the requirement of a hybrid control scheme such as a combined MPC-PID control scheme. In this manuscript, an efficient system-wide hybrid control strategy for an integrated continuous pharmaceutical tablet manufacturing process via direct compaction has been designed. The designed control system is a hybrid scheme of MPC-PID control. An effective controller parameter tuning strategy involving an ITAE method coupled with an optimization strategy has been used for tuning of both MPC and PID parameters. The designed hybrid control system has been implemented in a first-principles model-based flowsheet that was simulated in gPROMS (Process System Enterprise). Results demonstrate enhanced performance of critical quality attributes (CQAs) under the hybrid control scheme compared to only PID or MPC control schemes, illustrating the potential of a hybrid control scheme in improving pharmaceutical manufacturing operations. Copyright © 2013 Elsevier B.V. All rights reserved.

Repurposing mainstream CNC machine tools for laser-based additive manufacturing

NASA Astrophysics Data System (ADS)

Jones, Jason B.

2016-04-01

The advent of laser technology has been a key enabler for industrial 3D printing, known as Additive Manufacturing (AM). Despite its commercial success and unique technical capabilities, laser-based AM systems are not yet able to produce parts with the same accuracy and surface finish as CNC machining. To enable the geometry and material freedoms afforded by AM, yet achieve the precision and productivity of CNC machining, hybrid combinations of these two processes have started to gain traction. To achieve the benefits of combined processing, laser technology has been integrated into mainstream CNC machines - effectively repurposing them as hybrid manufacturing platforms. This paper reviews how this engineering challenge has prompted beam delivery innovations to allow automated changeover between laser processing and machining, using standard CNC tool changers. Handling laser-processing heads using the tool changer also enables automated change over between different types of laser processing heads, further expanding the breadth of laser processing flexibility in a hybrid CNC. This paper highlights the development, challenges and future impact of hybrid CNCs on laser processing.

A manufacturing error measurement methodology for a rotary vector reducer cycloidal gear based on a gear measuring center

NASA Astrophysics Data System (ADS)

Li, Tianxing; Zhou, Junxiang; Deng, Xiaozhong; Li, Jubo; Xing, Chunrong; Su, Jianxin; Wang, Huiliang

2018-07-01

A manufacturing error of a cycloidal gear is the key factor affecting the transmission accuracy of a robot rotary vector (RV) reducer. A methodology is proposed to realize the digitized measurement and data processing of the cycloidal gear manufacturing error based on the gear measuring center, which can quickly and accurately measure and evaluate the manufacturing error of the cycloidal gear by using both the whole tooth profile measurement and a single tooth profile measurement. By analyzing the particularity of the cycloidal profile and its effect on the actual meshing characteristics of the RV transmission, the cycloid profile measurement strategy is planned, and the theoretical profile model and error measurement model of cycloid-pin gear transmission are established. Through the digital processing technology, the theoretical trajectory of the probe and the normal vector of the measured point are calculated. By means of precision measurement principle and error compensation theory, a mathematical model for the accurate calculation and data processing of manufacturing error is constructed, and the actual manufacturing error of the cycloidal gear is obtained by the optimization iterative solution. Finally, the measurement experiment of the cycloidal gear tooth profile is carried out on the gear measuring center and the HEXAGON coordinate measuring machine, respectively. The measurement results verify the correctness and validity of the measurement theory and method. This methodology will provide the basis for the accurate evaluation and the effective control of manufacturing precision of the cycloidal gear in a robot RV reducer.

Project-Based Manufacturing Engineering Practice at Ibaraki University and Its Outcomes

NASA Astrophysics Data System (ADS)

Yamasaki, Kazuhiko; Wang, Dong F.; Maekawa, Katsuhiro

The real world experience of manufacturing processes from an idea stage to a final product must be related to classroom lectures in mechanical engineering curriculum, including design, materials engineering, dynamics and control. Various challenges and difficulties encountered during the manufacturing engineering practice also let students recognize their creativity as well as what kinds of knowledge is missing. Awareness is the start of growth. In line with this principle we have carried out the mechanical engineering practice for 10 years. Some modifications toward “project-based practice” , however, have been made through manufacturing engineers’ real activities. Drawing and specification, process control, cost management, and role-sharing arrangement are stressed during the semester course. The present paper describes how it works and what is left to improve further, such as a refinement of themes and a coaching method for bringing out the hidden talent in students.

Fiber Orientation Effects in Fused Filament Fabrication of Air-Cooled Heat Exchangers

NASA Astrophysics Data System (ADS)

Mulholland, T.; Goris, S.; Boxleitner, J.; Osswald, T. A.; Rudolph, N.

2018-03-01

Fused filament fabrication (FFF) is a type of additive manufacturing based on material extrusion that has long been considered a prototyping technology. However, the right application of material, process, and product can be used for manufacturing of end-use products, such as air-cooled heat exchangers made by adding fillers to the base polymer, enhancing the thermal conductivity. Fiber fillers lead to anisotropic thermal conductivity, which is governed by the process-induced fiber orientation. This article presents an experimental study on the microstructure-property relationship for carbon fiber-filled polyamide used in FFF. The fiber orientation is measured by micro-computed tomography, and the thermal conductivity of manufactured samples is measured. Although the thermal conductivity is raised by more than three times in the fiber orientation direction at a load of only 12 vol.%, the enhancement is low in the other directions, and this anisotropy, along with certain manufacturing restrictions, influences the final part performance.

Safe handling of cytotoxic compounds in a biopharmaceutical environment.

PubMed

Hensgen, Miriam I; Stump, Bernhard

2013-01-01

Handling cytotoxic drugs such as antibody-drug conjugates (ADCs) in a biopharmaceutical environment represents a challenge based on the potency of the compounds. These derivatives are dangerous to humans if they accidentally get in contact with the skin, are inhaled, or are ingested, either as pure compounds in their solid state or as a solution dissolved in a co-solvent. Any contamination of people involved in the manufacturing process has to be avoided. On the other hand, biopharmaceuticals need to be protected simultaneously against any contamination from the manufacturing personnel. Therefore, a tailor-made work environment is mandatory in order to manufacture ADCs. This asks for appropriate technical equipment to keep potential hazardous substances contained. In addition, clearly defined working procedures based on risk assessments as well as proper training for all personnel involved in the manufacturing process are needed to safely handle these highly potent pharmaceuticals.

Tribology symposium 1995. PD-Volume 72

DOE Office of Scientific and Technical Information (OSTI.GOV)

Masudi, H.

After the keynote presentation by Professor Aaron Cohen of Texas A and M University, entitled Processes Used in Design, the program is divided into five major sessions: Research and Development -- Recent research and development of tribological components; Tribology in Manufacturing -- The impact of tribology on modern manufacturing; Design/Design Representation -- Aspects of design related to tribological systems; Tribo-Chemistry/Tribo-Physics -- Discussion of chemical and physical behavior of substances as related to tribology; and Failure Analysis -- An analysis of failure, failure detection, and failure monitoring as related to manufacturing processes. Papers have been processed separately for inclusion on themore » data base.« less

Sustainability Characterization for Additive Manufacturing

PubMed Central

Mani, Mahesh; Lyons, Kevin W; Gupta, SK

2014-01-01

Additive manufacturing (AM) has the potential to create geometrically complex parts that require a high degree of customization, using less material and producing less waste. Recent studies have shown that AM can be an economically viable option for use by the industry, yet there are some inherent challenges associated with AM for wider acceptance. The lack of standards in AM impedes its use for parts production since industries primarily depend on established standards in processes and material selection to ensure the consistency and quality. Inability to compare AM performance against traditional manufacturing methods can be a barrier for implementing AM processes. AM process sustainability has become a driver due to growing environmental concerns for manufacturing. This has reinforced the importance to understand and characterize AM processes for sustainability. Process characterization for sustainability will help close the gaps for comparing AM performance to traditional manufacturing methods. Based on a literature review, this paper first examines the potential environmental impacts of AM. A methodology for sustainability characterization of AM is then proposed to serve as a resource for the community to benchmark AM processes for sustainability. Next, research perspectives are discussed along with relevant standardization efforts. PMID:26601038

A Hospital Is Not Just a Factory, but a Complex Adaptive System-Implications for Perioperative Care.

PubMed

Mahajan, Aman; Islam, Salim D; Schwartz, Michael J; Cannesson, Maxime

2017-07-01

Many methods used to improve hospital and perioperative services productivity and quality of care have assumed that the hospital is essentially a factory, and therefore, that industrial engineering and manufacturing-derived redesign approaches such as Six Sigma and Lean can be applied to hospitals and perioperative services just as they have been applied in factories. However, a hospital is not merely a factory but also a complex adaptive system (CAS). The hospital CAS has many subsystems, with perioperative care being an important one for which concepts of factory redesign are frequently advocated. In this article, we argue that applying only factory approaches such as lean methodologies or process standardization to complex systems such as perioperative care could account for difficulties and/or failures in improving performance in care delivery. Within perioperative services, only noncomplex/low-variance surgical episodes are amenable to manufacturing-based redesign. On the other hand, complex surgery/high-variance cases and preoperative segmentation (the process of distinguishing between normal and complex cases) can be viewed as CAS-like. These systems tend to self-organize, often resist or react unpredictably to attempts at control, and therefore require application of CAS principles to modify system behavior. We describe 2 examples of perioperative redesign to illustrate the concepts outlined above. These examples present complementary and contrasting cases from 2 leading delivery systems. The Mayo Clinic example illustrates the application of manufacturing-based redesign principles to a factory-like (high-volume, low-risk, and mature practice) clinical program, while the Kaiser Permanente example illustrates the application of both manufacturing-based and self-organization-based approaches to programs and processes that are not factory-like but CAS-like. In this article, we describe how factory-like processes and CAS can coexist within a hospital and how self-organization-based approaches can be used to improve care delivery in many situations where manufacturing-based approaches may not be appropriate.

A quality risk management model approach for cell therapy manufacturing.

PubMed

Lopez, Fabio; Di Bartolo, Chiara; Piazza, Tommaso; Passannanti, Antonino; Gerlach, Jörg C; Gridelli, Bruno; Triolo, Fabio

2010-12-01

International regulatory authorities view risk management as an essential production need for the development of innovative, somatic cell-based therapies in regenerative medicine. The available risk management guidelines, however, provide little guidance on specific risk analysis approaches and procedures applicable in clinical cell therapy manufacturing. This raises a number of problems. Cell manufacturing is a poorly automated process, prone to operator-introduced variations, and affected by heterogeneity of the processed organs/tissues and lot-dependent variability of reagent (e.g., collagenase) efficiency. In this study, the principal challenges faced in a cell-based product manufacturing context (i.e., high dependence on human intervention and absence of reference standards for acceptable risk levels) are identified and addressed, and a risk management model approach applicable to manufacturing of cells for clinical use is described for the first time. The use of the heuristic and pseudo-quantitative failure mode and effect analysis/failure mode and critical effect analysis risk analysis technique associated with direct estimation of severity, occurrence, and detection is, in this specific context, as effective as, but more efficient than, the analytic hierarchy process. Moreover, a severity/occurrence matrix and Pareto analysis can be successfully adopted to identify priority failure modes on which to act to mitigate risks. The application of this approach to clinical cell therapy manufacturing in regenerative medicine is also discussed. © 2010 Society for Risk Analysis.

Virtual Collaborative Simulation Environment for Integrated Product and Process Development

NASA Technical Reports Server (NTRS)

Gulli, Michael A.

1997-01-01

Deneb Robotics is a leader in the development of commercially available, leading edge three- dimensional simulation software tools for virtual prototyping,, simulation-based design, manufacturing process simulation, and factory floor simulation and training applications. Deneb has developed and commercially released a preliminary Virtual Collaborative Engineering (VCE) capability for Integrated Product and Process Development (IPPD). This capability allows distributed, real-time visualization and evaluation of design concepts, manufacturing processes, and total factory and enterprises in one seamless simulation environment.

Efficient 'Optical Furnace': A Cheaper Way to Make Solar Cells is Reaching the Marketplace

DOE Office of Scientific and Technical Information (OSTI.GOV)

von Kuegelgen, T.

In Bhushan Sopori's laboratory, you'll find a series of optical furnaces he has developed for fabricating solar cells. When not in use, they sit there discreetly among the lab equipment. But when a solar silicon wafer is placed inside one for processing, Sopori walks over to a computer and types in a temperature profile. Almost immediately this fires up the furnace, which glows inside and selectively heats up the silicon wafer to 800 degrees centigrade by the intense light it produces. Sopori, a principal engineer at the National Renewable Energy Laboratory, has been researching and developing optical furnace technology formore » around 20 years. He says it's a challenging technology to develop because there are many issues to consider when you process a solar cell, especially in optics. Despite the challenges, Sopori and his research team have advanced the technology to the point where it will benefit all solar cell manufacturers. They are now developing a commercial version of the furnace in partnership with a manufacturer. 'This advanced optical furnace is highly energy efficient, and it can be used to manufacture any type of solar cell,' he says. Each type of solar cell or manufacturing process typically requires a different furnace configuration and temperature profile. With NREL's new optical furnace system, a solar cell manufacturer can ask the computer for any temperature profile needed for processing a solar cell, and the same type of furnace is suitable for several solar cell fabrication process steps. 'In the future, solar cell manufacturers will only need this one optical furnace because it can be used for any process, including diffusion, metallization and oxidation,' Sopori says. 'This helps reduce manufacturing costs.' One startup company, Applied Optical Systems, has recognized the furnace's potential for manufacturing thin-film silicon cells. 'We'd like to develop thin-film silicon cells with higher efficiencies, up to 15 to 18 percent, and we believe this furnace will enable us to do so,' says A. Rangappan, founder and CEO of Applied Optical Systems. Rangappan also says it will take only a few minutes for the optical furnace to process a thin-film solar cell, which reduces manufacturing costs. Overall, he estimates the company's solar cell will cost around 80 cents per watt. For manufacturing these thin-film silicon cells, Applied Optical Systems and NREL have developed a partnership through a cooperative research and development agreement (CRADA) to construct an optical furnace system prototype. DOE is providing $500,000 from its Technology Commercialization Development Fund to help offset the prototype's development costs because of the technology's significant market potential. The program has provided the NREL technology transfer office with a total of $4 million to expand such collaborative efforts between NREL researchers and companies. Applied Optical will construct a small version of the optical furnace based on the prototype design in NREL's process development and integration laboratory through a separate CRADA. This small furnace will only develop one solar cell wafer at a time. Then, the company will construct a large, commercial-scale optical furnace at its own facilities, which will turn out around 1,000 solar cell wafers per hour. 'We hope to start using the optical furnace for manufacturing within four to five years,' Rangappan says. Meanwhile, another partnership using the optical furnace has evolved between NREL and SiXtron Advanced Materials, another startup. Together they'll use the optical furnace to optimize the metallization process for novel antireflective solar cell coatings. The process is not only expected to yield higher efficiencies for silicon-based solar cells, but also lowers processing costs and eliminates safety concerns for manufacturers. Most solar cell manufacturers currently use a plasma-enhanced chemical vapor deposition (PECVD) system with compressed and extremely pyrophoric silane gas (SiH4) for applying passivation antireflective coatings (ARC). If silane is exposed to air, the SiH4 will explode - a serious safety issue for high-volume manufacturers. SiXtron's process uses a solid, silicon-based polymer that's converted into noncompressed, nonexplosive gas, which then flows to a standard PECVD system. 'The solid source is so safe to handle that it can be shipped by FedEx,' says Zbigniew Barwicz, president and CEO of SiXtron. Barwicz says manufacturers can use the same PECVD processing equipment for the SiXtron process that they already use for SiH4, a plug-and-play solution. For this novel passivation ARC process, NREL is helping to optimize the metallization parameters. NREL has developed a new technology called optical processing. One of the applications of this process is fire-through contact formation of silicon solar cells.« less

Managing unexpected events in the manufacturing of biologic medicines.

PubMed

Grampp, Gustavo; Ramanan, Sundar

2013-08-01

The manufacturing of biologic medicines (biologics) requires robust process and facility design, rigorous regulatory compliance, and a well-trained workforce. Because of the complex attributes of biologics and their sensitivity to production and handling conditions, manufacturing of these medicines also requires a high-reliability manufacturing organization. As required by regulators, such an organization must monitor the state-of-control for the manufacturing process. A high-reliability organization also invests in an experienced and fully engaged technical support staff and fosters a management culture that rewards in-depth analysis of unexpected results, robust risk assessments, and timely and effective implementation of mitigation measures. Such a combination of infrastructure, technology, human capital, management, and a science-based operations culture does not occur without a strong organizational and financial commitment. These attributes of a high-reliability biologics manufacturer are difficult to achieve and may be differentiating factors as the supply of biologics diversifies in future years.

Defect recognition in CFRP components using various NDT methods within a smart manufacturing process

NASA Astrophysics Data System (ADS)

Schumacher, David; Meyendorf, Norbert; Hakim, Issa; Ewert, Uwe

2018-04-01

The manufacturing process of carbon fiber reinforced polymer (CFRP) components is gaining a more and more significant role when looking at the increasing amount of CFRPs used in industries today. The monitoring of the manufacturing process and hence the reliability of the manufactured products, is one of the major challenges we need to face in the near future. Common defects which arise during manufacturing process are e.g. porosity and voids which may lead to delaminations during operation and under load. To find irregularities and classify them as possible defects in an early stage of the manufacturing process is of high importance for the safety and reliability of the finished products, as well as of significant impact from an economical point of view. In this study we compare various NDT methods which were applied to similar CFRP laminate samples in order to detect and characterize regions of defective volume. Besides ultrasound, thermography and eddy current, different X-ray methods like radiography, laminography and computed tomography are used to investigate the samples. These methods are compared with the intention to evaluate their capability to reliably detect and characterize defective volume. Beyond the detection and evaluation of defects, we also investigate possibilities to combine various NDT methods within a smart manufacturing process in which the decision which method shall be applied is inherent within the process. Is it possible to design an in-line or at-line testing process which can recognize defects reliably and reduce testing time and costs? This study aims to show up opportunities of designing a smart NDT process synchronized to the production based on the concepts of smart production (Industry 4.0). A set of defective CFRP laminate samples and different NDT methods were used to demonstrate how effective defects are recognized and how communication between interconnected NDT sensors and the manufacturing process could be organized.

Real-time parameter optimization based on neural network for smart injection molding

NASA Astrophysics Data System (ADS)

Lee, H.; Liau, Y.; Ryu, K.

2018-03-01

The manufacturing industry has been facing several challenges, including sustainability, performance and quality of production. Manufacturers attempt to enhance the competitiveness of companies by implementing CPS (Cyber-Physical Systems) through the convergence of IoT(Internet of Things) and ICT(Information & Communication Technology) in the manufacturing process level. Injection molding process has a short cycle time and high productivity. This features have been making it suitable for mass production. In addition, this process is used to produce precise parts in various industry fields such as automobiles, optics and medical devices. Injection molding process has a mixture of discrete and continuous variables. In order to optimized the quality, variables that is generated in the injection molding process must be considered. Furthermore, Optimal parameter setting is time-consuming work to predict the optimum quality of the product. Since the process parameter cannot be easily corrected during the process execution. In this research, we propose a neural network based real-time process parameter optimization methodology that sets optimal process parameters by using mold data, molding machine data, and response data. This paper is expected to have academic contribution as a novel study of parameter optimization during production compare with pre - production parameter optimization in typical studies.

How Many Batches Are Needed for Process Validation under the New FDA Guidance?

PubMed

Yang, Harry

2013-01-01

The newly updated FDA Guidance for Industry on Process Validation: General Principles and Practices ushers in a life cycle approach to process validation. While the guidance no longer considers the use of traditional three-batch validation appropriate, it does not prescribe the number of validation batches for a prospective validation protocol, nor does it provide specific methods to determine it. This potentially could leave manufacturers in a quandary. In this paper, I develop a Bayesian method to address the issue. By combining process knowledge gained from Stage 1 Process Design (PD) with expected outcomes of Stage 2 Process Performance Qualification (PPQ), the number of validation batches for PPQ is determined to provide a high level of assurance that the process will consistently produce future batches meeting quality standards. Several examples based on simulated data are presented to illustrate the use of the Bayesian method in helping manufacturers make risk-based decisions for Stage 2 PPQ, and they highlight the advantages of the method over traditional Frequentist approaches. The discussions in the paper lend support for a life cycle and risk-based approach to process validation recommended in the new FDA guidance. The newly updated FDA Guidance for Industry on Process Validation: General Principles and Practices ushers in a life cycle approach to process validation. While the guidance no longer considers the use of traditional three-batch validation appropriate, it does not prescribe the number of validation batches for a prospective validation protocol, nor does it provide specific methods to determine it. This potentially could leave manufacturers in a quandary. In this paper, I develop a Bayesian method to address the issue. By combining process knowledge gained from Stage 1 Process Design (PD) with expected outcomes of Stage 2 Process Performance Qualification (PPQ), the number of validation batches for PPQ is determined to provide a high level of assurance that the process will consistently produce future batches meeting quality standards. Several examples based on simulated data are presented to illustrate the use of the Bayesian method in helping manufacturers make risk-based decisions for Stage 2 PPQ, and THEY highlight the advantages of the method over traditional Frequentist approaches. The discussions in the paper lend support for a life cycle and risk-based approach to process validation recommended in the new FDA guidance.

The Road to Realizing In-Space Manufacturing

NASA Technical Reports Server (NTRS)

Clinton, Raymond G.

2014-01-01

Additive Manufacturing in space offers tremendous potential for dramatic paradigm shift in the development and manufacturing of space architectures. Additive Manufacturing in space offers the potential for mission safety risk reduction for low Earth orbit and deep space exploration; new paradigms for maintenance, repair, and logistics. Leverage ground-based technology developments, process characterization, and material properties databases. Investments are required primarily in the microgravity environment. We must do the foundational work. It's not sexy, but it is required.

Additive Manufacturing of Silicon Carbide-Based Ceramic Matrix Composites: Technical Challenges and Opportunities

NASA Technical Reports Server (NTRS)

Singh, Mrityunjay; Halbig, Michael C.; Grady, Joseph E.

2016-01-01

Advanced SiC-based ceramic matrix composites offer significant contributions toward reducing fuel burn and emissions by enabling high overall pressure ratio (OPR) of gas turbine engines and reducing or eliminating cooling air in the hot-section components, such as shrouds, combustor liners, vanes, and blades. Additive manufacturing (AM), which allows high value, custom designed parts layer by layer, has been demonstrated for metals and polymer matrix composites. However, there has been limited activity on additive manufacturing of ceramic matrix composites (CMCs). In this presentation, laminated object manufacturing (LOM), binder jet process, and 3-D printing approaches for developing ceramic composite materials are presented. For the laminated object manufacturing (LOM), fiber prepreg laminates were cut into shape with a laser and stacked to form the desired part followed by high temperature heat treatments. For the binder jet, processing optimization was pursued through silicon carbide powder blending, infiltration with and without SiC nano powder loading, and integration of fibers into the powder bed. Scanning electron microscopy was conducted along with XRD, TGA, and mechanical testing. Various technical challenges and opportunities for additive manufacturing of ceramics and CMCs will be presented.

A kinetic modeling of chondrocyte culture for manufacture of tissue-engineered cartilage.

PubMed

Kino-Oka, Masahiro; Maeda, Yoshikatsu; Yamamoto, Takeyuki; Sugawara, Katsura; Taya, Masahito

2005-03-01

For repairing articular cartilage defects, innovative techniques based on tissue engineering have been developed and are now entering into the practical stage of clinical application by means of grafting in vitro cultured products. A variety of natural and artificial materials available for scaffolds, which permit chondrocyte cells to aggregate, have been designed for their ability to promote cell growth and differentiation. From the viewpoint of the manufacturing process for tissue-engineered cartilage, the diverse nature of raw materials (seeding cells) and end products (cultured cartilage) oblige us to design a tailor-made process with less reproducibility, which is an obstacle to establishing a production doctrine based on bioengineering knowledge concerning growth kinetics and modeling as well as designs of bioreactors and culture operations for certification of high product quality. In this article, we review the recent advances in the manufacturing of tissue-engineered cartilage. After outlining the manufacturing processes for tissue-engineered cartilage in the first section, the second and third sections, respectively, describe the three-dimensional culture of chondrocytes with Aterocollagen gel and kinetic model consideration as a tool for evaluating this culture process. In the final section, culture strategy is discussed in terms of the combined processes of monolayer growth (ex vivo chondrocyte cell expansion) and three-dimensional growth (construction of cultured cartilage in the gel).

Knowledge Reasoning with Semantic Data for Real-Time Data Processing in Smart Factory

PubMed Central

Wang, Shiyong; Li, Di; Liu, Chengliang

2018-01-01

The application of high-bandwidth networks and cloud computing in manufacturing systems will be followed by mass data. Industrial data analysis plays important roles in condition monitoring, performance optimization, flexibility, and transparency of the manufacturing system. However, the currently existing architectures are mainly for offline data analysis, not suitable for real-time data processing. In this paper, we first define the smart factory as a cloud-assisted and self-organized manufacturing system in which physical entities such as machines, conveyors, and products organize production through intelligent negotiation and the cloud supervises this self-organized process for fault detection and troubleshooting based on data analysis. Then, we propose a scheme to integrate knowledge reasoning and semantic data where the reasoning engine processes the ontology model with real time semantic data coming from the production process. Based on these ideas, we build a benchmarking system for smart candy packing application that supports direct consumer customization and flexible hybrid production, and the data are collected and processed in real time for fault diagnosis and statistical analysis. PMID:29415444

[A strategy of constructing the technological system for quality control of Chinese medicine based on process control and management].

PubMed

Cheng, Yi-Yu; Qian, Zhong-Zhi; Zhang, Bo-Li

2017-01-01

The current situation, bottleneck problems and severe challenges in quality control technology of Chinese Medicine (CM) are briefly described. It is presented to change the phenomenon related to the post-test as the main means and contempt for process control in drug regulation, reverse the situation of neglecting the development of process control and management technology for pharmaceutical manufacture and reconstruct the technological system for quality control of CM products. The regulation and technology system based on process control and management for controlling CM quality should be established to solve weighty realistic problems of CM industry from the root causes, including backwardness of quality control technology, weakness of quality risk control measures, poor reputation of product quality and so on. By this way, the obstacles from poor controllability of CM product quality could be broken. Concentrating on those difficult problems and weak links in the technical field of CM quality control, it is proposed to build CMC (Chemistry, Manufacturing and Controls) regulation for CM products with Chinese characteristics and promote the regulation international recognition as soon as possible. The CMC technical framework, which is clinical efficacy-oriented, manufacturing manner-centered and process control-focused, was designed. To address the clinical characteristics of traditional Chinese medicine (TCM) and the production feature of CM manufacture, it is suggested to establish quality control engineering for CM manufacturing by integrating pharmaceutical analysis, TCM chemistry, TCM pharmacology, pharmaceutical engineering, control engineering, management engineering and other disciplines. Further, a theoretical model of quality control engineering for CM manufacturing and the methodology of digital pharmaceutical engineering are proposed. A technology pathway for promoting CM standard and realizing the strategic goal of CM internationalization is elaborated. Copyright© by the Chinese Pharmaceutical Association.

Determination of the robot location in a workcell of a flexible production line

NASA Astrophysics Data System (ADS)

Banas, W.; Sekala, A.; Gwiazda, A.; Foit, K.; Hryniewicz, P.; Kost, G.

2015-11-01

Location of components of a manufacturing cell is apparently an easy task but even during the constructing of a manufacturing cell, in which is planned a production of one, simple component it is necessary, among others, to check access to all required points. The robot in a manufacturing cell must handle both machine tools located in a manufacturing cell and parts store (input and output one). It handles also transport equipment and auxiliary stands. Sometimes, during the design phase, the changes of robot location are necessary due to the limitation of access to its required working positions. Often succeeding changes of a manufacturing cell configuration are realized. They occur at the stages of visualization and simulation of robot program functioning. In special cases, it is even necessary to replace the planned robot with a robot of greater range or of a different configuration type. This article presents and describes the parameters and components which should be taken into consideration during designing robotised manufacturing cells. The main idea bases on application of advanced engineering programs to adding the designing process. Using this approach it could be possible to present the designing process of an exemplar flexible manufacturing cell intended to manufacture two similar components. The proposed model of such designed manufacturing cell could be easily extended to the manufacturing cell model in which it is possible to produce components belonging the one technological group of chosen similarity level. In particular, during the design process, one should take into consideration components which limit the ability of robot foundation. It is also important to show the method of determining the best location of robot foundation. The presented design method could also support the designing process of other robotised manufacturing cells.

150-nm DR contact holes die-to-database inspection

NASA Astrophysics Data System (ADS)

Kuo, Shen C.; Wu, Clare; Eran, Yair; Staud, Wolfgang; Hemar, Shirley; Lindman, Ofer

2000-07-01

Using a failure analysis-driven yield enhancements concept, based on an optimization of the mask manufacturing process and UV reticle inspection is studied and shown to improve the contact layer quality. This is achieved by relating various manufacturing processes to very fine tuned contact defect detection. In this way, selecting an optimized manufacturing process with fine-tuned inspection setup is achieved in a controlled manner. This paper presents a study, performed on a specially designed test reticle, which simulates production contact layers of design rule 250nm, 180nm and 150nm. This paper focuses on the use of advanced UV reticle inspection techniques as part of the process optimization cycle. Current inspection equipment uses traditional and insufficient methods of small contact-hole inspection and review.

Development of the supply chain oriented quality assurance system for aerospace manufacturing SMEs and its implementation perspectives

NASA Astrophysics Data System (ADS)

Hussein, Abdullahi; Cheng, Kai

2016-10-01

Aerospace manufacturing SMEs are continuously facing the challenge on managing their supply chain and complying with the aerospace manufacturing quality standard requirement due to their lack of resources and the nature of business. In this paper, the ERP system based approach is presented to quality control and assurance work in light of seamless integration of in-process production data and information internally and therefore managing suppliers more effectively and efficiently. The Aerospace Manufacturing Quality Assurance Standard (BS/EN9100) is one of the most recognised and essential protocols for developing the industry-operated-and-driven quality assurance systems. The research investigates using the ERP based system as an enabler to implement BS/EN9100 quality management system at manufacturing SMEs and the associated implementation and application perspectives. An application case study on a manufacturing SME is presented by using the SAP based implementation, which helps further evaluate and validate the approach and application system development.

Proposal of Heuristic Algorithm for Scheduling of Print Process in Auto Parts Supplier

NASA Astrophysics Data System (ADS)

Matsumoto, Shimpei; Okuhara, Koji; Ueno, Nobuyuki; Ishii, Hiroaki

We are interested in the print process on the manufacturing processes of auto parts supplier as an actual problem. The purpose of this research is to apply our scheduling technique developed in university to the actual print process in mass customization environment. Rationalization of the print process is depending on the lot sizing. The manufacturing lead time of the print process is long, and in the present method, production is done depending on worker’s experience and intuition. The construction of an efficient production system is urgent problem. Therefore, in this paper, in order to shorten the entire manufacturing lead time and to reduce the stock, we reexamine the usual method of the lot sizing rule based on heuristic technique, and we propose the improvement method which can plan a more efficient schedule.

Online measurement of bead geometry in GMAW-based additive manufacturing using passive vision

NASA Astrophysics Data System (ADS)

Xiong, Jun; Zhang, Guangjun

2013-11-01

Additive manufacturing based on gas metal arc welding is an advanced technique for depositing fully dense components with low cost. Despite this fact, techniques to achieve accurate control and automation of the process have not yet been perfectly developed. The online measurement of the deposited bead geometry is a key problem for reliable control. In this work a passive vision-sensing system, comprising two cameras and composite filtering techniques, was proposed for real-time detection of the bead height and width through deposition of thin walls. The nozzle to the top surface distance was monitored for eliminating accumulated height errors during the multi-layer deposition process. Various image processing algorithms were applied and discussed for extracting feature parameters. A calibration procedure was presented for the monitoring system. Validation experiments confirmed the effectiveness of the online measurement system for bead geometry in layered additive manufacturing.

The practice and perception of precautionary allergen labelling by the Australasian food manufacturing industry.

PubMed

Zurzolo, G A; Peters, R L; Koplin, J J; de Courten, M; Mathai, M L; Tye-Din, J A; Tang, M L K; Campbell, D E; Ponsonby, A-L; Prescott, S L; Gurrin, L; Dharmage, S C; Allen, K J

2017-07-01

The precautionary allergen labelling (PAL) and Voluntary Incidental Trace Allergen Labelling (VITAL ® ) tools were designed by industry to assist consumers with selecting safe foods for consumption. However, a sizeable proportion of food products bear no label, and it is unclear whether these products are free from allergens and therefore safe to consume or have simply not undergone a risk assessment and therefore remain unlabelled for that reason. To assess the prevalence of unlabelled products that have undergone a risk assessment process and to examine the factors influencing industry's uptake of the VITAL ® process. A web-based questionnaire was distributed to Australasian food and grocery manufacturers. One hundred and thirty-seven Australasian manufacturers were contacted, and 59 questionnaires were returned (response rate: 43%). The respondents represented 454 different manufacturing sites. Manufacturers reported that 23% (95% CI 19-28) of products (n=102/434) that had been through the VITAL ® risk assessment process had no PAL statement on the label. 34% (95% CI 30-38), (n=204/600) of products that had undergone another (non-VITAL ® ) risk assessment process had no PAL statement. In examining the factors that influenced industry's uptake of the VITAL ® process, 25 manufacturers reported on factors that influenced the uptake of the VITAL ® process, 76% (CI 95% 55-91) reported that VITAL ® was an effective tool because it was based on science; 52% (CI 95% 31-72) reported that it was too time-consuming and 36% (CI 95% 18-57) identified a concern with it not being endorsed by the government. Currently, we estimate that at least 30% of products may have been through a risk assessment process and yet bear no PAL statement on the label. Permissive labelling could be incorporated onto these products if they have been assessed to be safe for consumption. © 2017 John Wiley & Sons Ltd.

Study of activity based costing implementation for palm oil production using value-added and non-value-added activity consideration in PT XYZ palm oil mill

NASA Astrophysics Data System (ADS)

Sembiring, M. T.; Wahyuni, D.; Sinaga, T. S.; Silaban, A.

2018-02-01

Cost allocation at manufacturing industry particularly in Palm Oil Mill still widely practiced based on estimation. It leads to cost distortion. Besides, processing time determined by company is not in accordance with actual processing time in work station. Hence, the purpose of this study is to eliminates non-value-added activities therefore processing time could be shortened and production cost could be reduced. Activity Based Costing Method is used in this research to calculate production cost with Value Added and Non-Value-Added Activities consideration. The result of this study is processing time decreasing for 35.75% at Weighting Bridge Station, 29.77% at Sorting Station, 5.05% at Loading Ramp Station, and 0.79% at Sterilizer Station. Cost of Manufactured for Crude Palm Oil are IDR 5.236,81/kg calculated by Traditional Method, IDR 4.583,37/kg calculated by Activity Based Costing Method before implementation of Activity Improvement and IDR 4.581,71/kg after implementation of Activity Improvement Meanwhile Cost of Manufactured for Palm Kernel are IDR 2.159,50/kg calculated by Traditional Method, IDR 4.584,63/kg calculated by Activity Based Costing Method before implementation of Activity Improvement and IDR 4.582,97/kg after implementation of Activity Improvement.

A Multi-Component Automated Laser-Origami System for Cyber-Manufacturing

NASA Astrophysics Data System (ADS)

Ko, Woo-Hyun; Srinivasa, Arun; Kumar, P. R.

2017-12-01

Cyber-manufacturing systems can be enhanced by an integrated network architecture that is easily configurable, reliable, and scalable. We consider a cyber-physical system for use in an origami-type laser-based custom manufacturing machine employing folding and cutting of sheet material to manufacture 3D objects. We have developed such a system for use in a laser-based autonomous custom manufacturing machine equipped with real-time sensing and control. The basic elements in the architecture are built around the laser processing machine. They include a sensing system to estimate the state of the workpiece, a control system determining control inputs for a laser system based on the estimated data and user’s job requests, a robotic arm manipulating the workpiece in the work space, and middleware, named Etherware, supporting the communication among the systems. We demonstrate automated 3D laser cutting and bending to fabricate a 3D product as an experimental result.

Off-target model based OPC

NASA Astrophysics Data System (ADS)

Lu, Mark; Liang, Curtis; King, Dion; Melvin, Lawrence S., III

2005-11-01

Model-based Optical Proximity correction has become an indispensable tool for achieving wafer pattern to design fidelity at current manufacturing process nodes. Most model-based OPC is performed considering the nominal process condition, with limited consideration of through process manufacturing robustness. This study examines the use of off-target process models - models that represent non-nominal process states such as would occur with a dose or focus variation - to understands and manipulate the final pattern correction to a more process robust configuration. The study will first examine and validate the process of generating an off-target model, then examine the quality of the off-target model. Once the off-target model is proven, it will be used to demonstrate methods of generating process robust corrections. The concepts are demonstrated using a 0.13 μm logic gate process. Preliminary indications show success in both off-target model production and process robust corrections. With these off-target models as tools, mask production cycle times can be reduced.

Neutron residual stress measurement and numerical modeling in a curved thin-walled structure by laser powder bed fusion additive manufacturing

DOE PAGES

An, Ke; Yuan, Lang; Dial, Laura; ...

2017-09-11

Severe residual stresses in metal parts made by laser powder bed fusion additive manufacturing processes (LPBFAM) can cause both distortion and cracking during the fabrication processes. Limited data is currently available for both iterating through process conditions and design, and in particular, for validating numerical models to accelerate process certification. In this work, residual stresses of a curved thin-walled structure, made of Ni-based superalloy Inconel 625™ and fabricated by LPBFAM, were resolved by neutron diffraction without measuring the stress-free lattices along both the build and the transverse directions. The stresses of the entire part during fabrication and after cooling downmore » were predicted by a simplified layer-by-layer finite element based numerical model. The simulated and measured stresses were found in good quantitative agreement. The validated simplified simulation methodology will allow to assess residual stresses in more complex structures and to significantly reduce manufacturing cycle time.« less

Neutron residual stress measurement and numerical modeling in a curved thin-walled structure by laser powder bed fusion additive manufacturing

DOE Office of Scientific and Technical Information (OSTI.GOV)

An, Ke; Yuan, Lang; Dial, Laura

Severe residual stresses in metal parts made by laser powder bed fusion additive manufacturing processes (LPBFAM) can cause both distortion and cracking during the fabrication processes. Limited data is currently available for both iterating through process conditions and design, and in particular, for validating numerical models to accelerate process certification. In this work, residual stresses of a curved thin-walled structure, made of Ni-based superalloy Inconel 625™ and fabricated by LPBFAM, were resolved by neutron diffraction without measuring the stress-free lattices along both the build and the transverse directions. The stresses of the entire part during fabrication and after cooling downmore » were predicted by a simplified layer-by-layer finite element based numerical model. The simulated and measured stresses were found in good quantitative agreement. The validated simplified simulation methodology will allow to assess residual stresses in more complex structures and to significantly reduce manufacturing cycle time.« less

Evaluation of hybrid polymers for high-precision manufacturing of 3D optical interconnects by two-photon absorption lithography

NASA Astrophysics Data System (ADS)

Schleunitz, A.; Klein, J. J.; Krupp, A.; Stender, B.; Houbertz, R.; Gruetzner, G.

2017-02-01

The fabrication of optical interconnects has been widely investigated for the generation of optical circuit boards. Twophoton absorption (TPA) lithography (or high-precision 3D printing) as an innovative production method for direct manufacture of individual 3D photonic structures gains more and more attention when optical polymers are employed. In this regard, we have evaluated novel ORMOCER-based hybrid polymers tailored for the manufacture of optical waveguides by means of high-precision 3D printing. In order to facilitate future industrial implementation, the processability was evaluated and the optical performance of embedded waveguides was assessed. The results illustrate that hybrid polymers are not only viable consumables for industrial manufacture of polymeric micro-optics using generic processes such as UV molding. They also are potential candidates to fabricate optical waveguide systems down to the chip level where TPA-based emerging manufacturing techniques are engaged. Hence, it is shown that hybrid polymers continue to meet the increasing expectations of dynamically growing markets of micro-optics and optical interconnects due to the flexibility of the employed polymer material concept.

Overview of the Photovoltaic Manufacturing Technology (PVMaT) project

NASA Astrophysics Data System (ADS)

Witt, C. E.; Mitchell, R. L.; Mooney, G. D.

1993-08-01

The Photovoltaic Manufacturing Technology (PVMaT) project is a historic government/industry photovoltaic (PV) manufacturing R&D partnership composed of joint efforts between the federal government (through the US Department of Energy) and members of the US PV industry. The project's ultimate goal is to ensure that the US industry retains and extends its world leadership role in the manufacture and commercial development of PV components and systems. PVMaT is designed to do this by helping the US PV industry improve manufacturing processes, accelerate manufacturing cost reductions for PV modules, improve commercial product performance, and lay the groundwork for a substantial scale-up of US-based PV manufacturing capacities. Phase 1 of the project, the problem identification phase, was completed in early 1991. Phase 2, the problem solution phase, which addresses process-specific problems of specific manufacturers, is now underway with an expected duration of 5 years. Phase 3 addresses R&D problems that are relatively common to a number of PV companies or the PV industry as a whole. These 'generic' problem areas are being addressed through a teamed research approach.

A framework for the computer-aided planning and optimisation of manufacturing processes for components with functional graded properties

NASA Astrophysics Data System (ADS)

Biermann, D.; Gausemeier, J.; Heim, H.-P.; Hess, S.; Petersen, M.; Ries, A.; Wagner, T.

2014-05-01

In this contribution a framework for the computer-aided planning and optimisation of functional graded components is presented. The framework is divided into three modules - the "Component Description", the "Expert System" for the synthetisation of several process chains and the "Modelling and Process Chain Optimisation". The Component Description module enhances a standard computer-aided design (CAD) model by a voxel-based representation of the graded properties. The Expert System synthesises process steps stored in the knowledge base to generate several alternative process chains. Each process chain is capable of producing components according to the enhanced CAD model and usually consists of a sequence of heating-, cooling-, and forming processes. The dependencies between the component and the applied manufacturing processes as well as between the processes themselves need to be considered. The Expert System utilises an ontology for that purpose. The ontology represents all dependencies in a structured way and connects the information of the knowledge base via relations. The third module performs the evaluation of the generated process chains. To accomplish this, the parameters of each process are optimised with respect to the component specification, whereby the result of the best parameterisation is used as representative value. Finally, the process chain which is capable of manufacturing a functionally graded component in an optimal way regarding to the property distributions of the component description is presented by means of a dedicated specification technique.

Chemistry, manufacturing and control (CMC) and clinical trial technical support for influenza vaccine manufacturers.

PubMed

Wahid, Rahnuma; Holt, Renee; Hjorth, Richard; Berlanda Scorza, Francesco

2016-10-26

With the support of the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services, PATH has contributed to the World Health Organization's (WHO's) Global Action Plan for Influenza Vaccines (GAP) by providing technical and clinical assistance to several developing country vaccine manufacturers (DCVMs). GAP builds regionally based independent and sustainable influenza vaccine production capacity to mitigate the overall global shortage of influenza vaccines. The program also ensures adequate influenza vaccine manufacturing capacity in the event of an influenza pandemic. Since 2009, PATH has worked closely with two DCVMs in Vietnam: the Institute of Vaccines and Medical Biologicals (IVAC) and VABIOTECH. Beginning in 2013, PATH also began working with Torlak Institute in Serbia; Instituto Butantan in Brazil; Serum Institute of India Private Ltd. in India; and Changchun BCHT Biotechnology Co. (BCHT) in China. The DCVMs supported under the GAP program all had existing influenza vaccine manufacturing capability and required technical support from PATH to improve vaccine yield, process efficiency, and product formulation. PATH has provided customized technical support for the manufacturing process to each DCVM based on their respective requirements. Additionally, PATH, working with BARDA and WHO, supported several DCVMs in the clinical development of influenza vaccine candidates progressing toward national licensure or WHO prequalification. As a result of the activities outlined in this review, several companies were able to make excellent progress in developing state-of-the-art manufacturing processes and completing early phase clinical trials. Licensure trials are currently ongoing or planned for several DCVMs. Copyright © 2016 Elsevier Ltd. All rights reserved.

Enhancing Surface Finish of Additively Manufactured Titanium and Cobalt Chrome Elements Using Laser Based Finishing

NASA Astrophysics Data System (ADS)

Gora, Wojciech S.; Tian, Yingtao; Cabo, Aldara Pan; Ardron, Marcus; Maier, Robert R. J.; Prangnell, Philip; Weston, Nicholas J.; Hand, Duncan P.

Additive manufacturing (AM) offers the possibility of creating a complex free form object as a single element, which is not possible using traditional mechanical machining. Unfortunately the typically rough surface finish of additively manufactured parts is unsuitable for many applications. As a result AM parts must be post-processed; typically mechanically machined and/or and polished using either chemical or mechanical techniques (both of which have their limitations). Laser based polishing is based on remelting of a very thin surface layer and it offers potential as a highly repeatable, higher speed process capable of selective area polishing, and without any waste problems (no abrasives or liquids). In this paper an in-depth investigation of CW laser polishing of titanium and cobalt chrome AM elements is presented. The impact of different scanning strategies, laser parameters and initial surface condition on the achieved surface finish is evaluated.

Additive Manufacturing of Nickel-Base Superalloy IN100 Through Scanning Laser Epitaxy

NASA Astrophysics Data System (ADS)

Basak, Amrita; Das, Suman

2018-01-01

Scanning laser epitaxy (SLE) is a laser powder bed fusion (LPBF)-based additive manufacturing process that uses a high-power laser to consolidate metal powders facilitating the fabrication of three-dimensional objects. In the present study, SLE is used to produce samples of IN100, a high-γ' non-weldable nickel-base superalloy on similar chemistry substrates. A thorough analysis is performed using various advanced material characterization techniques such as high-resolution optical microscopy, scanning electron microscopy, energy dispersive x-ray spectroscopy, and Vickers microhardness measurements to characterize and compare the quality of the SLE-fabricated IN100 deposits with the investment cast IN100 substrates. The results show that the IN100 deposits have a finer γ/γ' microstructure, weaker elemental segregation, and higher microhardness compared with the substrate. Through this study, it is demonstrated that the SLE process has tremendous potential in the repair and manufacture of gas turbine hot-section components.

Analysis of 3D printing parameters of gears for hybrid manufacturing

NASA Astrophysics Data System (ADS)

Budzik, Grzegorz; Przeszlowski, Łukasz; Wieczorowski, Michal; Rzucidlo, Arkadiusz; Gapinski, Bartosz; Krolczyk, Grzegorz

2018-05-01

The paper deals with analysis and selection of parameters of rapid prototyping of gears by selective sintering of metal powders. Presented results show wide spectrum of application of RP systems in manufacturing processes of machine elements, basing on analysis of market in term of application of additive manufacturing technology in different sectors of industry. Considerable growth of these methods over the past years can be observed. The characteristic errors of printed model with respect to ideal one for each technique were pointed out. Special attention was paid to the method of preparation of numerical data CAD/STL/RP. Moreover the analysis of manufacturing processes of gear type elements was presented. The tested gears were modeled with different allowances for final machining and made by DMLS. Metallographic analysis and strength tests on prepared specimens were performed. The above mentioned analysis and tests were used to compare the real properties of material with the nominal ones. To improve the quality of surface after sintering the gears were subjected to final machining. The analysis of geometry of gears after hybrid manufacturing method was performed (fig.1). The manufacturing process was defined in a traditional way as well as with the aid of modern manufacturing techniques. Methodology and obtained results can be used for other machine elements than gears and constitutes the general theory of production processes in rapid prototyping methods as well as in designing and implementation of production.

