Tracking the course of the manufacturing process in selective laser melting

NASA Astrophysics Data System (ADS)

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

2014-02-01

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

21 CFR 211.103 - Calculation of yield.

Code of Federal Regulations, 2011 CFR

2011-04-01

...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls... at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of...

21 CFR 211.103 - Calculation of yield.

Code of Federal Regulations, 2010 CFR

2010-04-01

...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls... at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of...

Additive Manufacturing Infrared Inspection

NASA Technical Reports Server (NTRS)

Gaddy, Darrell; Nettles, Mindy

2015-01-01

The Additive Manufacturing Infrared Inspection Task started the development of a real-time dimensional inspection technique and digital quality record for the additive manufacturing process using infrared camera imaging and processing techniques. This project will benefit additive manufacturing by providing real-time inspection of internal geometry that is not currently possible and reduce the time and cost of additive manufactured parts with automated real-time dimensional inspections which deletes post-production inspections.

National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities.

PubMed

Ricordi, Camillo; Goldstein, Julia S; Balamurugan, A N; Szot, Gregory L; Kin, Tatsuya; Liu, Chengyang; Czarniecki, Christine W; Barbaro, Barbara; Bridges, Nancy D; Cano, Jose; Clarke, William R; Eggerman, Thomas L; Hunsicker, Lawrence G; Kaufman, Dixon B; Khan, Aisha; Lafontant, David-Erick; Linetsky, Elina; Luo, Xunrong; Markmann, James F; Naji, Ali; Korsgren, Olle; Oberholzer, Jose; Turgeon, Nicole A; Brandhorst, Daniel; Chen, Xiaojuan; Friberg, Andrew S; Lei, Ji; Wang, Ling-Jia; Wilhelm, Joshua J; Willits, Jamie; Zhang, Xiaomin; Hering, Bernhard J; Posselt, Andrew M; Stock, Peter G; Shapiro, A M James; Chen, Xiaojuan

2016-11-01

Eight manufacturing facilities participating in the National Institutes of Health-sponsored Clinical Islet Transplantation (CIT) Consortium jointly developed and implemented a harmonized process for the manufacture of allogeneic purified human pancreatic islet (PHPI) product evaluated in a phase 3 trial in subjects with type 1 diabetes. Manufacturing was controlled by a common master production batch record, standard operating procedures that included acceptance criteria for deceased donor organ pancreata and critical raw materials, PHPI product specifications, certificate of analysis, and test methods. The process was compliant with Current Good Manufacturing Practices and Current Good Tissue Practices. This report describes the manufacturing process for 75 PHPI clinical lots and summarizes the results, including lot release. The results demonstrate the feasibility of implementing a harmonized process at multiple facilities for the manufacture of a complex cellular product. The quality systems and regulatory and operational strategies developed by the CIT Consortium yielded product lots that met the prespecified characteristics of safety, purity, potency, and identity and were successfully transplanted into 48 subjects. No adverse events attributable to the product and no cases of primary nonfunction were observed. © 2016 by the American Diabetes Association.

National Institutes of Health–Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities

PubMed Central

Balamurugan, A.N.; Szot, Gregory L.; Kin, Tatsuya; Liu, Chengyang; Czarniecki, Christine W.; Barbaro, Barbara; Bridges, Nancy D.; Cano, Jose; Clarke, William R.; Eggerman, Thomas L.; Hunsicker, Lawrence G.; Kaufman, Dixon B.; Khan, Aisha; Lafontant, David-Erick; Linetsky, Elina; Luo, Xunrong; Markmann, James F.; Naji, Ali; Korsgren, Olle; Oberholzer, Jose; Turgeon, Nicole A.; Brandhorst, Daniel; Chen, Xiaojuan; Friberg, Andrew S.; Lei, Ji; Wang, Ling-jia; Wilhelm, Joshua J.; Willits, Jamie; Zhang, Xiaomin; Hering, Bernhard J.; Posselt, Andrew M.; Stock, Peter G.; Shapiro, A.M. James

2016-01-01

Eight manufacturing facilities participating in the National Institutes of Health–sponsored Clinical Islet Transplantation (CIT) Consortium jointly developed and implemented a harmonized process for the manufacture of allogeneic purified human pancreatic islet (PHPI) product evaluated in a phase 3 trial in subjects with type 1 diabetes. Manufacturing was controlled by a common master production batch record, standard operating procedures that included acceptance criteria for deceased donor organ pancreata and critical raw materials, PHPI product specifications, certificate of analysis, and test methods. The process was compliant with Current Good Manufacturing Practices and Current Good Tissue Practices. This report describes the manufacturing process for 75 PHPI clinical lots and summarizes the results, including lot release. The results demonstrate the feasibility of implementing a harmonized process at multiple facilities for the manufacture of a complex cellular product. The quality systems and regulatory and operational strategies developed by the CIT Consortium yielded product lots that met the prespecified characteristics of safety, purity, potency, and identity and were successfully transplanted into 48 subjects. No adverse events attributable to the product and no cases of primary nonfunction were observed. PMID:27465220

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.

Sandia National Labs: Manufacturing Science and Technology

Science.gov Websites

Additional Resources R&D Projects Current Partnerships Creating Partnerships Welcome to the Manufacturing Science and Technology home page Manufacturing Science and Technology Showcase The Manufacturing Science & Technology Center develops and applies advanced manufacturing processes for realization of

Design and implementation of a Windows NT network to support CNC activities

NASA Technical Reports Server (NTRS)

Shearrow, C. A.

1996-01-01

The Manufacturing, Materials, & Processes Technology Division is undergoing dramatic changes to bring it's manufacturing practices current with today's technological revolution. The Division is developing Computer Automated Design and Computer Automated Manufacturing (CAD/CAM) abilities. The development of resource tracking is underway in the form of an accounting software package called Infisy. These two efforts will bring the division into the 1980's in relationship to manufacturing processes. Computer Integrated Manufacturing (CIM) is the final phase of change to be implemented. This document is a qualitative study and application of a CIM application capable of finishing the changes necessary to bring the manufacturing practices into the 1990's. The documentation provided in this qualitative research effort includes discovery of the current status of manufacturing in the Manufacturing, Materials, & Processes Technology Division including the software, hardware, network and mode of operation. The proposed direction of research included a network design, computers to be used, software to be used, machine to computer connections, estimate a timeline for implementation, and a cost estimate. Recommendation for the division's improvement include action to be taken, software to utilize, and computer configurations.

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.

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.

Continuous flow technology vs. the batch-by-batch approach to produce pharmaceutical compounds.

PubMed

Cole, Kevin P; Johnson, Martin D

2018-01-01

For the manufacture of small molecule drugs, many pharmaceutical innovator companies have recently invested in continuous processing, which can offer significant technical and economic advantages over traditional batch methodology. This Expert Review will describe the reasons for this interest as well as many considerations and challenges that exist today concerning continuous manufacturing. Areas covered: Continuous processing is defined and many reasons for its adoption are described. The current state of continuous drug substance manufacturing within the pharmaceutical industry is summarized. Current key challenges to implementation of continuous manufacturing are highlighted, and an outlook provided regarding the prospects for continuous within the industry. Expert commentary: Continuous processing at Lilly has been a journey that started with the need for increased safety and capability. Over twelve years the original small, dedicated group has grown to more than 100 Lilly employees in discovery, development, quality, manufacturing, and regulatory designing in continuous drug substance processing. Recently we have focused on linked continuous unit operations for the purpose of all-at-once pharmaceutical manufacturing, but the technical and business drivers that existed in the very beginning for stand-alone continuous unit operations in hybrid processes have persisted, which merits investment in both approaches.

Potential of Continuous Manufacturing for Liposomal Drug Products.

PubMed

Worsham, Robert D; Thomas, Vaughan; Farid, Suzanne S

2018-05-21

Over the last several years, continuous manufacturing of pharmaceuticals has evolved from bulk APIs and solid oral dosages into the more complex realm of biologics. The development of continuous downstream processing techniques has allowed biologics manufacturing to realize the benefits (e.g. improved economics, more consistent quality) that come with continuous processing. If relevant processing techniques and principles are selected, the opportunity arises to develop continuous manufacturing designs for additional pharmaceutical products including liposomal drug formulations. Liposome manufacturing has some inherent aspects that make it favorable for a continuous process. Other aspects such as formulation refinement, materials of construction, and aseptic processing need development, but present an achievable challenge. This paper reviews the current state of continuous manufacturing technology applicable to liposomal drug product manufacturing and an assessment of the challenges and potential of this application. This article is protected by copyright. All rights reserved.

77 FR 16158 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-20

... ``cut'' from a sheet or roll of labels--is used. Persistent problems with drug product mislabeling and... believe that development and use of advanced code scanning equipment has made many current electronic... and other advanced scanning techniques have made current electronic systems reliable to the 100...

Analysis and evaluation in the production process and equipment area of the low-cost solar array project

NASA Technical Reports Server (NTRS)

Goldman, H.; Wolf, M.

1979-01-01

The energy consumed in manufacturing silicon solar cell modules was calculated for the current process, as well as for 1982 and 1986 projected processes. In addition, energy payback times for the above three sequences are shown. The module manufacturing energy was partitioned two ways. In one way, the silicon reduction, silicon purification, sheet formation, cell fabrication, and encapsulation energies were found. In addition, the facility, equipment, processing material and direct material lost-in-process energies were appropriated in junction formation processes and full module manufacturing sequences. A brief methodology accounting for the energy of silicon wafers lost-in-processing during cell manufacturing is described.

Towards a commercial process for the manufacture of genetically modified T cells for therapy

PubMed Central

Kaiser, A D; Assenmacher, M; Schröder, B; Meyer, M; Orentas, R; Bethke, U; Dropulic, B

2015-01-01

The recent successes of adoptive T-cell immunotherapy for the treatment of hematologic malignancies have highlighted the need for manufacturing processes that are robust and scalable for product commercialization. Here we review some of the more outstanding issues surrounding commercial scale manufacturing of personalized-adoptive T-cell medicinal products. These include closed system operations, improving process robustness and simplifying work flows, reducing labor intensity by implementing process automation, scalability and cost, as well as appropriate testing and tracking of products, all while maintaining strict adherence to Current Good Manufacturing Practices and regulatory guidelines. A decentralized manufacturing model is proposed, where in the future patients' cells could be processed at the point-of-care in the hospital. PMID:25613483

Electron beam additive manufacturing with wire - Analysis of the process

NASA Astrophysics Data System (ADS)

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

2018-05-01

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

78 FR 44455 - National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-24

... Sonoma County, California. The Site's main property contains a manufacturing building and adjoining... corner of the manufacturing facility. The Site building is currently occupied by three companies, which.... Sola manufactured ophthalmic lenses at the facility from 1978 through 2001. The manufacturing process...

Additive Manufacturing Technologies Used for Processing Polymers: Current Status and Potential Application in Prosthetic Dentistry.

PubMed

Revilla-León, Marta; Özcan, Mutlu

2018-04-22

There are 7 categories of additive manufacturing (AM) technologies, and a wide variety of materials can be used to build a CAD 3D object. The present article reviews the main AM processes for polymers for dental applications: stereolithography (SLA), digital light processing (DLP), material jetting (MJ), and material extrusion (ME). The manufacturing process, accuracy, and precision of these methods will be reviewed, as well as their prosthodontic applications. © 2018 by the American College of Prosthodontists.

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.

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.

A Review of PAT Strategies in Secondary Solid Oral Dosage Manufacturing of Small Molecules.

PubMed

Laske, Stephan; Paudel, Amrit; Scheibelhofer, Otto

2017-03-01

Pharmaceutical solid oral dosage product manufacturing is a well-established, yet revolutionizing area. To this end, process analytical technology (PAT) involves interdisciplinary and multivariate (chemical, physical, microbiological, and mathematical) methods for material (e.g., materials, intermediates, products) and process (e.g., temperature, pressure, throughput, etc.) analysis. This supports rational process modeling and enhanced control strategies for improved product quality and process efficiency. Therefore, it is often difficult to orient and find the relevant, integrated aspects of the current state-of-the-art. Especially, the link between fundamental research, in terms of sensor and control system development, to the application both in laboratory and manufacturing scale, is difficult to comprehend. This review compiles a nonexhaustive overview on current approaches from the recognized academia and industrial practices of PAT, including screening, selection, and final implementations in solid oral dosage manufacturing, through a wide diversity of use cases. Finally, the authors attempt to extract a common consensus toward developing PAT application guidance for different unit operations of drug product manufacturing. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

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...

21 CFR 111.365 - What precautions must you take to prevent contamination?

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN... necessary, the phase of manufacturing; and (k) Identifying all processing lines and major equipment used... specific batch or lot number and, when necessary, the phase of manufacturing. ...

