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.

Automotive Manufacturing Processes. Volume V - Manufacturing Processes and Equipment for the Mass Production and Assembly of Motor Vehicles

DOT National Transportation Integrated Search

1981-02-01

Extensive material substitution and resizing of the domestic automotive fleet, as well as the introduction of new technologies, will require major changes in the techniques and equipment used in the various manufacturing processes employed in the pro...

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.

Overview of the production of sintered SiC optics and optical sub-assemblies

NASA Astrophysics Data System (ADS)

Williams, S.; Deny, P.

2005-08-01

The following is an overview on sintered silicon carbide (SSiC) material properties and processing requirements for the manufacturing of components for advanced technology optical systems. The overview will compare SSiC material properties to typical materials used for optics and optical structures. In addition, it will review manufacturing processes required to produce optical components in detail by process step. The process overview will illustrate current manufacturing process and concepts to expand the process size capability. The overview will include information on the substantial capital equipment employed in the manufacturing of SSIC. This paper will also review common in-process inspection methodology and design rules. The design rules are used to improve production yield, minimize cost, and maximize the inherent benefits of SSiC for optical systems. Optimizing optical system designs for a SSiC manufacturing process will allow systems designers to utilize SSiC as a low risk, cost competitive, and fast cycle time technology for next generation optical systems.

40 CFR 98.72 - GHGs to report.

Code of Federal Regulations, 2011 CFR

2011-07-01

... GREENHOUSE GAS REPORTING Ammonia Manufacturing § 98.72 GHGs to report. You must report: (a) CO2 process..., reported for each ammonia manufacturing process unit following the requirements of this subpart (CO2... production, and therefore is not released to the ambient air from the ammonia manufacturing process unit). (b...

40 CFR 98.72 - GHGs to report.

Code of Federal Regulations, 2014 CFR

2014-07-01

... GREENHOUSE GAS REPORTING Ammonia Manufacturing § 98.72 GHGs to report. You must report: (a) CO2 process..., reported for each ammonia manufacturing process unit following the requirements of this subpart (CO2... production, and therefore is not released to the ambient air from the ammonia manufacturing process unit). (b...

40 CFR 98.72 - GHGs to report.

Code of Federal Regulations, 2013 CFR

2013-07-01

... GREENHOUSE GAS REPORTING Ammonia Manufacturing § 98.72 GHGs to report. You must report: (a) CO2 process..., reported for each ammonia manufacturing process unit following the requirements of this subpart (CO2... production, and therefore is not released to the ambient air from the ammonia manufacturing process unit). (b...

40 CFR 98.72 - GHGs to report.

Code of Federal Regulations, 2012 CFR

2012-07-01

... GREENHOUSE GAS REPORTING Ammonia Manufacturing § 98.72 GHGs to report. You must report: (a) CO2 process..., reported for each ammonia manufacturing process unit following the requirements of this subpart (CO2... production, and therefore is not released to the ambient air from the ammonia manufacturing process unit). (b...

Encapsulation Processing and Manufacturing Yield Analysis

NASA Technical Reports Server (NTRS)

Willis, P. B.

1984-01-01

The development of encapsulation processing and a manufacturing productivity analysis for photovoltaic cells are discussed. The goals were: (1) to understand the relationships between both formulation variables and process variables; (2) to define conditions required for optimum performance; (3) to predict manufacturing yield; and (4) to provide documentation to industry.

Encapsulation processing and manufacturing yield analysis

NASA Astrophysics Data System (ADS)

Willis, P. B.

1984-10-01

The development of encapsulation processing and a manufacturing productivity analysis for photovoltaic cells are discussed. The goals were: (1) to understand the relationships between both formulation variables and process variables; (2) to define conditions required for optimum performance; (3) to predict manufacturing yield; and (4) to provide documentation to industry.

Cleaning and Cleanliness Measurement of Additive Manufactured Parts

NASA Technical Reports Server (NTRS)

Mitchell, Mark A.; Edwards, Kevin; Fox, Eric; Boothe, Richard

2017-01-01

Additive Manufacturing processes allow for the manufacture of complex three dimensional components that otherwise could not be manufactured. Post treatment processes require the removal of any remnant bulk powder that may become entrapped within small cavities and channels within a component. This project focuses on several gross cleaning methods and the verification metrics associated with additive manufactured parts for oxygen propulsion usage.

Vacuum mechatronics

NASA Technical Reports Server (NTRS)

Hackwood, Susan; Belinski, Steven E.; Beni, Gerardo

1989-01-01

The discipline of vacuum mechatronics is defined as the design and development of vacuum-compatible computer-controlled mechanisms for manipulating, sensing and testing in a vacuum environment. The importance of vacuum mechatronics is growing with an increased application of vacuum in space studies and in manufacturing for material processing, medicine, microelectronics, emission studies, lyophylisation, freeze drying and packaging. The quickly developing field of vacuum mechatronics will also be the driving force for the realization of an advanced era of totally enclosed clean manufacturing cells. High technology manufacturing has increasingly demanding requirements for precision manipulation, in situ process monitoring and contamination-free environments. To remove the contamination problems associated with human workers, the tendency in many manufacturing processes is to move towards total automation. This will become a requirement in the near future for e.g., microelectronics manufacturing. Automation in ultra-clean manufacturing environments is evolving into the concept of self-contained and fully enclosed manufacturing. A Self Contained Automated Robotic Factory (SCARF) is being developed as a flexible research facility for totally enclosed manufacturing. The construction and successful operation of a SCARF will provide a novel, flexible, self-contained, clean, vacuum manufacturing environment. SCARF also requires very high reliability and intelligent control. The trends in vacuum mechatronics and some of the key research issues are reviewed.

40 CFR 98.76 - Data reporting requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

... (CONTINUED) MANDATORY GREENHOUSE GAS REPORTING Ammonia Manufacturing § 98.76 Data reporting requirements. In... specified in paragraphs (a) and (b) of this section, as applicable for each ammonia manufacturing process... paragraph (a): (1) Annual quantity of each type of feedstock consumed for ammonia manufacturing (scf of...

40 CFR 98.76 - Data reporting requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) MANDATORY GREENHOUSE GAS REPORTING Ammonia Manufacturing § 98.76 Data reporting requirements. In... specified in paragraphs (a) and (b) of this section, as applicable for each ammonia manufacturing process... paragraph (a): (1) Annual quantity of each type of feedstock consumed for ammonia manufacturing (scf of...

40 CFR 98.76 - Data reporting requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) MANDATORY GREENHOUSE GAS REPORTING Ammonia Manufacturing § 98.76 Data reporting requirements. In... specified in paragraphs (a) and (b) of this section, as applicable for each ammonia manufacturing process... (2) of this section: (1) Annual quantity of each type of feedstock consumed for ammonia manufacturing...

40 CFR 98.76 - Data reporting requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) MANDATORY GREENHOUSE GAS REPORTING Ammonia Manufacturing § 98.76 Data reporting requirements. In... specified in paragraphs (a) and (b) of this section, as applicable for each ammonia manufacturing process... this paragraph (a): (1) Annual quantity of each type of feedstock consumed for ammonia manufacturing...

40 CFR 98.76 - Data reporting requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) MANDATORY GREENHOUSE GAS REPORTING Ammonia Manufacturing § 98.76 Data reporting requirements. In... specified in paragraphs (a) and (b) of this section, as applicable for each ammonia manufacturing process... paragraph (a): (1) Annual quantity of each type of feedstock consumed for ammonia manufacturing (scf of...

Nonterrestrial material processing and manufacturing of large space systems

NASA Technical Reports Server (NTRS)

Vontiesenhausen, G. F.

1978-01-01

An attempt is made to provide pertinent and readily usable information on the extraterrestrial processing of materials and manufacturing of components and elements of these planned large space systems from preprocessed lunar materials which are made available at a processing and manufacturing site in space. Required facilities, equipment, machinery, energy and manpower are defined.

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.

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.

Additive manufacturing in production: challenges and opportunities

NASA Astrophysics Data System (ADS)

Ahuja, Bhrigu; Karg, Michael; Schmidt, Michael

2015-03-01

Additive manufacturing, characterized by its inherent layer by layer fabrication methodology has been coined by many as the latest revolution in the manufacturing industry. Due to its diversification of Materials, processes, system technology and applications, Additive Manufacturing has been synonymized with terminology such as Rapid prototyping, 3D printing, free-form fabrication, Additive Layer Manufacturing, etc. A huge media and public interest in the technology has led to an innovative attempt of exploring the technology for applications beyond the scope of the traditional engineering industry. Nevertheless, it is believed that a critical factor for the long-term success of Additive Manufacturing would be its ability to fulfill the requirements defined by the traditional manufacturing industry. A parallel development in market trends and product requirements has also lead to a wider scope of opportunities for Additive Manufacturing. The presented paper discusses some of the key challenges which are critical to ensure that Additive Manufacturing is truly accepted as a mainstream production technology in the industry. These challenges would highlight on various aspects of production such as product requirements, process management, data management, intellectual property, work flow management, quality assurance, resource planning, etc. In Addition, changing market trends such as product life cycle, mass customization, sustainability, environmental impact and localized production will form the foundation for the follow up discussion on the current limitations and the corresponding research opportunities. A discussion on ongoing research to address these challenges would include topics like process monitoring, design complexity, process standardization, multi-material and hybrid fabrication, new material development, etc.

40 CFR 63.600 - Applicability.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Standards for Hazardous Air Pollutants From Phosphoric Acid Manufacturing Plants § 63.600 Applicability. (a... apply to the owner or operator of each phosphoric acid manufacturing plant. (b) The requirements of this... affected sources at a phosphoric acid manufacturing plant: (1) Each wet-process phosphoric acid process...

40 CFR 63.600 - Applicability.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Standards for Hazardous Air Pollutants From Phosphoric Acid Manufacturing Plants § 63.600 Applicability. (a... apply to the owner or operator of each phosphoric acid manufacturing plant. (b) The requirements of this... affected sources at a phosphoric acid manufacturing plant: (1) Each wet-process phosphoric acid process...

40 CFR 763.171 - Labeling requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... ACT ASBESTOS Prohibition of the Manufacture, Importation, Processing, and Distribution in Commerce of Certain Asbestos-Containing Products; Labeling Requirements § 763.171 Labeling requirements. (a) After August 27, 1990, manufacturers, importers, and processors of all asbestos-containing products that are...

Supportability Technologies for Future Exploration Missions

NASA Technical Reports Server (NTRS)

Watson, Kevin; Thompson, Karen

2007-01-01

Future long-duration human exploration missions will be challenged by resupply limitations and mass and volume constraints. Consequently, it will be essential that the logistics footprint required to support these missions be minimized and that capabilities be provided to make them highly autonomous from a logistics perspective. Strategies to achieve these objectives include broad implementation of commonality and standardization at all hardware levels and across all systems, repair of failed hardware at the lowest possible hardware level, and manufacture of structural and mechanical replacement components as needed. Repair at the lowest hardware levels will require the availability of compact, portable systems for diagnosis of failures in electronic systems and verification of system functionality following repair. Rework systems will be required that enable the removal and replacement of microelectronic components with minimal human intervention to minimize skill requirements and training demand for crews. Materials used in the assembly of electronic systems (e.g. solders, fluxes, conformal coatings) must be compatible with the available repair methods and the spacecraft environment. Manufacturing of replacement parts for structural and mechanical applications will require additive manufacturing systems that can generate near-net-shape parts from the range of engineering alloys employed in the spacecraft structure and in the parts utilized in other surface systems. These additive manufacturing processes will need to be supported by real-time non-destructive evaluation during layer-additive processing for on-the-fly quality control. This will provide capabilities for quality control and may serve as an input for closed-loop process control. Additionally, non-destructive methods should be available for material property determination. These nondestructive evaluation processes should be incorporated with the additive manufacturing process - providing an in-process capability to ensure that material deposited during layer-additive processing meets required material property criteria.

14 CFR 21.143 - Quality control data requirements; prime manufacturer.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., purchased items, and parts and assemblies produced by manufacturers' suppliers including methods used to... special manufacturing processes involved, the means used to control the processes, the final test... procedure for recording review board decisions and disposing of rejected parts; (5) An outline of a system...

Precision manufacturing for clinical-quality regenerative medicines.

PubMed

Williams, David J; Thomas, Robert J; Hourd, Paul C; Chandra, Amit; Ratcliffe, Elizabeth; Liu, Yang; Rayment, Erin A; Archer, J Richard

2012-08-28

Innovations in engineering applied to healthcare make a significant difference to people's lives. Market growth is guaranteed by demographics. Regulation and requirements for good manufacturing practice-extreme levels of repeatability and reliability-demand high-precision process and measurement solutions. Emerging technologies using living biological materials add complexity. This paper presents some results of work demonstrating the precision automated manufacture of living materials, particularly the expansion of populations of human stem cells for therapeutic use as regenerative medicines. The paper also describes quality engineering techniques for precision process design and improvement, and identifies the requirements for manufacturing technology and measurement systems evolution for such therapies.

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.

CIM's bridge from CADD to CAM: Data management requirements for manufacturing engineering

NASA Technical Reports Server (NTRS)

Ford, S. J.

1984-01-01

Manufacturing engineering represents the crossroads of technical data management in a Computer Integrated Manufacturing (CIM) environment. Process planning, numerical control programming and tool design are the key functions which translate information from as engineered to as assembled. In order to transition data from engineering to manufacturing, it is necessary to introduce a series of product interpretations which contain an interim introduction of technical parameters. The current automation of the product definition and the production process places manufacturing engineering in the center of CAD/CAM with the responsibility of communicating design data to the factory floor via a manufacturing model of the data. A close look at data management requirements for manufacturing engineering is necessary in order to establish the overall specifications for CADD output, CAM input, and CIM integration. The functions and issues associated with the orderly evolution of computer aided engineering and manufacturing are examined.

27 CFR 40.355 - Return of manufacturer.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., DEPARTMENT OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Manufacture of Cigarette Papers and Tubes Taxes § 40.355 Return of manufacturer. (a) Requirement for filing. A manufacturer of cigarette papers and tubes shall file, for each factory...

27 CFR 40.355 - Return of manufacturer.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., DEPARTMENT OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Manufacture of Cigarette Papers and Tubes Taxes § 40.355 Return of manufacturer. (a) Requirement for filing. A manufacturer of cigarette papers and tubes shall file, for each factory...

27 CFR 40.355 - Return of manufacturer.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., DEPARTMENT OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Manufacture of Cigarette Papers and Tubes Taxes § 40.355 Return of manufacturer. (a) Requirement for filing. A manufacturer of cigarette papers and tubes shall file, for each factory...

27 CFR 40.355 - Return of manufacturer.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., DEPARTMENT OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Manufacture of Cigarette Papers and Tubes Taxes § 40.355 Return of manufacturer. (a) Requirement for filing. A manufacturer of cigarette papers and tubes shall file, for each factory...

27 CFR 40.355 - Return of manufacturer.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., DEPARTMENT OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Manufacture of Cigarette Papers and Tubes Taxes § 40.355 Return of manufacturer. (a) Requirement for filing. A manufacturer of cigarette papers and tubes shall file, for each factory...

Near infared spectroscopy in the forest products industry

Treesearch

Chi-Leung So; Brian K. Via; Leslie H. Groom; Lawrence R. Schimleck; Todd F. Shupe; Stephen S. Kelley; Timothy G. Rials

2004-01-01

Improving manufacturing efficiency and increasing product worth requires the right combination of actions throughout the manufacturing process. Many innovations have been developed over the last several decades to achieve these goals. Innovations typically work their way backwards in the manufacturing process, with an increasing level of monitoring occurring at the end...

Collaborative Manufacturing for Small-Medium Enterprises

NASA Astrophysics Data System (ADS)

Irianto, D.

2016-02-01

Manufacturing systems involve decisions concerning production processes, capacity, planning, and control. In a MTO manufacturing systems, strategic decisions concerning fulfilment of customer requirement, manufacturing cost, and due date of delivery are the most important. In order to accelerate the decision making process, research on decision making structure when receiving order and sequencing activities under limited capacity is required. An effective decision making process is typically required by small-medium components and tools maker as supporting industries to large industries. On one side, metal small-medium enterprises are expected to produce parts, components or tools (i.e. jigs, fixture, mold, and dies) with high precision, low cost, and exact delivery time. On the other side, a metal small- medium enterprise may have weak bargaining position due to aspects such as low production capacity, limited budget for material procurement, and limited high precision machine and equipment. Instead of receiving order exclusively, a small-medium enterprise can collaborate with other small-medium enterprise in order to fulfill requirements high quality, low manufacturing cost, and just in time delivery. Small-medium enterprises can share their best capabilities to form effective supporting industries. Independent body such as community service at university can take a role as a collaboration manager. The Laboratory of Production Systems at Bandung Institute of Technology has implemented shared manufacturing systems for small-medium enterprise collaboration.

Automotive Manufacturing Processes. Volume III - Casting and Forging Processes

DOT National Transportation Integrated Search

1981-02-01

Extensive material substitution and resizing of the domestic automotive fleet, as well as the introduction of new technologies, will require major changes in the techniques and equipment used in the various manufacturing processes employed in the pro...

21 CFR 106.3 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... any point in the manufacturing process before packaging. (c) Manufacturer. A manufacturer is a person... any vitamin, mineral, or other substance required in accordance with the table set out in section 412...

78 FR 4038 - Critical Parts for Airplane Propellers

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-18

... requiring a system of processes to identify and manage these parts throughout their service life. This rule... engineering process, a manufacturing process, and a service management process for propeller critical parts... engineering process, to how the part is manufactured and to how the part is maintained in service. Engineering...

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.

40 CFR 763.165 - Manufacture and importation prohibitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Manufacture and importation...) TOXIC SUBSTANCES CONTROL ACT ASBESTOS Prohibition of the Manufacture, Importation, Processing, and Distribution in Commerce of Certain Asbestos-Containing Products; Labeling Requirements § 763.165 Manufacture...

Automotive Manufacturing Processes. Volume IV - Metal Stamping and Plastic Forming Processes

DOT National Transportation Integrated Search

1981-02-01

Extensive material substitution and resizing of the domestic automotive fleet, as well as the introduction of new technologies, will require major changes in the techniques and equipment used in the various manufacturing processes employed in the pro...

27 CFR 40.524 - Retention of documents.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., AND PROCESSED TOBACCO Manufacture of Processed Tobacco Operations by Manufacturers of Processed... and reports required under this subpart, including copies of permits, authorizations, inventories, and... of an authorization, for three years following the close of the calendar year in which the operation...

40 CFR 63.11940 - What continuous monitoring requirements must I meet for control devices required to install CPMS...

Code of Federal Regulations, 2012 CFR

2012-07-01

... consistent with the manufacturer's recommendations within 15 days or by the next time any process vent stream... the manufacturer's recommendations within 15 days or by the next time any process vent stream is...) Determine gas stream flow using the design blower capacity, with appropriate adjustments for pressure drop...

40 CFR 98.72 - GHGs to report.

Code of Federal Regulations, 2010 CFR

2010-07-01

... GREENHOUSE GAS REPORTING Ammonia Manufacturing § 98.72 GHGs to report. You must report: (a) CO2 process..., reported for each ammonia manufacturing process unit following the requirements in this subpart. (b) CO2...

Analytic network process model for sustainable lean and green manufacturing performance indicator

NASA Astrophysics Data System (ADS)

Aminuddin, Adam Shariff Adli; Nawawi, Mohd Kamal Mohd; Mohamed, Nik Mohd Zuki Nik

2014-09-01

Sustainable manufacturing is regarded as the most complex manufacturing paradigm to date as it holds the widest scope of requirements. In addition, its three major pillars of economic, environment and society though distinct, have some overlapping among each of its elements. Even though the concept of sustainability is not new, the development of the performance indicator still needs a lot of improvement due to its multifaceted nature, which requires integrated approach to solve the problem. This paper proposed the best combination of criteria en route a robust sustainable manufacturing performance indicator formation via Analytic Network Process (ANP). The integrated lean, green and sustainable ANP model can be used to comprehend the complex decision system of the sustainability assessment. The finding shows that green manufacturing is more sustainable than lean manufacturing. It also illustrates that procurement practice is the most important criteria in the sustainable manufacturing performance indicator.

Near Infrared Spectroscopy in the Forest Products Industry, Forest Products Journal

Treesearch

Chi-Leung So; Brian K. Via; Leslie H. Groom; Laurence R. Schimleck; Todd F. Shupe; Stephen S. Kelley; Timothy G. Rials

2004-01-01

Improving manufacturing efficiency and increasing product worth requires the right combination of actions throughout the manufacturing process. Many innovations have been developed over the last several decades to achieve these goals. Innovations typically work their way backwards in the manufacturing process, with an increasing level of monitoring occurring at the...

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

Free-world microelectronic manufacturing equipment

NASA Astrophysics Data System (ADS)

Kilby, J. S.; Arnold, W. H.; Booth, W. T.; Cunningham, J. A.; Hutcheson, J. D.; Owen, R. W.; Runyan, W. R.; McKenney, Barbara L.; McGrain, Moira; Taub, Renee G.

1988-12-01

Equipment is examined and evaluated for the manufacture of microelectronic integrated circuit devices and sources for that equipment within the Free World. Equipment suitable for the following are examined: single-crystal silicon slice manufacturing and processing; required lithographic processes; wafer processing; device packaging; and test of digital integrated circuits. Availability of the equipment is also discussed, now and in the near future. Very adequate equipment for most stages of the integrated circuit manufacturing process is available from several sources, in different countries, although the best and most widely used versions of most manufacturing equipment are made in the United States or Japan. There is also an active market in used equipment, suitable for manufacture of capable integrated circuits with performance somewhat short of the present state of the art.

Utilization of curve offsets in additive manufacturing

NASA Astrophysics Data System (ADS)

Haseltalab, Vahid; Yaman, Ulas; Dolen, Melik

2018-05-01

Curve offsets are utilized in different fields of engineering and science. Additive manufacturing, which lately becomes an explicit requirement in manufacturing industry, utilizes curve offsets widely. One of the necessities of offsetting is for scaling which is required if there is shrinkage after the fabrication or if the surface quality of the resulting part is unacceptable. Therefore, some post-processing is indispensable. But the major application of curve offsets in additive manufacturing processes is for generating head trajectories. In a point-wise AM process, a correct tool-path in each layer can reduce lots of costs and increase the surface quality of the fabricated parts. In this study, different curve offset generation algorithms are analyzed to show their capabilities and disadvantages through some test cases and improvements on their drawbacks are suggested.

Product manufacturing, quality, and reliability initiatives to maintain a competitive advantage and meet customer expectations in the semiconductor industry

NASA Astrophysics Data System (ADS)

Capps, Gregory

Semiconductor products are manufactured and consumed across the world. The semiconductor industry is constantly striving to manufacture products with greater performance, improved efficiency, less energy consumption, smaller feature sizes, thinner gate oxides, and faster speeds. Customers have pushed towards zero defects and require a more reliable, higher quality product than ever before. Manufacturers are required to improve yields, reduce operating costs, and increase revenue to maintain a competitive advantage. Opportunities exist for integrated circuit (IC) customers and manufacturers to work together and independently to reduce costs, eliminate waste, reduce defects, reduce warranty returns, and improve quality. This project focuses on electrical over-stress (EOS) and re-test okay (RTOK), two top failure return mechanisms, which both make great defect reduction opportunities in customer-manufacturer relationship. Proactive continuous improvement initiatives and methodologies are addressed with emphasis on product life cycle, manufacturing processes, test, statistical process control (SPC), industry best practices, customer education, and customer-manufacturer interaction.

Low-Cost Opportunity for Small-Scale Manufacture of Hardwood Blanks

Treesearch

Bruce G. Hansen; Philip A. Araman

1985-01-01

We analyzed the manufacture of standard-size hardwood blanks from lumber on a relatively small scale by conventional processing. Requiring an investment of just over $200,000, the conventional mill can process 500 M bf (thousand board feet) of kiln-dried lumber annually. The study focused on the economics associated with manufacture of blanks from four species -...

21 CFR 111.90 - What requirements apply to treatments, in-process adjustments, and reprocessing when there is a...

Code of Federal Regulations, 2010 CFR

2010-04-01

... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... rejected dietary supplement or treat or provide an in-process adjustment to a component, packaging, or label to make it suitable for use in the manufacture of a dietary supplement unless: (1) Quality control...

16 CFR 300.25 - Country where wool products are processed or manufactured.

Code of Federal Regulations, 2014 CFR

2014-01-01

... an origin label on the unfinished product, the manufacturing processes as required in paragraph (a)(4... (a) (2), (3), or (4) of this section, a manufacturer needs to consider the origin of only those... of the name does not appear with such other words so as to refer to a kind of species of product...

16 CFR 300.25 - Country where wool products are processed or manufactured.

Code of Federal Regulations, 2013 CFR

2013-01-01

... an origin label on the unfinished product, the manufacturing processes as required in paragraph (a)(4... (a) (2), (3), or (4) of this section, a manufacturer needs to consider the origin of only those... of the name does not appear with such other words so as to refer to a kind of species of product...

16 CFR 300.25 - Country where wool products are processed or manufactured.

Code of Federal Regulations, 2012 CFR

2012-01-01

... an origin label on the unfinished product, the manufacturing processes as required in paragraph (a)(4... (a) (2), (3), or (4) of this section, a manufacturer needs to consider the origin of only those... of the name does not appear with such other words so as to refer to a kind of species of product...

Automotive Manufacturing Processes. volume I - Overview

DOT National Transportation Integrated Search

1981-02-01

Extensive material substitution and re-sizing of the domestic automotive fleet, as well as the introduction of new technologies, will require major changes in the techniques and equipment used in the various manufacturing processes employed in the pr...

Automotive Manufacturing Processes. Volume I - Overview

DOT National Transportation Integrated Search

1981-02-01

Extensive material substitution and re-sizing of the domestic automotive fleet, as well as the introduction of new technologies, will require major changes in the techniques and equipment used in the various manufacturing processes employed in the pr...

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.

Planning Study to Establish DoD Manufacturing Technology Information Analysis Center.

DTIC Science & Technology

1981-01-01

model for an MTIAC. 5-3 I Type of information inputs from potential MTIAC sources. 5-5 5-3 Processing functions required to produce MTIAC outputs. 5-8...short supply * Energy conservation and concerns of energy inten- siveness of various manufacturing processes and systems required for production of DOD...not play a major role in the process of MT invention, innovation, or diffusion. MT productivity efforts for private industry are carried out by

Manufacturing Planning Guide

NASA Technical Reports Server (NTRS)

Waid, Michael

2011-01-01

Manufacturing process, milestones and inputs are unknowns to first-time users of the manufacturing facilities. The Manufacturing Planning Guide aids in establishing expectations for both NASA and non-NASA facility customers. The potential audience for this guide includes both internal and commercial spaceflight hardware/software developers. It is intended to assist their project engineering personnel in manufacturing planning and execution. Material covered includes a roadmap of the manufacturing process, roles and responsibilities of facility and user, major milestones, facility capabilities, and inputs required by the facility. Samples of deliverables, products, and inputs necessary to define test scope, cost, and schedule are included as an appendix to the guide.

Space station automation study. Automation requirements derived from space manufacturing concepts. Volume 1: Executive summary

NASA Technical Reports Server (NTRS)

1984-01-01

The two manufacturing concepts developed represent innovative, technologically advanced manufacturing schemes. The concepts were selected to facilitate an in depth analysis of manufacturing automation requirements in the form of process mechanization, teleoperation and robotics, and artificial intelligence. While the cost effectiveness of these facilities has not been analyzed as part of this study, both appear entirely feasible for the year 2000 timeframe. The growing demand for high quality gallium arsenide microelectronics may warrant the ventures.

Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles; Garcia, Tom; Bizjak, Tara Gooen; Holte, Oyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti; Morefield, Elaine; Montgomery, Frank; Nasr, Moheb; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Zezza, Diane

2015-03-01

This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Key technologies for manufacturing and processing sheet materials: A global perspective

NASA Astrophysics Data System (ADS)

Demeri, Mahmoud Y.

2001-02-01

Modern industrial technologies continue to seek new materials and processes to produce products that meet design and functional requirements. Sheet materials made from ferrous and non-ferrous metals, laminates, composites, and reinforced plastics constitute a large percentage of today’s products, components, and systems. Major manufacturers of sheet products include automotive, aerospace, appliance, and food-packaging industries. The Second Global Symposium on Innovations in Materials Processing & Manufacturing: Sheet Materials is organized to provide a forum for presenting advances in sheet processing and manufacturing by worldwide researchers and engineers from industrial, research, and academic centers. The symposium, sponsored by the TMS Materials Processing & Manufacturing Division (MPMD), was planned for the 2001 TMS Annual Meeting, New Orleans, Louisiana, February 11 15, 2001. This article is a review of key papers submitted for publication in the concurrent volume. The selected papers present significant developments in the rapidly expanding areas of advanced sheet materials, innovative forming methods, industrial applications, primary and secondary processing, composite processing, and numerical modeling of manufacturing processes.

Advanced Near Net Shape Technology

NASA Technical Reports Server (NTRS)

Vickers, John

2015-01-01

The objective of the Advanced Near Net Shape Technology (ANNST) project is to radically improve near net shape manufacturing methods from the current Technology/ Manufacturing Readiness Levels (TRL/MRL 3-4) to the point where they are viable candidates (TRL/ MRL-6) for shortening the time and cost for insertion of new aluminum alloys and revolutionary manufacturing methods into the development/improvement of space structures. Conventional cyrotank manufacturing processes require fabrication of multiple pieces welded together to form a complete tank. A variety of near net shape manufacturing processes has demonstrated excellent potential for enabling single-piece construction of components such as domes, barrels, and ring frames. Utilization of such processes can dramatically reduce the extent of welding and joining needed to construct cryogenic tanks and other aerospace structures. The specific focus of this project is to successfully mature the integrally stiffened cylinder (ISC) process in which a single-piece cylinder with integral stiffeners is formed in one spin/flow forming process. Structural launch vehicle components, like cryogenic fuel tanks (e.g., space shuttle external tank), are currently fabricated via multipiece assembly of parts produced through subtractive manufacturing techniques. Stiffened structural panels are heavily machined from thick plate, which results in excessive scrap rates. Multipiece construction requires welds to assemble the structure, which increases the risk for defects and catastrophic failures.

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.

Automated process planning system

NASA Technical Reports Server (NTRS)

Mann, W.

1978-01-01

Program helps process engineers set up manufacturing plans for machined parts. System allows one to develop and store library of similar parts characteristics, as related to particular facility. Information is then used in interactive system to help develop manufacturing plans that meet required standards.

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.

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...

An Introduction to Intelligent Processing Programs Developed by the Air Force Manufacturing Technology Directorate

NASA Technical Reports Server (NTRS)

Sampson, Paul G.; Sny, Linda C.

1992-01-01

The Air Force has numerous on-going manufacturing and integration development programs (machine tools, composites, metals, assembly, and electronics) which are instrumental in improving productivity in the aerospace industry, but more importantly, have identified strategies and technologies required for the integration of advanced processing equipment. An introduction to four current Air Force Manufacturing Technology Directorate (ManTech) manufacturing areas is provided. Research is being carried out in the following areas: (1) machining initiatives for aerospace subcontractors which provide for advanced technology and innovative manufacturing strategies to increase the capabilities of small shops; (2) innovative approaches to advance machine tool products and manufacturing processes; (3) innovative approaches to advance sensors for process control in machine tools; and (4) efforts currently underway to develop, with the support of industry, the Next Generation Workstation/Machine Controller (Low-End Controller Task).

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.

Closing the Gap Between Process Control Theory and Practice

ERIC Educational Resources Information Center

Velazquez, Carlos; Cardona-Martinez, Nelson; Velazquez, Edwin

2010-01-01

The pressure on world-wide manufacturing industries to meet tougher demands and regulations has forced companies to focus on improving manufacturing using tools like process automation. This focus requires better-prepared students. The process control course of the Department of Chemical Engineering at the University of Puerto Rico at Mayaguez has…

40 CFR 763.165 - Manufacture and importation prohibitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) TOXIC SUBSTANCES CONTROL ACT ASBESTOS Prohibition of the Manufacture, Importation, Processing, and Distribution in Commerce of Certain Asbestos-Containing Products; Labeling Requirements § 763.165 Manufacture... following asbestos-containing products, either for use in the United States or for export: flooring felt and...

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.

40 CFR 704.102 - Hexachloronorbornadiene.

Code of Federal Regulations, 2010 CFR

2010-07-01

...., manufacture and processing) must report the information required in paragraph (d) separately for each activity... 3, 1986, or 30 days after making the management decision described in § 704.3 “Propose to... manufacture, importation, or processing volume of a particular chemical substance at any individual site owned...

16 CFR 1210.16 - Production testing.

Code of Federal Regulations, 2010 CFR

2010-01-01

... in the manufacturing process, the assembly process, the equipment used to manufacture the product, or... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Production testing. 1210.16 Section 1210.16... STANDARD FOR CIGARETTE LIGHTERS Certification Requirements § 1210.16 Production testing. (a) General...

A hybrid life cycle inventory of nano-scale semiconductor manufacturing.

PubMed

Krishnan, Nikhil; Boyd, Sarah; Somani, Ajay; Raoux, Sebastien; Clark, Daniel; Dornfeld, David

2008-04-15

The manufacturing of modern semiconductor devices involves a complex set of nanoscale fabrication processes that are energy and resource intensive, and generate significant waste. It is important to understand and reduce the environmental impacts of semiconductor manufacturing because these devices are ubiquitous components in electronics. Furthermore, the fabrication processes used in the semiconductor industry are finding increasing application in other products, such as microelectromechanical systems (MEMS), flat panel displays, and photovoltaics. In this work we develop a library of typical gate-to-gate materials and energy requirements, as well as emissions associated with a complete set of fabrication process models used in manufacturing a modern microprocessor. In addition, we evaluate upstream energy requirements associated with chemicals and materials using both existing process life cycle assessment (LCA) databases and an economic input-output (EIO) model. The result is a comprehensive data set and methodology that may be used to estimate and improve the environmental performance of a broad range of electronics and other emerging applications that involve nano and micro fabrication.

A Framework for Automating Cost Estimates in Assembly Processes

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

Calton, T.L.; Peters, R.R.

1998-12-09

When a product concept emerges, the manufacturing engineer is asked to sketch out a production strategy and estimate its cost. The engineer is given an initial product design, along with a schedule of expected production volumes. The engineer then determines the best approach to manufacturing the product, comparing a variey of alternative production strategies. The engineer must consider capital cost, operating cost, lead-time, and other issues in an attempt to maximize pro$ts. After making these basic choices and sketching the design of overall production, the engineer produces estimates of the required capital, operating costs, and production capacity. 177is process maymore » iterate as the product design is refined in order to improve its pe~ormance or manufacturability. The focus of this paper is on the development of computer tools to aid manufacturing engineers in their decision-making processes. This computer sof~are tool provides aj?amework in which accurate cost estimates can be seamlessly derivedfiom design requirements at the start of any engineering project. Z+e result is faster cycle times through first-pass success; lower ll~e cycie cost due to requirements-driven design and accurate cost estimates derived early in the process.« less

Space station automation study: Automation requriements derived from space manufacturing concepts,volume 2

NASA Technical Reports Server (NTRS)

1984-01-01

Automation reuirements were developed for two manufacturing concepts: (1) Gallium Arsenide Electroepitaxial Crystal Production and Wafer Manufacturing Facility, and (2) Gallium Arsenide VLSI Microelectronics Chip Processing Facility. A functional overview of the ultimate design concept incoporating the two manufacturing facilities on the space station are provided. The concepts were selected to facilitate an in-depth analysis of manufacturing automation requirements in the form of process mechanization, teleoperation and robotics, sensors, and artificial intelligence. While the cost-effectiveness of these facilities was not analyzed, both appear entirely feasible for the year 2000 timeframe.

Regulatory and Quality Considerations for Continuous Manufacturing May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles; Garcia, Tom; Bizjak, Tara Gooen; Holte, Oyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti; Morefield, Elaine; Montgomery, Frank; Nasr, Moheb; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Zezza, Diane

2015-03-01

This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Specificity of Good Manufacturing Practice (GMP) for Biomedical Cell Products.