Pharmacy on demand: New technologies to enable miniaturized and mobile drug manufacturing.

PubMed

Lewin, John J; Choi, Eugene J; Ling, Geoffrey

2016-01-15

Developmental pharmaceutical manufacturing systems and techniques designed to overcome the shortcomings of traditional batch processing methods are described. Conventional pharmaceutical manufacturing processes do not adequately address the needs of military and civilian patient populations and healthcare providers. Recent advances within the Defense Advanced Research Projects Agency (DARPA) Battlefield Medicine program suggest that miniaturized, flexible platforms for end-to-end manufacturing of pharmaceuticals are possible. Advances in continuous-flow synthesis, chemistry, biological engineering, and downstream processing, coupled with online analytics, automation, and enhanced process control measures, pave the way for disruptive innovation to improve the pharmaceutical supply chain and drug manufacturing base. These new technologies, along with current and ongoing advances in regulatory science, have the future potential to (1) permit "on demand" drug manufacturing on the battlefield and in other austere environments, (2) enhance the level of preparedness for chemical, biological, radiological, and nuclear threats, (3) enhance health authorities' ability to respond to natural disasters and other catastrophic events, (4) minimize shortages of drugs, (5) address gaps in the orphan drug market, (6) support and enable the continued drive toward precision medicine, and (7) enhance access to needed medications in underserved areas across the globe. Modular platforms under development by DARPA's Battlefield Medicine program may one day improve the safety, efficiency, and timeliness of drug manufacturing. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Advances in Neutron Radiography: Application to Additive Manufacturing Inconel 718

DOE PAGES

Bilheux, Hassina Z; Song, Gian; An, Ke; ...

2016-01-01

Reactor-based neutron radiography is a non-destructive, non-invasive characterization technique that has been extensively used for engineering materials such as inspection of components, evaluation of porosity, and in-operando observations of engineering parts. Neutron radiography has flourished at reactor facilities for more than four decades and is relatively new to accelerator-based neutron sources. Recent advances in neutron source and detector technologies, such as the Spallation Neutron Source (SNS) at the Oak Ridge National Laboratory (ORNL) in Oak Ridge, TN, and the microchannel plate (MCP) detector, respectively, enable new contrast mechanisms using the neutron scattering Bragg features for crystalline information such as averagemore » lattice strain, crystalline plane orientation, and identification of phases in a neutron radiograph. Additive manufacturing (AM) processes or 3D printing have recently become very popular and have a significant potential to revolutionize the manufacturing of materials by enabling new designs with complex geometries that are not feasible using conventional manufacturing processes. However, the technique lacks standards for process optimization and control compared to conventional processes. Residual stresses are a common occurrence in materials that are machined, rolled, heat treated, welded, etc., and have a significant impact on a component s mechanical behavior and durability. They may also arise during the 3D printing process, and defects such as internal cracks can propagate over time as the component relaxes after being removed from its build plate (the base plate utilized to print materials on). Moreover, since access to the AM material is possible only after the component has been fully manufactured, it is difficult to characterize the material for defects a priori to minimize expensive re-runs. Currently, validation of the AM process and materials is mainly through expensive trial-and-error experiments at the component level, whereas in conventional processes the level of confidence in predictive computational modeling is high enough to allow process and materials optimization through computational approaches. Thus, there is a clear need for non-destructive characterization techniques and for the establishment of processing- microstructure databases that can be used for developing and validating predictive modeling tools for AM.« less

Manufacturing plastic injection optical molds

NASA Astrophysics Data System (ADS)

Bourque, David

2008-08-01

ABCO Tool & Die, Inc. is a mold manufacturer specializing in the manufacturing of plastic injection molds for molded optical parts. The purpose of this presentation is to explain the concepts and procedures required to build a mold that produces precision optical parts. Optical molds can produce a variety of molded parts ranging from safety eyewear to sophisticated military lens parts, which must meet precise optical specifications. The manufacturing of these molds begins with the design engineering of precision optical components. The mold design and the related optical inserts are determined based upon the specific optical criteria and optical surface geometry. The mold manufacturing techniques will be based upon the optical surface geometry requirements and specific details. Manufacturing processes used will be specific to prescribed geometrical surface requirements of the molded part. The combined efforts result in a robust optical mold which can produce molded parts that meet the most precise optical specifications.

Artificial Intelligence Based Selection of Optimal Cutting Tool and Process Parameters for Effective Turning and Milling Operations

NASA Astrophysics Data System (ADS)

Saranya, Kunaparaju; John Rozario Jegaraj, J.; Ramesh Kumar, Katta; Venkateshwara Rao, Ghanta

2016-06-01

With the increased trend in automation of modern manufacturing industry, the human intervention in routine, repetitive and data specific activities of manufacturing is greatly reduced. In this paper, an attempt has been made to reduce the human intervention in selection of optimal cutting tool and process parameters for metal cutting applications, using Artificial Intelligence techniques. Generally, the selection of appropriate cutting tool and parameters in metal cutting is carried out by experienced technician/cutting tool expert based on his knowledge base or extensive search from huge cutting tool database. The present proposed approach replaces the existing practice of physical search for tools from the databooks/tool catalogues with intelligent knowledge-based selection system. This system employs artificial intelligence based techniques such as artificial neural networks, fuzzy logic and genetic algorithm for decision making and optimization. This intelligence based optimal tool selection strategy is developed using Mathworks Matlab Version 7.11.0 and implemented. The cutting tool database was obtained from the tool catalogues of different tool manufacturers. This paper discusses in detail, the methodology and strategies employed for selection of appropriate cutting tool and optimization of process parameters based on multi-objective optimization criteria considering material removal rate, tool life and tool cost.

Bandwidth Study on Energy Use and Potential Energy Saving Opportunities in U.S. Pulp and Paper Manufacturing

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sabine Brueske, Caroline Kramer, Aaron Fisher

2015-06-01

Energy bandwidth studies of U.S. manufacturing sectors can serve as foundational references in framing the range (or bandwidth) of potential energy savings opportunities. This bandwidth study examines energy consumption and potential energy savings opportunities in U.S. pulp and paper manufacturing. The study relies on multiple sources to estimate the energy used in six individual process areas, representing 52% of sector-wide energy consumption. Energy savings opportunities for individual processes are based on technologies currently in use or under development; the potential savings are then extrapolated to estimate sector-wide energy savings opportunity

A study of internal structure in components made by additive manufacturing process using 3 D X-ray tomography

DOE Office of Scientific and Technical Information (OSTI.GOV)

Raguvarun, K., E-mail: prajagopal@iitm.ac.in; Balasubramaniam, Krishnan, E-mail: prajagopal@iitm.ac.in; Rajagopal, Prabhu, E-mail: prajagopal@iitm.ac.in

Additive manufacturing methods are gaining increasing popularity for rapidly and efficiently manufacturing parts and components in the industrial context, as well as for domestic applications. However, except when used for prototyping or rapid visualization of components, industries are concerned with the load carrying capacity and strength achievable by additive manufactured parts. In this paper, the wire-arc additive manufacturing (AM) process based on gas tungsten arc welding (GTAW) has been examined for the internal structure and constitution of components generated by the process. High-resolution 3D X-ray tomography is used to gain cut-views through wedge-shaped parts created using this GTAW additive manufacturingmore » process with titanium alloy materials. In this work, two different control conditions for the GTAW process are considered. The studies reveal clusters of porosities, located in periodic spatial intervals along the sample cross-section. Such internal defects can have a detrimental effect on the strength of the resulting AM components, as shown in destructive testing studies. Closer examination of this phenomenon shows that defect clusters are preferentially located at GTAW traversal path intervals. These results highlight the strong need for enhanced control of process parameters in ensuring components with minimal defects and higher strength.« less

Lot sizing and unequal-sized shipment policy for an integrated production-inventory system

NASA Astrophysics Data System (ADS)

Giri, B. C.; Sharma, S.

2014-05-01

This article develops a single-manufacturer single-retailer production-inventory model in which the manufacturer delivers the retailer's ordered quantity in unequal shipments. The manufacturer's production process is imperfect and it may produce some defective items during a production run. The retailer performs a screening process immediately after receiving the order from the manufacturer. The expected average total cost of the integrated production-inventory system is derived using renewal theory and a solution procedure is suggested to determine the optimal production and shipment policy. An extensive numerical study based on different sets of parameter values is conducted and the optimal results so obtained are analysed to examine the relative performance of the models under equal and unequal shipment policies.

HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT FOR THE ADOPTION OF INNOVATIVE MEDICAL DEVICES WITHIN FRENCH HOSPITALS: OPPORTUNITIES AND CHALLENGES FOR INDUSTRY.

PubMed

Dutot, Camille; Mercier, Grégoire; Borget, Isabelle; de Sauvebeuf, Côme; Martelli, Nicolas

2017-01-01

Within French university hospitals, some internal committees are in charge of conducting hospital-based health technology assessment (Hb-HTA) to support managerial decisions regarding the adoption of innovations. For manufacturers, hospitals are usually the entry point for new and innovative medical devices, which cannot be accessed without the Hb-HTA committees' approval. Thus, the main objective of this pilot survey was to explore manufacturers' insights into Hb-HTA processes. A two-step pilot survey was conducted in 2014. First, semi-structured phone interviews were carried out to capture manufacturers' feedback on the Hb-HTA procedure. Second, a prospective and iterative questionnaire designed to explore manufacturers' market access strategies was administered. Eight manufacturers from the medical device industry completed the retrospective phone interviews, and five of them participated in the prospective survey. According to the overall feedback, the Hb-HTA process timeline and transparency are major issues, and the expectations of internal committees, especially in terms of clinical evidence, remain difficult to understand. However, despite this and due to the complexity of reimbursement processes at the national level, manufacturers are increasingly considering hospital adoption through Hb-HTA submission as a viable market access and coverage opportunity. Our study reaffirms the primary role of hospitals in the diffusion of innovative medical devices. However, to ensure efficient and broad access to innovation, cooperation between local and national HTA bodies is critical and should be promoted.

Manufacturing history of etanercept (Enbrel®): Consistency of product quality through major process revisions.

PubMed

Hassett, Brian; Singh, Ena; Mahgoub, Ehab; O'Brien, Julie; Vicik, Steven M; Fitzpatrick, Brian

2018-01-01

Etanercept (ETN) (Enbrel®) is a soluble protein that binds to, and specifically inhibits, tumor necrosis factor (TNF), a proinflammatory cytokine. ETN is synthesized in Chinese hamster ovary cells by recombinant DNA technology as a fusion protein, with a fully human TNFRII ectodomain linked to the Fc portion of human IgG1. Successful manufacture of biologics, such as ETN, requires sophisticated process and product understanding, as well as meticulous control of operations to maintain product consistency. The objective of this evaluation was to show that the product profile of ETN drug substance (DS) has been consistent over the course of production. Multiple orthogonal biochemical analyses, which included evaluation of attributes indicative of product purity, potency, and quality, were assessed on >2,000 batches of ETN from three sites of DS manufacture, during the period 1998-2015. Based on the key quality attributes of product purity (assessed by hydrophobic interaction chromatography HPLC), binding activity (to TNF by ELISA), potency (inhibition of TNF-induced apoptosis by cell-based bioassay) and quality (N-linked oligosaccharide map), we show that the integrity of ETN DS has remained consistent over time. This consistency was maintained through three major enhancements to the initial process of manufacturing that were supported by detailed comparability assessments, and approved by the European Medicines Agency. Examination of results for all major quality attributes for ETN DS indicates a highly consistent process for over 18 years and throughout changes to the manufacturing process, without affecting safety and efficacy, as demonstrated across a wide range of clinical trials of ETN in multiple inflammatory diseases.

Manufacturing and Machining Challenges of Hybrid Aluminium Metal Matix Composites

NASA Astrophysics Data System (ADS)

Baburaja, Kammuluri; Sainadh Teja, S.; Karthik Sri, D.; Kuldeep, J.; Gowtham, V.

2017-08-01

Manufacturing which involves material removal processes or material addition processes or material transformation processes. One or all the processes to obtain the final desired properties for a material with desired shape which meets the required precision and accuracy values for the expected service life of a material in working conditions. Researchers found the utility of aluminium to be the second largest after steel. Aluminium and its metal matrix composite possess wide applications in various applications in aerospace industry, automobile industry, Constructions and even in kitchen utensils. Hybrid Al-MMCconsist of two different materials, and one will be from organic origin along with the base material. In this paper an attempt is made to bring out the importance of utilization of aluminium and the challenges concerned in manufacturing and machining of hybrid aluminium MMC.

Cellulose nanocrystals the next big nano-thing?

NASA Astrophysics Data System (ADS)

Postek, Michael T.; Vladar, Andras; Dagata, John; Farkas, Natalia; Ming, Bin; Sabo, Ronald; Wegner, Theodore H.; Beecher, James

2008-08-01

Biomass surrounds us from the smallest alga to the largest redwood tree. Even the largest trees owe their strength to a newly-appreciated class of nanomaterials known as cellulose nanocrystals (CNC). Cellulose, the world's most abundant natural, renewable, biodegradable polymer, occurs as whisker like microfibrils that are biosynthesized and deposited in plant material in a continuous fashion. Therefore, the basic raw materials for a future of new nanomaterials breakthroughs already abound in the environment and are available to be utilized in an array of future materials once the manufacturing processes and nanometrology are fully developed. This presentation will discuss some of the instrumentation, metrology and standards issues associated with nanomanufacturing of cellulose nanocrystals. The use of lignocellulosic fibers derived from sustainable, annually renewable resources as a reinforcing phase in polymeric matrix composites provides positive environmental benefits with respect to ultimate disposability and raw material use. Today we lack the essential metrology infrastructure that would enable the manufacture of nanotechnology-based products based on CNCs (or other new nanomaterial) to significantly impact the U.S. economy. The basic processes common to manufacturing - qualification of raw materials, continuous synthesis methods, process monitoring and control, in-line and off-line characterization of product for quality control purposes, validation by standard reference materials - are not generally in place for nanotechnology based products, and thus are barriers to innovation. One advantage presented by the study of CNCs is that, unlike other nanomaterials, at least, cellulose nanocrystal manufacturing is already a sustainable and viable bulk process. Literally tons of cellulose nanocrystals can be generated each day, producing other viable byproducts such as glucose (for alternative fuel) and gypsum (for buildings).There is an immediate need for the development of the basic manufacturing metrology infrastructure to implement fundamental best practices for manufacturing and in the determination of properties for these for nanoscale materials and the resultant products.

Testing single point incremental forming moulds for rotomoulding operations

NASA Astrophysics Data System (ADS)

Afonso, Daniel; de Sousa, Ricardo Alves; Torcato, Ricardo

2017-10-01

Low pressure polymer processes as thermoforming or rotational moulding use much simpler moulds than high pressure processes like injection. However, despite the low forces involved in the process, moulds manufacturing for these applications is still a very material, energy and time consuming operation. Particularly in rotational moulding there is no standard for the mould manufacture and very different techniques are applicable. The goal of this research is to develop and validate a method for manufacturing plastically formed sheet metal moulds by single point incremental forming (SPIF) for rotomoulding and rotocasting operations. A Stewart platform based SPIF machine allow the forming of thick metal sheets, granting the required structural stiffness for the mould surface, and keeping a short manufacture lead time and low thermal inertia. The experimental work involves the proposal of a hollow part, design and fabrication of a sheet metal mould using dieless incremental forming techniques and testing its operation in the production of prototype parts.

Considerations on the construction of a Powder Bed Fusion platform for Additive Manufacturing

NASA Astrophysics Data System (ADS)

Andersen, Sebastian Aagaard; Nielsen, Karl-Emil; Pedersen, David Bue; Nielsen, Jakob Skov

As the demand for moulds and other tools becomes increasingly specific and complex, an additive manufacturing approach to production is making its way to the industry through laser based consolidation of metal powder particles by a method known as powder bed fusion. This paper concerns a variety of design choices facilitating the development of an experimental powder bed fusion machine tool, capable of manufacturing metal parts with strength matching that of conventional manufactured parts and a complexity surpassing that of subtractive processes. To understand the different mechanisms acting within such an experimental machine tool, a fully open and customizable rig is constructed. Emphasizing modularity in the rig, allows alternation of lasers, scanner systems, optical elements, powder deposition, layer height, temperature, atmosphere, and powder type. Through a custom-made software platform, control of the process is achieved, which extends into a graphical user interface, easing adjustment of process parameters and the job file generation.

Low-temperature deposition manufacturing: A novel and promising rapid prototyping technology for the fabrication of tissue-engineered scaffold.

PubMed

Liu, Wei; Wang, Daming; Huang, Jianghong; Wei, You; Xiong, Jianyi; Zhu, Weimin; Duan, Li; Chen, Jielin; Sun, Rong; Wang, Daping

2017-01-01

Developed in recent years, low-temperature deposition manufacturing (LDM) represents one of the most promising rapid prototyping technologies. It is not only based on rapid deposition manufacturing process but also combined with phase separation process. Besides the controlled macropore size, tissue-engineered scaffold fabricated by LDM has inter-connected micropores in the deposited lines. More importantly, it is a green manufacturing process that involves non-heating liquefying of materials. It has been employed to fabricate tissue-engineered scaffolds for bone, cartilage, blood vessel and nerve tissue regenerations. It is a promising technology in the fabrication of tissue-engineered scaffold similar to ideal scaffold and the design of complex organs. In the current paper, this novel LDM technology is introduced, and its control parameters, biomedical applications and challenges are included and discussed as well. Copyright © 2016 Elsevier B.V. All rights reserved.

Identified research directions for using manufacturing knowledge earlier in the product lifecycle

PubMed Central

Hedberg, Thomas D.; Hartman, Nathan W.; Rosche, Phil; Fischer, Kevin

2016-01-01

Design for Manufacturing (DFM), especially the use of manufacturing knowledge to support design decisions, has received attention in the academic domain. However, industry practice has not been studied enough to provide solutions that are mature for industry. The current state of the art for DFM is often rule-based functionality within Computer-Aided Design (CAD) systems that enforce specific design requirements. That rule-based functionality may or may not dynamically affect geometry definition. And, if rule-based functionality exists in the CAD system, it is typically a customization on a case-by-case basis. Manufacturing knowledge is a phrase with vast meanings, which may include knowledge on the effects of material properties decisions, machine and process capabilities, or understanding the unintended consequences of design decisions on manufacturing. One of the DFM questions to answer is how can manufacturing knowledge, depending on its definition, be used earlier in the product lifecycle to enable a more collaborative development environment? This paper will discuss the results of a workshop on manufacturing knowledge that highlights several research questions needing more study. This paper proposes recommendations for investigating the relationship of manufacturing knowledge with shape, behavior, and context characteristics of product to produce a better understanding of what knowledge is most important. In addition, the proposal includes recommendations for investigating the system-level barriers to reusing manufacturing knowledge and how model-based manufacturing may ease the burden of knowledge sharing. Lastly, the proposal addresses the direction of future research for holistic solutions of using manufacturing knowledge earlier in the product lifecycle. PMID:27990027

Identified research directions for using manufacturing knowledge earlier in the product lifecycle.

PubMed

Hedberg, Thomas D; Hartman, Nathan W; Rosche, Phil; Fischer, Kevin

2017-01-01

Design for Manufacturing (DFM), especially the use of manufacturing knowledge to support design decisions, has received attention in the academic domain. However, industry practice has not been studied enough to provide solutions that are mature for industry. The current state of the art for DFM is often rule-based functionality within Computer-Aided Design (CAD) systems that enforce specific design requirements. That rule-based functionality may or may not dynamically affect geometry definition. And, if rule-based functionality exists in the CAD system, it is typically a customization on a case-by-case basis. Manufacturing knowledge is a phrase with vast meanings, which may include knowledge on the effects of material properties decisions, machine and process capabilities, or understanding the unintended consequences of design decisions on manufacturing. One of the DFM questions to answer is how can manufacturing knowledge, depending on its definition, be used earlier in the product lifecycle to enable a more collaborative development environment? This paper will discuss the results of a workshop on manufacturing knowledge that highlights several research questions needing more study. This paper proposes recommendations for investigating the relationship of manufacturing knowledge with shape, behavior, and context characteristics of product to produce a better understanding of what knowledge is most important. In addition, the proposal includes recommendations for investigating the system-level barriers to reusing manufacturing knowledge and how model-based manufacturing may ease the burden of knowledge sharing. Lastly, the proposal addresses the direction of future research for holistic solutions of using manufacturing knowledge earlier in the product lifecycle.

Materials, Processes, and Facile Manufacturing for Bioresorbable Electronics: A Review.

PubMed

Yu, Xiaowei; Shou, Wan; Mahajan, Bikram K; Huang, Xian; Pan, Heng

2018-05-07

Bioresorbable electronics refer to a new class of advanced electronics that can completely dissolve or disintegrate with environmentally and biologically benign byproducts in water and biofluids. They have provided a solution to the growing electronic waste problem with applications in temporary usage of electronics such as implantable devices and environmental sensors. Bioresorbable materials such as biodegradable polymers, dissolvable conductors, semiconductors, and dielectrics are extensively studied, enabling massive progress of bioresorbable electronic devices. Processing and patterning of these materials are predominantly relying on vacuum-based fabrication methods so far. However, for the purpose of commercialization, nonvacuum, low-cost, and facile manufacturing/printing approaches are the need of the hour. Bioresorbable electronic materials are generally more chemically reactive than conventional electronic materials, which require particular attention in developing the low-cost manufacturing processes in ambient environment. This review focuses on material reactivity, ink availability, printability, and process compatibility for facile manufacturing of bioresorbable electronics. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Additive Manufacturing of Poly(3-hydroxybutyrate-co-3-hydroxyhexanoate)/poly(ε-caprolactone) Blend Scaffolds for Tissue Engineering.

PubMed

Puppi, Dario; Morelli, Andrea; Chiellini, Federica

2017-05-24

Additive manufacturing of scaffolds made of a polyhydroxyalkanoate blended with another biocompatible polymer represents a cost-effective strategy for combining the advantages of the two blend components in order to develop tailored tissue engineering approaches. The aim of this study was the development of novel poly(3-hydroxybutyrate- co -3-hydroxyhexanoate)/ poly(ε-caprolactone) (PHBHHx/PCL) blend scaffolds for tissue engineering by means of computer-aided wet-spinning, a hybrid additive manufacturing technique suitable for processing polyhydroxyalkanoates dissolved in organic solvents. The experimental conditions for processing tetrahydrofuran solutions containing the two polymers at different concentrations (PHBHHx/PCL weight ratio of 3:1, 2:1 or 1:1) were optimized in order to manufacture scaffolds with predefined geometry and internal porous architecture. PHBHHx/PCL scaffolds with a 3D interconnected network of macropores and a local microporosity of the polymeric matrix, as a consequence of the phase inversion process governing material solidification, were successfully fabricated. As shown by scanning electron microscopy, thermogravimetric, differential scanning calorimetric and uniaxial compressive analyses, blend composition significantly influenced the scaffold morphological, thermal and mechanical properties. In vitro biological characterization showed that the developed scaffolds were able to sustain the adhesion and proliferation of MC3T3-E1 murine preosteoblast cells. The additive manufacturing approach developed in this study, based on a polymeric solution processing method avoiding possible material degradation related to thermal treatments, could represent a powerful tool for the development of customized PHBHHx-based blend scaffolds for tissue engineering.

Real-time control for manufacturing space shuttle main engines: Work in progress

NASA Technical Reports Server (NTRS)

Ruokangas, Corinne C.

1988-01-01

During the manufacture of space-based assemblies such as Space Shuttle Main Engines, flexibility is required due to the high-cost and low-volume nature of the end products. Various systems have been developed pursuing the goal of adaptive, flexible manufacturing for several space applications, including an Advanced Robotic Welding System for the manufacture of complex components of the Space Shuttle Main Engines. The Advanced Robotic Welding System (AROWS) is an on-going joint effort, funded by NASA, between NASA/Marshall Space Flight Center, and two divisions of Rockwell International: Rocketdyne and the Science Center. AROWS includes two levels of flexible control of both motion and process parameters: Off-line programming using both geometric and weld-process data bases, and real-time control incorporating multiple sensors during weld execution. Both control systems were implemented using conventional hardware and software architectures. The feasibility of enhancing the real-time control system using the problem-solving architecture of Schemer is investigated and described.

Life‐cycle and cost of goods assessment of fed‐batch and perfusion‐based manufacturing processes for mAbs

PubMed Central

Bunnak, Phumthep; Allmendinger, Richard; Ramasamy, Sri V.; Lettieri, Paola

2016-01-01

Life‐cycle assessment (LCA) is an environmental assessment tool that quantifies the environmental impact associated with a product or a process (e.g., water consumption, energy requirements, and solid waste generation). While LCA is a standard approach in many commercial industries, its application has not been exploited widely in the bioprocessing sector. To contribute toward the design of more cost‐efficient, robust and environmentally‐friendly manufacturing process for monoclonal antibodies (mAbs), a framework consisting of an LCA and economic analysis combined with a sensitivity analysis of manufacturing process parameters and a production scale‐up study is presented. The efficiency of the framework is demonstrated using a comparative study of the two most commonly used upstream configurations for mAb manufacture, namely fed‐batch (FB) and perfusion‐based processes. Results obtained by the framework are presented using a range of visualization tools, and indicate that a standard perfusion process (with a pooling duration of 4 days) has similar cost of goods than a FB process but a larger environmental footprint because it consumed 35% more water, demanded 17% more energy, and emitted 17% more CO2 than the FB process. Water consumption was the most important impact category, especially when scaling‐up the processes, as energy was required to produce process water and water‐for‐injection, while CO2 was emitted from energy generation. The sensitivity analysis revealed that the perfusion process can be made more environmentally‐friendly than the FB process if the pooling duration is extended to 8 days. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:1324–1335, 2016 PMID:27390260

Life-cycle and cost of goods assessment of fed-batch and perfusion-based manufacturing processes for mAbs.

PubMed

Bunnak, Phumthep; Allmendinger, Richard; Ramasamy, Sri V; Lettieri, Paola; Titchener-Hooker, Nigel J

2016-09-01

Life-cycle assessment (LCA) is an environmental assessment tool that quantifies the environmental impact associated with a product or a process (e.g., water consumption, energy requirements, and solid waste generation). While LCA is a standard approach in many commercial industries, its application has not been exploited widely in the bioprocessing sector. To contribute toward the design of more cost-efficient, robust and environmentally-friendly manufacturing process for monoclonal antibodies (mAbs), a framework consisting of an LCA and economic analysis combined with a sensitivity analysis of manufacturing process parameters and a production scale-up study is presented. The efficiency of the framework is demonstrated using a comparative study of the two most commonly used upstream configurations for mAb manufacture, namely fed-batch (FB) and perfusion-based processes. Results obtained by the framework are presented using a range of visualization tools, and indicate that a standard perfusion process (with a pooling duration of 4 days) has similar cost of goods than a FB process but a larger environmental footprint because it consumed 35% more water, demanded 17% more energy, and emitted 17% more CO 2 than the FB process. Water consumption was the most important impact category, especially when scaling-up the processes, as energy was required to produce process water and water-for-injection, while CO 2 was emitted from energy generation. The sensitivity analysis revealed that the perfusion process can be made more environmentally-friendly than the FB process if the pooling duration is extended to 8 days. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:1324-1335, 2016. © 2016 The Authors Biotechnology Progress published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers.

Processing Multiyear Procurement (MYP) Submissions - A Handbook for Air Force Program Offices

DTIC Science & Technology

1985-05-01

Contracting and Manufacturing Policy; "Policy Letter 84-1l - Multiyear Contracting Guidance" Headquarters, United States Air Force, Washington, D.C...supplement to Air Force FAR Sup No. 17.191: as enclosed in Thomas E. Lloyd, Colonel, USAF, Assistant DCS/Contracting , and Manufacturing , "DCS...Contracting and Manufacturing Policy Letter 84-16, Multiyear Contracting Guidance." Headquarters, Air Force Systems Command, Andrew Air Force Base

Design of an Orthopedic Product by Using Additive Manufacturing Technology: The Arm Splint.

PubMed

Blaya, Fernando; Pedro, Pilar San; Silva, Julia López; D'Amato, Roberto; Heras, Enrique Soriano; Juanes, Juan Antonio

2018-02-05

The traditional fabrication process of custom-made splints has hardly undergone any progress since the beginning of its use at the end of the eighteenth century. New manufacturing techniques and the new materials can help to modernize this treatment method of fractures. The use of Additive Manufacturing has been proposed in recent years as an alternative process for the manufacture of splints and there has been an increase in public awareness and exploration. For this reason, in this study a splint model printed in 3D, that replaces the deficiencies of the cast maintaining its virtues, has been proposed. The proposed methodology is based on three-dimensional digitalization techniques and 3D modeling with reverse engineering software. The work integrates different scientific disciplines to achieve its main goal: to improve life quality of the patient. In addition, the splint has been designed based on the principles of sustainable development. The design of splint is made of Polycarbonate by technique of Additive Manufacturing with fused deposition manufacturing, and conceived with organic shapes, customizing openings and closing buttons with rubber. In this preliminary study the final result is a prototype of the 3D printed arm splint in a reduced scale by using PLA as material.

Measurement of sustainability index among paper manufacturing plants

NASA Astrophysics Data System (ADS)

Sharathkumar Reddy, V.; Jayakrishna, K.; Lal, Babu

2017-11-01

The paper manufacturing companies are facing challenges to implement sustainable manufacturing into their products and processes. Paper manufacturing has remarked as an intensive consumer of natural raw materials, energy and a major source of multiple pollutants. Thus, evaluating the sustainable manufacturing in these companies has become a necessity. This paper proposes a set of Performance Indicators (PIs) for evaluating the sustainable manufacturing appropriate to the paper manufacturing companies based on the triple bottom line of sustainability. The Technique for Order of Preference by Similarity to Ideal Solution (TOPSIS), a multi-criteria decision analysis method is applied to prioritize the performance indicators by summarizing the opinions of stakeholders. It is hoped that the proposed PIs enables and assists the paper manufacturing companies to achieve the higher performance in sustainable manufacturing and so as to increase their competitiveness.

Developing Materials Processing to Performance Modeling Capabilities and the Need for Exascale Computing Architectures (and Beyond)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Schraad, Mark William; Luscher, Darby Jon

Additive Manufacturing techniques are presenting the Department of Energy and the NNSA Laboratories with new opportunities to consider novel component production and repair processes, and to manufacture materials with tailored response and optimized performance characteristics. Additive Manufacturing technologies already are being applied to primary NNSA mission areas, including Nuclear Weapons. These mission areas are adapting to these new manufacturing methods, because of potential advantages, such as smaller manufacturing footprints, reduced needs for specialized tooling, an ability to embed sensing, novel part repair options, an ability to accommodate complex geometries, and lighter weight materials. To realize the full potential of Additivemore » Manufacturing as a game-changing technology for the NNSA’s national security missions; however, significant progress must be made in several key technical areas. In addition to advances in engineering design, process optimization and automation, and accelerated feedstock design and manufacture, significant progress must be made in modeling and simulation. First and foremost, a more mature understanding of the process-structure-property-performance relationships must be developed. Because Additive Manufacturing processes change the nature of a material’s structure below the engineering scale, new models are required to predict materials response across the spectrum of relevant length scales, from the atomistic to the continuum. New diagnostics will be required to characterize materials response across these scales. And not just models, but advanced algorithms, next-generation codes, and advanced computer architectures will be required to complement the associated modeling activities. Based on preliminary work in each of these areas, a strong argument for the need for Exascale computing architectures can be made, if a legitimate predictive capability is to be developed.« less

NASA's In-Space Manufacturing Project: Materials and Manufacturing Process Development Update

NASA Technical Reports Server (NTRS)

Prater, Tracie; Bean, Quincy; Werkheiser, Niki; Ledbetter, Frank

2017-01-01

The mission of NASA's In-Space Manufacturing (ISM) project is to identify, design, and implement on-demand, sustainable manufacturing solutions for fabrication, maintenance and repair during exploration missions. ISM has undertaken a phased strategy of incrementally increasing manufacturing capabilities to achieve this goal. The ISM project began with the development of the first 3D printer for the International Space Station. To date, the printer has completed two phases of flight operations. Results from phase I specimens indicated some differences in material properties between ground-processed and ISS-processed specimens, but results of follow-on analyses of these parts and a ground-based study with an equivalent printer strongly indicate that this variability is likely attributable to differences in manufacturing process settings between the ground and flight prints rather than microgravity effects on the fused deposition modeling (FDM) process. Analysis of phase II specimens from the 3D Printing in Zero G tech demo, which shed further light on the sources of material variability, will be presented. The ISM project has also developed a materials characterization plan for the Additive Manufacturing Facility, the follow-on commercial multimaterial 3D printing facility developed for ISS by Made in Space. This work will yield a suite of characteristic property values that can inform use of AMF by space system designers. Other project activities include development of an integrated 3D printer and recycler, known as the Refabricator, by Tethers Unlimited, which will be operational on ISS in 2018. The project also recently issued a broad area announcement for a multimaterial fabrication laboratory, which may include in-space manufacturing capabilities for metals, electronics, and polymeric materials, to be deployed on ISS in the 2022 timeframe.

Good Manufacturing Practices (GMP) manufacturing of advanced therapy medicinal products: a novel tailored model for optimizing performance and estimating costs.

PubMed

Abou-El-Enein, Mohamed; Römhild, Andy; Kaiser, Daniel; Beier, Carola; Bauer, Gerhard; Volk, Hans-Dieter; Reinke, Petra

2013-03-01

Advanced therapy medicinal products (ATMP) have gained considerable attention in academia due to their therapeutic potential. Good Manufacturing Practice (GMP) principles ensure the quality and sterility of manufacturing these products. We developed a model for estimating the manufacturing costs of cell therapy products and optimizing the performance of academic GMP-facilities. The "Clean-Room Technology Assessment Technique" (CTAT) was tested prospectively in the GMP facility of BCRT, Berlin, Germany, then retrospectively in the GMP facility of the University of California-Davis, California, USA. CTAT is a two-level model: level one identifies operational (core) processes and measures their fixed costs; level two identifies production (supporting) processes and measures their variable costs. The model comprises several tools to measure and optimize performance of these processes. Manufacturing costs were itemized using adjusted micro-costing system. CTAT identified GMP activities with strong correlation to the manufacturing process of cell-based products. Building best practice standards allowed for performance improvement and elimination of human errors. The model also demonstrated the unidirectional dependencies that may exist among the core GMP activities. When compared to traditional business models, the CTAT assessment resulted in a more accurate allocation of annual expenses. The estimated expenses were used to set a fee structure for both GMP facilities. A mathematical equation was also developed to provide the final product cost. CTAT can be a useful tool in estimating accurate costs for the ATMPs manufactured in an optimized GMP process. These estimates are useful when analyzing the cost-effectiveness of these novel interventions. Copyright © 2013 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

All-solid-state lithium-ion and lithium metal batteries - paving the way to large-scale production

NASA Astrophysics Data System (ADS)

Schnell, Joscha; Günther, Till; Knoche, Thomas; Vieider, Christoph; Köhler, Larissa; Just, Alexander; Keller, Marlou; Passerini, Stefano; Reinhart, Gunther

2018-04-01

Challenges and requirements for the large-scale production of all-solid-state lithium-ion and lithium metal batteries are herein evaluated via workshops with experts from renowned research institutes, material suppliers, and automotive manufacturers. Aiming to bridge the gap between materials research and industrial mass production, possible solutions for the production chains of sulfide and oxide based all-solid-state batteries from electrode fabrication to cell assembly and quality control are presented. Based on these findings, a detailed comparison of the production processes for a sulfide based all-solid-state battery with conventional lithium-ion cell production is given, showing that processes for composite electrode fabrication can be adapted with some effort, while the fabrication of the solid electrolyte separator layer and the integration of a lithium metal anode will require completely new processes. This work identifies the major steps towards mass production of all-solid-state batteries, giving insight into promising manufacturing technologies and helping stakeholders, such as machine engineering, cell producers, and original equipment manufacturers, to plan the next steps towards safer batteries with increased storage capacity.

Neural correlates of culturally familiar brands of car manufacturers.

PubMed

Schaefer, Michael; Berens, Harald; Heinze, Hans-Jochen; Rotte, Michael

2006-06-01

Brands have a high impact on people's economic decisions. People may prefer products of brands even among almost identical products. Brands can be defined as cultural-based symbols, which promise certain advantages of a product. Recent studies suggest that the prefrontal cortex may be crucial for the processing of brand knowledge. The aim of this study was to examine the neural correlates of culturally based brands. We confronted subjects with logos of car manufactures during an fMRI session and instructed them to imagine and use a car of these companies. As a control condition, we used graphically comparable logos of car manufacturers that were unfamiliar to the culture of the subjects participating in this study. If they did not know the logo of the brand, they were told to imagine and use a generic car. Results showed activation of a single region in the medial prefrontal cortex related to the logos of the culturally familiar brands. We discuss the results as self-relevant processing induced by the imagined use of cars of familiar brands and suggest that the prefrontal cortex plays a crucial role for processing culturally based brands.

Comparative study of manufacturing condyle implant using rapid prototyping and CNC machining

NASA Astrophysics Data System (ADS)

Bojanampati, S.; Karthikeyan, R.; Islam, MD; Venugopal, S.

2018-04-01

Injuries to the cranio-maxillofacial area caused by road traffic accidents (RTAs), fall from heights, birth defects, metabolic disorders and tumors affect a rising number of patients in the United Arab Emirates (UAE), and require maxillofacial surgery. Mandibular reconstruction poses a specific challenge in both functionality and aesthetics, and involves replacement of the damaged bone by a custom made implant. Due to material, design cycle time and manufacturing process time, such implants are in many instances not affordable to patients. In this paper, the feasibility of designing and manufacturing low-cost, custom made condyle implant is assessed using two different approaches, consisting of rapid prototyping and three-axis computer numerically controlled (CNC) machining. Two candidate rapid prototyping techniques are considered, namely fused deposition modeling (FDM) and three-dimensional printing followed by sand casting The feasibility of the proposed manufacturing processes is evaluated based on manufacturing time, cost, quality, and reliability.

Health Monitoring and Management for Manufacturing Workers in Adverse Working Conditions.

PubMed

Xu, Xiaoya; Zhong, Miao; Wan, Jiafu; Yi, Minglun; Gao, Tiancheng

2016-10-01

In adverse working conditions, environmental parameters such as metallic dust, noise, and environmental temperature, directly affect the health condition of manufacturing workers. It is therefore important to implement health monitoring and management based on important physiological parameters (e.g., heart rate, blood pressure, and body temperature). In recent years, new technologies, such as body area networks, cloud computing, and smart clothing, have allowed the improvement of the quality of services. In this article, we first give five-layer architecture for health monitoring and management of manufacturing workers. Then, we analyze the system implementation process, including environmental data processing, physical condition monitoring and system services and management, and present the corresponding algorithms. Finally, we carry out an evaluation and analysis from the perspective of insurance and compensation for manufacturing workers in adverse working conditions. The proposed scheme will contribute to the improvement of workplace conditions, realize health monitoring and management, and protect the interests of manufacturing workers.

A mask quality control tool for the OSIRIS multi-object spectrograph

NASA Astrophysics Data System (ADS)

López-Ruiz, J. C.; Vaz Cedillo, Jacinto Javier; Ederoclite, Alessandro; Bongiovanni, Ángel; González Escalera, Víctor

2012-09-01

OSIRIS multi object spectrograph uses a set of user-customised-masks, which are manufactured on-demand. The manufacturing process consists of drilling the specified slits on the mask with the required accuracy. Ensuring that slits are on the right place when observing is of vital importance. We present a tool for checking the quality of the process of manufacturing the masks which is based on analyzing the instrument images obtained with the manufactured masks on place. The tool extracts the slit information from these images, relates specifications with the extracted slit information, and finally communicates to the operator if the manufactured mask fulfills the expectations of the mask designer. The proposed tool has been built using scripting languages and using standard libraries such as opencv, pyraf and scipy. The software architecture, advantages and limits of this tool in the lifecycle of a multiobject acquisition are presented.

Investigation into the influence of laser energy input on selective laser melted thin-walled parts by response surface method

NASA Astrophysics Data System (ADS)

Liu, Yang; Zhang, Jian; Pang, Zhicong; Wu, Weihui

2018-04-01

Selective laser melting (SLM) provides a feasible way for manufacturing of complex thin-walled parts directly, however, the energy input during SLM process, namely derived from the laser power, scanning speed, layer thickness and scanning space, etc. has great influence on the thin wall's qualities. The aim of this work is to relate the thin wall's parameters (responses), namely track width, surface roughness and hardness to the process parameters considered in this research (laser power, scanning speed and layer thickness) and to find out the optimal manufacturing conditions. Design of experiment (DoE) was used by implementing composite central design to achieve better manufacturing qualities. Mathematical models derived from the statistical analysis were used to establish the relationships between the process parameters and the responses. Also, the effects of process parameters on each response were determined. Then, a numerical optimization was performed to find out the optimal process set at which the quality features are at their desired values. Based on this study, the relationship between process parameters and SLMed thin-walled structure was revealed and thus, the corresponding optimal process parameters can be used to manufactured thin-walled parts with high quality.

Indigenous Manufacturing realization of TWIN Source

NASA Astrophysics Data System (ADS)

Pandey, R.; Bandyopadhyay, M.; Parmar, D.; Yadav, R.; Tyagi, H.; Soni, J.; Shishangiya, H.; Sudhir Kumar, D.; Shah, S.; Bansal, G.; Pandya, K.; Parmar, K.; Vuppugalla, M.; Gahlaut, A.; Chakraborty, A.

2017-04-01

TWIN source is two RF driver based negative ion source that has been planned to bridge the gap between single driver based ROBIN source (currently operational) and eight river based DNB source (to be operated under IN-TF test facility). TWIN source experiments have been planned at IPR keeping the objective of long term domestic fusion programme to gain operational experiences on vacuum immersed multi driver RF based negative ion source. High vacuum compatible components of twin source are designed at IPR keeping an aim on indigenous built in attempt. These components of TWIN source are mainly stainless steel and OFC-Cu. Being high heat flux receiving components, one of the major functional requirements is continuous heat removal via water as cooling medium. Hence for the purpose stainless steel parts are provided with externally milled cooling lines and that shall be covered with a layer of OFC-cu which would be on the receiving side of high heat flux. Manufacturability of twin source components requires joining of these dissimilar materials via process like electrode position, electron beam welding and vacuum brazing. Any of these manufacturing processes shall give a vacuum tight joint having proper joint strength at operating temperature and pressure. Taking the indigenous development effort vacuum brazing (in non-nuclear environment) has been opted for joining of dissimilar materials of twin source being one of the most reliable joining techniques and commercially feasible across the suppliers of country. Manufacturing design improvisation for the components has been done to suit the vacuum brazing process requirement and to ease some of the machining without comprising over the functional and operational requirements. This paper illustrates the details on the indigenous development effort, design improvisation to suits manufacturability, vacuum brazing basics and its procedures for twin source components.

Gaps Analysis of Integrating Product Design, Manufacturing, and Quality Data in The Supply Chain Using Model-Based Definition.

PubMed

Trainer, Asa; Hedberg, Thomas; Feeney, Allison Barnard; Fischer, Kevin; Rosche, Phil

2016-01-01

Advances in information technology triggered a digital revolution that holds promise of reduced costs, improved productivity, and higher quality. To ride this wave of innovation, manufacturing enterprises are changing how product definitions are communicated - from paper to models. To achieve industry's vision of the Model-Based Enterprise (MBE), the MBE strategy must include model-based data interoperability from design to manufacturing and quality in the supply chain. The Model-Based Definition (MBD) is created by the original equipment manufacturer (OEM) using Computer-Aided Design (CAD) tools. This information is then shared with the supplier so that they can manufacture and inspect the physical parts. Today, suppliers predominantly use Computer-Aided Manufacturing (CAM) and Coordinate Measuring Machine (CMM) models for these tasks. Traditionally, the OEM has provided design data to the supplier in the form of two-dimensional (2D) drawings, but may also include a three-dimensional (3D)-shape-geometry model, often in a standards-based format such as ISO 10303-203:2011 (STEP AP203). The supplier then creates the respective CAM and CMM models and machine programs to produce and inspect the parts. In the MBE vision for model-based data exchange, the CAD model must include product-and-manufacturing information (PMI) in addition to the shape geometry. Today's CAD tools can generate models with embedded PMI. And, with the emergence of STEP AP242, a standards-based model with embedded PMI can now be shared downstream. The on-going research detailed in this paper seeks to investigate three concepts. First, that the ability to utilize a STEP AP242 model with embedded PMI for CAD-to-CAM and CAD-to-CMM data exchange is possible and valuable to the overall goal of a more efficient process. Second, the research identifies gaps in tools, standards, and processes that inhibit industry's ability to cost-effectively achieve model-based-data interoperability in the pursuit of the MBE vision. Finally, it also seeks to explore the interaction between CAD and CMM processes and determine if the concept of feedback from CAM and CMM back to CAD is feasible. The main goal of our study is to test the hypothesis that model-based-data interoperability from CAD-to-CAM and CAD-to-CMM is feasible through standards-based integration. This paper presents several barriers to model-based-data interoperability. Overall, the project team demonstrated the exchange of product definition data between CAD, CAM, and CMM systems using standards-based methods. While gaps in standards coverage were identified, the gaps should not stop industry's progress toward MBE. The results of our study provide evidence in support of an open-standards method to model-based-data interoperability, which would provide maximum value and impact to industry.

Design for Additive Bio-Manufacturing: From Patient-Specific Medical Devices to Rationally Designed Meta-Biomaterials.

PubMed

Zadpoor, Amir A

2017-07-25

Recent advances in additive manufacturing (AM) techniques in terms of accuracy, reliability, the range of processable materials, and commercial availability have made them promising candidates for production of functional parts including those used in the biomedical industry. The complexity-for-free feature offered by AM means that very complex designs become feasible to manufacture, while batch-size-indifference enables fabrication of fully patient-specific medical devices. Design for AM (DfAM) approaches aim to fully utilize those features for development of medical devices with substantially enhanced performance and biomaterials with unprecedented combinations of favorable properties that originate from complex geometrical designs at the micro-scale. This paper reviews the most important approaches in DfAM particularly those applicable to additive bio-manufacturing including image-based design pipelines, parametric and non-parametric designs, metamaterials, rational and computationally enabled design, topology optimization, and bio-inspired design. Areas with limited research have been identified and suggestions have been made for future research. The paper concludes with a brief discussion on the practical aspects of DfAM and the potential of combining AM with subtractive and formative manufacturing processes in so-called hybrid manufacturing processes.

Design for Additive Bio-Manufacturing: From Patient-Specific Medical Devices to Rationally Designed Meta-Biomaterials

PubMed Central

Zadpoor, Amir A.