21 CFR 113.5 - Current good manufacturing practice.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...

21 CFR 113.5 - Current good manufacturing practice.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...

21 CFR 113.5 - Current good manufacturing practice.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...

21 CFR 113.5 - Current good manufacturing practice.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...

Industrialization of mAb production technology The bioprocessing industry at a crossroads

PubMed Central

2009-01-01

Manufacturing processes for therapeutic monoclonal antibodies (mAbs) have evolved tremendously since the first licensed mAb product in 1986. The rapid growth in product demand for mAbs triggered parallel efforts to increase production capacity through construction of large bulk manufacturing plants as well as improvements in cell culture processes to raise product titers. This combination has led to an excess of manufacturing capacity, and together with improvements in conventional purification technologies, promises nearly unlimited production capacity in the foreseeable future. The increase in titers has also led to a marked reduction in production costs, which could then become a relatively small fraction of sales price for future products which are sold at prices at or near current levels. The reduction of capacity and cost pressures for current state-of-the-art bulk production processes may shift the focus of process development efforts and have important implications for both plant design and product development strategies for both biopharmaceutical and contract manufacturing companies. PMID:20065641

Additive manufacturing: Toward holistic design

DOE PAGES

Jared, Bradley H.; Aguilo, Miguel A.; Beghini, Lauren L.; ...

2017-03-18

Here, additive manufacturing offers unprecedented opportunities to design complex structures optimized for performance envelopes inaccessible under conventional manufacturing constraints. Additive processes also promote realization of engineered materials with microstructures and properties that are impossible via traditional synthesis techniques. Enthused by these capabilities, optimization design tools have experienced a recent revival. The current capabilities of additive processes and optimization tools are summarized briefly, while an emerging opportunity is discussed to achieve a holistic design paradigm whereby computational tools are integrated with stochastic process and material awareness to enable the concurrent optimization of design topologies, material constructs and fabrication processes.

Fully Disposable Manufacturing Concepts for Clinical and Commercial Manufacturing and Ballroom Concepts.

PubMed

Boedeker, Berthold; Goldstein, Adam; Mahajan, Ekta

2017-11-04

The availability and use of pre-sterilized disposables has greatly changed the methods used in biopharmaceuticals development and production, particularly from mammalian cell culture. Nowadays, almost all process steps from cell expansion, fermentation, cell removal, and purification to formulation and storage of drug substances can be carried out in disposables, although there are still limitations with single-use technologies, particularly in the areas of pretesting and quality control of disposables, bag and connections standardization and qualification, extractables and leachables (E/L) validation, and dependency on individual vendors. The current status of single-use technologies is summarized for all process unit operations using a standard mAb process as an example. In addition, current pros and cons of using disposables are addressed in a comparative way, including quality control and E/L validation.The continuing progress in developing single-use technologies has an important impact on manufacturing facilities, resulting in much faster, less expensive and simpler plant design, start-up, and operation, because cell culture process steps are no longer performed in hard-piped unit operations. This leads to simpler operations in a lab-like environment. Overall it enriches the current landscape of available facilities from standard hard-piped to hard-piped/disposables hybrid to completely single-use-based production plants using the current segregation and containment concept. At the top, disposables in combination with completely and functionally closed systems facilitate a new, revolutionary design of ballroom facilities without or with much less segregation, which enables us to perform good manufacturing practice manufacturing of different products simultaneously in unclassified but controlled areas.Finally, single-use processing in lab-like shell facilities is a big enabler of transferring and establishing production in emergent countries, and this is described in more detail in 7. Graphical Abstract.

Space Manufacturing: The Next Great Challenge

NASA Technical Reports Server (NTRS)

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

1998-01-01

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

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

PubMed

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

2007-09-27

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

21 CFR 129.1 - Current good manufacturing practice.

Code of Federal Regulations, 2011 CFR

2011-04-01

... drinking water are in conformance with or are operated or administered in conformity with good manufacturing practice to assure that bottled drinking water is safe and that it has been processed, bottled...) FOOD FOR HUMAN CONSUMPTION PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER General Provisions § 129.1...

Eddy current measurement of the thickness of top Cu film of the multilayer interconnects in the integrated circuit (IC) manufacturing process

NASA Astrophysics Data System (ADS)

Qu, Zilian; Meng, Yonggang; Zhao, Qian

2015-03-01

This paper proposes a new eddy current method, named equivalent unit method (EUM), for the thickness measurement of the top copper film of multilayer interconnects in the chemical mechanical polishing (CMP) process, which is an important step in the integrated circuit (IC) manufacturing. The influence of the underneath circuit layers on the eddy current is modeled and treated as an equivalent film thickness. By subtracting this equivalent film component, the accuracy of the thickness measurement of the top copper layer with an eddy current sensor is improved and the absolute error is 3 nm for sampler measurement.

Cost analysis of advanced turbine blade manufacturing processes

NASA Technical Reports Server (NTRS)

Barth, C. F.; Blake, D. E.; Stelson, T. S.

1977-01-01

A rigorous analysis was conducted to estimate relative manufacturing costs for high technology gas turbine blades prepared by three candidate materials process systems. The manufacturing costs for the same turbine blade configuration of directionally solidified eutectic alloy, an oxide dispersion strengthened superalloy, and a fiber reinforced superalloy were compared on a relative basis to the costs of the same blade currently in production utilizing the directional solidification process. An analytical process cost model was developed to quantitatively perform the cost comparisons. The impact of individual process yield factors on costs was also assessed as well as effects of process parameters, raw materials, labor rates and consumable items.

The implementation of tissue banking experiences for setting up a cGMP cell manufacturing facility.

PubMed

Arjmand, Babak; Emami-Razavi, Seyed Hassan; Larijani, Bagher; Norouzi-Javidan, Abbas; Aghayan, Hamid Reza

2012-12-01

Cell manufacturing for clinical applications is a unique form of biologics manufacturing that relies on maintenance of stringent work practices designed to ensure product consistency and prevent contamination by microorganisms or by another patient's cells. More extensive, prolonged laboratory processes involve greater risk of complications and possibly adverse events for the recipient, and so the need for control is correspondingly greater. To minimize the associate risks of cell manufacturing adhering to international quality standards is critical. Current good tissue practice (cGTP) and current good manufacturing practice (cGMP) are examples of general standards that draw a baseline for cell manufacturing facilities. In recent years, stem cell researches have found great public interest in Iran and different cell therapy projects have been started in country. In this review we described the role of our tissue banking experiences in establishing a new cGMP cell manufacturing facility. The authors concluded that, tissue banks and tissue banking experts can broaden their roles from preparing tissue grafts to manufacturing cell and tissue engineered products for translational researches and phase I clinical trials. Also they can collaborate with cell processing laboratories to develop SOPs, implement quality management system, and design cGMP facilities.

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.

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

PubMed

2012-03-20

The Food and Drug Administration (FDA) is amending the packaging and labeling control provisions of the current good manufacturing practice (CGMP) regulations for human and veterinary drug products by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons. FDA is also permitting the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment when cut labeling is used. This action is intended to protect consumers from labeling errors more likely to cause adverse health consequences, while eliminating the regulatory burden of applying the rule to labeling unlikely to reach or adversely affect consumers. This action is also intended to permit manufacturers to use a broader range of error prevention and labeling control techniques than permitted by current CGMPs.

21 CFR 211.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... foods are manufactured, processed, packed, or held under current good manufacturing practice. [43 FR... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Scope. 211.1 Section 211.1 Food and Drugs FOOD AND... MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS General Provisions § 211.1 Scope. Link to an amendment...

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.

Progress on the Ohio State University Get Away Special G-0318: DEAP

NASA Technical Reports Server (NTRS)

Sarigul, Nesrin; Mortensen, A. J.

1987-01-01

The Get Away Special program became a major presence at the Ohio State University with the award of GAS-0318 by the American Institute of Aeronautics and Astronautics. There are some twenty engineering researchers and students currently working on the project. GAS-0318 payload is an experimental manufacturing process known as Directional Electrostatic Accretion Process (DEAP). This high precision portable microgravity manufacturing method will revolutionize the manufacture and repair of spacecraft and space structures. The cost effectiveness of this process will be invaluable to future space development and exploration.

Manufacturing Improvement Program for the Oil and Gas Industry Supply Chain and Marketing Cluster

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

Taylor, Robert

This project supported upgrades for manufacturing companies in the oil and natural gas supply chain in Oklahoma. The goal is to provide assistance that will lead to the improved efficiency advancement of the manufacturing processes currently used by the existing manufacturing clients. The basis for the work is to improve the economic environment for the clients and the communities they serve.

Space Technology Mission Directorate: Game Changing Development

NASA Technical Reports Server (NTRS)

Gaddis, Stephen W.

2015-01-01

NASA and the aerospace community have deep roots in manufacturing technology and innovation. Through it's Game Changing Development Program and the Advanced Manufacturing Technology Project NASA develops and matures innovative, low-cost manufacturing processes and products. Launch vehicle propulsion systems are a particular area of interest since they typically comprise a large percentage of the total vehicle cost and development schedule. NASA is currently working to develop and utilize emerging technologies such as additive manufacturing (i.e. 3D printing) and computational materials and processing tools that could dramatically improve affordability, capability, and reduce schedule for rocket propulsion hardware.

Friction Stir Welding: Standards and Specifications in Today's U.S. Manufacturing and Fabrication

NASA Technical Reports Server (NTRS)

Ding, Robert Jeffrey

2008-01-01

New welding and technology advancements are reflected in the friction stir welding (FSW) specifications used in the manufacturing sector. A lack of publicly available specifications as one of the reasons that the FSW process has not propagate through the manufacturing sectors. FSW specifications are an integral supporting document to the legal agreement written between two entities for deliverable items. Understanding the process and supporting specifications is essential for a successful FSW manufacturing operation. This viewgraph presentation provides an overview of current FSW standards in the industry and discusses elements common to weld specifications.

Optimization Manufacture of Virus- and Tumor-Specific T Cells

PubMed Central

Lapteva, Natalia; Vera, Juan F.

2011-01-01

Although ex vivo expanded T cells are currently widely used in pre-clinical and clinical trials, the complexity of manufacture remains a major impediment for broader application. In this review we discuss current protocols for the ex vivo expansion of virus- and tumor-specific T cells and describe our experience in manufacture optimization using a gas-permeable static culture flask (G-Rex). This innovative device has revolutionized the manufacture process by allowing us to increase cell yields while decreasing the frequency of cell manipulation and in vitro culture time. It is now being used in good manufacturing practice (GMP) facilities for clinical cell production in our institution as well as many others in the US and worldwide. PMID:21915183

Additive Manufacturing: A Novel Method for Fabricating Cobalt-Chromium Removable Partial Denture Frameworks.

PubMed

Alifui-Segbaya, Frank; Williams, Robert John; George, Roy

2017-06-01

Additive manufacturing (AM) often referred to as 3D printing (3DP) has shown promise of being significantly viable in the construction of cobalt-chromium removable partial denture (RPD) frameworks. The current paper seeks to discuss AM technologies (photopolymerization processes and selective laser melting) and review their scope. The review also discusses the clinical relevance of cobalt-chromium RPD frameworks. All relevant publications in English over the last 10 years, when the first 3D-printed RPD framework was reported, are examined. The review notes that AM offers significant benefits in terms of speed of the manufacturing processes however cost and other aspects of current technologies remain a hindrance. Copyright© 2017 Dennis Barber Ltd.

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.

Computational manufacturing as a bridge between design and production.

PubMed

Tikhonravov, Alexander V; Trubetskov, Michael K

2005-11-10

Computational manufacturing of optical coatings is a research area that can be placed between theoretical designing and practical manufacturing in the same way that computational physics can be placed between theoretical and experimental physics. Investigations in this area have been performed for more than 30 years under the name of computer simulation of manufacturing and monitoring processes. Our goal is to attract attention to the increasing importance of computational manufacturing at the current state of the art in the design and manufacture of optical coatings and to demonstrate possible applications of this research tool.

Computational manufacturing as a bridge between design and production

NASA Astrophysics Data System (ADS)

Tikhonravov, Alexander V.; Trubetskov, Michael K.

2005-11-01

Computational manufacturing of optical coatings is a research area that can be placed between theoretical designing and practical manufacturing in the same way that computational physics can be placed between theoretical and experimental physics. Investigations in this area have been performed for more than 30 years under the name of computer simulation of manufacturing and monitoring processes. Our goal is to attract attention to the increasing importance of computational manufacturing at the current state of the art in the design and manufacture of optical coatings and to demonstrate possible applications of this research tool.

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

PubMed

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

2007-10-31

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

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

NASA Technical Reports Server (NTRS)

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

1994-01-01

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

Laser Additive Manufacturing of Magnetic Materials

NASA Astrophysics Data System (ADS)

Mikler, C. V.; Chaudhary, V.; Borkar, T.; Soni, V.; Jaeger, D.; Chen, X.; Contieri, R.; Ramanujan, R. V.; Banerjee, R.

2017-03-01

While laser additive manufacturing is becoming increasingly important in the context of next-generation manufacturing technologies, most current research efforts focus on optimizing process parameters for the processing of mature alloys for structural applications (primarily stainless steels, titanium base, and nickel base alloys) from pre-alloyed powder feedstocks to achieve properties superior to conventionally processed counterparts. However, laser additive manufacturing or processing can also be applied to functional materials. This article focuses on the use of directed energy deposition-based additive manufacturing technologies, such as the laser engineered net shaping (LENS™) process, to deposit magnetic alloys. Three case studies are presented: Fe-30 at.%Ni, permalloys of the type Ni-Fe-V and Ni-Fe-Mo, and Fe-Si-B-Cu-Nb (derived from Finemet) alloys. All these alloys have been processed from a blend of elemental powders used as the feedstock, and their resultant microstructures, phase formation, and magnetic properties are discussed in this paper. Although these alloys were produced from a blend of elemental powders, they exhibited relatively uniform microstructures and comparable magnetic properties to those of their conventionally processed counterparts.