PubMed

Tulina, M A; Pyatigorskaya, N V

2018-03-01

The article describes special aspects of Good Manufacturing Practice (GMP) for biomedical cell products (BMCP) that imply high standards of aseptics throughout the entire productio process, strict requirements to donors and to the procedure of biomaterial isolation, guaranty of tracing BMCP products, defining processing procedures which allow to identify BMCP as minimally manipulated; continuous quality control and automation of the control process at all stages of manufacturing, which will ensure product release simultaneously with completion of technological operations.

Framework for adaptive interoperability of manufacturing enterprises (FAIME): a case study

NASA Astrophysics Data System (ADS)

Sims, John E.; Chu, Bei Tseng B.; Long, Junshen; Matthews, Mike; Barnes, Johnny G.; Jones, Chris H.; Anderson, Rayne A.; Lambert, Russ; Drake, Doug C.; Hamilton, Mark A.; Connard, Mark

1997-01-01

In todays global economy, manufacturing industries require to connect disparate applications seamlessly. They require not only to exchange data and transactions, but present a single business process image to their employees in the office, headquarters, and on the plant floor. Also, it is imperative that small and medium size manufacturing companies deploy manufacturing execution systems applications in conjunction with modern enterprise resource programs for cycle time reduction and better quality. This paper presents the experiences and reflections on a project that created a tool set to assist the above be accomplished not only in a shorter cycle time, with a better predictable quality, and with an object oriented framework, but also a tool set that allows the manufacturer to still use legacy applications. This framework has the capability of plug-and- play so that future migrations and re-engineering of processes are more productive.

21 CFR 111.155 - What requirements apply to components of dietary supplements?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.155 What requirements apply to components of dietary... components before you use them in the manufacture of a dietary supplement until: (1) You collect...

21 CFR 111.155 - What requirements apply to components of dietary supplements?

Code of Federal Regulations, 2013 CFR

2013-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.155 What requirements apply to components of dietary... components before you use them in the manufacture of a dietary supplement until: (1) You collect...

21 CFR 111.370 - What requirements apply to rejected dietary supplements?

Code of Federal Regulations, 2013 CFR

2013-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or... 21 Food and Drugs 2 2013-04-01 2013-04-01 false What requirements apply to rejected dietary...

21 CFR 111.370 - What requirements apply to rejected dietary supplements?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or... 21 Food and Drugs 2 2014-04-01 2014-04-01 false What requirements apply to rejected dietary...

21 CFR 111.160 - What requirements apply to packaging and labels received?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

21 CFR 111.160 - What requirements apply to packaging and labels received?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

21 CFR 111.155 - What requirements apply to components of dietary supplements?

Code of Federal Regulations, 2011 CFR

2011-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.155 What requirements apply to components of dietary... components before you use them in the manufacture of a dietary supplement until: (1) You collect...

21 CFR 111.370 - What requirements apply to rejected dietary supplements?

Code of Federal Regulations, 2011 CFR

2011-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What requirements apply to rejected dietary...

21 CFR 111.155 - What requirements apply to components of dietary supplements?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.155 What requirements apply to components of dietary... components before you use them in the manufacture of a dietary supplement until: (1) You collect...

21 CFR 111.370 - What requirements apply to rejected dietary supplements?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or... 21 Food and Drugs 2 2012-04-01 2012-04-01 false What requirements apply to rejected dietary...

21 CFR 111.160 - What requirements apply to packaging and labels received?

Code of Federal Regulations, 2013 CFR

2013-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

21 CFR 111.160 - What requirements apply to packaging and labels received?

Code of Federal Regulations, 2011 CFR

2011-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

21 CFR 111.370 - What requirements apply to rejected dietary supplements?

Code of Federal Regulations, 2010 CFR

2010-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to rejected dietary...

40 CFR 725.1 - Scope and purpose.

Code of Federal Regulations, 2010 CFR

2010-07-01

... research and development for commercial purposes. New microorganisms for which manufacturers and importers... any microorganism that EPA determines by rule is being manufactured, imported, or processed for a significant new use. (b) Any manufacturer, importer, or processor required to report under section 5 of TSCA...

A risk-based auditing process for pharmaceutical manufacturers.

PubMed

Vargo, Susan; Dana, Bob; Rangavajhula, Vijaya; Rönninger, Stephan

2014-01-01

The purpose of this article is to share ideas on developing a risk-based model for the scheduling of audits (both internal and external). Audits are a key element of a manufacturer's quality system and provide an independent means of evaluating the manufacturer's or the supplier/vendor's compliance status. Suggestions for risk-based scheduling approaches are discussed in the article. Pharmaceutical manufacturers are required to establish and implement a quality system. The quality system is an organizational structure defining responsibilities, procedures, processes, and resources that the manufacturer has established to ensure quality throughout the manufacturing process. Audits are a component of the manufacturer's quality system and provide a systematic and an independent means of evaluating the manufacturer's overall quality system and compliance status. Audits are performed at defined intervals for a specified duration. The intention of the audit process is to focus on key areas within the quality system and may not cover all relevant areas during each audit. In this article, the authors provide suggestions for risk-based scheduling approaches to aid pharmaceutical manufacturers in identifying the key focus areas for an audit.

Simulation and Validation of Injection-Compression Filling Stage of Liquid Moulding with Fast Curing Resins

NASA Astrophysics Data System (ADS)

Martin, Ffion A.; Warrior, Nicholas A.; Simacek, Pavel; Advani, Suresh; Hughes, Adrian; Darlington, Roger; Senan, Eissa

2018-03-01

Very short manufacture cycle times are required if continuous carbon fibre and epoxy composite components are to be economically viable solutions for high volume composite production for the automotive industry. Here, a manufacturing process variant of resin transfer moulding (RTM), targets a reduction of in-mould manufacture time by reducing the time to inject and cure components. The process involves two stages; resin injection followed by compression. A flow simulation methodology using an RTM solver for the process has been developed. This paper compares the simulation prediction to experiments performed using industrial equipment. The issues encountered during the manufacturing are included in the simulation and their sensitivity to the process is explored.

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...

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.

Toward a space materials systems program

NASA Technical Reports Server (NTRS)

Vontiesenhausen, G. F.

1981-01-01

A program implementation model is presented which covers the early stages of space material processing and manufacturing. The model includes descriptions of major program elements, development and experiment requirements in space materials processing and manufacturing, and an integration of the model into NASA's long range plans as well as its evolution from present Materials Processing in Space plans.

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.

The role of the user within the medical device design and development process: medical device manufacturers' perspectives

PubMed Central

2011-01-01

Background Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD) process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so. Methods In-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any) they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device manufacturers' beliefs and attitudes towards user involvement within the MDDD process. Results A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process. Conclusions Medical device manufacturers often do not see the benefit of employing formal human factors engineering methods within the MDDD process. Research is required to better understand the day-to-day requirements of manufacturers within this sector. The development of new or adapted methods may be required if user involvement is to be fully realised. PMID:21356097

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.

30 CFR 7.98 - Technical requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... the manufacturing process to not more than 250 microinches. (ii) A means shall be provided to ensure...) The minimum thread engagement of fastenings shall be equal to or greater than the nominal diameter of... flame-arresting path shall be finished during the manufacturing process to not more than 250 microinches...

30 CFR 7.98 - Technical requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... the manufacturing process to not more than 250 microinches. (ii) A means shall be provided to ensure...) The minimum thread engagement of fastenings shall be equal to or greater than the nominal diameter of... flame-arresting path shall be finished during the manufacturing process to not more than 250 microinches...

30 CFR 7.98 - Technical requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

... the manufacturing process to not more than 250 microinches. (ii) A means shall be provided to ensure...) The minimum thread engagement of fastenings shall be equal to or greater than the nominal diameter of... flame-arresting path shall be finished during the manufacturing process to not more than 250 microinches...

29 CFR 570.33 - Prohibited occupations for minors 14 and 15 years of age.

Code of Federal Regulations, 2010 CFR

2010-07-01

... shall apply to all occupations other than the following: (a) Manufacturing, mining, or processing... revised text is set forth as follows: § 570.33 Occupations that are prohibited to minors 14 and 15 years... age: (a) Manufacturing, mining, or processing occupations, including occupations requiring the...

40 CFR 63.104 - Heat exchange system requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Standards for Organic Hazardous Air Pollutants From the Synthetic Organic Chemical Manufacturing Industry... subpart shall monitor each heat exchange system used to cool process equipment in a chemical manufacturing process unit meeting the conditions of § 63.100 (b)(1) through (b)(3) of this subpart, except for chemical...

40 CFR 63.104 - Heat exchange system requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Standards for Organic Hazardous Air Pollutants From the Synthetic Organic Chemical Manufacturing Industry... subpart shall monitor each heat exchange system used to cool process equipment in a chemical manufacturing process unit meeting the conditions of § 63.100 (b)(1) through (b)(3) of this subpart, except for chemical...

40 CFR 63.104 - Heat exchange system requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Standards for Organic Hazardous Air Pollutants From the Synthetic Organic Chemical Manufacturing Industry... subpart shall monitor each heat exchange system used to cool process equipment in a chemical manufacturing process unit meeting the conditions of § 63.100 (b)(1) through (b)(3) of this subpart, except for chemical...

Large Spun Formed Friction-Stir Welded Tank Domes for Liquid Propellant Tanks Made from AA2195: A Technology Demonstration for the Next Generation of Heavy Lift Launchers

NASA Technical Reports Server (NTRS)

Stachulla, M.; Pernpeinter, R.; Brewster J.; Curreri, P.; Hoffman, E.

2010-01-01

Improving structural efficiency while reducing manufacturing costs are key objectives when making future heavy-lift launchers more performing and cost efficient. The main enabling technologies are the application of advanced high performance materials as well as cost effective manufacture processes. This paper presents the status and main results of a joint industrial research & development effort to demonstrate TRL 6 of a novel manufacturing process for large liquid propellant tanks for launcher applications. Using high strength aluminium-lithium alloy combined with the spin forming manufacturing technique, this development aims at thinner wall thickness and weight savings up to 25% as well as a significant reduction in manufacturing effort. In this program, the concave spin forming process is used to manufacture tank domes from a single flat plate. Applied to aluminium alloy, this process allows reaching the highest possible material strength status T8, eliminating numerous welding steps which are typically necessary to assemble tank domes from 3D-curved panels. To minimize raw material costs for large diameter tank domes for launchers, the dome blank has been composed from standard plates welded together prior to spin forming by friction stir welding. After welding, the dome blank is contoured in order to meet the required wall thickness distribution. For achieving a material state of T8, also in the welding seams, the applied spin forming process allows the required cold stretching of the 3D-curved dome, with a subsequent ageing in a furnace. This combined manufacturing process has been demonstrated up to TRL 6 for tank domes with a 5.4 m diameter. In this paper, the manufacturing process as well as test results are presented. Plans are shown how this process could be applied to future heavy-lift launch vehicles developments, also for larger dome diameters.

Modeling of additive manufacturing processes for metals: Challenges and opportunities

DOE PAGES

Francois, Marianne M.; Sun, Amy; King, Wayne E.; ...

2017-01-09

Here, with the technology being developed to manufacture metallic parts using increasingly advanced additive manufacturing processes, a new era has opened up for designing novel structural materials, from designing shapes and complex geometries to controlling the microstructure (alloy composition and morphology). The material properties used within specific structural components are also designable in order to meet specific performance requirements that are not imaginable with traditional metal forming and machining (subtractive) techniques.

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2013 CFR

2013-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2014 CFR

2014-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2012 CFR

2012-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2011 CFR

2011-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2010 CFR

2010-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

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.

Manufacturing of GLARE Parts and Structures

NASA Astrophysics Data System (ADS)

Sinke, J.

2003-07-01

GLARE is a hybrid material consisting of alternating layers of metal sheets and composite layers, requiring special attention when manufacturing of parts and structures is concerned. On one hand the applicable manufacturing processes for GLARE are limited, on the other hand, due to the constituents and composition of the laminate, it offers new opportunities for production. One of the opportunities is the manufacture of very large skin panels by lay-up techniques. Lay-up techniques are common for full composites, but uncommon for metallic structures. Nevertheless, large GLARE skin panels are made by lay-up processes. In addition, the sequences of forming and laminating processes, that can be selected, offer manufacturing options that are not applicable to metals or full composites. With respect to conventional manufacturing processes, the possibilities for Fibre Metal Laminates in general, are limited. The limits are partly due to the different failure modes, partly due to the properties of the constituents in the laminate. For machining processes: the wear of the cutting tools during machining operations of GLARE stems from the abrasive nature of the glass fibres. For the forming processes: the limited formability, expressed by a small failure strain, is related to the glass fibres. However, although these manufacturing issues may restrict the use of manufacturing processes for FMLs, application of these laminates in aircraft is not hindered.

Current manufacturing processes of drug-eluting sutures.

PubMed

Champeau, Mathilde; Thomassin, Jean-Michel; Tassaing, Thierry; Jérôme, Christine

2017-11-01

Drug-eluting sutures represent the next generation of surgical sutures since they fulfill their mechanical functions but also deliver the drug in their vicinity after implantation. These implants are produced by a variety of manufacturing processes. Drug-eluting sutures represent the next generation of surgical sutures since they fulfill their mechanical functions but also deliver the drug in their vicinity after implantation. These implants are produced by a variety of manufacturing processes. Two general approaches can be followed: (i) the ones that add the API into the material during the manufacturing process of the suture and (ii) the ones that load the API to an already manufactured suture. Areas covered: This review provides an overview of the current manufacturing processes for drug-eluting suture production and discusses their benefits and drawbacks depending on the type of drugs. The mechanical properties and the drug delivery profile of drug-eluting sutures are highlighted since these implants must fulfill both criteria. Expert opinion: For limited drug contents, melt extrusion and electrospinning are the emerging processes since the drug is added during the suture manufacture process. Advantageously, the drug release profile can be tuned by controlling the processing parameters specific to each process and the composition of the drug-containing polymer. If high drug content is targeted, the coating or grafting of a drug layer on a pre-manufactured suture allows for preservation of the tensile strength requirements of the suture.

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.

Manufacturing methods of a composite cell case for a Ni-Cd battery

NASA Technical Reports Server (NTRS)

Bauer, J. L.; Bogner, R. S.; Lowe, E. P.; Orlowski, E.

1979-01-01

Graphite epoxy material for a nickel cadmium battery cell case has been evaluated and determined to perform in the simulated environment of the battery. The basic manufacturing method requires refinement to demonstrate production feasibility. The various facets of production scale-up, i.e., process and tooling development together with material and process control, have been integrated into a comprehensive manufacturing process that assures production reproducibility and product uniformity. Test results substantiate that a battery cell case produced from graphite epoxy pre-impregnated material utilizing internal pressure bag fabrication method is feasible.

System of error detection in the manufacture of garments using artificial vision

NASA Astrophysics Data System (ADS)

Moreno, J. J.; Aguila, A.; Partida, E.; Martinez, C. L.; Morales, O.; Tejeida, R.

2017-12-01

A computer vision system is implemented to detect errors in the cutting stage within the manufacturing process of garments in the textile industry. It provides solution to errors within the process that cannot be easily detected by any employee, in addition to significantly increase the speed of quality review. In the textile industry as in many others, quality control is required in manufactured products and this has been carried out manually by means of visual inspection by employees over the years. For this reason, the objective of this project is to design a quality control system using computer vision to identify errors in the cutting stage within the garment manufacturing process to increase the productivity of textile processes by reducing costs.

Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; revision of certain labeling controls--FDA. Final rule.

PubMed

1993-08-03

The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human and veterinary drug products to revise certain labeling control provisions. Specifically, the final rule defines the term "gang-printed labeling," specifies conditions for the use of gang-printed or cut labeling, exempts manufacturers that employ automated 100-percent labeling inspection systems from CGMP labeling reconciliation requirements, and requires manufacturers to identify filled drug product containers that are set aside and held in an unlabeled condition for future labeling operations. These changes are intended to reduce the frequency of drug product mislabeling and associated drug product recalls.

Space station automation study: Automation requirements derived from space manufacturing concepts. Volume 1: Executive summary

NASA Technical Reports Server (NTRS)

1984-01-01

The electroepitaxial process and the Very Large Scale Integration (VLSI) circuits (chips) facilities were chosen because each requires a very high degree of automation, and therefore involved extensive use of teleoperators, robotics, process mechanization, and artificial intelligence. Both cover a raw materials process and a sophisticated multi-step process and are therfore highly representative of the kinds of difficult operation, maintenance, and repair challenges which can be expected for any type of space manufacturing facility. Generic areas were identified which will require significant further study. The initial design will be based on terrestrial state-of-the-art hard automation. One hundred candidate missions were evaluated on the basis of automation portential and availability of meaning ful knowldege. The design requirements and unconstrained design concepts developed for the two missions are presented.

Implementation of a Web-Based Collaborative Process Planning System

NASA Astrophysics Data System (ADS)

Wang, Huifen; Liu, Tingting; Qiao, Li; Huang, Shuangxi

Under the networked manufacturing environment, all phases of product manufacturing involving design, process planning, machining and assembling may be accomplished collaboratively by different enterprises, even different manufacturing stages of the same part may be finished collaboratively by different enterprises. Based on the self-developed networked manufacturing platform eCWS(e-Cooperative Work System), a multi-agent-based system framework for collaborative process planning is proposed. In accordance with requirements of collaborative process planning, share resources provided by cooperative enterprises in the course of collaboration are classified into seven classes. Then a reconfigurable and extendable resource object model is built. Decision-making strategy is also studied in this paper. Finally a collaborative process planning system e-CAPP is developed and applied. It provides strong support for distributed designers to collaboratively plan and optimize product process though network.

Modification Of The Manufacturing Process Of A Composite Structure- From System Needs To Elementary Tests

NASA Astrophysics Data System (ADS)

Touzard, Jerome; Veilleraud, Frederic; Collias, Michael

2012-07-01

The SYLDA5 structure (SYstème de Lancement Double Ariane 5 - Ariane 5 dual launch system) is a lightweight carbon composite structure designed and manufactured by Astrium Space Transportation at Les Mureaux premises. In order to improve the manufacturing process of t he SYLDA5, a proposal was made by SYLDA5 technical team to change the manufacturing process of the composite sandwich parts. The SYLDA5 is however one of the main contributors in the dynamic behaviour of the upper part of Ariane 5 launcher and plays an important role in the qualification of the launcher. The present paper describes the overall qualification logic retained, from System requirements to material tests and to global System qualification, in a classical V- type design cycle. It demonstrates the necessity to take into account System needs when modifying a part of it, especially when the System is qualified with actual characteristics of t he parts that may not be defined in product’s initial requirements.

Energy requirement for the production of silicon solar arrays

NASA Technical Reports Server (NTRS)

Lindmayer, J.; Wihl, M.; Scheinine, A.; Morrison, A.

1977-01-01

An assessment of potential changes and alternative technologies which could impact the photovoltaic manufacturing process is presented. Topics discussed include: a multiple wire saw, ribbon growth techniques, silicon casting, and a computer model for a large-scale solar power plant. Emphasis is placed on reducing the energy demands of the manufacturing process.

Extraterrestrial processing and manufacturing of large space systems, volume 1, chapters 1-6

NASA Technical Reports Server (NTRS)

Miller, R. H.; Smith, D. B. S.

1979-01-01

Space program scenarios for production of large space structures from lunar materials are defined. The concept of the space manufacturing facility (SMF) is presented. The manufacturing processes and equipment for the SMF are defined and the conceptual layouts are described for the production of solar cells and arrays, structures and joints, conduits, waveguides, RF equipment radiators, wire cables, and converters. A 'reference' SMF was designed and its operation requirements are described.

System Architecture for a Military Weapon System Development Process to Integrate Design and the Manufacturing Process for Use by a Government Technical Development Agency

DTIC Science & Technology

2014-09-01

elements of functional structure. Frequently the requirement for this is to ensure long- term retention of skilled people through the provision of an...operational and manufacturable, greatly reducing the design work remaining for Milestone C. 14. SUBJECT TERMS System Architecture, manufacturing...specialized ammunition technology item such as a fuze takes too long, from initial concept through final production design, which is approved for

Numerical and Experimental Study of Ti6Al4V Components Manufactured Using Powder Bed Fusion Additive Manufacturing

NASA Astrophysics Data System (ADS)

Zielinski, Jonas; Mindt, Hans-Wilfried; Düchting, Jan; Schleifenbaum, Johannes Henrich; Megahed, Mustafa

2017-12-01

Powder bed fusion additive manufacturing of titanium alloys is an interesting manufacturing route for many applications requiring high material strength combined with geometric complexity. Managing powder bed fusion challenges, including porosity, surface finish, distortions and residual stresses of as-built material, is the key to bringing the advantages of this process to production main stream. This paper discusses the application of experimental and numerical analysis towards optimizing the manufacturing process of a demonstration component. Powder characterization including assessment of the reusability, assessment of material consolidation and process window optimization is pursued prior to applying the identified optima to study the distortion and residual stresses of the demonstrator. Comparisons of numerical predictions with measurements show good correlations along the complete numerical chain.

40 CFR 63.11562 - What are my initial compliance requirements?

Code of Federal Regulations, 2011 CFR

2011-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Standards and Compliance Requirements § 63.11562 What are my initial compliance requirements? (a) For asphalt processing operations, you must: (1) Demonstrate initial...

40 CFR 63.11562 - What are my initial compliance requirements?

Code of Federal Regulations, 2014 CFR

2014-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Standards and Compliance Requirements § 63.11562 What are my initial compliance requirements? (a) For asphalt processing operations, you must: (1) Demonstrate initial...

40 CFR 63.11562 - What are my initial compliance requirements?

Code of Federal Regulations, 2012 CFR

2012-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Standards and Compliance Requirements § 63.11562 What are my initial compliance requirements? (a) For asphalt processing operations, you must: (1) Demonstrate initial...

40 CFR 63.11562 - What are my initial compliance requirements?

Code of Federal Regulations, 2013 CFR

2013-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Standards and Compliance Requirements § 63.11562 What are my initial compliance requirements? (a) For asphalt processing operations, you must: (1) Demonstrate initial...

40 CFR 63.11562 - What are my initial compliance requirements?

Code of Federal Regulations, 2010 CFR

2010-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Standards and Compliance Requirements § 63.11562 What are my initial compliance requirements? (a) For asphalt processing operations, you must: (1) Demonstrate initial...

40 CFR Table 2 of Subpart Aaaaaaa... - Emission Limits for Asphalt Roofing Manufacturing (Coating) Operations

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 14 2011-07-01 2011-07-01 false Emission Limits for Asphalt Roofing... Pollutants for Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Other Requirements and... AAAAAAA of Part 63—Emission Limits for Asphalt Roofing Manufacturing (Coating) Operations For * * * 1...

40 CFR Table 2 of Subpart Aaaaaaa... - Emission Limits for Asphalt Roofing Manufacturing (Coating) Operations

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 15 2013-07-01 2013-07-01 false Emission Limits for Asphalt Roofing... Pollutants for Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Other Requirements and... AAAAAAA of Part 63—Emission Limits for Asphalt Roofing Manufacturing (Coating) Operations For * * * 1...

40 CFR Table 2 of Subpart Aaaaaaa... - Emission Limits for Asphalt Roofing Manufacturing (Coating) Operations

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 15 2014-07-01 2014-07-01 false Emission Limits for Asphalt Roofing... Pollutants for Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Other Requirements and... AAAAAAA of Part 63—Emission Limits for Asphalt Roofing Manufacturing (Coating) Operations For * * * 1...

40 CFR Table 2 of Subpart Aaaaaaa... - Emission Limits for Asphalt Roofing Manufacturing (Coating) Operations

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 15 2012-07-01 2012-07-01 false Emission Limits for Asphalt Roofing... Pollutants for Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Other Requirements and... AAAAAAA of Part 63—Emission Limits for Asphalt Roofing Manufacturing (Coating) Operations For * * * 1...

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

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.

Orodispersible films: Product transfer from lab-scale to continuous manufacturing.

PubMed

Thabet, Yasmin; Breitkreutz, Joerg

2018-01-15

Orodispersible films have been described as new beneficial dosage forms for special patient populations. Due to various production settings, different requirements on film formulations are required for non- continuous and continuous manufacturing. In this study, a continuous coating machine was qualified in regards of the process conditions for film compositions and their effects on the formed films. To investigate differences between both manufacturing processes, various film formulations of hydrochlorothiazide and hydroxypropylcellulose (HPC) or hydroxypropylmethycellulose (HPMC) as film formers were produced and the resulting films were characterized. The qualification of the continuously operating coating machine reveals no uniform heat distribution during drying. Coating solutions for continuous manufacturing should provide at least a dynamic viscosity of 1 Pa*s (wet film thickness of 500 μm, velocity of 15.9 cm/min). HPC films contain higher residuals of ethanol or acetone in bench-scale than in continuous production mode. Continuous production lead to lower drug content of the films. All continuously produced films disintegrate within less than 30 s. There are observed significant effects of the production process on the film characteristics. When transferring film manufacturing from lab-scale to continuous mode, film compositions, processing conditions and suitable characterization methods have to be carefully selected and adopted. Copyright © 2017 Elsevier B.V. All rights reserved.

Process and product development in the manufacturing of molecular therapeutics.

PubMed

Atkinson, E M; Christensen, J R

1999-08-01

In the development of molecular therapies, a great deal of attention has focused on tissue targets, gene delivery vectors, and expression cassettes. In order to become an approved therapy, however, a molecular therapeutic has to pass down the same product registration pathway as any other biological product. Moving from research into industrial production requires careful attention to regulatory, manufacturing and quality concerns. Early work on developing and characterizing robust and scaleable manufacturing processes will ultimately be rewarded by ease of implementation as the product is successful in clinical trials. Regulatory agencies require solid process and product characterization studies to demonstrate control and understanding of the molecular therapeutic. As the gene therapy industry matures, standards will continue to rise, creating an industry that is capable of producing safe, high-quality and effective therapies for many of the world's most difficult disease targets.

Fabrication of Thermoelectric Devices Using Additive-Subtractive Manufacturing Techniques: Application to Waste-Heat Energy Harvesting

NASA Astrophysics Data System (ADS)

Tewolde, Mahder

Thermoelectric generators (TEGs) are solid-state devices that convert heat directly into electricity. They are well suited for waste-heat energy harvesting applications as opposed to primary energy generation. Commercially available thermoelectric modules are flat, inflexible and have limited sizes available. State-of-art manufacturing of TEG devices relies on assembling prefabricated parts with soldering, epoxy bonding, and mechanical clamping. Furthermore, efforts to incorporate them onto curved surfaces such as exhaust pipes, pump housings, steam lines, mixing containers, reaction chambers, etc. require custom-built heat exchangers. This is costly and labor-intensive, in addition to presenting challenges in terms of space, thermal coupling, added weight and long-term reliability. Additive manufacturing technologies are beginning to address many of these issues by reducing part count in complex designs and the elimination of sub-assembly requirements. This work investigates the feasibility of utilizing such novel manufacturing routes for improving the manufacturing process of thermoelectric devices. Much of the research in thermoelectricity is primarily focused on improving thermoelectric material properties by developing of novel materials or finding ways to improve existing ones. Secondary to material development is improving the manufacturing process of TEGs to provide significant cost benefits. To improve the device fabrication process, this work explores additive manufacturing technologies to provide an integrated and scalable approach for TE device manufacturing directly onto engineering component surfaces. Additive manufacturing techniques like thermal spray and ink-dispenser printing are developed with the aim of improving the manufacturing process of TEGs. Subtractive manufacturing techniques like laser micromachining are also studied in detail. This includes the laser processing parameters for cutting the thermal spray materials efficiently by optimizing cutting speed and power while maintaining surface quality and interface properties. Key parameters are obtained from these experiments and used to develop a process that can be used to fabricate a working TEG directly onto the waste-heat component surface. A TEG module has been fabricated for the first time entirely by using thermal spray technology and laser micromachining. The target applications include automotive exhaust systems and other high-volume industrial waste heat sources. The application of TEGs for thermoelectrically powered sensors for Small Modular Reactors (SMRs) is presented. In conclusion, more ways to improve the fabrication process of TEGs are suggested.

Manufacture of Third-Generation Lentivirus for Preclinical Use, with Process Development Considerations for Translation to Good Manufacturing Practice.

PubMed

Gándara, Carolina; Affleck, Valerie; Stoll, Elizabeth Ann

2018-02-01

Lentiviral vectors are used in laboratories around the world for in vivo and ex vivo delivery of gene therapies, and increasingly clinical investigation as well as preclinical applications. The third-generation lentiviral vector system has many advantages, including high packaging capacity, stable gene expression in both dividing and post-mitotic cells, and low immunogenicity in the recipient organism. Yet, the manufacture of these vectors is challenging, especially at high titers required for direct use in vivo, and further challenges are presented by the process of translating preclinical gene therapies toward manufacture of products for clinical investigation. The goals of this paper are to report the protocol for manufacturing high-titer third-generation lentivirus for preclinical testing and to provide detailed information on considerations for translating preclinical viral vector manufacture toward scaled-up platforms and processes in order to make gene therapies under Good Manufacturing Practice that are suitable for clinical trials.

Manufacture of Third-Generation Lentivirus for Preclinical Use, with Process Development Considerations for Translation to Good Manufacturing Practice

PubMed Central

Gándara, Carolina; Affleck, Valerie; Stoll, Elizabeth Ann

2018-01-01

Lentiviral vectors are used in laboratories around the world for in vivo and ex vivo delivery of gene therapies, and increasingly clinical investigation as well as preclinical applications. The third-generation lentiviral vector system has many advantages, including high packaging capacity, stable gene expression in both dividing and post-mitotic cells, and low immunogenicity in the recipient organism. Yet, the manufacture of these vectors is challenging, especially at high titers required for direct use in vivo, and further challenges are presented by the process of translating preclinical gene therapies toward manufacture of products for clinical investigation. The goals of this paper are to report the protocol for manufacturing high-titer third-generation lentivirus for preclinical testing and to provide detailed information on considerations for translating preclinical viral vector manufacture toward scaled-up platforms and processes in order to make gene therapies under Good Manufacturing Practice that are suitable for clinical trials. PMID:29212357

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.

Selection of an Alternative Production Part Approval Process to Improve Weapon Systems Production Readiness

DTIC Science & Technology

2017-09-01

production outcomes: 1) knowledge gaps in technology, 2) design instability and 3) manufacturing knowledge gaps. Only manufacturing knowledge gaps...ability to produce at a desired production rate. Each item produced under this manufacturing development is to meet that item’s design requirements. The...represented with respect to assessing manufacturing design and development with a verification and demonstration. DOD acquisition waits to assess production

Low-cost manufacturing of the point focus concentrating module and its key component, the Fresnel lens. Final subcontract report, 31 January 1991--6 May 1991

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

Saifee, T.; Konnerth, A. III

1991-11-01

Solar Kinetics, Inc. (SKI) has been developing point-focus concentrating PV modules since 1986. SKI is currently in position to manufacture between 200 to 600 kilowatts annually of the current design by a combination of manual and semi-automated methods. This report reviews the current status of module manufacture and specifies the required approach to achieve a high-volume manufacturing capability and low cost. The approach taken will include process development concurrent with module design for automated manufacturing. The current effort reviews the major manufacturing costs and identifies components and processes whose improvements would produce the greatest effect on manufacturability and cost reduction.more » The Fresnel lens is one such key component. Investigating specific alternative manufacturing methods and sources has substantially reduced the lens costs and has exceeded the DOE cost-reduction goals. 15 refs.« less

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.

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.

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.

Diagnosis of the Computer-Controlled Milling Machine, Definition of the Working Errors and Input Corrections on the Basis of Mathematical Model

NASA Astrophysics Data System (ADS)

Starikov, A. I.; Nekrasov, R. Yu; Teploukhov, O. J.; Soloviev, I. V.; Narikov, K. A.

2016-10-01

Manufactures, machinery and equipment improve of constructively as science advances and technology, and requirements are improving of quality and longevity. That is, the requirements for surface quality and precision manufacturing, oil and gas equipment parts are constantly increasing. Production of oil and gas engineering products on modern machine tools with computer numerical control - is a complex synthesis of technical and electrical equipment parts, as well as the processing procedure. Technical machine part wears during operation and in the electrical part are accumulated mathematical errors. Thus, the above-mentioned disadvantages of any of the following parts of metalworking equipment affect the manufacturing process of products in general, and as a result lead to the flaw.

Manufacturing of glassy thin shell for adaptive optics: results achieved

NASA Astrophysics Data System (ADS)

Poutriquet, F.; Rinchet, A.; Carel, J.-L.; Leplan, H.; Ruch, E.; Geyl, R.; Marque, G.

2012-07-01

Glassy thin shells are key components for the development of adaptive optics and are part of future & innovative projects such as ELT. However, manufacturing thin shells is a real challenge. Even though optical requirements for the front face - or optical face - are relaxed compared to conventional passive mirrors, requirements concerning thickness uniformity are difficult to achieve. In addition, process has to be completely re-defined as thin mirror generates new manufacturing issues. In particular, scratches and digs requirement is more difficult as this could weaken the shell, handling is also an important issue due to the fragility of the mirror. Sagem, through REOSC program, has recently manufactured different types of thin shells in the frame of European projects: E-ELT M4 prototypes and VLT Deformable Secondary Mirror (VLT DSM).

40 CFR 63.605 - Monitoring requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

...) National Emission Standards for Hazardous Air Pollutants From Phosphoric Acid Manufacturing Plants § 63.605 Monitoring requirements. (a)(1) Each owner or operator of a new or existing wet-process phosphoric acid process line or superphosphoric acid process line subject to the provisions of this subpart shall install...

21 CFR 26.1 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN... regulatory systems means that the systems are sufficiently comparable to assure that the process of... require that the respective regulatory systems have identical procedures. (c) Good Manufacturing Practices...

How development and manufacturing will need to be structured--heads of development/manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Nepveux, Kevin; Sherlock, Jon-Paul; Futran, Mauricio; Thien, Michael; Krumme, Markus

2015-03-01

Continuous manufacturing (CM) is a process technology that has been used in the chemical industry for large-scale mass production of chemicals in single-purpose plants with benefit for many years. Recent interest has been raised to expand CM into the low-volume, high-value pharmaceutical business with its unique requirements regarding readiness for human use and the required quality, supply chain, and liability constraints in this business context. Using a fairly abstract set of definitions, this paper derives technical consequences of CM in different scenarios along the development-launch-supply axis in different business models and how they compare to batch processes. Impact of CM on functions in development is discussed and several operational models suitable for originators and other business models are discussed and specific aspects of CM are deduced from CM's technical characteristics. Organizational structures of current operations typically can support CM implementations with just minor refinements if the CM technology is limited to single steps or small sequences (bin-to-bin approach) and if the appropriate technical skill set is available. In such cases, a small, dedicated group focused on CM is recommended. The manufacturing strategy, as centralized versus decentralized in light of CM processes, is discussed and the potential impact of significantly shortened supply lead times on the organization that runs these processes. The ultimate CM implementation may be seen by some as a totally integrated monolithic plant, one that unifies chemistry and pharmaceutical operations into one plant. The organization supporting this approach will have to reflect this change in scope and responsibility. The other extreme, admittedly futuristic at this point, would be a highly decentralized approach with multiple smaller hubs; this would require a new and different organizational structure. This processing approach would open up new opportunities for products that, because of stability constraints or individualization to patients, do not allow centralized manufacturing approaches at all. Again, the entire enterprise needs to be restructured accordingly. The situation of CM in an outsourced operation business model is discussed. Next steps for the industry are recommended. In summary, opportunistic implementation of isolated steps in existing portfolios can be implemented with minimal organizational changes; the availability of the appropriate skills is the determining factor. The implementation of more substantial sequences requires business processes that consider the portfolio, not just single products. Exploration and implementation of complete process chains with consequences for quality decisions do require appropriate organizational support. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

Diverse task scheduling for individualized requirements in cloud manufacturing

NASA Astrophysics Data System (ADS)

Zhou, Longfei; Zhang, Lin; Zhao, Chun; Laili, Yuanjun; Xu, Lida

2018-03-01

Cloud manufacturing (CMfg) has emerged as a new manufacturing paradigm that provides ubiquitous, on-demand manufacturing services to customers through network and CMfg platforms. In CMfg system, task scheduling as an important means of finding suitable services for specific manufacturing tasks plays a key role in enhancing the system performance. Customers' requirements in CMfg are highly individualized, which leads to diverse manufacturing tasks in terms of execution flows and users' preferences. We focus on diverse manufacturing tasks and aim to address their scheduling issue in CMfg. First of all, a mathematical model of task scheduling is built based on analysis of the scheduling process in CMfg. To solve this scheduling problem, we propose a scheduling method aiming for diverse tasks, which enables each service demander to obtain desired manufacturing services. The candidate service sets are generated according to subtask directed graphs. An improved genetic algorithm is applied to searching for optimal task scheduling solutions. The effectiveness of the scheduling method proposed is verified by a case study with individualized customers' requirements. The results indicate that the proposed task scheduling method is able to achieve better performance than some usual algorithms such as simulated annealing and pattern search.