2017-01-01

Recent advances in additive manufacturing (AM) techniques in terms of accuracy, reliability, the range of processable materials, and commercial availability have made them promising candidates for production of functional parts including those used in the biomedical industry. The complexity-for-free feature offered by AM means that very complex designs become feasible to manufacture, while batch-size-indifference enables fabrication of fully patient-specific medical devices. Design for AM (DfAM) approaches aim to fully utilize those features for development of medical devices with substantially enhanced performance and biomaterials with unprecedented combinations of favorable properties that originate from complex geometrical designs at the micro-scale. This paper reviews the most important approaches in DfAM particularly those applicable to additive bio-manufacturing including image-based design pipelines, parametric and non-parametric designs, metamaterials, rational and computationally enabled design, topology optimization, and bio-inspired design. Areas with limited research have been identified and suggestions have been made for future research. The paper concludes with a brief discussion on the practical aspects of DfAM and the potential of combining AM with subtractive and formative manufacturing processes in so-called hybrid manufacturing processes. PMID:28757572

A Study on Real-Time Scheduling Methods in Holonic Manufacturing Systems

NASA Astrophysics Data System (ADS)

Iwamura, Koji; Taimizu, Yoshitaka; Sugimura, Nobuhiro

Recently, new architectures of manufacturing systems have been proposed to realize flexible control structures of the manufacturing systems, which can cope with the dynamic changes in the volume and the variety of the products and also the unforeseen disruptions, such as failures of manufacturing resources and interruptions by high priority jobs. They are so called as the autonomous distributed manufacturing system, the biological manufacturing system and the holonic manufacturing system. Rule-based scheduling methods were proposed and applied to the real-time production scheduling problems of the HMS (Holonic Manufacturing System) in the previous report. However, there are still remaining problems from the viewpoint of the optimization of the whole production schedules. New procedures are proposed, in the present paper, to select the production schedules, aimed at generating effective production schedules in real-time. The proposed methods enable the individual holons to select suitable machining operations to be carried out in the next time period. Coordination process among the holons is also proposed to carry out the coordination based on the effectiveness values of the individual holons.

In-TFT-array-process micro defect inspection using nonlinear principal component analysis.

PubMed

Liu, Yi-Hung; Wang, Chi-Kai; Ting, Yung; Lin, Wei-Zhi; Kang, Zhi-Hao; Chen, Ching-Shun; Hwang, Jih-Shang

2009-11-20

Defect inspection plays a critical role in thin film transistor liquid crystal display (TFT-LCD) manufacture, and has received much attention in the field of automatic optical inspection (AOI). Previously, most focus was put on the problems of macro-scale Mura-defect detection in cell process, but it has recently been found that the defects which substantially influence the yield rate of LCD panels are actually those in the TFT array process, which is the first process in TFT-LCD manufacturing. Defect inspection in TFT array process is therefore considered a difficult task. This paper presents a novel inspection scheme based on kernel principal component analysis (KPCA) algorithm, which is a nonlinear version of the well-known PCA algorithm. The inspection scheme can not only detect the defects from the images captured from the surface of LCD panels, but also recognize the types of the detected defects automatically. Results, based on real images provided by a LCD manufacturer in Taiwan, indicate that the KPCA-based defect inspection scheme is able to achieve a defect detection rate of over 99% and a high defect classification rate of over 96% when the imbalanced support vector machine (ISVM) with 2-norm soft margin is employed as the classifier. More importantly, the inspection time is less than 1 s per input image.

Design and development of a layer-based additive manufacturing process for the realization of metal parts of designed mesostructure

NASA Astrophysics Data System (ADS)

Williams, Christopher Bryant

Low-density cellular materials, metallic bodies with gaseous voids, are a unique class of materials that are characterized by their high strength, low mass, good energy absorption characteristics, and good thermal and acoustic insulation properties. In an effort to take advantage of this entire suite of positive mechanical traits, designers are tailoring the cellular mesostructure for multiple design objectives. Unfortunately, existing cellular material manufacturing technologies limit the design space as they are limited to certain part mesostructure, material type, and macrostructure. The opportunity that exists to improve the design of existing products, and the ability to reap the benefits of cellular materials in new applications is the driving force behind this research. As such, the primary research goal of this work is to design, embody, and analyze a manufacturing process that provides a designer the ability to specify the material type, material composition, void morphology, and mesostructure topology for any conceivable part geometry. The accomplishment of this goal is achieved in three phases of research: (1) Design---Following a systematic design process and a rigorous selection exercise, a layer-based additive manufacturing process is designed that is capable of meeting the unique requirements of fabricating cellular material geometry. Specifically, metal parts of designed mesostructure are fabricated via three-dimensional printing of metal oxide ceramic powder followed by post-processing in a reducing atmosphere. (2) Embodiment ---The primary research hypothesis is verified through the use of the designed manufacturing process chain to successfully realize metal parts of designed mesostructure. (3) Modeling & Evaluation ---The designed manufacturing process is modeled in this final research phase so as to increase understanding of experimental results and to establish a foundation for future analytical modeling research. In addition to an analysis of the physics of primitive creation and an investigation of failure modes during the layered fabrication of thin trusses, build time and cost models are presented in order to verify claims of the process's economic benefits. The main contribution of this research is the embodiment of a novel manner for realizing metal parts of designed mesostructure.

Risk-based Strategy to Determine Testing Requirement for the Removal of Residual Process Reagents as Process-related Impurities in Bioprocesses.

PubMed

Qiu, Jinshu; Li, Kim; Miller, Karen; Raghani, Anil

2015-01-01

The purpose of this article is to recommend a risk-based strategy for determining clearance testing requirements of the process reagents used in manufacturing biopharmaceutical products. The strategy takes account of four risk factors. Firstly, the process reagents are classified into two categories according to their safety profile and history of use: generally recognized as safe (GRAS) and potential safety concern (PSC) reagents. The clearance testing of GRAS reagents can be eliminated because of their safe use historically and process capability to remove these reagents. An estimated safety margin (Se) value, a ratio of the exposure limit to the estimated maximum reagent amount, is then used to evaluate the necessity for testing the PSC reagents at an early development stage. The Se value is calculated from two risk factors, the starting PSC reagent amount per maximum product dose (Me), and the exposure limit (Le). A worst-case scenario is assumed to estimate the Me value, that is common. The PSC reagent of interest is co-purified with the product and no clearance occurs throughout the entire purification process. No clearance testing is required for this PSC reagent if its Se value is ≥1; otherwise clearance testing is needed. Finally, the point of the process reagent introduction to the process is also considered in determining the necessity of the clearance testing for process reagents. How to use the measured safety margin as a criterion for determining PSC reagent testing at process characterization, process validation, and commercial production stages are also described. A large number of process reagents are used in the biopharmaceutical manufacturing to control the process performance. Clearance testing for all of the process reagents will be an enormous analytical task. In this article, a risk-based strategy is described to eliminate unnecessary clearance testing for majority of the process reagents using four risk factors. The risk factors included in the strategy are (i) safety profile of the reagents, (ii) the starting amount of the process reagents used in the manufacturing process, (iii) the maximum dose of the product, and (iv) the point of introduction of the process reagents in the process. The implementation of the risk-based strategy can eliminate clearance testing for approximately 90% of the process reagents used in the manufacturing processes. This science-based strategy allows us to ensure patient safety and meet regulatory agency expectations throughout the product development life cycle. © PDA, Inc. 2015.

Design, Development and Hotfire Testing of Monolithic Copper and Bimetallic Additively Manufactured Combustion Chambers

NASA Technical Reports Server (NTRS)

Gradl, Paul; Barnett, Greg; Brandsmeier, Will; Greene, Sandy Elam; Protz, Chris

2016-01-01

NASA and industry partners are working towards fabrication process development to reduce costs and schedules associated with manufacturing liquid rocket engine components with the goal of reducing overall mission costs. One such technique being evaluated is powder-bed fusion or selective laser melting (SLM) otherwise commonly referred to as additive manufacturing. The NASA Low Cost Upper Stage Propulsion (LCUSP) program was designed to develop processes and material characterization for the GRCop-84 copper-alloy commensurate with powder bed additive manufacturing, evaluate bimetallic deposition and complete testing of a full scale combustion chamber. As part of this development, the process has been transferred to industry partners to enable a long-term supply chain of monolithic copper combustion chambers. As a direct spin off of this program, NASA is working with industry partners to further develop the printing process for the GRCop-84 material in addition to the C-18150 (CuCrZr) material. To advance the process further and allow for optimization with multiple materials, NASA is also investigating the feasibility of bimetallic additively manufactured chambers. A 1.2k sized thrust-chamber was designed and developed to compare the printing process of the GRCop-84 and C-18150 SLM materials. A series of similar MCC liners also completed development with an Inconel 625 jacket bonded to the GRcop-84 liner evaluating direct metal deposition (DMD) laser and arc-based techniques. This paper describes the design, development, manufacturing and testing of these combustion chambers and associated lessons learned throughout the design and development process.

Rapid production of hollow SS316 profiles by extrusion based additive manufacturing

NASA Astrophysics Data System (ADS)

Rane, Kedarnath; Cataldo, Salvatore; Parenti, Paolo; Sbaglia, Luca; Mussi, Valerio; Annoni, Massimiliano; Giberti, Hermes; Strano, Matteo

2018-05-01

Complex shaped stainless steel tubes are often required for special purpose biomedical equipment. Nevertheless, traditional manufacturing technologies, such as extrusion, lack the ability to compete in a market of customized complex components because of associated expenses towards tooling and extrusion presses. To rapid manufacture few of such components with low cost and high precision, a new Extrusion based Additive Manufacturing (EAM) process, is proposed in this paper, and as an example, short stainless steel 316L complex shaped and sectioned tubes were prepared by EAM. Several sample parts were produced using this process; the dimensional stability, surface roughness and chemical composition of sintered samples were investigated to prove process competence. The results indicate that feedstock with a 316L particle content of 92.5 wt. % can be prepared with a sigma blade mixing, whose rheological behavior is fit for EAM. The green samples have sufficient strength to handle them for subsequent treatments. The sintered samples considerably shrunk to designed dimensions and have a homogeneous microstructure to impart mechanical strength. Whereas, maintaining comparable dimensional accuracy and chemical composition which are required for biomedical equipment still need iterations, a kinematic correction and modification in debinding cycle was proposed.

Novel active driven drop tower facility for microgravity experiments investigating production technologies on the example of substrate-free additive manufacturing

NASA Astrophysics Data System (ADS)

Lotz, Christoph; Wessarges, Yvonne; Hermsdorf, Jörg; Ertmer, Wolfgang; Overmeyer, Ludger

2018-04-01

Through the striving of humanity into space, new production processes and technologies for the use under microgravity will be essential in the future. Production of objects in space demands for new processes, like additive manufacturing. This paper presents the concept and the realization for a new machine to investigate microgravity production processes on earth. The machine is based on linear long stator drives and a vacuum chamber carrying up to 1000 kg. For the first time high repetition rate and associated low experimental costs can provide basic research. The paper also introduces the substrate-free additive manufacturing as a future research topic and one of our primary application.

Modeling of Powder Bed Manufacturing Defects

NASA Astrophysics Data System (ADS)

Mindt, H.-W.; Desmaison, O.; Megahed, M.; Peralta, A.; Neumann, J.

2018-01-01

Powder bed additive manufacturing offers unmatched capabilities. The deposition resolution achieved is extremely high enabling the production of innovative functional products and materials. Achieving the desired final quality is, however, hampered by many potential defects that have to be managed in due course of the manufacturing process. Defects observed in products manufactured via powder bed fusion have been studied experimentally. In this effort we have relied on experiments reported in the literature and—when experimental data were not sufficient—we have performed additional experiments providing an extended foundation for defect analysis. There is large interest in reducing the effort and cost of additive manufacturing process qualification and certification using integrated computational material engineering. A prerequisite is, however, that numerical methods can indeed capture defects. A multiscale multiphysics platform is developed and applied to predict and explain the origin of several defects that have been observed experimentally during laser-based powder bed fusion processes. The models utilized are briefly introduced. The ability of the models to capture the observed defects is verified. The root cause of the defects is explained by analyzing the numerical results thus confirming the ability of numerical methods to provide a foundation for rapid process qualification.

Opportunities and challenges of real-time release testing in biopharmaceutical manufacturing.

PubMed

Jiang, Mo; Severson, Kristen A; Love, John Christopher; Madden, Helena; Swann, Patrick; Zang, Li; Braatz, Richard D

2017-11-01

Real-time release testing (RTRT) is defined as "the ability to evaluate and ensure the quality of in-process and/or final drug product based on process data, which typically includes a valid combination of measured material attributes and process controls" (ICH Q8[R2]). This article discusses sensors (process analytical technology, PAT) and control strategies that enable RTRT for the spectrum of critical quality attributes (CQAs) in biopharmaceutical manufacturing. Case studies from the small-molecule and biologic pharmaceutical industry are described to demonstrate how RTRT can be facilitated by integrated manufacturing and multivariable control strategies to ensure the quality of products. RTRT can enable increased assurance of product safety, efficacy, and quality-with improved productivity including faster release and potentially decreased costs-all of which improve the value to patients. To implement a complete RTRT solution, biologic drug manufacturers need to consider the special attributes of their industry, particularly sterility and the measurement of viral and microbial contamination. Continued advances in on-line and in-line sensor technologies are key for the biopharmaceutical manufacturing industry to achieve the potential of RTRT. Related article: http://onlinelibrary.wiley.com/doi/10.1002/bit.26378/full. © 2017 Wiley Periodicals, Inc.

Assembly-line Simulation Program

NASA Technical Reports Server (NTRS)

Chamberlain, Robert G.; Zendejas, Silvino; Malhotra, Shan

1987-01-01

Costs and profits estimated for models based on user inputs. Standard Assembly-line Manufacturing Industry Simulation (SAMIS) program generalized so useful for production-line manufacturing companies. Provides accurate and reliable means of comparing alternative manufacturing processes. Used to assess impact of changes in financial parameters as cost of resources and services, inflation rates, interest rates, tax policies, and required rate of return of equity. Most important capability is ability to estimate prices manufacturer would have to receive for its products to recover all of costs of production and make specified profit. Written in TURBO PASCAL.

Recent developments in processing systems for cell and tissue cultures toward therapeutic application.

PubMed

Kino-oka, Masahiro; Taya, Masahito

2009-10-01

Innovative techniques of cell and tissue processing, based on tissue engineering, have been developed for therapeutic applications. Cell expansion and tissue reconstruction through ex vivo cultures are core processes used to produce engineered tissues with sufficient structural integrity and functionality. In manufacturing, strict management against contamination and human error is compelled due to direct use of un-sterilable products and the laboriousness of culture operations, respectively. Therefore, the development of processing systems for cell and tissue cultures is one of the critical issues for ensuring a stable process and quality of therapeutic products. However, the siting criterion of culture systems to date has not been made clear. This review article classifies some of the known processing systems into 'sealed-chamber' and 'sealed-vessel' culture systems based on the difference in their aseptic spaces, and describes the potential advantages of these systems and current states of culture systems, especially those established by Japanese companies. Moreover, on the basis of the guidelines for isolator systems used in aseptic processing for healthcare products, which are issued by the International Organization for Standardization, the siting criterion of the processing systems for cells and tissue cultures is discussed in perspective of manufacturing therapeutic products in consideration of the regulations according to the Good Manufacturing Practice.

Limiting factors in the production of deep microstructures

NASA Astrophysics Data System (ADS)

Tolfree, David W. L.; O'Neill, William; Tunna, Leslie; Sutcliffe, Christopher

1999-10-01

Microsystems increasingly require precision deep microstructures that can be cost-effectively designed and manufactured. New products must be able to meet the demands of the rapidly growing markets for microfluidic, micro- optical and micromechanical devices in industrial sectors which include chemicals, pharmaceuticals, biosciences, medicine and food. The realization of such products, first requires an effective process to design and manufacture prototypes. Two process methods used for the fabrication of high aspect-ratio microstructures are based on X-ray beam lithography with electroforming processes and direct micromachining with a frequency multiplied Nd:YAG laser using nanosecond pulse widths. Factors which limit the efficiency and precision obtainable using such processes are important parameters when deciding on the best fabrication method to use. A basic microstructure with narrow channels suitable for a microfluidic mixer have been fabricated using both these techniques and comparisons made of the limitations and suitability of the processes in respect of fast prototyping and manufacture or working devices.

Media fill for validation of a good manufacturing practice-compliant cell production process.

PubMed

Serra, Marta; Roseti, Livia; Bassi, Alessandra

2015-01-01

According to the European Regulation EC 1394/2007, the clinical use of Advanced Therapy Medicinal Products, such as Human Bone Marrow Mesenchymal Stem Cells expanded for the regeneration of bone tissue or Chondrocytes for Autologous Implantation, requires the development of a process in compliance with the Good Manufacturing Practices. The Media Fill test, consisting of a simulation of the expansion process by using a microbial growth medium instead of the cells, is considered one of the most effective ways to validate a cell production process. Such simulation, in fact, allows to identify any weakness in production that can lead to microbiological contamination of the final cell product as well as qualifying operators. Here, we report the critical aspects concerning the design of a Media Fill test to be used as a tool for the further validation of the sterility of a cell-based Good Manufacturing Practice-compliant production process.

Development the conceptual design of Knowledge Based System for Integrated Maintenance Strategy and Operation

NASA Astrophysics Data System (ADS)

Milana; Khan, M. K.; Munive, J. E.

2014-07-01

The importance of maintenance has escalated significantly by the increasing of automation in manufacturing process. This condition switches traditional maintenance perspective of inevitable cost into the business competitive driver. Consequently, maintenance strategy and operation decision needs to be synchronized to business and manufacturing concerns. This paper shows the development of conceptual design of Knowledge Based System for Integrated Maintenance Strategy and Operation (KBIMSO). The framework of KBIMSO is elaborated to show the process of how the KBIMSO works to reach the maintenance decision. By considering the multi-criteria of maintenance decision making, the KB system embedded with GAP and AHP to support integrated maintenance strategy and operation which is novel in this area. The KBIMSO is useful to review the existing maintenance system and give reasonable recommendation of maintenance decisions in respect to business and manufacturing perspective.

Product pricing in the Solar Array Manufacturing Industry - An executive summary of SAMICS

NASA Technical Reports Server (NTRS)

Chamberlain, R. G.

1978-01-01

Capabilities, methodology, and a description of input data to the Solar Array Manufacturing Industry Costing Standards (SAMICS) are presented. SAMICS were developed to provide a standardized procedure and data base for comparing manufacturing processes of Low-cost Solar Array (LSA) subcontractors, guide the setting of research priorities, and assess the progress of LSA toward its hundred-fold cost reduction goal. SAMICS can be used to estimate the manufacturing costs and product prices and determine the impact of inflation, taxes, and interest rates, but it is limited by its ignoring the effects of the market supply and demand and an assumption that all factories operate in a production line mode. The SAMICS methodology defines the industry structure, hypothetical supplier companies, and manufacturing processes and maintains a body of standardized data which is used to compute the final product price. The input data includes the product description, the process characteristics, the equipment cost factors, and production data for the preparation of detailed cost estimates. Activities validating that SAMICS produced realistic price estimates and cost breakdowns are described.

Manufacturing Energy Intensity and Opportunity Analysis for Fiber-Reinforced Polymer Composites and Other Lightweight Materials

DOE Office of Scientific and Technical Information (OSTI.GOV)

Liddell, Heather; Brueske, Sabine; Carpenter, Alberta

With their high strength-to-weight ratios, fiber-reinforced polymer (FRP) composites are important materials for lightweighting in structural applications; however, manufacturing challenges such as low process throughput and poor quality control can lead to high costs and variable performance, limiting their use in commercial applications. One of the most significant challenges for advanced composite materials is their high manufacturing energy intensity. This study explored the energy intensities of two lightweight FRP composite materials (glass- and carbon-fiber-reinforced polymers), with three lightweight metals (aluminum, magnesium, and titanium) and structural steel (as a reference material) included for comparison. Energy consumption for current typical and state-of-the-artmore » manufacturing processes were estimated for each material, deconstructing manufacturing process energy use by sub-process and manufacturing pathway in order to better understand the most energy intensive steps. Energy saving opportunities were identified and quantified for each production step based on a review of applied R&D technologies currently under development in order to estimate the practical minimum energy intensity. Results demonstrate that while carbon fiber reinforced polymer (CFRP) composites have the highest current manufacturing energy intensity of all materials considered, the large differences between current typical and state-of-the-art energy intensity levels (the 'current opportunity') and between state-of-the-art and practical minimum energy intensity levels (the 'R&D opportunity') suggest that large-scale energy savings are within reach.« less

[In vitro availability of minerals in infant foods with different protein source].

PubMed

Pérez-Llamas, F; Larqué, E; Marín, J F; Zamora, S

2001-01-01

As the result of the digestion process, it is produced at gastrointestinal level interactions between proteins-minerals and minerals-minerals that might modify the bioavailability of the nutrients initially designed for an adequate nutrition in infant formulas. The aim of the present study is to compare the in vitro availability of some minerals and trace elements (calcium, phosphorus, magnesium, iron and zinc) in infant formulas of initiation elaborated with different protein sources: formulas based on cow milk protein (whey-casein) versus vegetal protein (soy-based infant formulas). Also, for evaluating the effects of the different mineral supplementation in the availability of minerals, it was used infant formulas from two different manufacturers. Milk-protein based infant formulas showed for both manufacturers higher dialysis percentage (%) of phosphorus and zinc than the soy-protein based formulas. The availability of iron in the soy formula of the manufacturer A lowered significantly (P < 0.05) respect to the whey-casein based formula (9.6 +/- 2.3 versus 4.6 +/- 0.8), but not respect to the whey-casein formula of manufacturer B (9.6 +/- 1.1 versus 9.0 +/- 0.7), which might be due to the lowest proportion of phytic acid in this last commercial formula. Dialysability of all the minerals analysed from soy-protein based formulas showed significant differences depending on the manufacturer. The purification processes of the soy protein have a high repercussion in the mineral availability of soy-based infant formulas. It could be more interesting to use soy proteins more purified, with low level of phytic acid, in the elaboration of soy infants formulas, than the supplementation them with high amounts of minerals.

Fatigue Strength Prediction for Titanium Alloy TiAl6V4 Manufactured by Selective Laser Melting

NASA Astrophysics Data System (ADS)

Leuders, Stefan; Vollmer, Malte; Brenne, Florian; Tröster, Thomas; Niendorf, Thomas

2015-09-01

Selective laser melting (SLM), as a metalworking additive manufacturing technique, received considerable attention from industry and academia due to unprecedented design freedom and overall balanced material properties. However, the fatigue behavior of SLM-processed materials often suffers from local imperfections such as micron-sized pores. In order to enable robust designs of SLM components used in an industrial environment, further research regarding process-induced porosity and its impact on the fatigue behavior is required. Hence, this study aims at a transfer of fatigue prediction models, established for conventional process-routes, to the field of SLM materials. By using high-resolution computed tomography, load increase tests, and electron microscopy, it is shown that pore-based fatigue strength predictions for a titanium alloy TiAl6V4 have become feasible. However, the obtained accuracies are subjected to scatter, which is probably caused by the high defect density even present in SLM materials manufactured following optimized processing routes. Based on thorough examination of crack surfaces and crack initiation sites, respectively, implications for optimization of prediction accuracy of the models in focus are deduced.

Work-related musculoskeletal disorders (WMDs) risk assessment at core assembly production of electronic components manufacturing company

NASA Astrophysics Data System (ADS)

Yahya, N. M.; Zahid, M. N. O.

2018-03-01

This study conducted to assess the work-related musculoskeletal disorders (WMDs) among the workers at core assembly production in an electronic components manufacturing company located in Pekan, Pahang, Malaysia. The study is to identify the WMDs risk factor and risk level. A set of questionnaires survey based on modified Nordic Musculoskeletal Disorder Questionnaires have been distributed to respective workers to acquire the WMDs risk factor identification. Then, postural analysis was conducted in order to measure the respective WMDs risk level. The analysis were based on two ergonomics assessment tools; Rapid Upper Limb Assessment (RULA) and Rapid Entire Body Assessment (REBA). The study found that 30 respondents out of 36 respondents suffered from WMDs especially at shoulder, wrists and lower back. The WMDs risk have been identified from unloading process, pressing process and winding process. In term of the WMDs risk level, REBA and RULA assessment tools have indicated high risk level to unloading and pressing process. Thus, this study had established the WMDs risk factor and risk level of core assembly production in an electronic components manufacturing company at Malaysia environment.

Study of thermo-fluidic behavior of micro-droplet in inkjet-based micro manufacturing processes

NASA Astrophysics Data System (ADS)

Das, Raju; Mahapatra, Abhijit; Ball, Amit Kumar; Roy, Shibendu Shekhar; Murmu, Naresh Chandra

2017-06-01

Inkjet printing technology, a maskless, non-contact patterning operation, which has been a revelation in the field of micro and nano manufacturing for its use in the selective deposition of desired materials. It is becoming an exciting alternative technology such as lithography to print functional material on to a substrate. Selective deposition of functional materials on desired substrates is a basic requirement in many of the printing based micro and nano manufacturing operations like the fabrication of microelectronic devices, solar cell, Light-emitting Diode (LED) research fields like pharmaceutical industries for drug discovery purposes and in biotechnology to make DNA microarrays. In this paper, an attempt has been made to design and develop an indigenous Electrohydrodynamic Inkjet printing system for micro fabrication and to study the interrelationships between various thermos-fluidic parameters of the ink material in the printing process. The effect of printing process parameters on printing performance characteristics has also been studied. And the applicability of the process has also been experimentally demonstrated. The experimentally found results were quite satisfactory and accordance to its applicability.

Physical processing and emission characteristics of firelogs from cotton ginning byproducts

USDA-ARS?s Scientific Manuscript database

A study was conducted to evaluate the suitability of cotton ginning byproducts for manufacturing firelogs. Cotton burr with stem (CBS) a byproduct from cotton ginning operation was mixed with petroleum based paraffin wax to manufacture firelogs. The impact of varying the formulation of firelogs, an...

The Role of Laser Additive Manufacturing Methods of Metals in Repair, Refurbishment and Remanufacturing - Enabling Circular Economy

NASA Astrophysics Data System (ADS)

Leino, Maija; Pekkarinen, Joonas; Soukka, Risto

Circular economy is an economy model where products, components, and materials are aimed to be kept at their highest utility and value at all times. Repair, refurbishment and remanufacturing processes are procedures aiming at returning the value of the product during its life cycle. Additive manufacturing (AM) is expected to be an enabling technology in circular economy based business models. One of AM process that enables repair, refurbishment and remanufacturing is Directed Energy Deposition. Respectively Powder Bed Fusion enables manufacturing of replacement components on demand. The aim of this study is to identify the current research findings and state of art of utilizing AM in repair, refurbishment and remanufacturing processes of metallic products. The focus is in identifying possibilities of AM in promotion of circular economy and expected environmental benefits based on the found literature. Results of the study indicate significant potential in utilizing AM in repair, refurbishment and remanufacturing activities.

Virtual tryout planning in automotive industry based on simulation metamodels

NASA Astrophysics Data System (ADS)

Harsch, D.; Heingärtner, J.; Hortig, D.; Hora, P.

2016-11-01

Deep drawn sheet metal parts are increasingly designed to the feasibility limit, thus achieving a robust manufacturing is often challenging. The fluctuation of process and material properties often lead to robustness problems. Therefore, numerical simulations are used to detect the critical regions. To enhance the agreement with the real process conditions, the material data are acquired through a variety of experiments. Furthermore, the force distribution is taken into account. The simulation metamodel contains the virtual knowledge of a particular forming process, which is determined based on a series of finite element simulations with variable input parameters. Based on the metamodels, virtual process windows can be displayed for different configurations. This helps to improve the operating point as well as to adjust process settings in case the process becomes unstable. Furthermore, the time of tool tryout can be shortened due to transfer of the virtual knowledge contained in the metamodels on the optimisation of the drawbeads. This allows the tool manufacturer to focus on the essential, to save time and to recognize complex relationships.

Relative risk analysis of several manufactured nanomaterials: an insurance industry context.

PubMed

Robichaud, Christine Ogilvie; Tanzil, Dicksen; Weilenmann, Ulrich; Wiesner, Mark R

2005-11-15

A relative risk assessment is presented for the industrial fabrication of several nanomaterials. The production processes for five nanomaterials were selected for this analysis, based on their current or near-term potential for large-scale production and commercialization: single-walled carbon nanotubes, bucky balls (C60), one variety of quantum dots, alumoxane nanoparticles, and nano-titanium dioxide. The assessment focused on the activities surrounding the fabrication of nanomaterials, exclusive of any impacts or risks with the nanomaterials themselves. A representative synthesis method was selected for each nanomaterial based on its potential for scaleup. A list of input materials, output materials, and waste streams for each step of fabrication was developed and entered into a database that included key process characteristics such as temperature and pressure. The physical-chemical properties and quantities of the inventoried materials were used to assess relative risk based on factors such as volatility, carcinogenicity, flammability, toxicity, and persistence. These factors were first used to qualitatively rank risk, then combined using an actuarial protocol developed by the insurance industry for the purpose of calculating insurance premiums for chemical manufacturers. This protocol ranks three categories of risk relative to a 100 point scale (where 100 represents maximum risk): incident risk, normal operations risk, and latent contamination risk. Results from this analysis determined that relative environmental risk from manufacturing each of these five materials was comparatively low in relation to other common industrial manufacturing processes.

Network-based production quality control

NASA Astrophysics Data System (ADS)

Kwon, Yongjin; Tseng, Bill; Chiou, Richard

2007-09-01

This study investigates the feasibility of remote quality control using a host of advanced automation equipment with Internet accessibility. Recent emphasis on product quality and reduction of waste stems from the dynamic, globalized and customer-driven market, which brings opportunities and threats to companies, depending on the response speed and production strategies. The current trends in industry also include a wide spread of distributed manufacturing systems, where design, production, and management facilities are geographically dispersed. This situation mandates not only the accessibility to remotely located production equipment for monitoring and control, but efficient means of responding to changing environment to counter process variations and diverse customer demands. To compete under such an environment, companies are striving to achieve 100%, sensor-based, automated inspection for zero-defect manufacturing. In this study, the Internet-based quality control scheme is referred to as "E-Quality for Manufacturing" or "EQM" for short. By its definition, EQM refers to a holistic approach to design and to embed efficient quality control functions in the context of network integrated manufacturing systems. Such system let designers located far away from the production facility to monitor, control and adjust the quality inspection processes as production design evolves.

Load-adaptive scaffold architecturing: a bioinspired approach to the design of porous additively manufactured scaffolds with optimized mechanical properties.

PubMed

Rainer, Alberto; Giannitelli, Sara M; Accoto, Dino; De Porcellinis, Stefano; Guglielmelli, Eugenio; Trombetta, Marcella

2012-04-01

Computer-Aided Tissue Engineering (CATE) is based on a set of additive manufacturing techniques for the fabrication of patient-specific scaffolds, with geometries obtained from medical imaging. One of the main issues regarding the application of CATE concerns the definition of the internal architecture of the fabricated scaffolds, which, in turn, influences their porosity and mechanical strength. The present study envisages an innovative strategy for the fabrication of highly optimized structures, based on the a priori finite element analysis (FEA) of the physiological load set at the implant site. The resulting scaffold micro-architecture does not follow a regular geometrical pattern; on the contrary, it is based on the results of a numerical study. The algorithm was applied to a solid free-form fabrication process, using poly(ε-caprolactone) as the starting material for the processing of additive manufactured structures. A simple and intuitive geometry was chosen as a proof-of-principle application, on which finite element simulations and mechanical testing were performed. Then, to demonstrate the capability in creating mechanically biomimetic structures, the proximal femur subjected to physiological loading conditions was considered and a construct fitting a femur head portion was designed and manufactured.

Design of forging process variables under uncertainties

NASA Astrophysics Data System (ADS)

Repalle, Jalaja; Grandhi, Ramana V.

2005-02-01

Forging is a complex nonlinear process that is vulnerable to various manufacturing anomalies, such as variations in billet geometry, billet/die temperatures, material properties, and workpiece and forging equipment positional errors. A combination of these uncertainties could induce heavy manufacturing losses through premature die failure, final part geometric distortion, and reduced productivity. Identifying, quantifying, and controlling the uncertainties will reduce variability risk in a manufacturing environment, which will minimize the overall production cost. In this article, various uncertainties that affect the forging process are identified, and their cumulative effect on the forging tool life is evaluated. Because the forging process simulation is time-consuming, a response surface model is used to reduce computation time by establishing a relationship between the process performance and the critical process variables. A robust design methodology is developed by incorporating reliability-based optimization techniques to obtain sound forging components. A case study of an automotive-component forging-process design is presented to demonstrate the applicability of the method.

Process-Structure Linkages Using a Data Science Approach: Application to Simulated Additive Manufacturing Data

DOE Office of Scientific and Technical Information (OSTI.GOV)

Popova, Evdokia; Rodgers, Theron M.; Gong, Xinyi

A novel data science workflow is developed and demonstrated to extract process-structure linkages (i.e., reduced-order model) for microstructure evolution problems when the final microstructure depends on (simulation or experimental) processing parameters. Our workflow consists of four main steps: data pre-processing, microstructure quantification, dimensionality reduction, and extraction/validation of process-structure linkages. These methods that can be employed within each step vary based on the type and amount of available data. In this paper, this data-driven workflow is applied to a set of synthetic additive manufacturing microstructures obtained using the Potts-kinetic Monte Carlo (kMC) approach. Additive manufacturing techniques inherently produce complex microstructures thatmore » can vary significantly with processing conditions. Using the developed workflow, a low-dimensional data-driven model was established to correlate process parameters with the predicted final microstructure. In addition, the modular workflows developed and presented in this work facilitate easy dissemination and curation by the broader community.« less

Manufacturing of tailored tubes with a process integrated heat treatment

NASA Astrophysics Data System (ADS)

Hordych, Illia; Boiarkin, Viacheslav; Rodman, Dmytro; Nürnberger, Florian

2017-10-01

The usage of work-pieces with tailored properties allows for reducing costs and materials. One example are tailored tubes that can be used as end parts e.g. in the automotive industry or in domestic applications as well as semi-finished products for subsequent controlled deformation processes. An innovative technology to manufacture tubes is roll forming with a subsequent inductive heating and adapted quenching to obtain tailored properties in the longitudinal direction. This processing offers a great potential for the production of tubes with a wide range of properties, although this novel approach still requires a suited process design. Based on experimental data, a process simulation is being developed. The simulation shall be suitable for a virtual design of the tubes and allows for gaining a deeper understanding of the required processing. The model proposed shall predict microstructural and mechanical tube properties by considering process parameters, different geometries, batch-related influences etc. A validation is carried out using experimental data of tubes manufactured from various steel grades.

Process-Structure Linkages Using a Data Science Approach: Application to Simulated Additive Manufacturing Data

DOE PAGES

Popova, Evdokia; Rodgers, Theron M.; Gong, Xinyi; ...

2017-03-13

A novel data science workflow is developed and demonstrated to extract process-structure linkages (i.e., reduced-order model) for microstructure evolution problems when the final microstructure depends on (simulation or experimental) processing parameters. Our workflow consists of four main steps: data pre-processing, microstructure quantification, dimensionality reduction, and extraction/validation of process-structure linkages. These methods that can be employed within each step vary based on the type and amount of available data. In this paper, this data-driven workflow is applied to a set of synthetic additive manufacturing microstructures obtained using the Potts-kinetic Monte Carlo (kMC) approach. Additive manufacturing techniques inherently produce complex microstructures thatmore » can vary significantly with processing conditions. Using the developed workflow, a low-dimensional data-driven model was established to correlate process parameters with the predicted final microstructure. In addition, the modular workflows developed and presented in this work facilitate easy dissemination and curation by the broader community.« less

Industrializing Autologous Adoptive Immunotherapies: Manufacturing Advances and Challenges

PubMed Central

Iyer, Rohin K.; Bowles, Paul A.; Kim, Howard; Dulgar-Tulloch, Aaron

2018-01-01

Cell therapy has proven to be a burgeoning field of investigation, evidenced by hundreds of clinical trials being conducted worldwide across a variety of cell types and indications. Many cell therapies have been shown to be efficacious in humans, such as modified T-cells and natural killer (NK) cells. Adoptive immunotherapy has shown the most promise in recent years, with particular emphasis on autologous cell sources. Chimeric Antigen Receptor (CAR)-based T-cell therapy targeting CD19-expressing B-cell leukemias has shown remarkable efficacy and reproducibility in numerous clinical trials. Recent marketing approval of Novartis' Kymriah™ (tisagenlecleucel) and Gilead/Kite's Yescarta™ (axicabtagene ciloleucel) by the FDA further underscores both the promise and legwork to be done if manufacturing processes are to become widely accessible. Further work is needed to standardize, automate, close, and scale production to bring down costs and democratize these and other cell therapies. Given the multiple processing steps involved, commercial-scale manufacturing of these therapies necessitates tighter control over process parameters. This focused review highlights some of the most recent advances used in the manufacturing of therapeutic immune cells, with a focus on T-cells. We summarize key unit operations and pain points around current manufacturing solutions. We also review emerging technologies, approaches and reagents used in cell isolation, activation, transduction, expansion, in-process analytics, harvest, cryopreservation and thaw, and conclude with a forward-look at future directions in the manufacture of adoptive immunotherapies.

Industrializing Autologous Adoptive Immunotherapies: Manufacturing Advances and Challenges.

PubMed

Iyer, Rohin K; Bowles, Paul A; Kim, Howard; Dulgar-Tulloch, Aaron

2018-01-01

Cell therapy has proven to be a burgeoning field of investigation, evidenced by hundreds of clinical trials being conducted worldwide across a variety of cell types and indications. Many cell therapies have been shown to be efficacious in humans, such as modified T-cells and natural killer (NK) cells. Adoptive immunotherapy has shown the most promise in recent years, with particular emphasis on autologous cell sources. Chimeric Antigen Receptor (CAR)-based T-cell therapy targeting CD19-expressing B-cell leukemias has shown remarkable efficacy and reproducibility in numerous clinical trials. Recent marketing approval of Novartis' Kymriah™ (tisagenlecleucel) and Gilead/Kite's Yescarta™ (axicabtagene ciloleucel) by the FDA further underscores both the promise and legwork to be done if manufacturing processes are to become widely accessible. Further work is needed to standardize, automate, close, and scale production to bring down costs and democratize these and other cell therapies. Given the multiple processing steps involved, commercial-scale manufacturing of these therapies necessitates tighter control over process parameters. This focused review highlights some of the most recent advances used in the manufacturing of therapeutic immune cells, with a focus on T-cells. We summarize key unit operations and pain points around current manufacturing solutions. We also review emerging technologies, approaches and reagents used in cell isolation, activation, transduction, expansion, in-process analytics, harvest, cryopreservation and thaw, and conclude with a forward-look at future directions in the manufacture of adoptive immunotherapies.

Design and manufacturing of patient-specific orthodontic appliances by computer-aided engineering techniques.

PubMed

Barone, Sandro; Neri, Paolo; Paoli, Alessandro; Razionale, Armando Viviano

2018-01-01

Orthodontic treatments are usually performed using fixed brackets or removable oral appliances, which are traditionally made from alginate impressions and wax registrations. Among removable devices, eruption guidance appliances are used for early orthodontic treatments in order to intercept and prevent malocclusion problems. Commercially available eruption guidance appliances, however, are symmetric devices produced using a few standard sizes. For this reason, they are not able to meet all the specific patient's needs since the actual dental anatomies present various geometries and asymmetric conditions. In this article, a computer-aided design-based methodology for the design and manufacturing of a patient-specific eruption guidance appliances is presented. The proposed approach is based on the digitalization of several steps of the overall process: from the digital reconstruction of patients' anatomies to the manufacturing of customized appliances. A finite element model has been developed to evaluate the temporomandibular joint disks stress level caused by using symmetric eruption guidance appliances with different teeth misalignment conditions. The developed model can then be used to guide the design of a patient-specific appliance with the aim at reducing the patient discomfort. At this purpose, two different customization levels are proposed in order to face both arches and single tooth misalignment issues. A low-cost manufacturing process, based on an additive manufacturing technique, is finally presented and discussed.

Printed polymer photonic devices for optical interconnect systems

NASA Astrophysics Data System (ADS)

Subbaraman, Harish; Pan, Zeyu; Zhang, Cheng; Li, Qiaochu; Guo, L. J.; Chen, Ray T.

2016-03-01

Polymer photonic device fabrication usually relies on the utilization of clean-room processes, including photolithography, e-beam lithography, reactive ion etching (RIE) and lift-off methods etc, which are expensive and are limited to areas as large as a wafer. Utilizing a novel and a scalable printing process involving ink-jet printing and imprinting, we have fabricated polymer based photonic interconnect components, such as electro-optic polymer based modulators and ring resonator switches, and thermo-optic polymer switch based delay networks and demonstrated their operation. Specifically, a modulator operating at 15MHz and a 2-bit delay network providing up to 35.4ps are presented. In this paper, we also discuss the manufacturing challenges that need to be overcome in order to make roll-to-roll manufacturing practically viable. We discuss a few manufacturing challenges, such as inspection and quality control, registration, and web control, that need to be overcome in order to realize true implementation of roll-to-roll manufacturing of flexible polymer photonic systems. We have overcome these challenges, and currently utilizing our inhouse developed hardware and software tools, <10μm alignment accuracy at a 5m/min is demonstrated. Such a scalable roll-to-roll manufacturing scheme will enable the development of unique optoelectronic devices which can be used in a myriad of different applications, including communication, sensing, medicine, security, imaging, energy, lighting etc.

Study of the aroma formation and transformation during the manufacturing process of oolong tea by solid-phase micro-extraction and gas chromatography-mass spectrometry combined with chemometrics.

PubMed

Ma, Chengying; Li, Junxing; Chen, Wei; Wang, Wenwen; Qi, Dandan; Pang, Shi; Miao, Aiqing

2018-06-01

Oolong tea is a typical semi-fermented tea and is famous for its unique aroma. The aim of this study was to compare the volatile compounds during manufacturing process to reveal the formation of aroma. In this paper, a method was developed based on head-space solid phase microextraction/gas chromatography-mass spectrometry (HS-SPME/GC-MS) combined with chemometrics to assess volatile profiles during manufacturing process (fresh leaves, sun-withered leaves, rocked leaves and leaves after de-enzyming). A total of 24 aroma compounds showing significant differences during manufacturing process were identified. Subsequently, according to these aroma compounds, principal component analysis and hierarchical cluster analysis showed that the four samples were clearly distinguished from each other, which suggested that the 24 identified volatile compounds can represent the changes of volatile compounds during the four steps. Additionally, sun-withering, rocking and de-enzyming can influence the variations of volatile compounds in different degree, and we found the changes of volatile compounds in withering step were less than other two manufacturing process, indicating that the characteristic volatile compounds of oolong tea might be mainly formed in rocking stage by biological reactions and de-enzyming stage through thermal chemical transformations rather than withering stage. This study suggested that HS-SPME/GC-MS combined with chemometrics methods is accurate, sensitive, fast and ideal for rapid routine analysis of the aroma compounds changes in oolong teas during manufacturing processing. Copyright © 2018 Elsevier Ltd. All rights reserved.

Laser beam welding quality monitoring system based in high-speed (10 kHz) uncooled MWIR imaging sensors

NASA Astrophysics Data System (ADS)

Linares, Rodrigo; Vergara, German; Gutiérrez, Raúl; Fernández, Carlos; Villamayor, Víctor; Gómez, Luis; González-Camino, Maria; Baldasano, Arturo; Castro, G.; Arias, R.; Lapido, Y.; Rodríguez, J.; Romero, Pablo

2015-05-01

The combination of flexibility, productivity, precision and zero-defect manufacturing in future laser-based equipment are a major challenge that faces this enabling technology. New sensors for online monitoring and real-time control of laserbased processes are necessary for improving products quality and increasing manufacture yields. New approaches to fully automate processes towards zero-defect manufacturing demand smarter heads where lasers, optics, actuators, sensors and electronics will be integrated in a unique compact and affordable device. Many defects arising in laser-based manufacturing processes come from instabilities in the dynamics of the laser process. Temperature and heat dynamics are key parameters to be monitored. Low cost infrared imagers with high-speed of response will constitute the next generation of sensors to be implemented in future monitoring and control systems for laser-based processes, capable to provide simultaneous information about heat dynamics and spatial distribution. This work describes the result of using an innovative low-cost high-speed infrared imager based on the first quantum infrared imager monolithically integrated with Si-CMOS ROIC of the market. The sensor is able to provide low resolution images at frame rates up to 10 KHz in uncooled operation at the same cost as traditional infrared spot detectors. In order to demonstrate the capabilities of the new sensor technology, a low-cost camera was assembled on a standard production laser welding head, allowing to register melting pool images at frame rates of 10 kHz. In addition, a specific software was developed for defect detection and classification. Multiple laser welding processes were recorded with the aim to study the performance of the system and its application to the real-time monitoring of laser welding processes. During the experiments, different types of defects were produced and monitored. The classifier was fed with the experimental images obtained. Self-learning strategies were implemented with very promising results, demonstrating the feasibility of using low-cost high-speed infrared imagers in advancing towards a real-time / in-line zero-defect production systems.

Additive Manufacturing of Poly(3-hydroxybutyrate-co-3-hydroxyhexanoate)/poly(ε-caprolactone) Blend Scaffolds for Tissue Engineering

PubMed Central

Puppi, Dario; Morelli, Andrea; Chiellini, Federica

2017-01-01

Additive manufacturing of scaffolds made of a polyhydroxyalkanoate blended with another biocompatible polymer represents a cost-effective strategy for combining the advantages of the two blend components in order to develop tailored tissue engineering approaches. The aim of this study was the development of novel poly(3-hydroxybutyrate-co-3-hydroxyhexanoate)/ poly(ε-caprolactone) (PHBHHx/PCL) blend scaffolds for tissue engineering by means of computer-aided wet-spinning, a hybrid additive manufacturing technique suitable for processing polyhydroxyalkanoates dissolved in organic solvents. The experimental conditions for processing tetrahydrofuran solutions containing the two polymers at different concentrations (PHBHHx/PCL weight ratio of 3:1, 2:1 or 1:1) were optimized in order to manufacture scaffolds with predefined geometry and internal porous architecture. PHBHHx/PCL scaffolds with a 3D interconnected network of macropores and a local microporosity of the polymeric matrix, as a consequence of the phase inversion process governing material solidification, were successfully fabricated. As shown by scanning electron microscopy, thermogravimetric, differential scanning calorimetric and uniaxial compressive analyses, blend composition significantly influenced the scaffold morphological, thermal and mechanical properties. In vitro biological characterization showed that the developed scaffolds were able to sustain the adhesion and proliferation of MC3T3-E1 murine preosteoblast cells. The additive manufacturing approach developed in this study, based on a polymeric solution processing method avoiding possible material degradation related to thermal treatments, could represent a powerful tool for the development of customized PHBHHx-based blend scaffolds for tissue engineering. PMID:28952527

Solvent-free dry powder coating process for low-cost manufacturing of LiNi1/3Mn1/3Co1/3O2 cathodes in lithium-ion batteries

NASA Astrophysics Data System (ADS)

Al-Shroofy, Mohanad; Zhang, Qinglin; Xu, Jiagang; Chen, Tao; Kaur, Aman Preet; Cheng, Yang-Tse

2017-06-01

We report a solvent-free dry powder coating process for making LiNi1/3Mn1/3Co1/3O2 (NMC) positive electrodes in lithium-ion batteries. This process eliminates volatile organic compound emission and reduces thermal curing time from hours to minutes. A mixture of NMC, carbon black, and poly(vinylidene difluoride) was electrostatically sprayed onto an aluminum current collector, forming a uniformly distributed electrode with controllable thickness and porosity. Charge/discharge cycling of the dry-powder-coated electrodes in lithium-ion half cells yielded a discharge specific capacity of 155 mAh g-1 and capacity retention of 80% for more than 300 cycles when the electrodes were tested between 3.0 and 4.3 V at a rate of C/5. The long-term cycling performance and durability of dry-powder coated electrodes are similar to those made by the conventional wet slurry-based method. This solvent-free dry powder coating process is a potentially lower-cost, higher-throughput, and more environmentally friendly manufacturing process compared with the conventional wet slurry-based electrode manufacturing method.