Materials processing in space - A strategy for commercialization

NASA Technical Reports Server (NTRS)

Naumann, R. J.

1978-01-01

Major aerospace companies are talking about space factories manufacturing billions of dollars worth of high technology materials per year. On the other hand, a recent National Academy of Sciences study team saw little prospect for space manufacturing because, in their opinion, most of the disturbing effects of gravity in the processes they considered could be overcome on the ground for much less expenditure. This paper presents a current assessment of the problems and promises of the Materials Processing in Space Program and outlines a strategy for developing the first products of commercial value. These early products are expected to serve as paradigms of what can be accomplished by manufacturing in space and should stimulate industry to develop space manufacturing to whatever degree is economically justifiable.

Adaptive Multi-scale PHM for Robotic Assembly Processes

PubMed Central

Choo, Benjamin Y.; Beling, Peter A.; LaViers, Amy E.; Marvel, Jeremy A.; Weiss, Brian A.

2017-01-01

Adaptive multiscale prognostics and health management (AM-PHM) is a methodology designed to support PHM in smart manufacturing systems. As a rule, PHM information is not used in high-level decision-making in manufacturing systems. AM-PHM leverages and integrates component-level PHM information with hierarchical relationships across the component, machine, work cell, and production line levels in a manufacturing system. The AM-PHM methodology enables the creation of actionable prognostic and diagnostic intelligence up and down the manufacturing process hierarchy. Decisions are made with the knowledge of the current and projected health state of the system at decision points along the nodes of the hierarchical structure. A description of the AM-PHM methodology with a simulated canonical robotic assembly process is presented. PMID:28664161

40 CFR 52.777 - Control strategy: photochemical oxidants (hydrocarbons).

Code of Federal Regulations, 2013 CFR

2013-07-01

... lithography operations, business plastics, automotive plastics, and synthetic organic chemical manufacturing..., automotive plastics, and synthetic organic chemical manufacturing industries (SOCMI) batch processes... Michigan area, and an agreed order between U.S. Steel (currently USX Corporation) and the IDEM signed by...

40 CFR 52.777 - Control strategy: photochemical oxidants (hydrocarbons).

Code of Federal Regulations, 2012 CFR

2012-07-01

... lithography operations, business plastics, automotive plastics, and synthetic organic chemical manufacturing..., automotive plastics, and synthetic organic chemical manufacturing industries (SOCMI) batch processes... Michigan area, and an agreed order between U.S. Steel (currently USX Corporation) and the IDEM signed by...

Toward Higher QA: From Parametric Release of Sterile Parenteral Products to PAT for Other Pharmaceutical Dosage Forms.

PubMed

Hock, Sia Chong; Constance, Neo Xue Rui; Wah, Chan Lai

2012-01-01

Pharmaceutical products are generally subjected to end-product batch testing as a means of quality control. Due to the inherent limitations of conventional batch testing, this is not the most ideal approach for determining the pharmaceutical quality of the finished dosage form. In the case of terminally sterilized parenteral products, the limitations of conventional batch testing have been successfully addressed with the application of parametric release (the release of a product based on control of process parameters instead of batch sterility testing at the end of the manufacturing process). Consequently, there has been an increasing interest in applying parametric release to other pharmaceutical dosage forms, beyond terminally sterilized parenteral products. For parametric release to be possible, manufacturers must be capable of designing quality into the product, monitoring the manufacturing processes, and controlling the quality of intermediates and finished products in real-time. Process analytical technology (PAT) has been thought to be capable of contributing to these prerequisites. It is believed that the appropriate use of PAT tools can eventually lead to the possibility of real-time release of other pharmaceutical dosage forms, by-passing the need for end-product batch testing. Hence, this literature review attempts to present the basic principles of PAT, introduce the various PAT tools that are currently available, present their recent applications to pharmaceutical processing, and explain the potential benefits that PAT can bring to conventional ways of processing and quality assurance of pharmaceutical products. Last but not least, current regulations governing the use of PAT and the manufacturing challenges associated with PAT implementation are also discussed. Pharmaceutical products are generally subjected to end-product batch testing as a means of quality control. Due to the inherent limitations of conventional batch testing, this is not the most ideal approach. In the case of terminally sterilized parenteral products, these limitations have been successfully addressed with the application of parametric release (the release of a product based on control of process parameters instead of batch sterility testing at the end of the manufacturing process). Consequently, there has been an increasing interest in applying parametric release to other pharmaceutical dosage forms. With the advancement of process analytical technology (PAT), it is possible to monitor the manufacturing processes closely. This will eventually enable quality control of the intermediates and finished products, and thus their release in real-time. Hence, this literature review attempts to present the basic principles of PAT, introduce the various PAT tools that are currently available, present their recent applications to pharmaceutical processing, and explain the potential benefits that PAT can bring to conventional ways of processing and quality assurance of pharmaceutical products. It will also discuss the current regulations governing the use of PAT and the manufacturing challenges associated with the implementation of PAT.

A comparison of BPMN 2.0 with other notations for manufacturing processes

NASA Astrophysics Data System (ADS)

García-Domínguez, A.; Marcos, Mariano; Medina, I.

2012-04-01

In order to study their current practices and improve on them, manufacturing firms need to view their processes from several viewpoints at various abstraction levels. Several notations have been developed for this purpose, such as Value Stream Mappings or IDEF models. More recently, the BPMN 2.0 standard from the Object Management Group has been proposed for modeling business processes. A process organizes several activities (manual or automatic) into a single higher-level entity, which can be reused elsewhere in the organization. Its potential for standardizing business interactions is well-known, but there is little work on using BPMN 2.0 to model manufacturing processes. In this work some of the previous notations are outlined and BPMN 2.0 is positioned among them after discussing it in more depth. Some guidelines on using BPMN 2.0 for manufacturing are offered, and its advantages and disadvantages in comparison with the other notations are presented.

Advanced Manufacturing Systems in Food Processing and Packaging Industry

NASA Astrophysics Data System (ADS)

Shafie Sani, Mohd; Aziz, Faieza Abdul

2013-06-01

In this paper, several advanced manufacturing systems in food processing and packaging industry are reviewed, including: biodegradable smart packaging and Nano composites, advanced automation control system consists of fieldbus technology, distributed control system and food safety inspection features. The main purpose of current technology in food processing and packaging industry is discussed due to major concern on efficiency of the plant process, productivity, quality, as well as safety. These application were chosen because they are robust, flexible, reconfigurable, preserve the quality of the food, and efficient.

Conventional and Innovative Processing of Milk for Yogurt Manufacture; Development of Texture and Flavor: A Review.

PubMed

Sfakianakis, Panagiotis; Tzia, Constatnina

2014-03-11

Milk and yogurt are important elements of the human diet, due to their high nutritional value and their appealing sensory properties. During milk processing (homogenization, pasteurization) and further yogurt manufacture (fermentation) physicochemical changes occur that affect the flavor and texture of these products while the development of standardized processes contributes to the development of desirable textural and flavor characteristics. The processes that take place during milk processing and yogurt manufacture with conventional industrial methods, as well as with innovative methods currently proposed (ultra-high pressure, ultrasound, microfluidization, pulsed electric fields), and their effect on the texture and flavor of the final conventional or probiotic/prebiotic products will be presented in this review.

Conventional and Innovative Processing of Milk for Yogurt Manufacture; Development of Texture and Flavor: A Review

PubMed Central

Sfakianakis, Panagiotis; Tzia, Constatnina

2014-01-01

Milk and yogurt are important elements of the human diet, due to their high nutritional value and their appealing sensory properties. During milk processing (homogenization, pasteurization) and further yogurt manufacture (fermentation) physicochemical changes occur that affect the flavor and texture of these products while the development of standardized processes contributes to the development of desirable textural and flavor characteristics. The processes that take place during milk processing and yogurt manufacture with conventional industrial methods, as well as with innovative methods currently proposed (ultra-high pressure, ultrasound, microfluidization, pulsed electric fields), and their effect on the texture and flavor of the final conventional or probiotic/prebiotic products will be presented in this review. PMID:28234312

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.

Advantages of utilizing DMD based rapid manufacturing systems in mass customization applications

NASA Astrophysics Data System (ADS)

El-Siblani, A.

2010-02-01

The Use of DMD based Rapid Manufacturing Systems has proven to be very advantageous in the production of highly accurate plastic based components for use in mass customization market such as hearing aids, and dental markets. The voxelization process currently afforded with the DLP technology eliminates any layering effect associated with all existing additive Rapid Manufacturing technologies. The smooth accurate surfaces produced in an additive process utilizing DLP technology, through the voxelization approach, allow for the production of custom finished products. The implementation of DLP technology in rapid prototyping and rapid manufacturing systems allow for the usage of highly viscous photopolymer based liquid and paste composites for rapid manufacturing that could not be used in any other additive process prior to implementation of DLP technology in RP and RM systems. It also allowed for the greater throughput in production without sacrificing quality and accuracy.

A Single-use Strategy to Enable Manufacturing of Affordable Biologics.

PubMed

Jacquemart, Renaud; Vandersluis, Melissa; Zhao, Mochao; Sukhija, Karan; Sidhu, Navneet; Stout, Jim

2016-01-01

The current processing paradigm of large manufacturing facilities dedicated to single product production is no longer an effective approach for best manufacturing practices. Increasing competition for new indications and the launch of biosimilars for the monoclonal antibody market have put pressure on manufacturers to produce at lower cost. Single-use technologies and continuous upstream processes have proven to be cost-efficient options to increase biomass production but as of today the adoption has been only minimal for the purification operations, partly due to concerns related to cost and scale-up. This review summarizes how a single-use holistic process and facility strategy can overcome scale limitations and enable cost-efficient manufacturing to support the growing demand for affordable biologics. Technologies enabling high productivity, right-sized, small footprint, continuous, and automated upstream and downstream operations are evaluated in order to propose a concept for the flexible facility of the future.

Perfusion mammalian cell culture for recombinant protein manufacturing - A critical review.

PubMed

Bielser, Jean-Marc; Wolf, Moritz; Souquet, Jonathan; Broly, Hervé; Morbidelli, Massimo

The manufacturing of recombinant protein is traditionally divided in two main steps: upstream (cell culture and synthesis of the target protein) and downstream (purification and formulation of the protein into a drug substance or drug product). Today, cost pressure, market uncertainty and market growth, challenge the existing manufacturing technologies. Leaders in the field are active in designing the process of the future and continuous manufacturing is recurrently mentioned as a potential solution to address some of the current limitations. This review focuses on the application of continuous processing to the first step of the manufacturing process. Enabling technologies and operation modes are described in the first part. In the second part, recent advances in the field that have the potential to support its successful future development are critically discussed. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

21 CFR 226.30 - Equipment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Construction and Maintenance of Facilities and Equipment § 226.30 Equipment. Equipment used for the manufacture, processing, packaging, bulk... maintained in a clean and orderly manner and shall be of suitable design, size, construction, and location to...

Mycelium reinforced agricultural fiber bio-composites: Summary of research

USDA-ARS?s Scientific Manuscript database

Industry and the public sector have a growing interest in utilizing natural fibers, such as agricultural substrates, in the manufacture of components and products currently manufactured from fossil fuels. A patented process, developed by Ecovative Design, LLC (Ecovative), for growing fungal species ...

Cost model relationships between textile manufacturing processes and design details for transport fuselage elements

NASA Technical Reports Server (NTRS)

Metschan, Stephen L.; Wilden, Kurtis S.; Sharpless, Garrett C.; Andelman, Rich M.

1993-01-01

Textile manufacturing processes offer potential cost and weight advantages over traditional composite materials and processes for transport fuselage elements. In the current study, design cost modeling relationships between textile processes and element design details were developed. Such relationships are expected to help future aircraft designers to make timely decisions on the effect of design details and overall configurations on textile fabrication costs. The fundamental advantage of a design cost model is to insure that the element design is cost effective for the intended process. Trade studies on the effects of processing parameters also help to optimize the manufacturing steps for a particular structural element. Two methods of analyzing design detail/process cost relationships developed for the design cost model were pursued in the current study. The first makes use of existing databases and alternative cost modeling methods (e.g. detailed estimating). The second compares design cost model predictions with data collected during the fabrication of seven foot circumferential frames for ATCAS crown test panels. The process used in this case involves 2D dry braiding and resin transfer molding of curved 'J' cross section frame members having design details characteristic of the baseline ATCAS crown design.