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.

The complexity and cost of vaccine manufacturing - An overview.

PubMed

Plotkin, Stanley; Robinson, James M; Cunningham, Gerard; Iqbal, Robyn; Larsen, Shannon

2017-07-24

As companies, countries, and governments consider investments in vaccine production for routine immunization and outbreak response, understanding the complexity and cost drivers associated with vaccine production will help to inform business decisions. Leading multinational corporations have good understanding of the complex manufacturing processes, high technological and R&D barriers to entry, and the costs associated with vaccine production. However, decision makers in developing countries, donors and investors may not be aware of the factors that continue to limit the number of new manufacturers and have caused attrition and consolidation among existing manufacturers. This paper describes the processes and cost drivers in acquiring and maintaining licensure of childhood vaccines. In addition, when export is the goal, we describe the requirements to supply those vaccines at affordable prices to low-resource markets, including the process of World Health Organization (WHO) prequalification and supporting policy recommendation. By providing a generalized and consolidated view of these requirements we seek to build awareness in the global community of the benefits and costs associated with vaccine manufacturing and the challenges associated with maintaining consistent supply. We show that while vaccine manufacture may prima facie seem an economic growth opportunity, the complexity and high fixed costs of vaccine manufacturing limit potential profit. Further, for most lower and middle income countries a large majority of the equipment, personnel and consumables will need to be imported for years, further limiting benefits to the local economy. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Application of Twin Screw Extrusion in the Manufacture of Cocrystals, Part I: Four Case Studies

PubMed Central

Daurio, Dominick; Medina, Cesar; Saw, Robert; Nagapudi, Karthik; Alvarez-Núñez, Fernando

2011-01-01

The application of twin screw extrusion (TSE) as a scalable and green process for the manufacture of cocrystals was investigated. Four model cocrystal forming systems, Caffeine-Oxalic acid, Nicotinamide-trans cinnamic acid, Carbamazepine-Saccharin, and Theophylline-Citric acid, were selected for the study. The parameters of the extrusion process that influenced cocrystal formation were examined. TSE was found to be an effective method to make cocrystals for all four systems studied. It was demonstrated that temperature and extent of mixing in the extruder were the primary process parameters that influenced extent of conversion to the cocrystal in neat TSE experiments. In addition to neat extrusion, liquid-assisted TSE was also demonstrated for the first time as a viable process for making cocrystals. Notably, the use of catalytic amount of benign solvents led to a lowering of processing temperatures required to form the cocrystal in the extruder. TSE should be considered as an efficient, scalable, and environmentally friendly process for the manufacture of cocrystals with little to no solvent requirements. PMID:24310598

Materials Genome Initiative

NASA Technical Reports Server (NTRS)

Vickers, John

2015-01-01

The Materials Genome Initiative (MGI) project element is a cross-Center effort that is focused on the integration of computational tools to simulate manufacturing processes and materials behavior. These computational simulations will be utilized to gain understanding of processes and materials behavior to accelerate process development and certification to more efficiently integrate new materials in existing NASA projects and to lead to the design of new materials for improved performance. This NASA effort looks to collaborate with efforts at other government agencies and universities working under the national MGI. MGI plans to develop integrated computational/experimental/ processing methodologies for accelerating discovery and insertion of materials to satisfy NASA's unique mission demands. The challenges include validated design tools that incorporate materials properties, processes, and design requirements; and materials process control to rapidly mature emerging manufacturing methods and develop certified manufacturing processes

Development and manufacture of visor for helmet-mounted display

NASA Astrophysics Data System (ADS)

Krevor, David H.; McNelly, Gregg; Skubon, John; Speirs, Robert

2004-01-01

The manufacturing design and process development for the Visor for the JHMCS (Joint Helmet Mounted Cueing System) are discussed. The JHMCS system is a Helmet Mounted Display (HMD) system currently flying on the F-15, F-16 and F/A-18 aircraft. The Visor manufacturing processes are essential to both system performance and economy. The Visor functions both as the system optical combiner and personal protective equipment for the pilot. The Visor material is optical polycarbonate. For a military HMD system, the mechanical and environmental properties of the Visor are as necessary as the optical properties. The visor must meet stringent dimensional requirements to assure adequate system optical performance. Injection molding can provide dimensional fidelity to the requirements, if done properly. Concurrent design of the visor and the tool (i.e., the injection mold) is essential. The concurrent design necessarily considers manufacturing operations and the use environment of the Visor. Computer modeling of the molding process is a necessary input to the mold design. With proper attention to product design and tool development, it is possible to improve upon published standard dimensional tolerances for molded polycarbonate articles.

Manufacturing considerations for AMLCD cockpit displays

NASA Astrophysics Data System (ADS)

Luo, Fang-Chen

1995-06-01

AMLCD cockpit displays need to meet more stringent requirements compared with AMLCD commercial displays in areas such as environmental conditions, optical performance and device reliability. Special considerations are required for the manufacturing of AMLCD cockpit displays in each process step to address these issues. Some examples are: UV stable polarizers, wide-temperature LC material, strong LC glue seal, ESS test system, gray scale voltage EEPROM, etc.

Manufacturing Process Simulation of Large-Scale Cryotanks

NASA Technical Reports Server (NTRS)

Babai, Majid; Phillips, Steven; Griffin, Brian

2003-01-01

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 aide 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. As part of the SLI, The Boeing Company was awarded a basic period contract to research and propose options for both a metallic and a composite cryotank. Boeing then entered into a task agreement with the Marshall Space Flight Center to provide manufacturing simulation support. This paper highlights the accomplishments of this task agreement, while also introducing the capabilities of simulation software.

Solution-Processed Cu2Se Nanocrystal Films with Bulk-Like Thermoelectric Performance.

PubMed

Forster, Jason D; Lynch, Jared J; Coates, Nelson E; Liu, Jun; Jang, Hyejin; Zaia, Edmond; Gordon, Madeleine P; Szybowski, Maxime; Sahu, Ayaskanta; Cahill, David G; Urban, Jeffrey J

2017-06-05

Thermoelectric power generation can play a key role in a sustainable energy future by converting waste heat from power plants and other industrial processes into usable electrical power. Current thermoelectric devices, however, require energy intensive manufacturing processes such as alloying and spark plasma sintering. Here, we describe the fabrication of a p-type thermoelectric material, copper selenide (Cu 2 Se), utilizing solution-processing and thermal annealing to produce a thin film that achieves a figure of merit, ZT, which is as high as its traditionally processed counterpart, a value of 0.14 at room temperature. This is the first report of a fully solution-processed nanomaterial achieving performance equivalent to its bulk form and represents a general strategy to reduce the energy required to manufacture advanced energy conversion and harvesting materials.

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

Sure, They Can Build It But...Manufacturing Students Need Process Planning Skills

ERIC Educational Resources Information Center

Obi, Samuel C.

2007-01-01

Manufacturing systems students usually complete lab projects for class requirements. However, they often do not have an idea how many resources such as time, tools, and materials they will need to complete a project until they get into constructing it. Yet one of the first tasks of real-world manufacturing personnel when they receive new product…

The Impact of Granule Density on Tabletting and Pharmaceutical Product Performance.

PubMed

van den Ban, Sander; Goodwin, Daniel J

2017-05-01

The impact of granule densification in high-shear wet granulation on tabletting and product performance was investigated, at pharmaceutical production scale. Product performance criteria need to be balanced with the need to deliver manufacturability criteria to assure robust industrial scale tablet manufacturing processes. A Quality by Design approach was used to determine in-process control specifications for tabletting, propose a design space for disintegration and dissolution, and to understand the permitted operating limits and required controls for an industrial tabletting process. Granules of varying density (filling density) were made by varying water amount added, spray rate, and wet massing time in a design of experiment (DoE) approach. Granules were compressed into tablets to a range of thicknesses to obtain tablets of varying breaking force. Disintegration and dissolution performance was evaluated for the tablets made. The impact of granule filling density on tabletting was rationalised with compressibility, tabletability and compactibility. Tabletting and product performance criteria provided competing requirements for porosity. An increase in granule filling density impacted tabletability and compactability and limited the ability to achieve tablets of adequate mechanical strength. An increase in tablet solid fraction (decreased porosity) impacted disintegration and dissolution. An attribute-based design space for disintegration and dissolution was specified to achieve both product performance and manufacturability. The method of granulation and resulting granule filling density is a key design consideration to achieve both product performance and manufacturability required for modern industrial scale pharmaceutical product manufacture and distribution.

Implementation of a configurable laboratory information management system for use in cellular process development and manufacturing.

PubMed

Russom, Diana; Ahmed, Amira; Gonzalez, Nancy; Alvarnas, Joseph; DiGiusto, David

2012-01-01

Regulatory requirements for the manufacturing of cell products for clinical investigation require a significant level of record-keeping, starting early in process development and continuing through to the execution and requisite follow-up of patients on clinical trials. Central to record-keeping is the management of documentation related to patients, raw materials, processes, assays and facilities. To support these requirements, we evaluated several laboratory information management systems (LIMS), including their cost, flexibility, regulatory compliance, ongoing programming requirements and ability to integrate with laboratory equipment. After selecting a system, we performed a pilot study to develop a user-configurable LIMS for our laboratory in support of our pre-clinical and clinical cell-production activities. We report here on the design and utilization of this system to manage accrual with a healthy blood-donor protocol, as well as manufacturing operations for the production of a master cell bank and several patient-specific stem cell products. The system was used successfully to manage blood donor eligibility, recruiting, appointments, billing and serology, and to provide annual accrual reports. Quality management reporting features of the system were used to capture, report and investigate process and equipment deviations that occurred during the production of a master cell bank and patient products. Overall the system has served to support the compliance requirements of process development and phase I/II clinical trial activities for our laboratory and can be easily modified to meet the needs of similar laboratories.

Implementing high-temperature short-time media treatment in commercial-scale cell culture manufacturing processes.

PubMed

Pohlscheidt, Michael; Charaniya, Salim; Kulenovic, Fikret; Corrales, Mahalia; Shiratori, Masaru; Bourret, Justin; Meier, Steven; Fallon, Eric; Kiss, Robert

2014-04-01

The production of therapeutic proteins by mammalian cell culture is complex and sets high requirements for process, facility, and equipment design, as well as rigorous regulatory and quality standards. One particular point of concern and significant risk to supply chain is the susceptibility to contamination such as bacteria, fungi, mycoplasma, and viruses. Several technologies have been developed to create barriers for these agents to enter the process, e.g. filtration, UV inactivation, and temperature inactivation. However, if not implemented during development of the manufacturing process, these types of process changes can have significant impact on process performance if not managed appropriately. This article describes the implementation of the high-temperature short-time (HTST) treatment of cell culture media as an additional safety barrier against adventitious agents during the transfer of a large-scale commercial cell culture manufacturing process. The necessary steps and experiments, as well as subsequent results during qualification runs and routine manufacturing, are shown.

Real-time product attribute control to manufacture antibodies with defined N-linked glycan levels.

PubMed

Zupke, Craig; Brady, Lowell J; Slade, Peter G; Clark, Philip; Caspary, R Guy; Livingston, Brittney; Taylor, Lisa; Bigham, Kyle; Morris, Arvia E; Bailey, Robert W

2015-01-01

Pressures for cost-effective new therapies and an increased emphasis on emerging markets require technological advancements and a flexible future manufacturing network for the production of biologic medicines. The safety and efficacy of a product is crucial, and consistent product quality is an essential feature of any therapeutic manufacturing process. The active control of product quality in a typical biologic process is challenging because of measurement lags and nonlinearities present in the system. The current study uses nonlinear model predictive control to maintain a critical product quality attribute at a predetermined value during pilot scale manufacturing operations. This approach to product quality control ensures a more consistent product for patients, enables greater manufacturing efficiency, and eliminates the need for extensive process characterization by providing direct measures of critical product quality attributes for real time release of drug product. © 2015 American Institute of Chemical Engineers.

Gaining the Competitive Edge: Design for Manufacturing

NASA Technical Reports Server (NTRS)

Batill, Stephen M.; Pinkelman, Jim; Sellar, Richard

1993-01-01

The successful design of a commercial aircraft which is intended to be in direct competition with existing aircraft requires a market analysis to establish design requirements, the development of a concept to achieve those goals. and the ability to economically manufacture the aircraft. It is often the case that an engineer designs system components with only the perspective of a particular discipline. The relationship of that component to the entire system is often a minor consideration. In an effort to highlight the interaction that is necessary during the design process, the students were organized into design/build teams and required to integrate aspects of market analysis, engineering design, production and economics into their concepts. In order to facilitate this process a hypothetical "Aeroworld" was established. Having been furnished relevant demographic and economic data for "Aeroworld". students were given the task of designing and building an aircraft for a specific market while achieving an economically competitive design. Involvement of the team in the evolution of the design from market definition to technical development to manufacturing allowed the students to identify critical issues in the design process and to encounter many of the conflicting requirements which arise in an aerospace systems design.

40 CFR 704.104 - Hexafluoropropylene oxide.

Code of Federal Regulations, 2010 CFR

2010-07-01

... CONTROL ACT REPORTING AND RECORDKEEPING REQUIREMENTS Chemical-Specific Reporting and Recordkeeping Rules... qualify as small for purposes of reporting on the processing of that chemical substance at that site...: (1) Persons who manufacture or propose to manufacture HFPO for use as an intermediate in the...

76 FR 74749 - Critical Parts for Airplane Propellers

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-01

... manufacturer, and establish engineering, manufacture, and maintenance processes for those parts. The intended... a specific definition for a propeller critical part, or-- [rtarr9] Require type certificate holders..., however, has regulations that identify a specific definition for propeller critical part, and regulations...

Mass production of silicon pore optics for ATHENA

NASA Astrophysics Data System (ADS)

Wille, Eric; Bavdaz, Marcos; Collon, Maximilien

2016-07-01

Silicon Pore Optics (SPO) provide high angular resolution with low effective area density as required for the Advanced Telescope for High Energy Astrophysics (Athena). The x-ray telescope consists of several hundreds of SPO mirror modules. During the development of the process steps of the SPO technology, specific requirements of a future mass production have been considered right from the beginning. The manufacturing methods heavily utilise off-the-shelf equipment from the semiconductor industry, robotic automation and parallel processing. This allows to upscale the present production flow in a cost effective way, to produce hundreds of mirror modules per year. Considering manufacturing predictions based on the current technology status, we present an analysis of the time and resources required for the Athena flight programme. This includes the full production process starting with Si wafers up to the integration of the mirror modules. We present the times required for the individual process steps and identify the equipment required to produce two mirror modules per day. A preliminary timeline for building and commissioning the required infrastructure, and for flight model production of about 1000 mirror modules, is presented.

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.

Feasibility of commercial space manufacturing, production of pharmaceuticals. Volume 3: Product data

NASA Technical Reports Server (NTRS)

1978-01-01

The feasibility of commercial manufacturing of pharmaceuticals in space is analyzed and the study results are presented. The chronology of the study process is discussed. The separation of serum proteins by the continuous flow electrophoresis process is investigated. The production requirements of twelve candidate products including antihemophilic factor, beta cells, erythropoietin, epidermal growth factor, alpha-1-antitrypsin, and interferon are evaluated.

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.

Design and Implementation of an Innovative Manufacturing Process for Aerial and Land Supply Needs

DTIC Science & Technology

2011-06-30

buildup of the pad , the incoming web should be held in place during cutting operation to eliminate any shifting / tilting , this has been achieved by...the required number of layers of the folded sheets is stacked to meet the desired size of the pad , the finished pad is ejected and the process...continues for making the remaining pads . Development of such innovative manufacturing process provides immediate capability for the Department of

Development and qualification of additively manufactured parts for space

NASA Astrophysics Data System (ADS)

O'Brien, Michael J.

2018-02-01

Additive manufacturing (commonly called "3D printing") fabricates the desired final part directly from the input CAD (Computer Aided Design) file by depositing and fusing layer upon layer of the source material. New engineering designs are possible in which a single optimized part with novel topology can replace several traditional parts. The complex physics of metal deposition leads to variations in quality and to new flaws and residual stresses not seen in traditional manufacturing. Additive manufacturing currently has gaps in knowledge. Mission assurance will require: qualification and certification standards; sharing of data in handbooks; predictive models relating processing, microstructure and properties; and development of closed loop process control and non-destructive evaluation to reduce variability.

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

Verify Module for Reporting A/C and Off-Cycle GHG Credits for Light-Duty Vehicle and Truck Manufacturers

EPA Pesticide Factsheets

This EPA presentation provides information on using the new Verify module, streamlining the process required to electronically submit annual reporting of air conditioning (A/C) and off-cycle GHG credits for light duty manufacturers.

Virtual aluminum castings: An industrial application of ICME

NASA Astrophysics Data System (ADS)

Allison, John; Li, Mei; Wolverton, C.; Su, Xuming

2006-11-01

The automotive product design and manufacturing community is continually besieged by Hercule an engineering, timing, and cost challenges. Nowhere is this more evident than in the development of designs and manufacturing processes for cast aluminum engine blocks and cylinder heads. Increasing engine performance requirements coupled with stringent weight and packaging constraints are pushing aluminum alloys to the limits of their capabilities. To provide high-quality blocks and heads at the lowest possible cost, manufacturing process engineers are required to find increasingly innovative ways to cast and heat treat components. Additionally, to remain competitive, products and manufacturing methods must be developed and implemented in record time. To bridge the gaps between program needs and engineering reality, the use of robust computational models in up-front analysis will take on an increasingly important role. This article describes just such a computational approach, the Virtual Aluminum Castings methodology, which was developed and implemented at Ford Motor Company and demonstrates the feasibility and benefits of integrated computational materials engineering.

Manufacturing development for the SAFE 100 kW core

NASA Astrophysics Data System (ADS)

Carter, Robert; Roman, Jose; Salvail, Pat

2002-01-01

In stark contrast to what is sometimes considered the norm in traditional manufacturing processes, engineers at the Marshall Space Flight Center (MSFC) arc in the practice of altering the standard in an effort to realize other potential methods in core manufacturing. While remaining within the bounds of the materials database, we are researching into core manufacturing techniques that may have been overlooked in the past due to funding and/or time constraints. To augment proven core fabrication capabilities we are pursuing plating processes as another possible method for core build-up and assembly. Although brazing and a proprietary HIP cycle are used for module assembly (proven track record for stability and endurance), it is prudent to pursue secondary or backup methods of module and core assembly. For this reason heat tube manufacture and module assembly by means of plating is being investigated. Potentially, the plating processes will give engineers the ability to manufacture replacement modules for any module that might fail to perform nominally, and to assemble/disassemble a complete core in much less time than would be required for the conventional Braze-HIP process. Another area of improvement in core manufacturing capabilities is the installation of a sodium and lithium liquid metal heat pipe fill machine. This, along with the ability to Electron Beam Weld heat pipe seals and wet-in the pipes in the necessary vacuum atmosphere, will eliminate the need to ship potentially hazardous components outside for processing. In addition to developing core manufacturing techniques, the SAFE manufacturing team has been evaluating the thermal heat transfer characteristics, and manufacturability of several heat exchanger design concepts. .

Robot design for a vacuum environment

NASA Technical Reports Server (NTRS)

Belinski, S.; Trento, W.; Imani-Shikhabadi, R.; Hackwood, S.

1987-01-01

The cleanliness requirements for many processing and manufacturing tasks are becoming ever stricter, resulting in a greater interest in the vacuum environment. Researchers discuss the importance of this special environment, and the development of robots which are physically and functionally suited to vacuum processing tasks. Work is in progress at the Center for robotic Systems in Microelectronics (CRSM) to provide a robot for the manufacture of a revolutionary new gyroscope in high vacuum. The need for vacuum in this and other processes is discussed as well as the requirements for a vacuum-compatible robot. Finally, researchers present details on work done at the CRSM to modify an existing clean-room compatible robot for use at high vacuum.

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

The Benchmarks of Global Clean Energy Manufacturing will help policymakers and industry gain deeper understanding of global manufacturing of clean energy technologies. Increased knowledge of the product supply chains can inform decisions related to manufacturing facilities for extracting and processing raw materials, making the array of required subcomponents, and assembling and shipping the final product. This brochure summarized key findings from the analysis and includes important figures from the report. The report was prepared by the Clean Energy Manufacturing Analysis Center (CEMAC) analysts at the U.S. Department of Energy's National Renewable Energy Laboratory.

Hot working behavior of selective laser melted and laser metal deposited Inconel 718

NASA Astrophysics Data System (ADS)

Bambach, Markus; Sizova, Irina

2018-05-01

The production of Nickel-based high-temperature components is of great importance for the transport and energy sector. Forging of high-temperature alloys often requires expensive dies, multiple forming steps and leads to forged parts with tolerances that require machining to create the final shape and a large amount of scrap. Additive manufacturing offers the possibility to print the desired shapes directly as net-shape components, requiring only little additional effort in machining. Especially for high-temperature alloys carrying a large amount of energy per unit mass, additive manufacturing could be more energy-efficient than forging if the energy contained in the machining scrap exceeds the energy needed for powder production and laser processing. However, the microstructure and performance of 3d-printed parts will not reach the level of forged material unless further expensive processes such as hot-isostatic pressing are used. Using the design freedom and possibilities to locally engineer material, additive manufacturing could be combined with forging operations to novel process chains, offering the possibility to reduce the number of forging steps and to create near-net shape forgings with desired local properties. Some innovative process chains combining additive manufacturing and forging have been patented recently, but almost no scientific knowledge on the workability of 3D printed preforms exists. The present study investigates the flow stress and microstructure evolution during hot working of pre-forms produced by laser powder deposition and selective laser melting (Figure 1) and puts forward a model for the flow stress.

Application of high speed machining technology in aviation

NASA Astrophysics Data System (ADS)

Bałon, Paweł; Szostak, Janusz; Kiełbasa, Bartłomiej; Rejman, Edward; Smusz, Robert

2018-05-01

Aircraft structures are exposed to many loads during their working lifespan. Every particular action made during a flight is composed of a series of air movements which generate various aircraft loads. The most rigorous requirement which modern aircraft structures must fulfill is to maintain their high durability and reliability. This requirement involves taking many restrictions into account during the aircraft design process. The most important factor is the structure's overall mass, which has a crucial impact on both utility properties and cost-effectiveness. This makes aircraft one of the most complex results of modern technology. Additionally, there is currently an increasing utilization of high strength aluminum alloys, which requires the implementation of new manufacturing processes. High Speed Machining technology (HSM) is currently one of the most important machining technologies used in the aviation industry, especially in the machining of aluminium alloys. The primary difference between HSM and other milling techniques is the ability to select cutting parameters - depth of the cut layer, feed rate, and cutting speed in order to simultaneously ensure high quality, precision of the machined surface, and high machining efficiency, all of which shorten the manufacturing process of the integral components. In this paper, the authors explain the implementation of the HSM method in integral aircraft constructions. It presents the method of the airframe manufacturing method, and the final results. The HSM method is compared to the previous method where all subcomponents were manufactured by bending and forming processes, and then, they were joined by riveting.

Solution-Processed Cu 2Se Nanocrystal Films with Bulk-Like Thermoelectric Performance

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

Forster, Jason D.; Lynch, Jared J.; Coates, Nelson E.

Thermoelectric power generation can play a key role in a sustainable energy future by converting waste heat from power plants and other industrial processes into usable electrical power. Current thermoelectric devices, however, require energy intensive manufacturing processes such as alloying and spark plasma sintering. Here, we describe the fabrication of a p-type thermoelectric material, copper selenide (Cu 2 Se), utilizing solution-processing and thermal annealing to produce a thin film that achieves a figure of merit, ZT, which is as high as its traditionally processed counterpart, a value of 0.14 at room temperature. This is the first report of amore » fully solution-processed nanomaterial achieving performance equivalent to its bulk form and represents a general strategy to reduce the energy required to manufacture advanced energy conversion and harvesting materials.« less

Solution-Processed Cu 2Se Nanocrystal Films with Bulk-Like Thermoelectric Performance

DOE PAGES

Forster, Jason D.; Lynch, Jared J.; Coates, Nelson E.; ...

2017-06-05

Thermoelectric power generation can play a key role in a sustainable energy future by converting waste heat from power plants and other industrial processes into usable electrical power. Current thermoelectric devices, however, require energy intensive manufacturing processes such as alloying and spark plasma sintering. Here, we describe the fabrication of a p-type thermoelectric material, copper selenide (Cu 2 Se), utilizing solution-processing and thermal annealing to produce a thin film that achieves a figure of merit, ZT, which is as high as its traditionally processed counterpart, a value of 0.14 at room temperature. This is the first report of amore » fully solution-processed nanomaterial achieving performance equivalent to its bulk form and represents a general strategy to reduce the energy required to manufacture advanced energy conversion and harvesting materials.« less

Fabrication of light water reactor tritium targets

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

Pilger, J.P.

1991-11-01

The mission of the Fabrication Development Task of the Tritium Target Development Project is: to produce a documented technology basis, including specifications and procedures for target rod fabrication; to demonstrate that light water tritium targets can be manufactured at a rate consistent with tritium production requirements; and to develop quality control methods to evaluate target rod components and assemblies, and establish correlations between evaluated characteristics and target rod performance. Many of the target rod components: cladding tubes, end caps, plenum springs, etc., have similar counterparts in LWR fuel rods. High production rate manufacture and inspection of these components has beenmore » adequately demonstrated by nuclear fuel rod manufacturers. This summary describes the more non-conventional manufacturing processes and inspection techniques developed to fabricate target rod components whose manufacturability at required production rates had not been previously demonstrated.« less

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.

Reticle variation influence on manufacturing line and wafer device performance

NASA Astrophysics Data System (ADS)

Nistler, John L.; Spurlock, Kyle

1994-01-01

Cost effective manufacturing of devices at 0.5, 0.35 and 0.25μm geometries will be highly dependent on a companys' ability to obtain an economic return on investment. The high capital investment in equipment and facilities, not to mention the related chemical and wafer costs, for producing 200mm silicon wafers requires aspects of wafer processing to be tightly controlled. Reduction in errors and enhanced yield management requires early correction or avoidance of reticle problems. It is becoming increasingly important to recognize and track all pertinent factors impacting both the technical and financial viability of a wafer manufacturing fabrication area. Reticle related effects on wafer manufacturing can be costly and affect the total quality perceived by the device customer.

Lithium-Ion Batteries for Aerospace Applications

NASA Technical Reports Server (NTRS)

Surampudi, S.; Halpert, G.; Marsh, R. A.; James, R.

1999-01-01

This presentation reviews: (1) the goals and objectives, (2) the NASA and Airforce requirements, (3) the potential near term missions, (4) management approach, (5) the technical approach and (6) the program road map. The objectives of the program include: (1) develop high specific energy and long life lithium ion cells and smart batteries for aerospace and defense applications, (2) establish domestic production sources, and to demonstrate technological readiness for various missions. The management approach is to encourage the teaming of universities, R&D organizations, and battery manufacturing companies, to build on existing commercial and government technology, and to develop two sources for manufacturing cells and batteries. The technological approach includes: (1) develop advanced electrode materials and electrolytes to achieve improved low temperature performance and long cycle life, (2) optimize cell design to improve specific energy, cycle life and safety, (3) establish manufacturing processes to ensure predictable performance, (4) establish manufacturing processes to ensure predictable performance, (5) develop aerospace lithium ion cells in various AH sizes and voltages, (6) develop electronics for smart battery management, (7) develop a performance database required for various applications, and (8) demonstrate technology readiness for the various missions. Charts which review the requirements for the Li-ion battery development program are presented.

How Development and Manufacturing Will Need to Be Structured-Heads of Development/Manufacturing May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Nepveux, Kevin; Sherlock, Jon-Paul; Futran, Mauricio; Thien, Michael; Krumme, Markus

2015-03-01

Continuous manufacturing (CM) is a process technology that has been used in the chemical industry for large-scale mass production of chemicals in single-purpose plants with benefit for many years. Recent interest has been raised to expand CM into the low-volume, high-value pharmaceutical business with its unique requirements regarding readiness for human use and the required quality, supply chain, and liability constraints in this business context. Using a fairly abstract set of definitions, this paper derives technical consequences of CM in different scenarios along the development-launch-supply axis in different business models and how they compare to batch processes. Impact of CM on functions in development is discussed and several operational models suitable for originators and other business models are discussed and specific aspects of CM are deduced from CM's technical characteristics. Organizational structures of current operations typically can support CM implementations with just minor refinements if the CM technology is limited to single steps or small sequences (bin-to-bin approach) and if the appropriate technical skill set is available. In such cases, a small, dedicated group focused on CM is recommended. The manufacturing strategy, as centralized versus decentralized in light of CM processes, is discussed and the potential impact of significantly shortened supply lead times on the organization that runs these processes. The ultimate CM implementation may be seen by some as a totally integrated monolithic plant, one that unifies chemistry and pharmaceutical operations into one plant. The organization supporting this approach will have to reflect this change in scope and responsibility. The other extreme, admittedly futuristic at this point, would be a highly decentralized approach with multiple smaller hubs; this would require a new and different organizational structure. This processing approach would open up new opportunities for products that, because of stability constraints or individualization to patients, do not allow centralized manufacturing approaches at all. Again, the entire enterprise needs to be restructured accordingly. The situation of CM in an outsourced operation business model is discussed. Next steps for the industry are recommended. In summary, opportunistic implementation of isolated steps in existing portfolios can be implemented with minimal organizational changes; the availability of the appropriate skills is the determining factor. The implementation of more substantial sequences requires business processes that consider the portfolio, not just single products. Exploration and implementation of complete process chains with consequences for quality decisions do require appropriate organizational support. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

40 CFR Table 1 to Subpart Hhhh of... - Minimum Requirements for Monitoring and Recordkeeping

Code of Federal Regulations, 2010 CFR

2010-07-01

...-hour block averages. 2. Other process or control device parameters specified in your OMM b plan. As... value for each product manufactured during the operating day. 6. UF-to-latex ratio in the binder c For... Required if a thermal oxidizer is used to control formaldehyde emissions. b Required if process...

78 FR 74146 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-10

... for, the manufacture, preproduction design validation (including a process to assess the performance... requirements governing the design, manufacture, packing, labeling, storage, installation, and servicing of all... for Quality Assurance in Design/Development, Production, Installation, and Servicing.'' The CGMP/QS...

75 FR 63834 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-18

... facilities and controls used for, the manufacture, preproduction design validation (including a process to... requirements governing the design, manufacture, packing, labeling, storage, installation, and servicing of all... Model for Quality Assurance in Design/Development, Production, Installation, and Servicing.'' The CGMP...

40 CFR 704.25 - 11-Aminoundecanoic acid.

Code of Federal Regulations, 2010 CFR

2010-07-01

... CONTROL ACT REPORTING AND RECORDKEEPING REQUIREMENTS Chemical-Specific Reporting and Recordkeeping Rules... not qualify as small for purposes of reporting on the processing of that chemical substance at that... section: (1) Persons who manufacture or propose to manufacture 11-AA: (i) For use as an intermediate in...

7 CFR 58.145 - Composition and wholesomeness.

Code of Federal Regulations, 2010 CFR

2010-01-01

... contamination or adulteration of the milk or dairy products during manufacturing. All substances and ingredients used in the processing or manufacturing of any dairy product shall be subject to inspection and shall... requirements of the Federal Food, Drug, and Cosmetic Act as to their composition and wholesomeness. ...

Metal Additive Manufacturing: A Review

NASA Astrophysics Data System (ADS)

Frazier, William E.

2014-06-01

This paper reviews the state-of-the-art of an important, rapidly emerging, manufacturing technology that is alternatively called additive manufacturing (AM), direct digital manufacturing, free form fabrication, or 3D printing, etc. A broad contextual overview of metallic AM is provided. AM has the potential to revolutionize the global parts manufacturing and logistics landscape. It enables distributed manufacturing and the productions of parts-on-demand while offering the potential to reduce cost, energy consumption, and carbon footprint. This paper explores the material science, processes, and business consideration associated with achieving these performance gains. It is concluded that a paradigm shift is required in order to fully exploit AM potential.

49 CFR 178.39 - Specification 3BN seamless nickel cylinders.

Code of Federal Regulations, 2013 CFR

2013-10-01

... manufactured using equipment and processes adequate to ensure that each cylinder produced conforms to the.... A reasonably smooth and uniform surface finish is required. Cylinders closed in by spinning process... plugs, etc.) for those openings. Threads conforming to the following are required on openings: (1...

49 CFR 178.39 - Specification 3BN seamless nickel cylinders.

Code of Federal Regulations, 2014 CFR

2014-10-01

... manufactured using equipment and processes adequate to ensure that each cylinder produced conforms to the.... A reasonably smooth and uniform surface finish is required. Cylinders closed in by spinning process... plugs, etc.) for those openings. Threads conforming to the following are required on openings: (1...

49 CFR 178.39 - Specification 3BN seamless nickel cylinders.

Code of Federal Regulations, 2012 CFR

2012-10-01

... manufactured using equipment and processes adequate to ensure that each cylinder produced conforms to the.... A reasonably smooth and uniform surface finish is required. Cylinders closed in by spinning process... plugs, etc.) for those openings. Threads conforming to the following are required on openings: (1...

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

40 CFR 63.1091 - What do the waste requirements do?

Code of Federal Regulations, 2010 CFR

2010-07-01

...) National Emission Standards for Ethylene Manufacturing Process Units: Heat Exchange Systems and Waste... Operations. There are some differences between the ethylene production waste requirements and those of...

CVD diamond substrate for microelectronics. Final report

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

Burden, J.; Gat, R.

1996-11-01

Chemical Vapor Deposition (CVD) of diamond films has evolved dramatically in recent years, and commercial opportunities for diamond substrates in thermal management applications are promising. The objective of this technology transfer initiative (TTI) is for Applied Science and Technology, Inc. (ASTEX) and AlliedSignal Federal Manufacturing and Technologies (FM&T) to jointly develop and document the manufacturing processes and procedures required for the fabrication of multichip module circuits using CVD diamond substrates, with the major emphasis of the project concentrating on lapping/polishing prior to metallization. ASTEX would provide diamond films for the study, and FM&T would use its experience in lapping, polishing,more » and substrate metallization to perform secondary processing on the parts. The primary goal of the project was to establish manufacturing processes that lower the manufacturing cost sufficiently to enable broad commercialization of the technology.« less

P80 SRM low torque flex-seal development - thermal and chemical modeling of molding process

NASA Astrophysics Data System (ADS)

Descamps, C.; Gautronneau, E.; Rousseau, G.; Daurat, M.

2009-09-01

The development of the flex-seal component of the P80 nozzle gave the opportunity to set up new design and manufacturing process methods. Due to the short development lead time required by VEGA program, the usual manufacturing iterative tests work flow, which is usually time consuming, had to be enhanced in order to use a more predictive approach. A newly refined rubber vulcanization description was built up and identified on laboratory samples. This chemical model was implemented in a thermal analysis code. The complete model successfully supports the manufacturing processes. These activities were conducted with the support of ESA/CNES Research & Technologies and DGA (General Delegation for Armament).

Method of manufacturing carbon nanotubes

NASA Technical Reports Server (NTRS)

Benavides, Jeanette M. (Inventor); Leidecker, Henning W. (Inventor); Frazier, Jeffrey (Inventor)

2004-01-01

A process for manufacturing carbon nanotubes, including a step of inducing electrical current through a carbon anode and a carbon cathode under conditions effective to produce the carbon nanotubes, wherein the carbon cathode is larger than the carbon anode. Preferably, a welder is used to induce the electrical current via an arc welding process. Preferably, an exhaust hood is placed on the anode, and the process does not require a closed or pressurized chamber. The process provides high-quality, single-walled carbon nanotubes, while eliminating the need for a metal catalyst.