Risk management for moisture related effects in dry manufacturing processes: a statistical approach.

PubMed

Quiroz, Jorge; Strong, John; Zhang, Lanju

2016-03-01

A risk- and science-based approach to control the quality in pharmaceutical manufacturing includes a full understanding of how product attributes and process parameters relate to product performance through a proactive approach in formulation and process development. For dry manufacturing, where moisture content is not directly manipulated within the process, the variability in moisture of the incoming raw materials can impact both the processability and drug product quality attributes. A statistical approach is developed using individual raw material historical lots as a basis for the calculation of tolerance intervals for drug product moisture content so that risks associated with excursions in moisture content can be mitigated. The proposed method is based on a model-independent approach that uses available data to estimate parameters of interest that describe the population of blend moisture content values and which do not require knowledge of the individual blend moisture content values. Another advantage of the proposed tolerance intervals is that, it does not require the use of tabulated values for tolerance factors. This facilitates the implementation on any spreadsheet program like Microsoft Excel. A computational example is used to demonstrate the proposed method.

Esthetic considerations for the treatment of the edentulous maxilla based on current informatic alternatives: a case report.

PubMed

Rodríguez-Tizcareño, Mario H; Barajas, Lizbeth; Pérez-Gásque, Marisol; Gómez, Salvador

2012-06-01

This report presents a protocol used to transfer the virtual treatment plan data to the surgical and prosthetic reality and its clinical application, bone site augmentation with computer-custom milled bovine bone graft blocks to their ideal architecture form, implant insertion based on image-guided stent fabrication, and the restorative manufacturing process through computed tomography-based software programs and navigation systems and the computer-aided design and manufacturing techniques for the treatment of the edentulous maxilla.

Experimental and numerical study on optimization of the single point incremental forming of AINSI 304L stainless steel sheet

NASA Astrophysics Data System (ADS)

Saidi, B.; Giraud-Moreau, L.; Cherouat, A.; Nasri, R.

2017-09-01

AINSI 304L stainless steel sheets are commonly formed into a variety of shapes for applications in the industrial, architectural, transportation and automobile fields, it’s also used for manufacturing of denture base. In the field of dentistry, there is a need for personalized devises that are custom made for the patient. The single point incremental forming process is highly promising in this area for manufacturing of denture base. The single point incremental forming process (ISF) is an emerging process based on the use of a spherical tool, which is moved along CNC controlled tool path. One of the major advantages of this process is the ability to program several punch trajectories on the same machine in order to obtain different shapes. Several applications of this process exist in the medical field for the manufacturing of personalized titanium prosthesis (cranial plate, knee prosthesis...) due to the need of product customization to each patient. The objective of this paper is to study the incremental forming of AISI 304L stainless steel sheets for future applications in the dentistry field. During the incremental forming process, considerable forces can occur. The control of the forming force is particularly important to ensure the safe use of the CNC milling machine and preserve the tooling and machinery. In this paper, the effect of four different process parameters on the maximum force is studied. The proposed approach consists in using an experimental design based on experimental results. An analysis of variance was conducted with ANOVA to find the input parameters allowing to minimize the maximum forming force. A numerical simulation of the incremental forming process is performed with the optimal input process parameters. Numerical results are compared with the experimental ones.

A study on Aerosol jet printing technology in LED module manufacturing

NASA Astrophysics Data System (ADS)

Rudorfer, Andreas; Tscherner, Martin; Palfinger, Christian; Reil, Frank; Hartmann, Paul; Seferis, Ioannis E.; Zych, Eugeniusz; Wenzl, Franz P.

2016-09-01

State of the art fabrication of LED modules based on chip-on-board (COB) technology comprises some shortcomings both with respect to the manufacturing process itself but also with regard to potential sources of failures and manufacturing impreciseness. One promising alternative is additive manufacturing, a technology which has gained a lot of attention during the last years due to its materials and cost saving capabilities. Especially direct-write technologies like Aerosol jet printing have demonstrated advantages compared to other technological approaches when printing high precision layers or high precision electronic circuits on substrates which, as an additional advantage, also can be flexible and 3D shaped. Based on test samples and test structures manufactured by Aerosol jet printing technology, in this context we discuss the potentials of additive manufacturing in various aspects of LED module fabrication, ranging from the deposition of the die-attach material, wire bond replacement by printed electrical connects as well as aspects of high-precision phosphor layer deposition for color conversion and white light generation.

Friction Stir Additive Manufacturing: Route to High Structural Performance

NASA Astrophysics Data System (ADS)

Palanivel, S.; Sidhar, H.; Mishra, R. S.

2015-03-01

Aerospace and automotive industries provide the next big opportunities for additive manufacturing. Currently, the additive industry is confronted with four major challenges that have been identified in this article. These challenges need to be addressed for the additive technologies to march into new frontiers and create additional markets. Specific potential success in the transportation sectors is dependent on the ability to manufacture complicated structures with high performance. Most of the techniques used for metal-based additive manufacturing are fusion based because of their ability to fulfill the computer-aided design to component vision. Although these techniques aid in fabrication of complex shapes, achieving high structural performance is a key problem due to the liquid-solid phase transformation. In this article, friction stir additive manufacturing (FSAM) is shown as a potential solid-state process for attaining high-performance lightweight alloys for simpler geometrical applications. To illustrate FSAM as a high-performance route, manufactured builds of Mg-4Y-3Nd and AA5083 are shown as examples. In the Mg-based alloy, an average hardness of 120 HV was achieved in the built structure and was significantly higher than that of the base material (97 HV). Similarly for the Al-based alloy, compared with the base hardness of 88 HV, the average built hardness was 104 HV. A potential application of FSAM is illustrated by taking an example of a simple stiffener assembly.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lherbier, Louis, W.; Novotnak, David, J.; Herling, Darrell, R.

Hot forming processes such as forging, die casting and glass forming require tooling that is subjected to high temperatures during the manufacturing of components. Current tooling is adversely affected by prolonged exposure at high temperatures. Initial studies were conducted to determine the root cause of tool failures in a number of applications. Results show that tool failures vary and depend on the operating environment under which they are used. Major root cause failures include (1) thermal softening, (2) fatigue and (3) tool erosion, all of which are affected by process boundary conditions such as lubrication, cooling, process speed, etc. Whilemore » thermal management is a key to addressing tooling failures, it was clear that new tooling materials with superior high temperature strength could provide improved manufacturing efficiencies. These efficiencies are based on the use of functionally graded materials (FGM), a new subset of hybrid tools with customizable properties that can be fabricated using advanced powder metallurgy manufacturing technologies. Modeling studies of the various hot forming processes helped identify the effect of key variables such as stress, temperature and cooling rate and aid in the selection of tooling materials for specific applications. To address the problem of high temperature strength, several advanced powder metallurgy nickel and cobalt based alloys were selected for evaluation. These materials were manufactured into tooling using two relatively new consolidation processes. One process involved laser powder deposition (LPD) and the second involved a solid state dynamic powder consolidation (SSDPC) process. These processes made possible functionally graded materials (FGM) that resulted in shaped tooling that was monolithic, bi-metallic or substrate coated. Manufacturing of tooling with these processes was determined to be robust and consistent for a variety of materials. Prototype and production testing of FGM tooling showed the benefits of the nickel and cobalt based powder metallurgy alloys in a number of applications evaluated. Improvements in tool life ranged from three (3) to twenty (20) or more times than currently used tooling. Improvements were most dramatic where tool softening and deformation were the major cause of tool failures in hot/warm forging applications. Significant improvement was also noted in erosion of aluminum die casting tooling. Cost and energy savings can be realized as a result of increased tooling life, increased productivity and a reduction in scrap because of improved dimensional controls. Although LPD and SSDPC tooling usually have higher acquisition costs, net tooling costs per component produced drops dramatically with superior tool performance. Less energy is used to manufacture the tooling because fewer tools are required and less recycling of used tools are needed for the hot forming process. Energy is saved during the component manufacturing cycle because more parts can be produced in shorter periods of time. Energy is also saved by minimizing heating furnace idling time because of less downtime for tooling changes.« less

Commercial-scale biotherapeutics manufacturing facility for plant-made pharmaceuticals.

PubMed

Holtz, Barry R; Berquist, Brian R; Bennett, Lindsay D; Kommineni, Vally J M; Munigunti, Ranjith K; White, Earl L; Wilkerson, Don C; Wong, Kah-Yat I; Ly, Lan H; Marcel, Sylvain

2015-10-01

Rapid, large-scale manufacture of medical countermeasures can be uniquely met by the plant-made-pharmaceutical platform technology. As a participant in the Defense Advanced Research Projects Agency (DARPA) Blue Angel project, the Caliber Biotherapeutics facility was designed, constructed, commissioned and released a therapeutic target (H1N1 influenza subunit vaccine) in <18 months from groundbreaking. As of 2015, this facility was one of the world's largest plant-based manufacturing facilities, with the capacity to process over 3500 kg of plant biomass per week in an automated multilevel growing environment using proprietary LED lighting. The facility can commission additional plant grow rooms that are already built to double this capacity. In addition to the commercial-scale manufacturing facility, a pilot production facility was designed based on the large-scale manufacturing specifications as a way to integrate product development and technology transfer. The primary research, development and manufacturing system employs vacuum-infiltrated Nicotiana benthamiana plants grown in a fully contained, hydroponic system for transient expression of recombinant proteins. This expression platform has been linked to a downstream process system, analytical characterization, and assessment of biological activity. This integrated approach has demonstrated rapid, high-quality production of therapeutic monoclonal antibody targets, including a panel of rituximab biosimilar/biobetter molecules and antiviral antibodies against influenza and dengue fever. © 2015 Society for Experimental Biology, Association of Applied Biologists and John Wiley & Sons Ltd.

Six Sigma-based approach to optimise the diffusion process of crystalline silicon solar cell manufacturing

NASA Astrophysics Data System (ADS)

Prasad, A. Guru; Saravanan, S.; Gijo, E. V.; Dasari, Sreenivasa Murty; Tatachar, Raghu; Suratkar, Prakash

2016-02-01

Silicon-based photovoltaics (PV) plays the dominant role in the history of PV due to the continuous process and technology improvement in silicon solar cells and its manufacturing flow. In general, silicon solar cell process uses either p-type- or n-type-doped silicon as the starting material. Currently, most of the PV industries use p-type, boron-doped silicon wafer as the starting material. In this work too, the boron-doped wafers were considered as the starting material to create pn junction and phosphorus was used as n-type doping material. Industries use either phosphorous oxy chloride (POCl3) or ortho phosphoric acid (H3PO4) as the precursor for doping phosphorous. While the industries use POCl3 as the precursor, the throughput is lesser than that of the industries' use of H3PO4 due to the manufacturing limitations of the POCl3-based equipments. Hence, in order to achieve the operational excellence in POCl3-based equipments, business strategies such as the Six Sigma methodology have to be adapted. This paper describes the application of Six Sigma Define-Measure-Analyze-Improve-Control methodology for throughput improvement of the phosphorus doping process. The optimised recipe has been implemented in the production and it is running successfully. As a result of this project, an effective gain of 0.9 MW was reported per annum.

Green tea flavour determinants and their changes over manufacturing processes.

PubMed

Han, Zhuo-Xiao; Rana, Mohammad M; Liu, Guo-Feng; Gao, Ming-Jun; Li, Da-Xiang; Wu, Fu-Guang; Li, Xin-Bao; Wan, Xiao-Chun; Wei, Shu

2016-12-01

Flavour determinants in tea infusions and their changes during manufacturing processes were studied using Camellia sinensis cultivars 'Bai-Sang Cha' ('BAS') possessing significant floral scents and 'Fuding-Dabai Cha' ('FUD') with common green tea odour. Metabolite profiling based on odour activity threshold revealed that 'BAS' contained higher levels of the active odorants β-ionone, linalool and its two oxides, geraniol, epoxylinalool, decanal and taste determinant catechins than 'FUD' (p<0.05). Enhanced transcription of some terpenoid and catechin biosynthetic genes in 'BAS' suggested genetically enhanced production of those flavour compounds. Due to manufacturing processes, the levels of linalool and geraniol decreased whereas those of β-ionone, linalool oxides, indole and cis-jasmone increased. Compared with pan-fire treatment, steam treatment reduced the levels of catechins and proportion of geraniol, linalool and its derivatives, consequently, reducing catechin-related astringency and monoterpenol-related floral scent. Our study suggests that flavour determinant targeted modulation could be made through genotype and manufacturing improvements. Copyright © 2016 Elsevier Ltd. All rights reserved.

In situ process monitoring in selective laser sintering using optical coherence tomography

NASA Astrophysics Data System (ADS)

Gardner, Michael R.; Lewis, Adam; Park, Jongwan; McElroy, Austin B.; Estrada, Arnold D.; Fish, Scott; Beaman, Joseph J.; Milner, Thomas E.

2018-04-01

Selective laser sintering (SLS) is an efficient process in additive manufacturing that enables rapid part production from computer-based designs. However, SLS is limited by its notable lack of in situ process monitoring when compared with other manufacturing processes. We report the incorporation of optical coherence tomography (OCT) into an SLS system in detail and demonstrate access to surface and subsurface features. Video frame rate cross-sectional imaging reveals areas of sintering uniformity and areas of excessive heat error with high temporal resolution. We propose a set of image processing techniques for SLS process monitoring with OCT and report the limitations and obstacles for further OCT integration with SLS systems.

Particle Engineering Via Mechanical Dry Coating in the Design of Pharmaceutical Solid Dosage Forms.

PubMed

Qu, Li; Morton, David A V; Zhou, Qi Tony

2015-01-01

Cohesive powders are problematic in the manufacturing of pharmaceutical solid dosage forms because they exhibit poor flowability, fluidization and aerosolization. These undesirable bulk properties of cohesive powders represent a fundamental challenge in the design of efficient pharmaceutical manufacturing processes. Recently, mechanical dry coating has attracted increasing attention as it can improve the bulk properties of cohesive powders in a cheaper, simpler, safer and more environment-friendly way than the existing solvent-based counterparts. In this review, mechanical dry coating techniques are outlined and their potential applications in formulation and manufacturing of pharmaceutical solid dosage forms are discussed. Reported data from the literature have shown that mechanical dry coating holds promise for the design of superior pharmaceutical solid formulations or manufacturing processes by engineering the interfaces of cohesive powders in an efficient and economical way.

Portable Positron Measurement System (PPMS)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Akers, Doug

Portable Positron Measurement System (PPMS) is an automated, non-destructive inspection system based on positron annihilation, which characterizes a material's in situatomic-level properties during the manufacturing processes of formation, solidification, and heat treatment. Simultaneous manufacturing and quality monitoring now are possible. Learn more about the lab's project on our facebook site http://www.facebook.com/idahonationallaboratory.

Portable Positron Measurement System (PPMS)

ScienceCinema

None

2017-12-09

Portable Positron Measurement System (PPMS) is an automated, non-destructive inspection system based on positron annihilation, which characterizes a material's in situatomic-level properties during the manufacturing processes of formation, solidification, and heat treatment. Simultaneous manufacturing and quality monitoring now are possible. Learn more about the lab's project on our facebook site http://www.facebook.com/idahonationallaboratory.

Data management for Computer-Aided Engineering (CAE)

NASA Technical Reports Server (NTRS)

Bryant, W. A.; Smith, M. R.

1984-01-01

Analysis of data flow through the design and manufacturing processes has established specific information management requirements and identified unique problems. The application of data management technology to the engineering/manufacturing environment addresses these problems. An overview of the IPAD prototype data base management system, representing a partial solution to these problems, is presented here.

Program Evolves from Basic CAD to Total Manufacturing Experience

ERIC Educational Resources Information Center

Cassola, Joel

2011-01-01

Close to a decade ago, John Hersey High School (JHHS) in Arlington Heights, Illinois, made a transition from a traditional classroom-based pre-engineering program. The new program is geared towards helping students understand the entire manufacturing process. Previously, a JHHS student would design a project in computer-aided design (CAD) software…

A QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016.

PubMed

Santos, Ana M C; Doria, Mara S; Meirinhos-Soares, Luís; Almeida, António J; Menezes, José C

2018-01-01

Microbial quality control of non-sterile drug products has been a concern to regulatory agencies and the pharmaceutical industry since the 1960s. Despite being an old challenge to companies, microbial contamination still affects a high number of manufacturers of non-sterile products. Consequences go well beyond the obvious direct costs related to batch rejections or product recalls, as human lives and a company's reputation are significantly impacted if such events occur. To better manage risk and establish effective mitigation strategies, it is necessary to understand the microbial hazards involved in non-sterile drug products manufacturing, be able to evaluate their potential impact on final product quality, and apply mitigation actions. Herein we discuss the most likely root causes involved in microbial contaminations referenced in warning letters issued by US health authorities and non-compliance reports issued by European health authorities over a period of several years. The quality risk management tools proposed were applied to the data gathered from those databases, and a generic risk ranking was provided based on a panel of non-sterile drug product manufacturers that was assembled and given the opportunity to perform the risk assessments. That panel identified gaps and defined potential mitigation actions, based on their own experience of potential risks expected for their processes. Major findings clearly indicate that the manufacturers affected by the warning letters should focus their attention on process improvements and microbial control strategies, especially those related to microbial analysis and raw material quality control. Additionally, the WLs considered frequently referred to failures in quality-related issues, which indicates that the quality commitment should be reinforced at most companies to avoid microbiological contaminations. LAY ABSTRACT: Microbial contamination of drug products affects the quality of non-sterile drug products produced by numerous manufacturers, representing a major risk to patients. It is necessary to understand the microbial hazards involved in the manufacturing process and evaluate their impact on final product quality so that effective prevention strategies can be implemented. A risk-based classification of most likely root causes for microbial contamination found in the warning letters issued by the US Food and Drug Administration and the European Medicines Agency is proposed. To validate the likely root causes extracted from the warning letters, a subject matter expert panel made of several manufacturers was formed and consulted. A quality risk management approach to assess microbiological contamination of non-sterile drug products is proposed for the identification of microbial hazards involved in the manufacturing process. To enable ranking of microbial contamination risks, quality risk management metrics related to criticality and overall risk were applied. The results showed that manufacturers of non-sterile drug products should improve their microbial control strategy, with special attention to quality controls of raw materials, primary containers, and closures. Besides that, they should invest in a more robust quality system and culture. As a start, manufacturers may consider investigating their specific microbiological risks, adressing their sites' own microbial ecology, type of manufacturing processes, and dosage form characteristics, as these may lead to increased contamination risks. Authorities should allow and enforce innovative, more comprehensive, and more effective approaches to in-process contamination monitoring and controls. © PDA, Inc. 2018.

15 CFR 400.33 - Restrictions on manufacturing and processing activity.

Code of Federal Regulations, 2010 CFR

2010-01-01

...-TRADE ZONES BOARD Manufacturing and Processing Activity-Reviews § 400.33 Restrictions on manufacturing and processing activity. (a) In general. In approving manufacturing or processing activity for a zone... 15 Commerce and Foreign Trade 2 2010-01-01 2010-01-01 false Restrictions on manufacturing and...

21 CFR 1005.25 - Service of process on manufacturers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Service of process on manufacturers. 1005.25....25 Service of process on manufacturers. (a) Every manufacturer of electronic products, prior to... United States as the manufacturer's agent upon whom service of all processes, notices, orders, decisions...

Development of Manufacturing Technology to Accelerate Cost Reduction of Low Concentration and

DOE Office of Scientific and Technical Information (OSTI.GOV)

Detrick, Adam

The purpose of this project was to accelerate deployment of cost-effective US-based manufacturing of Solaria’s unique c-Si module technology. This effort successfully resulted in the development of US-based manufacturing technology to support two highly-differentiated, market leading product platforms. The project was initially predicated on developing Solaria’s low-concentration PV (LCPV) module technology which at the time of the award was uniquely positioned to exceed the SunShot price goal of $0.50/Wp for standard c-Si modules. The Solaria LCPV module is a 2.5x concentrator that leverages proven, high-reliability PV module materials and low silicon cell usage into a technology package that already hadmore » the lowest direct material cost and leading Levelized Cost of Electricity (LCOE). With over 25 MW commercially deployed globally, the Solaria module was well positioned to continue to lead in PV module cost reduction. Throughout the term of the contract, market conditions changed dramatically and so to did Solaria’s product offerings to support this. However, the manufacturing technology developed for the LCPV module was successfully leveraged and optimized to support two new and different product platforms. BIPV “PowerVision” and High-efficiency “PowerXT” modules. The primary barrier to enabling high-volume PV module manufacturing in the US is the high manual labor component in certain unique aspects of our manufacturing process. The funding was used to develop unique manufacturing automation which makes the manual labor components of these key processes more efficient and increase throughput. At the core of Solaria’s product offerings are its unique and proprietary techniques for dicing and re-arranging solar cells into modules with highly-differentiated characteristics that address key gaps in the c-Si market. It is these techniques that were successfully evolved and deployed into US-based manufacturing site with SunShot funding. Today, Solaria is currently positioned to become the market leader with these two technologies over the coming 24 months largely due to the successful innovations of the underlying manufacturing technology. This success will leverage US-based manufacturing technology and the associated US-jobs to support. Solaria views the project as highly successful and a great example of SunShot funding enabling the creating of US jobs and the deployment of ubiquitous solar energy products.« less

Personal manufacturing systems

NASA Astrophysics Data System (ADS)

Bailey, P.

1992-04-01

Personal Manufacturing Systems are the missing link in the automation of the design-to- manufacture process. A PMS will act as a CAD peripheral, closing the loop around the designer enabling him to directly produce models, short production runs or soft tooling with as little fuss as he might otherwise plot a drawing. Whereas conventional 5-axis CNC machines are based on orthogonal axes and simple incremental movements, the PMS is based on a geodetic structure and complex co-ordinated 'spline' movements. The software employs a novel 3D pixel technique for give itself 'spatial awareness' and an expert system to determine the optimum machining conditions. A completely automatic machining strategy can then be determined.

3D construction and repair from welding and material science perspectives

NASA Astrophysics Data System (ADS)

Marya, Surendar; Hascoet, Jean-Yves

2016-10-01

Additive manufacturing, based on layer-by-layer deposition of a feedstock material from a 3D data, can be mechanistically associated to welding. With feedstock fusion based processes, both additive manufacturing and welding implement similar heat sources, feedstock materials and translation mechanisms. From material science perspectives, additive manufacturing can take clue from lessons learned by millennium old welding technology to rapidly advance in its quest to generate fit for service metallic parts. This paper illustrates material science highlights extracted from the fabrication of a 316 L air vent and the functional repair of a Monel K500 (UNS N0500) with Inconel 625.

Electro-optic product design for manufacture: where next?

NASA Astrophysics Data System (ADS)

Barr, John R. M.; MacDonald, M.; Jeffery, G.; Troughton, M.

2016-10-01

Manufacturing of electro-optic products for military environments poses a large number of apparently intractable and mutually contradictory problems. The ability to successfully engage in this area presents an intellectual challenge of a high order. The Advanced Targeting Sector of Leonardo's Airborne and Space Systems Division, based in Edinburgh, has developed a successful range of electro-optic products and transitioned these into a volume, and high value, manufacturing environment. As products cycle through the design process, there has been strong feedback from users, suppliers, and most importantly from our manufacturing organization, that has driven evolution of our design practices. It is fair to say that recent pointer trackers and lasers bear little resemblance to those designed and built 10 years ago. Looking ahead, this process will only continue. There are interesting technologies that will drive improvements in manufacturability, reliability and usability of electro-optic products. Examples might include freeform optics, additive manufacture of metal components, and laser welding of optics to metals, to name but a few. These have uses across our product portfolio and, when sufficiently matured, will have a major impact on the product quality and reliability

Process-Based Cost Modeling of Photonics Manufacture: The Cost Competitiveness of Monolithic Integration of a 1550-nm DFB Laser and an Electroabsorptive Modulator on an InP Platform

NASA Astrophysics Data System (ADS)

Fuchs, Erica R. H.; Bruce, E. J.; Ram, R. J.; Kirchain, Randolph E.

2006-08-01

The monolithic integration of components holds promise to increase network functionality and reduce packaging expense. Integration also drives down yield due to manufacturing complexity and the compounding of failures across devices. Consensus is lacking on the economically preferred extent of integration. Previous studies on the cost feasibility of integration have used high-level estimation methods. This study instead focuses on accurate-to-industry detail, basing a process-based cost model of device manufacture on data collected from 20 firms across the optoelectronics supply chain. The model presented allows for the definition of process organization, including testing, as well as processing conditions, operational characteristics, and level of automation at each step. This study focuses on the cost implications of integration of a 1550-nm DFB laser with an electroabsorptive modulator on an InP platform. Results show the monolithically integrated design to be more cost competitive over discrete component options regardless of production scale. Dominant cost drivers are packaging, testing, and assembly. Leveraging the technical detail underlying model projections, component alignment, bonding, and metal-organic chemical vapor deposition (MOCVD) are identified as processes where technical improvements are most critical to lowering costs. Such results should encourage exploration of the cost advantages of further integration and focus cost-driven technology development.

In-TFT-Array-Process Micro Defect Inspection Using Nonlinear Principal Component Analysis

PubMed Central

Liu, Yi-Hung; Wang, Chi-Kai; Ting, Yung; Lin, Wei-Zhi; Kang, Zhi-Hao; Chen, Ching-Shun; Hwang, Jih-Shang

2009-01-01

Defect inspection plays a critical role in thin film transistor liquid crystal display (TFT-LCD) manufacture, and has received much attention in the field of automatic optical inspection (AOI). Previously, most focus was put on the problems of macro-scale Mura-defect detection in cell process, but it has recently been found that the defects which substantially influence the yield rate of LCD panels are actually those in the TFT array process, which is the first process in TFT-LCD manufacturing. Defect inspection in TFT array process is therefore considered a difficult task. This paper presents a novel inspection scheme based on kernel principal component analysis (KPCA) algorithm, which is a nonlinear version of the well-known PCA algorithm. The inspection scheme can not only detect the defects from the images captured from the surface of LCD panels, but also recognize the types of the detected defects automatically. Results, based on real images provided by a LCD manufacturer in Taiwan, indicate that the KPCA-based defect inspection scheme is able to achieve a defect detection rate of over 99% and a high defect classification rate of over 96% when the imbalanced support vector machine (ISVM) with 2-norm soft margin is employed as the classifier. More importantly, the inspection time is less than 1 s per input image. PMID:20057957

A unified dislocation density-dependent physical-based constitutive model for cold metal forming

NASA Astrophysics Data System (ADS)

Schacht, K.; Motaman, A. H.; Prahl, U.; Bleck, W.

2017-10-01

Dislocation-density-dependent physical-based constitutive models of metal plasticity while are computationally efficient and history-dependent, can accurately account for varying process parameters such as strain, strain rate and temperature; different loading modes such as continuous deformation, creep and relaxation; microscopic metallurgical processes; and varying chemical composition within an alloy family. Since these models are founded on essential phenomena dominating the deformation, they have a larger range of usability and validity. Also, they are suitable for manufacturing chain simulations since they can efficiently compute the cumulative effect of the various manufacturing processes by following the material state through the entire manufacturing chain and also interpass periods and give a realistic prediction of the material behavior and final product properties. In the physical-based constitutive model of cold metal plasticity introduced in this study, physical processes influencing cold and warm plastic deformation in polycrystalline metals are described using physical/metallurgical internal variables such as dislocation density and effective grain size. The evolution of these internal variables are calculated using adequate equations that describe the physical processes dominating the material behavior during cold plastic deformation. For validation, the model is numerically implemented in general implicit isotropic elasto-viscoplasticity algorithm as a user-defined material subroutine (UMAT) in ABAQUS/Standard and used for finite element simulation of upsetting tests and a complete cold forging cycle of case hardenable MnCr steel family.

Delivering Value In A Global Aerospace Manufacturer Through The Effective Use Of Numerical Process Simulation

NASA Astrophysics Data System (ADS)

Ward, M. J.; Walløe, S. J.

2004-06-01

Numerical models are used extensively in the aerospace sector to identify appropriate manufacturing parameters, and to minimize the risk associated with new product introduction and manufacturing change. This usage is equally prevalent in original equipment manufacturers (OEMs), and in their supply chains. The wide range of manufacturing processes and production environments involved, coupled with the varying degrees of technology maturity associated with numerical models of different processes leads to a situation of significant complexity from the OEM perspective. In addition, the intended use of simulation technology can vary considerably between applications, from simple geometric assessment of die shape at one extreme, to full process design or development at the other. Consequently there is an increasing trend towards multi-scale modelling, i.e. the use of several different model types, with differing attributes in terms of accuracy and speed to support a range of different new product introduction decisions. This makes the allocation of appropriate levels of activity to the research and implementation of new capabilities a difficult problem. This paper uses a number of industrial cases studies to illustrate a framework for making such allocation decisions such that value to the OEM is maximized, and investigates how such a framework is likely to shift over the next few years based on technological developments.

Electron beam additive manufacturing with wire - Analysis of the process

NASA Astrophysics Data System (ADS)

Weglowski, Marek St.; Błacha, Sylwester; Pilarczyk, Jan; Dutkiewicz, Jan; Rogal, Łukasz

2018-05-01

The electron beam additive manufacturing process with wire is a part of global trend to find fast and efficient methods for producing complex shapes elements from costly metal alloys such as stainless steels, nickel alloys, titanium alloys etc. whose production by other conventional technologies is unprofitable or technically impossible. Demand for additive manufacturing is linked to the development of new technologies in the automotive, aerospace and machinery industries. The aim of the presented work was to carried out research on electron beam additive manufacturing with a wire as a deposited (filler) material. The scope of the work was to investigate the influence of selected technological parameters such as: wire feed rate, beam current, travelling speed, acceleration voltage on stability of the deposition process and geometric dimensions of the padding welds. The research revealed that, at low beam currents, the deposition process is unstable. The padding weld reinforcement is non-uniform. Irregularity of the width, height and straightness of the padding welds can be observed. At too high acceleration voltage and beam current, burn-through of plate and excess penetration weld can be revealed. The achieved results and gained knowledge allowed to produce, based on EBAM with wire process, whole structure from stainless steel.

Gaps Analysis of Integrating Product Design, Manufacturing, and Quality Data in The Supply Chain Using Model-Based Definition

PubMed Central

Trainer, Asa; Hedberg, Thomas; Feeney, Allison Barnard; Fischer, Kevin; Rosche, Phil

2017-01-01

Advances in information technology triggered a digital revolution that holds promise of reduced costs, improved productivity, and higher quality. To ride this wave of innovation, manufacturing enterprises are changing how product definitions are communicated – from paper to models. To achieve industry's vision of the Model-Based Enterprise (MBE), the MBE strategy must include model-based data interoperability from design to manufacturing and quality in the supply chain. The Model-Based Definition (MBD) is created by the original equipment manufacturer (OEM) using Computer-Aided Design (CAD) tools. This information is then shared with the supplier so that they can manufacture and inspect the physical parts. Today, suppliers predominantly use Computer-Aided Manufacturing (CAM) and Coordinate Measuring Machine (CMM) models for these tasks. Traditionally, the OEM has provided design data to the supplier in the form of two-dimensional (2D) drawings, but may also include a three-dimensional (3D)-shape-geometry model, often in a standards-based format such as ISO 10303-203:2011 (STEP AP203). The supplier then creates the respective CAM and CMM models and machine programs to produce and inspect the parts. In the MBE vision for model-based data exchange, the CAD model must include product-and-manufacturing information (PMI) in addition to the shape geometry. Today's CAD tools can generate models with embedded PMI. And, with the emergence of STEP AP242, a standards-based model with embedded PMI can now be shared downstream. The on-going research detailed in this paper seeks to investigate three concepts. First, that the ability to utilize a STEP AP242 model with embedded PMI for CAD-to-CAM and CAD-to-CMM data exchange is possible and valuable to the overall goal of a more efficient process. Second, the research identifies gaps in tools, standards, and processes that inhibit industry's ability to cost-effectively achieve model-based-data interoperability in the pursuit of the MBE vision. Finally, it also seeks to explore the interaction between CAD and CMM processes and determine if the concept of feedback from CAM and CMM back to CAD is feasible. The main goal of our study is to test the hypothesis that model-based-data interoperability from CAD-to-CAM and CAD-to-CMM is feasible through standards-based integration. This paper presents several barriers to model-based-data interoperability. Overall, the project team demonstrated the exchange of product definition data between CAD, CAM, and CMM systems using standards-based methods. While gaps in standards coverage were identified, the gaps should not stop industry's progress toward MBE. The results of our study provide evidence in support of an open-standards method to model-based-data interoperability, which would provide maximum value and impact to industry. PMID:28691120

[Quality by design approaches for pharmaceutical development and manufacturing of Chinese medicine].

PubMed

Xu, Bing; Shi, Xin-Yuan; Wu, Zhi-Sheng; Zhang, Yan-Ling; Wang, Yun; Qiao, Yan-Jiang

2017-03-01

The pharmaceutical quality was built by design, formed in the manufacturing process and improved during the product's lifecycle. Based on the comprehensive literature review of pharmaceutical quality by design (QbD), the essential ideas and implementation strategies of pharmaceutical QbD were interpreted. Considering the complex nature of Chinese medicine, the "4H" model was innovated and proposed for implementing QbD in pharmaceutical development and industrial manufacture of Chinese medicine product. "4H" corresponds to the acronym of holistic design, holistic information analysis, holistic quality control, and holistic process optimization, which is consistent with the holistic concept of Chinese medicine theory. The holistic design aims at constructing both the quality problem space from the patient requirement and the quality solution space from multidisciplinary knowledge. Holistic information analysis emphasizes understanding the quality pattern of Chinese medicine by integrating and mining multisource data and information at a relatively high level. The batch-to-batch quality consistence and manufacturing system reliability can be realized by comprehensive application of inspective quality control, statistical quality control, predictive quality control and intelligent quality control strategies. Holistic process optimization is to improve the product quality and process capability during the product lifecycle management. The implementation of QbD is useful to eliminate the ecosystem contradictions lying in the pharmaceutical development and manufacturing process of Chinese medicine product, and helps guarantee the cost effectiveness. Copyright© by the Chinese Pharmaceutical Association.

Dynamic Models and Coordination Analysis of Reverse Supply Chain with Remanufacturing

NASA Astrophysics Data System (ADS)

Yan, Nina

In this paper, we establish a reverse chain system with one manufacturer and one retailer under demand uncertainties. Distinguishing between the recycling process of the retailer and the remanufacturing process of the manufacturer, we formulate a two-stage dynamic model for reverse supply chain based on remanufacturing. Using buyback contract as coordination mechanism and applying dynamic programming the optimal decision problems for each stage are analyzed. It concluded that the reverse supply chain system could be coordinated under the given condition. Finally, we carry out numerical calculations to analyze the expected profits for the manufacturer and the retailer under different recovery rates and recovery prices and the outcomes validate the theoretical analyses.

Measurement of fracture toughness of metallic materials produced by additive manufacturing

NASA Astrophysics Data System (ADS)

Quénard, O.; Dorival, O.; Guy, Ph.; Votié, A.; Brethome, K.

2018-04-01

This study focuses on the microstructure and mechanical properties of metallic materials produced by additive layer manufacturing (ALM), especially the laser beam melting process. The influence of the specimen orientation during the ALM process and that of two post-build thermal treatments were investigated. The identified metal powder is Ti-6Al-4V (titanium base). Metallographic analysis shows their effects on the microstructure of the metals. Mechanical experiments involving tensile tests as well as toughness tests were performed according to ASTM (American Society for Testing and Materials) norms. The results show that the main influence is that of the thermal treatments; however the manufacturing stacking direction may lead to some anisotropy in the mechanical properties.

Additively Manufactured IN718 Components with Wirelessly Powered and Interrogated Embedded Sensing

DOE Office of Scientific and Technical Information (OSTI.GOV)

Attridge, Paul; Bajekal, Sanjay; Klecka, Michael

A methodology is described for embedding commercial-off-the-shelf sensors together with wireless communication and power circuit elements using direct laser metal sintered additively manufactured components. Physics based models of the additive manufacturing processes and sensor/wireless level performance models guided the design and embedment processes. A combination of cold spray deposition and laser engineered net shaping was used to fashion the transmitter/receiving elements and embed the sensors, thereby providing environmental protection and component robustness/survivability for harsh conditions. By design, this complement of analog and digital sensors were wirelessly powered and interrogated using a health and utilization monitoring system; enabling real-time, in situmore » prognostics and diagnostics.« less

Totally Integrated Munitions Enterprise ''Affordable Munitions Production for the 21st Century''

DOE Office of Scientific and Technical Information (OSTI.GOV)

Burleson, R.R.; Poggio, M.E.; Rosenberg, S.J.

2000-09-13

The U.S. Army faces several munitions manufacturing issues: downsizing of the organic production base, timely fielding of affordable smart munitions, and munitions replenishment during national emergencies. Totally Integrated Munitions Enterprise (TIME) is addressing these complex issues via the development and demonstration of an integrated enterprise. The enterprise will include the tools, network, and open modular architecture controllers to enable accelerated acquisition, shortened concept to volume production, lower life cycle costs, capture of critical manufacturing processes, and communication of process parameters between remote sites to rapidly spin-off production for replenishment by commercial sources. TIME addresses the enterprise as a system, integratingmore » design, engineering, manufacturing, administration, and logistics.« less

Totally Integrated Munitions Enterprise ''Affordable Munitions Production for the 21st Century''

DOE Office of Scientific and Technical Information (OSTI.GOV)

Burleson, R.R.; Poggio, M.E.; Rosenberg, S.J.

2000-07-14

The U.S. Army faces several munitions manufacturing issues: downsizing of the organic production base, timely fielding of affordable smart munitions, and munitions replenishment during national emergencies. TIME is addressing these complex issues via the development and demonstration of an integrated enterprise. The enterprise will include the tools, network, and open modular architecture controller to enable accelerated acquisition, shortened concept to volume production, lower life cycle costs, capture of critical manufacturing processes, and communication of process parameters between remote sites to rapidly spin-off production for replenishment by commercial sources. TIME addresses the enterprise as a system, integrating design, engineering, manufacturing, administration,more » and logistics.« less

Totally Integrated Munitions Enterprise ''Affordable Munitions Production for the 21st Century''

DOE Office of Scientific and Technical Information (OSTI.GOV)

Burleson, R.R.; Poggio, M.E.; Rosenberg, S.J.

2000-08-18

The U.S. Army faces several munitions manufacturing issues: downsizing of the organic production base, timely fielding of affordable smart munitions, and munitions replenishment during national emergencies. Totally Integrated Munitions Enterprise (TIME) is addressing these complex issues via the development and demonstration of an integrated enterprise. The enterprise will include the tools, network, and open modular architecture controllers to enable accelerated acquisition, shortened concept to volume production, lower life cycle costs, capture of critical manufacturing processes, and communication of process parameters between remote sites to rapidly spin-off production for replenishment by commercial sources. TIME addresses the enterprise as a system, integratingmore » design, engineering, manufacturing, administration, and logistics.« less

TF4SM: A Framework for Developing Traceability Solutions in Small Manufacturing Companies

PubMed Central

Bordel Sánchez, Borja; Alcarria, Ramón; Martín, Diego; Robles, Tomás

2015-01-01

Nowadays, manufacturing processes have become highly complex. Besides, more and more, governmental institutions require companies to implement systems to trace a product’s life (especially for foods, clinical materials or similar items). In this paper, we propose a new framework, based on cyber-physical systems, for developing traceability systems in small manufacturing companies (which because of their size cannot implement other commercial products). We propose a general theoretical framework, study the requirements of these companies in relation to traceability systems, propose a reference architecture based on both previous elements and build the first minimum functional prototype, to compare our solution to a traditional tag-based traceability system. Results show that our system reduces the number of inefficiencies and reaction time. PMID:26610509

TF4SM: A Framework for Developing Traceability Solutions in Small Manufacturing Companies.

PubMed

Bordel Sánchez, Borja; Alcarria, Ramón; Martín, Diego; Robles, Tomás

2015-11-20

Nowadays, manufacturing processes have become highly complex. Besides, more and more, governmental institutions require companies to implement systems to trace a product's life (especially for foods, clinical materials or similar items). In this paper, we propose a new framework, based on cyber-physical systems, for developing traceability systems in small manufacturing companies (which because of their size cannot implement other commercial products). We propose a general theoretical framework, study the requirements of these companies in relation to traceability systems, propose a reference architecture based on both previous elements and build the first minimum functional prototype, to compare our solution to a traditional tag-based traceability system. Results show that our system reduces the number of inefficiencies and reaction time.

Knowledge Assisted Integrated Design of a Component and Its Manufacturing Process

NASA Astrophysics Data System (ADS)

Gautham, B. P.; Kulkarni, Nagesh; Khan, Danish; Zagade, Pramod; Reddy, Sreedhar; Uppaluri, Rohith

Integrated design of a product and its manufacturing processes would significantly reduce the total cost of the products as well as the cost of its development. However this would only be possible if we have a platform that allows us to link together simulations tools used for product design, performance evaluation and its manufacturing processes in a closed loop. In addition to that having a comprehensive knowledgebase that provides systematic knowledge guided assistance to product or process designers who may not possess in-depth design knowledge or in-depth knowledge of the simulation tools, would significantly speed up the end-to-end design process. In this paper, we propose a process and illustrate a case for achieving an integrated product and manufacturing process design assisted by knowledge support for the user to make decisions at various stages. We take transmission component design as an example. The example illustrates the design of a gear for its geometry, material selection and its manufacturing processes, particularly, carburizing-quenching and tempering, and feeding the material properties predicted during heat treatment into performance estimation in a closed loop. It also identifies and illustrates various decision stages in the integrated life cycle and discusses the use of knowledge engineering tools such as rule-based guidance, to assist the designer make informed decisions. Simulation tools developed on various commercial, open-source platforms as well as in-house tools along with knowledge engineering tools are linked to build a framework with appropriate navigation through user-friendly interfaces. This is illustrated through examples in this paper.

Study of flow stress and spall strength of additively manufactured Ti-6-4 alloy

NASA Astrophysics Data System (ADS)

Cohen, Amitay; Paris, Vitaly; Yosef-Hai, Arnon; Gudinetsky, Eli; Tiferet, Eitan

2017-06-01

The use of additive manufacturing (AM) by Electron Beam Melting (EBM) or Selective Laser Melting (SLM) has extensively grown in the past few years. A major goal in AM is to manufacture materials with mechanical properties at least as good as traditionally manufactured materials. In this work we present results of planar impact tests and Split Hopkinson Pressure Bar tests (SHPB) on Ti-6-4 manufactured by EBM and SLM processes. Results of planar impact tests on SLM samples display slightly higher spall strength compared to EBM while the stress at Hugoniot elastic limit (HEL) is practically the same. Stress strain curves based on SHPB measurements at two different strain rates present similar plastic flow stresses for SLM and EBM processed Ti-6-4 alloy, while the flow stress is about 20% higher than reported for commercial reference material. The strain to failure of both materials shows considerable strain rate sensitivity. The results of post-mortem analysis of spall fracture will also be presented.

Manufacturing process design for multi commodities in agriculture

NASA Astrophysics Data System (ADS)

Prasetyawan, Yudha; Santosa, Andrian Henry

2017-06-01

High-potential commodities within particular agricultural sectors should be accompanied by maximum benefit value that can be attained by both local farmers and business players. In several cases, the business players are small-medium enterprises (SMEs) which have limited resources to perform added value process of the local commodities into the potential products. The weaknesses of SMEs such as the manual production process with low productivity, limited capacity to maintain prices, and unattractive packaging due to conventional production. Agricultural commodity is commonly created into several products such as flour, chips, crackers, oil, juice, and other products. This research was initiated by collecting data by interview method particularly to obtain the perspectives of SMEs as the business players. Subsequently, the information was processed based on the Quality Function Deployment (QFD) to determine House of Quality from the first to fourth level. A proposed design as the result of QFD was produced and evaluated with Technology Assessment Model (TAM) and continued with a revised design. Finally, the revised design was analyzed with financial perspective to obtain the cost structure of investment, operational, maintenance, and workers. The machine that performs manufacturing process, as the result of revised design, was prototyped and tested to determined initial production process. The designed manufacturing process offers IDR 337,897, 651 of Net Present Value (NPV) in comparison with the existing process value of IDR 9,491,522 based on similar production input.

JOWOG 22/2 - Actinide Chemical Technology (July 9-13, 2012)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jackson, Jay M.; Lopez, Jacquelyn C.; Wayne, David M.

2012-07-05

The Plutonium Science and Manufacturing Directorate provides world-class, safe, secure, and reliable special nuclear material research, process development, technology demonstration, and manufacturing capabilities that support the nation's defense, energy, and environmental needs. We safely and efficiently process plutonium, uranium, and other actinide materials to meet national program requirements, while expanding the scientific and engineering basis of nuclear weapons-based manufacturing, and while producing the next generation of nuclear engineers and scientists. Actinide Process Chemistry (NCO-2) safely and efficiently processes plutonium and other actinide compounds to meet the nation's nuclear defense program needs. All of our processing activities are done in amore » world class and highly regulated nuclear facility. NCO-2's plutonium processing activities consist of direct oxide reduction, metal chlorination, americium extraction, and electrorefining. In addition, NCO-2 uses hydrochloric and nitric acid dissolutions for both plutonium processing and reduction of hazardous components in the waste streams. Finally, NCO-2 is a key team member in the processing of plutonium oxide from disassembled pits and the subsequent stabilization of plutonium oxide for safe and stable long-term storage.« less

Carbon black dispersion pre-plating technology for printed wire board manufacturing. Final technology evaluation report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Folsom, D.W.; Gavaskar, A.R.; Jones, J.A.

1993-10-01

The project compared chemical use, waste generation, cost, and product quality between electroless copper and carbon-black-based preplating technologies at the printed wire board (PWB) manufacturing facility of McCurdy Circuits in Orange, CA. The carbon-black based preplating technology evaluated is used as an alternative process for electroless copper (EC) plating of through-holes before electrolytic copper plating. The specific process used at McCurdy is the BlackHole (BH) technology process, which uses a dispersion of carbon black in an aqueous solution to provide a conductive surface for subsequent electrolytic copper plating. The carbon-black dispersion technology provided effective waste reduction and long-term cost savings.more » The economic analysis determined that the new process was cost efficient because chemical use was reduced and the process proved more efficient; the payback period was less than 4 yrs.« less

Cold pressure welding of aluminium-steel blanks: Manufacturing process and electrochemical surface preparation

NASA Astrophysics Data System (ADS)

Schmidt, Hans Christian; Homberg, Werner; Orive, Alejandro Gonzalez; Grundmeier, Guido; Hordych, Illia; Maier, Hans Jürgen

2018-05-01

In this study the manufacture of aluminium-steel blanks by cold pressure welding and their preparation for a welding process through electrochemical surface treatment are investigated and discussed. The cold pressure welding process was done with an incremental rolling tool that allows for the partial pressure welding of two blanks along a prepared path. The influence of the surface preparation by electrochemical deposition of bond promoting organosilane-based agents and roughening on a nano-scale is investigated and compared to conventional surface treatments. Coating the surfaces with a thin organosilane-based film incorporating specific functional groups should promote additional bonding between the mating oxide layers; its influence on the total weld strength is studied. Pressure welding requires suitable process strategies, and the current advances in the proposed incremental rolling process for the combination of mild steel and aluminium are presented.