Achieving continuous manufacturing for final dosage formation: challenges and how to meet them. May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Byrn, Stephen; Futran, Maricio; Thomas, Hayden; Jayjock, Eric; Maron, Nicola; Meyer, Robert F; Myerson, Allan S; Thien, Michael P; Trout, Bernhardt L

2015-03-01

We describe the key issues and possibilities for continuous final dosage formation, otherwise known as downstream processing or drug product manufacturing. A distinction is made between heterogeneous processing and homogeneous processing, the latter of which is expected to add more value to continuous manufacturing. We also give the key motivations for moving to continuous manufacturing, some of the exciting new technologies, and the barriers to implementation of continuous manufacturing. Continuous processing of heterogeneous blends is the natural first step in converting existing batch processes to continuous. In heterogeneous processing, there are discrete particles that can segregate, versus in homogeneous processing, components are blended and homogenized such that they do not segregate. Heterogeneous processing can incorporate technologies that are closer to existing technologies, where homogeneous processing necessitates the development and incorporation of new technologies. Homogeneous processing has the greatest potential for reaping the full rewards of continuous manufacturing, but it takes long-term vision and a more significant change in process development than heterogeneous processing. Heterogeneous processing has the detriment that, as the technologies are adopted rather than developed, there is a strong tendency to incorporate correction steps, what we call below "The Rube Goldberg Problem." Thus, although heterogeneous processing will likely play a major role in the near-term transformation of heterogeneous to continuous processing, it is expected that homogeneous processing is the next step that will follow. Specific action items for industry leaders are: Form precompetitive partnerships, including industry (pharmaceutical companies and equipment manufacturers), government, and universities. These precompetitive partnerships would develop case studies of continuous manufacturing and ideally perform joint-technology development, including development of small-scale equipment and processes. Develop ways to invest internally in continuous manufacturing. How best to do this will depend on the specifics of a given organization, in particular the current development projects. Upper managers will need to energize their process developers to incorporate continuous manufacturing in at least part of their processes to gain experience and demonstrate directly the benefits. Training of continuous manufacturing technologies, organizational approaches, and regulatory approaches is a key area that industrial leaders should pursue together. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

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

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

Guest, Daniel A.; Cairns, Douglas S.

2014-02-01

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

Laser 3D micro-manufacturing

NASA Astrophysics Data System (ADS)

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

2016-06-01

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

Applying Value Stream Mapping Technique for Production Improvement in a Manufacturing Company: A Case Study

NASA Astrophysics Data System (ADS)

Jeyaraj, K. L.; Muralidharan, C.; Mahalingam, R.; Deshmukh, S. G.

2013-01-01

The purpose of this paper is to explain how value stream mapping (VSM) is helpful in lean implementation and to develop the road map to tackle improvement areas to bridge the gap between the existing state and the proposed state of a manufacturing firm. Through this case study, the existing stage of manufacturing is mapped with the help of VSM process symbols and the biggest improvement areas like excessive TAKT time, production, and lead time are identified. Some modifications in current state map are suggested and with these modifications future state map is prepared. Further TAKT time is calculated to set the pace of production processes. This paper compares the current state and future state of a manufacturing firm and witnessed 20 % reduction in TAKT time, 22.5 % reduction in processing time, 4.8 % reduction in lead time, 20 % improvement in production, 9 % improvement in machine utilization, 7 % improvement in man power utilization, objective improvement in workers skill level, and no change in the product and semi finished product inventory level. The findings are limited due to the focused nature of the case study. This case study shows that VSM is a powerful tool for lean implementation and allows the industry to understand and continuously improve towards lean manufacturing.

Consistent and efficient processing of ADCP streamflow measurements

USGS Publications Warehouse

Mueller, David S.; Constantinescu, George; Garcia, Marcelo H.; Hanes, Dan

2016-01-01

The use of Acoustic Doppler Current Profilers (ADCPs) from a moving boat is a commonly used method for measuring streamflow. Currently, the algorithms used to compute the average depth, compute edge discharge, identify invalid data, and estimate velocity and discharge for invalid data vary among manufacturers. These differences could result in different discharges being computed from identical data. Consistent computational algorithm, automated filtering, and quality assessment of ADCP streamflow measurements that are independent of the ADCP manufacturer are being developed in a software program that can process ADCP moving-boat discharge measurements independent of the ADCP used to collect the data.

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.

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.

21 CFR 211.68 - Automatic, mechanical, and electronic equipment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS... satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such... designed to assure proper performance. Written records of those calibration checks and inspections shall be...

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.

The development of additive manufacturing technique for nickel-base alloys: A review

NASA Astrophysics Data System (ADS)

Zadi-Maad, Ahmad; Basuki, Arif

2018-04-01

Nickel-base alloys are an attractive alloy due to its excellent mechanical properties, a high resistance to creep deformation, corrosion, and oxidation. However, it is a hard task to control performance when casting or forging for this material. In recent years, additive manufacturing (AM) process has been implemented to replace the conventional directional solidification process for the production of nickel-base alloys. Due to its potentially lower cost and flexibility manufacturing process, AM is considered as a substitute technique for the existing. This paper provides a comprehensive review of the previous work related to the AM techniques for Ni-base alloys while highlighting current challenges and methods to solving them. The properties of conventionally manufactured Ni-base alloys are also compared with the AM fabricated alloys. The mechanical properties obtained from tension, hardness and fatigue test are included, along with discussions of the effect of post-treatment process. Recommendations for further work are also provided.

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

Integrating Materials, Manufacturing, Design and Validation for Sustainability in Future Transport Systems

NASA Astrophysics Data System (ADS)

Price, M. A.; Murphy, A.; Butterfield, J.; McCool, R.; Fleck, R.

2011-05-01

The predictive methods currently used for material specification, component design and the development of manufacturing processes, need to evolve beyond the current `metal centric' state of the art, if advanced composites are to realise their potential in delivering sustainable transport solutions. There are however, significant technical challenges associated with this process. Deteriorating environmental, political, economic and social conditions across the globe have resulted in unprecedented pressures to improve the operational efficiency of the manufacturing sector generally and to change perceptions regarding the environmental credentials of transport systems in particular. There is a need to apply new technologies and develop new capabilities to ensure commercial sustainability in the face of twenty first century economic and climatic conditions as well as transport market demands. A major technology gap exists between design, analysis and manufacturing processes in both the OEMs, and the smaller companies that make up the SME based supply chain. As regulatory requirements align with environmental needs, manufacturers are increasingly responsible for the broader lifecycle aspects of vehicle performance. These include not only manufacture and supply but disposal and re-use or re-cycling. In order to make advances in the reduction of emissions coupled with improved economic efficiency through the provision of advanced lightweight vehicles, four key challenges are identified as follows: Material systems, Manufacturing systems, Integrated design methods using digital manufacturing tools and Validation systems. This paper presents a project which has been designed to address these four key issues, using at its core, a digital framework for the creation and management of key parameters related to the lifecycle performance of thermoplastic composite parts and structures. It aims to provide capability for the proposition, definition, evaluation and demonstration of advanced lightweight structures for new generation vehicles in the context of whole life performance parameters.

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

NASA Astrophysics Data System (ADS)

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

2000-07-01

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

21 CFR 211.105 - Equipment identification.

Code of Federal Regulations, 2010 CFR

2010-04-01

...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls... all times to indicate their contents and, when necessary, the phase of processing of the batch. (b...

21 CFR 211.105 - Equipment identification.

Code of Federal Regulations, 2011 CFR

2011-04-01

...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls... all times to indicate their contents and, when necessary, the phase of processing of the batch. (b...

Manufacturing Superconducting Cables

NASA Technical Reports Server (NTRS)

England, Christopher

1996-01-01

Process proposed for manufacture of cables containing ceramic high-temperature-superconductor YBa(2)Cu(3)O(7-a). For protection, superconducting ceramic encapsulated before activation. Cables carry electrical current with little or no loss of power when cooled to or below temperatures of about minus 200 degrees C. Process accommodates brittle nature of YBa(2)Cu(3)O(7-a) and economical and readily controllable. Also flexible in sense modified to accommodate variety of precursor materials to be processed into YBa(2)Cu(3)O(7-a).

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

Jared, Bradley H.; Aguilo, Miguel A.; Beghini, Lauren L.

Here, additive manufacturing offers unprecedented opportunities to design complex structures optimized for performance envelopes inaccessible under conventional manufacturing constraints. Additive processes also promote realization of engineered materials with microstructures and properties that are impossible via traditional synthesis techniques. Enthused by these capabilities, optimization design tools have experienced a recent revival. The current capabilities of additive processes and optimization tools are summarized briefly, while an emerging opportunity is discussed to achieve a holistic design paradigm whereby computational tools are integrated with stochastic process and material awareness to enable the concurrent optimization of design topologies, material constructs and fabrication processes.

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

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

Sabine Brueske, Caroline Kramer, Aaron Fisher

2015-06-01

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

Evaluation of Aqueous and Powder Processing Techniques for Production of Pu-238-Fueled General Purpose Heat Sources

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

Not Available

2008-06-01

This report evaluates alternative processes that could be used to produce Pu-238 fueled General Purpose Heat Sources (GPHS) for radioisotope thermoelectric generators (RTG). Fabricating GPHSs with the current process has remained essentially unchanged since its development in the 1970s. Meanwhile, 30 years of technological advancements have been made in the fields of chemistry, manufacturing, ceramics, and control systems. At the Department of Energy’s request, alternate manufacturing methods were compared to current methods to determine if alternative fabrication processes could reduce the hazards, especially the production of respirable fines, while producing an equivalent GPHS product. An expert committee performed the evaluationmore » with input from four national laboratories experienced in Pu-238 handling.« less

Overview of several applications of chemical downstream etching (CDE) for IC manufacturing: advantages and drawbacks versus WET processes

NASA Astrophysics Data System (ADS)

de Buttet, Côme; Prevost, Emilie; Campo, Alain; Garnier, Philippe; Zoll, Stephane; Vallier, Laurent; Cunge, Gilles; Maury, Patrick; Massin, Thomas; Chhun, Sonarith

2017-03-01

Today the IC manufacturing faces lots of problematics linked to the continuous down scaling of printed structures. Some of those issues are related to wet processing, which are often used in the IC manufacturing flow for wafer cleaning, material etching and surface preparation. In the current work we summarize the limitations for the next nodes of wet processing such as metallic contaminations, wafer charging, corrosion and pattern collapse. As a replacement, we promoted the isotropic chemical dry etching (CDE) which is supposed to fix all the above drawbacks. Etching steps of SI3N4 layers were evaluated in order to prove the interest of such technique.

Additive manufacturing for steels: a review

NASA Astrophysics Data System (ADS)

Zadi-Maad, A.; Rohib, R.; Irawan, A.

2018-01-01

Additive manufacturing (AM) of steels involves the layer by layer consolidation of powder or wire feedstock using a heating beam to form near net shape products. For the past decades, the AM technique reaches the maturation of both research grade and commercial production due to significant research work from academic, government and industrial research organization worldwide. AM process has been implemented to replace the conventional process of steel fabrication due to its potentially lower cost and flexibility manufacturing. This paper provides a review of previous research related to the AM methods followed by current challenges issues. The relationship between microstructure, mechanical properties, and process parameters will be discussed. Future trends and recommendation for further works are also provided.

Gin saw wear test

USDA-ARS?s Scientific Manuscript database

Most current gin saw manufacturers use a 1074 steel or similar as a basis to manufacture their saw blades. The saw teeth are individually punched on the edges of the blades and then the blade goes through a heat treating process prior to use. There are indications from other industries with similar ...

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

NASA Astrophysics Data System (ADS)

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

2018-06-01

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

Additive Manufacturing of Porous Metal

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

Dehoff, Ryan R.; Kirka, Michael M.

2017-06-01

Currently, helium is obtained through separation from natural gas. The current industrial process incurs significant costs and requires large energy resources to successfully achieve separation. Through utilizing Additive Manufacturing (AM) technologies it is possible to reduce both of these burdens when refining helium gas. The ability to engineer porosity levels within Inconel 718 discs for controlled separation of helium from natural gas was investigated. Arrays of samples fabricated using the electron beam melting process were analyzed for their relative porosity density. Based upon the measurements, full scale discs were fabricated, and subsequently tested to determine their effectiveness in separating heliummore » from liquefied natural gas.« less

Rapid Solidification and Phase Transformations in Additive Manufactured Materials

DOE PAGES

Asle Zaeem, Mohsen; Clarke, Amy Jean

2016-01-14

Within the past few years, additive manufacturing (AM) has emerged as a promising manufacturing technique to enable the production of complex engineering structures with high efficiency and accuracy. Among the important factors establishing AM as a sustainable manufacturing process is the ability to control the microstructures and properties of AM products. In most AM processes, such as laser sintering (LS), laser melting (LM), and laser metal deposition (LMD), rapid solidification and high-temperature phase transformations play primary roles in determining nano- and microstructures, and consequently the mechanical and other properties of AM products. This topic of JOM is dedicated to summarizingmore » the current research efforts in the area of rapid solidification and phase transformations in additively manufactured materials. Finally, a brief summary follows below of 10 journal articles in this topic.« less

Green perspective in food industry production line design: A review

NASA Astrophysics Data System (ADS)

Xian, C. Y.; Sin, T. C.; Liyana, M. R. N.; Awang, A.; Fathullah, M.