Material Stream Strategy for Lithium and Inorganics (U)

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

Safarik, Douglas Joseph; Dunn, Paul Stanton; Korzekwa, Deniece Rochelle

Design Agency Responsibilities: Manufacturing Support to meet Stockpile Stewardship goals for maintaining the nuclear stockpile through experimental and predictive modeling capability. Development and maintenance of Manufacturing Science expertise to assess material specifications and performance boundaries, and their relationship to processing parameters. Production Engineering Evaluations with competence in design requirements, material specifications, and manufacturing controls. Maintenance and enhancement of Aging Science expertise to support Stockpile Stewardship predictive science capability.

Conductor requirements for high-temperature superconducting utility power transformers

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

Pleva, E. F.; Mehrotra, V.; Schwenterly, S W

High-temperature superconducting (HTS) coated conductors in utility power transformers must satisfy a set of operating requirements that are driven by two major considerations-HTS transformers must be economically competitive with conventional units, and the conductor must be robust enough to be used in a commercial manufacturing environment. The transformer design and manufacturing process will be described in order to highlight the various requirements that it imposes on the HTS conductor. Spreadsheet estimates of HTS transformer costs allow estimates of the conductor cost required for an HTS transformer to be competitive with a similarly performing conventional unit.

Industrial Photogrammetry - Accepted Metrology Tool or Exotic Niche

NASA Astrophysics Data System (ADS)

Bösemann, Werner

2016-06-01

New production technologies like 3D printing and other adaptive manufacturing technologies have changed the industrial manufacturing process, often referred to as next industrial revolution or short industry 4.0. Such Cyber Physical Production Systems combine virtual and real world through digitization, model building process simulation and optimization. It is commonly understood that measurement technologies are the key to combine the real and virtual worlds (eg. [Schmitt 2014]). This change from measurement as a quality control tool to a fully integrated step in the production process has also changed the requirements for 3D metrology solutions. Key words like MAA (Measurement Assisted Assembly) illustrate that new position of metrology in the industrial production process. At the same time it is obvious that these processes not only require more measurements but also systems to deliver the required information in high density in a short time. Here optical solutions including photogrammetry for 3D measurements have big advantages over traditional mechanical CMM's. The paper describes the relevance of different photogrammetric solutions including state of the art, industry requirements and application examples.

Estimating the system price of redox flow batteries for grid storage

NASA Astrophysics Data System (ADS)

Ha, Seungbum; Gallagher, Kevin G.

2015-11-01

Low-cost energy storage systems are required to support extensive deployment of intermittent renewable energy on the electricity grid. Redox flow batteries have potential advantages to meet the stringent cost target for grid applications as compared to more traditional batteries based on an enclosed architecture. However, the manufacturing process and therefore potential high-volume production price of redox flow batteries is largely unquantified. We present a comprehensive assessment of a prospective production process for aqueous all vanadium flow battery and nonaqueous lithium polysulfide flow battery. The estimated investment and variable costs are translated to fixed expenses, profit, and warranty as a function of production volume. When compared to lithium-ion batteries, redox flow batteries are estimated to exhibit lower costs of manufacture, here calculated as the unit price less materials costs, owing to their simpler reactor (cell) design, lower required area, and thus simpler manufacturing process. Redox flow batteries are also projected to achieve the majority of manufacturing scale benefits at lower production volumes as compared to lithium-ion. However, this advantage is offset due to the dramatically lower present production volume of flow batteries compared to competitive technologies such as lithium-ion.

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.

Long-term experiences in cryopreservation of mobilized peripheral blood stem cells using a closed-bag system: a technology with potential for broader application.

PubMed

Spoerl, Silvia; Peter, Robert; Wäscher, Dagmar; Verbeek, Mareike; Menzel, Helge; Peschel, Christian; Krackhardt, Angela M

2015-11-01

In several European countries, preparation of cellular products with open manufacturing systems as used for cryopreservation of peripheral blood stem cells (PBSCs) needs to be performed in a clean-room facility. However, this form of manufacturing is highly expensive and laborious. Thus, safe techniques providing improved efficacy regarding time and material, which are in accordance with legal requirements are highly desirable. We have developed, validated, and applied a simple method for cryopreservation of PBSCs within a functionally closed-bag system using the closed cryo freeze prep set. This process fulfills good manufacturing practice requirements and allows for the cryopreservation of PBSCs without a clean-room facility. In addition to cryopreservation of PBSCs, we have recently successfully modified our system for processing, portioning, and cryopreservation of allogeneic donor lymphocytes. Since 2010, cryopreservation of PBSCs using a closed-bag system has been performed in our facility on a routine basis and 210 patients and healthy donors have been included in this analysis. No significant reduction in viability of CD34+ cells and no process-related contamination were observed. Outcome of hematopoietic stem cell transplantation regarding time of engraftment and infectious complications is comparable to products manufactured in conventional clean-room facilities. Our data confirm that cryopreservation of PBSCs within a functionally closed-bag system is safe, effective, and economical. Furthermore, the system has the potential to be extended to other manufacturing processes of cellular products. © 2015 AABB.

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.

Status of the secondary mirrors (M2) for the Gemini 8-m telescopes

NASA Astrophysics Data System (ADS)

Knohl, Ernst-Dieter; Schoeppach, Armin; Pickering, Michael A.

1998-08-01

The 1-m diameter lightweight secondary mirrors (M2) for the Gemini 8-m telescopes will be the largest CVD-SiC mirrors ever produced. The design and manufacture of these mirrors is a very challenging task. In this paper we will discuss the mirror design, structural and mechanical analysis, and the CVD manufacturing process used to produce the mirror blanks. The lightweight design consist of a thin faceplate (4-mm) and triangular backstructure cells with ribs of varying heights. The main drivers in the design were weight (40 kg) and manufacturing limitations imposed on the backstructure cells and mirror mounts. Finite element modeling predicts that the mirror design will meet all of the Gemini M2 requirements for weight, mechanical integrity, resonances, and optical performance. Special design considerations were necessary to avoid stress concentration in the mounting areas and to meet the requirement that the mirror survive an 8-g earthquake. The highest risk step in the mirror blank manufacturing process is the near-net-shape CVD deposition of the thin, curved faceplate. Special tooling and procedures had to be developed to produce faceplates free of fractures, cracks, and stress during the cool-down from deposition temperature (1350 C) to room temperature. Due to time delay with the CVD manufacturing process in the meantime a backup solution from Zerodur has been started. This mirror is now in the advanced polishing process. Because the design of both mirrors is very similar an excellent comparison of both solutions is possible.

Space processing economics

NASA Technical Reports Server (NTRS)

Bredt, J. H.

1974-01-01

Two types of space processing operations may be considered economically justified; they are manufacturing operations that make profits and experiment operations that provide needed applied research results at lower costs than those of alternative methods. Some examples from the Skylab experiments suggest that applied research should become cost effective soon after the space shuttle and Spacelab become operational. In space manufacturing, the total cost of space operations required to process materials must be repaid by the value added to the materials by the processing. Accurate estimates of profitability are not yet possible because shuttle operational costs are not firmly established and the markets for future products are difficult to estimate. However, approximate calculations show that semiconductor products and biological preparations may be processed on a scale consistent with market requirements and at costs that are at least compatible with profitability using the Shuttle/Spacelab system.

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.

A guide to manufacturing CAR T cell therapies.

PubMed

Vormittag, Philipp; Gunn, Rebecca; Ghorashian, Sara; Veraitch, Farlan S

2018-02-17

In recent years, chimeric antigen receptor (CAR) modified T cells have been used as a treatment for haematological malignancies in several phase I and II trials and with Kymriah of Novartis and Yescarta of KITE Pharma, the first CAR T cell therapy products have been approved. Promising clinical outcomes have yet been tempered by the fact that many therapies may be prohibitively expensive to manufacture. The process is not yet defined, far from being standardised and often requires extensive manual handling steps. For academia, big pharma and contract manufacturers it is difficult to obtain an overview over the process strategies and their respective advantages and disadvantages. This review details current production processes being used for CAR T cells with a particular focus on efficacy, reproducibility, manufacturing costs and release testing. By undertaking a systematic analysis of the manufacture of CAR T cells from reported clinical trial data to date, we have been able to quantify recent trends and track the uptake of new process technology. Delivering new processing options will be key to the success of the CAR-T cells ensuring that excessive manufacturing costs do not disrupt the delivery of exciting new therapies to the wide possible patient cohort. Copyright © 2018 Elsevier Ltd. All rights reserved.

75 FR 64394 - Buy America Waiver Notification

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-19

... The FHWA's Buy America policy in 23 CFR 635.410 requires a domestic manufacturing process for any... opposed the approval of the waiver request. The PennDOT contacted the potential domestic manufactures Berg... production run. During the 15-day comment period, the FHWA conducted additional nationwide review to locate...

78 FR 21389 - Notice of Issuance of Final Determination Concerning Certain Ultrasound Systems

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-10

... ultrasound units, known as the S2000 and Antares ultrasound systems, engineered, designed, and subject to... healthcare professionals. One of the most critical elements required for the manufacture of a functional... use of licensing keys. Manufacturing Process Electronics Module Assembly: You state that the...

49 CFR 178.38 - Specification 3B seamless steel cylinders.

Code of Federal Regulations, 2012 CFR

2012-10-01

... the heat number. (d) Manufacture. Cylinders must be manufactured using equipment and processes... plugs, etc.) for those openings. Threads, conforming to the following, are required on all openings: (1) Threads must be clean cut, even, without checks, and to gauge. (2) Taper threads when used, must be of a...

49 CFR 178.38 - Specification 3B seamless steel cylinders.

Code of Federal Regulations, 2010 CFR

2010-10-01

... the heat number. (d) Manufacture. Cylinders must be manufactured using equipment and processes... plugs, etc.) for those openings. Threads, conforming to the following, are required on all openings: (1) Threads must be clean cut, even, without checks, and to gauge. (2) Taper threads when used, must be of a...

49 CFR 178.44 - Specification 3HT seamless steel cylinders for aircraft use.

Code of Federal Regulations, 2013 CFR

2013-10-01

... cylinder. (d) Manufacture. Cylinders must be manufactured using equipment and processes adequate to ensure.... (h) Openings in cylinders and connections (valves, fuse plugs, etc.) for those openings. Threads conforming to the following are required on openings: (1) Threads must be clean cut, even, without cracks...

49 CFR 178.38 - Specification 3B seamless steel cylinders.

Code of Federal Regulations, 2013 CFR

2013-10-01

... the heat number. (d) Manufacture. Cylinders must be manufactured using equipment and processes... plugs, etc.) for those openings. Threads, conforming to the following, are required on all openings: (1) Threads must be clean cut, even, without checks, and to gauge. (2) Taper threads when used, must be of a...

49 CFR 178.44 - Specification 3HT seamless steel cylinders for aircraft use.

Code of Federal Regulations, 2012 CFR

2012-10-01

... cylinder. (d) Manufacture. Cylinders must be manufactured using equipment and processes adequate to ensure.... (h) Openings in cylinders and connections (valves, fuse plugs, etc.) for those openings. Threads conforming to the following are required on openings: (1) Threads must be clean cut, even, without cracks...

49 CFR 178.38 - Specification 3B seamless steel cylinders.

Code of Federal Regulations, 2014 CFR

2014-10-01

... the heat number. (d) Manufacture. Cylinders must be manufactured using equipment and processes... plugs, etc.) for those openings. Threads, conforming to the following, are required on all openings: (1) Threads must be clean cut, even, without checks, and to gauge. (2) Taper threads when used, must be of a...

49 CFR 178.44 - Specification 3HT seamless steel cylinders for aircraft use.

Code of Federal Regulations, 2014 CFR

2014-10-01

... cylinder. (d) Manufacture. Cylinders must be manufactured using equipment and processes adequate to ensure.... (h) Openings in cylinders and connections (valves, fuse plugs, etc.) for those openings. Threads conforming to the following are required on openings: (1) Threads must be clean cut, even, without cracks...

Method and apparatus for manufacturing gas tags

DOEpatents

Gross, K.C.; Laug, M.T.

1996-12-17

For use in the manufacture of gas tags employed in a gas tagging failure detection system for a nuclear reactor, a plurality of commercial feed gases each having a respective noble gas isotopic composition are blended under computer control to provide various tag gas mixtures having selected isotopic ratios which are optimized for specified defined conditions such as cost. Using a new approach employing a discrete variable structure rather than the known continuous-variable optimization problem, the computer controlled gas tag manufacturing process employs an analytical formalism from condensed matter physics known as stochastic relaxation, which is a special case of simulated annealing, for input feed gas selection. For a tag blending process involving M tag isotopes with N distinct feed gas mixtures commercially available from an enriched gas supplier, the manufacturing process calculates the cost difference between multiple combinations and specifies gas mixtures which approach the optimum defined conditions. The manufacturing process is then used to control tag blending apparatus incorporating tag gas canisters connected by stainless-steel tubing with computer controlled valves, with the canisters automatically filled with metered quantities of the required feed gases. 4 figs.

Method and apparatus for manufacturing gas tags

DOEpatents

Gross, Kenny C.; Laug, Matthew T.

1996-01-01

For use in the manufacture of gas tags employed in a gas tagging failure detection system for a nuclear reactor, a plurality of commercial feed gases each having a respective noble gas isotopic composition are blended under computer control to provide various tag gas mixtures having selected isotopic ratios which are optimized for specified defined conditions such as cost. Using a new approach employing a discrete variable structure rather than the known continuous-variable optimization problem, the computer controlled gas tag manufacturing process employs an analytical formalism from condensed matter physics known as stochastic relaxation, which is a special case of simulated annealing, for input feed gas selection. For a tag blending process involving M tag isotopes with N distinct feed gas mixtures commercially available from an enriched gas supplier, the manufacturing process calculates the cost difference between multiple combinations and specifies gas mixtures which approach the optimum defined conditions. The manufacturing process is then used to control tag blending apparatus incorporating tag gas canisters connected by stainless-steel tubing with computer controlled valves, with the canisters automatically filled with metered quantities of the required feed gases.

INTEGRATION OF COST MODELS AND PROCESS SIMULATION TOOLS FOR OPTIMUM COMPOSITE MANUFACTURING PROCESS

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

Pack, Seongchan; Wilson, Daniel; Aitharaju, Venkat

Manufacturing cost of resin transfer molded composite parts is significantly influenced by the cycle time, which is strongly related to the time for both filling and curing of the resin in the mold. The time for filling can be optimized by various injection strategies, and by suitably reducing the length of the resin flow distance during the injection. The curing time can be reduced by the usage of faster curing resins, but it requires a high pressure injection equipment, which is capital intensive. Predictive manufacturing simulation tools that are being developed recently for composite materials are able to provide variousmore » scenarios of processing conditions virtually well in advance of manufacturing the parts. In the present study, we integrate the cost models with process simulation tools to study the influence of various parameters such as injection strategies, injection pressure, compression control to minimize high pressure injection, resin curing rate, and demold time on the manufacturing cost as affected by the annual part volume. A representative automotive component was selected for the study and the results are presented in this paper« less

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.

A review on recent technologies for the manufacture of pulmonary drugs.

PubMed

Hadiwinoto, Gabriela Daisy; Lip Kwok, Philip Chi; Lakerveld, Richard

2018-01-01

This review discusses recent developments in the manufacture of inhalable dry powder formulations. Pulmonary drugs have distinct advantages compared with other drug administration routes. However, requirements of drugs properties complicate the manufacture. Control over crystallization to make particles with the desired properties in a single step is often infeasible, which calls for micronization techniques. Although spray drying produces particles in the desired size range, a stable solid state may not be attainable. Supercritical fluids may be used as a solvent or antisolvent, which significantly reduces solvent waste. Future directions include application areas such as biopharmaceuticals for dry powder inhalers and new processing strategies to improve the control over particle formation such as continuous manufacturing with in-line process analytical technologies.

SAMIS- STANDARD ASSEMBLY-LINE MANUFACTURING INDUSTRY SIMULATION

NASA Technical Reports Server (NTRS)

Chamberlain, R. G.

1994-01-01

The Standard Assembly-Line Manufacturing Industry Simulation (SAMIS) program was originally developed to model a hypothetical U. S. industry which manufactures silicon solar modules for use in electricity generation. The SAMIS program has now been generalized to the extent that it should be useful for simulating many different production-line manufacturing industries and companies. The most important capability of SAMIS is its ability to "simulate" an industry based on a model developed by the user with the aid of the SAMIS program. The results of the simulation are a set of financial reports which detail the requirements, including quantities and cost, of the companies and processes which comprise the industry. SAMIS provides a fair, consistent, and reliable means of comparing manufacturing processes being developed by numerous independent efforts. It can also be used to assess the industry-wide impact of changes in financial parameters, such as cost of resources and services, inflation rates, interest rates, tax policies, and required return on equity. Because of the large amount of data needed to describe an industry, a major portion of SAMIS is dedicated to data entry and maintenance. This activity in SAMIS is referred to as model management. Model management requires a significant amount of interaction through a system of "prompts" which make it possible for persons not familiar with computers, or the SAMIS program, to provide all of the data necessary to perform a simulation. SAMIS is written in TURBO PASCAL (version 2.0 required for compilation) and requires 10 meg of hard disk space, an 8087 coprocessor, and an IBM color graphics monitor. Executables and source code are provided. SAMIS was originally developed in 1978; the IBM PC version was developed in 1985. Release 6.1 was made available in 1986, and includes the PC-IPEG program.

Laser dimpling process parameters selection and optimization using surrogate-driven process capability space

NASA Astrophysics Data System (ADS)

Ozkat, Erkan Caner; Franciosa, Pasquale; Ceglarek, Dariusz

2017-08-01

Remote laser welding technology offers opportunities for high production throughput at a competitive cost. However, the remote laser welding process of zinc-coated sheet metal parts in lap joint configuration poses a challenge due to the difference between the melting temperature of the steel (∼1500 °C) and the vapourizing temperature of the zinc (∼907 °C). In fact, the zinc layer at the faying surface is vapourized and the vapour might be trapped within the melting pool leading to weld defects. Various solutions have been proposed to overcome this problem over the years. Among them, laser dimpling has been adopted by manufacturers because of its flexibility and effectiveness along with its cost advantages. In essence, the dimple works as a spacer between the two sheets in lap joint and allows the zinc vapour escape during welding process, thereby preventing weld defects. However, there is a lack of comprehensive characterization of dimpling process for effective implementation in real manufacturing system taking into consideration inherent changes in variability of process parameters. This paper introduces a methodology to develop (i) surrogate model for dimpling process characterization considering multiple-inputs (i.e. key control characteristics) and multiple-outputs (i.e. key performance indicators) system by conducting physical experimentation and using multivariate adaptive regression splines; (ii) process capability space (Cp-Space) based on the developed surrogate model that allows the estimation of a desired process fallout rate in the case of violation of process requirements in the presence of stochastic variation; and, (iii) selection and optimization of the process parameters based on the process capability space. The proposed methodology provides a unique capability to: (i) simulate the effect of process variation as generated by manufacturing process; (ii) model quality requirements with multiple and coupled quality requirements; and (iii) optimize process parameters under competing quality requirements such as maximizing the dimple height while minimizing the dimple lower surface area.

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.

How to unlock the benefits of MRP (materiel requirements planning) II and Just-in-Time.

PubMed

Jacobi, M A

1994-05-01

Manufacturing companies need to use the best and most applicable parts of MRP II and JIT to run their businesses effectively. MRP II provides the methodology to plan and control the total resources of the company and focuses on the processes that add value to their customers' products. It is the cornerstone of total quality management, as it reduces the variability and costly activities in the communication and subsequent execution of the required steps from customer order to shipment. JIT focuses on simplifying the total business operation and execution of business processes. MRP II and JIT are the foundations for successful manufacturing businesses.

Manufacturability improvements in EUV resist processing toward NXE:3300 processing

NASA Astrophysics Data System (ADS)

Kuwahara, Yuhei; Matsunaga, Koichi; Shimoaoki, Takeshi; Kawakami, Shinichiro; Nafus, Kathleen; Foubert, Philippe; Goethals, Anne-Marie; Shimura, Satoru

2014-03-01

As the design rule of semiconductor process gets finer, extreme ultraviolet lithography (EUVL) technology is aggressively studied as a process for 22nm half pitch and beyond. At present, the studies for EUV focus on manufacturability. It requires fine resolution, uniform, smooth patterns and low defectivity, not only after lithography but also after the etch process. In the first half of 2013, a CLEAN TRACKTM LITHIUS ProTMZ-EUV was installed at imec for POR development in preparation of the ASML NXE:3300. This next generation coating/developing system is equipped with state of the art defect reduction technology. This tool with advanced functions can achieve low defect levels. This paper reports on the progress towards manufacturing defectivity levels and latest optimizations towards the NXE:3300 POR for both lines/spaces and contact holes at imec.

Microeconomics of advanced process window control for 50-nm gates

NASA Astrophysics Data System (ADS)

Monahan, Kevin M.; Chen, Xuemei; Falessi, Georges; Garvin, Craig; Hankinson, Matt; Lev, Amir; Levy, Ady; Slessor, Michael D.

2002-07-01

Fundamentally, advanced process control enables accelerated design-rule reduction, but simple microeconomic models that directly link the effects of advanced process control to profitability are rare or non-existent. In this work, we derive these links using a simplified model for the rate of profit generated by the semiconductor manufacturing process. We use it to explain why and how microprocessor manufacturers strive to avoid commoditization by producing only the number of dies required to satisfy the time-varying demand in each performance segment. This strategy is realized using the tactic known as speed binning, the deliberate creation of an unnatural distribution of microprocessor performance that varies according to market demand. We show that the ability of APC to achieve these economic objectives may be limited by variability in the larger manufacturing context, including measurement delays and process window variation.

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.

40 CFR 63.8685 - What are my general requirements for complying with this subpart?

Code of Federal Regulations, 2013 CFR

2013-07-01

... SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing General Compliance Requirements § 63.8685 What are my general...

40 CFR 63.8685 - What are my general requirements for complying with this subpart?

Code of Federal Regulations, 2011 CFR

2011-07-01

... SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing General Compliance Requirements § 63.8685 What are my general...

40 CFR 63.8685 - What are my general requirements for complying with this subpart?

Code of Federal Regulations, 2010 CFR

2010-07-01

... SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing General Compliance Requirements § 63.8685 What are my general...

40 CFR 63.8685 - What are my general requirements for complying with this subpart?

Code of Federal Regulations, 2014 CFR

2014-07-01

... SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing General Compliance Requirements § 63.8685 What are my general...

40 CFR 63.8685 - What are my general requirements for complying with this subpart?

Code of Federal Regulations, 2012 CFR

2012-07-01

... SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing General Compliance Requirements § 63.8685 What are my general...

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.

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.

Implementation of Statistical Process Control: Evaluating the Mechanical Performance of a Candidate Silicone Elastomer Docking Seal

NASA Technical Reports Server (NTRS)

Oravec, Heather Ann; Daniels, Christopher C.

2014-01-01

The National Aeronautics and Space Administration has been developing a novel docking system to meet the requirements of future exploration missions to low-Earth orbit and beyond. A dynamic gas pressure seal is located at the main interface between the active and passive mating components of the new docking system. This seal is designed to operate in the harsh space environment, but is also to perform within strict loading requirements while maintaining an acceptable level of leak rate. In this study, a candidate silicone elastomer seal was designed, and multiple subscale test articles were manufactured for evaluation purposes. The force required to fully compress each test article at room temperature was quantified and found to be below the maximum allowable load for the docking system. However, a significant amount of scatter was observed in the test results. Due to the stochastic nature of the mechanical performance of this candidate docking seal, a statistical process control technique was implemented to isolate unusual compression behavior from typical mechanical performance. The results of this statistical analysis indicated a lack of process control, suggesting a variation in the manufacturing phase of the process. Further investigation revealed that changes in the manufacturing molding process had occurred which may have influenced the mechanical performance of the seal. This knowledge improves the chance of this and future space seals to satisfy or exceed design specifications.

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.

Scaleable processes for the manufacture of therapeutic quantities of plasmid DNA.

PubMed

Shamlou, Parviz Ayazi

2003-06-01

The need for scaleable processes to manufacture therapeutic plasmid DNA (pDNA) is easy to overlook when attention is focused primarily on vector design and establishment of early clinical results. pDNA is a large molecule and has properties that are similar to those of the contaminating chromosomal DNA. These, combined with the low initial concentration of plasmids in the host cell, provide unique process challenges that require significant upfront design to establish robust manufacturing processes that can also comply with current Good Manufacturing Practice ('cGMP') and produce milligram-to-kilogram quantities of pDNA product. This review describes promising scaleable processes that are currently being assessed for production of therapeutic supercoiled pDNA. Fermentation strategies for improving supercoiled plasmid yield and reducing contaminant concentrations are reviewed, and downstream processes are assessed for their ability to efficiently remove cellular contaminants, separate the supercoiled form of the pDNA from its open circular and linear forms, and prepare the purified drug substance for formulation. Current strategies are presented for developing stable delivery systems, and approaches to quality assurance and quality control are discussed.

Mask manufacturing of advanced technology designs using multi-beam lithography (Part 1)

NASA Astrophysics Data System (ADS)

Green, Michael; Ham, Young; Dillon, Brian; Kasprowicz, Bryan; Hur, Ik Boum; Park, Joong Hee; Choi, Yohan; McMurran, Jeff; Kamberian, Henry; Chalom, Daniel; Klikovits, Jan; Jurkovic, Michal; Hudek, Peter

2016-10-01

As optical lithography is extended into 10nm and below nodes, advanced designs are becoming a key challenge for mask manufacturers. Techniques including advanced Optical Proximity Correction (OPC) and Inverse Lithography Technology (ILT) result in structures that pose a range of issues across the mask manufacturing process. Among the new challenges are continued shrinking Sub-Resolution Assist Features (SRAFs), curvilinear SRAFs, and other complex mask geometries that are counter-intuitive relative to the desired wafer pattern. Considerable capability improvements over current mask making methods are necessary to meet the new requirements particularly regarding minimum feature resolution and pattern fidelity. Advanced processes using the IMS Multi-beam Mask Writer (MBMW) are feasible solutions to these coming challenges. In this paper, we study one such process, characterizing mask manufacturing capability of 10nm and below structures with particular focus on minimum resolution and pattern fidelity.

Mask manufacturing of advanced technology designs using multi-beam lithography (part 2)

NASA Astrophysics Data System (ADS)

Green, Michael; Ham, Young; Dillon, Brian; Kasprowicz, Bryan; Hur, Ik Boum; Park, Joong Hee; Choi, Yohan; McMurran, Jeff; Kamberian, Henry; Chalom, Daniel; Klikovits, Jan; Jurkovic, Michal; Hudek, Peter

2016-09-01

As optical lithography is extended into 10nm and below nodes, advanced designs are becoming a key challenge for mask manufacturers. Techniques including advanced optical proximity correction (OPC) and Inverse Lithography Technology (ILT) result in structures that pose a range of issues across the mask manufacturing process. Among the new challenges are continued shrinking sub-resolution assist features (SRAFs), curvilinear SRAFs, and other complex mask geometries that are counter-intuitive relative to the desired wafer pattern. Considerable capability improvements over current mask making methods are necessary to meet the new requirements particularly regarding minimum feature resolution and pattern fidelity. Advanced processes using the IMS Multi-beam Mask Writer (MBMW) are feasible solutions to these coming challenges. In this paper, Part 2 of our study, we further characterize an MBMW process for 10nm and below logic node mask manufacturing including advanced pattern analysis and write time demonstration.

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.

The application of pentaprism scanning technology on the manufacturing of M3MP

NASA Astrophysics Data System (ADS)

Qi, Erhui; Hu, Haixiang; Hu, Haifei; Cole, Glen; Luo, Xiao; Ford, Virginia; Zhang, Xuejun

2016-10-01

The PSS (pentaprism scanning system) has advantages of simple structure, needless of reference flat, be able of on-site testing, etc, it plays an important role in large flat reflective mirror's manufacturing, especially the high accuracy testing of low order aberrations. The PSS system measures directly the slope information of the tested flat surface. Aimed at the unique requirement of M3MP, which is the prototype mirror of the tertiary mirror in TMT (Thirty Meter Telescope) project, this paper analyzed the slope distribution of low order aberrations, power and astigmatism, which is very important in the manufacturing process of M3MP. Then the sample route lines of PSS are reorganized and new data process algorism is implemented. All this work is done to improve PSS's measure sensitivity of power and astigmatism, for guiding the manufacturing process of M3MP.

Advanced Q-switched DPSS lasers for ID-card marking

NASA Astrophysics Data System (ADS)

Hertwig, Michael; Paster, Martin; Terbrueggen, Ralf

2008-02-01

Increased homeland security concerns across the world have generated a strong demand for forgery-proof ID documents. Manufacturers currently employ a variety of high technology techniques to produce documents that are difficult to copy. However, production costs and lead times are still a concern when considering any possible manufacturing technology. Laser marking has already emerged as an important tool in the manufacturer's arsenal, and is currently being utilized to produce a variety of documents, such as plastic ID cards, drivers' licenses, health insurance cards and passports. The marks utilized can range from simple barcodes and text to high resolution, true grayscale images. The technical challenges posed by these marking tasks include delivering adequate mark legibility, minimizing substrate burning or charring, accurately reproducing grayscale data, and supporting the required process throughput. This article covers the advantages and basic requirements on laser marking of cards and reviews how laser output parameters affect marking quality, speed and overall process economics.

Analyzing the requirements for mass production of small wind turbine generators

NASA Astrophysics Data System (ADS)

Anuskiewicz, T.; Asmussen, J.; Frankenfield, O.

Mass producibility of small wind turbine generators to give manufacturers design and cost data for profitable production operations is discussed. A 15 kW wind turbine generator for production in annual volumes from 1,000 to 50,000 units is discussed. Methodology to cost the systems effectively is explained. The process estimate sequence followed is outlined with emphasis on the process estimate sheets compiled for each component and subsystem. These data enabled analysts to develop cost breakdown profiles crucial in manufacturing decision-making. The appraisal also led to various design recommendations including replacement of aluminum towers with cost effective carbon steel towers. Extensive cost information is supplied in tables covering subassemblies, capital requirements, and levelized energy costs. The physical layout of the plant is depicted to guide manufacturers in taking advantage of the growing business opportunity now offered in conjunction with the national need for energy development.

Additive Manufacturing of Tooling for Refrigeration Cabinet Foaming Processes

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

Post, Brian K; Nuttall, David; Cukier, Michael

The primary objective of this project was to leverage the Big Area Additive Manufacturing (BAAM) process and materials into a long term, quick change tooling concept to drastically reduce product lead and development timelines and costs. Current refrigeration foam molds are complicated to manufacture involving casting several aluminum parts in an approximate shape, machining components of the molds and post fitting and shimming of the parts in an articulated fixture. The total process timeline can take over 6 months. The foaming process is slower than required for production, therefore multiple fixtures, 10 to 27, are required per refrigerator model. Moldsmore » are particular to a specific product configuration making mixed model assembly challenging for sequencing, mold changes or auto changeover features. The initial goal was to create a tool leveraging the ORNL materials and additive process to build a tool in 4 to 6 weeks or less. A secondary goal was to create common fixture cores and provide lightweight fixture sections that could be revised in a very short time to increase equipment flexibility reduce lead times, lower the barriers to first production trials, and reduce tooling costs.« less

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.

24 CFR 3288.110 - Alternative Process agreements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 5 2010-04-01 2010-04-01 false Alternative Process agreements... HOUSING AND URBAN DEVELOPMENT MANUFACTURED HOME DISPUTE RESOLUTION PROGRAM Alternative Process in HUD-Administered States § 3288.110 Alternative Process agreements. (a) Required agreement. To use the Alternative...

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.

16 CFR 1615.31 - Labeling, recordkeeping, advertising, retail display and guaranties.

Code of Federal Regulations, 2010 CFR

2010-01-01

... records required must establish a line of continuity through the process of manufacture of each production... manufacturing specifications relating the same to prototype and production testing and to the production units... such sale or delivery shall be identified by production unit or by style. A style is a garment design...

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.

10 CFR 32.26 - Gas and aerosol detectors containing byproduct material: Requirements for license to manufacture...

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Gas and aerosol detectors containing byproduct material... CONTAINING BYPRODUCT MATERIAL Exempt Concentrations and Items § 32.26 Gas and aerosol detectors containing... application for a specific license to manufacture, process, or produce gas and aerosol detectors containing...

10 CFR 32.26 - Gas and aerosol detectors containing byproduct material: Requirements for license to manufacture...

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Gas and aerosol detectors containing byproduct material... CONTAINING BYPRODUCT MATERIAL Exempt Concentrations and Items § 32.26 Gas and aerosol detectors containing... application for a specific license to manufacture, process, or produce gas and aerosol detectors containing...

40 CFR 63.1386 - Notification, recordkeeping, and reporting requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... microfiche; and (iii) The owner or operator may report required information on paper or on a labeled computer... exceedance was corrected; (v) The formulation of each binder batch and the LOI and density for each product... binder formulation; (vi) Process parameter level(s) for RS and FA manufacturing lines that use process...

21 CFR 111.460 - What requirements apply to holding in-process material?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to holding in-process material? 111.460 Section 111.460 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

40 CFR 63.1094 - What waste streams are exempt from the requirements of this subpart?

Code of Federal Regulations, 2010 CFR

2010-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Ethylene Manufacturing Process Units: Heat Exchange... section are exempt from this subpart. (a) Waste in the form of gases or vapors that is emitted from process fluids. (b) Waste that is contained in a segregated storm water sewer system. Waste Requirements ...

40 CFR 63.11498 - What are the standards and compliance requirements for wastewater systems?

Code of Federal Regulations, 2010 CFR

2010-07-01

... Chemical Manufacturing Area Sources Standards and Compliance Requirements § 63.11498 What are the standards... each wastewater stream using process knowledge, engineering assessment, or test data. Also, you must...

40 CFR 63.7188 - What are my monitoring installation, operation, and maintenance requirements?

Code of Federal Regulations, 2011 CFR

2011-07-01

... Semiconductor Manufacturing Compliance Requirements § 63.7188 What are my monitoring installation, operation... emissions of your semiconductor process vent through a closed vent system to a control device, you must...

40 CFR 63.7188 - What are my monitoring installation, operation, and maintenance requirements?

Code of Federal Regulations, 2010 CFR

2010-07-01

... Semiconductor Manufacturing Compliance Requirements § 63.7188 What are my monitoring installation, operation... emissions of your semiconductor process vent through a closed vent system to a control device, you must...

40 CFR 63.11498 - What are the standards and compliance requirements for wastewater systems?

Code of Federal Regulations, 2012 CFR

2012-07-01

... Chemical Manufacturing Area Sources Standards and Compliance Requirements § 63.11498 What are the standards... each wastewater stream using process knowledge, engineering assessment, or test data. Also, you must...

Factory-Calibrated Continuous Glucose Sensors: The Science Behind the Technology.

PubMed

Hoss, Udo; Budiman, Erwin Satrya

2017-05-01

The use of commercially available continuous glucose monitors for diabetes management requires sensor calibrations, which until recently are exclusively performed by the patient. A new development is the implementation of factory calibration for subcutaneous glucose sensors, which eliminates the need for user calibrations and the associated blood glucose tests. Factory calibration means that the calibration process is part of the sensor manufacturing process and performed under controlled laboratory conditions. The ability to move from a user calibration to factory calibration is based on several technical requirements related to sensor stability and the robustness of the sensor manufacturing process. The main advantages of factory calibration over the conventional user calibration are: (a) more convenience for the user, since no more fingersticks are required for calibration and (b) elimination of use errors related to the execution of the calibration process, which can lead to sensor inaccuracies. The FreeStyle Libre ™ and FreeStyle Libre Pro ™ flash continuous glucose monitoring systems are the first commercially available sensor systems using factory-calibrated sensors. For these sensor systems, no user calibrations are required throughout the sensor wear duration.