Intelligent Weld Manufacturing: Role of Integrated Computational Welding Engineering

DOE PAGES

David, Stan A.; Chen, Jian; Feng, Zhili; ...

2017-12-02

A master welder uses his sensory perceptions to evaluate the process and connect them with his/her knowledge base to take the necessary corrective measures with his/her acquired skills to make a good weld. All these actions must take place in real time. Success depends on intuition and skills, and the procedure is labor-intensive and frequently unreliable. The solution is intelligent weld manufacturing. The ultimate goal of intelligent weld manufacturing would involve sensing and control of heat source position, weld temperature, weld penetration, defect formation and ultimately control of microstructure and properties. This involves a solution to a problem (welding) withmore » many highly coupled and nonlinear variables. The trend is to use an emerging tool known as intelligent control. This approach enables the user to choose a desirable end factor such as properties, defect control, or productivity to derive the selection of process parameters such as current, voltage, or speed to provide for appropriate control of the process. Important elements of intelligent manufacturing are sensing and control theory and design, process modeling, and artificial intelligence. Significant progress has been made in all these areas. Integrated computational welding engineering (ICWE) is an emerging field that will aid in the realization of intelligent weld manufacturing. The paper will discuss the progress in process modeling, microstructure, properties, and process control and automation and the importance of ICWE. Also, control and automation strategies for friction stir welding will be discussed.« less

Intelligent Weld Manufacturing: Role of Integrated Computational Welding Engineering

DOE Office of Scientific and Technical Information (OSTI.GOV)

David, Stan A.; Chen, Jian; Feng, Zhili

A master welder uses his sensory perceptions to evaluate the process and connect them with his/her knowledge base to take the necessary corrective measures with his/her acquired skills to make a good weld. All these actions must take place in real time. Success depends on intuition and skills, and the procedure is labor-intensive and frequently unreliable. The solution is intelligent weld manufacturing. The ultimate goal of intelligent weld manufacturing would involve sensing and control of heat source position, weld temperature, weld penetration, defect formation and ultimately control of microstructure and properties. This involves a solution to a problem (welding) withmore » many highly coupled and nonlinear variables. The trend is to use an emerging tool known as intelligent control. This approach enables the user to choose a desirable end factor such as properties, defect control, or productivity to derive the selection of process parameters such as current, voltage, or speed to provide for appropriate control of the process. Important elements of intelligent manufacturing are sensing and control theory and design, process modeling, and artificial intelligence. Significant progress has been made in all these areas. Integrated computational welding engineering (ICWE) is an emerging field that will aid in the realization of intelligent weld manufacturing. The paper will discuss the progress in process modeling, microstructure, properties, and process control and automation and the importance of ICWE. Also, control and automation strategies for friction stir welding will be discussed.« less

Emission factors of air toxics from semiconductor manufacturing in Korea.

PubMed

Eom, Yun-Sung; Hong, Ji-Hyung; Lee, Suk-Jo; Lee, Eun-Jung; Cha, Jun-Seok; Lee, Dae-Gyun; Bang, Sun-Ae

2006-11-01

The development of local, accurate emission factors is very important for the estimation of reliable national emissions and air quality management. For that, this study is performed for pollutants released to the atmosphere with source-specific emission tests from the semiconductor manufacturing industry. The semiconductor manufacturing industry is one of the major sources of air toxics or hazardous air pollutants (HAPs); thus, understanding the emission characteristics of the emission source is a very important factor in the development of a control strategy. However, in Korea, there is a general lack of information available on air emissions from the semiconductor industry. The major emission sources of air toxics examined from the semiconductor manufacturing industry were wet chemical stations, coating applications, gaseous operations, photolithography, and miscellaneous devices in the wafer fabrication and semiconductor packaging processes. In this study, analyses of emission characteristics, and the estimations of emission data and factors for air toxics, such as acids, bases, heavy metals, and volatile organic compounds from the semiconductor manufacturing process have been performed. The concentration of hydrogen chloride from the packaging process was the highest among all of the processes. In addition, the emission factor of total volatile organic compounds (TVOCs) for the packaging process was higher than that of the wafer fabrication process. Emission factors estimated in this study were compared with those of Taiwan for evaluation, and they were found to be of similar level in the case of TVOCs and fluorine compounds.

Fully additive manufacture of a polymer cantilever with an embedded functional layer

NASA Astrophysics Data System (ADS)

Kanazawa, Shusuke; Kusaka, Yasuyuki; Horii, Yoshinori; Ushijima, Hirobumi

2018-03-01

In this paper, we report on an efficient and unique printing-based process for fabricating a cantilever structure with an embedded functional layer. The process is used to form a micro suspended structure via the one-batch transfer of stacked layers from a dummy substrate. The mechanism of the transfer process is clearly explained by the order of adhesion strengths of all interfaces. As a demonstration, a strain gauge which consisted of a polymer cantilever with an embedded conductive wire was successfully fabricated. It is expected that the proposed process will widely contribute to the efficient manufacture of useful sensors and actuators.

20 years of KVH fiber optic gyro technology: the evolution from large, low performance FOGs to compact, precise FOGs and FOG-based inertial systems

NASA Astrophysics Data System (ADS)

Napoli, Jay

2016-05-01

Precision fiber optic gyroscopes (FOGs) are critical components for an array of platforms and applications ranging from stabilization and pointing orientation of payloads and platforms to navigation and control for unmanned and autonomous systems. In addition, FOG-based inertial systems provide extremely accurate data for geo-referencing systems. Significant improvements in the performance of FOGs and FOG-based inertial systems at KVH are due, in large part, to advancements in the design and manufacture of optical fiber, as well as in manufacturing operations and signal processing. Open loop FOGs, such as those developed and manufactured by KVH Industries, offer tactical-grade performance in a robust, small package. The success of KVH FOGs and FOG-based inertial systems is due to innovations in key fields, including the development of proprietary D-shaped fiber with an elliptical core, and KVH's unique ThinFiber. KVH continually improves its FOG manufacturing processes and signal processing, which result in improved accuracies across its entire FOG product line. KVH acquired its FOG capabilities, including its patented E•Core fiber, when the company purchased Andrew Corporation's Fiber Optic Group in 1997. E•Core fiber is unique in that the light-guiding core - critical to the FOG's performance - is elliptically shaped. The elliptical core produces a fiber that has low loss and high polarization-maintaining ability. In 2010, KVH developed its ThinFiber, a 170-micron diameter fiber that retains the full performance characteristics of E•Core fiber. ThinFiber has enabled the development of very compact, high-performance open-loop FOGs, which are also used in a line of FOG-based inertial measurement units and inertial navigation systems.

Technology of High-speed Direct Laser Deposition from Ni-based Superalloys

NASA Astrophysics Data System (ADS)

Klimova-Korsmik, Olga; Turichin, Gleb; Zemlyakov, Evgeniy; Babkin, Konstantin; Petrovsky, Pavel; Travyanov, Andrey

Recently, additive manufacturing is the one of most perspective technologies; it can replace conventional methods of casting and subsequent time-consuming machining. One of the most interesting additive technologies - high-speed direct laser deposition (HSDLD) allows realizing heterophase process during the manufacturing, which there is process takes place with a partial melting of powder. This is particularly important for materials, which are sensitive to strong fluctuations of temperature treatment regimes, like nickel base alloys with high content of gamma prime phase. This alloys are interested for many industrial areas, mostly there are used in engine systems, aircraft and shipbuilding, aeronautics. Heating and cooling rates during the producing process determine structure and affect on its properties. Using HSDLD process it possible to make a products from Ni superalloys with ultrafine microstructure and satisfactory mechanical characteristics without special subsequent heatreatment.

Progress in manufacturing large primary aircraft structures using the stitching/RTM process

NASA Technical Reports Server (NTRS)

Markus, Alan; Thrash, Patrick; Rohwer, Kim

1993-01-01

The Douglas Aircraft/NASA Act contract has been focused over the past three years at developing a materials, manufacturing, and cost base for stitched/Resin Transfer Molded (RTM) composites. The goal of the program is to develop RTM and stitching technology to provide enabling technology for application of these materials in primary aircraft structure with a high degree of confidence. Presented in this paper will be the progress to date in the area of manufacturing and associated cost values of stitched/RTM composites.

Nucleation and growth of chimney pores during electron-beam additive manufacturing

DOE PAGES

Cordero, Zachary C.; Dinwiddie, Ralph B.; Immel, David; ...

2016-12-05

The nucleation and growth of chimney pores during powder-bed, electron-beam additive manufacturing is investigated using in-situ infrared thermography as well as microcomputed tomography of as-printed parts. The pores are found to nucleate at dimples on the part s surface, clearly demonstrating how process parameters can affect surface roughness, which can in turn affect the internal defect structure in an additive manufactured part. Based on the results of this study, several strategies for suppressing the formation of chimney pores are discussed.

Finite element analysis of the design and manufacture of thin-walled pressure vessels used as aerosol cans

NASA Astrophysics Data System (ADS)

Abdussalam, Ragba Mohamed

Thin-walled cylinders are used extensively in the food packaging and cosmetics industries. The cost of material is a major contributor to the overall cost and so improvements in design and manufacturing processes are always being sought. Shape optimisation provides one method for such improvements. Aluminium aerosol cans are a particular form of thin-walled cylinder with a complex shape consisting of truncated cone top, parallel cylindrical section and inverted dome base. They are manufactured in one piece by a reverse-extrusion process, which produces a vessel with a variable thickness from 0.31 mm in the cylinder up to 1.31 mm in the base for a 53 mm diameter can. During manufacture, packaging and charging, they are subjected to pressure, axial and radial loads and design calculations are generally outside the British and American pressure vessel codes. 'Design-by-test' appears to be the favoured approach. However, a more rigorous approach is needed in order to optimise the designs. Finite element analysis (FEA) is a powerful tool for predicting stress, strain and displacement behaviour of components and structures. FEA is also used extensively to model manufacturing processes. In this study, elastic and elastic-plastic FEA has been used to develop a thorough understanding of the mechanisms of yielding, 'dome reversal' (an inherent safety feature, where the base suffers elastic-plastic buckling at a pressure below the burst pressure) and collapse due to internal pressure loading and how these are affected by geometry. It has also been used to study the buckling behaviour under compressive axial loading. Furthermore, numerical simulations of the extrusion process (in order to investigate the effects of tool geometry, friction coefficient and boundary conditions) have been undertaken. Experimental verification of the buckling and collapse behaviours has also been carried out and there is reasonable agreement between the experimental data and the numerical predictions.

Implementation of Lean System on Erbium Doped Fibre Amplifier Manufacturing Process to Reduce Production Time

NASA Astrophysics Data System (ADS)

Maneechote, T.; Luangpaiboon, P.

2010-10-01

A manufacturing process of erbium doped fibre amplifiers is complicated. It needs to meet the customers' requirements under a present economic status that products need to be shipped to customers as soon as possible after purchasing orders. This research aims to study and improve processes and production lines of erbium doped fibre amplifiers using lean manufacturing systems via an application of computer simulation. Three scenarios of lean tooled box systems are selected via the expert system. Firstly, the production schedule based on shipment date is combined with a first in first out control system. The second scenario focuses on a designed flow process plant layout. Finally, the previous flow process plant layout combines with production schedule based on shipment date including the first in first out control systems. The computer simulation with the limited data via an expected value is used to observe the performance of all scenarios. The most preferable resulted lean tooled box systems from a computer simulation are selected to implement in the real process of a production of erbium doped fibre amplifiers. A comparison is carried out to determine the actual performance measures via an analysis of variance of the response or the production time per unit achieved in each scenario. The goodness of an adequacy of the linear statistical model via experimental errors or residuals is also performed to check the normality, constant variance and independence of the residuals. The results show that a hybrid scenario of lean manufacturing system with the first in first out control and flow process plant lay out statistically leads to better performance in terms of the mean and variance of production times.

Evaluating Process Sustainability Using Flowsheet Monitoring

EPA Science Inventory

Environmental metric software can be used to evaluate the sustainability of a chemical based on data from the chemical process that is used to manufacture it. One problem in developing environmental metric software is that chemical process simulation packages typically do not rea...

[Construction of NIRS-based process analytical system for production of salvianolic acid for injection and relative discussion].

PubMed

Zhang, Lei; Yue, Hong-Shui; Ju, Ai-Chun; Ye, Zheng-Liang

2016-10-01

Currently, near infrared spectroscopy (NIRS) has been considered as an efficient tool for achieving process analytical technology(PAT) in the manufacture of traditional Chinese medicine (TCM) products. In this article, the NIRS based process analytical system for the production of salvianolic acid for injection was introduced. The design of the process analytical system was described in detail, including the selection of monitored processes and testing mode, and potential risks that should be avoided. Moreover, the development of relative technologies was also presented, which contained the establishment of the monitoring methods for the elution of polyamide resin and macroporous resin chromatography processes, as well as the rapid analysis method for finished products. Based on author's experience of research and work, several issues in the application of NIRS to the process monitoring and control in TCM production were then raised, and some potential solutions were also discussed. The issues include building the technical team for process analytical system, the design of the process analytical system in the manufacture of TCM products, standardization of the NIRS-based analytical methods, and improving the management of process analytical system. Finally, the prospect for the application of NIRS in the TCM industry was put forward. Copyright© by the Chinese Pharmaceutical Association.

Cell therapy-processing economics: small-scale microfactories as a stepping stone toward large-scale macrofactories.

PubMed

Harrison, Richard P; Medcalf, Nicholas; Rafiq, Qasim A

2018-03-01

Manufacturing methods for cell-based therapies differ markedly from those established for noncellular pharmaceuticals and biologics. Attempts to 'shoehorn' these into existing frameworks have yielded poor outcomes. Some excellent clinical results have been realized, yet emergence of a 'blockbuster' cell-based therapy has so far proved elusive.  The pressure to provide these innovative therapies, even at a smaller scale, remains. In this process, economics research paper, we utilize cell expansion research data combined with operational cost modeling in a case study to demonstrate the alternative ways in which a novel mesenchymal stem cell-based therapy could be provided at small scale. This research outlines the feasibility of cell microfactories but highlighted that there is a strong pressure to automate processes and split the quality control cost-burden over larger production batches. The study explores one potential paradigm of cell-based therapy provisioning as a potential exemplar on which to base manufacturing strategy.

George E. Pake Prize: A Few Challenges in the Evolution of Semiconductor Device/Manufacturing Technology

NASA Astrophysics Data System (ADS)

Doering, Robert

In the early 1980s, the semiconductor industry faced the related challenges of ``scaling through the one-micron barrier'' and converting single-level-metal NMOS integrated circuits to multi-level-metal CMOS. Multiple advances in lithography technology and device materials/process integration led the way toward the deep-sub-micron transistors and interconnects that characterize today's electronic chips. In the 1990s, CMOS scaling advanced at an accelerated pace enabled by rapid advances in many aspects of optical lithography. However, the industry also needed to continue the progress in manufacturing on ever-larger silicon wafers to maintain economy-of-scale trends. Simultaneously, the increasing complexity and absolute-precision requirements of manufacturing compounded the necessity for new processes, tools, and control methodologies. This talk presents a personal perspective on some of the approaches that addressed the aforementioned challenges. In particular, early work on integrating silicides, lightly-doped-drain FETs, shallow recessed isolation, and double-level metal will be discussed. In addition, some pioneering efforts in deep-UV lithography and single-wafer processing will be covered. The latter will be mainly based on results from the MMST Program - a 100 M +, 5-year R&D effort, funded by DARPA, the U.S. Air Force, and Texas Instruments, that developed a wide range of new technologies for advanced semiconductor manufacturing. The major highlight of the program was the demonstration of sub-3-day cycle time for manufacturing 350-nm CMOS integrated circuits in 1993. This was principally enabled by the development of: (1) 100% single-wafer processing, including rapid-thermal processing (RTP), and (2) computer-integrated-manufacturing (CIM), including real-time, in-situ process control.

Quantification of uncertainty in machining operations for on-machine acceptance.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Claudet, Andre A.; Tran, Hy D.; Su, Jiann-Chemg

2008-09-01

Manufactured parts are designed with acceptance tolerances, i.e. deviations from ideal design conditions, due to unavoidable errors in the manufacturing process. It is necessary to measure and evaluate the manufactured part, compared to the nominal design, to determine whether the part meets design specifications. The scope of this research project is dimensional acceptance of machined parts; specifically, parts machined using numerically controlled (NC, or also CNC for Computer Numerically Controlled) machines. In the design/build/accept cycle, the designer will specify both a nominal value, and an acceptable tolerance. As part of the typical design/build/accept business practice, it is required to verifymore » that the part did meet acceptable values prior to acceptance. Manufacturing cost must include not only raw materials and added labor, but also the cost of ensuring conformance to specifications. Ensuring conformance is a substantial portion of the cost of manufacturing. In this project, the costs of measurements were approximately 50% of the cost of the machined part. In production, cost of measurement would be smaller, but still a substantial proportion of manufacturing cost. The results of this research project will point to a science-based approach to reducing the cost of ensuring conformance to specifications. The approach that we take is to determine, a priori, how well a CNC machine can manufacture a particular geometry from stock. Based on the knowledge of the manufacturing process, we are then able to decide features which need further measurements from features which can be accepted 'as is' from the CNC. By calibration of the machine tool, and establishing a machining accuracy ratio, we can validate the ability of CNC to fabricate to a particular level of tolerance. This will eliminate the costs of checking for conformance for relatively large tolerances.« less

Monitoring system for the quality assessment in additive manufacturing

NASA Astrophysics Data System (ADS)

Carl, Volker

2015-03-01

Additive Manufacturing (AM) refers to a process by which a set of digital data -representing a certain complex 3dim design - is used to grow the respective 3dim real structure equal to the corresponding design. For the powder-based EOS manufacturing process a variety of plastic and metal materials can be used. Thereby, AM is in many aspects a very powerful tool as it can help to overcome particular limitations in conventional manufacturing. AM enables more freedom of design, complex, hollow and/or lightweight structures as well as product individualisation and functional integration. As such it is a promising approach with respect to the future design and manufacturing of complex 3dim structures. On the other hand, it certainly calls for new methods and standards in view of quality assessment. In particular, when utilizing AM for the design of complex parts used in aviation and aerospace technologies, appropriate monitoring systems are mandatory. In this respect, recently, sustainable progress has been accomplished by joining the common efforts and concerns of a manufacturer Additive Manufacturing systems and respective materials (EOS), along with those of an operator of such systems (MTU Aero Engines) and experienced application engineers (Carl Metrology), using decent know how in the field of optical and infrared methods regarding non-destructive-examination (NDE). The newly developed technology is best described by a high-resolution layer by layer inspection technique, which allows for a 3D tomography-analysis of the complex part at any time during the manufacturing process. Thereby, inspection costs are kept rather low by using smart image-processing methods as well as CMOS sensors instead of infrared detectors. Moreover, results from conventional physical metallurgy may easily be correlated with the predictive results of the monitoring system which not only allows for improvements of the AM monitoring system, but finally leads to an optimisation of the quality and insurance of material security of the complex structure being manufactured. Both, our poster and our oral presentation will explain the data flow between the above mentioned parties involved. A suitable monitoring system for Additive Manufacturing will be introduced, along with a presentation of the respective high resolution data acquisition, as well as the image processing and the data analysis allowing for a precise control of the 3dim growth-process.

Monitoring system for the quality assessment in additive manufacturing

DOE Office of Scientific and Technical Information (OSTI.GOV)

Carl, Volker, E-mail: carl@t-zfp.de

Additive Manufacturing (AM) refers to a process by which a set of digital data -representing a certain complex 3dim design - is used to grow the respective 3dim real structure equal to the corresponding design. For the powder-based EOS manufacturing process a variety of plastic and metal materials can be used. Thereby, AM is in many aspects a very powerful tool as it can help to overcome particular limitations in conventional manufacturing. AM enables more freedom of design, complex, hollow and/or lightweight structures as well as product individualisation and functional integration. As such it is a promising approach with respectmore » to the future design and manufacturing of complex 3dim structures. On the other hand, it certainly calls for new methods and standards in view of quality assessment. In particular, when utilizing AM for the design of complex parts used in aviation and aerospace technologies, appropriate monitoring systems are mandatory. In this respect, recently, sustainable progress has been accomplished by joining the common efforts and concerns of a manufacturer Additive Manufacturing systems and respective materials (EOS), along with those of an operator of such systems (MTU Aero Engines) and experienced application engineers (Carl Metrology), using decent know how in the field of optical and infrared methods regarding non-destructive-examination (NDE). The newly developed technology is best described by a high-resolution layer by layer inspection technique, which allows for a 3D tomography-analysis of the complex part at any time during the manufacturing process. Thereby, inspection costs are kept rather low by using smart image-processing methods as well as CMOS sensors instead of infrared detectors. Moreover, results from conventional physical metallurgy may easily be correlated with the predictive results of the monitoring system which not only allows for improvements of the AM monitoring system, but finally leads to an optimisation of the quality and insurance of material security of the complex structure being manufactured. Both, our poster and our oral presentation will explain the data flow between the above mentioned parties involved. A suitable monitoring system for Additive Manufacturing will be introduced, along with a presentation of the respective high resolution data acquisition, as well as the image processing and the data analysis allowing for a precise control of the 3dim growth-process.« less

Alternating phase-shifted mask for logic gate levels, design, and mask manufacturing

NASA Astrophysics Data System (ADS)

Liebmann, Lars W.; Graur, Ioana C.; Leipold, William C.; Oberschmidt, James M.; O'Grady, David S.; Regaill, Denis

1999-07-01

While the benefits of alternating phase shifted masks in improving lithographic process windows at increased resolution are well known throughout the lithography community, broad implementation of this potentially powerful technique has been slow due to the inherent complexity of the layout design and mask manufacturing process. This paper will review a project undertaken at IBM's Semiconductor Research and Development Center and Mask Manufacturing and Development facility to understand the technical and logistical issues associated with the application of alternating phase shifted mask technology to the gate level of a full microprocessor chip. The work presented here depicts an important milestone toward integration of alternating phase shifted masks into the manufacturing process by demonstrating an automated design solution and yielding a functional alternating phase shifted mask. The design conversion of the microprocessor gate level to a conjugate twin shifter alternating phase shift layout was accomplished with IBM's internal design system that automatically scaled the design, added required phase regions, and resolved phase conflicts. The subsequent fabrication of a nearly defect free phase shifted mask, as verified by SEM based die to die inspection, highlights the maturity of the alternating phase shifted mask manufacturing process in IBM's internal mask facility. Well defined and recognized challenges in mask inspection and repair remain and the layout of alternating phase shifted masks present a design and data preparation overhead, but the data presented here demonstrate the feasibility of designing and building manufacturing quality alternating phase shifted masks for the gate level of a microprocessor.

40 CFR 723.175 - Chemical substances used in or for the manufacture or processing of instant photographic and peel...

Code of Federal Regulations, 2010 CFR

2010-07-01

... manufacture and processing in the special production area. All manufacturing, processing, and use operations... shape or design during manufacture, (ii) which has end use function(s) dependent in whole or in part... production area, the ambient air concentration of the new chemical substance during manufacture, processing...

United States Air Force Computer-Aided Acquisition and Logistics Support (CALS) Evolution of Computer Integrated Manufacturing (CIM) Technologies

DTIC Science & Technology

1988-11-01

Manufacturing System 22 4. Similar Parts Based Shape or Manufactuting Process 24 5. Projected Annual Unit Robot Sales and Installed Base Through 1992 30 6. U.S...effort needed to perform personnel, product design, marketing , and advertising, and finance tasks of the firm. Level III controls the resource...planning and accounting functions of the firm. Systems at this level support purchasing, accounts payable, accounts receivable, master scheduling and sales

Carbon Nanotube Integration with a CMOS Process

PubMed Central

Perez, Maximiliano S.; Lerner, Betiana; Resasco, Daniel E.; Pareja Obregon, Pablo D.; Julian, Pedro M.; Mandolesi, Pablo S.; Buffa, Fabian A.; Boselli, Alfredo; Lamagna, Alberto

2010-01-01

This work shows the integration of a sensor based on carbon nanotubes using CMOS technology. A chip sensor (CS) was designed and manufactured using a 0.30 μm CMOS process, leaving a free window on the passivation layer that allowed the deposition of SWCNTs over the electrodes. We successfully investigated with the CS the effect of humidity and temperature on the electrical transport properties of SWCNTs. The possibility of a large scale integration of SWCNTs with CMOS process opens a new route in the design of more efficient, low cost sensors with high reproducibility in their manufacture. PMID:22319330

Finite Element Modelling and Analysis of Conventional Pultrusion Processes

NASA Astrophysics Data System (ADS)

Akishin, P.; Barkanov, E.; Bondarchuk, A.

2015-11-01

Pultrusion is one of many composite manufacturing techniques and one of the most efficient methods for producing fiber reinforced polymer composite parts with a constant cross-section. Numerical simulation is helpful for understanding the manufacturing process and developing scientific means for the pultrusion tooling design. Numerical technique based on the finite element method has been developed for the simulation of pultrusion processes. It uses the general purpose finite element software ANSYS Mechanical. It is shown that the developed technique predicts the temperature and cure profiles, which are in good agreement with those published in the open literature.

Structural optimization under overhang constraints imposed by additive manufacturing technologies

NASA Astrophysics Data System (ADS)

Allaire, G.; Dapogny, C.; Estevez, R.; Faure, A.; Michailidis, G.

2017-12-01

This article addresses one of the major constraints imposed by additive manufacturing processes on shape optimization problems - that of overhangs, i.e. large regions hanging over void without sufficient support from the lower structure. After revisiting the 'classical' geometric criteria used in the literature, based on the angle between the structural boundary and the build direction, we propose a new mechanical constraint functional, which mimics the layer by layer construction process featured by additive manufacturing technologies, and thereby appeals to the physical origin of the difficulties caused by overhangs. This constraint, as well as some variants, is precisely defined; their shape derivatives are computed in the sense of Hadamard's method, and numerical strategies are extensively discussed, in two and three space dimensions, to efficiently deal with the appearance of overhang features in the course of shape optimization processes.

Paths of Improving the Technological Process of Manufacture of GTE Turbine Blades

NASA Astrophysics Data System (ADS)

Vdovin, R. A.; Smelov, V. G.; Bolotov, M. A.; Pronichev, N. D.

2016-08-01

The article provides an analysis of the problems at manufacture of blades of the turbine of gas-turbine engines and power stations is provided in article, and also paths of perfecting of technological process of manufacture of blades are offered. The analysis of the main systems of basing of blades in the course of machining and the control methods of the processed blades existing at the enterprises with the indication of merits and demerits is carried out. In work criteria in the form of the mathematical models of a spatial distribution of an allowance considering the uniform distribution of an allowance on a feather profile are developed. The considered methods allow to reduce percent of release of marriage and to reduce labor input when polishing path part of a feather of blades of the turbine.

Simulation and design of ECT differential bobbin probes for the inspection of cracks in bolts

NASA Astrophysics Data System (ADS)

Ra, S. W.; Im, K. H.; Lee, S. G.; Kim, H. J.; Song, S. J.; Kim, S. K.; Cho, Y. T.; Woo, Y. D.; Jung, J. A.

2015-12-01

All Various defects could be generated in bolts for a use of oil filters for the manufacturing process and then may affect to the safety and quality in bolts. Also, fine defects may be imbedded in oil filter system during multiple forging manufacturing processes. So it is very important that such defects be investigated and screened during the multiple manufacturing processes. Therefore, in order effectively to evaluate the fine defects, the design parameters for bobbin-types were selected under a finite element method (FEM) simulations and Eddy current testing (ECT). Especially the FEM simulations were performed to make characterization in the crack detection of the bolts and the parameters such as number of turns of the coil, the coil size and applied frequency were calculated based on the simulation results.

Post Processing Methods used to Improve Surface Finish of Products which are Manufactured by Additive Manufacturing Technologies: A Review

NASA Astrophysics Data System (ADS)

Kumbhar, N. N.; Mulay, A. V.

2016-08-01

The Additive Manufacturing (AM) processes open the possibility to go directly from Computer-Aided Design (CAD) to a physical prototype. These prototypes are used as test models before it is finalized as well as sometimes as a final product. Additive Manufacturing has many advantages over the traditional process used to develop a product such as allowing early customer involvement in product development, complex shape generation and also save time as well as money. Additive manufacturing also possess some special challenges that are usually worth overcoming such as Poor Surface quality, Physical Properties and use of specific raw material for manufacturing. To improve the surface quality several attempts had been made by controlling various process parameters of Additive manufacturing and also applying different post processing techniques on components manufactured by Additive manufacturing. The main objective of this work is to document an extensive literature review in the general area of post processing techniques which are used in Additive manufacturing.

Applications of Raman Spectroscopy in Biopharmaceutical Manufacturing: A Short Review.

PubMed

Buckley, Kevin; Ryder, Alan G

2017-06-01

The production of active pharmaceutical ingredients (APIs) is currently undergoing its biggest transformation in a century. The changes are based on the rapid and dramatic introduction of protein- and macromolecule-based drugs (collectively known as biopharmaceuticals) and can be traced back to the huge investment in biomedical science (in particular in genomics and proteomics) that has been ongoing since the 1970s. Biopharmaceuticals (or biologics) are manufactured using biological-expression systems (such as mammalian, bacterial, insect cells, etc.) and have spawned a large (>€35 billion sales annually in Europe) and growing biopharmaceutical industry (BioPharma). The structural and chemical complexity of biologics, combined with the intricacy of cell-based manufacturing, imposes a huge analytical burden to correctly characterize and quantify both processes (upstream) and products (downstream). In small molecule manufacturing, advances in analytical and computational methods have been extensively exploited to generate process analytical technologies (PAT) that are now used for routine process control, leading to more efficient processes and safer medicines. In the analytical domain, biologic manufacturing is considerably behind and there is both a huge scope and need to produce relevant PAT tools with which to better control processes, and better characterize product macromolecules. Raman spectroscopy, a vibrational spectroscopy with a number of useful properties (nondestructive, non-contact, robustness) has significant potential advantages in BioPharma. Key among them are intrinsically high molecular specificity, the ability to measure in water, the requirement for minimal (or no) sample pre-treatment, the flexibility of sampling configurations, and suitability for automation. Here, we review and discuss a representative selection of the more important Raman applications in BioPharma (with particular emphasis on mammalian cell culture). The review shows that the properties of Raman have been successfully exploited to deliver unique and useful analytical solutions, particularly for online process monitoring. However, it also shows that its inherent susceptibility to fluorescence interference and the weakness of the Raman effect mean that it can never be a panacea. In particular, Raman-based methods are intrinsically limited by the chemical complexity and wide analyte-concentration-profiles of cell culture media/bioprocessing broths which limit their use for quantitative analysis. Nevertheless, with appropriate foreknowledge of these limitations and good experimental design, robust analytical methods can be produced. In addition, new technological developments such as time-resolved detectors, advanced lasers, and plasmonics offer potential of new Raman-based methods to resolve existing limitations and/or provide new analytical insights.

PLAT: An Automated Fault and Behavioural Anomaly Detection Tool for PLC Controlled Manufacturing Systems.

PubMed

Ghosh, Arup; Qin, Shiming; Lee, Jooyeoun; Wang, Gi-Nam

2016-01-01

Operational faults and behavioural anomalies associated with PLC control processes take place often in a manufacturing system. Real time identification of these operational faults and behavioural anomalies is necessary in the manufacturing industry. In this paper, we present an automated tool, called PLC Log-Data Analysis Tool (PLAT) that can detect them by using log-data records of the PLC signals. PLAT automatically creates a nominal model of the PLC control process and employs a novel hash table based indexing and searching scheme to satisfy those purposes. Our experiments show that PLAT is significantly fast, provides real time identification of operational faults and behavioural anomalies, and can execute within a small memory footprint. In addition, PLAT can easily handle a large manufacturing system with a reasonable computing configuration and can be installed in parallel to the data logging system to identify operational faults and behavioural anomalies effectively.

PLAT: An Automated Fault and Behavioural Anomaly Detection Tool for PLC Controlled Manufacturing Systems

PubMed Central

Ghosh, Arup; Qin, Shiming; Lee, Jooyeoun

2016-01-01

Operational faults and behavioural anomalies associated with PLC control processes take place often in a manufacturing system. Real time identification of these operational faults and behavioural anomalies is necessary in the manufacturing industry. In this paper, we present an automated tool, called PLC Log-Data Analysis Tool (PLAT) that can detect them by using log-data records of the PLC signals. PLAT automatically creates a nominal model of the PLC control process and employs a novel hash table based indexing and searching scheme to satisfy those purposes. Our experiments show that PLAT is significantly fast, provides real time identification of operational faults and behavioural anomalies, and can execute within a small memory footprint. In addition, PLAT can easily handle a large manufacturing system with a reasonable computing configuration and can be installed in parallel to the data logging system to identify operational faults and behavioural anomalies effectively. PMID:27974882

Evaluating Process Sustainability Using Flowsheet Monitoring (Abstract)

EPA Science Inventory

Environmental metric software can be used to evaluate the sustainability of a chemical based upon data from the chemical process that is used to manufacture it. One problem in developing environmental metric software is that chemical process simulation packages typically do not p...

Advanced optical manufacturing digital integrated system

NASA Astrophysics Data System (ADS)

Tao, Yizheng; Li, Xinglan; Li, Wei; Tang, Dingyong

2012-10-01

It is necessarily to adapt development of advanced optical manufacturing technology with modern science technology development. To solved these problems which low of ration, ratio of finished product, repetition, consistent in big size and high precision in advanced optical component manufacturing. Applied business driven and method of Rational Unified Process, this paper has researched advanced optical manufacturing process flow, requirement of Advanced Optical Manufacturing integrated System, and put forward architecture and key technology of it. Designed Optical component core and Manufacturing process driven of Advanced Optical Manufacturing Digital Integrated System. the result displayed effective well, realized dynamic planning Manufacturing process, information integration improved ratio of production manufactory.

3D printing of high-strength aluminium alloys

NASA Astrophysics Data System (ADS)

Martin, John H.; Yahata, Brennan D.; Hundley, Jacob M.; Mayer, Justin A.; Schaedler, Tobias A.; Pollock, Tresa M.

2017-09-01

Metal-based additive manufacturing, or three-dimensional (3D) printing, is a potentially disruptive technology across multiple industries, including the aerospace, biomedical and automotive industries. Building up metal components layer by layer increases design freedom and manufacturing flexibility, thereby enabling complex geometries, increased product customization and shorter time to market, while eliminating traditional economy-of-scale constraints. However, currently only a few alloys, the most relevant being AlSi10Mg, TiAl6V4, CoCr and Inconel 718, can be reliably printed; the vast majority of the more than 5,500 alloys in use today cannot be additively manufactured because the melting and solidification dynamics during the printing process lead to intolerable microstructures with large columnar grains and periodic cracks. Here we demonstrate that these issues can be resolved by introducing nanoparticles of nucleants that control solidification during additive manufacturing. We selected the nucleants on the basis of crystallographic information and assembled them onto 7075 and 6061 series aluminium alloy powders. After functionalization with the nucleants, we found that these high-strength aluminium alloys, which were previously incompatible with additive manufacturing, could be processed successfully using selective laser melting. Crack-free, equiaxed (that is, with grains roughly equal in length, width and height), fine-grained microstructures were achieved, resulting in material strengths comparable to that of wrought material. Our approach to metal-based additive manufacturing is applicable to a wide range of alloys and can be implemented using a range of additive machines. It thus provides a foundation for broad industrial applicability, including where electron-beam melting or directed-energy-deposition techniques are used instead of selective laser melting, and will enable additive manufacturing of other alloy systems, such as non-weldable nickel superalloys and intermetallics. Furthermore, this technology could be used in conventional processing such as in joining, casting and injection moulding, in which solidification cracking and hot tearing are also common issues.

3D printing of high-strength aluminium alloys.

PubMed

Martin, John H; Yahata, Brennan D; Hundley, Jacob M; Mayer, Justin A; Schaedler, Tobias A; Pollock, Tresa M

2017-09-20

Metal-based additive manufacturing, or three-dimensional (3D) printing, is a potentially disruptive technology across multiple industries, including the aerospace, biomedical and automotive industries. Building up metal components layer by layer increases design freedom and manufacturing flexibility, thereby enabling complex geometries, increased product customization and shorter time to market, while eliminating traditional economy-of-scale constraints. However, currently only a few alloys, the most relevant being AlSi10Mg, TiAl6V4, CoCr and Inconel 718, can be reliably printed; the vast majority of the more than 5,500 alloys in use today cannot be additively manufactured because the melting and solidification dynamics during the printing process lead to intolerable microstructures with large columnar grains and periodic cracks. Here we demonstrate that these issues can be resolved by introducing nanoparticles of nucleants that control solidification during additive manufacturing. We selected the nucleants on the basis of crystallographic information and assembled them onto 7075 and 6061 series aluminium alloy powders. After functionalization with the nucleants, we found that these high-strength aluminium alloys, which were previously incompatible with additive manufacturing, could be processed successfully using selective laser melting. Crack-free, equiaxed (that is, with grains roughly equal in length, width and height), fine-grained microstructures were achieved, resulting in material strengths comparable to that of wrought material. Our approach to metal-based additive manufacturing is applicable to a wide range of alloys and can be implemented using a range of additive machines. It thus provides a foundation for broad industrial applicability, including where electron-beam melting or directed-energy-deposition techniques are used instead of selective laser melting, and will enable additive manufacturing of other alloy systems, such as non-weldable nickel superalloys and intermetallics. Furthermore, this technology could be used in conventional processing such as in joining, casting and injection moulding, in which solidification cracking and hot tearing are also common issues.

GMP-conformant on-site manufacturing of a CD133+ stem cell product for cardiovascular regeneration.

PubMed

Skorska, Anna; Müller, Paula; Gaebel, Ralf; Große, Jana; Lemcke, Heiko; Lux, Cornelia A; Bastian, Manuela; Hausburg, Frauke; Zarniko, Nicole; Bubritzki, Sandra; Ruch, Ulrike; Tiedemann, Gudrun; David, Robert; Steinhoff, Gustav

2017-02-10

CD133 + stem cells represent a promising subpopulation for innovative cell-based therapies in cardiovascular regeneration. Several clinical trials have shown remarkable beneficial effects following their intramyocardial transplantation. Yet, the purification of CD133 + stem cells is typically performed in centralized clean room facilities using semi-automatic manufacturing processes based on magnetic cell sorting (MACS®). However, this requires time-consuming and cost-intensive logistics. CD133 + stem cells were purified from patient-derived sternal bone marrow using the recently developed automatic CliniMACS Prodigy® BM-133 System (Prodigy). The entire manufacturing process, as well as the subsequent quality control of the final cell product (CP), were realized on-site and in compliance with EU guidelines for Good Manufacturing Practice. The biological activity of automatically isolated CD133 + cells was evaluated and compared to manually isolated CD133 + cells via functional assays as well as immunofluorescence microscopy. In addition, the regenerative potential of purified stem cells was assessed 3 weeks after transplantation in immunodeficient mice which had been subjected to experimental myocardial infarction. We established for the first time an on-site manufacturing procedure for stem CPs intended for the treatment of ischemic heart diseases using an automatized system. On average, 0.88 × 10 6 viable CD133 + cells with a mean log 10 depletion of 3.23 ± 0.19 of non-target cells were isolated. Furthermore, we demonstrated that these automatically isolated cells bear proliferation and differentiation capacities comparable to manually isolated cells in vitro. Moreover, the automatically generated CP shows equal cardiac regeneration potential in vivo. Our results indicate that the Prodigy is a powerful system for automatic manufacturing of a CD133 + CP within few hours. Compared to conventional manufacturing processes, future clinical application of this system offers multiple benefits including stable CP quality and on-site purification under reduced clean room requirements. This will allow saving of time, reduced logistics and diminished costs.

A meta-model based approach for rapid formability estimation of continuous fibre reinforced components

NASA Astrophysics Data System (ADS)

Zimmerling, Clemens; Dörr, Dominik; Henning, Frank; Kärger, Luise

2018-05-01

Due to their high mechanical performance, continuous fibre reinforced plastics (CoFRP) become increasingly important for load bearing structures. In many cases, manufacturing CoFRPs comprises a forming process of textiles. To predict and optimise the forming behaviour of a component, numerical simulations are applied. However, for maximum part quality, both the geometry and the process parameters must match in mutual regard, which in turn requires numerous numerically expensive optimisation iterations. In both textile and metal forming, a lot of research has focused on determining optimum process parameters, whilst regarding the geometry as invariable. In this work, a meta-model based approach on component level is proposed, that provides a rapid estimation of the formability for variable geometries based on pre-sampled, physics-based draping data. Initially, a geometry recognition algorithm scans the geometry and extracts a set of doubly-curved regions with relevant geometry parameters. If the relevant parameter space is not part of an underlying data base, additional samples via Finite-Element draping simulations are drawn according to a suitable design-table for computer experiments. Time saving parallel runs of the physical simulations accelerate the data acquisition. Ultimately, a Gaussian Regression meta-model is built from the data base. The method is demonstrated on a box-shaped generic structure. The predicted results are in good agreement with physics-based draping simulations. Since evaluations of the established meta-model are numerically inexpensive, any further design exploration (e.g. robustness analysis or design optimisation) can be performed in short time. It is expected that the proposed method also offers great potential for future applications along virtual process chains: For each process step along the chain, a meta-model can be set-up to predict the impact of design variations on manufacturability and part performance. Thus, the method is considered to facilitate a lean and economic part and process design under consideration of manufacturing effects.

A quantitative risk assessment of exposure to adventitious agents in a cell culture-derived subunit influenza vaccine.

PubMed

Gregersen, Jens-Peter

2008-06-19

A risk-assessment model has demonstrated the ability of a new cell culture-based vaccine manufacturing process to reduce the level of any adventitious agent to a million-fold below infectious levels. The cell culture-derived subunit influenza vaccine (OPTAFLU), Novartis Vaccines and Diagnostics) is produced using Madin-Darby canine kidney (MDCK) cells to propagate seasonal viral strains, as an alternative to embryonated chicken-eggs. As only a limited range of mammalian viruses can grow in MDCK cells, similar to embryonated eggs, MDCK cells can act as an effective filter for a wide range of adventitious agents that might be introduced during vaccine production. However, the introduction of an alternative cell substrate (for example, MDCK cells) into a vaccine manufacturing process requires thorough investigations to assess the potential for adventitious agent risk in the final product, in the unlikely event that contamination should occur. The risk assessment takes into account the entire manufacturing process, from initial influenza virus isolation, through to blending of the trivalent subunit vaccine and worst-case residual titres for the final vaccine formulation have been calculated for >20 viruses or virus families. Maximum residual titres for all viruses tested were in the range of 10(-6) to 10(-16) infectious units per vaccine dose. Thus, the new cell culture-based vaccine manufacturing process can reduce any adventitious agent to a level that is unable to cause infection.

Process monitoring and control with CHEMIN, a miniaturized CCD-based instrument for simultaneous XRD/XRF analysis

NASA Astrophysics Data System (ADS)

Vaniman, David T.; Bish, D.; Guthrie, G.; Chipera, S.; Blake, David E.; Collins, S. Andy; Elliott, S. T.; Sarrazin, P.

1999-10-01

There is a large variety of mining and manufacturing operations where process monitoring and control can benefit from on-site analysis of both chemical and mineralogic constituents. CHEMIN is a CCD-based instrument capable of both X-ray fluorescence (XRF; chemical) and X-ray diffraction (XRD; mineralogic) analysis. Monitoring and control with an instrument like CHEMIN can be applied to feedstocks, intermediate materials, and final products to optimize production. Examples include control of cement feedstock, of ore for smelting, and of minerals that pose inhalation hazards in the workplace. The combined XRD/XRF capability of CHEMIN can be used wherever a desired commodity is associated with unwanted constituents that may be similar in chemistry or structure but not both (e.g., Ca in both gypsum and feldspar, where only the gypsum is desired to make wallboard). In the mining industry, CHEMIN can determine mineral abundances on the spot and enable more economical mining by providing the means to assay when is being mined, quickly and frequently, at minimal cost. In manufacturing, CHEMIN could be used to spot-check the chemical composition and crystalline makeup of a product at any stage of production. Analysis by CHEMIN can be used as feedback in manufacturing processes where rates of heating, process temperature, mixture of feedstocks, and other variables must be adjusted in real time to correct structure and/or chemistry of the product (e.g., prevention of periclase and alkali sulfate coproduction in cement manufacture).

Hook tool manufacture in New Caledonian crows: behavioural variation and the influence of raw materials.

PubMed

Klump, Barbara C; Sugasawa, Shoko; St Clair, James J H; Rutz, Christian

2015-11-18

New Caledonian crows use a range of foraging tools, and are the only non-human species known to craft hooks. Based on a small number of observations, their manufacture of hooked stick tools has previously been described as a complex, multi-stage process. Tool behaviour is shaped by genetic predispositions, individual and social learning, and/or ecological influences, but disentangling the relative contributions of these factors remains a major research challenge. The properties of raw materials are an obvious, but largely overlooked, source of variation in tool-manufacture behaviour. We conducted experiments with wild-caught New Caledonian crows, to assess variation in their hooked stick tool making, and to investigate how raw-material properties affect the manufacture process. In Experiment 1, we showed that New Caledonian crows' manufacture of hooked stick tools can be much more variable than previously thought (85 tools by 18 subjects), and can involve two newly-discovered behaviours: 'pulling' for detaching stems and bending of the tool shaft. Crows' tool manufactures varied significantly: in the number of different action types employed; in the time spent processing the hook and bending the tool shaft; and in the structure of processing sequences. In Experiment 2, we examined the interaction of crows with raw materials of different properties, using a novel paradigm that enabled us to determine subjects' rank-ordered preferences (42 tools by 7 subjects). Plant properties influenced: the order in which crows selected stems; whether a hooked tool was manufactured; the time required to release a basic tool; and, possibly, the release technique, the number of behavioural actions, and aspects of processing behaviour. Results from Experiment 2 suggested that at least part of the natural behavioural variation observed in Experiment 1 is due to the effect of raw-material properties. Our discovery of novel manufacture behaviours indicates a plausible scenario for the evolutionary origins, and gradual refinement, of New Caledonian crows' hooked stick tool making. Furthermore, our experimental demonstration of a link between raw-material properties and aspects of tool manufacture provides an alternative hypothesis for explaining regional differences in tool behaviours observed in New Caledonian crows, and some primate species.

Time-based analysis of the apheresis platelet supply chain in England.

PubMed

Wilding, R; Cotton, S; Dobbin, J; Chapman, J; Yates, N

2011-10-01

During 2009/2010 loss of platelets within NHS Blood and Transplant (NHSBT) due to time expiry was 9.3%. Hospitals remain reluctant to hold stocks of platelets due to the poor shelf life at issue. The purpose of this study was to identify areas for time compression in the apheresis platelet supply chain to extend the shelf life available for hospitals and reduce wastage in NHSBT. This was done within the context of NHSBT reconfiguring their supply chain and moving towards a consolidated and centralised approach. Time based process mapping was applied to identify value and non-value adding time in two manufacturing models. A large amount of the non-value adding time in the apheresis platelet supply chain is due to transportation and waiting for the next process in the manufacturing process to take place. Time based process mapping provides an effective 'lens' for supply chain professionals to identify opportunities for improvement in the platelet supply chain. © 2011 The Author(s). Vox Sanguinis © 2011 International Society of Blood Transfusion.