2017-09-01

The design of green manufacturing process in food industries is currently a hot research topic in the multidisciplinary area of applied chemistry, biology and technology. Several process such as freezing, cutting, drying, tempering, bleaching, sterilization, extraction and filtering have been applied efficiency in the food industry. Due to the rapid development of food and peripheral technology, the use of new physical processing or auxiliary processing methods can maintain food inherent nutrients, texture, color, and freshness and also reduce environmental pollution and energy consumption in food processing. Hence, this review paper will study and summarize the effects of green manufacturing process in food industries in term of waste reduction, materials and sustainability manufacturing. In any case, All the food processing equipment must comply with strict standards and regulation, this action will ensure the securing the food quality and safety of food products to consumers.

Advanced Thermoplastic Polymers and Additive Manufacturing Applied to ISS Columbus Toolbox: Lessons Learnt and Results

NASA Astrophysics Data System (ADS)

Ferrino, Marinella; Secondo, Ottaviano; Sabbagh, Amir; Della Sala, Emilio

2014-06-01

In the frame of the International Space Station (ISS) Exploitation Program a new toolbox has been realized by TAS-I to accommodate the tools currently in use on the ISS Columbus Module utilizing full-scale prototypes obtained with 3D rapid prototyping. The manufacturing of the flight hardware by means of advanced thermoplastic polymer UL TEM 9085 and additive manufacturing Fused Deposition Modelling (FDM) technology represent innovative elements. In this paper, the results achieved and the lessons learned are analyzed to promote future technology know-how. The acquired experience confirmed that the additive manufacturing process allows to save time/cost and to realize new shapes/features to introduce innovation in products and future design processes for space applications.

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.

Evaluation of Hand Lay-Up and Resin Transfer Molding in Composite Wind Turbine Blade Manufacturing

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

CAIRNS,DOUGLAS S.; SHRAMSTAD,JON D.

2000-06-01

The majority of the wind turbine blade industry currently uses low cost hand lay-up manufacturing techniques to process composite blades. While there are benefits to the hand lay-up process, drawbacks inherent to this process along with advantages of other techniques suggest that better manufacturing alternatives may be available. Resin Transfer Molding (RTM) was identified as a processing alternative and shows promise in addressing the shortcomings of hand lay-up. This report details a comparison of the RTM process to hand lay-up of composite wind turbine blade structures. Several lay-up schedules and critical turbine blade structures were chosen for comparison of theirmore » properties resulting from RTM and hand lay-up processing. The geometries investigated were flat plate, thin and thick flanged T-stiffener, I-beam, and root connection joint. It was found that the manufacturing process played an important role in laminate thickness, fiber volume, and weight for the geometries investigated. RTM was found to reduce thickness and weight and increase fiber volumes for all substructures. RTM resulted in tighter material transition radii and eliminated the need for most secondary bonding operations. These results would significantly reduce the weight of wind turbine blades. Hand lay-up was consistently slower in fabrication times for the structures investigated. A comparison of mechanical properties showed no significant differences after employing fiber volume normalization techniques to account for geometry differences resulting from varying fiber volumes. The current root specimen design does not show significant mechanical property differences according to process and exceeds all static and fatigue requirements.« less

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.

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.

Lubricant base oil and wax processing. [Glossary included

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

Sequeira, A. Jr.

1994-01-01

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

Testing the Digital Thread in Support of Model-Based Manufacturing and Inspection

PubMed Central

Hedberg, Thomas; Lubell, Joshua; Fischer, Lyle; Maggiano, Larry; Feeney, Allison Barnard

2016-01-01

A number of manufacturing companies have reported anecdotal evidence describing the benefits of Model-Based Enterprise (MBE). Based on this evidence, major players in industry have embraced a vision to deploy MBE. In our view, the best chance of realizing this vision is the creation of a single “digital thread.” Under MBE, there exists a Model-Based Definition (MBD), created by the Engineering function, that downstream functions reuse to complete Model-Based Manufacturing and Model-Based Inspection activities. The ensemble of data that enables the combination of model-based definition, manufacturing, and inspection defines this digital thread. Such a digital thread would enable real-time design and analysis, collaborative process-flow development, automated artifact creation, and full-process traceability in a seamless real-time collaborative development among project participants. This paper documents the strengths and weaknesses in the current, industry strategies for implementing MBE. It also identifies gaps in the transition and/or exchange of data between various manufacturing processes. Lastly, this paper presents measured results from a study of model-based processes compared to drawing-based processes and provides evidence to support the anecdotal evidence and vision made by industry. PMID:27325911

Application of Fourier transform near-infrared spectroscopy to optimization of green tea steaming process conditions.

PubMed

Ono, Daiki; Bamba, Takeshi; Oku, Yuichi; Yonetani, Tsutomu; Fukusaki, Eiichiro

2011-09-01

In this study, we constructed prediction models by metabolic fingerprinting of fresh green tea leaves using Fourier transform near-infrared (FT-NIR) spectroscopy and partial least squares (PLS) regression analysis to objectively optimize of the steaming process conditions in green tea manufacture. The steaming process is the most important step for manufacturing high quality green tea products. However, the parameter setting of the steamer is currently determined subjectively by the manufacturer. Therefore, a simple and robust system that can be used to objectively set the steaming process parameters is necessary. We focused on FT-NIR spectroscopy because of its simple operation, quick measurement, and low running costs. After removal of noise in the spectral data by principal component analysis (PCA), PLS regression analysis was performed using spectral information as independent variables, and the steaming parameters set by experienced manufacturers as dependent variables. The prediction models were successfully constructed with satisfactory accuracy. Moreover, the results of the demonstrated experiment suggested that the green tea steaming process parameters could be predicted on a larger manufacturing scale. This technique will contribute to improvement of the quality and productivity of green tea because it can objectively optimize the complicated green tea steaming process and will be suitable for practical use in green tea manufacture. Copyright © 2011 The Society for Biotechnology, Japan. Published by Elsevier B.V. All rights reserved.

Case study of lean manufacturing application in a die casting manufacturing company

NASA Astrophysics Data System (ADS)

Ching, Ng Tan; Hoe, Clarence Chan Kok; Hong, Tang Sai; Ghobakhloo, Morteza; Pin, Chen Kah

2015-05-01

The case study of lean manufacturing aims to study the application of lean manufacturing in a die casting manufacturing company located in Pulau Penang, Malaysia. This case study describes mainly about the important concepts and applications of lean manufacturing which could gradually help the company in increasing the profit by studying and analyzing their current manufacturing process and company culture. Many approaches of lean manufacturing are studied in this project which includes: 5S housekeeping, Kaizen, and Takt Time. Besides, the lean tools mentioned, quality tool such as the House of Quality is being used as an analysis tool to continuously improve the product quality. In short, the existing lean culture in the company is studied and analyzed, with recommendations written at the end of this paper.

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.

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

PubMed

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

2017-01-01

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

Process Control and Development for Ultrasonic Additive Manufacturing with Embedded Fibers

NASA Astrophysics Data System (ADS)

Hehr, Adam J.

Ultrasonic additive manufacturing (UAM) is a recent additive manufacturing technology which combines ultrasonic metal welding, CNC machining, and mechanized foil layering to create large gapless near net-shape metallic parts. The process has been attracting much attention lately due to its low formation temperature, the capability to join dissimilar metals, and the ability to create complex design features not possible with traditional subtractive processes alone. These process attributes enable light-weighting of structures and components in an unprecedented way. However, UAM is currently limited to niche areas due to the lack of quality tracking and inadequate scientific understanding of the process. As a result, this thesis work is focused on improving both component quality tracking and process understanding through the use of average electrical power input to the welder. Additionally, the understanding and application space of embedding fibers into metals using UAM is investigated, with particular focus on NiTi shape memory alloy fibers.

40 CFR 720.45 - Information that must be included in the notice form.

Code of Federal Regulations, 2013 CFR

2013-07-01

... relating to the manufacture, processing, distribution in commerce, use, and disposal of the new chemical substance: (a)(1) The specific chemical identity of the substance that the person intends to manufacture or import, which includes the following: (i) The currently correct Chemical Abstracts (CA) name for the...

40 CFR 720.45 - Information that must be included in the notice form.

Code of Federal Regulations, 2014 CFR

2014-07-01

... relating to the manufacture, processing, distribution in commerce, use, and disposal of the new chemical substance: (a)(1) The specific chemical identity of the substance that the person intends to manufacture or import, which includes the following: (i) The currently correct Chemical Abstracts (CA) name for the...

40 CFR 720.45 - Information that must be included in the notice form.

Code of Federal Regulations, 2012 CFR

2012-07-01

... relating to the manufacture, processing, distribution in commerce, use, and disposal of the new chemical substance: (a)(1) The specific chemical identity of the substance that the person intends to manufacture or import, which includes the following: (i) The currently correct Chemical Abstracts (CA) name for the...

40 CFR 720.45 - Information that must be included in the notice form.

Code of Federal Regulations, 2011 CFR

2011-07-01

... relating to the manufacture, processing, distribution in commerce, use, and disposal of the new chemical substance: (a)(1) The specific chemical identity of the substance that the person intends to manufacture or import, which includes the following: (i) The currently correct Chemical Abstracts (CA) name for the...

Current use and potential of additive manufacturing for optical applications

NASA Astrophysics Data System (ADS)

Brunelle, Matthew; Ferralli, Ian; Whitsitt, Rebecca; Medicus, Kate

2017-10-01

Additive manufacturing, or 3D printing, has become widely used in recent years for the creation of both prototype and end-use parts. Because the parts are created in a layer-by-layer manner, the flexibility of additive manufacturing is unparalleled and has opened the design space to enable features like undercuts and internal channels which cannot exist on traditional, subtractively manufactured parts. This flexibility can also be leveraged for optical applications. This paper outlines some of the current uses of 3D printing in the optical manufacturing process at Optimax. Several materials and additive technologies are utilized, including polymer printing through fused deposition modeling, which creates parts by depositing a softened thermoplastic filament in a layerwise fashion. Stereolithography, which uses light to cure layers of a photopolymer resin, will also be discussed. These technologies are used to manufacture functional prototypes, fixtures, sealed housings, and other components. Additionally, metal printing through selective laser melting, which uses a laser to melt metal powder layers into a dense solid, will be discussed due to the potential to manufacture thermally stable opticalmechanical assembly frameworks and functional optics. Examples of several additively manufactured optical components will be shown.

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

NASA Astrophysics Data System (ADS)

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

2018-04-01

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

Agile Electro-Mechanical Product Accelerator - Final Research Performance Progress Report

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

Schmidt, Brian

2016-07-29

NCDMM recognized the need to focus on the most efficient use of limited resources while ensuring compliance with regulations and minimizing the energy intensity and environmental impact of manufactured components. This was accomplished through the evaluation of current machining and processing practices, and their efficiencies, to further the sustainability of manufacturing as a whole. Additionally, the activities also identified, and furthered the implementation of new “best practices” within the southwestern Pennsylvania manufacturing sector.

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.

Additive Manufacturing Technology for Biomedical Components: A review

NASA Astrophysics Data System (ADS)

Aimi Zaharin, Haizum; Rani, Ahmad Majdi Abdul; Lenggo Ginta, Turnad; Azam, Farooq I.

2018-03-01

Over the last decades, additive manufacturing has shown potential application in ranging fields. No longer a prototyping technology, it is now being utilised as a manufacturing technology for giant industries such as the automotive, aircraft and recently in the medical industry. It is a very successful method that provides health-care solution in biomedical sectors by producing patient-specific prosthetics, improve tissues engineering and facilitate pre-operating session. This paper thus presents a brief overview of the most commercially important additive manufacturing technologies, which is currently available for fabricating biomedical components such as Stereolithography (SLA), Selective Laser Sintering (SLS), Selective Laser Melting (SLM), Fused Deposition Modelling (FDM) and Electron Beam Melting (EBM). It introduces the basic principles of the main process, highlights some of the beneficial applications in medical industry and the current limitation of applied technology.

Microencapsulation of Bacterial Cells by Emulsion Technique for Probiotic Application.

PubMed

Mandal, Surajit; Hati, Subrota

2017-01-01

Probiotics are dietary concepts to improve the dynamics of intestinal microbial balance favorably. Careful screening of probiotic strains for their technological suitability can also allow selection of strains with the best manufacturing and food technology characteristics. However, even the most robust probiotic bacteria are currently in the range of food applications to which they can be applied. Additionally, bacteria with exceptional functional heath properties are ruled out due to technological limitations. New process and formulation technologies will enable both expansion of the range of products in to which probiotics can be applied and the use of efficacious stains that currently cannot be manufactured or stored with existing technologies. Viability of probiotics has been both a marketing and technological concern for many industrial produces. Probiotics are difficult to work with, the bacteria often die during processing, and shelf life is unpredictable. Probiotics are extremely susceptible environmental conditions such as oxygen, processing and preservation treatments, acidity, and salt concentration, which collectively affect the overall viability of probiotics. Manufacturers have long been fortifying products with probiotics; they have faced significant processing challenges regarding the stability and survivability of probiotics during processing and preservation treatments, storage as well during their passage through GIT. Application of microencapsulation significantly improves the stability of probiotics during food processing and gastrointestinal transit.