Factory-Calibrated Continuous Glucose Sensors: The Science Behind the Technology

PubMed Central

Budiman, Erwin Satrya

2017-01-01

Abstract The use of commercially available continuous glucose monitors for diabetes management requires sensor calibrations, which until recently are exclusively performed by the patient. A new development is the implementation of factory calibration for subcutaneous glucose sensors, which eliminates the need for user calibrations and the associated blood glucose tests. Factory calibration means that the calibration process is part of the sensor manufacturing process and performed under controlled laboratory conditions. The ability to move from a user calibration to factory calibration is based on several technical requirements related to sensor stability and the robustness of the sensor manufacturing process. The main advantages of factory calibration over the conventional user calibration are: (a) more convenience for the user, since no more fingersticks are required for calibration and (b) elimination of use errors related to the execution of the calibration process, which can lead to sensor inaccuracies. The FreeStyle Libre™ and FreeStyle Libre Pro™ flash continuous glucose monitoring systems are the first commercially available sensor systems using factory-calibrated sensors. For these sensor systems, no user calibrations are required throughout the sensor wear duration. PMID:28541139

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.

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.

21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

Code of Federal Regulations, 2010 CFR

2010-04-01

... monitoring required under subpart E; (4) Conducting any required material review and making any required disposition decision; (5) Approving or rejecting any reprocessing; (6) Determining whether all in-process... and to determine that the product is consistent with your purchase order. ...

Space processing applications payload equipment study. Volume 2C: Data acquisition and process control

NASA Technical Reports Server (NTRS)

Kayton, M.; Smith, A. G.

1974-01-01

The services provided by the Spacelab Information Management System are discussed. The majority of the services are provided by the common-support subsystems in the Support Module furnished by the Spacelab manufacturer. The information processing requirements for the space processing applications (SPA) are identified. The requirements and capabilities for electric power, display and control panels, recording and telemetry, intercom, and closed circuit television are analyzed.

Low cost composite manufacturing utilizing intelligent pultrusion and resin transfer molding (IPRTM)

NASA Astrophysics Data System (ADS)

Bradley, James E.; Wysocki, Tadeusz S., Jr.

1993-02-01

This article describes an innovative method for the economical manufacturing of large, intricately-shaped tubular composite parts. Proprietary intelligent process control techniques are combined with standard pultrusion and RTM methodologies to provide high part throughput, performance, and quality while substantially reducing scrap, rework costs, and labor requirements. On-line process monitoring and control is achieved through a smart tooling interface consisting of modular zone tiles installed on part-specific die assemblies. Real-time archiving of process run parameters provides enhanced SPC and SQC capabilities.

Vision Systems Illuminate Industrial Processes

NASA Technical Reports Server (NTRS)

2013-01-01

When NASA designs a spacecraft to undertake a new mission, innovation does not stop after the design phase. In many cases, these spacecraft are firsts of their kind, requiring not only remarkable imagination and expertise in their conception but new technologies and methods for their manufacture. In the realm of manufacturing, NASA has from necessity worked on the cutting-edge, seeking new techniques and materials for creating unprecedented structures, as well as capabilities for reducing the cost and increasing the efficiency of existing manufacturing technologies. From friction stir welding enhancements (Spinoff 2009) to thermoset composites (Spinoff 2011), NASA s innovations in manufacturing have often transferred to the public in ways that enable the expansion of the Nation s industrial productivity. NASA has long pursued ways of improving upon and ensuring quality results from manufacturing processes ranging from arc welding to thermal coating applications. But many of these processes generate blinding light (hence the need for special eyewear during welding) that obscures the process while it is happening, making it difficult to monitor and evaluate. In the 1980s, NASA partnered with a company to develop technology to address this issue. Today, that collaboration has spawned multiple commercial products that not only support effective manufacturing for private industry but also may support NASA in the use of an exciting, rapidly growing field of manufacturing ideal for long-duration space missions.

International Conference on Harmonisation; Guidance on Q11 Development and Manufacture of Drug Substances; availability. Notice.

PubMed

2012-11-20

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q11 Development and Manufacture of Drug Substances.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes approaches to developing and understanding the manufacturing process of a drug substance and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information across the three regions. The discussion of principles in the guidance is intended to apply only to the manufacture of drug substance, not the manufacture of finished drug products.

Characterization and manufacture of braided composites for large commercial aircraft structures

NASA Technical Reports Server (NTRS)

Fedro, Mark J.; Willden, Kurtis

1992-01-01

Braided composite materials, one of the advanced material forms which is under investigation in Boeing's ATCAS program, have been recognized as a potential cost-effective material form for fuselage structural elements. Consequently, there is a strong need for more knowledge in the design, manufacture, test, and analysis of textile structural composites. The overall objective of this work is to advance braided composite technology towards applications to a large commercial transport fuselage. This paper summarizes the mechanics of materials and manufacturing demonstration results which have been obtained in order to acquire an understanding of how braided composites can be applied to a commercial fuselage. Textile composites consisting of 1D, 2D triaxial, and 3D braid patterns with thermoplastic and two RTM resin systems were investigated. The structural performance of braided composites was evaluated through an extensive mechanical test program. Analytical methods were also developed and applied to predict the following: internal fiber architectures, stiffnesses, fiber stresses, failure mechanisms, notch effects, and the entire history of failure of the braided composites specimens. The applicability of braided composites to a commercial transport fuselage was further assessed through a manufacturing demonstration. Three foot fuselage circumferential hoop frames were manufactured to demonstrate the feasibility of consistently producing high quality braided/RTM composite primary structures. The manufacturing issues (tooling requirements, processing requirements, and process/quality control) addressed during the demonstration are summarized. The manufacturing demonstration in conjunction with the mechanical test results and developed analytical methods increased the confidence in the ATCAS approach to the design, manufacture, test, and analysis of braided composites.

40 CFR 63.132 - Process wastewater provisions-general.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 10 2014-07-01 2014-07-01 false Process wastewater provisions-general... Manufacturing Industry for Process Vents, Storage Vessels, Transfer Operations, and Wastewater § 63.132 Process wastewater provisions—general. (a) Existing sources. This paragraph specifies the requirements applicable to...

40 CFR 63.132 - Process wastewater provisions-general.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 10 2013-07-01 2013-07-01 false Process wastewater provisions-general... Manufacturing Industry for Process Vents, Storage Vessels, Transfer Operations, and Wastewater § 63.132 Process wastewater provisions—general. (a) Existing sources. This paragraph specifies the requirements applicable to...

40 CFR 63.132 - Process wastewater provisions-general.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 9 2010-07-01 2010-07-01 false Process wastewater provisions-general... Manufacturing Industry for Process Vents, Storage Vessels, Transfer Operations, and Wastewater § 63.132 Process wastewater provisions—general. (a) Existing sources. This paragraph specifies the requirements applicable to...

40 CFR 63.132 - Process wastewater provisions-general.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 10 2012-07-01 2012-07-01 false Process wastewater provisions-general... Manufacturing Industry for Process Vents, Storage Vessels, Transfer Operations, and Wastewater § 63.132 Process wastewater provisions—general. (a) Existing sources. This paragraph specifies the requirements applicable to...

40 CFR 63.132 - Process wastewater provisions-general.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 9 2011-07-01 2011-07-01 false Process wastewater provisions-general... Manufacturing Industry for Process Vents, Storage Vessels, Transfer Operations, and Wastewater § 63.132 Process wastewater provisions—general. (a) Existing sources. This paragraph specifies the requirements applicable to...

Bayesian assurance and sample size determination in the process validation life-cycle.

PubMed

Faya, Paul; Seaman, John W; Stamey, James D

2017-01-01

Validation of pharmaceutical manufacturing processes is a regulatory requirement and plays a key role in the assurance of drug quality, safety, and efficacy. The FDA guidance on process validation recommends a life-cycle approach which involves process design, qualification, and verification. The European Medicines Agency makes similar recommendations. The main purpose of process validation is to establish scientific evidence that a process is capable of consistently delivering a quality product. A major challenge faced by manufacturers is the determination of the number of batches to be used for the qualification stage. In this article, we present a Bayesian assurance and sample size determination approach where prior process knowledge and data are used to determine the number of batches. An example is presented in which potency uniformity data is evaluated using a process capability metric. By using the posterior predictive distribution, we simulate qualification data and make a decision on the number of batches required for a desired level of assurance.

Process quality engineering for bioreactor-driven manufacturing of tissue-engineered constructs for bone regeneration.

PubMed

Papantoniou Ir, Ioannis; Chai, Yoke Chin; Luyten, Frank P; Schrooten Ir, Jan

2013-08-01

The incorporation of Quality-by-Design (QbD) principles in tissue-engineering bioprocess development toward clinical use will ensure that manufactured constructs possess prerequisite quality characteristics addressing emerging regulatory requirements and ensuring the functional in vivo behavior. In this work, the QbD principles were applied on a manufacturing process step for the in vitro production of osteogenic three-dimensional (3D) hybrid scaffolds that involves cell matrix deposition on a 3D titanium (Ti) alloy scaffold. An osteogenic cell source (human periosteum-derived cells) cultured in a bioinstructive medium was used to functionalize regular Ti scaffolds in a perfusion bioreactor, resulting in an osteogenic hybrid carrier. A two-level three-factor fractional factorial design of experiments was employed to explore a range of production-relevant process conditions by simultaneously changing value levels of the following parameters: flow rate (0.5-2 mL/min), cell culture duration (7-21 days), and cell-seeding density (1.5×10(3)-3×10(3) cells/cm(2)). This approach allowed to evaluate the individual impact of the aforementioned process parameters upon key quality attributes of the produced hybrids, such as collagen production, mineralization level, and cell number. The use of a fractional factorial design approach helped create a design space in which hybrid scaffolds of predefined quality attributes may be robustly manufactured while minimizing the number of required experiments.

Manufacturability: from design to SPC limits through "corner-lot" characterization

NASA Astrophysics Data System (ADS)

Hogan, Timothy J.; Baker, James C.; Wesneski, Lisa; Black, Robert S.; Rothenbury, Dave

2004-12-01

Texas Instruments" Digital Micro-mirror Device, is used in a wide variety of optical display applications ranging from fixed and portable projectors to high-definition television (HDTV) to digital cinema projection systems. A new DMD pixel architecture, called "FTP", was designed and qualified by Texas Instruments DLPTMTM Group in 2003 to meet increased performance objectives for brightness and contrast ratio. Coordination between design, test and fabrication groups was required to balance pixel performance requirements and manufacturing capability. "Corner Lot" designed experiments (DOE) were used to verify "fabrication space" available for the pixel design. The corner lot technique allows confirmation of manufacturability projections early in the design/qualification cycle. Through careful design and analysis of the corner-lot DOE, a balance of critical dimension (cd) "budgets" is possible so that specification and process control limits can be established that meet both customer and factory requirements. The application of corner-lot DOE is illustrated in a case history of the DMD "FTP" pixel. The process for balancing test parameter requirements with multiple critical dimension budgets is shown. MEMS/MOEMS device design and fabrication can use similar techniques to achieve agressive design-to-qualification goals.

Manufacturability: from design to SPC limits through "corner-lot" characterization

NASA Astrophysics Data System (ADS)

Hogan, Timothy J.; Baker, James C.; Wesneski, Lisa; Black, Robert S.; Rothenbury, Dave

2005-01-01

Texas Instruments" Digital Micro-mirror Device, is used in a wide variety of optical display applications ranging from fixed and portable projectors to high-definition television (HDTV) to digital cinema projection systems. A new DMD pixel architecture, called "FTP", was designed and qualified by Texas Instruments DLPTMTM Group in 2003 to meet increased performance objectives for brightness and contrast ratio. Coordination between design, test and fabrication groups was required to balance pixel performance requirements and manufacturing capability. "Corner Lot" designed experiments (DOE) were used to verify "fabrication space" available for the pixel design. The corner lot technique allows confirmation of manufacturability projections early in the design/qualification cycle. Through careful design and analysis of the corner-lot DOE, a balance of critical dimension (cd) "budgets" is possible so that specification and process control limits can be established that meet both customer and factory requirements. The application of corner-lot DOE is illustrated in a case history of the DMD "FTP" pixel. The process for balancing test parameter requirements with multiple critical dimension budgets is shown. MEMS/MOEMS device design and fabrication can use similar techniques to achieve agressive design-to-qualification goals.

Distributive Distillation Enabled by Microchannel Process Technology

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

Arora, Ravi

The application of microchannel technology for distributive distillation was studied to achieve the Grand Challenge goals of 25% energy savings and 10% return on investment. In Task 1, a detailed study was conducted and two distillation systems were identified that would meet the Grand Challenge goals if the microchannel distillation technology was used. Material and heat balance calculations were performed to develop process flow sheet designs for the two distillation systems in Task 2. The process designs were focused on two methods of integrating the microchannel technology 1) Integrating microchannel distillation to an existing conventional column, 2) Microchannel distillation formore » new plants. A design concept for a modular microchannel distillation unit was developed in Task 3. In Task 4, Ultrasonic Additive Machining (UAM) was evaluated as a manufacturing method for microchannel distillation units. However, it was found that a significant development work would be required to develop process parameters to use UAM for commercial distillation manufacturing. Two alternate manufacturing methods were explored. Both manufacturing approaches were experimentally tested to confirm their validity. The conceptual design of the microchannel distillation unit (Task 3) was combined with the manufacturing methods developed in Task 4 and flowsheet designs in Task 2 to estimate the cost of the microchannel distillation unit and this was compared to a conventional distillation column. The best results were for a methanol-water separation unit for the use in a biodiesel facility. For this application microchannel distillation was found to be more cost effective than conventional system and capable of meeting the DOE Grand Challenge performance requirements.« less

Optimizing Polymer Infusion Process for Thin Ply Textile Composites with Novel Matrix System

PubMed Central

Bhudolia, Somen K.; Perrotey, Pavel; Joshi, Sunil C.

2017-01-01

For mass production of structural composites, use of different textile patterns, custom preforming, room temperature cure high performance polymers and simplistic manufacturing approaches are desired. Woven fabrics are widely used for infusion processes owing to their high permeability but their localised mechanical performance is affected due to inherent associated crimps. The current investigation deals with manufacturing low-weight textile carbon non-crimp fabrics (NCFs) composites with a room temperature cure epoxy and a novel liquid Methyl methacrylate (MMA) thermoplastic matrix, Elium®. Vacuum assisted resin infusion (VARI) process is chosen as a cost effective manufacturing technique. Process parameters optimisation is required for thin NCFs due to intrinsic resistance it offers to the polymer flow. Cycles of repetitive manufacturing studies were carried out to optimise the NCF-thermoset (TS) and NCF with novel reactive thermoplastic (TP) resin. It was noticed that the controlled and optimised usage of flow mesh, vacuum level and flow speed during the resin infusion plays a significant part in deciding the final quality of the fabricated composites. The material selections, the challenges met during the manufacturing and the methods to overcome these are deliberated in this paper. An optimal three stage vacuum technique developed to manufacture the TP and TS composites with high fibre volume and lower void content is established and presented. PMID:28772654

Optimizing Polymer Infusion Process for Thin Ply Textile Composites with Novel Matrix System.

PubMed

Bhudolia, Somen K; Perrotey, Pavel; Joshi, Sunil C

2017-03-15

For mass production of structural composites, use of different textile patterns, custom preforming, room temperature cure high performance polymers and simplistic manufacturing approaches are desired. Woven fabrics are widely used for infusion processes owing to their high permeability but their localised mechanical performance is affected due to inherent associated crimps. The current investigation deals with manufacturing low-weight textile carbon non-crimp fabrics (NCFs) composites with a room temperature cure epoxy and a novel liquid Methyl methacrylate (MMA) thermoplastic matrix, Elium ® . Vacuum assisted resin infusion (VARI) process is chosen as a cost effective manufacturing technique. Process parameters optimisation is required for thin NCFs due to intrinsic resistance it offers to the polymer flow. Cycles of repetitive manufacturing studies were carried out to optimise the NCF-thermoset (TS) and NCF with novel reactive thermoplastic (TP) resin. It was noticed that the controlled and optimised usage of flow mesh, vacuum level and flow speed during the resin infusion plays a significant part in deciding the final quality of the fabricated composites. The material selections, the challenges met during the manufacturing and the methods to overcome these are deliberated in this paper. An optimal three stage vacuum technique developed to manufacture the TP and TS composites with high fibre volume and lower void content is established and presented.

Standardization of Good Manufacturing Practice-compliant production of bone marrow-derived human mesenchymal stromal cells for immunotherapeutic applications.

PubMed

Wuchter, Patrick; Bieback, Karen; Schrezenmeier, Hubert; Bornhäuser, Martin; Müller, Lutz P; Bönig, Halvard; Wagner, Wolfgang; Meisel, Roland; Pavel, Petra; Tonn, Torsten; Lang, Peter; Müller, Ingo; Renner, Matthias; Malcherek, Georg; Saffrich, Rainer; Buss, Eike C; Horn, Patrick; Rojewski, Markus; Schmitt, Anita; Ho, Anthony D; Sanzenbacher, Ralf; Schmitt, Michael

2015-02-01

Human mesenchymal stem or stromal cells (MSCs) represent a potential resource not only for regenerative medicine but also for immunomodulatory cell therapies. The application of different MSC culture protocols has significantly hampered the comparability of experimental and clinical data from different laboratories and has posed a major obstacle for multicenter clinical trials. Manufacturing of cell products for clinical application in the European Community must be conducted in compliance with Good Manufacturing Practice and requires a manufacturing license. In Germany, the Paul-Ehrlich-Institut as the Federal Authority for Vaccines and Biomedicines is critically involved in the approval process. This report summarizes a consensus meeting between researchers, clinicians and regulatory experts on standard quality requirements for MSC production. The strategy for quality control testing depends on the product's cell composition, the manufacturing process and the indication and target patient population. Important quality criteria in this sense are, among others, the immunophenotype of the cells, composition of the culture medium and the risk for malignant transformation, as well as aging and the immunosuppressive potential of the manufactured MSCs. This position paper intends to provide relevant information to interested parties regarding these criteria to foster the development of scientifically valid and harmonized quality standards and to support approval of MSC-based investigational medicinal products. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Cost-Benefit Analysis for the Advanced Near Net Shape Technology (ANNST) Method for Fabricating Stiffened Cylinders

NASA Technical Reports Server (NTRS)

Stoner, Mary Cecilia; Hehir, Austin R.; Ivanco, Marie L.; Domack, Marcia S.

2016-01-01

This cost-benefit analysis assesses the benefits of the Advanced Near Net Shape Technology (ANNST) manufacturing process for fabricating integrally stiffened cylinders. These preliminary, rough order-of-magnitude results report a 46 to 58 percent reduction in production costs and a 7-percent reduction in weight over the conventional metallic manufacturing technique used in this study for comparison. Production cost savings of 35 to 58 percent were reported over the composite manufacturing technique used in this study for comparison; however, the ANNST concept was heavier. In this study, the predicted return on investment of equipment required for the ANNST method was ten cryogenic tank barrels when compared with conventional metallic manufacturing. The ANNST method was compared with the conventional multi-piece metallic construction and composite processes for fabricating integrally stiffened cylinders. A case study compared these three alternatives for manufacturing a cylinder of specified geometry, with particular focus placed on production costs and process complexity, with cost analyses performed by the analogy and parametric methods. Furthermore, a scalability study was conducted for three tank diameters to assess the highest potential payoff of the ANNST process for manufacture of large-diameter cryogenic tanks. The analytical hierarchy process (AHP) was subsequently used with a group of selected subject matter experts to assess the value of the various benefits achieved by the ANNST method for potential stakeholders. The AHP study results revealed that decreased final cylinder mass and quality assurance were the most valued benefits of cylinder manufacturing methods, therefore emphasizing the relevance of the benefits achieved with the ANNST process for future projects.

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.

40 CFR Table 6 to Subpart Lllll of... - Requirements for Reports

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing Pt. 63, Subpt. LLLLL, Table 6 Table 6 to Subpart LLLLL of Part 63—Requirements for Reports You...

Advanced development of TFA-MOD coated conductors

NASA Astrophysics Data System (ADS)

Rupich, M. W.; Li, X.; Sathyamurthy, S.; Thieme, C.; Fleshler, S.

2011-11-01

American Superconductor is manufacturing 2G wire for initial commercial applications. The 2G wire properties satisfy the requirements for these initial projects; however, improvements in the critical current, field performance and cost are required to address the broad range of potential commercial and military applications. In order to meet the anticipated the performance and cost requirements, AMSC's R&D effort is focused on two major areas: (1) higher critical current and (2) enhanced flux pinning. AMSC's current 2G production wire, designed around a 0.8 μm thick YBCO layer deposited by a Metal Organic Deposition (MOD) process, carries a critical current in the range of 200-300 A/cm-w (77 K, sf). Achieving higher critical current requires increasing the thickness of the YBCO layer. This paper describes recent progress at AMSC on increasing the critical current of MOD-YBCO films using processes compatible with low-cost, high-rate manufacturing.

Vaccine provision: Delivering sustained & widespread use.

PubMed

Preiss, Scott; Garçon, Nathalie; Cunningham, Anthony L; Strugnell, Richard; Friedland, Leonard R

2016-12-20

The administration of a vaccine to a recipient is the final step in a development and production process that may have begun several decades earlier. Here we describe the scale and complexity of the processes that brings a candidate vaccine through clinical development to the recipient. These challenges include ensuring vaccine quality (between 100 and 500 different Quality Control tests are performed during production to continually assess safety, potency and purity); making decisions about optimal vaccine presentation (pre-filled syringes versus multi-dose vials) that affect capacity and supply; and the importance of maintaining the vaccine cold chain (most vaccines have stringent storage temperature requirements necessary to maintain activity and potency). The ultimate aim is to make sure that an immunogenic product matching the required specifications reaches the recipient. The process from concept to licensure takes 10-30years. Vaccine licensure is based on a file submitted to regulatory agencies which contains the comprehensive compilation of chemistry, manufacturing information, assay procedures, preclinical and clinical trial results, and proposals for post-licensure effectiveness and safety data collection. Expedited development and licensure pathways may be sought in emergency settings: e.g., the 2009 H1N1 influenza pandemic, the 2014 West African Ebola outbreak and meningococcal serogroup B meningitis outbreaks in the United States and New Zealand. Vaccines vary in the complexity of their manufacturing process. Influenza vaccines are particularly challenging to produce and delays in manufacturing may occur, leading to vaccine shortages during the influenza season. Shortages can be difficult to resolve due to long manufacturing lead times and stringent, but variable, local regulations. New technologies are driving the development of new vaccines with simplified manufacturing requirements and with quality specifications that can be confirmed with fewer tests. These technologies could have far-reaching effects on supply, cost of goods, and on response timing to a medical need until product availability. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Launching the dialogue: Safety and innovation as partners for success in advanced manufacturing.

PubMed

Geraci, C L; Tinkle, S S; Brenner, S A; Hodson, L L; Pomeroy-Carter, C A; Neu-Baker, N

2018-06-01

Emerging and novel technologies, materials, and information integrated into increasingly automated and networked manufacturing processes or into traditional manufacturing settings are enhancing the efficiency and productivity of manufacturing. Globally, there is a move toward a new era in manufacturing that is characterized by: (1) the ability to create and deliver more complex designs of products; (2) the creation and use of materials with new properties that meet a design need; (3) the employment of new technologies, such as additive and digital techniques that improve on conventional manufacturing processes; and (4) a compression of the time from initial design concept to the creation of a final product. Globally, this movement has many names, but "advanced manufacturing" has become the shorthand for this complex integration of material and technology elements that enable new ways to manufacture existing products, as well as new products emerging from new technologies and new design methods. As the breadth of activities associated with advanced manufacturing suggests, there is no single advanced manufacturing industry. Instead, aspects of advanced manufacturing can be identified across a diverse set of business sectors that use manufacturing technologies, ranging from the semiconductors and electronics to the automotive and pharmaceutical industries. The breadth and diversity of advanced manufacturing may change the occupational and environmental risk profile, challenge the basic elements of comprehensive health and safety (material, process, worker, environment, product, and general public health and safety), and provide an opportunity for development and dissemination of occupational and environmental health and safety (OEHS) guidance and best practices. It is unknown how much the risk profile of different elements of OEHS will change, thus requiring an evolution of health and safety practices. These changes may be accomplished most effectively through multi-disciplinary, multi-sector, public-private dialogue that identifies issues and offers solutions.

Automation of cellular therapy product manufacturing: results of a split validation comparing CD34 selection of peripheral blood stem cell apheresis product with a semi-manual vs. an automatic procedure.

PubMed

Hümmer, Christiane; Poppe, Carolin; Bunos, Milica; Stock, Belinda; Wingenfeld, Eva; Huppert, Volker; Stuth, Juliane; Reck, Kristina; Essl, Mike; Seifried, Erhard; Bonig, Halvard

2016-03-16

Automation of cell therapy manufacturing promises higher productivity of cell factories, more economical use of highly-trained (and costly) manufacturing staff, facilitation of processes requiring manufacturing steps at inconvenient hours, improved consistency of processing steps and other benefits. One of the most broadly disseminated engineered cell therapy products is immunomagnetically selected CD34+ hematopoietic "stem" cells (HSCs). As the clinical GMP-compliant automat CliniMACS Prodigy is being programmed to perform ever more complex sequential manufacturing steps, we developed a CD34+ selection module for comparison with the standard semi-automatic CD34 "normal scale" selection process on CliniMACS Plus, applicable for 600 × 10(6) target cells out of 60 × 10(9) total cells. Three split-validation processings with healthy donor G-CSF-mobilized apheresis products were performed; feasibility, time consumption and product quality were assessed. All processes proceeded uneventfully. Prodigy runs took about 1 h longer than CliniMACS Plus runs, albeit with markedly less hands-on operator time and therefore also suitable for less experienced operators. Recovery of target cells was the same for both technologies. Although impurities, specifically T- and B-cells, were 5 ± 1.6-fold and 4 ± 0.4-fold higher in the Prodigy products (p = ns and p = 0.013 for T and B cell depletion, respectively), T cell contents per kg of a virtual recipient receiving 4 × 10(6) CD34+ cells/kg was below 10 × 10(3)/kg even in the worst Prodigy product and thus more than fivefold below the specification of CD34+ selected mismatched-donor stem cell products. The products' theoretical clinical usability is thus confirmed. This split validation exercise of a relatively short and simple process exemplifies the potential of automatic cell manufacturing. Automation will further gain in attractiveness when applied to more complex processes, requiring frequent interventions or handling at unfavourable working hours, such as re-targeting of T-cells.

Feasibility of commercial space manufacturing, production of pharmaceuticals. Volume 2: Technical analysis

NASA Technical Reports Server (NTRS)

1978-01-01

A technical analysis on the feasibility of commercial manufacturing of pharmaceuticals in space is presented. The method of obtaining pharmaceutical company involvement, laboratory results of the separation of serum proteins by the continuous flow electrophoresis process, the selection and study of candidate products, and their production requirements is described. The candidate products are antihemophilic factor, beta cells, erythropoietin, epidermal growth factor, alpha-1-antitrypsin and interferon. Production mass balances for antihemophelic factor, beta cells, and erythropoietin were compared for space versus ground operation. A conceptual description of a multiproduct processing system for space operation is discussed. Production requirements for epidermal growth factor of alpha-1-antitrypsin and interferon are presented.

Application of quality by design for 3D printed bone prostheses and scaffolds

PubMed Central

Martinez-Marquez, Daniel; Mirnajafizadeh, Ali; Carty, Christopher P.

2018-01-01

3D printing is an emergent manufacturing technology recently being applied in the medical field for the development of custom bone prostheses and scaffolds. However, successful industry transformation to this new design and manufacturing approach requires technology integration, concurrent multi-disciplinary collaboration, and a robust quality management framework. This latter change enabler is the focus of this study. While a number of comprehensive quality frameworks have been developed in recent decades to ensure that the manufacturing of medical devices produces reliable products, they are centred on the traditional context of standardised manufacturing techniques. The advent of 3D printing technologies and the prospects for mass customisation provides significant market opportunities, but also presents a serious challenge to regulatory bodies tasked with managing and assuring product quality and safety. Before 3D printing bone prostheses and scaffolds can gain traction, industry stakeholders, such as regulators, clients, medical practitioners, insurers, lawyers, and manufacturers, would all require a high degree of confidence that customised manufacturing can achieve the same quality outcomes as standardised manufacturing. A Quality by Design (QbD) approach to custom 3D printed prostheses can help to ensure that products are designed and manufactured correctly from the beginning without errors. This paper reports on the adaptation of the QbD approach for the development process of 3D printed custom bone prosthesis and scaffolds. This was achieved through the identification of the Critical Quality Attributes of such products, and an extensive review of different design and fabrication methods for 3D printed bone prostheses. Research outcomes include the development of a comprehensive design and fabrication process flow diagram, and categorised risks associated with the design and fabrication processes of such products. An extensive systematic literature review and post-hoc evaluation survey with experts was completed to evaluate the likely effectiveness of the herein suggested QbD framework. PMID:29649231

Application of quality by design for 3D printed bone prostheses and scaffolds.

PubMed

Martinez-Marquez, Daniel; Mirnajafizadeh, Ali; Carty, Christopher P; Stewart, Rodney A

2018-01-01

3D printing is an emergent manufacturing technology recently being applied in the medical field for the development of custom bone prostheses and scaffolds. However, successful industry transformation to this new design and manufacturing approach requires technology integration, concurrent multi-disciplinary collaboration, and a robust quality management framework. This latter change enabler is the focus of this study. While a number of comprehensive quality frameworks have been developed in recent decades to ensure that the manufacturing of medical devices produces reliable products, they are centred on the traditional context of standardised manufacturing techniques. The advent of 3D printing technologies and the prospects for mass customisation provides significant market opportunities, but also presents a serious challenge to regulatory bodies tasked with managing and assuring product quality and safety. Before 3D printing bone prostheses and scaffolds can gain traction, industry stakeholders, such as regulators, clients, medical practitioners, insurers, lawyers, and manufacturers, would all require a high degree of confidence that customised manufacturing can achieve the same quality outcomes as standardised manufacturing. A Quality by Design (QbD) approach to custom 3D printed prostheses can help to ensure that products are designed and manufactured correctly from the beginning without errors. This paper reports on the adaptation of the QbD approach for the development process of 3D printed custom bone prosthesis and scaffolds. This was achieved through the identification of the Critical Quality Attributes of such products, and an extensive review of different design and fabrication methods for 3D printed bone prostheses. Research outcomes include the development of a comprehensive design and fabrication process flow diagram, and categorised risks associated with the design and fabrication processes of such products. An extensive systematic literature review and post-hoc evaluation survey with experts was completed to evaluate the likely effectiveness of the herein suggested QbD framework.

Development of an advanced uncooled 10-Gb DFB laser for volume manufacture

NASA Astrophysics Data System (ADS)

Burns, Gordon; Charles, Paul M.

2003-03-01

Optical communication systems operating at 10Gbit/s such as 10Gigabit Ethernet are becoming more and more important in Local Area Networks (LAN) and Metropolitan Area Networks (MAN). This market requires optical transceivers of low cost, size and power consumption. This drives a need for uncooled DFB lasers directly modulated at 10Gbit/s. This paper describes the development of a state of the art uncooled high speed DFB laser which is capable of being manufactured in high volume at the low cost demanded by the GbE market. A DFB laser was designed by developing technological building blocks within the 'conventional" InGaAsP materials system, using existing well proven manufacturing processes modules wherever possible, limiting the design risk to a few key areas where innovation was required. The temperature and speed performance of the InGaAsP SMQW active layer system was carefully optimized and then coupled with a low parasitic lateral confinement system. Using concurrent engineering, new processes were demonstrated to have acceptable process capability within a manufacturing fabrication environment, proving their ability to support high volume manufacturing requirements. The DFB laser fabricated was shown to operate at 100C chip temperature with an open eye at 10Gbit/s operation (with an extinction ratio >5dB). Up to 90C operation this DFB shows threshold current as low as 29mA, optical power as high as 13mW and it meets the 10Gb scaled Ethernet mask with extinction ratio >6dB. It was found that the high temperature dynamic behavior of these lasers could not be fully predicted from static test data. A production test strategy was therefore followed where equipment was designed to fully test devices/subassemblies at 100C and up to 20Gbit/s at key points in the product build. This facilitated the rapid optimisation of product yields upon manufacturing ramp up and minimization of product costs. This state of the art laser is now transferred into volume manufacture.

Preparing clinical grade Ag-specific T cells for adoptive immunotherapy trials

PubMed Central

DiGiusto, DL; Cooper, LJN

2007-01-01

The production of clinical-grade T cells for adoptive immunotherapy has evolved from the ex vivo numerical expansion of tumor-infiltrating lymphocytes to sophisticated bioengineering processes often requiring cell selection, genetic modification and other extensive tissue culture manipulations, to produce desired cells with improved therapeutic potential. Advancements in understanding the biology of lymphocyte signaling, activation, homing and sustained in vivo proliferative potential have redefined the strategies used to produce T cells suitable for clinical investigation. When combined with new technical methods in cell processing and culturing, the therapeutic potential of T cells manufactured in academic centers has improved dramatically. Paralleling these technical achievements in cell manufacturing is the development of broadly applied regulatory standards that define the requirements for the clinical implementation of cell products with ever-increasing complexity. In concert with academic facilities operating in compliance with current good manufacturing practice, the prescribing physician can now infuse T cells with a highly selected or endowed phenotype that has been uniformly manufactured according to standard operating procedures and that meets federal guidelines for quality of investigational cell products. In this review we address salient issues related to the technical, immunologic, practical and regulatory aspects of manufacturing these advanced T-cell products for clinical use. PMID:17943498

40 CFR 763.167 - Processing prohibitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... CONTROL ACT ASBESTOS Prohibition of the Manufacture, Importation, Processing, and Distribution in Commerce of Certain Asbestos-Containing Products; Labeling Requirements § 763.167 Processing prohibitions. (a..., any of the asbestos-containing products listed at § 763.165(a). (b) After August 26, 1996, no person...

Three-Axis Distributed Fiber Optic Strain Measurement in 3D Woven Composite Structures

NASA Technical Reports Server (NTRS)

Castellucci, Matt; Klute, Sandra; Lally, Evan M.; Froggatt, Mark E.; Lowry, David

2013-01-01

Recent advancements in composite materials technologies have broken further from traditional designs and require advanced instrumentation and analysis capabilities. Success or failure is highly dependent on design analysis and manufacturing processes. By monitoring smart structures throughout manufacturing and service life, residual and operational stresses can be assessed and structural integrity maintained. Composite smart structures can be manufactured by integrating fiber optic sensors into existing composite materials processes such as ply layup, filament winding and three-dimensional weaving. In this work optical fiber was integrated into 3D woven composite parts at a commercial woven products manufacturing facility. The fiber was then used to monitor the structures during a VARTM manufacturing process, and subsequent static and dynamic testing. Low cost telecommunications-grade optical fiber acts as the sensor using a high resolution commercial Optical Frequency Domain Reflectometer (OFDR) system providing distributed strain measurement at spatial resolutions as low as 2mm. Strain measurements using the optical fiber sensors are correlated to resistive strain gage measurements during static structural loading. Keywords: fiber optic, distributed strain sensing, Rayleigh scatter, optical frequency domain reflectometry

40 CFR 63.2485 - What requirements must I meet for wastewater streams and liquid streams in open systems within an...

Code of Federal Regulations, 2010 CFR

2010-07-01

... Pollutants: Miscellaneous Organic Chemical Manufacturing Emission Limits, Work Practice Standards, and... be if the contents of the wastewater tank were not heated, treated by an exothermic reaction, or... uses the term “chemical manufacturing process unit,” the term “MCPU” applies for the purposes of this...

Improving lumber yield using a dual system

Treesearch

R. Edward Thomas; Omar Espinoza; Urs Buehlmann

2015-01-01

Rough mills embody the process of cutting up kiln-dried lumber to components used by discrete wood products manufacturers to manufacture products like furniture, kitchen cabinets, flooring, or other items. Rough mills traditionally have either ripped the lumber first (e.g., the lumber is first cut into strips lengthwise) then cut the strips to the required part lengths...

75 FR 364 - Notice of a Project Waiver of Section 1605 (Buy American Requirement) of the American Recovery...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-05

... City, ND for the Zenon ZeeWeed 1000 membrane filter manufactured by General Electric Water & Process... membrane filters are manufactured in Canada, and meet Valley City's performance specifications and... the purchase of the Zenon ZeeWeed 1000 membrane filter for the Surface Water Treatment Plant upgrades...