Electronic Design Automation: Integrating the Design and Manufacturing Functions

NASA Technical Reports Server (NTRS)

Bachnak, Rafic; Salkowski, Charles

1997-01-01

As the complexity of electronic systems grows, the traditional design practice, a sequential process, is replaced by concurrent design methodologies. A major advantage of concurrent design is that the feedback from software and manufacturing engineers can be easily incorporated into the design. The implementation of concurrent engineering methodologies is greatly facilitated by employing the latest Electronic Design Automation (EDA) tools. These tools offer integrated simulation of the electrical, mechanical, and manufacturing functions and support virtual prototyping, rapid prototyping, and hardware-software co-design. This report presents recommendations for enhancing the electronic design and manufacturing capabilities and procedures at JSC based on a concurrent design methodology that employs EDA tools.

Six Sigma methods applied to cryogenic coolers assembly line

NASA Astrophysics Data System (ADS)

Ventre, Jean-Marc; Germain-Lacour, Michel; Martin, Jean-Yves; Cauquil, Jean-Marc; Benschop, Tonny; Griot, René

2009-05-01

Six Sigma method have been applied to manufacturing process of a rotary Stirling cooler: RM2. Name of the project is NoVa as main goal of the Six Sigma approach is to reduce variability (No Variability). Project has been based on the DMAIC guideline following five stages: Define, Measure, Analyse, Improve, Control. Objective has been set on the rate of coolers succeeding performance at first attempt with a goal value of 95%. A team has been gathered involving people and skills acting on the RM2 manufacturing line. Measurement System Analysis (MSA) has been applied to test bench and results after R&R gage show that measurement is one of the root cause for variability in RM2 process. Two more root causes have been identified by the team after process mapping analysis: regenerator filling factor and cleaning procedure. Causes for measurement variability have been identified and eradicated as shown by new results from R&R gage. Experimental results show that regenerator filling factor impacts process variability and affects yield. Improved process haven been set after new calibration process for test bench, new filling procedure for regenerator and an additional cleaning stage have been implemented. The objective for 95% coolers succeeding performance test at first attempt has been reached and kept for a significant period. RM2 manufacturing process is now managed according to Statistical Process Control based on control charts. Improvement in process capability have enabled introduction of sample testing procedure before delivery.

Product design for energy reduction in concurrent engineering: An Inverted Pyramid Approach

NASA Astrophysics Data System (ADS)

Alkadi, Nasr M.

Energy factors in product design in concurrent engineering (CE) are becoming an emerging dimension for several reasons; (a) the rising interest in "green design and manufacturing", (b) the national energy security concerns and the dramatic increase in energy prices, (c) the global competition in the marketplace and global climate change commitments including carbon tax and emission trading systems, and (d) the widespread recognition of the need for sustainable development. This research presents a methodology for the intervention of energy factors in concurrent engineering product development process to significantly reduce the manufacturing energy requirement. The work presented here is the first attempt at integrating the design for energy in concurrent engineering framework. It adds an important tool to the DFX toolbox for evaluation of the impact of design decisions on the product manufacturing energy requirement early during the design phase. The research hypothesis states that "Product Manufacturing Energy Requirement is a Function of Design Parameters". The hypothesis was tested by conducting experimental work in machining and heat treating that took place at the manufacturing lab of the Industrial and Management Systems Engineering Department (IMSE) at West Virginia University (WVU) and at a major U.S steel manufacturing plant, respectively. The objective of the machining experiment was to study the effect of changing specific product design parameters (Material type and diameter) and process design parameters (metal removal rate) on a gear head lathe input power requirement through performing defined sets of machining experiments. The objective of the heat treating experiment was to study the effect of varying product charging temperature on the fuel consumption of a walking beams reheat furnace. The experimental work in both directions have revealed important insights into energy utilization in machining and heat-treating processes and its variance based on product, process, and system design parameters. In depth evaluation to how the design and manufacturing normally happen in concurrent engineering provided a framework to develop energy system levels in machining within the concurrent engineering environment using the method of "Inverted Pyramid Approach", (IPA). The IPA features varying levels of output energy based information depending on the input design parameters that is available during each stage (level) of the product design. The experimental work, the in-depth evaluation of design and manufacturing in CE, and the developed energy system levels in machining provided a solid base for the development of the model for the design for energy reduction in CE. The model was used to analyze an example part where 12 evolving designs were thoroughly reviewed to investigate the sensitivity of energy to design parameters in machining. The model allowed product design teams to address manufacturing energy concerns early during the design stage. As a result, ranges for energy sensitive design parameters impacting product manufacturing energy consumption were found in earlier levels. As designer proceeds to deeper levels in the model, this range tightens and results in significant energy reductions.

Modeling of industrial stream and resources of machine-building enterpriser complex of wood preparation

NASA Astrophysics Data System (ADS)

Sereda, T. G.; Kostarev, S. N.

2018-03-01

Theoretical bases of linkage of material streams of the machine-building enterprise and the automated system of decision-making are developed. The process of machine-building manufacture is submitted by the existential system. The equation of preservation of movement is based on calculation of volume of manufacture. The basis of resource variables includes capacities and operators of the equipment. Indignations such as a defect and failure are investigated in the existential basis. The equation of a stream of details on a manufacturing route is made. The received analytical expression expresses a condition of a stream of movement of details in view of influence of work of the equipment and traumatism of the personnel.

Workplace exposure to nanoparticles and the application of provisional nanoreference values in times of uncertain risks

NASA Astrophysics Data System (ADS)

van Broekhuizen, Pieter; van Broekhuizen, Fleur; Cornelissen, Ralf; Reijnders, Lucas

2012-03-01

Nano reference values (NRVs) for occupational use of nanomaterials were tested as provisional substitute for Occupational Exposure Limits (OELs). NRVs can be used as provisional limit values until Health-Based OELs or derived no-effect levels (DNEL) become available. NRVs were defined for 8 h periods (time weighted average) and for short-term exposure periods (15 min-time weighted average). To assess the usefulness of these NRVs, airborne number concentrations of nanoparticles (NPs) in the workplace environment were measured during paint manufacturing, electroplating, light equipment manufacturing, non-reflective glass production, production of pigment concentrates and car refinishing. Activities monitored were handling of solid engineered NPs (ENP), abrasion, spraying and heating during occupational use of nanomaterials (containing ENPs) and machining nanosurfaces. The measured concentrations are often presumed to contain ENPs as well as process-generated NPs (PGNP). The PGNP are found to be a significant source for potential exposure and cannot be ignored in risk assessment. Levels of NPs identified in workplace air were up to several millions of nanoparticles/cm3. Conventional components in paint manufacturing like CaCO3 and talc may contain a substantial amount of nanosized particulates giving rise to airborne nanoparticle concentrations. It is argued that risk assessments carried out for e.g. paint manufacturing processes using conventional non-nano components should take into account potential nanoparticle emissions as well. The concentrations measured were compared with particle-based NRVs and with mass-based values that have also been proposed for workers protection. It is concluded that NRVs can be used for risk management for handling or processing of nanomaterials at workplaces provided that the scope of NRVs is not limited to ENPs only, but extended to the exposure to process-generated NPs as well.

A combined approach of simulation and analytic hierarchy process in assessing production facility layouts

NASA Astrophysics Data System (ADS)

Ramli, Razamin; Cheng, Kok-Min

2014-07-01

One of the important areas of concern in order to obtain a competitive level of productivity in a manufacturing system is the layout design and material transportation system (conveyor system). However, changes in customers' requirements have triggered the need to design other alternatives of the manufacturing layout for existing production floor. Hence, this paper discusses effective alternatives of the process layout specifically, the conveyor system layout. Subsequently, two alternative designs for the conveyor system were proposed with the aims to increase the production output and minimize space allocation. The first proposed layout design includes the installation of conveyor oven in the particular manufacturing room based on priority, and the second one is the one without the conveyor oven in the layout. Simulation technique was employed to design the new facility layout. Eventually, simulation experiments were conducted to understand the performance of each conveyor layout design based on operational characteristics, which include predicting the output of layouts. Utilizing the Analytic Hierarchy Process (AHP), the newly and improved layout designs were assessed before the final selection was done. As a comparison, the existing conveyor system layout was included in the assessment process. Relevant criteria involved in this layout design problem were identified as (i) usage of space of each design, (ii) operator's utilization rates, (iii) return of investment (ROI) of the layout, and (iv) output of the layout. In the final stage of AHP analysis, the overall priority of each alternative layout was obtained and thus, a selection for final use by the management was made based on the highest priority value. This efficient planning and designing of facility layout in a particular manufacturing setting is able to minimize material handling cost, minimize overall production time, minimize investment in equipment, and optimize utilization of space.

Metal Big Area Additive Manufacturing: Process Modeling and Validation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Simunovic, Srdjan; Nycz, Andrzej; Noakes, Mark W

Metal Big Area Additive Manufacturing (mBAAM) is a new additive manufacturing (AM) technology for printing large-scale 3D objects. mBAAM is based on the gas metal arc welding process and uses a continuous feed of welding wire to manufacture an object. An electric arc forms between the wire and the substrate, which melts the wire and deposits a bead of molten metal along the predetermined path. In general, the welding process parameters and local conditions determine the shape of the deposited bead. The sequence of the bead deposition and the corresponding thermal history of the manufactured object determine the long rangemore » effects, such as thermal-induced distortions and residual stresses. Therefore, the resulting performance or final properties of the manufactured object are dependent on its geometry and the deposition path, in addition to depending on the basic welding process parameters. Physical testing is critical for gaining the necessary knowledge for quality prints, but traversing the process parameter space in order to develop an optimized build strategy for each new design is impractical by pure experimental means. Computational modeling and optimization may accelerate development of a build process strategy and saves time and resources. Because computational modeling provides these opportunities, we have developed a physics-based Finite Element Method (FEM) simulation framework and numerical models to support the mBAAM process s development and design. In this paper, we performed a sequentially coupled heat transfer and stress analysis for predicting the final deformation of a small rectangular structure printed using the mild steel welding wire. Using the new simulation technologies, material was progressively added into the FEM simulation as the arc weld traversed the build path. In the sequentially coupled heat transfer and stress analysis, the heat transfer was performed to calculate the temperature evolution, which was used in a stress analysis to evaluate the residual stresses and distortions. In this formulation, we assume that physics is directionally coupled, i.e. the effect of stress of the component on the temperatures is negligible. The experiment instrumentation (measurement types, sensor types, sensor locations, sensor placements, measurement intervals) and the measurements are presented. The temperatures and distortions from the simulations show good correlation with experimental measurements. Ongoing modeling work is also briefly discussed.« less

Fusion processing of itraconazole solid dispersions by kinetisol dispersing: a comparative study to hot melt extrusion.

PubMed

DiNunzio, James C; Brough, Chris; Miller, Dave A; Williams, Robert O; McGinity, James W

2010-03-01

KinetiSol Dispersing (KSD) is a novel high energy manufacturing process investigated here for the production of pharmaceutical solid dispersions. Solid dispersions of itraconazole (ITZ) and hypromellose were produced by KSD and compared to identical formulations produced by hot melt extrusion (HME). Materials were characterized for solid state properties by modulated differential scanning calorimetry and X-ray diffraction. Dissolution behavior was studied under supersaturated conditions. Oral bioavailability was determined using a Sprague-Dawley rat model. Results showed that KSD was able to produce amorphous solid dispersions in under 15 s while production by HME required over 300 s. Dispersions produced by KSD exhibited single phase solid state behavior indicated by a single glass transition temperature (T(g)) whereas compositions produced by HME exhibited two T(g)s. Increased dissolution rates for compositions manufactured by KSD were also observed compared to HME processed material. Near complete supersaturation was observed for solid dispersions produced by either manufacturing processes. Oral bioavailability from both processes showed enhanced AUC compared to crystalline ITZ. Based on the results presented from this study, KSD was shown to be a viable manufacturing process for the production of pharmaceutical solid dispersions, providing benefits over conventional techniques including: enhanced mixing for improved homogeneity and reduced processing times. 2009 Wiley-Liss, Inc. and the American Pharmacists Association

UOE Pipe Numerical Model: Manufacturing Process And Von Mises Residual Stresses Resulted After Each Technological Step

NASA Astrophysics Data System (ADS)

Delistoian, Dmitri; Chirchor, Mihael

2017-12-01

Fluid transportation from production areas to final customer is effectuated by pipelines. For oil and gas industry, pipeline safety and reliability represents a priority. From this reason, pipe quality guarantee directly influence pipeline designed life, but first of all protects environment. A significant number of longitudinally welded pipes, for onshore/offshore pipelines, are manufactured by UOE method. This method is based on cold forming. In present study, using finite element method is modeled UOE pipe manufacturing process and is obtained von Mises stresses for each step. Numerical simulation is performed for L415 MB (X60) steel plate with 7,9 mm thickness, length 30 mm and width 1250mm, as result it is obtained a DN 400 pipe.

Abnormal Condition Monitoring of Workpieces Based on RFID for Wisdom Manufacturing Workshops.

PubMed

Zhang, Cunji; Yao, Xifan; Zhang, Jianming

2015-12-03

Radio Frequency Identification (RFID) technology has been widely used in many fields. However, previous studies have mainly focused on product life cycle tracking, and there are few studies on real-time status monitoring of workpieces in manufacturing workshops. In this paper, a wisdom manufacturing model is introduced, a sensing-aware environment for a wisdom manufacturing workshop is constructed, and RFID event models are defined. A synthetic data cleaning method is applied to clean the raw RFID data. The Complex Event Processing (CEP) technology is adopted to monitor abnormal conditions of workpieces in real time. The RFID data cleaning method and data mining technology are examined by simulation and physical experiments. The results show that the synthetic data cleaning method preprocesses data well. The CEP based on the Rifidi(®) Edge Server technology completed abnormal condition monitoring of workpieces in real time. This paper reveals the importance of RFID spatial and temporal data analysis in real-time status monitoring of workpieces in wisdom manufacturing workshops.

Abnormal Condition Monitoring of Workpieces Based on RFID for Wisdom Manufacturing Workshops

PubMed Central

Zhang, Cunji; Yao, Xifan; Zhang, Jianming

2015-01-01

Radio Frequency Identification (RFID) technology has been widely used in many fields. However, previous studies have mainly focused on product life cycle tracking, and there are few studies on real-time status monitoring of workpieces in manufacturing workshops. In this paper, a wisdom manufacturing model is introduced, a sensing-aware environment for a wisdom manufacturing workshop is constructed, and RFID event models are defined. A synthetic data cleaning method is applied to clean the raw RFID data. The Complex Event Processing (CEP) technology is adopted to monitor abnormal conditions of workpieces in real time. The RFID data cleaning method and data mining technology are examined by simulation and physical experiments. The results show that the synthetic data cleaning method preprocesses data well. The CEP based on the Rifidi® Edge Server technology completed abnormal condition monitoring of workpieces in real time. This paper reveals the importance of RFID spatial and temporal data analysis in real-time status monitoring of workpieces in wisdom manufacturing workshops. PMID:26633418

Emissions of volatile organic compounds (VOCs) from the food and drink industries of the European community

NASA Astrophysics Data System (ADS)

Passant, Neil R.; Richardson, Stephen J.; Swannell, Richard P. J.; Gibson, N.; Woodfield, M. J.; van der Lugt, Jan Pieter; Wolsink, Johan H.; Hesselink, Paul G. M.

Estimates were made of the amounts of volatile organic compounds (VOCs) released into the atmosphere as a result of the industrial manufacture and processing of food and drink in the European Community. The estimates were based on a review of literature sources, industrial and government contacts and recent measurements. Data were found on seven food manufacturing sectors (baking, vegetable oil extraction, solid fat processing, animal rendering, fish meal processing, coffee production and sugar beet processing) and three drink manufacturing sectors (brewing, spirit production and wine making). The principle of a data quality label is advocated to illustrate the authors' confidence in the data, and to highlight areas for further research. Emissions of ethanol from bread baking and spirit maturation were found to be the principle sources. However, significant losses of hexane and large quantities of an ill-defined mixture of partially oxidized hydrocarbons were noted principally from seed oil extraction and the drying of plant material, respectively. This latter mixture included low molecular weight aldehydes, carboxylic acids, ketones, amines and esters. However, the precise composition of many emissions were found to be poorly understood. The total emission from the food and drink industry in the EC was calculated as 260 kt yr -1. However, many processes within the target industry were found to be completely uncharacterized and therefore not included in the overall estimate (e.g. soft drink manufacture, production of animal food, flavourings, vinegar, tea, crisps and other fried snacks). Moreover, the use of data quality labels illustrated the fact that many of our estimates were based on limited data. Hence, further emissions monitoring is recommended from identified sources (e.g. processing of sugar beet, solid fat and fish meal) and from uncharacterized sources.

Multicenter Study on Incubation Conditions for Environmental Monitoring and Aseptic Process Simulation.

PubMed

Guinet, Roland; Berthoumieu, Nicole; Dutot, Philippe; Triquet, Julien; Ratajczak, Medhi; Thibaudon, Michel; Bechaud, Philippe; Arliaud, Christophe; Miclet, Edith; Giordano, Florine; Larcon, Marjorie; Arthaud, Catherine

Environmental monitoring and aseptic process simulations represent an integral part of the microbiological quality control system of sterile pharmaceutical products manufacturing operations. However, guidance documents and manufacturers practices differ regarding recommendations for incubation time and incubation temperature, and, consequently, the environmental monitoring and aseptic process simulation incubation strategy should be supported by validation data. To avoid any bias coming from in vitro studies or from single-site manufacturing in situ studies, we performed a collaborative study at four manufacturing sites with four samples at each location. The environmental monitoring study was performed with tryptic soy agar settle plates and contact plates, and the aseptic process simulation study was performed with tryptic soy broth and thioglycolate broth. The highest recovery rate was obtained with settle plates (97.7%) followed by contact plates (65.4%) and was less than 20% for liquid media (tryptic soy broth 19% and thioglycolate broth 17%). Gram-positive cocci and non-spore-forming Gram-positive rods were largely predominant with more than 95% of growth and recovered best at 32.5 °C. The highest recovery of molds was obtained at 22.5 °C alone or as the first incubation temperature. Strict anaerobes were not recovered. At the end of the five days of incubation no significant statistical difference was obtained between the four conditions. Based on these data a single incubation temperature at 32.5 °C could be recommended for these four manufacturing sites for both environmental monitoring and aseptic process simulation, and a second plate could be used, periodically incubated at 22.5 °C. Similar studies should be considered for all manufacturing facilities in order to determine the optimal incubation temperature regime for both viable environmental monitoring and aseptic process simulation. Microbiological environmental monitoring and aseptic process simulation confirm that pharmaceutical cleanrooms are in an appropriate hygienic condition for manufacturing of sterile drug products. Guidance documents from different health authorities or expert groups differ regarding recommendation of the applied incubation time and incubation temperature, leading to variable manufacturers practices. Some recent publications have demonstrated that laboratory studies are not relevant to determine the best incubation regime and that in situ manufacturing site studies should be used. To solve any possible bias coming from laboratory studies or single-site in situ studies, we conducted a multicenter study at four manufacturing sites with a significant amount of real environmental monitoring samples collected directly from the environment in pharmaceutical production during manufacturing operations with four solid and liquid nutrient media. These samples were then incubated under four different conditions suggested in the guidance documents. We believe that the results of our multicenter study confirming recent other single-site in situ studies could be the basis of the strategy to determine the best incubation regime for both viable environmental monitoring and aseptic process simulation in any manufacturing facility. © PDA, Inc. 2017.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Simpson, L.; Britt, J.; Birkmire, R.

ITN Energy Systems, Inc., and Global Solar Energy, Inc., assisted by NREL's PV Manufacturing R&D program, have continued to advance CIGS production technology by developing trajectory-oriented predictive/control models, fault-tolerance control, control platform development, in-situ sensors, and process improvements. Modeling activities included developing physics-based and empirical models for CIGS and sputter-deposition processing, implementing model-based control, and applying predictive models to the construction of new evaporation sources and for control. Model-based control is enabled by implementing reduced or empirical models into a control platform. Reliability improvement activities include implementing preventive maintenance schedules; detecting failed sensors/equipment and reconfiguring to tinue processing; and systematicmore » development of fault prevention and reconfiguration strategies for the full range of CIGS PV production deposition processes. In-situ sensor development activities have resulted in improved control and indicated the potential for enhanced process status monitoring and control of the deposition processes. Substantial process improvements have been made, including significant improvement in CIGS uniformity, thickness control, efficiency, yield, and throughput. In large measure, these gains have been driven by process optimization, which in turn have been enabled by control and reliability improvements due to this PV Manufacturing R&D program.« less

Toward Higher QA: From Parametric Release of Sterile Parenteral Products to PAT for Other Pharmaceutical Dosage Forms.

PubMed

Hock, Sia Chong; Constance, Neo Xue Rui; Wah, Chan Lai

2012-01-01

Pharmaceutical products are generally subjected to end-product batch testing as a means of quality control. Due to the inherent limitations of conventional batch testing, this is not the most ideal approach for determining the pharmaceutical quality of the finished dosage form. In the case of terminally sterilized parenteral products, the limitations of conventional batch testing have been successfully addressed with the application of parametric release (the release of a product based on control of process parameters instead of batch sterility testing at the end of the manufacturing process). Consequently, there has been an increasing interest in applying parametric release to other pharmaceutical dosage forms, beyond terminally sterilized parenteral products. For parametric release to be possible, manufacturers must be capable of designing quality into the product, monitoring the manufacturing processes, and controlling the quality of intermediates and finished products in real-time. Process analytical technology (PAT) has been thought to be capable of contributing to these prerequisites. It is believed that the appropriate use of PAT tools can eventually lead to the possibility of real-time release of other pharmaceutical dosage forms, by-passing the need for end-product batch testing. Hence, this literature review attempts to present the basic principles of PAT, introduce the various PAT tools that are currently available, present their recent applications to pharmaceutical processing, and explain the potential benefits that PAT can bring to conventional ways of processing and quality assurance of pharmaceutical products. Last but not least, current regulations governing the use of PAT and the manufacturing challenges associated with PAT implementation are also discussed. Pharmaceutical products are generally subjected to end-product batch testing as a means of quality control. Due to the inherent limitations of conventional batch testing, this is not the most ideal approach. In the case of terminally sterilized parenteral products, these limitations have been successfully addressed with the application of parametric release (the release of a product based on control of process parameters instead of batch sterility testing at the end of the manufacturing process). Consequently, there has been an increasing interest in applying parametric release to other pharmaceutical dosage forms. With the advancement of process analytical technology (PAT), it is possible to monitor the manufacturing processes closely. This will eventually enable quality control of the intermediates and finished products, and thus their release in real-time. Hence, this literature review attempts to present the basic principles of PAT, introduce the various PAT tools that are currently available, present their recent applications to pharmaceutical processing, and explain the potential benefits that PAT can bring to conventional ways of processing and quality assurance of pharmaceutical products. It will also discuss the current regulations governing the use of PAT and the manufacturing challenges associated with the implementation of PAT.

Microgravity Manufacturing Via Fused Deposition

NASA Technical Reports Server (NTRS)

Cooper, K. G.; Griffin, M. R.

2003-01-01

Manufacturing polymer hardware during space flight is currently outside the state of the art. A process called fused deposition modeling (FDM) can make this approach a reality by producing net-shaped components of polymer materials directly from a CAE model. FDM is a rapid prototyping process developed by Stratasys, Inc.. which deposits a fine line of semi-molten polymer onto a substrate while moving via computer control to form the cross-sectional shape of the part it is building. The build platen is then lowered and the process is repeated, building a component directly layer by layer. This method enables direct net-shaped production of polymer components directly from a computer file. The layered manufacturing process allows for the manufacture of complex shapes and internal cavities otherwise impossible to machine. This task demonstrated the benefits of the FDM technique to quickly and inexpensively produce replacement components or repair broken hardware in a Space Shuttle or Space Station environment. The intent of the task was to develop and fabricate an FDM system that was lightweight, compact, and required minimum power consumption to fabricate ABS plastic hardware in microgravity. The final product of the shortened task turned out to be a ground-based breadboard device, demonstrating miniaturization capability of the system.

Automated design synthesis of robotic/human workcells for improved manufacturing system design in hazardous environments

DOE Office of Scientific and Technical Information (OSTI.GOV)

Williams, Joshua M.

Manufacturing tasks that are deemed too hazardous for workers require the use of automation, robotics, and/or other remote handling tools. The associated hazards may be radiological or nonradiological, and based on the characteristics of the environment and processing, a design may necessitate robotic labor, human labor, or both. There are also other factors such as cost, ergonomics, maintenance, and efficiency that also effect task allocation and other design choices. Handling the tradeoffs of these factors can be complex, and lack of experience can be an issue when trying to determine if and what feasible automation/robotics options exist. To address thismore » problem, we utilize common engineering design approaches adapted more for manufacturing system design in hazardous environments. We limit our scope to the conceptual and embodiment design stages, specifically a computational algorithm for concept generation and early design evaluation. In regard to concept generation, we first develop the functional model or function structure for the process, using the common 'verb-noun' format for describing function. A common language or functional basis for manufacturing was developed and utilized to formalize function descriptions and guide rules for function decomposition. Potential components for embodiment are also grouped in terms of this functional language and are stored in a database. The properties of each component are given as quantitative and qualitative criteria. Operators are also rated for task-relevant criteria which are used to address task compatibility. Through the gathering of process requirements/constraints, construction of the component database, and development of the manufacturing basis and rule set, design knowledge is stored and available for computer use. Thus, once the higher level process functions are defined, the computer can automate the synthesis of new design concepts through alternating steps of embodiment and function structure updates/decomposition. In the process, criteria guide function allocation of components/operators and help ensure compatibility and feasibility. Through multiple function assignment options and varied function structures, multiple design concepts are created. All of the generated designs are then evaluated based on a number of relevant evaluation criteria: cost, dose, ergonomics, hazards, efficiency, etc. These criteria are computed using physical properties/parameters of each system based on the qualities an engineer would use to make evaluations. Nuclear processes such as oxide conversion and electrorefining are utilized to aid algorithm development and provide test cases for the completed program. Through our approach, we capture design knowledge related to manufacturing and other operations in hazardous environments to enable a computational program to automatically generate and evaluate system design concepts.« less

Nanoband array electrode as a platform for high sensitivity enzyme-based glucose biosensing.

PubMed

Falk, Magnus; Sultana, Reshma; Swann, Marcus J; Mount, Andrew R; Freeman, Neville J

2016-12-01

We describe a novel glucose biosensor based on a nanoband array electrode design, manufactured using standard semiconductor processing techniques, and bio-modified with glucose oxidase immobilized at the nanoband electrode surface. The nanoband array architecture allows for efficient diffusion of glucose and oxygen to the electrode, resulting in a thousand-fold improvement in sensitivity and wide linear range compared to a conventional electrode. The electrode constitutes a robust and manufacturable sensing platform. Copyright © 2016 Elsevier B.V. All rights reserved.

A preliminary investigation of the Environmental Control and Life Support Subsystem (EC/LSS) for the space construction base manufacturing modules

NASA Technical Reports Server (NTRS)

Wells, H. B.

1977-01-01

The preliminary data of the environmental control and life support subsystem for a space construction base manufacturing module was reported. A space processing module, which is capable of performing production biological experiments, was chosen as a baseline configuration. The primary assemblies and components considered for use were humidity and temperature control, ventilation fan, cabin fan, water separator, condensate storage, overboard dumping, distribution system, contaminant monitoring, cabin sensors, and fire and smoke detection.

A new large-scale manufacturing platform for complex biopharmaceuticals.

PubMed

Vogel, Jens H; Nguyen, Huong; Giovannini, Roberto; Ignowski, Jolene; Garger, Steve; Salgotra, Anil; Tom, Jennifer

2012-12-01

Complex biopharmaceuticals, such as recombinant blood coagulation factors, are addressing critical medical needs and represent a growing multibillion-dollar market. For commercial manufacturing of such, sometimes inherently unstable, molecules it is important to minimize product residence time in non-ideal milieu in order to obtain acceptable yields and consistently high product quality. Continuous perfusion cell culture allows minimization of residence time in the bioreactor, but also brings unique challenges in product recovery, which requires innovative solutions. In order to maximize yield, process efficiency, facility and equipment utilization, we have developed, scaled-up and successfully implemented a new integrated manufacturing platform in commercial scale. This platform consists of a (semi-)continuous cell separation process based on a disposable flow path and integrated with the upstream perfusion operation, followed by membrane chromatography on large-scale adsorber capsules in rapid cycling mode. Implementation of the platform at commercial scale for a new product candidate led to a yield improvement of 40% compared to the conventional process technology, while product quality has been shown to be more consistently high. Over 1,000,000 L of cell culture harvest have been processed with 100% success rate to date, demonstrating the robustness of the new platform process in GMP manufacturing. While membrane chromatography is well established for polishing in flow-through mode, this is its first commercial-scale application for bind/elute chromatography in the biopharmaceutical industry and demonstrates its potential in particular for manufacturing of potent, low-dose biopharmaceuticals. Copyright © 2012 Wiley Periodicals, Inc.

Lightweight bio-composites based on hemp fibres produced by conventional and unconventional processes

NASA Astrophysics Data System (ADS)

Boccarusso, L.; Durante, M.; Formisano, A.; Langella, A.; Minutolo, F. Memola Capece

2017-10-01

Considering that nowadays the interest in the use of bio-composite materials is increasing more and more, this work is focused on the manufacturing of lightweight components based on hemp fibres for future applications, for example as a core for sandwich structures. Three different no-complex processes were used: a conventional hand lay-up, an unconventional infusion process and a hand lay-up process followed by injection moulding. They were used to produce bio-composite structures using an epoxy resin and/or a polyurethane foam as matrix. Depending on the process used for the manufacturing, laminates with different values of density were obtained. A detailed study in terms of both static and dynamic properties was carried out and the different mechanical behaviour for each sample typology was highlighted. The results showed that the process in which both the epoxy resin and the polyurethane foam were used as matrix allowed to obtain laminates with lower density and higher specific mechanical properties.

Development of Integrated Programs for Aerospace-vehicle Design (IPAD): Product manufacture interactions with the design process

NASA Technical Reports Server (NTRS)

Crowell, H. A.

1979-01-01

The product manufacturing interactions with the design process and the IPAD requirements to support the interactions are described. The data requirements supplied to manufacturing by design are identified and quantified. Trends in computer-aided manufacturing are discussed and the manufacturing process of the 1980's is anticipated.

Fault detection in heavy duty wheels by advanced vibration processing techniques and lumped parameter modeling

NASA Astrophysics Data System (ADS)

Malago`, M.; Mucchi, E.; Dalpiaz, G.

2016-03-01

Heavy duty wheels are used in applications such as automatic vehicles and are mainly composed of a polyurethane tread glued to a cast iron hub. In the manufacturing process, the adhesive application between tread and hub is a critical assembly phase, since it is completely made by an operator and a contamination of the bond area may happen. Furthermore, the presence of rust on the hub surface can contribute to worsen the adherence interface, reducing the operating life. In this scenario, a quality control procedure for fault detection to be used at the end of the manufacturing process has been developed. This procedure is based on vibration processing techniques and takes advantages of the results of a lumped parameter model. Indicators based on cyclostationarity can be considered as key parameters to be adopted in a monitoring test station at the end of the production line due to their not deterministic characteristics.

Dry etching technologies for the advanced binary film

NASA Astrophysics Data System (ADS)

Iino, Yoshinori; Karyu, Makoto; Ita, Hirotsugu; Yoshimori, Tomoaki; Azumano, Hidehito; Muto, Makoto; Nonaka, Mikio

2011-11-01

ABF (Advanced Binary Film) developed by Hoya as a photomask for 32 (nm) and larger specifications provides excellent resistance to both mask cleaning and 193 (nm) excimer laser and thereby helps extend the lifetime of the mask itself compared to conventional photomasks and consequently reduces the semiconductor manufacturing cost [1,2,3]. Because ABF uses Ta-based films, which are different from Cr film or MoSi films commonly used for photomask, a new process is required for its etching technology. A patterning technology for ABF was established to perform the dry etching process for Ta-based films by using the knowledge gained from absorption layer etching for EUV mask that required the same Ta-film etching process [4]. Using the mask etching system ARES, which is manufactured by Shibaura Mechatronics, and its optimized etching process, a favorable CD (Critical Dimension) uniformity, a CD linearity and other etching characteristics were obtained in ABF patterning. Those results are reported here.

The challenges of lean manufacturing implementation in kitting assembly

NASA Astrophysics Data System (ADS)

Fansuri, A. F. H.; Rose, A. N. M.; Nik Mohamed, N. M. Z.; Ahmad, H.

2017-10-01

Literature studies shows that lean manufacturing goes way back with the original founder Eli Whitney in year 1799. The main purpose of lean manufacturing is to identify and eliminate waste in production. The application of lean manufacturing can be carried out in any industrial processes with regards to the understanding of lean principles, theories and practices. Kitting is one of the important aspects in a successful production. The continuous supply of materials from store to production has to be systematic and able to achieve lean standard for it to be successful. The objective of this paper is to review the implementation of lean manufacturing in kitting assembly. Previous papers show that, the implementation of lean manufacturing in kitting assembly may be beneficial to the organization such as reduce in space occupancy, part shortages, lead time and manpower. Based on previous research, some industries may tend to change between kitting and line stocking which are due to lack of understanding when implementing kitting and causes longer lead time and materials overflow in store. With a proper understanding on what to kit, where to kit, how to kit, why to kit and who kits the material with a standardised process flow may ensure the success of kitting.

Bioelectrochemical Integration of Waste Heat Recovery, Waste-to- Energy Conversion, and Waste-to-Chemical Conversion with Industrial Gas and Chemical Manufacturing Processes

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mac Dougall, James

2016-02-05

Many U.S. manufacturing facilities generate unrecovered, low-grade waste heat, and also generate or are located near organic-content waste effluents. Bioelectrochemical systems, such as microbial fuel cells and microbial electrolysis cells, provide a means to convert organic-content effluents into electric power and useful chemical products. A novel biochemical electrical system for industrial manufacturing processes uniquely integrates both waste heat recovery and waste effluent conversion, thereby significantly reducing manufacturing energy requirements. This project will enable the further development of this technology so that it can be applied across a wide variety of US manufacturing segments, including the chemical, food, pharmaceutical, refinery, andmore » pulp and paper industries. It is conservatively estimated that adoption of this technology could provide nearly 40 TBtu/yr of energy, or more than 1% of the U.S. total industrial electricity use, while reducing CO 2 emissions by more than 6 million tons per year. Commercialization of this technology will make a significant contribution to DOE’s Industrial Technology Program goals for doubling energy efficiency and providing a more robust and competitive domestic manufacturing base.« less

40 CFR 761.193 - Maintenance of monitoring records by persons who import, manufacture, process, distribute in...

Code of Federal Regulations, 2013 CFR

2013-07-01

... persons who import, manufacture, process, distribute in commerce, or use chemicals containing... records by persons who import, manufacture, process, distribute in commerce, or use chemicals containing inadvertently generated PCBs. (a) Persons who import, manufacture, process, distribute in commerce, or use...

40 CFR 761.193 - Maintenance of monitoring records by persons who import, manufacture, process, distribute in...

Code of Federal Regulations, 2011 CFR

2011-07-01

... persons who import, manufacture, process, distribute in commerce, or use chemicals containing... records by persons who import, manufacture, process, distribute in commerce, or use chemicals containing inadvertently generated PCBs. (a) Persons who import, manufacture, process, distribute in commerce, or use...

40 CFR 761.193 - Maintenance of monitoring records by persons who import, manufacture, process, distribute in...

Code of Federal Regulations, 2012 CFR

2012-07-01

... persons who import, manufacture, process, distribute in commerce, or use chemicals containing... records by persons who import, manufacture, process, distribute in commerce, or use chemicals containing inadvertently generated PCBs. (a) Persons who import, manufacture, process, distribute in commerce, or use...

40 CFR 761.193 - Maintenance of monitoring records by persons who import, manufacture, process, distribute in...

Code of Federal Regulations, 2014 CFR

2014-07-01

... persons who import, manufacture, process, distribute in commerce, or use chemicals containing... records by persons who import, manufacture, process, distribute in commerce, or use chemicals containing inadvertently generated PCBs. (a) Persons who import, manufacture, process, distribute in commerce, or use...

Integrated Process Modeling-A Process Validation Life Cycle Companion.

PubMed

Zahel, Thomas; Hauer, Stefan; Mueller, Eric M; Murphy, Patrick; Abad, Sandra; Vasilieva, Elena; Maurer, Daniel; Brocard, Cécile; Reinisch, Daniela; Sagmeister, Patrick; Herwig, Christoph

2017-10-17

During the regulatory requested process validation of pharmaceutical manufacturing processes, companies aim to identify, control, and continuously monitor process variation and its impact on critical quality attributes (CQAs) of the final product. It is difficult to directly connect the impact of single process parameters (PPs) to final product CQAs, especially in biopharmaceutical process development and production, where multiple unit operations are stacked together and interact with each other. Therefore, we want to present the application of Monte Carlo (MC) simulation using an integrated process model (IPM) that enables estimation of process capability even in early stages of process validation. Once the IPM is established, its capability in risk and criticality assessment is furthermore demonstrated. IPMs can be used to enable holistic production control strategies that take interactions of process parameters of multiple unit operations into account. Moreover, IPMs can be trained with development data, refined with qualification runs, and maintained with routine manufacturing data which underlines the lifecycle concept. These applications will be shown by means of a process characterization study recently conducted at a world-leading contract manufacturing organization (CMO). The new IPM methodology therefore allows anticipation of out of specification (OOS) events, identify critical process parameters, and take risk-based decisions on counteractions that increase process robustness and decrease the likelihood of OOS events.

A combinaison of UV curing technology with ATL process

NASA Astrophysics Data System (ADS)

Balbzioui, I.; Hasiaoui, B.; Barbier, G.; L'hostis, G.; Laurent, F.; Ibrahim, A.; Durand, B.

2017-10-01

In order to reduce the time and the cost of manufacturing composite, UV curing technology combined with automated tape placement process (ATL) based on reverse approach by working with a fixed head was studied in this article. First, a brief description of the developed head placement is presented. Mechanical properties are then evaluated by varying process parameters, including compaction force and tape placement speed. Finally, a parametric study is carried out to identify suitable materials and process parameters to manufacture a photo composite material with high mechanical performances. The obtained results show that UV curing is a very good alternative for thermal polymerization because of its fast cure speed due to less dependency on temperature.

An international technology platform for influenza vaccines.

PubMed

Hendriks, Jan; Holleman, Marit; de Boer, Otto; de Jong, Patrick; Luytjes, Willem

2011-07-01

Since 2008, the World Health Organization has provided seed grants to 11 manufacturers in low- and middle-income countries to establish or improve their pandemic influenza vaccine production capacity. To facilitate this ambitious project, an influenza vaccine technology platform (or "hub") was established at the Netherlands Vaccine Institute for training and technology transfer to developing countries. During its first two years of operation, a robust and transferable monovalent pilot process for egg-based inactivated whole virus influenza A vaccine production was established under international Good Manufacturing Practice standards, as well as in-process and release assays. A course curriculum was designed, including a two-volume practical handbook on production and quality control. Four generic hands-on training courses were successfully realized for over 40 employees from 15 developing country manufacturers. Planned extensions to the curriculum include cell-culture based technology for viral vaccine production, split virion influenza production, and generic adjuvant formulation. We conclude that technology transfer through the hub model works well, significantly builds vaccine manufacturing capacity in developing countries, and thereby increases global and equitable access to vaccines of high public health relevance. Copyright © 2011 Elsevier Ltd. All rights reserved.

Numerical modeling of heat-transfer and the influence of process parameters on tailoring the grain morphology of IN718 in electron beam additive manufacturing

DOE PAGES

Raghavan, Narendran; Dehoff, Ryan; Pannala, Sreekanth; ...

2016-04-26

The fabrication of 3-D parts from CAD models by additive manufacturing (AM) is a disruptive technology that is transforming the metal manufacturing industry. The correlation between solidification microstructure and mechanical properties has been well understood in the casting and welding processes over the years. This paper focuses on extending these principles to additive manufacturing to understand the transient phenomena of repeated melting and solidification during electron beam powder melting process to achieve site-specific microstructure control within a fabricated component. In this paper, we have developed a novel melt scan strategy for electron beam melting of nickel-base superalloy (Inconel 718) andmore » also analyzed 3-D heat transfer conditions using a parallel numerical solidification code (Truchas) developed at Los Alamos National Laboratory. The spatial and temporal variations of temperature gradient (G) and growth velocity (R) at the liquid-solid interface of the melt pool were calculated as a function of electron beam parameters. By manipulating the relative number of voxels that lie in the columnar or equiaxed region, the crystallographic texture of the components can be controlled to an extent. The analysis of the parameters provided optimum processing conditions that will result in columnar to equiaxed transition (CET) during the solidification. Furthermore, the results from the numerical simulations were validated by experimental processing and characterization thereby proving the potential of additive manufacturing process to achieve site-specific crystallographic texture control within a fabricated component.« less

Survey of the US materials processing and manufacturing in space program

NASA Technical Reports Server (NTRS)

Mckannan, E. C.

1981-01-01

To promote potential commercial applications of low-g technology, the materials processing and manufacturing in space program is structured to: (1) analyze the scientific principles of gravitational effects on processes used in producing materials; (2) apply the research toward the technology used to control production process (on Earth or in space, as appropriate); and (3) establish the legal and managerial framework for commercial ventures. Presently federally funded NASA research is described as well as agreements for privately funded commercial activity, and a proposed academic participation process. The future scope of the program and related capabilities using ground based facilities, aircraft, sounding rockets, and space shuttles are discussed. Areas of interest described include crystal growth; solidification of metals and alloys; containerless processing; fluids and chemical processes (including biological separation processes); and processing extraterrestrial materials.

Quarterly Report: Microchannel-Assisted Nanomaterial Deposition Technology for Photovoltaic Material Production

DOE Office of Scientific and Technical Information (OSTI.GOV)

Palo, Daniel R.

2011-04-26

Quarterly report to ITP for Nanomanufacturing program. Report covers FY11 Q2. The primary objective of this project is to develop a nanomanufacturing process which will reduce the manufacturing energy, environmental discharge, and production cost associated with current nano-scale thin-film photovoltaic (PV) manufacturing approaches. The secondary objective is to use a derivative of this nanomanufacturing process to enable greener, more efficient manufacturing of higher efficiency quantum dot-based photovoltaic cells now under development. The work is to develop and demonstrate a scalable (pilot) microreactor-assisted nanomaterial processing platform for the production, purification, functionalization, and solution deposition of nanomaterials for photovoltaic applications. The highmore » level task duration is shown. Phase I consists of a pilot platform for Gen II PV films along with parallel efforts aimed at Gen III PV quantum dot materials. Status of each task is described.« less

An interval programming model for continuous improvement in micro-manufacturing

NASA Astrophysics Data System (ADS)

Ouyang, Linhan; Ma, Yizhong; Wang, Jianjun; Tu, Yiliu; Byun, Jai-Hyun

2018-03-01

Continuous quality improvement in micro-manufacturing processes relies on optimization strategies that relate an output performance to a set of machining parameters. However, when determining the optimal machining parameters in a micro-manufacturing process, the economics of continuous quality improvement and decision makers' preference information are typically neglected. This article proposes an economic continuous improvement strategy based on an interval programming model. The proposed strategy differs from previous studies in two ways. First, an interval programming model is proposed to measure the quality level, where decision makers' preference information is considered in order to determine the weight of location and dispersion effects. Second, the proposed strategy is a more flexible approach since it considers the trade-off between the quality level and the associated costs, and leaves engineers a larger decision space through adjusting the quality level. The proposed strategy is compared with its conventional counterparts using an Nd:YLF laser beam micro-drilling process.

Additive manufacturing of three-dimensional (3D) microfluidic-based microelectromechanical systems (MEMS) for acoustofluidic applications.

PubMed

Cesewski, Ellen; Haring, Alexander P; Tong, Yuxin; Singh, Manjot; Thakur, Rajan; Laheri, Sahil; Read, Kaitlin A; Powell, Michael D; Oestreich, Kenneth J; Johnson, Blake N

2018-06-13

Three-dimensional (3D) printing now enables the fabrication of 3D structural electronics and microfluidics. Further, conventional subtractive manufacturing processes for microelectromechanical systems (MEMS) relatively limit device structure to two dimensions and require post-processing steps for interface with microfluidics. Thus, the objective of this work is to create an additive manufacturing approach for fabrication of 3D microfluidic-based MEMS devices that enables 3D configurations of electromechanical systems and simultaneous integration of microfluidics. Here, we demonstrate the ability to fabricate microfluidic-based acoustofluidic devices that contain orthogonal out-of-plane piezoelectric sensors and actuators using additive manufacturing. The devices were fabricated using a microextrusion 3D printing system that contained integrated pick-and-place functionality. Additively assembled materials and components included 3D printed epoxy, polydimethylsiloxane (PDMS), silver nanoparticles, and eutectic gallium-indium as well as robotically embedded piezoelectric chips (lead zirconate titanate (PZT)). Electrical impedance spectroscopy and finite element modeling studies showed the embedded PZT chips exhibited multiple resonant modes of varying mode shape over the 0-20 MHz frequency range. Flow visualization studies using neutrally buoyant particles (diameter = 0.8-70 μm) confirmed the 3D printed devices generated bulk acoustic waves (BAWs) capable of size-selective manipulation, trapping, and separation of suspended particles in droplets and microchannels. Flow visualization studies in a continuous flow format showed suspended particles could be moved toward or away from the walls of microfluidic channels based on selective actuation of in-plane or out-of-plane PZT chips. This work suggests additive manufacturing potentially provides new opportunities for the design and fabrication of acoustofluidic and microfluidic devices.

Pixel-based OPC optimization based on conjugate gradients.

PubMed

Ma, Xu; Arce, Gonzalo R

2011-01-31

Optical proximity correction (OPC) methods are resolution enhancement techniques (RET) used extensively in the semiconductor industry to improve the resolution and pattern fidelity of optical lithography. In pixel-based OPC (PBOPC), the mask is divided into small pixels, each of which is modified during the optimization process. Two critical issues in PBOPC are the required computational complexity of the optimization process, and the manufacturability of the optimized mask. Most current OPC optimization methods apply the steepest descent (SD) algorithm to improve image fidelity augmented by regularization penalties to reduce the complexity of the mask. Although simple to implement, the SD algorithm converges slowly. The existing regularization penalties, however, fall short in meeting the mask rule check (MRC) requirements often used in semiconductor manufacturing. This paper focuses on developing OPC optimization algorithms based on the conjugate gradient (CG) method which exhibits much faster convergence than the SD algorithm. The imaging formation process is represented by the Fourier series expansion model which approximates the partially coherent system as a sum of coherent systems. In order to obtain more desirable manufacturability properties of the mask pattern, a MRC penalty is proposed to enlarge the linear size of the sub-resolution assistant features (SRAFs), as well as the distances between the SRAFs and the main body of the mask. Finally, a projection method is developed to further reduce the complexity of the optimized mask pattern.

Exploring Flow Procedures for Diazonium Formation.

PubMed

Hu, Te; Baxendale, Ian R; Baumann, Marcus

2016-07-14

The synthesis of diazonium salts is historically an important transformation extensively utilized in dye manufacture. However the highly reactive nature of the diazonium functionality has additionally led to the development of many new reactions including several carbon-carbon bond forming processes. It is therefore highly desirable to determine optimum conditions for the formation of diazonium compounds utilizing the latest processing tools such as flow chemistry to take advantage of the increased safety and continuous manufacturing capabilities. Herein we report a series of flow-based procedures to prepare diazonium salts for subsequent in-situ consumption.