Towards a service bus for distributed manufacturing

NASA Astrophysics Data System (ADS)

Delgado-Gomes, Vasco; Oliveira-Lima, José A.; Martins, João F.; Jardim-Gonçalves, Ricardo

2013-10-01

The electronic exchange of data between industrial equipment, manufacturing and information systems of companies is becoming increasingly important with the current trend of reducing products' life cycle, wide range of diversified products, and the need to answer the specific needs of each consumer. In this context, quality, time, costs involved in integrating information over the company's internal processes, and in the interaction of these processes with their customers, suppliers and other business partners are in many sectors, far beyond what the current technology and communications solutions enable. This paper presents a communication infrastructure to integrate several companies from different sectors of the supply chain, to exchange their heterogeneous information using a data model which is composed by different standards.

Impact of Alternative Medical Device Approval Processes on Costs and Health

PubMed Central

George, Benjamin P.; Venkataraman, Vinayak; Dorsey, E. Ray

2014-01-01

Background Medical devices are often introduced prior to randomized‐trial evidence of efficacy and this slows completion of trials. Alternative regulatory approaches include restricting device use outside of trials prior to trial evidence of efficacy (like the drug approval process) or restricting out‐of‐trial use but permitting coverage within trials such as Medicare's Coverage with Study Participation (CSP). Methods We compared the financial impact to manufacturers and insurers of three regulatory alternatives: (1) limited regulation (current approach), (2) CSP, and (3) restrictive regulation (like the current drug approval process). Using data for patent foramen ovale closure devices, we modeled key parameters including recruitment time, probability of device efficacy, market adoption, and device cost/price to calculate profits to manufacturers, costs to insurers, and overall societal impact on health. Results For manufacturers, profits were greatest under CSP—driven by faster market adoption of effective devices—followed by restrictive regulation. Societal health benefit in total quality‐adjusted life years was greatest under CSP. Insurers’ expenditures for ineffective devices were greatest with limited regulation. Findings were robust over a reasonable range of probabilities of trial success. Conclusions Regulation restricting out‐of‐trial device use and extending limited insurance coverage to clinical trial participants may balance manufacturer and societal interests. PMID:25185975

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

PubMed

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

2016-01-15

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

Development of the Upgraded DC Brush Gear Motor for Spacebus Platforms

NASA Technical Reports Server (NTRS)

Berning, Robert H.; Viout, Olivier

2010-01-01

The obsolescence of materials and processes used in the manufacture of traditional DC brush gear motors has necessitated the development of an upgraded DC brush gear motor (UBGM). The current traditional DC brush gear motor (BGM) design was evaluated using Six-Sigma process to identify potential design and production process improvements. The development effort resulted in a qualified UBGM design which improved manufacturability and reduced production costs. Using Six-Sigma processes and incorporating lessons learned during the development process also improved motor performance for UBGM making it a more viable option for future use as a deployment mechanism in space flight applications.

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.

Plastics processing: statistics, current practices, and evaluation.

PubMed

Cooke, F

1993-11-01

The health care industry uses a huge quantity of plastic materials each year. Much of the machinery currently used, or supplied, for plastics processing is unsuitable for use in a clean environment. In this article, the author outlines the reasons for the current situation and urges companies to re-examine their plastic-processing methods, whether performed in-house or subcontracted out. Some of the factors that should be considered when evaluating plastics-processing equipment are outlined to assist companies in remaining competitive and complying with impending EC regulations on clean room standards for manufacturing areas.

Integrating Design and Manufacturing for a High Speed Civil Transport Wing

NASA Technical Reports Server (NTRS)

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

1994-01-01

The aerospace industry is currently addressing the problem of integrating design and manufacturing. Because of the difficulties associated with using conventional, procedural techniques and algorithms, it is the authors' belief that the only feasible way to integrate the two concepts is with the development of an appropriate Knowledge-Based System (KBS). The authors propose a methodology for an aircraft producibility assessment, including a KBS, that addresses both procedural and heuristic aspects of integrating design and manufacturing of a High Speed Civil Transport (HSCT) wing. The HSCT was chosen as the focus of this investigation since it is a current NASA/aerospace industry initiative full of technological challenges involving many disciplines. The paper gives a brief background of selected previous supersonic transport studies followed by descriptions of key relevant design and manufacturing methodologies. Georgia Tech's Concurrent Engineering/Integrated Product and Process Development methodology is discussed with reference to this proposed conceptual producibility assessment. Evaluation criteria are presented that relate pertinent product and process parameters to overall product producibility. In addition, the authors' integration methodology and reasons for selecting a KBS to integrate design and manufacturing are presented in this paper. Finally, a proposed KBS is given, as well as statements of future work and overall investigation objectives.

21 CFR 184.1143 - Ammonium sulfate.

Code of Federal Regulations, 2010 CFR

2010-04-01

... chapter, and processing aid as defined in § 170.3(o)(24) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 0.15 percent for baked goods as defined in...

21 CFR 184.1095 - Sulfuric acid.

Code of Federal Regulations, 2010 CFR

2010-04-01

... § 170.3(o)(23) of this chapter and processing aid as defined in § 170.3(o)(24) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 0.014 percent for...

The reliability-quality relationship for quality systems and quality risk management.

PubMed

Claycamp, H Gregg; Rahaman, Faiad; Urban, Jason M

2012-01-01

Engineering reliability typically refers to the probability that a system, or any of its components, will perform a required function for a stated period of time and under specified operating conditions. As such, reliability is inextricably linked with time-dependent quality concepts, such as maintaining a state of control and predicting the chances of losses from failures for quality risk management. Two popular current good manufacturing practice (cGMP) and quality risk management tools, failure mode and effects analysis (FMEA) and root cause analysis (RCA) are examples of engineering reliability evaluations that link reliability with quality and risk. Current concepts in pharmaceutical quality and quality management systems call for more predictive systems for maintaining quality; yet, the current pharmaceutical manufacturing literature and guidelines are curiously silent on engineering quality. This commentary discusses the meaning of engineering reliability while linking the concept to quality systems and quality risk management. The essay also discusses the difference between engineering reliability and statistical (assay) reliability. The assurance of quality in a pharmaceutical product is no longer measured only "after the fact" of manufacturing. Rather, concepts of quality systems and quality risk management call for designing quality assurance into all stages of the pharmaceutical product life cycle. Interestingly, most assays for quality are essentially static and inform product quality over the life cycle only by being repeated over time. Engineering process reliability is the fundamental concept that is meant to anticipate quality failures over the life cycle of the product. Reliability is a well-developed theory and practice for other types of manufactured products and manufacturing processes. Thus, it is well known to be an appropriate index of manufactured product quality. This essay discusses the meaning of reliability and its linkages with quality systems and quality risk management.

Planning for the semiconductor manufacturer of the future

NASA Technical Reports Server (NTRS)

Fargher, Hugh E.; Smith, Richard A.

1992-01-01

Texas Instruments (TI) is currently contracted by the Air Force Wright Laboratory and the Defense Advanced Research Projects Agency (DARPA) to develop the next generation flexible semiconductor wafer fabrication system called Microelectronics Manufacturing Science & Technology (MMST). Several revolutionary concepts are being pioneered on MMST, including the following: new single-wafer rapid thermal processes, in-situ sensors, cluster equipment, and advanced Computer Integrated Manufacturing (CIM) software. The objective of the project is to develop a manufacturing system capable of achieving an order of magnitude improvement in almost all aspects of wafer fabrication. TI was awarded the contract in Oct., 1988, and will complete development with a fabrication facility demonstration in April, 1993. An important part of MMST is development of the CIM environment responsible for coordinating all parts of the system. The CIM architecture being developed is based on a distributed object oriented framework made of several cooperating subsystems. The software subsystems include the following: process control for dynamic control of factory processes; modular processing system for controlling the processing equipment; generic equipment model which provides an interface between processing equipment and the rest of the factory; specification system which maintains factory documents and product specifications; simulator for modelling the factory for analysis purposes; scheduler for scheduling work on the factory floor; and the planner for planning and monitoring of orders within the factory. This paper first outlines the division of responsibility between the planner, scheduler, and simulator subsystems. It then describes the approach to incremental planning and the way in which uncertainty is modelled within the plan representation. Finally, current status and initial results are described.

Current Good Manufacturing Practice Production of an Oncolytic Recombinant Vesicular Stomatitis Viral Vector for Cancer Treatment

PubMed Central

Meseck, M.; Derecho, I.; Lopez, P.; Knoblauch, C.; McMahon, R.; Anderson, J.; Dunphy, N.; Quezada, V.; Khan, R.; Huang, P.; Dang, W.; Luo, M.; Hsu, D.; Woo, S.L.C.; Couture, L.

2011-01-01

Abstract Vesicular stomatitis virus (VSV) is an oncolytic virus currently being investigated as a promising tool to treat cancer because of its ability to selectively replicate in cancer cells. To enhance the oncolytic property of the nonpathologic laboratory strain of VSV, we generated a recombinant vector [rVSV(MΔ51)-M3] expressing murine gammaherpesvirus M3, a secreted viral chemokine-binding protein that binds to a broad range of mammalian chemokines with high affinity. As previously reported, when rVSV(MΔ51)-M3 was used in an orthotopic model of hepatocellular carcinoma (HCC) in rats, it suppressed inflammatory cell migration to the virus-infected tumor site, which allowed for enhanced intratumoral virus replication leading to increased tumor necrosis and substantially prolonged survival. These encouraging results led to the development of this vector for clinical translation in patients with HCC. However, a scalable current Good Manufacturing Practice (cGMP)-compliant manufacturing process has not been described for this vector. To produce the quantities of high-titer virus required for clinical trials, a process that is amenable to GMP manufacturing and scale-up was developed. We describe here a large-scale (50-liter) vector production process capable of achieving crude titers on the order of 109 plaque-forming units (PFU)/ml under cGMP. This process was used to generate a master virus seed stock and a clinical lot of the clinical trial agent under cGMP with an infectious viral titer of approximately 2 × 1010 PFU/ml (total yield, 1 × 1013 PFU). The lot has passed all U.S. Food and Drug Administration-mandated release testing and will be used in a phase 1 clinical translational trial in patients with advanced HCC. PMID:21083425

Current good manufacturing practice production of an oncolytic recombinant vesicular stomatitis viral vector for cancer treatment.

PubMed

Ausubel, L J; Meseck, M; Derecho, I; Lopez, P; Knoblauch, C; McMahon, R; Anderson, J; Dunphy, N; Quezada, V; Khan, R; Huang, P; Dang, W; Luo, M; Hsu, D; Woo, S L C; Couture, L

2011-04-01

Vesicular stomatitis virus (VSV) is an oncolytic virus currently being investigated as a promising tool to treat cancer because of its ability to selectively replicate in cancer cells. To enhance the oncolytic property of the nonpathologic laboratory strain of VSV, we generated a recombinant vector [rVSV(MΔ51)-M3] expressing murine gammaherpesvirus M3, a secreted viral chemokine-binding protein that binds to a broad range of mammalian chemokines with high affinity. As previously reported, when rVSV(MΔ51)-M3 was used in an orthotopic model of hepatocellular carcinoma (HCC) in rats, it suppressed inflammatory cell migration to the virus-infected tumor site, which allowed for enhanced intratumoral virus replication leading to increased tumor necrosis and substantially prolonged survival. These encouraging results led to the development of this vector for clinical translation in patients with HCC. However, a scalable current Good Manufacturing Practice (cGMP)-compliant manufacturing process has not been described for this vector. To produce the quantities of high-titer virus required for clinical trials, a process that is amenable to GMP manufacturing and scale-up was developed. We describe here a large-scale (50-liter) vector production process capable of achieving crude titers on the order of 10(9) plaque-forming units (PFU)/ml under cGMP. This process was used to generate a master virus seed stock and a clinical lot of the clinical trial agent under cGMP with an infectious viral titer of approximately 2 × 10(10) PFU/ml (total yield, 1 × 10(13) PFU). The lot has passed all U.S. Food and Drug Administration-mandated release testing and will be used in a phase 1 clinical translational trial in patients with advanced HCC.

Freeform Optics: current challenges for future serial production

NASA Astrophysics Data System (ADS)

Schindler, C.; Köhler, T.; Roth, E.

2017-10-01

One of the major developments in optics industry recently is the commercial manufacturing of freeform surfaces for optical mid- and high performance systems. The loss of limitation on rotational symmetry enables completely new optical design solutions - but causes completely new challenges for the manufacturer too. Adapting the serial production from radial-symmetric to freeform optics cannot be done just by the extension of machine capabilities and software for every process step. New solutions for conventional optics productions or completely new process chains are necessary.

An evaluation of GTAW-P versus GTA welding of alloy 718

NASA Technical Reports Server (NTRS)

Gamwell, W. R.; Kurgan, C.; Malone, T. W.