16 CFR 303.33 - Country where textile fiber products are processed or manufactured.

Code of Federal Regulations, 2013 CFR

2013-01-01

... [Foreign Country]”. (ii) When the U.S. Customs Service requires an origin label on the unfinished product... manufacturer needs to consider the origin of only those materials that are covered under the Act and that are... species of product. Variant spellings which clearly indicate the English name of the country, such as...

16 CFR 303.33 - Country where textile fiber products are processed or manufactured.

Code of Federal Regulations, 2014 CFR

2014-01-01

... [Foreign Country]”. (ii) When the U.S. Customs Service requires an origin label on the unfinished product... manufacturer needs to consider the origin of only those materials that are covered under the Act and that are... species of product. Variant spellings which clearly indicate the English name of the country, such as...

16 CFR 303.33 - Country where textile fiber products are processed or manufactured.

Code of Federal Regulations, 2012 CFR

2012-01-01

... [Foreign Country]”. (ii) When the U.S. Customs Service requires an origin label on the unfinished product... manufacturer needs to consider the origin of only those materials that are covered under the Act and that are... species of product. Variant spellings which clearly indicate the English name of the country, such as...

Dynamic control of moisture during hot pressing of wood composites

Treesearch

Cheng Piao; Todd F. Shupe; Chung Y. Hse

2006-01-01

Hot pressing is an important step in the manufacture of wood composites. In the conventional pressing system, hot press output often acts as a constraint to increased production. Severe drying of the furnish (e.g., particles, flakes, or fibers) required by this process substantially increases the manufacturing cost and creates air-polluting emissions of volatile...

A Needs Assessment for the Introduction of a Food Science Program at the Univ. of Guyana

ERIC Educational Resources Information Center

Morrison, Donna

2012-01-01

This research describes the outcome of a needs assessment to determine whether the Univ. of Guyana should introduce a Food Science program. The research design utilized interviews and questionnaires to large manufacturing organizations and agroprocessors to determine if the required skills are available for the manufacturing process. Results…

A practical approach for exploration and modeling of the design space of a bacterial vaccine cultivation process.

PubMed

Streefland, M; Van Herpen, P F G; Van de Waterbeemd, B; Van der Pol, L A; Beuvery, E C; Tramper, J; Martens, D E; Toft, M

2009-10-15

A licensed pharmaceutical process is required to be executed within the validated ranges throughout the lifetime of product manufacturing. Changes to the process, especially for processes involving biological products, usually require the manufacturer to demonstrate that the safety and efficacy of the product remains unchanged by new or additional clinical testing. Recent changes in the regulations for pharmaceutical processing allow broader ranges of process settings to be submitted for regulatory approval, the so-called process design space, which means that a manufacturer can optimize his process within the submitted ranges after the product has entered the market, which allows flexible processes. In this article, the applicability of this concept of the process design space is investigated for the cultivation process step for a vaccine against whooping cough disease. An experimental design (DoE) is applied to investigate the ranges of critical process parameters that still result in a product that meets specifications. The on-line process data, including near infrared spectroscopy, are used to build a descriptive model of the processes used in the experimental design. Finally, the data of all processes are integrated in a multivariate batch monitoring model that represents the investigated process design space. This article demonstrates how the general principles of PAT and process design space can be applied for an undefined biological product such as a whole cell vaccine. The approach chosen for model development described here, allows on line monitoring and control of cultivation batches in order to assure in real time that a process is running within the process design space.

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.

Arginine-glycine-aspartic acid functional branched semi-interpenetrating hydrogels.

PubMed

Plenderleith, Richard A; Pateman, Christopher J; Rodenburg, Cornelia; Haycock, John W; Claeyssens, Frederik; Sammon, Chris; Rimmer, Stephen

2015-10-14

For the first time a series of functional hydrogels based on semi-interpenetrating networks with both branched and crosslinked polymer components have been prepared and we show the successful use of these materials as substrates for cell culture. The materials consist of highly branched poly(N-isopropyl acrylamide)s with peptide functionalised end groups in a continuous phase of crosslinked poly(vinyl pyrrolidone). Functionalisation of the end groups of the branched polymer component with the GRGDS peptide produces a hydrogel that supports cell adhesion and proliferation. The materials provide a new synthetic functional biomaterial that has many of the features of extracellular matrix, and as such can be used to support tissue regeneration and cell culture. This class of high water content hydrogel material has important advantages over other functional hydrogels in its synthesis and does not require post-processing modifications nor are functional-monomers, which change the polymerisation process, required. Thus, the systems are amenable to large scale and bespoke manufacturing using conventional moulding or additive manufacturing techniques. Processing using additive manufacturing is exemplified by producing tubes using microstereolithography.

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.

A Review of the Aging Process and Facilities Topic.

PubMed

Jornitz, Maik W

2015-01-01

Aging facilities have become a concern in the pharmaceutical and biopharmaceutical manufacturing industry, so much that task forces are formed by trade organizations to address the topic. Too often, examples of aging or obsolete equipment, unit operations, processes, or entire facilities have been encountered. Major contributors to this outcome are the failure to invest in new equipment, disregarding appropriate maintenance activities, and neglecting the implementation of modern technologies. In some cases, a production process is insufficiently modified to manufacture a new product in an existing process that was used to produce a phased-out product. In other instances, manufacturers expanded the facility or processes to fulfill increasing demand and the scaling occurred in a non-uniform manner, which led to non-optimal results. Regulatory hurdles of post-approval changes in the process may thwart companies' efforts to implement new technologies. As an example, some changes have required 4 years to gain global approval. This paper will address cases of aging processes and facilities aside from modernizing options. © PDA, Inc. 2015.

21 CFR 111.135 - What quality control operations are required for product complaints?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What quality control operations are required for... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for Quality Control § 111.135 What quality control operations are required for...

Application of a mathematical model for ergonomics in lean manufacturing.

PubMed

Botti, Lucia; Mora, Cristina; Regattieri, Alberto

2017-10-01

The data presented in this article are related to the research article "Integrating ergonomics and lean manufacturing principles in a hybrid assembly line" (Botti et al., 2017) [1]. The results refer to the application of the mathematical model for the design of lean processes in hybrid assembly lines, meeting both the lean principles and the ergonomic requirements for safe assembly work. Data show that the success of a lean strategy is possible when ergonomics of workers is a parameter of the assembly process design.

40 CFR 63.1092 - What are the major differences between the requirements of 40 CFR part 61, subpart FF, and the...

Code of Federal Regulations, 2010 CFR

2010-07-01

... the requirements of 40 CFR part 61, subpart FF, and the waste requirements for ethylene production... (CONTINUED) National Emission Standards for Ethylene Manufacturing Process Units: Heat Exchange Systems and... requirements of 40 CFR part 61, subpart FF, and the waste requirements for ethylene production sources? The...

Design, Development and Validation of the Eurostar 3000 Large Propellant Tank

NASA Astrophysics Data System (ADS)

Autric, J.-M.; Catherall, D.; Figues, C.; Brockhoff, T.; Lafranconi, R.

2004-10-01

EADS Astrium has undertaken the design and development of an enlarged propellant tank for its high modular Eurostar 3000 telecom satellites platform. The design and development activities included fracture, stress and functional analysis, the manufacturing of development models for the propellant management device, the qualification of new manufacturing processes and the optimization of the design with respect to the main requirements. The successful design and development-testing phase has allowed starting the manufacturing of the qualification model.

21 CFR 111.153 - What are the requirements under this subpart G for written procedures?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.153 What are the requirements under this subpart G for...

21 CFR 111.153 - What are the requirements under this subpart G for written procedures?

Code of Federal Regulations, 2013 CFR

2013-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.153 What are the requirements under this subpart G for...

21 CFR 111.153 - What are the requirements under this subpart G for written procedures?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.153 What are the requirements under this subpart G for...

21 CFR 111.153 - What are the requirements under this subpart G for written procedures?

Code of Federal Regulations, 2011 CFR

2011-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.153 What are the requirements under this subpart G for...

21 CFR 111.153 - What are the requirements under this subpart G for written procedures?

Code of Federal Regulations, 2010 CFR

2010-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.153 What are the requirements under this subpart G for...

40 CFR Table 1 of Subpart Aaaaaaa... - Emission Limits for Asphalt Processing (Refining) Operations

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 15 2012-07-01 2012-07-01 false Emission Limits for Asphalt Processing... Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Other Requirements and Information... of Part 63—Emission Limits for Asphalt Processing (Refining) Operations For * * * You must meet the...

40 CFR Table 1 of Subpart Aaaaaaa... - Emission Limits for Asphalt Processing (Refining) Operations

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 15 2013-07-01 2013-07-01 false Emission Limits for Asphalt Processing... Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Other Requirements and Information... of Part 63—Emission Limits for Asphalt Processing (Refining) Operations For * * * You must meet the...

40 CFR Table 1 of Subpart Aaaaaaa... - Emission Limits for Asphalt Processing (Refining) Operations

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 14 2011-07-01 2011-07-01 false Emission Limits for Asphalt Processing... Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Other Requirements and Information... of Part 63—Emission Limits for Asphalt Processing (Refining) Operations For * * * You must meet the...

40 CFR Table 1 of Subpart Aaaaaaa... - Emission Limits for Asphalt Processing (Refining) Operations

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 15 2014-07-01 2014-07-01 false Emission Limits for Asphalt Processing... Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Other Requirements and Information... of Part 63—Emission Limits for Asphalt Processing (Refining) Operations For * * * You must meet the...

40 CFR Table 1 of Subpart Aaaaaaa... - Emission Limits for Asphalt Processing (Refining) Operations

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 14 2010-07-01 2010-07-01 false Emission Limits for Asphalt Processing... Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Other Requirements and Information... of Part 63—Emission Limits for Asphalt Processing (Refining) Operations For * * * You must meet the...

49 CFR 543.7 - Processing an exemption petition.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 6 2010-10-01 2010-10-01 false Processing an exemption petition. 543.7 Section... § 543.7 Processing an exemption petition. (a) NHTSA processes any complete petition. If a manufacturer submits a petition that does not contain all the information required by this part, NHTSA informs the...

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.

Integrated intelligent sensor for the textile industry

NASA Astrophysics Data System (ADS)

Peltie, Philippe; David, Dominique

1996-08-01

A new sensor has been developed for pantyhose inspection. Unlike a first complete inspection machine devoted to post- manufacturing control of the whole panty, this sensor will be directly integrated on currently existing manufacturing machines, and will combine advantages of miniaturization is to design an intelligent, compact and very cheap product, which should be integrated without requiring any modifications of host machines. The sensor part was designed to achieve closed acquisition, and various solutions have been explored to maintain adequate depth of field. The illumination source will be integrated in the device. The processing part will include correction facilities and electronic processing. Finally, high-level information will be output in order to interface directly with the manufacturing machine automate.

A 3D bioprinting exemplar of the consequences of the regulatory requirements on customized processes.

PubMed

Hourd, Paul; Medcalf, Nicholas; Segal, Joel; Williams, David J

2015-01-01

Computer-aided 3D printing approaches to the industrial production of customized 3D functional living constructs for restoration of tissue and organ function face significant regulatory challenges. Using the manufacture of a customized, 3D-bioprinted nasal implant as a well-informed but hypothetical exemplar, we examine how these products might be regulated. Existing EU and USA regulatory frameworks do not account for the differences between 3D printing and conventional manufacturing methods or the ability to create individual customized products using mechanized rather than craft approaches. Already subject to extensive regulatory control, issues related to control of the computer-aided design to manufacture process and the associated software system chain present additional scientific and regulatory challenges for manufacturers of these complex 3D-bioprinted advanced combination products.

Neural manufacturing: a novel concept for processing modeling, monitoring, and control

NASA Astrophysics Data System (ADS)

Fu, Chi Y.; Petrich, Loren; Law, Benjamin

1995-09-01

Semiconductor fabrication lines have become extremely costly, and achieving a good return from such a high capital investment requires efficient utilization of these expensive facilities. It is highly desirable to shorten processing development time, increase fabrication yield, enhance flexibility, improve quality, and minimize downtime. We propose that these ends can be achieved by applying recent advances in the areas of artificial neural networks, fuzzy logic, machine learning, and genetic algorithms. We use the term neural manufacturing to describe such applications. This paper describes our use of artificial neural networks to improve the monitoring and control of semiconductor process.

Potential for on-orbit manufacture of large space structures using the pultrusion process

NASA Technical Reports Server (NTRS)

Wilson, Maywood L.; Macconochie, Ian O.; Johnson, Gary S.

1987-01-01

On-orbit manufacture of lightweight, high-strength, advanced-composite structures using the pultrusion process is proposed. This process is adaptable to a zero-gravity environment by using preimpregnated graphite-fiber reinforcement systems. The reinforcement material is preimpregnated with a high-performance thermoplastic resin at a ground station, is coiled on spools for compact storage, and is transported into Earth orbit. A pultrusion machine is installed in the Shuttle cargo bay from which very long lengths of the desired structure is fabricated on-orbit. Potential structural profiles include rods, angles, channels, hat sections, tubes, honeycomb-cored panels, and T, H, and I beams. A potential pultrudable thermoplastic/graphite composite material is presented as a model for determining the effect on Earth-to-orbit package density of an on-orbit manufacture, the package density is increased by 132 percent, and payload volume requirement is decreased by 56.3 percent. The fabrication method has the potential for on-orbit manufacture of structural members for space platforms, large space antennas, and long tethers.

Grain Structure Control of Additively Manufactured Metallic Materials

PubMed Central

Faierson, Eric J.

2017-01-01

Grain structure control is challenging for metal additive manufacturing (AM). Grain structure optimization requires the control of grain morphology with grain size refinement, which can improve the mechanical properties of additive manufactured components. This work summarizes methods to promote fine equiaxed grains in both the additive manufacturing process and subsequent heat treatment. Influences of temperature gradient, solidification velocity and alloy composition on grain morphology are discussed. Equiaxed solidification is greatly promoted by introducing a high density of heterogeneous nucleation sites via powder rate control in the direct energy deposition (DED) technique or powder surface treatment for powder-bed techniques. Grain growth/coarsening during post-processing heat treatment can be restricted by presence of nano-scale oxide particles formed in-situ during AM. Grain refinement of martensitic steels can also be achieved by cyclic austenitizing in post-processing heat treatment. Evidently, new alloy powder design is another sustainable method enhancing the capability of AM for high-performance components with desirable microstructures.

40 CFR 761.372 - Specific requirements for relatively clean surfaces.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Specific requirements for relatively clean surfaces. 761.372 Section 761.372 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING...

3D FE simulation of semi-finishing machining of Ti6Al4V additively manufactured by direct metal laser sintering

NASA Astrophysics Data System (ADS)

Imbrogno, Stano; Rinaldi, Sergio; Raso, Antonio; Bordin, Alberto; Bruschi, Stefania; Umbrello, Domenico

2018-05-01

The Additive Manufacturing techniques are gaining more and more interest in various industrial fields due to the possibility of drastically reduce the material waste during the production processes, revolutionizing the standard scheme and strategies of the manufacturing processes. However, the metal parts shape produced, frequently do not satisfy the tolerances as well as the surface quality requirements. During the design phase, the finite element simulation results a fundamental tool to help the engineers in the correct decision of the most suitable process parameters, especially in manufacturing processes, in order to produce products of high quality. The aim of this work is to develop a 3D finite element model of semi-finishing turning operation of Ti6Al4V, produced via Direct Metal Laser Sintering (DMLS). A customized user sub-routine was built-up in order to model the mechanical behavior of the material under machining operations to predict the main fundamental variables as cutting forces and temperature. Moreover, the machining induced alterations are also studied by the finite element model developed.

Modeling the economics of landfilling organic processing waste streams

NASA Astrophysics Data System (ADS)

Rosentrater, Kurt A.

2005-11-01

As manufacturing industries become more cognizant of the ecological effects that their firms have on the surrounding environment, their waste streams are increasingly becoming viewed not only as materials in need of disposal, but also as resources that can be reused, recycled, or reprocessed into valuable products. Within the food processing sector are many examples of various liquid, sludge, and solid biological and organic waste streams that require remediation. Alternative disposal methods for food and other bio-organic manufacturing waste streams are increasingly being investigated. Direct shipping, blending, extrusion, pelleting, and drying are commonly used to produce finished human food, animal feed, industrial products, and components ready for further manufacture. Landfilling, the traditional approach to waste remediation, however, should not be dismissed entirely. It does provide a baseline to which all other recycling and reprocessing options should be compared. This paper discusses the implementation of a computer model designed to examine the economics of landfilling bio-organic processing waste streams. Not only are these results applicable to food processing operations, but any industrial or manufacturing firm would benefit from examining the trends discussed here.

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.

Bioresorbable scaffolds for bone tissue engineering: optimal design, fabrication, mechanical testing and scale-size effects analysis.

PubMed

Coelho, Pedro G; Hollister, Scott J; Flanagan, Colleen L; Fernandes, Paulo R

2015-03-01

Bone scaffolds for tissue regeneration require an optimal trade-off between biological and mechanical criteria. Optimal designs may be obtained using topology optimization (homogenization approach) and prototypes produced using additive manufacturing techniques. However, the process from design to manufacture remains a research challenge and will be a requirement of FDA design controls to engineering scaffolds. This work investigates how the design to manufacture chain affects the reproducibility of complex optimized design characteristics in the manufactured product. The design and prototypes are analyzed taking into account the computational assumptions and the final mechanical properties determined through mechanical tests. The scaffold is an assembly of unit-cells, and thus scale size effects on the mechanical response considering finite periodicity are investigated and compared with the predictions from the homogenization method which assumes in the limit infinitely repeated unit cells. Results show that a limited number of unit-cells (3-5 repeated on a side) introduce some scale-effects but the discrepancies are below 10%. Higher discrepancies are found when comparing the experimental data to numerical simulations due to differences between the manufactured and designed scaffold feature shapes and sizes as well as micro-porosities introduced by the manufacturing process. However good regression correlations (R(2) > 0.85) were found between numerical and experimental values, with slopes close to 1 for 2 out of 3 designs. Copyright © 2015 IPEM. Published by Elsevier Ltd. All rights reserved.

FDA 2011 process validation guidance: lifecycle compliance model.

PubMed

Campbell, Cliff

2014-01-01

This article has been written as a contribution to the industry's efforts in migrating from a document-driven to a data-driven compliance mindset. A combination of target product profile, control engineering, and general sum principle techniques is presented as the basis of a simple but scalable lifecycle compliance model in support of modernized process validation. Unit operations and significant variables occupy pole position within the model, documentation requirements being treated as a derivative or consequence of the modeling process. The quality system is repositioned as a subordinate of system quality, this being defined as the integral of related "system qualities". The article represents a structured interpretation of the U.S. Food and Drug Administration's 2011 Guidance for Industry on Process Validation and is based on the author's educational background and his manufacturing/consulting experience in the validation field. The U.S. Food and Drug Administration's Guidance for Industry on Process Validation (2011) provides a wide-ranging and rigorous outline of compliant drug manufacturing requirements relative to its 20(th) century predecessor (1987). Its declared focus is patient safety, and it identifies three inter-related (and obvious) stages of the compliance lifecycle. Firstly, processes must be designed, both from a technical and quality perspective. Secondly, processes must be qualified, providing evidence that the manufacturing facility is fully "roadworthy" and fit for its intended purpose. Thirdly, processes must be verified, meaning that commercial batches must be monitored to ensure that processes remain in a state of control throughout their lifetime.

Process Makes Thermoplastic Prepreg Ribbon

NASA Technical Reports Server (NTRS)

Wilson, Maywood L.; Johnson, Gary S.

1995-01-01

Manufacturing process produces ribbon of composite material (prepreg) consisting of continuous lengthwise fibers impregnated with thermoplastic resin. Ribbon can later be cut into sheets of required sizes and shapes, stacked, then heated under pressure to form composite-material structural components. Process accommodates variety of thermoplastic resins and variety of fibers.

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.

Friction Spinning—New Innovative Tool Systems For The Production of Complex Functionally Graded Workpieces

NASA Astrophysics Data System (ADS)

Homberg, Werner; Hornjak, Daniel

2011-05-01

Friction spinning is a new innovative and promising incremental forming technology implying high potential regarding the manufacturing of complex functionally graded workpieces and enhancing existing forming limits of conventional metal spinning processes. The friction spinning process is based on the integration of thermo-mechanical friction subprocesses in this incremental forming process. By choosing the appropriate process parameters, e.g. axial feed rate or relative motion, the contact conditions between tool and workpiece can be influenced in a defined way and, thus, a required temperature profile can be obtained. Friction spinning allows the extension of forming limits compared to conventional metal spinning in order to produce multifunctional components with locally varying properties and the manufacturing of e.g. complex hollow parts made of tubes, profiles, or sheet metals. In this way, it meets the demands regarding efficiency and the manufacturing of functionally graded lightweight components. There is e.g. the possibility of locally increasing the wall thickness in joining zones and, as a consequence, achieving higher quality of the joint at decreased expense. These products are not or only hardly producible by conventional processes so far. In order to benefit from the advantages and potentials of this new innovative process new tooling systems and concepts are indispensable which fulfill the special requirements of this thermo-mechanical process concerning thermal and tribological loads and which allow simultaneous and defined forming and friction operations. An important goal of the corresponding research work at the Chair of Forming and Machining Technology at the University of Paderborn is the development of tool systems that allow the manufacturing of such complex parts by simple uniaxial or sequential biaxial linear tool paths. In the paper, promising tool systems and geometries as well as results of theoretical and experimental research work (e.g. regarding the influence and interaction of process parameters on the workpiece quality) will be discussed. Furthermore, possibilities regarding the manufacturing of geometries (demonstrator workpieces) which are not or only hardly producible with conventional processes will be presented.

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.

3D Printing Multi-Functionality: Embedded RF Antennas and Components

NASA Technical Reports Server (NTRS)

Shemelya, C. M.; Zemba, M.; Liang, M.; Espalin, D.; Kief, C.; Xin, H.; Wicker, R. B.; MacDonald, E. W.

2015-01-01

Significant research and press has recently focused on the fabrication freedom of Additive Manufacturing (AM) to create both conceptual models and final end-use products. This flexibility allows design modifications to be immediately reflected in 3D printed structures, creating new paradigms within the manufacturing process. 3D printed products will inevitably be fabricated locally, with unit-level customization, optimized to unique mission requirements. However, for the technology to be universally adopted, the processes must be enhanced to incorporate additional technologies; such as electronics, actuation, and electromagnetics. Recently, a novel 3D printing platform, Multi3D manufacturing, was funded by the presidential initiative for revitalizing manufacturing in the USA using 3D printing (America Makes - also known as the National Additive Manufacturing Innovation Institute). The Multi3D system specifically targets 3D printed electronics in arbitrary form; and building upon the potential of this system, this paper describes RF antennas and components fabricated through the integration of material extrusion 3D printing with embedded wire, mesh, and RF elements.

Just-in-time Design and Additive Manufacture of Patient-specific Medical Implants

NASA Astrophysics Data System (ADS)

Shidid, Darpan; Leary, Martin; Choong, Peter; Brandt, Milan

Recent advances in medical imaging and manufacturing science have enabled the design and production of complex, patient-specific orthopaedic implants. Additive Manufacture (AM) generates three-dimensional structures layer by layer, and is not subject to the constraints associated with traditional manufacturing methods. AM provides significant opportunities for the design of novel geometries and complex lattice structures with enhanced functional performance. However, the design and manufacture of patient-specific AM implant structures requires unique expertise in handling various optimization platforms. Furthermore, the design process for complex structures is computationally intensive. The primary aim of this research is to enable the just-in-time customisation of AM prosthesis; whereby AM implant design and manufacture be completed within the time constraints of a single surgical procedure, while minimising prosthesis mass and optimising the lattice structure to match the stiffness of the surrounding bone tissue. In this research, a design approach using raw CT scan data is applied to the AM manufacture of femoral prosthesis. Using the proposed just-in-time concept, the mass of the prosthesis was rapidly designed and manufactured while satisfying the associated structural requirements. Compressive testing of lattice structures manufactured using proposed method shows that the load carrying capacity of the resected composite bone can be recovered by up to 85% and the compressive stiffness of the AM prosthesis is statistically indistinguishable from the stiffness of the initial bone.

A thematic analysis of the strengths and weaknesses of manufacturers' submissions to the NICE Single Technology Assessment (STA) process.

PubMed

Carroll, Christopher; Kaltenthaler, Eva; FitzGerald, Patrick; Boland, Angela; Dickson, Rumona

2011-10-01

The NICE Single Technology Appraisal (STA) process in the UK has been underway for five years. Evidence Review Groups (ERGs) critically appraise submissions from manufacturers on the clinical and cost effectiveness of new technologies. This study analysed the ERGs' assessment of the strengths and weaknesses of 30 manufacturers' submissions to the STA process. Thematic analysis was performed on the textual descriptions of the strengths and weakness of manufacturer submissions, as outlined by the ERGs in their reports. Various themes emerged from the data. These themes related to the processes applied in the submissions; the content of the submission (e.g. the amount and quality of evidence); the reporting of the submissions' review and analysis processes; the reliability and validity of the submissions' findings; and how far the submission had satisfied the STA process objectives. STA submissions could be improved if attention were paid to transparency in the reporting, conduct and justification of review and modelling processes and analyses, as well as greater robustness in the choice of data and closer adherence to the scope or decision problem. Where this adherence is not possible, more detailed justification of the choice of evidence or data is required. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

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.

Selective recovery of silver from waste low-temperature co-fired ceramic and valorization through silver nanoparticle synthesis.

PubMed

Swain, Basudev; Shin, Dongyoon; Joo, So Yeong; Ahn, Nak Kyoon; Lee, Chan Gi; Yoon, Jin-Ho

2017-11-01

Considering the value of silver metal and silver nanoparticles, the waste generated during manufacturing of low temperature co-fired ceramic (LTCC) were recycled through the simple yet cost effective process by chemical-metallurgy. Followed by leaching optimization, silver was selectively recovered through precipitation. The precipitated silver chloride was valorized though silver nanoparticle synthesis by a simple one-pot greener synthesis route. Through leaching-precipitation optimization, quantitative selective recovery of silver chloride was achieved, followed by homogeneous pure silver nanoparticle about 100nm size were synthesized. The reported recycling process is a simple process, versatile, easy to implement, requires minimum facilities and no specialty chemicals, through which semiconductor manufacturing industry can treat the waste generated during manufacturing of LTCC and reutilize the valorized silver nanoparticles in manufacturing in a close loop process. Our reported process can address issues like; (i) waste disposal, as well as value-added silver recovery, (ii) brings back the material to production stream and address the circular economy, and (iii) can be part of lower the futuristic carbon economy and cradle-to-cradle technology management, simultaneously. Copyright © 2017 Elsevier Ltd. All rights reserved.

3D Printing of Polymer-Bonded Rare-Earth Magnets With a Variable Magnetic Compound Fraction for a Predefined Stray Field.

PubMed

Huber, Christian; Abert, Claas; Bruckner, Florian; Groenefeld, Martin; Schuschnigg, Stephan; Teliban, Iulian; Vogler, Christoph; Wautischer, Gregor; Windl, Roman; Suess, Dieter

2017-08-25

Additive manufacturing of polymer-bonded magnets is a recently developed technique, for single-unit production, and for structures that have been impossible to manufacture previously. Also, new possibilities to create a specific stray field around the magnet are triggered. The current work presents a method to 3D print polymer-bonded magnets with a variable magnetic compound fraction distribution. This means the saturation magnetization can be adjusted during the printing process to obtain a required external field of the manufactured magnets. A low-cost, end-user 3D printer with a mixing extruder is used to mix permanent magnetic filaments with pure polyamide (PA12) filaments. The magnetic filaments are compounded, extruded, and characterized for the printing process. To deduce the quality of the manufactured magnets with a variable magnetic compound fraction, an inverse stray field framework is developed. The effectiveness of the printing process and the simulation method is shown. It can also be used to manufacture magnets that produce a predefined stray field in a given region. This opens new possibilities for magnetic sensor applications. This setup and simulation framework allows the design and manufacturing of polymer-bonded permanent magnets, which are impossible to create with conventional methods.

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.

40 CFR 63.8680 - What is the purpose of this subpart?

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing... national emission standards for hazardous air pollutants (NESHAP) for existing and new asphalt processing and asphalt roofing manufacturing facilities. This subpart also establishes requirements to...

40 CFR 63.8680 - What is the purpose of this subpart?

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing... national emission standards for hazardous air pollutants (NESHAP) for existing and new asphalt processing and asphalt roofing manufacturing facilities. This subpart also establishes requirements to...

40 CFR 63.8680 - What is the purpose of this subpart?

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing... national emission standards for hazardous air pollutants (NESHAP) for existing and new asphalt processing and asphalt roofing manufacturing facilities. This subpart also establishes requirements to...

40 CFR 63.8680 - What is the purpose of this subpart?

Code of Federal Regulations, 2012 CFR

2012-07-01

...) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing... national emission standards for hazardous air pollutants (NESHAP) for existing and new asphalt processing and asphalt roofing manufacturing facilities. This subpart also establishes requirements to...

40 CFR 63.8680 - What is the purpose of this subpart?

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing... national emission standards for hazardous air pollutants (NESHAP) for existing and new asphalt processing and asphalt roofing manufacturing facilities. This subpart also establishes requirements to...

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...

Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects

PubMed Central

Sabata, Roger; Verges, Josep; Zugaza, José L.; Ruiz, Adolfina; Clares, Beatriz

2016-01-01

Mesenchymal stem cells (MSCs) are one of the main stem cells that have been used for advanced therapies and regenerative medicine. To carry out the translational clinical application of MSCs, their manufacturing and administration in human must be controlled; therefore they should be considered as medicine: stem cell-based medicinal products (SCMPs). The development of MSCs as SCMPs represents complicated therapeutics due to their extreme complex nature and rigorous regulatory oversights. The manufacturing process of MSCs needs to be addressed in clean environments in compliance with requirements of Good Manufacturing Practice (GMP). Facilities should maintain these GMP conditions according to international and national medicinal regulatory frameworks that introduce a number of specifications in order to produce MSCs as safe SCMPs. One of these important and complex requirements is the environmental monitoring. Although a number of environmental requirements are clearly defined, some others are provided as recommendations. In this review we aim to outline the current issues with regard to international guidelines which impact environmental monitoring in cleanrooms and clean areas for the manufacturing of MSCs. PMID:27999600

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

21 CFR 111.65 - What are the requirements for quality control operations?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What are the requirements for quality control... Process Control System § 111.65 What are the requirements for quality control operations? You must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for...

A flexible architecture for advanced process control solutions

NASA Astrophysics Data System (ADS)

Faron, Kamyar; Iourovitski, Ilia

2005-05-01

Advanced Process Control (APC) is now mainstream practice in the semiconductor manufacturing industry. Over the past decade and a half APC has evolved from a "good idea", and "wouldn"t it be great" concept to mandatory manufacturing practice. APC developments have primarily dealt with two major thrusts, algorithms and infrastructure, and often the line between them has been blurred. The algorithms have evolved from very simple single variable solutions to sophisticated and cutting edge adaptive multivariable (input and output) solutions. Spending patterns in recent times have demanded that the economics of a comprehensive APC infrastructure be completely justified for any and all cost conscious manufacturers. There are studies suggesting integration costs as high as 60% of the total APC solution costs. Such cost prohibitive figures clearly diminish the return on APC investments. This has limited the acceptance and development of pure APC infrastructure solutions for many fabs. Modern APC solution architectures must satisfy the wide array of requirements from very manual R&D environments to very advanced and automated "lights out" manufacturing facilities. A majority of commercially available control solutions and most in house developed solutions lack important attributes of scalability, flexibility, and adaptability and hence require significant resources for integration, deployment, and maintenance. Many APC improvement efforts have been abandoned and delayed due to legacy systems and inadequate architectural design. Recent advancements (Service Oriented Architectures) in the software industry have delivered ideal technologies for delivering scalable, flexible, and reliable solutions that can seamlessly integrate into any fabs" existing system and business practices. In this publication we shall evaluate the various attributes of the architectures required by fabs and illustrate the benefits of a Service Oriented Architecture to satisfy these requirements. Blue Control Technologies has developed an advance service oriented architecture Run to Run Control System which addresses these requirements.

Introduction of novel 3D-printed superficial applicators for high-dose-rate skin brachytherapy.

PubMed

Jones, Emma-Louise; Tonino Baldion, Anna; Thomas, Christopher; Burrows, Tom; Byrne, Nick; Newton, Victoria; Aldridge, Sarah

Custom-made surface mold applicators often allow more flexibility when carrying out skin brachytherapy, particularly for small treatment areas with high surface obliquity. They can, however, be difficult to manufacture, particularly if there is a lack of experience in superficial high-dose-rate brachytherapy techniques or with limited resources. We present a novel method of manufacturing superficial brachytherapy applicators utilizing three-dimensional (3D)-printing techniques. We describe the treatment planning process and the process of applicator manufacture. The treatment planning process, with the introduction of a pre-plan, allows for an "ideal" catheter arrangement within an applicator to be determined, exploiting varying catheter orientations, heights, and curvatures if required. The pre-plan arrangement is then 3D printed to the exact specifications of the pre-plan applicator design. This results in improved target volume coverage and improved sparing of organs at risk. Using a pre-plan technique for ideal catheter placement followed by automated 3D-printed applicator manufacture has greatly improved the entire process of superficial high-dose-rate brachytherapy treatment. We are able to design and manufacture flexible, well-fitting, superior quality applicators resulting in a more efficient and improved patient pathway and patient experience. Copyright © 2016 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

Highly oriented carbon fiber–polymer composites via additive manufacturing

DOE PAGES

Tekinalp, Halil L.; Kunc, Vlastimil; Velez-Garcia, Gregorio M.; ...

2014-10-16

Additive manufacturing, diverging from traditional manufacturing techniques, such as casting and machining materials, can handle complex shapes with great design flexibility without the typical waste. Although this technique has been mainly used for rapid prototyping, interest is growing in using this method to directly manufacture actual parts of complex shape. To use 3D-printing additive manufacturing in wide spread applications, the technique and the feedstock materials require improvements to meet the mechanical requirements of load-bearing components. Thus, we investigated the short fiber (0.2 mm to 0.4 mm) reinforced acrylonitrile-butadiene-styrene composites as a feedstock for 3D-printing in terms of their processibility, microstructuremore » and mechanical performance; and also provided comparison with traditional compression molded composites. The tensile strength and modulus of 3D-printed samples increased ~115% and ~700%, respectively. 3D-printer yielded samples with very high fiber orientation in printing direction (up to 91.5 %), whereas, compression molding process yielded samples with significantly less fiber orientation. Microstructure-mechanical property relationships revealed that although the relatively high porosity is observed in the 3D-printed composites as compared to those produced by the conventional compression molding technique, they both exhibited comparable tensile strength and modulus. Furthermore, this phenomena is explained based on the changes in fiber orientation, dispersion and void formation.« less

Manufacturing challenges in the commercial production of recombinant coagulation factor VIII.

PubMed

Jiang, R; Monroe, T; McRogers, R; Larson, P J

2002-03-01

Advances in gene technology have led to the development of a method to manufacture recombinant coagulation Factor VIII (rFVIII) for haemophilia A. Because rFVIII is a large and complex protein, its commercialization has required that many challenges in manufacturing, purification and processing be overcome. In order to license the first generation of rFVIII (Kogenate) in 1993, Bayer Corporation invested over 10 years in research and manufacturing development. Seven additional years were subsequently devoted to research and manufacturing improvements in order to accomplish the recent licensing of a second rFVIII product (KOGENATE Bayer or Kogenate FS). This product differs from its predecessor, in that human albumin is removed from the purification and the formulation steps. In addition, fewer chromatography steps are involved resulting in greater yields per mL of conditioned medium, and a solvent-detergent viral inactivation step replaces the heat-processing step used for the previous product. Despite these changes in the manufacturing, the protein backbone and carbohydrate structure of the final rFVIII molecule are identical. The complexity of the production processes is reflected by over 100 000 manufacturing data entries and by 600 quality control tests for each batch of rFVIII. Manufacturers are continuing to develop the next generation of rFVIII, which will be produced without the addition of any human or animal proteins or byproducts. Investments in research, development and manufacturing technology are expected to result in the development of new products with enhanced safety profiles, and in an increase in the production capacity for products that are chronically in short supply.