Silicon Valley's Processing Needs versus San Jose State University's Manufacturing Systems Processing Component: Implications for Industrial Technology

ERIC Educational Resources Information Center

Obi, Samuel C.

2004-01-01

Manufacturing professionals within universities tend to view manufacturing systems from a global perspective. This perspective tends to assume that manufacturing processes are employed equally in every manufacturing enterprise, irrespective of the geography and the needs of the people in those diverse regions. But in reality local and societal…

An Update to a Conformal Ablative Thermal Protection System for Planetary and Human Exploration Missions

NASA Technical Reports Server (NTRS)

Beck, R.; Arnold, J.; Gasch, M.; Stackpoole, M.; Venkatapathy, E.

2014-01-01

As described at IPPW-10, in FY12, the CA-TPS element focused on establishing materials requirements based on MSL-type and COTS Low Earth orbit (LEO) conditions (q 250 Wcm2) to develop and deliver a conformal ablative TPS. This involved down selecting, manufacturing and testing two of the best candidate materials, demonstrating uniform infiltration of resins into baseline 2-cm thick carbon felt, selecting a primary conformal material formulation based on novel arc jet and basic material properties testing, developing and demonstrating instrumentation for felt-based materials and, based on the data, developing a low fidelity material response model so that the conformal ablator TPS thickness for missions could be established. In addition, the project began to develop Industry Partnerships. Since the nominal thickness of baseline carbon felts was only 2-cm, a partnership with a rayon felt developer was made in order to upgrade equipment, establish the processes required and attempt to manufacture 10-cm thick white goods. A partnership with a processing house was made to develop the methodology to carbonize large pieces of the white goods into 7.5-cm thick carbon felt. In FY13, more advanced testing and modeling of the down selected conformal material was performed. Material thermal properties tests and structural properties tests were performed. The first 3 and 4-point bend tests were performed on the conformal ablator as well as PICA for comparison and the conformal ablator had outstanding behavior compared to PICA. Arc jet testing was performed with instrumented samples of both the conformal ablator and standard PICA at heating rates ranging from 40 to 400 Wcm2 and shear as high as 600 Pa. The results from these tests showed a remarkable improvement in the thermal penetration through the conformal ablator when compared to PICAs response. The data from these tests were used to develop a mid-fidelity thermal response model. Additional arc jet testing in the same conditions on various seam designs were very successful in showing that the material could be joined with a minimum of adhesive and required no complicated gap and gap filler design for installation. In addition, the partnership with industry to manufacture thicker rayon felt was very successful. The vendor made a 2-m wide by 30-m long sample of 10-cm thick rayon felt. When carbonized, the resulting thickness was over 7.5-cm thick, nearly 4 times the thickest off-the-shelf carbon felt. In FY14, the project has initiated a partnership with another vendor to begin the scale-up manufacturing effort. This year, the vendor will duplicate the process and manufacture at the current scale for comparison with NASA-processed materials. Properties testing and arc jet testing will be performed on the vendor-processed materials. Planning for manufacturing large, 1-m x 1-m, panels will begin as well. In FY15, the vendor will then manufacture large panels and the project will build a 2-m x 2-m Manufacturing Demonstration Unit (MDU).

Conformal Ablative Thermal Protection System for Planetary and Human Exploration Missions: An Update of the Technology Maturation Effort

NASA Technical Reports Server (NTRS)

Beck, R.; Arnold, J.; Gasch, M.; Stackpoole, M.; Venkatapathy, E.

2014-01-01

This presentation will update the community on the development of conformal ablative TPS. As described at IPPW-10, in FY12, the CA-TPS element focused on establishing materials requirements based on MSL-type and COTS Low Earth orbit (LEO) conditions (q 250 Wcm2) to develop and deliver a conformal ablative TPS. This involved downselecting, manufacturing and testing two of the best candidate materials, demonstrating uniform infiltration of resins into baseline 2-cm thick carbon felt, selecting a primary conformal material formulation based on novel arc jet and basic material properties testing, developing and demonstrating instrumentation for felt-based materials and, based on the data, developing a low fidelity material response model so that the conformal ablator TPS thickness for missions could be established. In addition, the project began to develop Industry Partnerships. Since the nominal thickness of baseline carbon felts was only 2-cm, a partnership with a rayon felt developer was made in order to upgrade equipment, establish the processes required and attempt to manufacture 10-cm thick white goods. A partnership with a processing house was made to develop the methodology to carbonize large pieces of the white goods into 7.5-cm thick carbon felt.In FY13, more advanced testing and modeling of the downselected conformal material was performed. Material thermal properties tests and structural properties tests were performed. The first 3 and 4-point bend tests were performed on the conformal ablator as well as PICA for comparison and the conformal ablator had outstanding behavior compared to PICA. Arc jet testing was performed with instrumented samples of both the conformal ablator and standard PICA at heating rates ranging from 40 to 400 Wcm2 and shear as high as 600 Pa. The results from these tests showed a remarkable improvement in the thermal penetration through the conformal ablator when compared to PICAs response. The data from these tests were used to develop a mid-fidelity thermal response model. Additional arc jet testing in the same conditions on various seam designs were very successful in showing that the material could be joined with a minimum of adhesive and required no complicated gap and gap filler design for installation. In addition, the partnership with industry to manufacture thicker rayon felt was very successful. The vendor made a 2-m wide by 30-m long sample of 10-cm thick rayon felt. When carbonized, the resulting thickness was over 7.5-cm thick, nearly 4 times the thickest off-the-shelf carbon felt. In FY14, the project has initiated a partnership with another vendor to begin the scale-up manufacturing effort. This year, the vendor will duplicate the process and manufacture at the current scale for comparison with NASA-processed materials. Properties testing and arc jet testing will be performed on the vendor-processed materials. Planning for manufacturing large, 1-m x 1-m, panels will begin as well. In FY15, the vendor will then manufacture large panels and the project will build a 2-m x 2-m Manufacturing Demonstration Unit (MDU).

In Vitro Analysis of the Fracture Resistance of CAD/CAM Denture Base Resins.

PubMed

Steinmassl, Otto; Offermanns, Vincent; Stöckl, Wolfgang; Dumfahrt, Herbert; Grunert, Ingrid; Steinmassl, Patricia-Anca

2018-03-08

Computer-aided design and computer-aided manufacturing (CAD/CAM) denture base manufacturers claim to produce their resin pucks under high heat and pressure. Therefore, CAD/CAM dentures are assumed to have enhanced mechanical properties and, as a result, are often produced with lower denture base thicknesses than conventional, manually fabricated dentures. The aim of this study was to investigate if commercially available CAD/CAM denture base resins have more favourable mechanical properties than conventionally processed denture base resins. For this purpose, a series of three-point bending tests conforming to ISO specifications were performed on a total of 80 standardised, rectangular CAD/CAM denture base resin specimens from five different manufacturers (AvaDent, Baltic Denture System, Vita VIONIC, Whole You Nexteeth, and Wieland Digital Dentures). A heat-polymerising resin and an autopolymerising resin served as the control groups. The breaking load, fracture toughness, and the elastic modulus were assessed. Additionally, the fracture surface roughness and texture were investigated. Only one CAD/CAM resin showed a significantly increased breaking load. Two CAD/CAM resins had a significantly higher fracture toughness than the control groups, and all CAD/CAM resins had higher elastic moduli than the controls. Our results indicate that CAD/CAM denture base resins do not generally have better mechanical properties than manually processed resins. Therefore, the lower minimum denture base thicknesses should be regarded with some caution.

In Vitro Analysis of the Fracture Resistance of CAD/CAM Denture Base Resins

PubMed Central

Stöckl, Wolfgang; Dumfahrt, Herbert; Grunert, Ingrid

2018-01-01

Computer-aided design and computer-aided manufacturing (CAD/CAM) denture base manufacturers claim to produce their resin pucks under high heat and pressure. Therefore, CAD/CAM dentures are assumed to have enhanced mechanical properties and, as a result, are often produced with lower denture base thicknesses than conventional, manually fabricated dentures. The aim of this study was to investigate if commercially available CAD/CAM denture base resins have more favourable mechanical properties than conventionally processed denture base resins. For this purpose, a series of three-point bending tests conforming to ISO specifications were performed on a total of 80 standardised, rectangular CAD/CAM denture base resin specimens from five different manufacturers (AvaDent, Baltic Denture System, Vita VIONIC, Whole You Nexteeth, and Wieland Digital Dentures). A heat-polymerising resin and an autopolymerising resin served as the control groups. The breaking load, fracture toughness, and the elastic modulus were assessed. Additionally, the fracture surface roughness and texture were investigated. Only one CAD/CAM resin showed a significantly increased breaking load. Two CAD/CAM resins had a significantly higher fracture toughness than the control groups, and all CAD/CAM resins had higher elastic moduli than the controls. Our results indicate that CAD/CAM denture base resins do not generally have better mechanical properties than manually processed resins. Therefore, the lower minimum denture base thicknesses should be regarded with some caution. PMID:29518022

Development of a High Volume Capable Process to Manufacture High Performance Photovoltaic Cells: Cooperative Research and Development Final Report, CRADA Number CRD-08-322

DOE Office of Scientific and Technical Information (OSTI.GOV)

Geisz, J. F.

2012-11-01

The intent of the work is for RFMD and NREL to cooperate in the development of a commercially viable and high volume capable process to manufacture high performance photovoltaic cells, based on inverted metamorphic (IMM) GaAs technology. The successful execution of the agreement will result in the production of a PV cell using technology that is capable of conversion efficiency at par with the market at the time of release (reference 2009: 37-38%), using RFMD's production facilities. The CRADA work has been divided into three phases: (1) a foundation phase where the teams will demonstrate the manufacturing of a basicmore » PV cell at RFMD's production facilities; (2) a technology demonstration phase where the teams will demonstrate the manufacturing of prototype PV cells using IMM technology at RFMD's production facilities, and; (3) a production readiness phase where the teams will demonstrate the capability to manufacture PV cells using IMM technology with high yields, high reliability, high reproducibility and low cost.« less

Gaussian process-based surrogate modeling framework for process planning in laser powder-bed fusion additive manufacturing of 316L stainless steel

DOE PAGES

Tapia, Gustavo; Khairallah, Saad A.; Matthews, Manyalibo J.; ...

2017-09-22

Here, Laser Powder-Bed Fusion (L-PBF) metal-based additive manufacturing (AM) is complex and not fully understood. Successful processing for one material, might not necessarily apply to a different material. This paper describes a workflow process that aims at creating a material data sheet standard that describes regimes where the process can be expected to be robust. The procedure consists of building a Gaussian process-based surrogate model of the L-PBF process that predicts melt pool depth in single-track experiments given a laser power, scan speed, and laser beam size combination. The predictions are then mapped onto a power versus scan speed diagrammore » delimiting the conduction from the keyhole melting controlled regimes. This statistical framework is shown to be robust even for cases where experimental training data might be suboptimal in quality, if appropriate physics-based filters are applied. Additionally, it is demonstrated that a high-fidelity simulation model of L-PBF can equally be successfully used for building a surrogate model, which is beneficial since simulations are getting more efficient and are more practical to study the response of different materials, than to re-tool an AM machine for new material powder.« less

Gaussian process-based surrogate modeling framework for process planning in laser powder-bed fusion additive manufacturing of 316L stainless steel

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tapia, Gustavo; Khairallah, Saad A.; Matthews, Manyalibo J.

Here, Laser Powder-Bed Fusion (L-PBF) metal-based additive manufacturing (AM) is complex and not fully understood. Successful processing for one material, might not necessarily apply to a different material. This paper describes a workflow process that aims at creating a material data sheet standard that describes regimes where the process can be expected to be robust. The procedure consists of building a Gaussian process-based surrogate model of the L-PBF process that predicts melt pool depth in single-track experiments given a laser power, scan speed, and laser beam size combination. The predictions are then mapped onto a power versus scan speed diagrammore » delimiting the conduction from the keyhole melting controlled regimes. This statistical framework is shown to be robust even for cases where experimental training data might be suboptimal in quality, if appropriate physics-based filters are applied. Additionally, it is demonstrated that a high-fidelity simulation model of L-PBF can equally be successfully used for building a surrogate model, which is beneficial since simulations are getting more efficient and are more practical to study the response of different materials, than to re-tool an AM machine for new material powder.« less

Incremental electrohydraulic forming - A new approach for the manufacture of structured multifunctional sheet metal blanks

NASA Astrophysics Data System (ADS)

Djakow, Eugen; Springer, Robert; Homberg, Werner; Piper, Mark; Tran, Julian; Zibart, Alexander; Kenig, Eugeny

2017-10-01

Electrohydraulic Forming (EHF) processes permit the production of complex, sharp-edged geometries even when high-strength materials are used. Unfortunately, the forming zone is often limited as compared to other sheet metal forming processes. The use of a special industrial-robot-based tool setup and an incremental process strategy could provide a promising solution for this problem. This paper describes such an innovative approach using an electrohydraulic incremental forming machine, which can be employed to manufacture the large multifunctional and complex part geometries in steel, aluminium, magnesium and reinforced plastic that are employed in lightweight constructions or heating elements.

Precision laser processing for micro electronics and fiber optic manufacturing

NASA Astrophysics Data System (ADS)

Webb, Andrew; Osborne, Mike; Foster-Turner, Gideon; Dinkel, Duane W.

2008-02-01

The application of laser based materials processing for precision micro scale manufacturing in the electronics and fiber optic industry is becoming increasingly widespread and accepted. This presentation will review latest laser technologies available and discuss the issues to be considered in choosing the most appropriate laser and processing parameters. High repetition rate, short duration pulsed lasers have improved rapidly in recent years in terms of both performance and reliability enabling flexible, cost effective processing of many material types including metal, silicon, plastic, ceramic and glass. Demonstrating the relevance of laser micromachining, application examples where laser processing is in use for production will be presented, including miniaturization of surface mount capacitors by applying a laser technique for demetalization of tracks in the capacitor manufacturing process and high quality laser machining of fiber optics including stripping, cleaving and lensing, resulting in optical quality finishes without the need for traditional polishing. Applications include telecoms, biomedical and sensing. OpTek Systems was formed in 2000 and provide fully integrated systems and sub contract services for laser processes. They are headquartered in the UK and are establishing a presence in North America through a laser processing facility in South Carolina and sales office in the North East.

Cost Models for MMC Manufacturing Processes

NASA Technical Reports Server (NTRS)

Elzey, Dana M.; Wadley, Haydn N. G.

1996-01-01

Processes for the manufacture of advanced metal matrix composites are rapidly approaching maturity in the research laboratory and there is growing interest in their transition to industrial production. However, research conducted to date has almost exclusively focused on overcoming the technical barriers to producing high-quality material and little attention has been given to the economical feasibility of these laboratory approaches and process cost issues. A quantitative cost modeling (QCM) approach was developed to address these issues. QCM are cost analysis tools based on predictive process models relating process conditions to the attributes of the final product. An important attribute, of the QCM approach is the ability to predict the sensitivity of material production costs to product quality and to quantitatively explore trade-offs between cost and quality. Applications of the cost models allow more efficient direction of future MMC process technology development and a more accurate assessment of MMC market potential. Cost models were developed for two state-of-the art metal matrix composite (MMC) manufacturing processes: tape casting and plasma spray deposition. Quality and Cost models are presented for both processes and the resulting predicted quality-cost curves are presented and discussed.

21 CFR 201.122 - Drugs for processing, repacking, or manufacturing.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drugs for processing, repacking, or manufacturing... for processing, repacking, or manufacturing. A drug in a bulk package, except tablets, capsules, or... manufacturing, processing, or repacking”; and if in substantially all dosage forms in which it may be dispensed...

Manufacturing of Nanocomposite Carbon Fibers and Composite Cylinders

NASA Technical Reports Server (NTRS)

Tan, Seng; Zhou, Jian-guo

2013-01-01

Pitch-based nanocomposite carbon fibers were prepared with various percentages of carbon nanofibers (CNFs), and the fibers were used for manufacturing composite structures. Experimental results show that these nanocomposite carbon fibers exhibit improved structural and electrical conductivity properties as compared to unreinforced carbon fibers. Composite panels fabricated from these nanocomposite carbon fibers and an epoxy system also show the same properties transformed from the fibers. Single-fiber testing per ASTM C1557 standard indicates that the nanocomposite carbon fiber has a tensile modulus of 110% higher, and a tensile strength 17.7% times higher, than the conventional carbon fiber manufactured from pitch. Also, the electrical resistance of the carbon fiber carbonized at 900 C was reduced from 4.8 to 2.2 ohm/cm. The manufacturing of the nanocomposite carbon fiber was based on an extrusion, non-solvent process. The precursor fibers were then carbonized and graphitized. The resultant fibers are continuous.

The presence of Enterococcus, coliforms and E. coli in a commercial yeast manufacturing process.

PubMed

O'Brien, S S; Lindsay, D; von Holy, A

2004-07-01

This study evaluated a typical commercial yeast manufacturing process for bacterial contamination. Product line samples of a commercial yeast manufacturing process and the corresponding seed yeast manufacturing process were obtained upstream from the final compressed and dry yeast products. All samples were analysed before (non-PI) and after preliminary incubation (PI) at 37 degrees C for 24 h. The PI procedure was incorporated for amplification of bacterial counts below the lower detection limit. Enterococcus, coliform and Escherichia coli counts were quantified by standard pour-plate techniques using selective media. Presence at all stages and progressive increases in counts of Enterococcus, coliforms and E. coli during processing in the commercial manufacturing operation suggested that the primary source of contamination of both compressed and dry yeast with these bacteria was the seed yeast manufacturing process and that contamination was amplified throughout the commercial yeast manufacturing process. This was confirmed by surveys of the seed yeast manufacturing process which indicated that contamination of the seed yeast with Enterococcus, coliforms and E. coli occurred during scale up of seed yeast biomass destined as inoculum for the commercial fermentation.

Integration of Machining and Inspection in Aerospace Manufacturing

NASA Astrophysics Data System (ADS)

Simpson, Bart; Dicken, Peter J.

2011-12-01

The main challenge for aerospace manufacturers today is to develop the ability to produce high-quality products on a consistent basis as quickly as possible and at the lowest-possible cost. At the same time, rising material prices are making the cost of scrap higher than ever so making it more important to minimise waste. Proper inspection and quality control methods are no longer a luxury; they are an essential part of every manufacturing operation that wants to grow and be successful. However, simply bolting on some quality control procedures to the existing manufacturing processes is not enough. Inspection must be fully-integrated with manufacturing for the investment to really produce significant improvements. The traditional relationship between manufacturing and inspection is that machining is completed first on the company's machine tools and the components are then transferred to dedicated inspection equipment to be approved or rejected. However, as machining techniques become more sophisticated, and as components become larger and more complex, there are a growing number of cases where closer integration is required to give the highest productivity and the biggest reductions in wastage. Instead of a simple linear progression from CAD to CAM to machining to inspection, a more complicated series of steps is needed, with extra data needed to fill any gaps in the information available at the various stages. These new processes can be grouped under the heading of "adaptive machining". The programming of most machining operations is based around knowing three things: the position of the workpiece on the machine, the starting shape of the material to be machined, and the final shape that needs to be achieved at the end of the operation. Adaptive machining techniques allow successful machining when at least one of those elements is unknown, by using in-process measurement to close the information gaps in the process chain. It also allows any errors to be spotted earlier in the manufacturing process, so helping the problems to be resolved more quickly and at lower cost.

Integrating Materials, Manufacturing, Design and Validation for Sustainability in Future Transport Systems

NASA Astrophysics Data System (ADS)

Price, M. A.; Murphy, A.; Butterfield, J.; McCool, R.; Fleck, R.

2011-05-01

The predictive methods currently used for material specification, component design and the development of manufacturing processes, need to evolve beyond the current `metal centric' state of the art, if advanced composites are to realise their potential in delivering sustainable transport solutions. There are however, significant technical challenges associated with this process. Deteriorating environmental, political, economic and social conditions across the globe have resulted in unprecedented pressures to improve the operational efficiency of the manufacturing sector generally and to change perceptions regarding the environmental credentials of transport systems in particular. There is a need to apply new technologies and develop new capabilities to ensure commercial sustainability in the face of twenty first century economic and climatic conditions as well as transport market demands. A major technology gap exists between design, analysis and manufacturing processes in both the OEMs, and the smaller companies that make up the SME based supply chain. As regulatory requirements align with environmental needs, manufacturers are increasingly responsible for the broader lifecycle aspects of vehicle performance. These include not only manufacture and supply but disposal and re-use or re-cycling. In order to make advances in the reduction of emissions coupled with improved economic efficiency through the provision of advanced lightweight vehicles, four key challenges are identified as follows: Material systems, Manufacturing systems, Integrated design methods using digital manufacturing tools and Validation systems. This paper presents a project which has been designed to address these four key issues, using at its core, a digital framework for the creation and management of key parameters related to the lifecycle performance of thermoplastic composite parts and structures. It aims to provide capability for the proposition, definition, evaluation and demonstration of advanced lightweight structures for new generation vehicles in the context of whole life performance parameters.

Simultaneously enhanced strength and ductility for 3D-printed stainless steel 316L by selective laser melting

NASA Astrophysics Data System (ADS)

Sun, Zhongji; Tan, Xipeng; Tor, Shu Beng; Chua, Chee Kai

2018-04-01

Laser-based powder-bed fusion additive manufacturing or three-dimensional printing technology has gained tremendous attention due to its controllable, digital, and automated manufacturing process, which can afford a refined microstructure and superior strength. However, it is a major challenge to additively manufacture metal parts with satisfactory ductility and toughness. Here we report a novel selective laser melting process to simultaneously enhance the strength and ductility of stainless steel 316L by in-process engineering its microstructure into a <011> crystallographic texture. We find that the tensile strength and ductility of SLM-built stainless steel 316L samples could be enhanced by 16% and 40% respectively, with the engineered <011> textured microstructure compared to the common <001> textured microstructure. This is because the favorable nano-twinning mechanism was significantly more activated in the <011> textured stainless steel 316L samples during plastic deformation. In addition, kinetic simulations were performed to unveil the relationship between the melt pool geometry and crystallographic texture. The new additive manufacturing strategy of engineering the crystallographic texture can be applied to other metals and alloys with twinning-induced plasticity. This work paves the way to additively manufacture metal parts with high strength and high ductility.

Environmental and risk screening for prioritizing pollution prevention opportunities in the U.S. printed wiring board manufacturing industry.

PubMed

Lam, Carl W; Lim, Seong-Rin; Schoenung, Julie M

2011-05-15

Modern manufacturing of printed wiring boards (PWBs) involves extensive use of various hazardous chemicals in different manufacturing steps such as board preparation, circuit design transfer, etching and plating processes. Two complementary environmental screening methods developed by the U.S. EPA, namely: (i) the Tool for the Reduction and Assessment of Chemical and Other Environmental Impacts (TRACI) and (ii) Risk-Screening Environmental Indicators (RSEI), are used to quantify geographic and chemical environmental impacts in the U.S. PWB manufacturing industry based on Toxics Release Inventory (TRI) data. Although the release weight percentages of industrial chemicals such as methanol, glycol ethers and dimethylformamide comprise the larger fraction of reported air and water emissions, results indicate that lead, copper and their compounds' releases correspond to the highest environmental impact from toxicity potentials and risk-screening scores. Combining these results with further knowledge of PWB manufacturing, select alternative chemical processes and materials for pollution prevention are discussed. Examples of effective pollution prevention options in the PWB industry include spent etchant recovery technologies, and process and material substitutions. In addition, geographic assessment of environmental burden highlights states where promotion of pollution prevention strategies and emissions regulations can have the greatest effect to curb the PWB industry's toxic release impacts. Copyright © 2011 Elsevier B.V. All rights reserved.

Controlling high-throughput manufacturing at the nano-scale

NASA Astrophysics Data System (ADS)

Cooper, Khershed P.

2013-09-01

Interest in nano-scale manufacturing research and development is growing. The reason is to accelerate the translation of discoveries and inventions of nanoscience and nanotechnology into products that would benefit industry, economy and society. Ongoing research in nanomanufacturing is focused primarily on developing novel nanofabrication techniques for a variety of applications—materials, energy, electronics, photonics, biomedical, etc. Our goal is to foster the development of high-throughput methods of fabricating nano-enabled products. Large-area parallel processing and highspeed continuous processing are high-throughput means for mass production. An example of large-area processing is step-and-repeat nanoimprinting, by which nanostructures are reproduced again and again over a large area, such as a 12 in wafer. Roll-to-roll processing is an example of continuous processing, by which it is possible to print and imprint multi-level nanostructures and nanodevices on a moving flexible substrate. The big pay-off is high-volume production and low unit cost. However, the anticipated cost benefits can only be realized if the increased production rate is accompanied by high yields of high quality products. To ensure product quality, we need to design and construct manufacturing systems such that the processes can be closely monitored and controlled. One approach is to bring cyber-physical systems (CPS) concepts to nanomanufacturing. CPS involves the control of a physical system such as manufacturing through modeling, computation, communication and control. Such a closely coupled system will involve in-situ metrology and closed-loop control of the physical processes guided by physics-based models and driven by appropriate instrumentation, sensing and actuation. This paper will discuss these ideas in the context of controlling high-throughput manufacturing at the nano-scale.

Advances in High Temperature Materials for Additive Manufacturing

NASA Astrophysics Data System (ADS)

Nordin, Nurul Amira Binti; Johar, Muhammad Akmal Bin; Ibrahim, Mohd Halim Irwan Bin; Marwah, Omar Mohd Faizan bin

2017-08-01

In today’s technology, additive manufacturing has evolved over the year that commonly known as 3D printing. Currently, additive manufacturing have been applied for many industries such as for automotive, aerospace, medical and other commercial product. The technologies are supported by materials for the manufacturing process to produce high quality product. Plus, additive manufacturing technologies has been growth from the lowest to moderate and high technology to fulfil manufacturing industries obligation. Initially from simple 3D printing such as fused deposition modelling (FDM), poly-jet, inkjet printing, to selective laser sintering (SLS), and electron beam melting (EBM). However, the high technology of additive manufacturing nowadays really needs high investment to carry out the process for fine products. There are three foremost type of material which is polymer, metal and ceramic used for additive manufacturing application, and mostly they were in the form of wire feedstock or powder. In circumstance, it is crucial to recognize the characteristics of each type of materials used in order to understand the behaviours of the materials on high temperature application via additive manufacturing. Therefore, this review aims to provide excessive inquiry and gather the necessary information for further research on additive material materials for high temperature application. This paper also proposed a new material based on powder glass, which comes from recycled tempered glass from automotive industry, having a huge potential to be applied for high temperature application. The technique proposed for additive manufacturing will minimize some cost of modelling with same quality of products compare to the others advanced technology used for high temperature application.

[Research on optimal modeling strategy for licorice extraction process based on near-infrared spectroscopy technology].

PubMed

Wang, Hai-Xia; Suo, Tong-Chuan; Yu, He-Shui; Li, Zheng

2016-10-01

The manufacture of traditional Chinese medicine (TCM) products is always accompanied by processing complex raw materials and real-time monitoring of the manufacturing process. In this study, we investigated different modeling strategies for the extraction process of licorice. Near-infrared spectra associate with the extraction time was used to detemine the states of the extraction processes. Three modeling approaches, i.e., principal component analysis (PCA), partial least squares regression (PLSR) and parallel factor analysis-PLSR (PARAFAC-PLSR), were adopted for the prediction of the real-time status of the process. The overall results indicated that PCA, PLSR and PARAFAC-PLSR can effectively detect the errors in the extraction procedure and predict the process trajectories, which has important significance for the monitoring and controlling of the extraction processes. Copyright© by the Chinese Pharmaceutical Association.

21 CFR 864.9900 - Cord blood processing system and storage container.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cord blood processing system and storage container... Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) § 864.9900 Cord blood processing system and storage container. (a) Identification. A cord blood processing system and storage...

21 CFR 864.9900 - Cord blood processing system and storage container.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Cord blood processing system and storage container... Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) § 864.9900 Cord blood processing system and storage container. (a) Identification. A cord blood processing system and storage...

21 CFR 864.9900 - Cord blood processing system and storage container.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cord blood processing system and storage container... Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) § 864.9900 Cord blood processing system and storage container. (a) Identification. A cord blood processing system and storage...

21 CFR 864.9900 - Cord blood processing system and storage container.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Cord blood processing system and storage container... Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) § 864.9900 Cord blood processing system and storage container. (a) Identification. A cord blood processing system and storage...

21 CFR 864.9900 - Cord blood processing system and storage container.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cord blood processing system and storage container... Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) § 864.9900 Cord blood processing system and storage container. (a) Identification. A cord blood processing system and storage...

A novel microgrid demand-side management system for manufacturing facilities

NASA Astrophysics Data System (ADS)

Harper, Terance J.

Thirty-one percent of annual energy consumption in the United States occurs within the industrial sector, where manufacturing processes account for the largest amount of energy consumption and carbon emissions. For this reason, energy efficiency in manufacturing facilities is increasingly important for reducing operating costs and improving profits. Using microgrids to generate local sustainable power should reduce energy consumption from the main utility grid along with energy costs and carbon emissions. Also, microgrids have the potential to serve as reliable energy generators in international locations where the utility grid is often unstable. For this research, a manufacturing process that had approximately 20 kW of peak demand was matched with a solar photovoltaic array that had a peak output of approximately 3 KW. An innovative Demand-Side Management (DSM) strategy was developed to manage the process loads as part of this smart microgrid system. The DSM algorithm managed the intermittent nature of the microgrid and the instantaneous demand of the manufacturing process. The control algorithm required three input signals; one from the microgrid indicating the availability of renewable energy, another from the manufacturing process indicating energy use as a percent of peak production, and historical data for renewable sources and facility demand. Based on these inputs the algorithm had three modes of operation: normal (business as usual), curtailment (shutting off non-critical loads), and energy storage. The results show that a real-time management of a manufacturing process with a microgrid will reduce electrical consumption and peak demand. The renewable energy system for this research was rated to provide up to 13% of the total manufacturing capacity. With actively managing the process loads with the DSM program alone, electrical consumption from the utility grid was reduced by 17% on average. An additional 24% reduction was accomplished when the microgrid and DSM program was enabled together, resulting in a total reduction of 37%. On average, peak demand was reduced by 6%, but due to the intermittency of the renewable source and the billing structure for peak demand, only a 1% reduction was obtained. During a billing period, it only takes one day when solar irradiance is poor to affect the demand reduction capabilities. To achieve further demand reduction, energy storage should be introduced and integrated.

76 FR 8362 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-14

..., Glass Manufacturing and Secondary Nonferrous Metals Processing Area Sources (Renewal) AGENCY... for Clay Ceramics Manufacturing, Glass Manufacturing and Secondary Nonferrous Metals Processing Area..., glass manufacturing, and secondary nonferrous metals processing area sources. Estimated Number of...

The Use of Multidimensional Image-Based Analysis to Accurately Monitor Cell Growth in 3D Bioreactor Culture

PubMed Central

Baradez, Marc-Olivier; Marshall, Damian

2011-01-01

The transition from traditional culture methods towards bioreactor based bioprocessing to produce cells in commercially viable quantities for cell therapy applications requires the development of robust methods to ensure the quality of the cells produced. Standard methods for measuring cell quality parameters such as viability provide only limited information making process monitoring and optimisation difficult. Here we describe a 3D image-based approach to develop cell distribution maps which can be used to simultaneously measure the number, confluency and morphology of cells attached to microcarriers in a stirred tank bioreactor. The accuracy of the cell distribution measurements is validated using in silico modelling of synthetic image datasets and is shown to have an accuracy >90%. Using the cell distribution mapping process and principal component analysis we show how cell growth can be quantitatively monitored over a 13 day bioreactor culture period and how changes to manufacture processes such as initial cell seeding density can significantly influence cell morphology and the rate at which cells are produced. Taken together, these results demonstrate how image-based analysis can be incorporated in cell quality control processes facilitating the transition towards bioreactor based manufacture for clinical grade cells. PMID:22028809

The use of multidimensional image-based analysis to accurately monitor cell growth in 3D bioreactor culture.

PubMed

Baradez, Marc-Olivier; Marshall, Damian

2011-01-01

The transition from traditional culture methods towards bioreactor based bioprocessing to produce cells in commercially viable quantities for cell therapy applications requires the development of robust methods to ensure the quality of the cells produced. Standard methods for measuring cell quality parameters such as viability provide only limited information making process monitoring and optimisation difficult. Here we describe a 3D image-based approach to develop cell distribution maps which can be used to simultaneously measure the number, confluency and morphology of cells attached to microcarriers in a stirred tank bioreactor. The accuracy of the cell distribution measurements is validated using in silico modelling of synthetic image datasets and is shown to have an accuracy >90%. Using the cell distribution mapping process and principal component analysis we show how cell growth can be quantitatively monitored over a 13 day bioreactor culture period and how changes to manufacture processes such as initial cell seeding density can significantly influence cell morphology and the rate at which cells are produced. Taken together, these results demonstrate how image-based analysis can be incorporated in cell quality control processes facilitating the transition towards bioreactor based manufacture for clinical grade cells.

A Process Management System for Networked Manufacturing

NASA Astrophysics Data System (ADS)

Liu, Tingting; Wang, Huifen; Liu, Linyan

With the development of computer, communication and network, networked manufacturing has become one of the main manufacturing paradigms in the 21st century. Under the networked manufacturing environment, there exist a large number of cooperative tasks susceptible to alterations, conflicts caused by resources and problems of cost and quality. This increases the complexity of administration. Process management is a technology used to design, enact, control, and analyze networked manufacturing processes. It supports efficient execution, effective management, conflict resolution, cost containment and quality control. In this paper we propose an integrated process management system for networked manufacturing. Requirements of process management are analyzed and architecture of the system is presented. And a process model considering process cost and quality is developed. Finally a case study is provided to explain how the system runs efficiently.

Processing of pure Ti by rapid prototyping based on laser cladding

NASA Astrophysics Data System (ADS)

Arias-González, F.; del Val, J.; Comesaña, R.; Lusquiños, F.; Quintero, F.; Riveiro, A.; Boutinguiza, M.; Pou, J.

2013-11-01

Rapid prototyping based on laser cladding is an additive manufacturing (AM) process based on the overlapping of cladding tracks to produce functional components. Powder or wire are fed into a melting pool created using laser radiation as a heat source and the relative movement between the beam and the work piece makes possible to generate pieces layer-by-layer. This technique can be applied for any material which can be melted and the components can be manufactured directly according to a computer aided design (CAD) model. Additive manufacturing is particularly interesting to produce titanium components because, in this case, the loss of material produced by subtractive manufacturing methods is highly costly. Moreover, titanium and its alloys are widely used in biomedical, aircraft, chemical and marine industries due to their biocompatibility, excellent corrosion resistance and superior strength-to-weight ratio. In this research work, a near-infrared laser delivering a maximum power of 500W is used to produce pure titanium thin parts. Dimensions and surface morphology are characterized using Optical Microscopy (OM) and Scanning Electron Microscopy (SEM), the hardness by nanoindentation and the composition by X-Ray Diffraction (XRD) and Energy Dispersive X-Ray Spectroscopy (EDS). The aim of this work is to establish the conditions under which satisfactory properties are obtained and to understand the relationship between microstructure/properties and deposition parameters.

78 FR 64735 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

...The Food and Drug Administration (FDA) is proposing regulations for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish requirements for current good manufacturing practice in manufacturing, processing, packing, and holding of animal food. FDA also is proposing regulations to require that certain facilities establish and implement hazard analysis and risk-based preventive controls for food for animals. FDA is taking this action to provide greater assurance that animal food is safe and will not cause illness or injury to animals or humans and is intended to build an animal food safety system for the future that makes modern, science and risk-based preventive controls the norm across all sectors of the animal food system.

The application of additive technologies in creation a medical simulator-trainer of the human head operating field

NASA Astrophysics Data System (ADS)

Kashapov, L. N.; Kashapov, N. F.; Kashapov, R. N.; Pashaev, B. Y.

2016-06-01

The aim of the work was to determine the possible application of additive manufacturing technology during the manufacturing process as close as possible to reality of medical simulator-trainers. In work were used some additive manufacturing technologies: selective laser sintering (SLS), fused deposition modeling (FDM), binder Jetting. As a result, a prototype of simulator-trainer of the human head operating field, which based on the CT real patient, was manufactured and conducted its tests. It was found that structure, which is obtained with the use of 3D-printers ProJet 160, most appropriate and closest to the real properties of the bone.

Design and Fabrication of Full Wheatstone-Bridge-Based Angular GMR Sensors.

PubMed

Yan, Shaohua; Cao, Zhiqiang; Guo, Zongxia; Zheng, Zhenyi; Cao, Anni; Qi, Yue; Leng, Qunwen; Zhao, Weisheng

2018-06-05

Since the discovery of the giant magnetoresistive (GMR) effect, GMR sensors have gained much attention in last decades due to their high sensitivity, small size, and low cost. The full Wheatstone-bridge-based GMR sensor is most useful in terms of the application point of view. However, its manufacturing process is usually complex. In this paper, we present an efficient and concise approach to fabricate a full Wheatstone-bridge-based angular GMR sensor by depositing one GMR film stack, utilizing simple patterned processes, and a concise post-annealing procedure based on a special layout. The angular GMR sensor is of good linear performance and achieves a sensitivity of 0.112 mV/V/Oe at the annealing temperature of 260 °C in the magnetic field range from -50 to +50 Oe. This work provides a design and method for GMR-sensor manufacturing that is easy for implementation and suitable for mass production.

Concise Review: Mind the Gap: Challenges in Characterizing and Quantifying Cell- and Tissue-Based Therapies for Clinical Translation

PubMed Central

Rayment, Erin A; Williams, David J

2010-01-01

There are many challenges associated with characterizing and quantifying cells for use in cell- and tissue-based therapies. From a regulatory perspective, these advanced treatments must not only be safe and effective but also be made by high-quality manufacturing processes that allow for on-time delivery of viable products. Although sterility assays can be adapted from conventional bioprocessing, cell- and tissue-based therapies require more stringent safety assessments, especially in relation to use of animal products, immune reaction, and potential instability due to extended culture times. Furthermore, cell manufacturers who plan to use human embryonic stem cells in their therapies need to be particularly stringent in their final purification steps, due to the unrestricted growth potential of these cells. This review summarizes the current issues in characterization and quantification for cell- and tissue-based therapies, dividing these challenges into the regulatory themes of safety, potency, and manufacturing quality. It outlines current assays in use, as well as highlights the limits of many of these product release tests. Mode of action is discussed, with particular reference to in vitro surrogate assays that can be used to provide information to correlate with proposed in vivo patient efficacy. Importantly, this review highlights the requirement for basic research to improve current knowledge on the in vivo fate of these treatments; as well as an improved stakeholder negotiation process to identify the measurement requirements that will ensure the manufacture of the best possible cell- and tissue-based therapies within the shortest timeframe for the most patient benefit. PMID:20333747

Improving post-detonation energetics residues estimations for the Life Cycle Environmental Assessment process for munitions.

EPA Science Inventory

The Life Cycle Environmental Assessment (LCEA) process for military munitions tracks possible environmental impacts incurred during all phases of the life of a munition. The greatest energetics-based emphasis in the current LCEA process is on manufacturing. A review of recent LCE...

Materials Manufactured from 3D Printed Synthetic Biology Arrays

NASA Technical Reports Server (NTRS)

Gentry, Diana; Micks, Ashley

2013-01-01

Many complex, biologically-derived materials have extremely useful properties (think wood or silk), but are unsuitable for space-related applications due to production, manufacturing, or processing limitations. Large-scale ecosystem-based production, such as raising and harvesting trees for wood, is impractical in a self-contained habitat such as a space station or potential Mars colony. Manufacturing requirements, such as the specialized equipment needed to harvest and process cotton, add too much upmass for current launch technology. Cells in nature are already highly specialized for making complex biological materials on a micro scale. We envision combining these strengths with the recently emergent technologies of synthetic biology and 3D printing to create 3D-structured arrays of cells that are bioengineered to secrete different materials in a specified three-dimensional pattern.

Consolidation & Factors Influencing Sintering Process in Polymer Powder Based Additive Manufacturing

NASA Astrophysics Data System (ADS)

Sagar, M. B.; Elangovan, K.

2017-08-01

Additive Manufacturing (AM) is two decade old technology; where parts are build layer manufacturing method directly from a CAD template. Over the years, AM techniques changes the future way of part fabrication with enhanced intricacy and custom-made features are aimed. Commercially polymers, metals, ceramic and metal-polymer composites are in practice where polymers enhanced the expectations in AM and are considered as a kind of next industrial revolution. Growing trend in polymer application motivated to study their feasibility and properties. Laser sintering, Heat sintering and Inhibition sintering are the most successful AM techniques for polymers but having least application. The presentation gives up selective sintering of powder polymers and listed commercially available polymer materials. Important significant factors for effective processing and analytical approaches to access them are discussed.

Achieving continuous manufacturing for final dosage formation: challenges and how to meet them. May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Byrn, Stephen; Futran, Maricio; Thomas, Hayden; Jayjock, Eric; Maron, Nicola; Meyer, Robert F; Myerson, Allan S; Thien, Michael P; Trout, Bernhardt L

2015-03-01

We describe the key issues and possibilities for continuous final dosage formation, otherwise known as downstream processing or drug product manufacturing. A distinction is made between heterogeneous processing and homogeneous processing, the latter of which is expected to add more value to continuous manufacturing. We also give the key motivations for moving to continuous manufacturing, some of the exciting new technologies, and the barriers to implementation of continuous manufacturing. Continuous processing of heterogeneous blends is the natural first step in converting existing batch processes to continuous. In heterogeneous processing, there are discrete particles that can segregate, versus in homogeneous processing, components are blended and homogenized such that they do not segregate. Heterogeneous processing can incorporate technologies that are closer to existing technologies, where homogeneous processing necessitates the development and incorporation of new technologies. Homogeneous processing has the greatest potential for reaping the full rewards of continuous manufacturing, but it takes long-term vision and a more significant change in process development than heterogeneous processing. Heterogeneous processing has the detriment that, as the technologies are adopted rather than developed, there is a strong tendency to incorporate correction steps, what we call below "The Rube Goldberg Problem." Thus, although heterogeneous processing will likely play a major role in the near-term transformation of heterogeneous to continuous processing, it is expected that homogeneous processing is the next step that will follow. Specific action items for industry leaders are: Form precompetitive partnerships, including industry (pharmaceutical companies and equipment manufacturers), government, and universities. These precompetitive partnerships would develop case studies of continuous manufacturing and ideally perform joint-technology development, including development of small-scale equipment and processes. Develop ways to invest internally in continuous manufacturing. How best to do this will depend on the specifics of a given organization, in particular the current development projects. Upper managers will need to energize their process developers to incorporate continuous manufacturing in at least part of their processes to gain experience and demonstrate directly the benefits. Training of continuous manufacturing technologies, organizational approaches, and regulatory approaches is a key area that industrial leaders should pursue together. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Low-Cost Nanocellulose-Reinforced High-Temperature Polymer Composites for Additive Manufacturing

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ozcan, Soydan; Tekinalp, Halil L.; Love, Lonnie J.

2016-07-13

ORNL worked with American Process Inc. to demonstrate the potential use of bio-based BioPlus ® lignin-coated cellulose nanofibrils (L-CNF) as a reinforcing agent in the development of polymer feedstock suitable for additive manufacturing. L-CNF-reinforced polylactic acid (PLA) testing coupons were prepared and up to 69% increase in tensile strength and 133% increase in elastic modulus were demonstrated.

The Effect of the Elimination of Micromotion and Tissue Strain on Intracortical Device Performance

DTIC Science & Technology

2016-10-01

promise for translation into the clinic. SMP-based probes are compatible with reliable manufacturing practices. 15. SUBJECT TERMS Intracortical probe...addition, the fabrication approaches used to create these test structures take advantage of industrial level manufacturing processes such that...Ravikumar et al. (2014) “The Effect of Residual Endotoxin Contamination on the Neuroinflammatory Response to Sterilized Intracortical Microelectrodes” J

Evidence based vaccinology.

PubMed

Nalin, David R

2002-02-22

Evidence based vaccinology (EBV) is the identification and use of the best evidence in making and implementing decisions during all of the stages of the life of a vaccine, including pre-licensure vaccine development and post-licensure manufacture and research, and utilization of the vaccine for disease control. Vaccines, unlike most pharmaceuticals, are in a continuous process of development both before and after licensure. Changes in biologics manufacturing technology and changes that vaccines induce in population and disease biology lead to periodic review of regimens (and sometimes dosage) based on changing immunologic data or public perceptions relevant to vaccine safety and effectiveness. EBV includes the use of evidence based medicine (EBM) both in clinical trials and in national disease containment programs. The rationale for EBV is that the highest evidentiary standards are required to maintain a rigorous scientific basis of vaccine quality control in manufacture and to ensure valid determination of vaccine efficacy, field effectiveness and safety profiles (including post-licensure safety monitoring), cost-benefit analyses, and risk:benefit ratios. EBV is increasingly based on statistically validated, clearly defined laboratory, manufacturing, clinical and epidemiological research methods and procedures, codified as good laboratory practices (GLP), good manufacturing practices (GMP), good clinical research practices (GCRP) and in clinical and public health practice (good vaccination practices, GVP). Implementation demands many data-driven decisions made by a spectrum of specialists pre- and post-licensure, and is essential to maintaining public confidence in vaccines.

Design of novel materials for additive manufacturing - Isotropic microstructure and high defect tolerance.

PubMed

Günther, J; Brenne, F; Droste, M; Wendler, M; Volkova, O; Biermann, H; Niendorf, T

2018-01-22

Electron Beam Melting (EBM) is a powder-bed additive manufacturing technology enabling the production of complex metallic parts with generally good mechanical properties. However, the performance of powder-bed based additively manufactured materials is governed by multiple factors that are difficult to control. Alloys that solidify in cubic crystal structures are usually affected by strong anisotropy due to the formation of columnar grains of preferred orientation. Moreover, processing induced defects and porosity detrimentally influence static and cyclic mechanical properties. The current study presents results on processing of a metastable austenitic CrMnNi steel by EBM. Due to multiple phase transformations induced by intrinsic heat-treatment in the layer-wise EBM process the material develops a fine-grained microstructure almost without a preferred crystallographic grain orientation. The deformation-induced phase transformation yields high damage tolerance and, thus, excellent mechanical properties less sensitive to process-induced inhomogeneities. Various scan strategies were applied to evaluate the width of an appropriate process window in terms of microstructure evolution, porosity and change of chemical composition.

40 CFR 63.2465 - What requirements must I meet for process vents that emit hydrogen halide and halogen HAP or HAP...

Code of Federal Regulations, 2010 CFR

2010-07-01

... Pollutants: Miscellaneous Organic Chemical Manufacturing Emission Limits, Work Practice Standards, and... the mass emission rate of HAP metals based on process knowledge, engineering assessment, or test data...

Reduction of Surface Roughness by Means of Laser Processing over Additive Manufacturing Metal Parts.

PubMed

Alfieri, Vittorio; Argenio, Paolo; Caiazzo, Fabrizia; Sergi, Vincenzo

2016-12-31

Optimization of processing parameters and exposure strategies is usually performed in additive manufacturing to set up the process; nevertheless, standards for roughness may not be evenly matched on a single complex part, since surface features depend on the building direction of the part. This paper aims to evaluate post processing treating via laser surface modification by means of scanning optics and beam wobbling to process metal parts resulting from selective laser melting of stainless steel in order to improve surface topography. The results are discussed in terms of roughness, geometry of the fusion zone in the cross-section, microstructural modification, and microhardness so as to assess the effects of laser post processing. The benefits of beam wobbling over linear scanning processing are shown, as heat effects in the base metal are proven to be lower.