1991-01-01

Mechanical properties were evaluated to determine statistically whether the pulsed current gas tungsten arc welding (GTAW-P) process produces welds in alloy 718 with room temperature structural performance equivalent to current Space Shuttle Main Engine (SSME) welds manufactured by the constant current GTAW-P process. Evaluations were conducted on two base metal lots, two filler metal lots, two heat input levels, and two welding processes. The material form was 0.125-inch (3.175-mm) alloy 718 sheet. Prior to welding, sheets were treated to either the ST or STA-1 condition. After welding, panels were left as welded or heat treated to the STA-1 condition, and weld beads were left intact or machined flush. Statistical analyses were performed on yield strength, ultimate tensile strength (UTS), and high cycle fatigue (HCF) properties for all the post welded material conditions. Analyses of variance were performed on the data to determine if there were any significant effects on UTS or HCF life due to variations in base metal, filler metal, heat input level, or welding process. Statistical analyses showed that the GTAW-P process does produce welds with room temperature structural performance equivalent to current SSME welds manufactured by the GTAW process, regardless of prior material condition or post welding condition.

Surface texture and hardness of dental alloys processed by alternative technologies

NASA Astrophysics Data System (ADS)

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

2017-08-01

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

Firmware Development Improves System Efficiency

NASA Technical Reports Server (NTRS)

Chern, E. James; Butler, David W.

1993-01-01

Most manufacturing processes require physical pointwise positioning of the components or tools from one location to another. Typical mechanical systems utilize either stop-and-go or fixed feed-rate procession to accomplish the task. The first approach achieves positional accuracy but prolongs overall time and increases wear on the mechanical system. The second approach sustains the throughput but compromises positional accuracy. A computer firmware approach has been developed to optimize this point wise mechanism by utilizing programmable interrupt controls to synchronize engineering processes 'on the fly'. This principle has been implemented in an eddy current imaging system to demonstrate the improvement. Software programs were developed that enable a mechanical controller card to transmit interrupts to a system controller as a trigger signal to initiate an eddy current data acquisition routine. The advantages are: (1) optimized manufacturing processes, (2) increased throughput of the system, (3) improved positional accuracy, and (4) reduced wear and tear on the mechanical system.

Manufacture of tumor- and virus-specific T lymphocytes for adoptive cell therapies

PubMed Central

Wang, X; Rivière, I

2015-01-01

Adoptive transfer of tumor-infiltrating lymphocytes (TILs) and genetically engineered T lymphocytes expressing chimeric antigen receptors (CARs) or conventional alpha/beta T-cell receptors (TCRs), collectively termed adoptive cell therapy (ACT), is an emerging novel strategy to treat cancer patients. Application of ACT has been constrained by the ability to isolate and expand functional tumor-reactive T cells. The transition of ACT from a promising experimental regimen to an established standard of care treatment relies largely on the establishment of safe, efficient, robust and cost-effective cell manufacturing protocols. The manufacture of cellular products under current good manufacturing practices (cGMPs) has a critical role in the process. Herein, we review current manufacturing methods for the large-scale production of clinical-grade TILs, virus-specific and genetically modified CAR or TCR transduced T cells in the context of phase I/II clinical trials as well as the regulatory pathway to get these complex personalized cellular products to the clinic. PMID:25721207

Manufacture of tumor- and virus-specific T lymphocytes for adoptive cell therapies.

PubMed

Wang, X; Rivière, I

2015-03-01

Adoptive transfer of tumor-infiltrating lymphocytes (TILs) and genetically engineered T lymphocytes expressing chimeric antigen receptors (CARs) or conventional alpha/beta T-cell receptors (TCRs), collectively termed adoptive cell therapy (ACT), is an emerging novel strategy to treat cancer patients. Application of ACT has been constrained by the ability to isolate and expand functional tumor-reactive T cells. The transition of ACT from a promising experimental regimen to an established standard of care treatment relies largely on the establishment of safe, efficient, robust and cost-effective cell manufacturing protocols. The manufacture of cellular products under current good manufacturing practices (cGMPs) has a critical role in the process. Herein, we review current manufacturing methods for the large-scale production of clinical-grade TILs, virus-specific and genetically modified CAR or TCR transduced T cells in the context of phase I/II clinical trials as well as the regulatory pathway to get these complex personalized cellular products to the clinic.

Nano-Magnets and Additive Manufacturing for Electric Motors

NASA Technical Reports Server (NTRS)

Misra, Ajay K.

2014-01-01

High power density is required for application of electric motors in hybrid electric propulsion. Potential path to achieve high power density in electric motors include advanced materials, lightweight thermal management, lightweight structural concepts, high power density power electronics, and advanced manufacturing. This presentation will focus on two key technologies for achieving high power density, advanced magnets and additive manufacturing. The maximum energy product in current magnets is reaching their theoretical limits as a result of material and process improvements. Future improvements in the maximum energy product for magnets can be achieved through development of nanocomposite magnets combining the hard magnetic phase and soft magnetic phase at the nanoscale level. The presentation will provide an overview of the current state of development for nanocomposite magnets and the future path for doubling the maximum energy product. The other part of the presentation will focus on the role of additive manufacturing in fabrication of high power density electric motors. The presentation will highlight the potential opportunities for applying additive manufacturing to fabricate electric motors.

Development of Critical Profilometers to Meet Current and Future NASA Composite Overwrapped Pressure Vessel (COPV) Inspection Needs

NASA Technical Reports Server (NTRS)

Saulsberry, Regor; Nichols, Charles

2012-01-01

This project is part of a multi-center effort to develop and validate critical NDE techniques which can be implemented into current and future NASA spacecraft COPV manufacturing processes. After decades of COPV development, manufacturing variance is still high and has necessitated higher safety factors and additional mass to be flown on spacecraft (reducing overall performance). Additionally, the NASA Engineering and Safety Center (NESC) indicated that nondestructive evaluation (NDE) was not adequately implemented during Shuttle and International Space Station (ISS) COPV manufacturing and provisions were not made for on-going structural integrity and health checks during the various spacecraft programs. This project helps to provide additional data needed to help address these issues. This project seeks to develop and install internal and external laser profilometers at COPV manufacturing facilities to provide data needed to improve COPV quality and consistency. This project also investigates other scanning techniques that will enhance the system to more completely meet manufacturing needs, thus transforming the profilometer into what has been termed the "Universal Manufacturing COPV Scanner".

Histo-anatomic 3D printing of dental structures.

PubMed

Schweiger, J; Beuer, F; Stimmelmayr, M; Edelhoff, D; Magne, P; Güth, J F

2016-11-04

The creation of dental restorations with natural appearance and biomechanics represents a major challenge for the restorative team. The manufacturing-process of high-aesthetic restorations from tooth-coloured restorative materials is currently dominated by manual manufacturing procedures and the outcome is highly dependent on the knowledge and skills of the performing dental technician. On the other hand, due to the simplicity of the manufacturing process, CAD/CAM restorations from different material classes gain more and more acceptance in the daily routine. Multi-layered restorations show significant aesthetic advantages versus monolithic ones, but are difficult to fabricate using digital technologies. The key element for the successful automated digital fabrication of aesthetic anterior restorations seems to be the form of the individual dentine core as defined by dentine enamel junction (DEJ) covered by a more transparent layer of material imitating the enamel layer to create the outer enamel surface (OES). This article describes the possibilities and technologies available for so-called '4D-printing'. It introduces the digital manufacturing process of multilayered anterior teeth using 3D multipart printing, taking the example of manufacturing replicas of extracted intact natural teeth.

Using Innovative Technologies for Manufacturing and Evaluating Rocket Engine Hardware

NASA Technical Reports Server (NTRS)

Betts, Erin M.; Hardin, Andy

2011-01-01

Many of the manufacturing and evaluation techniques that are currently used for rocket engine component production are traditional methods that have been proven through years of experience and historical precedence. As we enter into a new space age where new launch vehicles are being designed and propulsion systems are being improved upon, it is sometimes necessary to adopt new and innovative techniques for manufacturing and evaluating hardware. With a heavy emphasis on cost reduction and improvements in manufacturing time, manufacturing techniques such as Direct Metal Laser Sintering (DMLS) and white light scanning are being adopted and evaluated for their use on J-2X, with hopes of employing both technologies on a wide variety of future projects. DMLS has the potential to significantly reduce the processing time and cost of engine hardware, while achieving desirable material properties by using a layered powdered metal manufacturing process in order to produce complex part geometries. The white light technique is a non-invasive method that can be used to inspect for geometric feature alignment. Both the DMLS manufacturing method and the white light scanning technique have proven to be viable options for manufacturing and evaluating rocket engine hardware, and further development and use of these techniques is recommended.

Analysis and evalaution in the production process and equipment area of the low-cost solar array project. [including modifying gaseous diffusion and using ion implantation

NASA Technical Reports Server (NTRS)

Goldman, H.; Wolf, M.

1979-01-01

The manufacturing methods for photovoltaic solar energy utilization are assessed. Economic and technical data on the current front junction formation processes of gaseous diffusion and ion implantation are presented. Future proposals, including modifying gaseous diffusion and using ion implantation, to decrease the cost of junction formation are studied. Technology developments in current processes and an economic evaluation of the processes are included.

Additive direct-write microfabrication for MEMS: A review

NASA Astrophysics Data System (ADS)

Teh, Kwok Siong

2017-12-01

Direct-write additive manufacturing refers to a rich and growing repertoire of well-established fabrication techniques that builds solid objects directly from computer- generated solid models without elaborate intermediate fabrication steps. At the macroscale, direct-write techniques such as stereolithography, selective laser sintering, fused deposition modeling ink-jet printing, and laminated object manufacturing have significantly reduced concept-to-product lead time, enabled complex geometries, and importantly, has led to the renaissance in fabrication known as the maker movement. The technological premises of all direct-write additive manufacturing are identical—converting computer generated three-dimensional models into layers of two-dimensional planes or slices, which are then reconstructed sequentially into threedimensional solid objects in a layer-by-layer format. The key differences between the various additive manufacturing techniques are the means of creating the finished layers and the ancillary processes that accompany them. While still at its infancy, direct-write additive manufacturing techniques at the microscale have the potential to significantly lower the barrier-of-entry—in terms of cost, time and training—for the prototyping and fabrication of MEMS parts that have larger dimensions, high aspect ratios, and complex shapes. In recent years, significant advancements in materials chemistry, laser technology, heat and fluid modeling, and control systems have enabled additive manufacturing to achieve higher resolutions at the micrometer and nanometer length scales to be a viable technology for MEMS fabrication. Compared to traditional MEMS processes that rely heavily on expensive equipment and time-consuming steps, direct-write additive manufacturing techniques allow for rapid design-to-prototype realization by limiting or circumventing the need for cleanrooms, photolithography and extensive training. With current direct-write additive manufacturing technologies, it is possible to fabricate unsophisticated micrometer scale structures at adequate resolutions and precisions using materials that range from polymers, metals, ceramics, to composites. In both academia and industry, direct-write additive manufacturing offers extraordinary promises to revolutionize research and development in microfabrication and MEMS technologies. Importantly, direct-write additive manufacturing could appreciably augment current MEMS fabrication technologies, enable faster design-to-product cycle, empower new paradigms in MEMS designs, and critically, encourage wider participation in MEMS research at institutions or for individuals with limited or no access to cleanroom facilities. This article aims to provide a limited review of the current landscape of direct-write additive manufacturing techniques that are potentially applicable for MEMS microfabrication.

Approach to a manufacture-oriented modeling of bent tubes depending on the curvature distribution during three-roll-push-bending

NASA Astrophysics Data System (ADS)

Groth, Sebastian; Engel, Bernd; Frohn, Peter

2018-05-01

Kinematic bending processes such as three-roll-push-bending are used to manufacture freeform bent part systems. Due to the kinematic shaping, the bent parts have a characteristic infeed and outfeed area in the transition zone from the straight section into the curved area. These transition zones are currently not considered in the design process, which results in a geometric shape deviation between the CAD model and the bent part. Within this publication, a sensitivity analysis examines the influence of different parameters on the transition zone and the shape deviation. In addition, an approach is presented, which allows a manufacture-oriented modeling of the bending geometry.

Role of RIS/APC for manufacturing RFG/LSD. [Refinery Information Systems/Advanced Process Control, ReFormulated Gasoline/Low Sulfur Diesels

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

Latour, P.R.

Revolutionary changes in quality specifications (number, complexity, uncertainty, economic sensitivity) for reformulated gasolines (RFG) and low-sulfur diesels (LSD) are being addressed by powerful, new, computer-integrated manufacturing technology for Refinery Information Systems and Advanced Process Control (RIS/APC). This paper shows how the five active RIS/APC functions: performance measurement, optimization, scheduling, control and integration are used to manufacture new, clean fuels competitively. With current industry spending for this field averaging 2 to 3 cents/bbl crude, many refineries can capture 50 to 100 cents/bbl if the technology is properly employed and sustained throughout refining operations, organizations, and businesses.

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.

Process-Structure-Property Relationships for 316L Stainless Steel Fabricated by Additive Manufacturing and Its Implication for Component Engineering

NASA Astrophysics Data System (ADS)

Yang, Nancy; Yee, J.; Zheng, B.; Gaiser, K.; Reynolds, T.; Clemon, L.; Lu, W. Y.; Schoenung, J. M.; Lavernia, E. J.