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.

EUV patterning improvement toward high-volume manufacturing

NASA Astrophysics Data System (ADS)

Kuwahara, Yuhei; Matsunaga, Koichi; Kawakami, Shinichiro; Nafus, Kathleen; Foubert, Philippe; Goethals, Anne-Marie

2015-03-01

Extreme ultraviolet lithography (EUVL) technology is a promising candidate for a semiconductor process for 18nm half pitch and beyond. So far, the studies of EUV for manufacturability have been focused on particular aspects. It still requires fine resolution, uniform and smooth patterns, and low defectivity, not only after lithography but also after the etch process. Tokyo Electron Limited and imec are continuously collaborating to improve manufacturing quality of the process of record (POR) on a CLEAN TRACKTM LITHIUS ProTMZ-EUV. This next generation coating/developing system has been upgraded with defectivity reduction enhancements which are applied along with TELTM best known methods. We have evaluated process defectivity post lithography and post etch. Apart from defectivity, FIRMTM rinse material and application compatibility with sub 18nm patterning is improved to prevent line pattern collapse and increase process window on next generation resist materials. This paper reports on the progress of defectivity and patterning performance optimization towards the NXE:3300 POR.

[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.

3D Printing in Zero-G ISS Technology Demonstration

NASA Technical Reports Server (NTRS)

Johnston, Mallory M.; Werkheiser, Mary J.; Cooper, Kenneth G.; Snyder, Michael P.; Edmunson, Jennifer E.

2014-01-01

The National Aeronautics and Space Administration (NASA) has a long term strategy to fabricate components and equipment on-demand for manned missions to the Moon, Mars, and beyond. To support this strategy, NASA and Made in Space, Inc. are developing the 3D Printing In Zero-G payload as a Technology Demonstration for the International Space Station. The 3D Printing In Zero-G experiment will be the first machine to perform 3D printing in space. The greater the distance from Earth and the longer the mission duration, the more difficult resupply becomes; this requires a change from the current spares, maintenance, repair, and hardware design model that has been used on the International Space Station up until now. Given the extension of the ISS Program, which will inevitably result in replacement parts being required, the ISS is an ideal platform to begin changing the current model for resupply and repair to one that is more suitable for all exploration missions. 3D Printing, more formally known as Additive Manufacturing, is the method of building parts/ objects/tools layer-by-layer. The 3D Print experiment will use extrusion-based additive manufacturing, which involves building an object out of plastic deposited by a wire-feed via an extruder head. Parts can be printed from data files loaded on the device at launch, as well as additional files uplinked to the device while on-orbit. The plastic extrusion additive manufacturing process is a low-energy, low-mass solution to many common needs on board the ISS. The 3D Print payload will serve as the ideal first step to proving that process in space. It is unreasonable to expect NASA to launch large blocks of material from which parts or tools can be traditionally machined, and even more unreasonable to fly up specialized manufacturing hardware to perform the entire range of function traditionally machining requires. The technology to produce parts on demand, in space, offers unique design options that are not possible through traditional manufacturing methods while offering cost-effective, high-precision, low-unit on-demand manufacturing. Thus, Additive Manufacturing capabilities are the foundation of an advanced manufacturing in space roadmap.

40 CFR 439.2 - General monitoring requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... chemistry, products and by-products resulting from each of the manufacturing processes. This determination... the permitting authority, reconfirmed by an annual chemical analysis of wastewater from each...

40 CFR 439.2 - General monitoring requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... chemistry, products and by-products resulting from each of the manufacturing processes. This determination... the permitting authority, reconfirmed by an annual chemical analysis of wastewater from each...

Five-Axis Ultrasonic Additive Manufacturing for Nuclear Component Manufacture

NASA Astrophysics Data System (ADS)

Hehr, Adam; Wenning, Justin; Terrani, Kurt; Babu, Sudarsanam Suresh; Norfolk, Mark

2017-03-01

Ultrasonic additive manufacturing (UAM) is a three-dimensional metal printing technology which uses high-frequency vibrations to scrub and weld together both similar and dissimilar metal foils. There is no melting in the process and no special atmosphere requirements are needed. Consequently, dissimilar metals can be joined with little to no intermetallic compound formation, and large components can be manufactured. These attributes have the potential to transform manufacturing of nuclear reactor core components such as control elements for the High Flux Isotope Reactor at Oak Ridge National Laboratory. These components are hybrid structures consisting of an outer cladding layer in contact with the coolant with neutron-absorbing materials inside, such as neutron poisons for reactor control purposes. UAM systems are built into a computer numerical control (CNC) framework to utilize intermittent subtractive processes. These subtractive processes are used to introduce internal features as the component is being built and for net shaping. The CNC framework is also used for controlling the motion of the welding operation. It is demonstrated here that curved components with embedded features can be produced using a five-axis code for the welder for the first time.

Five-axis ultrasonic additive manufacturing for nuclear component manufacture

DOE PAGES

Hehr, Adam; Wenning, Justin; Terrani, Kurt A.; ...

2016-01-01

Ultrasonic additive manufacturing (UAM) is a three-dimensional metal printing technology which uses high-frequency vibrations to scrub and weld together both similar and dissimilar metal foils. There is no melting in the process and no special atmosphere requirements are needed. Consequently, dissimilar metals can be joined with little to no intermetallic compound formation, and large components can be manufactured. These attributes have the potential to transform manufacturing of nuclear reactor core components such as control elements for the High Flux Isotope Reactor at Oak Ridge National Laboratory. These components are hybrid structures consisting of an outer cladding layer in contact withmore » the coolant with neutron-absorbing materials inside, such as neutron poisons for reactor control purposes. UAM systems are built into a computer numerical control (CNC) framework to utilize intermittent subtractive processes. These subtractive processes are used to introduce internal features as the component is being built and for net shaping. The CNC framework is also used for controlling the motion of the welding operation. Lastly, it is demonstrated here that curved components with embedded features can be produced using a five-axis code for the welder for the first time.« less

Amorphous silicon photovoltaic manufacturing technology, phase 2A

NASA Astrophysics Data System (ADS)

Duran, G.; Mackamul, K.; Metcalf, D.

1995-01-01

Utility Power Group (UPG), and its lower-tier subcontractor, Advanced Photovoltaic Systems, Inc. (APS) have conducted efforts in developing their manufacturing lines. UPG has focused on the automation of encapsulation and termination processes developed in Phase 1. APS has focused on completion of the encapsulation and module design tasks, while continuing the process and quality control and automation projects. The goal is to produce 55 watt (stabilized) EP50 modules in a new facility. In the APS Trenton EUREKA manufacturing facility, APS has: (1) Developed high throughput lamination procedures; (2) Optimized existing module designs; (3) Developed new module designs for architectural applications; (4) Developed enhanced deposition parameter control; (5) Designed equipment required to manufacture new EUREKA modules developed during Phase II; (6) Improved uniformity of thin-film materials deposition; and (7) Improved the stabilized power output of the APS EP50 EUREKA module to 55 watts. In the APS Fairfield EUREKA manufacturing facility, APS has: (1) Introduced the new products developed under Phase 1 into the APS Fairfield EUREKA module production line; (2) Increased the extent of automation in the production line; (3) Introduced Statistical Process Control to the module production line; and (4) Transferred-progress made in the APS Trenton facility into the APS Fairfield facility.

Flexible Biomanufacturing Processes that Address the Needs of the Future.

PubMed

Diel, Bernhard; Manzke, Christian; Peuker, Thorsten

2014-01-01

: As the age of the blockbuster drug recedes, the business model for the biopharmaceutical industry is evolving at an ever-increasing pace. The personalization of medicine, the emergence of biosimilars and biobetters, and the need to provide vaccines globally are just some of the factors forcing biomanufacturers to rethink how future manufacturing capability is implemented. One thing is clear: the traditional manufacturing strategy of constructing large-scale, purpose-built, capital-intensive facilities will no longer meet the industry's emerging production and economic requirements. Therefore, the authors of this chapter describe the new approach for designing and implementing flexible production processes for monoclonal antibodies and focus on the points to consider as well as the lessons learned from past experience in engineering such systems. A conceptual integrated design is presented that can be used as a blueprint for next-generation biomanufacturing facilities. In addition, this chapter discusses the benefits of the new approach with respect to flexibility, cost, and schedule. The concept presented here can be applied to other biopharmaceutical manufacturing processes and facilities, including-but not limited to-vaccine manufacturing, multiproduct and/or multiprocess capability, clinical manufacturing, and so on.

Capability approval programme for Microwave Hybrid Integrated Circuits (MHICS)

NASA Astrophysics Data System (ADS)

1990-11-01

The general requirements for capability approval of a manufacturing line for Microwave Hybrid Integrated Circuits (MHICs) are defined. ESA approval mandate will be exercized upon conclusion of the evaluation phase and at the end of the program. Before the evaluation phase can commence, the manufacturer must define the capability approval domain by specifying the processes, materials and technology for which approval is sought.

Lightweighting Automotive Materials for Increased Fuel Efficiency and Delivering Advanced Modeling and Simulation Capabilities to U.S. Manufacturers

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

Hale, Steve

Abstract The National Center for Manufacturing Sciences (NCMS) worked with the U.S. Department of Energy (DOE), National Energy Technology Laboratory (NETL), to bring together research and development (R&D) collaborations to develop and accelerate the knowledgebase and infrastructure for lightweighting materials and manufacturing processes for their use in structural and applications in the automotive sector. The purpose/importance of this DOE program: • 2016 CAFÉ standards. • Automotive industry technology that shall adopt the insertion of lightweighting material concepts towards manufacturing of production vehicles. • Development and manufacture of advanced research tools for modeling and simulation (M&S) applications to reduce manufacturing andmore » material costs. • U.S. competitiveness that will help drive the development and manufacture of the next generation of materials. NCMS established a focused portfolio of applied R&D projects utilizing lightweighting materials for manufacture into automotive structures and components. Areas that were targeted in this program: • Functionality of new lightweighting materials to meet present safety requirements. • Manufacturability using new lightweighting materials. • Cost reduction for the development and use of new lightweighting materials. The automotive industry’s future continuously evolves through innovation, and lightweight materials are key in achieving a new era of lighter, more efficient vehicles. Lightweight materials are among the technical advances needed to achieve fuel/energy efficiency and reduce carbon dioxide (CO2) emissions: • Establish design criteria methodology to identify the best materials for lightweighting. • Employ state-of-the-art design tools for optimum material development for their specific applications. • Match new manufacturing technology to production volume. • Address new process variability with new production-ready processes.« less

Silicon photonics and challenges for fabrication

NASA Astrophysics Data System (ADS)

Feilchenfeld, N. B.; Nummy, K.; Barwicz, T.; Gill, D.; Kiewra, E.; Leidy, R.; Orcutt, J. S.; Rosenberg, J.; Stricker, A. D.; Whiting, C.; Ayala, J.; Cucci, B.; Dang, D.; Doan, T.; Ghosal, M.; Khater, M.; McLean, K.; Porth, B.; Sowinski, Z.; Willets, C.; Xiong, C.; Yu, C.; Yum, S.; Giewont, K.; Green, W. M. J.

2017-03-01

Silicon photonics is rapidly becoming the key enabler for meeting the future data speed and volume required by the Internet of Things. A stable manufacturing process is needed to deliver cost and yield expectations to the technology marketplace. We present the key challenges and technical results from both 200mm and 300mm facilities for a silicon photonics fabrication process which includes monolithic integration with CMOS. This includes waveguide patterning, optical proximity correction for photonic devices, silicon thickness uniformity and thick material patterning for passive fiber to waveguide alignment. The device and process metrics show that the transfer of the silicon photonics process from 200mm to 300mm will provide a stable high volume manufacturing platform for silicon photonics designs.

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.

Ion beam figuring of silicon aspheres

NASA Astrophysics Data System (ADS)

Demmler, Marcel; Zeuner, Michael; Luca, Alfonz; Dunger, Thoralf; Rost, Dirk; Kiontke, Sven; Krüger, Marcus

2011-03-01

Silicon lenses are widely used for infrared applications. Especially for portable devices the size and weight of the optical system are very important factors. The use of aspherical silicon lenses instead of spherical silicon lenses results in a significant reduction of weight and size. The manufacture of silicon lenses is more challenging than the manufacture of standard glass lenses. Typically conventional methods like diamond turning, grinding and polishing are used. However, due to the high hardness of silicon, diamond turning is very difficult and requires a lot of experience. To achieve surfaces of a high quality a polishing step is mandatory within the manufacturing process. Nevertheless, the required surface form accuracy cannot be achieved through the use of conventional polishing methods because of the unpredictable behavior of the polishing tools, which leads to an unstable removal rate. To overcome these disadvantages a method called Ion Beam Figuring can be used to manufacture silicon lenses with high surface form accuracies. The general advantage of the Ion Beam Figuring technology is a contactless polishing process without any aging effects of the tool. Due to this an excellent stability of the removal rate without any mechanical surface damage is achieved. The related physical process - called sputtering - can be applied to any material and is therefore also applicable to materials of high hardness like Silicon (SiC, WC). The process is realized through the commercially available ion beam figuring system IonScan 3D. During the process, the substrate is moved in front of a focused broad ion beam. The local milling rate is controlled via a modulated velocity profile, which is calculated specifically for each surface topology in order to mill the material at the associated positions to the target geometry. The authors will present aspherical silicon lenses with very high surface form accuracies compared to conventionally manufactured lenses.

A Review of Selective Laser Melted NiTi Shape Memory Alloy

PubMed Central

Khoo, Zhong Xun; Shen, Yu Fang

2018-01-01

NiTi shape memory alloys (SMAs) have the best combination of properties among the different SMAs. However, the limitations of conventional manufacturing processes and the poor manufacturability of NiTi have critically limited its full potential applicability. Thus, additive manufacturing, commonly known as 3D printing, has the potential to be a solution in fabricating complex NiTi smart structures. Recently, a number of studies on Selective Laser Melting (SLM) of NiTi were conducted to explore the various aspects of SLM-produced NiTi. Compared to producing conventional metals through the SLM process, the fabrication of NiTi SMA is much more challenging. Not only do the produced parts require a high density that leads to good mechanical properties, strict composition control is needed as well for the SLM NiTi to possess suitable phase transformation characteristics. Additionally, obtaining a good shape memory effect from the SLM NiTi samples is another challenging task that requires further understanding. This paper presents the results of the effects of energy density and SLM process parameters on the properties of SLM NiTi. Its shape memory properties and potential applications were then reviewed and discussed. PMID:29596320

Digital Image Processing in Private Industry.

ERIC Educational Resources Information Center

Moore, Connie

1986-01-01

Examines various types of private industry optical disk installations in terms of business requirements for digital image systems in five areas: records management; transaction processing; engineering/manufacturing; information distribution; and office automation. Approaches for implementing image systems are addressed as well as key success…

Insect pest management decisions in food processing facilities

USDA-ARS?s Scientific Manuscript database

Pest management decision making in food processing facilities such as flour mills, rice mills, human and pet food manufacturing facilities, distribution centers and warehouses, and retail stores is a challenging undertaking. Insect pest management programs require an understanding of the food facili...

EMPRESS: A European Project to Enhance Process Control Through Improved Temperature Measurement

NASA Astrophysics Data System (ADS)

Pearce, J. V.; Edler, F.; Elliott, C. J.; Rosso, L.; Sutton, G.; Andreu, A.; Machin, G.

2017-08-01

A new European project called EMPRESS, funded by the EURAMET program `European Metrology Program for Innovation and Research,' is described. The 3 year project, which started in the summer of 2015, is intended to substantially augment the efficiency of high-value manufacturing processes by improving temperature measurement techniques at the point of use. The project consortium has 18 partners and 5 external collaborators, from the metrology sector, high-value manufacturing, sensor manufacturing, and academia. Accurate control of temperature is key to ensuring process efficiency and product consistency and is often not achieved to the level required for modern processes. Enhanced efficiency of processes may take several forms including reduced product rejection/waste; improved energy efficiency; increased intervals between sensor recalibration/maintenance; and increased sensor reliability, i.e., reduced amount of operator intervention. Traceability of temperature measurements to the International Temperature Scale of 1990 (ITS-90) is a critical factor in establishing low measurement uncertainty and reproducible, consistent process control. Introducing such traceability in situ (i.e., within the industrial process) is a theme running through this project.

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.

Architecture for distributed design and fabrication

NASA Astrophysics Data System (ADS)

McIlrath, Michael B.; Boning, Duane S.; Troxel, Donald E.

1997-01-01

We describe a flexible, distributed system architecture capable of supporting collaborative design and fabrication of semi-conductor devices and integrated circuits. Such capabilities are of particular importance in the development of new technologies, where both equipment and expertise are limited. Distributed fabrication enables direct, remote, physical experimentation in the development of leading edge technology, where the necessary manufacturing resources are new, expensive, and scarce. Computational resources, software, processing equipment, and people may all be widely distributed; their effective integration is essential in order to achieve the realization of new technologies for specific product requirements. Our architecture leverages is essential in order to achieve the realization of new technologies for specific product requirements. Our architecture leverages current vendor and consortia developments to define software interfaces and infrastructure based on existing and merging networking, CIM, and CAD standards. Process engineers and product designers access processing and simulation results through a common interface and collaborate across the distributed manufacturing environment.

A framework for development of an intelligent system for design and manufacturing of stamping dies

NASA Astrophysics Data System (ADS)

Hussein, H. M. A.; Kumar, S.

2014-07-01

An integration of computer aided design (CAD), computer aided process planning (CAPP) and computer aided manufacturing (CAM) is required for development of an intelligent system to design and manufacture stamping dies in sheet metal industries. In this paper, a framework for development of an intelligent system for design and manufacturing of stamping dies is proposed. In the proposed framework, the intelligent system is structured in form of various expert system modules for different activities of design and manufacturing of dies. All system modules are integrated with each other. The proposed system takes its input in form of a CAD file of sheet metal part, and then system modules automate all tasks related to design and manufacturing of stamping dies. Modules are coded using Visual Basic (VB) and developed on the platform of AutoCAD software.

A modular assembling platform for manufacturing of microsystems by optical tweezers

NASA Astrophysics Data System (ADS)

Ksouri, Sarah Isabelle; Aumann, Andreas; Ghadiri, Reza; Prüfer, Michael; Baer, Sebastian; Ostendorf, Andreas

2013-09-01

Due to the increased complexity in terms of materials and geometries for microsystems new assembling techniques are required. Assembling techniques from the semiconductor industry are often very specific and cannot fulfill all specifications in more complex microsystems. Therefore, holographic optical tweezers are applied to manipulate structures in micrometer range with highest flexibility and precision. As is well known non-spherical assemblies can be trapped and controlled by laser light and assembled with an additional light modulator application, where the incident laser beam is rearranged into flexible light patterns in order to generate multiple spots. The complementary building blocks are generated by a two-photon-polymerization process. The possibilities of manufacturing arbitrary microstructures and the potential of optical tweezers lead to the idea of combining manufacturing techniques with manipulation processes to "microrobotic" processes. This work presents the manipulation of generated complex microstructures with optical tools as well as a storage solution for 2PP assemblies. A sample holder has been developed for the manual feeding of 2PP building blocks. Furthermore, a modular assembling platform has been constructed for an `all-in-one' 2PP manufacturing process as a dedicated storage system. The long-term objective is the automation process of feeding and storage of several different 2PP micro-assemblies to realize an automated assembly process.

Evaluation of ARCAM Deposited Ti-6Al-4V

NASA Technical Reports Server (NTRS)

Slattery, Kevin; Slaughter, Blake; Speorl, Emily; Good, James; Gilley, Scott; McLemore, Carole

2008-01-01

A wide range of Metal Additive Manufacturing (MAM) technologies are becoming available. One of the challenges in using new technologies for aerospace systems is demonstrating that the process and system has the ability to manufacture components that meet the high quality requirements on a statistically significant basis. The widest-used system for small to medium sized components is the ARCAM system manufactured in Gothenburg, Sweden. This system features a 4kW electron-beam gun, and has a chamber volume of 250mm long x 250mm wide x 250mm to 400mm tall. This paper will describe the basis for the quality and consistency requirements, the experimental and evaluation procedures used for the evaluation, and an analysis of the results for Ti-6Al-4V.

U-10Mo Baseline Fuel Fabrication Process Description

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

Hubbard, Lance R.; Arendt, Christina L.; Dye, Daniel F.

This document provides a description of the U.S. High Power Research Reactor (USHPRR) low-enriched uranium (LEU) fuel fabrication process. This document is intended to be used in conjunction with the baseline process flow diagram (PFD) presented in Appendix A. The baseline PFD is used to document the fabrication process, communicate gaps in technology or manufacturing capabilities, convey alternatives under consideration, and as the basis for a dynamic simulation model of the fabrication process. The simulation model allows for the assessment of production rates, costs, and manufacturing requirements (manpower, fabrication space, numbers and types of equipment, etc.) throughout the lifecycle ofmore » the USHPRR program. This document, along with the accompanying PFD, is updated regularly« less

In-Space Manufacturing: Pioneering a Sustainable Path to Mars

NASA Technical Reports Server (NTRS)

Werkheiser, Niki

2015-01-01

In order to provide meaningful impacts to exploration technology needs, the In-Space Manufacturing (ISM) Initiative must influence exploration systems design now. In-space manufacturing offers: dramatic paradigm shift in the development and creation of space architectures; efficiency gain and risk reduction for low Earth orbit and deep space exploration; and "pioneering" approach to maintenance, repair, and logistics leading to sustainable, affordable supply chain model. In order to develop application-based capabilities in time to support NASA budget and schedule, ISM must be able to leverage the significant commercial developments, which requires innovative, agile collaborative mechanisms (contracts, challenges, SBIR's, etc.); and NASA-unique investments to focus primarily on adapting the technologies and processes to the microgravity environment. We must do the foundational work - it is the critical path for taking these technologies from lab curiosities to institutionalized capabilities: characterize, certify, institutionalize, design for Additive Manufacturing (AM). Ideally, International Space Station (ISS) U.S. lab rack or partial rack space should be identified for in-space manufacturing utilization in order to continue technology development of a suite of capabilities required for exploration missions, as well as commercialization on ISS.

Quality By Design: Concept To Applications.

PubMed

Swain, Suryakanta; Padhy, Rabinarayan; Jena, Bikash Ranjan; Babu, Sitty Manohar

2018-03-08

Quality by Design is associated to the modern, systematic, scientific and novel approach which is concerned with pre-distinct objectives that not only focus on product, process understanding but also leads to process control. It predominantly signifies the design and product improvement and the manufacturing process in order to fulfill the predefined manufactured goods or final products quality characteristics. It is quite essential to identify desire and required product performance report such as Target Product Profile, typical Quality Target Product Profile (QTPP) and Critical Quality attributes (CQA). This review highlighted about the concepts of QbD design space, for critical material attributes (CMAs) as well as the critical process parameters that can totally affect the CQAs within which the process shall be unaffected and consistently manufacture the required product. Risk assessment tools and design of experiments are its prime components. This paper outlines the basic knowledge of QbD, the key elements; steps as well as various tools for QbD implementation in pharmaceutics field are presented briefly. In addition to this, quite a lot of applications of QbD in numerous pharmaceutical related unit operations are discussed and summarized. This article provides a complete data as well as the road map for universal implementation and application of QbD for pharmaceutical products. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Development of a Self Aligned CMOS Process for Flash Lamp Annealed Polycrystalline Silicon TFTs

NASA Astrophysics Data System (ADS)

Bischoff, Paul

The emerging active matrix liquid crystal (AMLCD) display market requires a high performing semiconductor material to meet rising standards of operation. Currently amorphous silicon (a-Si) dominates the market but it does not have the required mobility for it to be used in AMLCD manufacturing. Other materials have been developed including crystallizing a-Si into poly-silicon. A new approach to crystallization through the use of flash lamp annealing (FLA) decreases manufacturing time and greatly improves carrier mobility. Previous work on FLA silicon for the use in CMOS transistors revealed significant lateral dopant diffusion into the channel greatly increasing the minimum channel length required for a working device. This was further confounded by the gate overlap due to misalignment during lithography patterning steps. Through the use of furnace dopant activation instead of FLA dopant activation and a self aligned gate the minimum size transistor can be greatly reduced. A new lithography mask and process flow were developed for the furnace annealing and self aligned gate. Fabrication of the self aligned devices resulted in oxidation of the Molybdenum self aligned gate. Further development is needed to successfully manufacture these devices. Non-self aligned transistors were made simultaneously with self aligned devices and used the furnace activation. These devices showed an increase in sheet resistance from 250 O to 800 O and lower mobility from 380 to 40.2 V/cm2s. The lower mobility can be contributed to an increase in implanted trap density indicating furnace annealing is an inferior activation method over FLA. The minimum transistor size however was reduced from 20 to 5 mum. With improvements in the self aligned process high performing small devices can be manufactured.

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.

30 CFR 7.304 - Technical requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... (coarse, loose fitting) threads. The covers shall be secured against loosening. (5) Flat surfaces between... flame-arresting path shall be finished during the manufacturing process to not more than 250 microinches... requirements as the pole piece. (12) Coil-thread inserts, if used in holes for fastenings, shall meet the...

30 CFR 7.304 - Technical requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

... (coarse, loose fitting) threads. The covers shall be secured against loosening. (5) Flat surfaces between... flame-arresting path shall be finished during the manufacturing process to not more than 250 microinches... requirements as the pole piece. (12) Coil-thread inserts, if used in holes for fastenings, shall meet the...

30 CFR 7.304 - Technical requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (coarse, loose fitting) threads. The covers shall be secured against loosening. (5) Flat surfaces between... flame-arresting path shall be finished during the manufacturing process to not more than 250 microinches... requirements as the pole piece. (12) Coil-thread inserts, if used in holes for fastenings, shall meet the...

30 CFR 7.304 - Technical requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... (coarse, loose fitting) threads. The covers shall be secured against loosening. (5) Flat surfaces between... flame-arresting path shall be finished during the manufacturing process to not more than 250 microinches... requirements as the pole piece. (12) Coil-thread inserts, if used in holes for fastenings, shall meet the...

30 CFR 7.304 - Technical requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... (coarse, loose fitting) threads. The covers shall be secured against loosening. (5) Flat surfaces between... flame-arresting path shall be finished during the manufacturing process to not more than 250 microinches... requirements as the pole piece. (12) Coil-thread inserts, if used in holes for fastenings, shall meet the...

77 FR 9237 - Agency Information Collection Activities; Proposed Collection; Comment Request; Risk Management...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-16

... Activities; Proposed Collection; Comment Request; Risk Management Program Requirements and Petitions To..., non-chemical manufacturers, etc. Title: Risk Management Program Requirements and Petitions to Modify... regulated substance in a process develop and implement a risk management program and submit a risk...

Orion Heat Shield Manufacturing Producibility Improvements for the EM-1 Flight Test Program

NASA Technical Reports Server (NTRS)

Koenig, William J.; Stewart, Michael; Harris, Richard F.

2018-01-01

This paper describes how the ORION program is incorporating improvements in the heat shield design and manufacturing processes reducing programmatic risk and ensuring crew safety in support of NASA's Exploration missions. The approach for the EFT-1 heat shield utilized a low risk Apollo heritage design and manufacturing process using an Avcoat TPS ablator with a honeycomb substrate to provide a one piece heat shield to meet the mission re-entry heating environments. The EM-1 mission will have additional flight systems installed to fly to the moon and return to Earth. Heat shield design and producibility improvements have been incorporated in the EM-1 vehicle to meet deep space mission requirements. The design continues to use the Avcoat material, but in a block configuration to enable improvements in consistant and repeatable application processes using tile bonding experience developed on the Space Shuttle Transportation System Program.

The sales learning curve.

PubMed

Leslie, Mark; Holloway, Charles A

2006-01-01

When a company launches a new product into a new market, the temptation is to immediately ramp up sales force capacity to gain customers as quickly as possible. But hiring a full sales force too early just causes the firm to burn through cash and fail to meet revenue expectations. Before it can sell an innovative product efficiently, the entire organization needs to learn how customers will acquire and use it, a process the authors call the sales learning curve. The concept of a learning curve is well understood in manufacturing. Employees transfer knowledge and experience back and forth between the production line and purchasing, manufacturing, engineering, planning, and operations. The sales learning curve unfolds similarly through the give-and-take between the company--marketing, sales, product support, and product development--and its customers. As customers adopt the product, the firm modifies both the offering and the processes associated with making and selling it. Progress along the manufacturing curve is measured by tracking cost per unit: The more a firm learns about the manufacturing process, the more efficient it becomes, and the lower the unit cost goes. Progress along the sales learning curve is measured in an analogous way: The more a company learns about the sales process, the more efficient it becomes at selling, and the higher the sales yield. As the sales yield increases, the sales learning process unfolds in three distinct phases--initiation, transition, and execution. Each phase requires a different size--and kind--of sales force and represents a different stage in a company's production, marketing, and sales strategies. Adjusting those strategies as the firm progresses along the sales learning curve allows managers to plan resource allocation more accurately, set appropriate expectations, avoid disastrous cash shortfalls, and reduce both the time and money required to turn a profit.

FPGA chip performance improvement with gate shrink through alternating PSM 90nm process

NASA Astrophysics Data System (ADS)

Yu, Chun-Chi; Shieh, Ming-Feng; Liu, Erick; Lin, Benjamin; Ho, Jonathan; Wu, Xin; Panaite, Petrisor; Chacko, Manoj; Zhang, Yunqiang; Lei, Wen-Kang

2005-11-01

In the post-physical verification space called 'Mask Synthesis' a key component of design-for-manufacturing (DFM), double-exposure based, dark-field, alternating PSM (Alt-PSM) is being increasingly applied at the 90nm node in addition with other mature resolution enhancement techniques (RETs) such as optical proximity correction (OPC) and sub-resolution assist features (SRAF). Several high-performance IC manufacturers already use alt-PSM technology in 65nm production. At 90nm having strong control over the lithography process is a critical component in meeting targeted yield goals. However, implementing alt-PSM in production has been challenging due to several factors such as phase conflict errors, mask manufacturing, and the increased production cost due to the need for two masks in the process. Implementation of Alt-PSM generally requires phase compliance rules and proper phase topology in the layout and this has been successful for the technology node with these rules implemented. However, this may not be true for a mature, production process technology, in this case 90 nm. Especially, in the foundry-fabless business model where the foundry provides a standard set of design rules to its customers for a given process technology, and where not all the foundry customers require Alt-PSM in their tapeout flow. With minimum design changes, design houses usually are motivated by higher product performance for the existing designs. What follows is an in-depth review of the motivation to apply alt-PSM on a production FPGA, the DFM challenges to each partner faced, its effect on the tapeout flow, and how design, manufacturing, and EDA teams worked together to resolve phase conflicts, tapeout the chip, and finally verify the silicon results in production.

A NEW INNOVATIVE LOW-COST MANUFACTURING PROCESS TO PRODUCE TITANIUM - PHASE I

EPA Science Inventory

All titanium is produced by the Kroll process, which is a batch process for the magnesium (Mg) reduction of titanium tetrachloride (TiCl₄). Separate operations are required to produce the toxic and very corrosive TiCl₄, which must be stored and transporte...

Enhancing Biodiesel from Kemiri Sunan Oil Manufacturing using Ultrasonics

NASA Astrophysics Data System (ADS)

Supriyadi, Slamet; Purwanto; Anggoro, Didi Dwi; Hermawan

2018-02-01

Kemiri Sunan (Reutalis trisperma (Blanco) Airy Shaw) is a potential plant to be developed as biodiesel feedstock. The advantage of Kemiri Sunan seeds when compared to other biodiesel raw materials is their high oil content. This plant is also very good for land conservation. Due the increasingly demand for biodiesel, research and new methods to increase its biodiesel production continue to be undertaken. The weakness of conventional biodiesel manufacturing process is in the mixing process in which mechanical stirring and heating in the trans-esterification process require more energy and a longer time. A higher and stronger mixing process is required to increase the contact area between the two phases of the mixed substance to produce the emulsion. Ultrasonic is a tool that can be useful for a liquid mixing process that tends to be separated. Ultrasonic waves can cause mixing intensity at the micro level and increase mass transfer, so the reaction can be performed at a much faster rate. This study is to figure out the effect of ultrasonic irradiation on the transesterification process of biodiesel from Kemiri Sunan Oil.

Unintended Consequences: How Qualification Constrains Innovation

NASA Technical Reports Server (NTRS)

Brice, Craig A.

2011-01-01

The development and implementation of new materials and manufacturing processes for aerospace application is often hindered by the high cost and long time span associated with current qualification procedures. The data requirements necessary for material and process qualification are extensive and often require millions of dollars and multiple years to complete. Furthermore, these qualification data can become obsolete for even minor changes to the processing route. This burden is a serious impediment to the pursuit of revolutionary new materials and more affordable processing methods for air vehicle structures. The application of integrated computational materials engineering methods to this problem can help to reduce the barriers to rapid insertion of new materials and processes. By establishing predictive capability for the development of microstructural features in relation to processing and relating this to critical property characteristics, a streamlined approach to qualification is possible. This paper critically examines the advantages and challenges to a modeling-assisted qualification approach for aerospace structural materials. An example of how this approach might apply towards the emerging field of additive manufacturing is discussed in detail.

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.

Automatic hot wire GTA welding of pipe offers speed and increased deposition

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

Sykes, I.; Digiacomo, J.

1995-07-01

Heavy-wall pipe welding for the power and petrochemical industry must meet code requirements. Contractors strive to meet these requirements in the most productive way possible. The challenge put to orbital welding equipment manufacturers is to produce pipe welding equipment that cost-effectively produces code-quality welds. Orbital welding equipment using the GTA process has long produced outstanding quality results but has lacked the deposition rate to compete cost effectively with other manual and semiautomatic processes such as SMAW, FCAW and GMAW. In recent years, significant progress has been made with the use of narrow-groove weld joint designs to reduce weld joint volumemore » and improve welding times. Astro Arc Polysoude, an orbital welding equipment manufacturer based in Sun Valley, Calif., and Nantes, France, has combined the hot wire GTAW process with orbital welding equipment using a narrow-groove weld joint design. Field test results show this process and procedure is a good alternative for many heavy-wall-pipe welding applications.« less

Global Manufacturing of CAR T Cell Therapy.

PubMed

Levine, Bruce L; Miskin, James; Wonnacott, Keith; Keir, Christopher

2017-03-17

Immunotherapy using chimeric antigen receptor-modified T cells has demonstrated high response rates in patients with B cell malignancies, and chimeric antigen receptor T cell therapy is now being investigated in several hematologic and solid tumor types. Chimeric antigen receptor T cells are generated by removing T cells from a patient's blood and engineering the cells to express the chimeric antigen receptor, which reprograms the T cells to target tumor cells. As chimeric antigen receptor T cell therapy moves into later-phase clinical trials and becomes an option for more patients, compliance of the chimeric antigen receptor T cell manufacturing process with global regulatory requirements becomes a topic for extensive discussion. Additionally, the challenges of taking a chimeric antigen receptor T cell manufacturing process from a single institution to a large-scale multi-site manufacturing center must be addressed. We have anticipated such concerns in our experience with the CD19 chimeric antigen receptor T cell therapy CTL019. In this review, we discuss steps involved in the cell processing of the technology, including the use of an optimal vector for consistent cell processing, along with addressing the challenges of expanding chimeric antigen receptor T cell therapy to a global patient population.

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.

Manufacturing PDMS micro lens array using spin coating under a multiphase system

NASA Astrophysics Data System (ADS)

Sun, Rongrong; Yang, Hanry; Rock, D. Mitchell; Danaei, Roozbeh; Panat, Rahul; Kessler, Michael R.; Li, Lei

2017-05-01

The development of micro lens arrays has garnered much interest due to increased demand of miniaturized systems. Traditional methods for manufacturing micro lens arrays have several shortcomings. For example, they require expensive facilities and long lead time, and traditional lens materials (i.e. glass) are typically heavy, costly and difficult to manufacture. In this paper, we explore a method for manufacturing a polydimethylsiloxane (PDMS) micro lens array using a simple spin coating technique. The micro lens array, formed under an interfacial tension dominated system, and the influence of material properties and process parameters on the fabricated lens shape are examined. The lenses fabricated using this method show comparable optical properties—including surface finish and image quality—with a reduced cost and manufacturing lead time.