Reduction of Surface Roughness by Means of Laser Processing over Additive Manufacturing Metal Parts

PubMed Central

Alfieri, Vittorio; Argenio, Paolo; Caiazzo, Fabrizia; Sergi, Vincenzo

2016-01-01

Optimization of processing parameters and exposure strategies is usually performed in additive manufacturing to set up the process; nevertheless, standards for roughness may not be evenly matched on a single complex part, since surface features depend on the building direction of the part. This paper aims to evaluate post processing treating via laser surface modification by means of scanning optics and beam wobbling to process metal parts resulting from selective laser melting of stainless steel in order to improve surface topography. The results are discussed in terms of roughness, geometry of the fusion zone in the cross-section, microstructural modification, and microhardness so as to assess the effects of laser post processing. The benefits of beam wobbling over linear scanning processing are shown, as heat effects in the base metal are proven to be lower. PMID:28772380

Technology transfer and scale-up of the Flublok recombinant hemagglutinin (HA) influenza vaccine manufacturing process.

PubMed

Buckland, Barry; Boulanger, Robert; Fino, Mireli; Srivastava, Indresh; Holtz, Kathy; Khramtsov, Nikolai; McPherson, Clifton; Meghrous, Jamal; Kubera, Paul; Cox, Manon M J

2014-09-22

Multiple different hemagglutinin (HA) protein antigens have been reproducibly manufactured at the 650L scale by Protein Sciences Corporation (PSC) based on an insect cell culture with baculovirus infection. Significantly, these HA protein antigens were produced by the same Universal Manufacturing process as described in the biological license application (BLA) for the first recombinant influenza vaccine approved by the FDA (Flublok). The technology is uniquely designed so that a change in vaccine composition can be readily accommodated from one HA protein antigen to another one. Here we present a vaccine candidate to combat the recently emerged H7N9 virus as an example starting with the genetic sequence for the required HA, creation of the baculovirus and ending with purified protein antigen (or vaccine component) at the 10L scale accomplished within 38 days under GMP conditions. The same process performance is being achieved at the 2L, 10L, 100L, 650L and 2500L scale. An illustration is given of how the technology was transferred from the benchmark 650L scale facility to a retrofitted microbial facility at the 2500L scale within 100 days which includes the time for facility engineering changes. The successful development, technology transfer and scale-up of the Flublok process has major implications for being ready to make vaccine rapidly on a worldwide scale as a defense against pandemic influenza. The technology described does not have the same vulnerability to mutations in the egg adapted strain, and resulting loss in vaccine efficacy, faced by egg based manufacture. Copyright © 2014 Elsevier Ltd. All rights reserved.

Biological implications of lab-on-a-chip devices fabricated using multi-jet modelling and stereolithography processes

NASA Astrophysics Data System (ADS)

Zhu, Feng; Macdonald, Niall; Skommer, Joanna; Wlodkowic, Donald

2015-06-01

Current microfabrication methods are often restricted to two-dimensional (2D) or two and a half dimensional (2.5D) structures. Those fabrication issues can be potentially addressed by emerging additive manufacturing technologies. Despite rapid growth of additive manufacturing technologies in tissue engineering, microfluidics has seen relatively little developments with regards to adopting 3D printing for rapid fabrication of complex chip-based devices. This has been due to two major factors: lack of sufficient resolution of current rapid-prototyping methods (usually >100 μm ) and optical transparency of polymers to allow in vitro imaging of specimens. We postulate that adopting innovative fabrication processes can provide effective solutions for prototyping and manufacturing of chip-based devices with high-aspect ratios (i.e. above ration of 20:1). This work provides a comprehensive investigation of commercially available additive manufacturing technologies as an alternative for rapid prototyping of complex monolithic Lab-on-a-Chip devices for biological applications. We explored both multi-jet modelling (MJM) and several stereolithography (SLA) processes with five different 3D printing resins. Compared with other rapid prototyping technologies such as PDMS soft lithography and infrared laser micromachining, we demonstrated that selected SLA technologies had superior resolution and feature quality. We also for the first time optimised the post-processing protocols and demonstrated polymer features under scanning electronic microscope (SEM). Finally we demonstrate that selected SLA polymers have optical properties enabling high-resolution biological imaging. A caution should be, however, exercised as more work is needed to develop fully bio-compatible and non-toxic polymer chemistries.

Technical and economic analysis of solvent-based lithium-ion electrode drying with water and NMP

DOE PAGES

Wood, David L.; Quass, Jeffrey D.; Li, Jianlin; ...

2017-05-16

Processing lithium-ion battery (LIB) electrode dispersions with water as the solvent during primary drying offers many advantages over N-methylpyrrolidone (NMP). An in-depth analysis of the comparative drying costs of LIB electrodes is discussed for both NMP- and water-based dispersion processing in terms of battery pack $/kWh. Electrode coating manufacturing and capital equipment cost savings are compared for water vs. conventional NMP organic solvent processing. A major finding of this work is that the total electrode manufacturing costs, whether water- or NMP-based, contribute about 8–9% of the total pack cost. However, it was found that up to a 2 × reductionmore » in electrode processing (drying and solvent recovery) cost can be expected along with a $3–6 M savings in associated plant capital equipment (for a plant producing 100,000 10-kWh Plug-in Hybrid Electric Vehicle (PHEV) batteries) using water as the electrode solvent. This paper shows a different perspective in that the most important benefits of aqueous electrode processing actually revolve around capital equipment savings and environmental stewardship and not processing cost savings.« less

A system approach for reducing the environmental impact of manufacturing and sustainability improvement of nano-scale manufacturing

NASA Astrophysics Data System (ADS)

Yuan, Yingchun

This dissertation develops an effective and economical system approach to reduce the environmental impact of manufacturing. The system approach is developed by using a process-based holistic method for upstream analysis and source reduction of the environmental impact of manufacturing. The system approach developed consists of three components of a manufacturing system: technology, energy and material, and is useful for sustainable manufacturing as it establishes a clear link between manufacturing system components and its overall sustainability performance, and provides a framework for environmental impact reductions. In this dissertation, the system approach developed is applied for environmental impact reduction of a semiconductor nano-scale manufacturing system, with three case scenarios analyzed in depth on manufacturing process improvement, clean energy supply, and toxic chemical material selection. The analysis on manufacturing process improvement is conducted on Atomic Layer Deposition of Al2O3 dielectric gate on semiconductor microelectronics devices. Sustainability performance and scale-up impact of the ALD technology in terms of environmental emissions, energy consumption, nano-waste generation and manufacturing productivity are systematically investigated and the ways to improve the sustainability of the ALD technology are successfully developed. The clean energy supply is studied using solar photovoltaic, wind, and fuel cells systems for electricity generation. Environmental savings from each clean energy supply over grid power are quantitatively analyzed, and costs for greenhouse gas reductions on each clean energy supply are comparatively studied. For toxic chemical material selection, an innovative schematic method is developed as a visual decision tool for characterizing and benchmarking the human health impact of toxic chemicals, with a case study conducted on six chemicals commonly used as solvents in semiconductor manufacturing. Reliability of the schematic method is validated by comparing its benchmark results on 104 chemicals with that from the conventional Human Toxicity Potential (HTP) method. This dissertation concludes with discussions on environmental impact assessment of nanotechnologies and sustainability management of nano-particles. As nano-manufacturing is emerging for wide industrial applications, improvement and expansion of the system approach would be valuable for use in the environmental management of nano-manufacturing and in the risk control of nano-particles in the interests of public health and the environment.

Towards better process understanding: chemometrics and multivariate measurements in manufacturing of solid dosage forms.

PubMed

Matero, Sanni; van Den Berg, Frans; Poutiainen, Sami; Rantanen, Jukka; Pajander, Jari

2013-05-01

The manufacturing of tablets involves many unit operations that possess multivariate and complex characteristics. The interactions between the material characteristics and process related variation are presently not comprehensively analyzed due to univariate detection methods. As a consequence, current best practice to control a typical process is to not allow process-related factors to vary i.e. lock the production parameters. The problem related to the lack of sufficient process understanding is still there: the variation within process and material properties is an intrinsic feature and cannot be compensated for with constant process parameters. Instead, a more comprehensive approach based on the use of multivariate tools for investigating processes should be applied. In the pharmaceutical field these methods are referred to as Process Analytical Technology (PAT) tools that aim to achieve a thorough understanding and control over the production process. PAT includes the frames for measurement as well as data analyzes and controlling for in-depth understanding, leading to more consistent and safer drug products with less batch rejections. In the optimal situation, by applying these techniques, destructive end-product testing could be avoided. In this paper the most prominent multivariate data analysis measuring tools within tablet manufacturing and basic research on operations are reviewed. Copyright © 2013 Wiley Periodicals, Inc.

Assessing the influence of component processing and donor characteristics on quality of red cell concentrates using quality control data.

PubMed

Jordan, A; Chen, D; Yi, Q-L; Kanias, T; Gladwin, M T; Acker, J P

2016-07-01

Quality control (QC) data collected by blood services are used to monitor production and to ensure compliance with regulatory standards. We demonstrate how analysis of quality control data can be used to highlight the sources of variability within red cell concentrates (RCCs). We merged Canadian Blood Services QC data with manufacturing and donor records for 28 227 RCC between June 2011 and October 2014. Units were categorized based on processing method, bag manufacturer, donor age and donor sex, then assessed based on product characteristics: haemolysis and haemoglobin levels, unit volume, leucocyte count and haematocrit. Buffy-coat method (top/bottom)-processed units exhibited lower haemolysis than units processed using the whole-blood filtration method (top/top). Units from female donors exhibited lower haemolysis than male donations. Processing method influenced unit volume and the ratio of additive solution to residual plasma. Stored red blood cell characteristics are influenced by prestorage processing and donor factors. Understanding the relationship between processing, donors and RCC quality will help blood services to ensure the safety of transfused products. © 2016 International Society of Blood Transfusion.

Simulation based energy-resource efficient manufacturing integrated with in-process virtual management

NASA Astrophysics Data System (ADS)

Katchasuwanmanee, Kanet; Cheng, Kai; Bateman, Richard

2016-09-01

As energy efficiency is one of the key essentials towards sustainability, the development of an energy-resource efficient manufacturing system is among the great challenges facing the current industry. Meanwhile, the availability of advanced technological innovation has created more complex manufacturing systems that involve a large variety of processes and machines serving different functions. To extend the limited knowledge on energy-efficient scheduling, the research presented in this paper attempts to model the production schedule at an operation process by considering the balance of energy consumption reduction in production, production work flow (productivity) and quality. An innovative systematic approach to manufacturing energy-resource efficiency is proposed with the virtual simulation as a predictive modelling enabler, which provides real-time manufacturing monitoring, virtual displays and decision-makings and consequentially an analytical and multidimensional correlation analysis on interdependent relationships among energy consumption, work flow and quality errors. The regression analysis results demonstrate positive relationships between the work flow and quality errors and the work flow and energy consumption. When production scheduling is controlled through optimization of work flow, quality errors and overall energy consumption, the energy-resource efficiency can be achieved in the production. Together, this proposed multidimensional modelling and analysis approach provides optimal conditions for the production scheduling at the manufacturing system by taking account of production quality, energy consumption and resource efficiency, which can lead to the key competitive advantages and sustainability of the system operations in the industry.

Context-based virtual metrology

NASA Astrophysics Data System (ADS)

Ebersbach, Peter; Urbanowicz, Adam M.; Likhachev, Dmitriy; Hartig, Carsten; Shifrin, Michael

2018-03-01

Hybrid and data feed forward methodologies are well established for advanced optical process control solutions in highvolume semiconductor manufacturing. Appropriate information from previous measurements, transferred into advanced optical model(s) at following step(s), provides enhanced accuracy and exactness of the measured topographic (thicknesses, critical dimensions, etc.) and material parameters. In some cases, hybrid or feed-forward data are missed or invalid for dies or for a whole wafer. We focus on approaches of virtual metrology to re-create hybrid or feed-forward data inputs in high-volume manufacturing. We discuss missing data inputs reconstruction which is based on various interpolation and extrapolation schemes and uses information about wafer's process history. Moreover, we demonstrate data reconstruction approach based on machine learning techniques utilizing optical model and measured spectra. And finally, we investigate metrics that allow one to assess error margin of virtual data input.

[Application of risk-based approach for determination of critical factors in technology transfer of production of medicinal products].

PubMed

Beregovykh, V V; Spitskiy, O R

2014-01-01

Risk-based approach is used for examination of impact of different factors on quality of medicinal products in technology transfer. A general diagram is offered for risk analysis execution in technology transfer from pharmaceutical development to production. When transferring technology to full- scale commercial production it is necessary to investigate and simulate production process application beforehand in new real conditions. The manufacturing process is the core factorfor risk analysis having the most impact on quality attributes of a medicinal product. Further importantfactors are linked to materials and products to be handled and manufacturing environmental conditions such as premises, equipment and personnel. Usage of risk-based approach in designing of multipurpose production facility of medicinal products is shown where quantitative risk analysis tool RAMM (Risk Analysis and Mitigation Matrix) was applied.

Plasma-based EUV light source

DOEpatents

Shumlak, Uri; Golingo, Raymond; Nelson, Brian A.

2010-11-02

Various mechanisms are provided relating to plasma-based light source that may be used for lithography as well as other applications. For example, a device is disclosed for producing extreme ultraviolet (EUV) light based on a sheared plasma flow. The device can produce a plasma pinch that can last several orders of magnitude longer than what is typically sustained in a Z-pinch, thus enabling the device to provide more power output than what has been hitherto predicted in theory or attained in practice. Such power output may be used in a lithography system for manufacturing integrated circuits, enabling the use of EUV wavelengths on the order of about 13.5 nm. Lastly, the process of manufacturing such a plasma pinch is discussed, where the process includes providing a sheared flow of plasma in order to stabilize it for long periods of time.

Continuous counter-current chromatography for capture and polishing steps in biopharmaceutical production.

PubMed

Steinebach, Fabian; Müller-Späth, Thomas; Morbidelli, Massimo

2016-09-01

The economic advantages of continuous processing of biopharmaceuticals, which include smaller equipment and faster, efficient processes, have increased interest in this technology over the past decade. Continuous processes can also improve quality assurance and enable greater controllability, consistent with the quality initiatives of the FDA. Here, we discuss different continuous multi-column chromatography processes. Differences in the capture and polishing steps result in two different types of continuous processes that employ counter-current column movement. Continuous-capture processes are associated with increased productivity per cycle and decreased buffer consumption, whereas the typical purity-yield trade-off of classical batch chromatography can be surmounted by continuous processes for polishing applications. In the context of continuous manufacturing, different but complementary chromatographic columns or devices are typically combined to improve overall process performance and avoid unnecessary product storage. In the following, these various processes, their performances compared with batch processing and resulting product quality are discussed based on a review of the literature. Based on various examples of applications, primarily monoclonal antibody production processes, conclusions are drawn about the future of these continuous-manufacturing technologies. Copyright © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Manufacture of high aspect ratio micro-pillar wall shear stress sensor arrays

NASA Astrophysics Data System (ADS)

Gnanamanickam, Ebenezer P.; Sullivan, John P.

2012-12-01

In the field of experimental fluid mechanics the measurement of unsteady, distributed wall shear stress has proved historically challenging. Recently, sensors based on an array of flexible micro-pillars have shown promise in carrying out such measurements. Similar sensors find use in other applications such as cellular mechanics. This work presents a manufacturing technique that can manufacture micro-pillar arrays of high aspect ratio. An electric discharge machine (EDM) is used to manufacture a micro-drilling tool. This micro-drilling tool is used to form holes in a wax sheet which acts as the mold for the micro-pillar array. Silicone rubber is cast in these molds to yield a micro-pillar array. Using this technique, micro-pillar arrays with a maximum aspect ratio of about 10 have been manufactured. Manufacturing issues encountered, steps to alleviate them and the potential of the process to manufacture similar micro-pillar arrays in a time-efficient manner are also discussed.

Sustainable design and manufacturing of multifunctional polymer nanocomposite coatings: A multiscale systems approach

NASA Astrophysics Data System (ADS)

Xiao, Jie

Polymer nanocomposites have a great potential to be a dominant coating material in a wide range of applications in the automotive, aerospace, ship-making, construction, and pharmaceutical industries. However, how to realize design sustainability of this type of nanostructured materials and how to ensure the true optimality of the product quality and process performance in coating manufacturing remain as a mountaintop area. The major challenges arise from the intrinsic multiscale nature of the material-process-product system and the need to manipulate the high levels of complexity and uncertainty in design and manufacturing processes. This research centers on the development of a comprehensive multiscale computational methodology and a computer-aided tool set that can facilitate multifunctional nanocoating design and application from novel function envisioning and idea refinement, to knowledge discovery and design solution derivation, and further to performance testing in industrial applications and life cycle analysis. The principal idea is to achieve exceptional system performance through concurrent characterization and optimization of materials, product and associated manufacturing processes covering a wide range of length and time scales. Multiscale modeling and simulation techniques ranging from microscopic molecular modeling to classical continuum modeling are seamlessly coupled. The tight integration of different methods and theories at individual scales allows the prediction of macroscopic coating performance from the fundamental molecular behavior. Goal-oriented design is also pursued by integrating additional methods for bio-inspired dynamic optimization and computational task management that can be implemented in a hierarchical computing architecture. Furthermore, multiscale systems methodologies are developed to achieve the best possible material application towards sustainable manufacturing. Automotive coating manufacturing, that involves paint spay and curing, is specifically discussed in this dissertation. Nevertheless, the multiscale considerations for sustainable manufacturing, the novel concept of IPP control, and the new PPDE-based optimization method are applicable to other types of manufacturing, e.g., metal coating development through electroplating. It is demonstrated that the methodological development in this dissertation can greatly facilitate experimentalists in novel material invention and new knowledge discovery. At the same time, they can provide scientific guidance and reveal various new opportunities and effective strategies for sustainable manufacturing.

76 FR 40052 - Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-07

... Current Good Manufacturing 0910-AG10 Practice in Manufacturing, Processing, Packing or Holding Animal Food... in Manufacturing, Processing, Packing or Holding Animal Food Legal Authority: 21 U.S.C. 342; 21 U.S.C... constitute on farm manufacturing or processing of food that is not grown, raised, or consumed on a farm or...

Patterned wafer geometry grouping for improved overlay control

NASA Astrophysics Data System (ADS)

Lee, Honggoo; Han, Sangjun; Woo, Jaeson; Park, Junbeom; Song, Changrock; Anis, Fatima; Vukkadala, Pradeep; Jeon, Sanghuck; Choi, DongSub; Huang, Kevin; Heo, Hoyoung; Smith, Mark D.; Robinson, John C.

2017-03-01

Process-induced overlay errors from outside the litho cell have become a significant contributor to the overlay error budget including non-uniform wafer stress. Previous studies have shown the correlation between process-induced stress and overlay and the opportunity for improvement in process control, including the use of patterned wafer geometry (PWG) metrology to reduce stress-induced overlay signatures. Key challenges of volume semiconductor manufacturing are how to improve not only the magnitude of these signatures, but also the wafer to wafer variability. This work involves a novel technique of using PWG metrology to provide improved litho-control by wafer-level grouping based on incoming process induced overlay, relevant for both 3D NAND and DRAM. Examples shown in this study are from 19 nm DRAM manufacturing.

Investigation of dimensional variation in parts manufactured by fused deposition modeling using Gauge Repeatability and Reproducibility

NASA Astrophysics Data System (ADS)

Mohamed, Omar Ahmed; Hasan Masood, Syed; Lal Bhowmik, Jahar

2018-02-01

In the additive manufacturing (AM) market, the question is raised by industry and AM users on how reproducible and repeatable the fused deposition modeling (FDM) process is in providing good dimensional accuracy. This paper aims to investigate and evaluate the repeatability and reproducibility of the FDM process through a systematic approach to answer this frequently asked question. A case study based on the statistical gage repeatability and reproducibility (gage R&R) technique is proposed to investigate the dimensional variations in the printed parts of the FDM process. After running the simulation and analysis of the data, the FDM process capability is evaluated, which would help the industry for better understanding the performance of FDM technology.

Manufacturing Process Simulation of Large-Scale Cryotanks

NASA Technical Reports Server (NTRS)

Babai, Majid; Phillips, Steven; Griffin, Brian; Munafo, Paul M. (Technical Monitor)

2002-01-01

NASA's Space Launch Initiative (SLI) is an effort to research and develop the technologies needed to build a second-generation reusable launch vehicle. It is required that this new launch vehicle be 100 times safer and 10 times cheaper to operate than current launch vehicles. Part of the SLI includes the development of reusable composite and metallic cryotanks. The size of these reusable tanks is far greater than anything ever developed and exceeds the design limits of current manufacturing tools. Several design and manufacturing approaches have been formulated, but many factors must be weighed during the selection process. Among these factors are tooling reachability, cycle times, feasibility, and facility impacts. The manufacturing process simulation capabilities available at NASA's Marshall Space Flight Center have played a key role in down selecting between the various manufacturing approaches. By creating 3-D manufacturing process simulations, the varying approaches can be analyzed in a virtual world before any hardware or infrastructure is built. This analysis can detect and eliminate costly flaws in the various manufacturing approaches. The simulations check for collisions between devices, verify that design limits on joints are not exceeded, and provide cycle times which aid in the development of an optimized process flow. In addition, new ideas and concerns are often raised after seeing the visual representation of a manufacturing process flow. The output of the manufacturing process simulations allows for cost and safety comparisons to be performed between the various manufacturing approaches. This output helps determine which manufacturing process options reach the safety and cost goals of the SLI.

A simple approach to industrial laser safety.

PubMed

Lewandowski, Michael A; Hinz, Michael W

2005-02-01

Industrial applications of lasers include marking, welding, cutting, and other material processing. Lasers used in these ways have significant power output but are generally designed to limit operator exposure to direct or scattered laser radiation to harmless levels in order to meet the Federal Laser Product Performance Standard (21CFR1040) for Class 1 laser products. Interesting challenges occur when companies integrate high power lasers into manufacturing or process control equipment. A significant part of the integration process is developing engineering and administrative controls to produce an acceptable level of laser safety while balancing production, maintenance, and service requirements. 3M Company uses a large number of high power lasers in numerous manufacturing processes. Whether the laser is purchased as a Class 1 laser product or whether it is purchased as a Class 4 laser and then integrated into a manufacturing application, 3M Company has developed an industrial laser safety program that maintains a high degree of laser safety while facilitating the rapid and economical integration of laser technology into the manufacturing workplace. This laser safety program is based on the requirements and recommendations contained in the American National Standard for Safe Use of Lasers, ANSI Z136.1. The fundamental components of the 3M program include hazard evaluation, engineering, administrative, and procedural controls, protective equipment, signs and labels, training, and re-evaluation upon change. This program is implemented in manufacturing facilities and has resulted in an excellent history of laser safety and an effective and efficient use of laser safety resources.

Scheduling job shop - A case study

NASA Astrophysics Data System (ADS)

Abas, M.; Abbas, A.; Khan, W. A.

2016-08-01

The scheduling in job shop is important for efficient utilization of machines in the manufacturing industry. There are number of algorithms available for scheduling of jobs which depend on machines tools, indirect consumables and jobs which are to be processed. In this paper a case study is presented for scheduling of jobs when parts are treated on available machines. Through time and motion study setup time and operation time are measured as total processing time for variety of products having different manufacturing processes. Based on due dates different level of priority are assigned to the jobs and the jobs are scheduled on the basis of priority. In view of the measured processing time, the times for processing of some new jobs are estimated and for efficient utilization of the machines available an algorithm is proposed and validated.

A hybrid life-cycle inventory for multi-crystalline silicon PV module manufacturing in China

NASA Astrophysics Data System (ADS)

Yao, Yuan; Chang, Yuan; Masanet, Eric

2014-11-01

China is the world’s largest manufacturer of multi-crystalline silicon photovoltaic (mc-Si PV) modules, which is a key enabling technology in the global transition to renewable electric power systems. This study presents a hybrid life-cycle inventory (LCI) of Chinese mc-Si PV modules, which fills a critical knowledge gap on the environmental implications of mc-Si PV module manufacturing in China. The hybrid LCI approach combines process-based LCI data for module and poly-silicon manufacturing plants with a 2007 China IO-LCI model for production of raw material and fuel inputs to estimate ‘cradle to gate’ primary energy use, water consumption, and major air pollutant emissions (carbon dioxide, methane, sulfur dioxide, nitrous oxide, and nitrogen oxides). Results suggest that mc-Si PV modules from China may come with higher environmental burdens that one might estimate if one were using LCI results for mc-Si PV modules manufactured elsewhere. These higher burdens can be reasonably explained by the efficiency differences in China’s poly-silicon manufacturing processes, the country’s dependence on highly polluting coal-fired electricity, and the expanded system boundaries associated with the hybrid LCI modeling framework. The results should be useful for establishing more conservative ranges on the potential ‘cradle to gate’ impacts of mc-Si PV module manufacturing for more robust LCAs of PV deployment scenarios.

The strategic relevance of manufacturing technology: An overall quality concept to promote innovation preventing drug shortage.

PubMed

Panzitta, Michele; Ponti, Mauro; Bruno, Giorgio; Cois, Giancarlo; D'Arpino, Alessandro; Minghetti, Paola; Mendicino, Francesca Romana; Perioli, Luana; Ricci, Maurizio

2017-01-10

Manufacturing is the bridge between research and patient: without product, there is no clinical outcome. Shortage has a variety of causes, in this paper we analyse only causes related to manufacturing technology and we use shortage as a paradigm highliting the relevance of Pharmaceutical Technology. Product and process complexity and capacity issues are the main challenge for the Pharmaceutical Industry Supply chain. Manufacturing Technology should be acknowledged as a R&D step and as a very important matter during University degree in Pharmacy and related disciplines, promoting collaboration between Academia and Industry, measured during HTA step and rewarded in terms of price and reimbursement. The above elements are not yet properly recognised, and manufacturing technology is taken in to consideration only when a shortage is in place. In a previous work, Panzitta et al. proposed to perform a full technology assessment at the Health Technological Assessment stage, evaluating three main technical aspects of a medicine: manufacturing process, physicochemical properties, and formulation characteristics. In this paper, we develop the concept of manufacturing appraisal, providing a technical overview of upcoming challenges, a risk based approach and an economic picture of shortage costs. We develop also an overall quality concept, not limited to GMP factors but broaden to all elements leading to a robust supply and promoting technical innovation. Copyright © 2016 Elsevier B.V. All rights reserved.

Ceramic-Based 4D Components: Additive Manufacturing (AM) of Ceramic-Based Functionally Graded Materials (FGM) by Thermoplastic 3D Printing (T3DP).

PubMed

Scheithauer, Uwe; Weingarten, Steven; Johne, Robert; Schwarzer, Eric; Abel, Johannes; Richter, Hans-Jürgen; Moritz, Tassilo; Michaelis, Alexander

2017-11-28

In our study, we investigated the additive manufacturing (AM) of ceramic-based functionally graded materials (FGM) by the direct AM technology thermoplastic 3D printing (T3DP). Zirconia components with varying microstructures were additively manufactured by using thermoplastic suspensions with different contents of pore-forming agents (PFA), which were co-sintered defect-free. Different materials were investigated concerning their suitability as PFA for the T3DP process. Diverse zirconia-based suspensions were prepared and used for the AM of single- and multi-material test components. All of the samples were sintered defect-free, and in the end, we could realize a brick wall-like component consisting of dense (<1% porosity) and porous (approx. 5% porosity) zirconia areas to combine different properties in one component. T3DP opens the door to the AM of further ceramic-based 4D components, such as multi-color, multi-material, or especially, multi-functional components.

Ceramic-Based 4D Components: Additive Manufacturing (AM) of Ceramic-Based Functionally Graded Materials (FGM) by Thermoplastic 3D Printing (T3DP)

PubMed Central

Weingarten, Steven; Johne, Robert; Schwarzer, Eric; Richter, Hans-Jürgen; Michaelis, Alexander

2017-01-01

In our study, we investigated the additive manufacturing (AM) of ceramic-based functionally graded materials (FGM) by the direct AM technology thermoplastic 3D printing (T3DP). Zirconia components with varying microstructures were additively manufactured by using thermoplastic suspensions with different contents of pore-forming agents (PFA), which were co-sintered defect-free. Different materials were investigated concerning their suitability as PFA for the T3DP process. Diverse zirconia-based suspensions were prepared and used for the AM of single- and multi-material test components. All of the samples were sintered defect-free, and in the end, we could realize a brick wall-like component consisting of dense (<1% porosity) and porous (approx. 5% porosity) zirconia areas to combine different properties in one component. T3DP opens the door to the AM of further ceramic-based 4D components, such as multi-color, multi-material, or especially, multi-functional components. PMID:29182541

A Bayesian Approach to Determination of F, D, and Z Values Used in Steam Sterilization Validation.

PubMed

Faya, Paul; Stamey, James D; Seaman, John W

2017-01-01

For manufacturers of sterile drug products, steam sterilization is a common method used to provide assurance of the sterility of manufacturing equipment and products. The validation of sterilization processes is a regulatory requirement and relies upon the estimation of key resistance parameters of microorganisms. Traditional methods have relied upon point estimates for the resistance parameters. In this paper, we propose a Bayesian method for estimation of the well-known D T , z , and F o values that are used in the development and validation of sterilization processes. A Bayesian approach allows the uncertainty about these values to be modeled using probability distributions, thereby providing a fully risk-based approach to measures of sterility assurance. An example is given using the survivor curve and fraction negative methods for estimation of resistance parameters, and we present a means by which a probabilistic conclusion can be made regarding the ability of a process to achieve a specified sterility criterion. LAY ABSTRACT: For manufacturers of sterile drug products, steam sterilization is a common method used to provide assurance of the sterility of manufacturing equipment and products. The validation of sterilization processes is a regulatory requirement and relies upon the estimation of key resistance parameters of microorganisms. Traditional methods have relied upon point estimates for the resistance parameters. In this paper, we propose a Bayesian method for estimation of the critical process parameters that are evaluated in the development and validation of sterilization processes. A Bayesian approach allows the uncertainty about these parameters to be modeled using probability distributions, thereby providing a fully risk-based approach to measures of sterility assurance. An example is given using the survivor curve and fraction negative methods for estimation of resistance parameters, and we present a means by which a probabilistic conclusion can be made regarding the ability of a process to achieve a specified sterility criterion. © PDA, Inc. 2017.

Bidding-based autonomous process planning and scheduling

NASA Astrophysics Data System (ADS)

Gu, Peihua; Balasubramanian, Sivaram; Norrie, Douglas H.

1995-08-01

Improving productivity through computer integrated manufacturing systems (CIMS) and concurrent engineering requires that the islands of automation in an enterprise be completely integrated. The first step in this direction is to integrate design, process planning, and scheduling. This can be achieved through a bidding-based process planning approach. The product is represented in a STEP model with detailed design and administrative information including design specifications, batch size, and due dates. Upon arrival at the manufacturing facility, the product registered in the shop floor manager which is essentially a coordinating agent. The shop floor manager broadcasts the product's requirements to the machines. The shop contains autonomous machines that have knowledge about their functionality, capabilities, tooling, and schedule. Each machine has its own process planner and responds to the product's request in a different way that is consistent with its capabilities and capacities. When more than one machine offers certain process(es) for the same requirements, they enter into negotiation. Based on processing time, due date, and cost, one of the machines wins the contract. The successful machine updates its schedule and advises the product to request raw material for processing. The concept was implemented using a multi-agent system with the task decomposition and planning achieved through contract nets. The examples are included to illustrate the approach.

Development of Pulsed Processes for the Manufacture of Solar Cells

NASA Technical Reports Server (NTRS)

1979-01-01

The development status of the process based upon ion implantation for the introduction of junctions and back surface fields is described. A process sequence is presented employing ion implantation and pulse processing. Efforts to improve throughout and descrease process element costs for furnace annealing are described. Design studies for a modular 3,000 wafer per hour pulse processor are discussed.

Achieving continuous manufacturing: technologies and approaches for synthesis, workup, and isolation of drug substance. May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Baxendale, Ian R; Braatz, Richard D; Hodnett, Benjamin K; Jensen, Klavs F; Johnson, Martin D; Sharratt, Paul; Sherlock, Jon-Paul; Florence, Alastair J

2015-03-01

This whitepaper highlights current challenges and opportunities associated with continuous synthesis, workup, and crystallization of active pharmaceutical ingredients (drug substances). We describe the technologies and requirements at each stage and emphasize the different considerations for developing continuous processes compared with batch. In addition to the specific sequence of operations required to deliver the necessary chemical and physical transformations for continuous drug substance manufacture, consideration is also given to how adoption of continuous technologies may impact different manufacturing stages in development from discovery, process development, through scale-up and into full scale production. The impact of continuous manufacture on drug substance quality and the associated challenges for control and for process safety are also emphasized. In addition to the technology and operational considerations necessary for the adoption of continuous manufacturing (CM), this whitepaper also addresses the cultural, as well as skills and training, challenges that will need to be met by support from organizations in order to accommodate the new work flows. Specific action items for industry leaders are: Develop flow chemistry toolboxes, exploiting the advantages of flow processing and including highly selective chemistries that allow use of simple and effective continuous workup technologies. Availability of modular or plug and play type equipment especially for workup to assist in straightforward deployment in the laboratory. As with learning from other industries, standardization is highly desirable and will require cooperation across industry and academia to develop and implement. Implement and exploit process analytical technologies (PAT) for real-time dynamic control of continuous processes. Develop modeling and simulation techniques to support continuous process development and control. Progress is required in multiphase systems such as crystallization. Involve all parts of the organization from discovery, research and development, and manufacturing in the implementation of CM. Engage with academia to develop the training provision to support the skills base for CM, particularly in flow chemistry, physical chemistry, and chemical engineering skills at the chemistry-process interface. Promote and encourage publication and dissemination of examples of CM across the sector to demonstrate capability, engage with regulatory comment, and establish benchmarks for performance and highlight challenges. Develop the economic case for CM of drug substance. This will involve various stakeholders at project and business level, however establishing the critical economic drivers is critical to driving the transformation in manufacturing. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Sensor-based atomic layer deposition for rapid process learning and enhanced manufacturability

NASA Astrophysics Data System (ADS)

Lei, Wei

In the search for sensor based atomic layer deposition (ALD) process to accelerate process learning and enhance manufacturability, we have explored new reactor designs and applied in-situ process sensing to W and HfO 2 ALD processes. A novel wafer scale ALD reactor, which features fast gas switching, good process sensing compatibility and significant similarity to the real manufacturing environment, is constructed. The reactor has a unique movable reactor cap design that allows two possible operation modes: (1) steady-state flow with alternating gas species; or (2) fill-and-pump-out cycling of each gas, accelerating the pump-out by lifting the cap to employ the large chamber volume as ballast. Downstream quadrupole mass spectrometry (QMS) sampling is applied for in-situ process sensing of tungsten ALD process. The QMS reveals essential surface reaction dynamics through real-time signals associated with byproduct generation as well as precursor introduction and depletion for each ALD half cycle, which are then used for process learning and optimization. More subtle interactions such as imperfect surface saturation and reactant dose interaction are also directly observed by QMS, indicating that ALD process is more complicated than the suggested layer-by-layer growth. By integrating in real-time the byproduct QMS signals over each exposure and plotting it against process cycle number, the deposition kinetics on the wafer is directly measured. For continuous ALD runs, the total integrated byproduct QMS signal in each ALD run is also linear to ALD film thickness, and therefore can be used for ALD film thickness metrology. The in-situ process sensing is also applied to HfO2 ALD process that is carried out in a furnace type ALD reactor. Precursor dose end-point control is applied to precisely control the precursor dose in each half cycle. Multiple process sensors, including quartz crystal microbalance (QCM) and QMS are used to provide real time process information. The sensing results confirm the proposed surface reaction path and once again reveal the complexity of ALD processes. The impact of this work includes: (1) It explores new ALD reactor designs which enable the implementation of in-situ process sensors for rapid process learning and enhanced manufacturability; (2) It demonstrates in the first time that in-situ QMS can reveal detailed process dynamics and film growth kinetics in wafer-scale ALD process, and thus can be used for ALD film thickness metrology. (3) Based on results from two different processes carried out in two different reactors, it is clear that ALD is a more complicated process than normally believed or advertised, but real-time observation of the operational chemistries in ALD by in-situ sensors provides critical insight to the process and the basis for more effective process control for ALD applications.

Magnesium in North America: A Changing Landscape

NASA Astrophysics Data System (ADS)

Slade, Susan

The changing landscape of North American manufacturing in the context of global competition is impacting the market of all raw materials, including magnesium. Current automotive fuel economy legislation and pending legislation on the emissions of greenhouse gases are impacting magnesium's largest consuming industries, such as aluminum, automotive components, steel and transition metals. These industries are all considering innovative ways to efficiently incorporate the needed raw materials into their processes. The North American magnesium market differs from other regions based on maturity, supply streams, changing manufacturing capabilities and trade cases, combined with the transformation of North American manufacturing.

Additive Manufacturing of IN100 Superalloy Through Scanning Laser Epitaxy for Turbine Engine Hot-Section Component Repair: Process Development, Modeling, Microstructural Characterization, and Process Control

NASA Astrophysics Data System (ADS)

Acharya, Ranadip; Das, Suman

2015-09-01

This article describes additive manufacturing (AM) of IN100, a high gamma-prime nickel-based superalloy, through scanning laser epitaxy (SLE), aimed at the creation of thick deposits onto like-chemistry substrates for enabling repair of turbine engine hot-section components. SLE is a metal powder bed-based laser AM technology developed for nickel-base superalloys with equiaxed, directionally solidified, and single-crystal microstructural morphologies. Here, we combine process modeling, statistical design-of-experiments (DoE), and microstructural characterization to demonstrate fully metallurgically bonded, crack-free and dense deposits exceeding 1000 μm of SLE-processed IN100 powder onto IN100 cast substrates produced in a single pass. A combined thermal-fluid flow-solidification model of the SLE process compliments DoE-based process development. A customized quantitative metallography technique analyzes digital cross-sectional micrographs and extracts various microstructural parameters, enabling process model validation and process parameter optimization. Microindentation measurements show an increase in the hardness by 10 pct in the deposit region compared to the cast substrate due to microstructural refinement. The results illustrate one of the very few successes reported for the crack-free deposition of IN100, a notoriously "non-weldable" hot-section alloy, thus establishing the potential of SLE as an AM method suitable for hot-section component repair and for future new-make components in high gamma-prime containing crack-prone nickel-based superalloys.

40 CFR 63.149 - Control requirements for certain liquid streams in open systems within a chemical manufacturing...

Code of Federal Regulations, 2010 CFR

2010-07-01

... streams in open systems within a chemical manufacturing process unit. 63.149 Section 63.149 Protection of... open systems within a chemical manufacturing process unit. (a) The owner or operator shall comply with... Air Pollutants From the Synthetic Organic Chemical Manufacturing Industry for Process Vents, Storage...

19 CFR Appendix A to Part 191 - General Manufacturing Drawback Rulings

Code of Federal Regulations, 2014 CFR

2014-04-01

... drawback; and 9. Description of the manufacturing or production process, unless specifically described in...) and 55207(1) (see § 191.9 of this part). D. Process Of Manufacture Or Production The imported... it is first separated in the manufacturing process. 2. Appearing-in method The appearing in basis may...

19 CFR Appendix A to Part 191 - General Manufacturing Drawback Rulings

Code of Federal Regulations, 2013 CFR

2013-04-01

... drawback; and 9. Description of the manufacturing or production process, unless specifically described in...) and 55207(1) (see § 191.9 of this part). D. Process Of Manufacture Or Production The imported... it is first separated in the manufacturing process. 2. Appearing-in method The appearing in basis may...

19 CFR Appendix A to Part 191 - General Manufacturing Drawback Rulings

Code of Federal Regulations, 2011 CFR

2011-04-01

... drawback; and 9. Description of the manufacturing or production process, unless specifically described in...) and 55207(1) (see § 191.9 of this part). D. Process Of Manufacture Or Production The imported... it is first separated in the manufacturing process. 2. Appearing-in method The appearing in basis may...

19 CFR Appendix A to Part 191 - General Manufacturing Drawback Rulings

Code of Federal Regulations, 2012 CFR

2012-04-01

... drawback; and 9. Description of the manufacturing or production process, unless specifically described in...) and 55207(1) (see § 191.9 of this part). D. Process Of Manufacture Or Production The imported... it is first separated in the manufacturing process. 2. Appearing-in method The appearing in basis may...

Extended device profiles and testing procedures for the approval process of integrated medical devices using the IEEE 11073 communication standard.

PubMed

Janß, Armin; Thorn, Johannes; Schmitz, Malte; Mildner, Alexander; Dell'Anna-Pudlik, Jasmin; Leucker, Martin; Radermacher, Klaus

2018-02-23

Nowadays, only closed and proprietary integrated operating room systems (IORS) from big manufacturers are available on the market. Hence, the interconnection of components from third-party vendors is only possible with increased time and costs. In the context of the German Federal Ministry of Education and Research (BMBF)-funded project OR.NET (2012-2016), the open integration of medical devices from different manufacturers was addressed. An integrated operating theater based on the open communication standard IEEE 11073 shall give clinical operators the opportunity to choose medical devices independently of the manufacturer. This approach would be advantageous especially for hospital operators and small- and medium-sized enterprises (SME) of medical devices. Actual standards and concepts regarding technical feasibility and the approval process do not cope with the requirements for a modular integration of medical devices in the operating room (OR), based on an open communication standard. Therefore, innovative approval strategies and corresponding certification and test procedures, which cover actual legal and normative standards, have to be developed in order to support the future risk management and the usability engineering process of open integrated medical devices in the OR. The use of standardized device and service profiles and a three-step testing procedure, including conformity, interoperability and integration tests are described in this paper and shall support the manufacturers to integrate their medical devices without disclosing the medical devices' risk analysis and related confidential expertise or proprietary information.

The research and realization of digital management platform for ultra-precision optical elements within life-cycle

NASA Astrophysics Data System (ADS)

Wang, Juan; Wang, Jian; Li, Lijuan; Zhou, Kun

2014-08-01

In order to solve the information fusion, process integration, collaborative design and manufacturing for ultra-precision optical elements within life-cycle management, this paper presents a digital management platform which is based on product data and business processes by adopting the modern manufacturing technique, information technique and modern management technique. The architecture and system integration of the digital management platform are discussed in this paper. The digital management platform can realize information sharing and interaction for information-flow, control-flow and value-stream from user's needs to offline in life-cycle, and it can also enhance process control, collaborative research and service ability of ultra-precision optical elements.

Intelligent system of coordination and control for manufacturing

NASA Astrophysics Data System (ADS)

Ciortea, E. M.

2016-08-01

This paper wants shaping an intelligent system monitoring and control, which leads to optimizing material and information flows of the company. The paper presents a model for tracking and control system using intelligent real. Production system proposed for simulation analysis provides the ability to track and control the process in real time. Using simulation models be understood: the influence of changes in system structure, commands influence on the general condition of the manufacturing process conditions influence the behavior of some system parameters. Practical character consists of tracking and real-time control of the technological process. It is based on modular systems analyzed using mathematical models, graphic-analytical sizing, configuration, optimization and simulation.

Manufacturing DTaP-based combination vaccines: industrial challenges around essential public health tools.

PubMed

Vidor, Emmanuel; Soubeyrand, Benoit

2016-12-01

The manufacture of DTP-backboned combination vaccines is complex, and vaccine quality is evaluated by both batch composition and conformance of manufacturing history. Since their first availability, both the manufacturing regulations for DTP combination vaccines and their demand have evolved significantly. This has resulted in a constant need to modify manufacturing and quality control processes. Areas covered: Regulations that govern the manufacture of complex vaccines can be inconsistent between countries and need to be aligned with the regulatory requirements that apply in all countries of distribution. Changes in product mix and quantities can lead to uncertainty in vaccine supply maintenance. These problems are discussed in the context of the importance of these products as essential public health tools. Expert commentary: Increasing demand for complex vaccines globally has led to problems in supply due to intrinsically complex manufacturing and regulatory procedures. Vaccine manufacturers are fully engaged in the resolution of these challenges, but currently changes in demand need ideally to be anticipated approximately 3 years in advance due to long production cycle times.

Application of Rapid Prototyping and Wire Arc Spray to the Fabrication of Injection Mold Tools (MSFC Center Director's Discretionary Fund)

NASA Technical Reports Server (NTRS)

Cooper, K. G.

2000-01-01

Rapid prototyping (RP) is a layer-by-layer-based additive manufacturing process for constructing three-dimensional representations of a computer design from a wax, plastic, or similar material. Wire arc spray (WAS) is a metal spray forming technique, which deposits thin layers of metal onto a substrate or pattern. Marshall Space Flight Center currently has both capabilities in-house, and this project proposed merging the two processes into an innovative manufacturing technique, in which intermediate injection molding tool halves were to be fabricated with RP and WAS metal forming.

Influence of the forming process on the mechanical behavior of a commingled carbon PPS composite part

NASA Astrophysics Data System (ADS)

Patou, J.; De Luycker, E.; Bonnaire, R.; Cutard, T.; Bernhart, G.

2018-05-01

In this research work, the influence of the forming process on commingled thermoplastic composite parts mechanical behavior was investigated. The aim of this work is to evaluate the influence of fabric shearing on the mechanical response of composite laminate. Different sheets with a given shear angle are manufactured. Tensile experimental results are compared with the properties obtained from a simple model based on the laminate plate theory for various off angles. Later, the link with a tetrahedron shape 3D part manufactured by punch deep drawing will be made.

A tutorial for developing a topical cream formulation based on the Quality by Design approach.

PubMed

Simões, Ana; Veiga, Francisco; Vitorino, Carla; Figueiras, Ana

2018-06-20

The pharmaceutical industry has entered in a new era, as there is a growing interest in increasing the quality standards of dosage forms, through the implementation of more structured development and manufacturing approaches. For many decades, the manufacturing of drug products was controlled by a regulatory framework to guarantee the quality of the final product through a fixed process and exhaustive testing. Limitations related to the Quality by Test (QbT) system have been widely acknowledged. The emergence of Quality by Design (QbD) as a systematic and risk-based approach introduced a new quality concept based on a good understanding of how raw materials and process parameters influence the final quality profile. Although the QbD system has been recognized as a revolutionary approach to product development and manufacturing, its full implementation in the pharmaceutical field is still limited. This is particularly evident in the case of semisolid complex formulation development. The present review aims at establishing a practical QbD framework to describe all stages comprised in the pharmaceutical development of a conventional cream in a comprehensible manner. Copyright © 2018. Published by Elsevier Inc.

Boosting Manufacturing through Modular Chemical Process Intensification

ScienceCinema

None

2018-06-12

Manufacturing USA's Rapid Advancement in Process Intensification Deployment Institute will focus on developing breakthrough technologies to boost domestic energy productivity and energy efficiency by 20 percent in five years through manufacturing processes.

Boosting Manufacturing through Modular Chemical Process Intensification

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

2016-12-09

Manufacturing USA's Rapid Advancement in Process Intensification Deployment Institute will focus on developing breakthrough technologies to boost domestic energy productivity and energy efficiency by 20 percent in five years through manufacturing processes.