Clinical manufacturing of CAR T cells: foundation of a promising therapy

PubMed Central

Wang, Xiuyan; Rivière, Isabelle

2016-01-01

The treatment of cancer patients with autologous T cells expressing a chimeric antigen receptor (CAR) is one of the most promising adoptive cellular therapy approaches. Reproducible manufacturing of high-quality, clinical-grade CAR-T cell products is a prerequisite for the wide application of this technology. Product quality needs to be built-in within every step of the manufacturing process. We summarize herein the requirements and logistics to be considered, as well as the state of the art manufacturing platforms available. CAR-T cell therapy may be on the verge of becoming standard of care for a few clinical indications. Yet, many challenges pertaining to manufacturing standardization and product characterization remain to be overcome in order to achieve broad usage and eventual commercialization of this therapeutic modality. PMID:27347557

Comparison of electron beam and laser beam powder bed fusion additive manufacturing process for high temperature turbine component materials

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

Dryepondt, Sebastien N; Pint, Bruce A; Ryan, Daniel

2016-04-01

The evolving 3D printer technology is now at the point where some turbine components could be additive manufactured (AM) for both development and production purposes. However, this will require a significant evaluation program to qualify the process and components to meet current design and quality standards. The goal of the project was to begin characterization of the microstructure and mechanical properties of Nickel Alloy X (Ni-22Cr-18Fe-9Mo) test bars fabricated by powder bed fusion (PBF) AM processes that use either an electron beam (EB) or laser beam (LB) power source. The AM materials produced with the EB and LB processes displayedmore » significant differences in microstructure and resultant mechanical properties. Accordingly, during the design analysis of AM turbine components, the specific mechanical behavior of the material produced with the selected AM process should be considered. Comparison of the mechanical properties of both the EB and LB materials to those of conventionally processed Nickel Alloy X materials indicates the subject AM materials are viable alternatives for manufacture of some turbine components.« less

Application of response surface methodology to maximize the productivity of scalable automated human embryonic stem cell manufacture.

PubMed

Ratcliffe, Elizabeth; Hourd, Paul; Guijarro-Leach, Juan; Rayment, Erin; Williams, David J; Thomas, Robert J

2013-01-01

Commercial regenerative medicine will require large quantities of clinical-specification human cells. The cost and quality of manufacture is notoriously difficult to control due to highly complex processes with poorly defined tolerances. As a step to overcome this, we aimed to demonstrate the use of 'quality-by-design' tools to define the operating space for economic passage of a scalable human embryonic stem cell production method with minimal cell loss. Design of experiments response surface methodology was applied to generate empirical models to predict optimal operating conditions for a unit of manufacture of a previously developed automatable and scalable human embryonic stem cell production method. Two models were defined to predict cell yield and cell recovery rate postpassage, in terms of the predictor variables of media volume, cell seeding density, media exchange and length of passage. Predicted operating conditions for maximized productivity were successfully validated. Such 'quality-by-design' type approaches to process design and optimization will be essential to reduce the risk of product failure and patient harm, and to build regulatory confidence in cell therapy manufacturing processes.

Using a simulation assistant in modeling manufacturing systems

NASA Technical Reports Server (NTRS)

Schroer, Bernard J.; Tseng, Fan T.; Zhang, S. X.; Wolfsberger, John W.

1988-01-01

Numerous simulation languages exist for modeling discrete event processes, and are now ported to microcomputers. Graphic and animation capabilities were added to many of these languages to assist the users build models and evaluate the simulation results. With all these languages and added features, the user is still plagued with learning the simulation language. Futhermore, the time to construct and then to validate the simulation model is always greater than originally anticipated. One approach to minimize the time requirement is to use pre-defined macros that describe various common processes or operations in a system. The development of a simulation assistant for modeling discrete event manufacturing processes is presented. A simulation assistant is defined as an interactive intelligent software tool that assists the modeler in writing a simulation program by translating the modeler's symbolic description of the problem and then automatically generating the corresponding simulation code. The simulation assistant is discussed with emphasis on an overview of the simulation assistant, the elements of the assistant, and the five manufacturing simulation generators. A typical manufacturing system will be modeled using the simulation assistant and the advantages and disadvantages discussed.

Feasibility of using Big Area Additive Manufacturing to Directly Manufacture Boat Molds

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

Post, Brian K.; Chesser, Phillip C.; Lind, Randall F.

The goal of this project was to explore the feasibility of using Big Area Additive Manufacturing (BAAM) to directly manufacture a boat mold without the need for coatings. All prior tooling projects with BAAM required the use to thick coatings to overcome the surface finish limitations of the BAAM process. While the BAAM process significantly lowers the cost of building the mold, the high cost element rapidly became the coatings (cost of the material, labor on coating, and finishing). As an example, the time and cost to manufacture the molds for the Wind Turbine project with TPI Composites Inc. andmore » the molds for the submarine project with Carderock Naval Warfare Systems was a fraction of the time and cost of the coatings. For this project, a catamaran boat hull mold was designed, manufactured, and assembled with an additional 0.15” thickness of material on all mold surfaces. After printing, the mold was immediately machined and assembled. Alliance MG, LLC (AMG), the industry partner of this project, experimented with mold release agents on the carbon-fiber reinforced acrylonitrile butadiene styrene (CF ABS) to verify that the material can be directly used as a mold (rather than needing a coating). In addition, for large molds (such as the wind turbine mold with TPI Composites Inc.), the mold only provided the target surface. A steel subframe had to be manufactured to provide structural integrity. If successful, this will significantly reduce the time and cost necessary for manufacturing large resin infusion molds using the BAAM process.« less

40 CFR 439.2 - General monitoring requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... assessment of the process chemistry, products and by-products resulting from each of the manufacturing... applications for approval by the permitting authority, reconfirmed by an annual chemical analysis of wastewater...

40 CFR 439.2 - General monitoring requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... assessment of the process chemistry, products and by-products resulting from each of the manufacturing... applications for approval by the permitting authority, reconfirmed by an annual chemical analysis of wastewater...

40 CFR 439.2 - General monitoring requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

... assessment of the process chemistry, products and by-products resulting from each of the manufacturing... applications for approval by the permitting authority, reconfirmed by an annual chemical analysis of wastewater...

K-9 training aids made using additive manufacturing

DOEpatents

Reynolds, John G.; Durban, Matthew M.; Gash, Alexander E.; Grapes, Michael D.; Kelley, Ryan S.; Sullivan, Kyle T.

2018-02-20

Additive Manufacturing (AM) is used to make aids that target the training of K-9s to detect explosives. The process uses mixtures of explosives and matrices commonly used in AM. The explosives are formulated into a mixture with the matrix and printed using AM techniques and equipment. The explosive concentrations are kept less than 10% by wt. of the mixture to conform to requirements of shipping and handling.

LSSA (Low-cost Silicon Solar Array) project

NASA Technical Reports Server (NTRS)

1976-01-01

Methods are explored for economically generating electrical power to meet future requirements. The Low-Cost Silicon Solar Array Project (LSSA) was established to reduce the price of solar arrays by improving manufacturing technology, adapting mass production techniques, and promoting user acceptance. The new manufacturing technology includes the consideration of new silicon refinement processes, silicon sheet growth techniques, encapsulants, and automated assembly production being developed under contract by industries and universities.

24 CFR 3282.207 - Manufactured home consumer manual requirements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 24 Housing and Urban Development 5 2014-04-01 2014-04-01 false Manufactured home consumer manual... HOUSING AND URBAN DEVELOPMENT MANUFACTURED HOME PROCEDURAL AND ENFORCEMENT REGULATIONS Manufacturer Inspection and Certification Requirements § 3282.207 Manufactured home consumer manual requirements. (a) The...

24 CFR 3282.207 - Manufactured home consumer manual requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 24 Housing and Urban Development 5 2012-04-01 2012-04-01 false Manufactured home consumer manual... HOUSING AND URBAN DEVELOPMENT MANUFACTURED HOME PROCEDURAL AND ENFORCEMENT REGULATIONS Manufacturer Inspection and Certification Requirements § 3282.207 Manufactured home consumer manual requirements. (a) The...

24 CFR 3282.207 - Manufactured home consumer manual requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 24 Housing and Urban Development 5 2013-04-01 2013-04-01 false Manufactured home consumer manual... HOUSING AND URBAN DEVELOPMENT MANUFACTURED HOME PROCEDURAL AND ENFORCEMENT REGULATIONS Manufacturer Inspection and Certification Requirements § 3282.207 Manufactured home consumer manual requirements. (a) The...

24 CFR 3282.207 - Manufactured home consumer manual requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 24 Housing and Urban Development 5 2011-04-01 2011-04-01 false Manufactured home consumer manual... HOUSING AND URBAN DEVELOPMENT MANUFACTURED HOME PROCEDURAL AND ENFORCEMENT REGULATIONS Manufacturer Inspection and Certification Requirements § 3282.207 Manufactured home consumer manual requirements. (a) The...

Validation of Reverse-Engineered and Additive-Manufactured Microsurgical Instrument Prototype.

PubMed

Singh, Ramandeep; Suri, Ashish; Anand, Sneh; Baby, Britty

2016-12-01

With advancements in imaging techniques, neurosurgical procedures are becoming highly precise and minimally invasive, thus demanding development of new ergonomically aesthetic instruments. Conventionally, neurosurgical instruments are manufactured using subtractive manufacturing methods. Such a process is complex, time-consuming, and impractical for prototype development and validation of new designs. Therefore, an alternative design process has been used utilizing blue light scanning, computer-aided designing, and additive manufacturing direct metal laser sintering (DMLS) for microsurgical instrument prototype development. Deviations of DMLS-fabricated instrument were studied by superimposing scan data of fabricated instrument with the computer-aided designing model. Content and concurrent validity of the fabricated prototypes was done by a group of 15 neurosurgeons by performing sciatic nerve anastomosis in small laboratory animals. Comparative scoring was obtained for the control and study instrument. T test was applied to the individual parameters and P values for force (P < .0001) and surface roughness (P < .01) were found to be statistically significant. These 2 parameters were further analyzed using objective measures. Results depicts that additive manufacturing by DMLS provides an effective method for prototype development. However, direct application of these additive-manufactured instruments in the operating room requires further validation. © The Author(s) 2016.

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

Effect of manufacturing process sequence on the corrosion resistance characteristics of coated metallic bipolar plates

NASA Astrophysics Data System (ADS)

Dur, Ender; Cora, Ömer Necati; Koç, Muammer

2014-01-01

Metallic bipolar plate (BPP) with high corrosion and low contact resistance, durability, strength, low cost, volume, and weight requirements is one of the critical parts of the PEMFC. This study is dedicated to understand the effect of the process sequence (manufacturing then coating vs. coating then manufacturing) on the corrosion resistance of coated metallic bipolar plates. To this goal, three different PVD coatings (titanium nitride (TiN), chromium nitride (CrN), zirconium nitride (ZrN)), with three thicknesses, (0.1, 0.5, 1 μm) were applied on BPPs made of 316L stainless steel alloy before and after two types of manufacturing (i.e., stamping or hydroforming). Corrosion test results indicated that ZrN coating exhibited the best corrosion protection while the performance of TiN coating was the lowest among the tested coatings and thicknesses. For most of the cases tested, in which coating was applied before manufacturing, occurrence of corrosion was found to be more profound than the case where coating was applied after manufacturing. Increasing the coating thickness was found to improve the corrosion resistance. It was also revealed that hydroformed BPPs performed slightly better than stamped BPPs in terms of the corrosion behavior.

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

The Nature of Automated Jobs and Their Educational and Training Requirements.

ERIC Educational Resources Information Center

Fine, S.A.

Objective information concerning the impact of automation on educational and training requirements was obtained for 132 employees engaged in electron tube, computer, and steel manufacturing processes through management questionnaire responses, analysis of job functions, and employer interviews before and after the introduction of automation. The…

27 CFR 40.63 - Corporate documents.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2013-04-01 2013-04-01 false Corporate documents. 40.63... PROCESSED TOBACCO Qualification Requirements for Manufacturers of Tobacco Products § 40.63 Corporate... furnish with its application for permit, required by § 40.62, a true copy of the corporate charter or a...

27 CFR 40.63 - Corporate documents.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2010-04-01 2010-04-01 false Corporate documents. 40.63... PROCESSED TOBACCO Qualification Requirements for Manufacturers of Tobacco Products § 40.63 Corporate... furnish with its application for permit, required by § 40.62, a true copy of the corporate charter or a...

27 CFR 40.63 - Corporate documents.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2011-04-01 2011-04-01 false Corporate documents. 40.63... PROCESSED TOBACCO Qualification Requirements for Manufacturers of Tobacco Products § 40.63 Corporate... furnish with its application for permit, required by § 40.62, a true copy of the corporate charter or a...

27 CFR 40.63 - Corporate documents.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2014-04-01 2014-04-01 false Corporate documents. 40.63... PROCESSED TOBACCO Qualification Requirements for Manufacturers of Tobacco Products § 40.63 Corporate... furnish with its application for permit, required by § 40.62, a true copy of the corporate charter or a...

27 CFR 40.63 - Corporate documents.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2012-04-01 2011-04-01 true Corporate documents. 40.63... PROCESSED TOBACCO Qualification Requirements for Manufacturers of Tobacco Products § 40.63 Corporate... furnish with its application for permit, required by § 40.62, a true copy of the corporate charter or a...

76 FR 38187 - International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-29

...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q11 Development and Manufacture of Drug Substances.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes approaches to developing process and drug substance understanding and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The draft guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information across the three regions.

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.

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.

Integration of Energy Consumption and CO2 Emissions into the DES Tool with Lean Thinking

NASA Astrophysics Data System (ADS)

Nujoom, Reda; Wang, Qian

2018-01-01

Products are often made by accomplishing a number of manufacturing processes on a sequential flow line which is also known as manufacturing systems. In a traditional way, design or evaluation of a manufacturing system involves a determination or an analysis of the system performance by adjusting system parameters relating to such as system capacity, material processing time, material-handling and transportation and shop-floor layout. Environment related parameters, however, are not considered or considered as separate issues. In the past decade, there has been a growing concern about the environmental protection and governments almost in all over the world enforced certain rules and regulation to promote energy saving and reduce carbon dioxide (CO2) emissions in manufacturing industry. To date, development of a sustainable manufacturing system requires designers who need not merely to apply traditional methods of improving system efficiency and productivity but also examine the environmental issues in production of the developed manufacturing system. Most researchers, however, focused on operational systems, which do not incorporate the effect of environmental factors that may also affect the system performance. This paper presents a research work aiming to addresses these issues in design and evaluation of sustainable manufacturing systems incorporating parameters of energy consumption and CO2 emissions into a DES (discrete event simulation) tool.

Investigations on the corrosion resistance of metallic bipolar plates (BPP) in proton exchange membrane fuel cells (PEMFC) - understanding the effects of material, coating and manufacturing

NASA Astrophysics Data System (ADS)

Dur, Ender

Polymer Electrolyte Membrane Fuel Cell (PEMFC) systems are promising technology for contributing to meet the deficiency of world`s clean and sustainable energy requirements in the near future. Metallic bipolar plate (BPP) as one of the most significant components of PEMFC device accounts for the largest part of the fuel cell`s stack. Corrosion for metallic bipolar plates is a critical issue, which influences the performance and durability of PEMFC. Corrosion causes adverse impacts on the PEMFC`s performance jeopardizing commercialization. This research is aimed at determining the corrosion resistance of metallic BPPs, particularly stainless steels, used in PEMFC from different aspects. Material selection, coating selection, manufacturing process development and cost considerations need to be addressed in terms of the corrosion behavior to justify the use of stainless steels as a BPP material in PEMFC and to make them commercially feasible in industrial applications. In this study, Ti, Ni, SS304, SS316L, and SS 430 blanks, and BPPs comprised of SS304 and SS316L were examined in terms of the corrosion behavior. SS316L plates were coated to investigate the effect of coatings on the corrosion resistance performance. Stamping and hydroforming as manufacturing processes, and three different coatings (TiN, CrN, ZrN) applied via the Physical Vapor Deposition (PVD) method in three different thicknesses were selected to observe the effects of manufacturing processes, coating types and coating thicknesses on the corrosion resistance of BPP, respectively. Uncoated-coated blank and formed BPP were subjected to two different corrosion tests: potentiostatic and potentiodynamic. Some of the substantial results: 1- Manufacturing processes have an adverse impact on the corrosion resistance. 2- Hydroformed plates have slightly higher corrosion resistance than stamped samples. 3- BPPs with higher channel size showed better corrosion resistance. 4- Since none of the uncoated samples meet the 2015 target of the U.S. Department of Energy, surface coating is required. 5- ZrN and CrN coated BPPs exhibited higher corrosion resistance meeting DOE target while TiN coated samples had the lowest corrosion resistance. Higher coating thicknesses improved the corrosion resistance of the BPPs. 6- Process sequence between coating and manufacturing is not significant for hydroforming case (ZrN and CrN) and stamping case (CrN) in terms of the corrosion resistance. In other words, coating the BPP`s substrate material before manufacturing process does not always decrease the corrosion resistance of the BPPs.

The legal framework governing the quality of (traditional) herbal medicinal products in the European Union.

PubMed

Kroes, Burt H

2014-12-02

In the European Union a complex regulatory framework is in place for the regulation of (traditional) herbal medicinal products. It is based on the principle that a marketing authorisation granted by the competent authorities is required for placing medicinal products on the market. The requirements and procedures for acquiring such a marketing authorisation are laid down in regulations, directives and scientific guidelines. This paper gives an overview of the quality requirements for (traditional) herbal medicinal products that are contained in European pharmaceutical legislation. Pharmaceutical quality of medicinal product is the basis for ensuring safe and effective medicines. The basic principles governing the assurance of the quality of medicinal products in the European Union are primarily defined in the amended Directive 2001/83/EC and Directive 2003/63/EC. Quality requirements of herbal medicinal products are also laid down in scientific guidelines. Scientific guidelines provide a basis for practical harmonisation of how the competent authorities of EU Member States interpret and apply the detailed requirements for the demonstration of quality laid down in regulations and directives. Detailed quality requirements for herbal medicinal products on the European market are contained in European Union (EU) pharmaceutical legislation. They include a system of manufacturing authorisations which ensures that all herbal medicinal products on the European market are manufactured/imported only by authorised manufacturers, whose activities are regularly inspected by the competent authorities. Additionally, as starting materials only active substances are allowed which have been manufactured in accordance with the GMP for starting materials as adopted by the Community. The European regulatory framework encompasses specific requirements for herbal medicinal products. These requirements are independent from the legal status. Thus, the same quality standards equally apply to herbal products based on clinical evidence and traditional herbal medicinal products. The basic principle is that the quality of herbal medicinal products is intrinsically associated with the quality standard of the herbal substances and/or herbal preparations. Furthermore, the herbal substance or herbal preparation in its entirety is regarded as the active substance. Consequently, a mere determination of the content of marker(s) or constituents with known therapeutic activity is not sufficient for the quality control of herbal medicinal products. Specific quality requirements include thorough product characterisation, adherence to the Good Agricultural and Collection Practices, good manufacturing practices and validated manufacturing process, e.g., raw material testing, in-process testing, fingerprint characterisation etc. Quality control of herbal medicinal products is primarily intended to define the quality of the herbal substance/preparation and herbal medicinal product rather than to establish full characterisation. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

40 CFR 63.1089 - What records must I keep?

Code of Federal Regulations, 2011 CFR

2011-07-01

...) National Emission Standards for Ethylene Manufacturing Process Units: Heat Exchange Systems and Waste Operations Recordkeeping and Reporting Requirements for Heat Exchange Systems § 63.1089 What records must I...

40 CFR 63.1089 - What records must I keep?

Code of Federal Regulations, 2010 CFR

2010-07-01

...) National Emission Standards for Ethylene Manufacturing Process Units: Heat Exchange Systems and Waste Operations Recordkeeping and Reporting Requirements for Heat Exchange Systems § 63.1089 What records must I...

40 CFR 63.1089 - What records must I keep?

Code of Federal Regulations, 2013 CFR

2013-07-01

...) National Emission Standards for Ethylene Manufacturing Process Units: Heat Exchange Systems and Waste Operations Recordkeeping and Reporting Requirements for Heat Exchange Systems § 63.1089 What records must I...

40 CFR 63.1089 - What records must I keep?

Code of Federal Regulations, 2014 CFR

2014-07-01

...) National Emission Standards for Ethylene Manufacturing Process Units: Heat Exchange Systems and Waste Operations Recordkeeping and Reporting Requirements for Heat Exchange Systems § 63.1089 What records must I...

40 CFR 63.1089 - What records must I keep?

Code of Federal Regulations, 2012 CFR

2012-07-01

...) National Emission Standards for Ethylene Manufacturing Process Units: Heat Exchange Systems and Waste Operations Recordkeeping and Reporting Requirements for Heat Exchange Systems § 63.1089 What records must I...

Surface-specific additive manufacturing test artefacts

NASA Astrophysics Data System (ADS)

Townsend, Andrew; Racasan, Radu; Blunt, Liam

2018-06-01

Many test artefact designs have been proposed for use with additive manufacturing (AM) systems. These test artefacts have primarily been designed for the evaluation of AM form and dimensional performance. A series of surface-specific measurement test artefacts designed for use in the verification of AM manufacturing processes are proposed here. Surface-specific test artefacts can be made more compact because they do not require the large dimensions needed for accurate dimensional and form measurements. The series of three test artefacts are designed to provide comprehensive information pertaining to the manufactured surface. Measurement possibilities include deviation analysis, surface texture parameter data generation, sub-surface analysis, layer step analysis and build resolution comparison. The test artefacts are designed to provide easy access for measurement using conventional surface measurement techniques, for example, focus variation microscopy, stylus profilometry, confocal microscopy and scanning electron microscopy. Additionally, the test artefacts may be simply visually inspected as a comparative tool, giving a fast indication of process variation between builds. The three test artefacts are small enough to be included in every build and include built-in manufacturing traceability information, making them a convenient physical record of the build.

Composites Materials and Manufacturing Technologies for Space Applications

NASA Technical Reports Server (NTRS)

Vickers, J. H.; Tate, L. C.; Gaddis, S. W.; Neal, R. E.

2016-01-01

Composite materials offer significant advantages in space applications. Weight reduction is imperative for deep space systems. However, the pathway to deployment of composites alternatives is problematic. Improvements in the materials and processes are needed, and extensive testing is required to validate the performance, qualify the materials and processes, and certify components. Addressing these challenges could lead to the confident adoption of composites in space applications and provide spin-off technical capabilities for the aerospace and other industries. To address the issues associated with composites applications in space systems, NASA sponsored a Technical Interchange Meeting (TIM) entitled, "Composites Materials and Manufacturing Technologies for Space Applications," the proceedings of which are summarized in this Conference Publication. The NASA Space Technology Mission Directorate and the Game Changing Program chartered the meeting. The meeting was hosted by the National Center for Advanced Manufacturing (NCAM)-a public/private partnership between NASA, the State of Louisiana, Louisiana State University, industry, and academia, in association with the American Composites Manufacturers Association. The Louisiana Center for Manufacturing Sciences served as the coordinator for the TIM.

Logistics for the implementation of lead-free solders on electronic assemblies

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

Vianco, P.T.; Artaki, I.

1993-12-31

The prospects of legislative and regulatory action aimed at taxing, restricting or banning lead-bearing materials from manufactured products has prompted the electronics community to examine the implementation of lead-free solders to replace currently used lead-containing alloys in the manufacture of electronic devices and assemblies. The logistics for changing the well established ``tin-lead solder technology`` require not only the selection of new compositions but also the qualification of different surface finishes and manufacturing processes. The meniscometer/wetting balance technique was used to evaluate the wettability of several candidate lead-free solders as well as to establish windows on processing parameters so as tomore » facilitate prototype manufacturing. Electroplated and electroless 100Sn coatings, as well as organic preservatives, were also examined as potential alternative finishes for device leads and terminations as well as circuit board conductor surfaces to replace traditional tin-lead layers. Sandia National Laboratories and AT&T have implemented a program to qualify the manufacturing feasibility of surface mount prototype circuit boards using several commercial lead-free solders by infrared reflow technology.« less

Using of material-technological modelling for designing production of closed die forgings

NASA Astrophysics Data System (ADS)

Ibrahim, K.; Vorel, I.; Jeníček, Š.; Káňa, J.; Aišman, D.; Kotěšovec, V.

2017-02-01

Production of forgings is a complex and demanding process which consists of a number of forging operations and, in many cases, includes post-forge heat treatment. An optimized manufacturing line is a prerequisite for obtaining prime-quality products which in turn are essential to profitable operation of a forging company. Problems may, however, arise from modifications to the manufacturing route due to changing customer needs. As a result, the production may have to be suspended temporarily to enable changeover and optimization. Using material-technological modelling, the required modifications can be tested and optimized under laboratory conditions outside the plant without disrupting the production. Thanks to material-technological modelling, the process parameters can be varied rapidly in response to changes in market requirements. Outcomes of the modelling runs include optimum parameters for the forging part’s manufacturing route, values of mechanical properties, and results of microstructure analysis. This article describes the use of material-technological modelling for exploring the impact of the amount of deformation and the rate of cooling of a particular forged part from the finish-forging temperature on its microstructure and related mechanical properties.

Challenges and opportunities in the manufacture and expansion of cells for therapy.

PubMed

Maartens, Joachim H; De-Juan-Pardo, Elena; Wunner, Felix M; Simula, Antonio; Voelcker, Nicolas H; Barry, Simon C; Hutmacher, Dietmar W

2017-10-01

Laboratory-based ex vivo cell culture methods are largely manual in their manufacturing processes. This makes it extremely difficult to meet regulatory requirements for process validation, quality control and reproducibility. Cell culture concepts with a translational focus need to embrace a more automated approach where cell yields are able to meet the quantitative production demands, the correct cell lineage and phenotype is readily confirmed and reagent usage has been optimized. Areas covered: This article discusses the obstacles inherent in classical laboratory-based methods, their concomitant impact on cost-of-goods and that a technology step change is required to facilitate translation from bed-to-bedside. Expert opinion: While traditional bioreactors have demonstrated limited success where adherent cells are used in combination with microcarriers, further process optimization will be required to find solutions for commercial-scale therapies. New cell culture technologies based on 3D-printed cell culture lattices with favourable surface to volume ratios have the potential to change the paradigm in industry. An integrated Quality-by-Design /System engineering approach will be essential to facilitate the scaled-up translation from proof-of-principle to clinical validation.

40 CFR 63.11561 - What are my standards and management practices?

Code of Federal Regulations, 2013 CFR

2013-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Standards and Compliance Requirements § 63.11561 What are my standards and management practices? (a) For asphalt processing operations, you must meet the emission limits...

40 CFR 63.11561 - What are my standards and management practices?

Code of Federal Regulations, 2012 CFR

2012-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Standards and Compliance Requirements § 63.11561 What are my standards and management practices? (a) For asphalt processing operations, you must meet the emission limits...

40 CFR 63.11561 - What are my standards and management practices?

Code of Federal Regulations, 2014 CFR

2014-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Standards and Compliance Requirements § 63.11561 What are my standards and management practices? (a) For asphalt processing operations, you must meet the emission limits...

40 CFR 63.11561 - What are my standards and management practices?

Code of Federal Regulations, 2011 CFR

2011-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Standards and Compliance Requirements § 63.11561 What are my standards and management practices? (a) For asphalt processing operations, you must meet the emission limits...

Structural Integrity of an Electron Beam Melted Titanium Alloy.

PubMed

Lancaster, Robert; Davies, Gareth; Illsley, Henry; Jeffs, Spencer; Baxter, Gavin

2016-06-14

Advanced manufacturing encompasses the wide range of processes that consist of "3D printing" of metallic materials. One such method is Electron Beam Melting (EBM), a modern build technology that offers significant potential for lean manufacture and a capability to produce fully dense near-net shaped components. However, the manufacture of intricate geometries will result in variable thermal cycles and thus a transient microstructure throughout, leading to a highly textured structure. As such, successful implementation of these technologies requires a comprehensive assessment of the relationships of the key process variables, geometries, resultant microstructures and mechanical properties. The nature of this process suggests that it is often difficult to produce representative test specimens necessary to achieve a full mechanical property characterisation. Therefore, the use of small scale test techniques may be exploited, specifically the small punch (SP) test. The SP test offers a capability for sampling miniaturised test specimens from various discrete locations in a thin-walled component, allowing a full characterisation across a complex geometry. This paper provides support in working towards development and validation strategies in order for advanced manufactured components to be safely implemented into future gas turbine applications. This has been achieved by applying the SP test to a series of Ti-6Al-4V variants that have been manufactured through a variety of processing routes including EBM and investigating the structural integrity of each material and how this controls the mechanical response.

Design process optimization, virtual prototyping of manufacturing, and foundry-portable DFM (Invited Paper)

NASA Astrophysics Data System (ADS)

Hogan, James; Progler, Christopher; Chatila, Ahmad; Bruggeman, Bert; Heins, Mitchell; Pack, Robert; Boksha, Victor

2005-05-01

We consider modern design for manufacturing (DFM) as a manifestation of IC industry re-integration and intensive cost management dynamics. In that regard DFM is somewhat different from so-called design for yield (DFY) which essentially focuses on productivity (yield) management (that is not to say that DFM and DFY do not have significant overlaps and interactions). We clearly see the shaping of a new "full-chip DFM" infrastructure on the background of the "back to basics" design-manufacturing re-integration dynamics. In the presented work we are focusing on required DFM-efficiencies in a "foundry-fabless" link. Concepts of "virtual prototyping of manufacturing", "design process optimization", and "foundry-portable DFM" models are explored. Both senior management of the industry and leading design groups finally realize the need for a radical change of design styles. Some of the DFM super-goals are to isolate designers from process details and to make designs foundry portable. It requires qualification of designs at different foundries. In their turn, foundries specified and are implementing a set of DFM rules: "action-required", "recommended", and "guidelines" while asking designers to provide netlist and testing information. Also, we observe strong signs of innovation coming back to the mask industry. Powerful solutions are emerging and shaping up toward mask-centered IP as a business. While it seems that pure-play foundries have found their place for now in the "IDM+" model (supporting manufacturing capacity of IDMs) it is not obvious how sustainable the model is. Wafer as a production unit is not sufficient anymore; foundries are being asked by large customers to price products in terms of good die. It brings back the notion of the old ASIC business model where the foundry is responsible for dealing with both random and systematic yield issues for a given design. One scenario of future development would be that some of the leading foundries might eventually transform themselves into IDMs. Another visible trend: some of the manufacturing capacities started to diversify business by providing services for new emerging markets (for example, new energy and medicine applications). Finally it is very unclear what"s going to happen to fabless players. We continue building on the "Think SPICE again!" methodology introduced last year and expanding on previous platforms' discussion. Model expression of DFM, most probably, will be supplied by the equipment suppliers and yield management community. Actual content for a design intent model will be provided by manufacturing. Much like SPICE it describes the behavior and not what the actual measurement in manufacturing is. When the model is available and populated, a design automation solution can be created that will allow a designer to extract, analyze, simulate, and optimize the circuit prior to handoff to manufacturing.

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.

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.

Closed-Loop Multitarget Optimization for Discovery of New Emulsion Polymerization Recipes

PubMed Central

2015-01-01

Self-optimization of chemical reactions enables faster optimization of reaction conditions or discovery of molecules with required target properties. The technology of self-optimization has been expanded to discovery of new process recipes for manufacture of complex functional products. A new machine-learning algorithm, specifically designed for multiobjective target optimization with an explicit aim to minimize the number of “expensive” experiments, guides the discovery process. This “black-box” approach assumes no a priori knowledge of chemical system and hence particularly suited to rapid development of processes to manufacture specialist low-volume, high-value products. The approach was demonstrated in discovery of process recipes for a semibatch emulsion copolymerization, targeting a specific particle size and full conversion. PMID:26435638

Modeling and control of flow during impregnation of heterogeneous porous media, with application to composite mold-filling processes

NASA Astrophysics Data System (ADS)

Bickerton, Simon

Liquid Composite Molding (LCM) encompasses a growing list of composite material manufacturing techniques. These processes have provided the promise for complex fiber reinforced plastics parts, manufactured from a single molding step. In recent years a significant research effort has been invested in development of process simulations, providing tools that have advanced current LCM technology and broadened the range of applications. The requirement for manufacture of larger, more complex parts has motivated investigation of active control of LCM processes. Due to the unlimited variety of part geometries that can be produced, finite element based process simulations will be used to some extent in design of actively controlled processes. Ongoing efforts are being made to improve material parameter specification for process simulations, increasing their value as design tools. Several phenomena occurring during mold filling have been addressed through flow visualization experimentation and analysis of manufactured composite parts. The influence of well defined air channels within a mold cavity is investigated, incorporating their effects within existing filling simulations. Three different flow configurations have been addressed, testing the application of 'equivalent permeabilities', effectively approximating air channels as representative porous media. LCM parts having doubly curved regions require preform fabrics to undergo significant, and varying deformation throughout a mold cavity. Existing methods for predicting preform deformation, and the resulting permeability distribution have been applied to a conical mold geometry. Comparisons between experiment and simulation are promising, while the geometry studied has required large deformation over much of the part, shearing the preform fabric beyond the scope of the models applied. An investigational study was performed to determine the magnitude of effect, if any, on mold filling caused by corners within LCM mold cavities. The molds applied in this study have required careful consideration of cavity thickness variations. Any effects on mold filling due to corner radii have been overshadowed by those due to preform compression. While numerical tools are available to study actively controlled mold filling in a virtual environment, some development is required for the physical equipment to implement this in practice. A versatile, multiple line fluid injection system is developed here. The equipment and control algorithms employed have provided servo control of flow rate, or injection pressure, and have been tested under very challenging conditions. The single injection line developed is expanded to a multiple line system, and shows great potential for application to actual resin systems. A case study is presented, demonstrating design and implementation of a simple actively controlled injection scheme. The experimental facility developed provides an excellent testbed for application of actively controlled mold filling concepts, an area that is providing great promise for the advancement of LCM processes.

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.

To repair or not to repair: with FAVOR there is no question

NASA Astrophysics Data System (ADS)

Garetto, Anthony; Schulz, Kristian; Tabbone, Gilles; Himmelhaus, Michael; Scheruebl, Thomas

2016-10-01

In the mask shop the challenges associated with today's advanced technology nodes, both technical and economic, are becoming increasingly difficult. The constant drive to continue shrinking features means more masks per device, smaller manufacturing tolerances and more complexity along the manufacturing line with respect to the number of manufacturing steps required. Furthermore, the extremely competitive nature of the industry makes it critical for mask shops to optimize asset utilization and processes in order to maximize their competitive advantage and, in the end, profitability. Full maximization of profitability in such a complex and technologically sophisticated environment simply cannot be achieved without the use of smart automation. Smart automation allows productivity to be maximized through better asset utilization and process optimization. Reliability is improved through the minimization of manual interactions leading to fewer human error contributions and a more efficient manufacturing line. In addition to these improvements in productivity and reliability, extra value can be added through the collection and cross-verification of data from multiple sources which provides more information about our products and processes. When it comes to handling mask defects, for instance, the process consists largely of time consuming manual interactions that are error prone and often require quick decisions from operators and engineers who are under pressure. The handling of defects itself is a multiple step process consisting of several iterations of inspection, disposition, repair, review and cleaning steps. Smaller manufacturing tolerances and features with higher complexity contribute to a higher number of defects which must be handled as well as a higher level of complexity. In this paper the recent efforts undertaken by ZEISS to provide solutions which address these challenges, particularly those associated with defectivity, will be presented. From automation of aerial image analysis to the use of data driven decision making to predict and propose the optimized back end of line process flow, productivity and reliability improvements are targeted by smart automation. Additionally the generation of the ideal aerial image from the design and several repair enhancement features offer additional capabilities to improve the efficiency and yield associated with defect handling.

21 CFR 107.240 - Notification requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., and Cosmetic Act (the act)) that reasonably supports the conclusion that an infant formula that has been processed by the manufacturer and that has left an establishment subject to the control of the...

21 CFR 107.240 - Notification requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., and Cosmetic Act (the act)) that reasonably supports the conclusion that an infant formula that has been processed by the manufacturer and that has left an establishment subject to the control of the...