2017-04-01

We investigate the process-structure-property relationships for 316L stainless steel prototyping utilizing 3-D laser engineered net shaping (LENS), a commercial direct energy deposition additive manufacturing process. The study concluded that the resultant physical metallurgy of 3-D LENS 316L prototypes is dictated by the interactive metallurgical reactions, during instantaneous powder feeding/melting, molten metal flow and liquid metal solidification. The study also showed 3-D LENS manufacturing is capable of building high strength and ductile 316L prototypes due to its fine cellular spacing from fast solidification cooling, and the well-fused epitaxial interfaces at metal flow trails and interpass boundaries. However, without further LENS process control and optimization, the deposits are vulnerable to localized hardness variation attributed to heterogeneous microstructure, i.e., the interpass heat-affected zone (HAZ) from repetitive thermal heating during successive layer depositions. Most significantly, the current deposits exhibit anisotropic tensile behavior, i.e., lower strain and/or premature interpass delamination parallel to build direction (axial). This anisotropic behavior is attributed to the presence of interpass HAZ, which coexists with flying feedstock inclusions and porosity from incomplete molten metal fusion. The current observations and findings contribute to the scientific basis for future process control and optimization necessary for material property control and defect mitigation.

Integrated continuous processing of proteins expressed as inclusion bodies: GCSF as a case study.

PubMed

Kateja, Nikhil; Agarwal, Harshit; Hebbi, Vishwanath; Rathore, Anurag S

2017-07-01

Affordability of biopharmaceuticals continues to be a challenge, particularly in developing economies. This has fuelled advancements in manufacturing that can offer higher productivity and better economics without sacrificing product quality in the form of an integrated continuous manufacturing platform. While platform processes for monoclonal antibodies have existed for more than a decade, development of an integrated continuous manufacturing process for bacterial proteins has received relatively scant attention. In this study, we propose an end-to-end integrated continuous downstream process (from inclusion bodies to unformulated drug substance) for a therapeutic protein expressed in Escherichia coli as inclusion body. The final process consisted of a continuous refolding in a coiled flow inverter reactor directly coupled to a three-column periodic counter-current chromatography for capture of the product followed by a three-column con-current chromatography for polishing. The continuous bioprocessing train was run uninterrupted for 26 h to demonstrate its capability and the resulting output was analyzed for the various critical quality attributes, namely product purity (>99%), high molecular weight impurities (<0.5%), host cell proteins (<100 ppm), and host cell DNA (<10 ppb). All attributes were found to be consistent over the period of operation. The developed assembly offers smaller facility footprint, higher productivity, fewer hold steps, and significantly higher equipment and resin utilization. The complexities of process integration in the context of continuous processing have been highlighted. We hope that the study presented here will promote development of highly efficient, universal, end-to-end, fully continuous platforms for manufacturing of biotherapeutics. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 33:998-1009, 2017. © 2016 American Institute of Chemical Engineers.

Additive Technology: Update on Current Materials and Applications in Dentistry.

PubMed

Barazanchi, Abdullah; Li, Kai Chun; Al-Amleh, Basil; Lyons, Karl; Waddell, J Neil

2017-02-01

Additive manufacturing or 3D printing is becoming an alternative to subtractive manufacturing or milling in the area of computer-aided manufacturing. Research on material for use in additive manufacturing is ongoing, and a wide variety of materials are being used or developed for use in dentistry. Some materials, however, such as cobalt chromium, still lack sufficient research to allow definite conclusions about the suitability of their use in clinical dental practice. Despite this, due to the wide variety of machines that use additive manufacturing, there is much more flexibility in the build material and geometry when building structures compared with subtractive manufacturing. Overall additive manufacturing produces little material waste and is energy efficient when compared to subtractive manufacturing, due to passivity and the additive layering nature of the build process. Such features make the technique suitable to be used with fabricating structures out of hard to handle materials such as cobalt chromium. The main limitations of this technology include the appearance of steps due to layering of material and difficulty in fabricating certain material generally used in dentistry for use in 3D printing such as ceramics. The current pace of technological development, however, promises exciting possibilities. © 2016 by the American College of Prosthodontists.

A Framework for Revitalizing American Manufacturing

DTIC Science & Technology

2009-12-01

remedial education and support services, modernize facilities, and expand high-quality online course offerings.  Invest in high-quality job... risk , high-reward research in areas of critical national need. One 17 current area of focus is research on advanced manufacturing processes and...competitiveness. The Department is working to streamline the delivery of government services to businesses so that they can better assess their needs

EDITORIAL: Ensuring sustainability with green nanotechnology Ensuring sustainability with green nanotechnology

NASA Astrophysics Data System (ADS)

Wong, Stanislaus; Karn, Barbara

2012-07-01

Nanotechnology offers immense promise for developing new technologies that are more sustainable than current technologies. All major industrial sectors have felt nanotechnology's impact, mainly from the incorporation of nanomaterials into their products. For example, nanotechnology has improved the design and performance of products in areas as diverse as electronics, medicine and medical devices, food and agriculture, cosmetics, chemicals, materials, coatings, energy, as well as many others. Moreover, the revenues from nanotechnology-enabled products are not trivial. For instance, Lux Research maintains that commercial sales in both Europe and the USA will attain revenues of over 1 trillion from nano-enabled products by 2015. The manufacturing of the nanomaterials for these products uses many processes equivalent to chemical manufacturing processes. As a result, manufacturing nanomaterials can produce either harmful pollutants or adverse environmental impacts similar to those from chemical manufacturing. Unlike the chemical industry, however, those same processes are not ingrained in the manufacturing of nanomaterials, and the opportunity exists at the initial design stage to purposely account for and mitigate out potentially harmful environmental impacts. While prevention has not been a priority in current industries, it can become a main concern for the new and future industries that manufacture nanomaterials on a bulk commercial scale. This is where green nanotechnology comes in. Green nanotechnology involves deliberate efforts aimed at developing meaningful and reasonable protocols for generating products and their associated production processes in a benign fashion. The goal is a conscious minimization of risks associated with the products of nanoscience. The green products of nanotechnology are those that are used in either direct or indirect environmental applications. Direct environmental applications provide benefits such as monitoring using nano-enabled sensors, remediation of hazardous waste sites with nanomaterials, or treatment of wastewater and drinking water with nanomaterials. Indirect environmental applications include, for example, the saved energy associated with either lighter nanocomposite materials in transport vehicles or reduced waste from smaller products. The production and process aspects of green nanotechnology involve both making nanomaterials in a more environmentally benign fashion and using nanomaterials to make current chemical processes more environmentally acceptable. Examples of producing nanomaterials in a 'greener manner' could involve but are not limited to the use of supercritical CO2, water, or ionic liquids to replace a volatile organic solvent. Either self-assembly or templating might also be used to eliminate waste in manufacturing. Renewables could be utilized as replacements for either nonrenewable and/or toxic starting materials. Microwave techniques might potentially help to conserve energy, as could both facile thermal and hydrothermal processes. Catalytic and photocatalytic reactions could also increase efficiency and decrease the formation of harmful byproducts. In addition, engineered nanomaterials themselves can be used as catalysts in current chemical processes and as separation membranes to aid in the efficiency of these operations. Furthermore, in order to be truly green, these products and processes must be considered within a lifecycle framework. The papers in this special issue are but a small sampling of the myriad of possibilities that green nanotechnology holds. In the nascent nanotechnology industry, green nanotechnology offers the opportunity to get it right in the first place. It is not too late to take Ben Franklin's words to heart, 'an ounce of prevention is worth a pound of cure'.

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.

Additive Manufacturing of Low Cost Upper Stage Propulsion Components

NASA Technical Reports Server (NTRS)

Protz, Christopher; Bowman, Randy; Cooper, Ken; Fikes, John; Taminger, Karen; Wright, Belinda

2014-01-01

NASA is currently developing Additive Manufacturing (AM) technologies and design tools aimed at reducing the costs and manufacturing time of regeneratively cooled rocket engine components. These Low Cost Upper Stage Propulsion (LCUSP) tasks are funded through NASA's Game Changing Development Program in the Space Technology Mission Directorate. The LCUSP project will develop a copper alloy additive manufacturing design process and develop and optimize the Electron Beam Freeform Fabrication (EBF3) manufacturing process to direct deposit a nickel alloy structural jacket and manifolds onto an SLM manufactured GRCop chamber and Ni-alloy nozzle. In order to develop these processes, the project will characterize both the microstructural and mechanical properties of the SLMproduced GRCop-84, and will explore and document novel design techniques specific to AM combustion devices components. These manufacturing technologies will be used to build a 25K-class regenerative chamber and nozzle (to be used with tested DMLS injectors) that will be tested individually and as a system in hot fire tests to demonstrate the applicability of the technologies. These tasks are expected to bring costs and manufacturing time down as spacecraft propulsion systems typically comprise more than 70% of the total vehicle cost and account for a significant portion of the development schedule. Additionally, high pressure/high temperature combustion chambers and nozzles must be regeneratively cooled to survive their operating environment, causing their design to be time consuming and costly to build. LCUSP presents an opportunity to develop and demonstrate a process that can infuse these technologies into industry, build competition, and drive down costs of future engines.

A glove-likeability study of specially-treated gloves in the detonator manufacturing and packaging industry

DOE PAGES

Cournoyer, Michael E.; Lawton, Cindy M.; Lounsbury, James B.; ...

2016-03-22

We use hand gloves (hereafter referred to as gloves) in the detonator manufacturing and packaging operations. As part of a process improvement program, new glove formulations have been considered that lower the overall risk of detonator operations by reducing ergonomic injury factors. Gloves with a specially treated surface for extra grip and control are now commercially available and have been recommended for use in detonator operations. A Glove Likeability Study demonstrated that detonator manufacturing and packaging workers prefer gloves with a specially treated surface over currently approved gloves made from latex and nitrile formulations. Glove material compatibility tests indicate thatmore » the recommended gloves are as compatible if not more compatible as the currently approved gloves for working with secondary explosives. Thus, these gloves with a specially treated surface for extra grip and control are now available for tasks where sensitivity and fingertip control are crucial. Replacement of the current gloves with gloves with a specially treated surface improves the safety configuration of detonator manufacturing and packaging operations.« less

A glove-likeability study of specially-treated gloves in the detonator manufacturing and packaging industry

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

Cournoyer, Michael E.; Lawton, Cindy M.; Lounsbury, James B.

We use hand gloves (hereafter referred to as gloves) in the detonator manufacturing and packaging operations. As part of a process improvement program, new glove formulations have been considered that lower the overall risk of detonator operations by reducing ergonomic injury factors. Gloves with a specially treated surface for extra grip and control are now commercially available and have been recommended for use in detonator operations. A Glove Likeability Study demonstrated that detonator manufacturing and packaging workers prefer gloves with a specially treated surface over currently approved gloves made from latex and nitrile formulations. Glove material compatibility tests indicate thatmore » the recommended gloves are as compatible if not more compatible as the currently approved gloves for working with secondary explosives. Thus, these gloves with a specially treated surface for extra grip and control are now available for tasks where sensitivity and fingertip control are crucial. Replacement of the current gloves with gloves with a specially treated surface improves the safety configuration of detonator manufacturing and packaging operations.« less

21 CFR 110.5 - Current good manufacturing practice.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 110.5 Section...) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD General Provisions § 110.5 Current good manufacturing practice. (a) The criteria and...

Industrializing Autologous Adoptive Immunotherapies: Manufacturing Advances and Challenges

PubMed Central

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

2018-01-01

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

Industrializing Autologous Adoptive Immunotherapies: Manufacturing Advances and Challenges.

PubMed

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

2018-01-01

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

Adaptive Multi-scale Prognostics and Health Management for Smart Manufacturing Systems

PubMed Central

Choo, Benjamin Y.; Adams, Stephen C.; Weiss, Brian A.; Marvel, Jeremy A.; Beling, Peter A.

2017-01-01

The Adaptive Multi-scale Prognostics and Health Management (AM-PHM) is a methodology designed to enable PHM in smart manufacturing systems. In application, PHM information is not yet fully utilized in higher-level decision-making in manufacturing systems. AM-PHM leverages and integrates lower-level PHM information such as from a machine or component with hierarchical relationships across the component, machine, work cell, and assembly line levels in a manufacturing system. The AM-PHM methodology enables the creation of actionable prognostic and diagnostic intelligence up and down the manufacturing process hierarchy. Decisions are then made with the knowledge of the current and projected health state of the system at decision points along the nodes of the hierarchical structure. To overcome the issue of exponential explosion of complexity associated with describing a large manufacturing system, the AM-PHM methodology takes a hierarchical Markov Decision Process (MDP) approach into describing the system and solving for an optimized policy. A description of the AM-PHM methodology is followed by a simulated industry-inspired example to demonstrate the effectiveness of AM-PHM. PMID:28736651

Improving post-detonation energetics residues estimations for the Life Cycle Environmental Assessment process for munitions.

EPA Science Inventory

The Life Cycle Environmental Assessment (LCEA) process for military munitions tracks possible environmental impacts incurred during all phases of the life of a munition. The greatest energetics-based emphasis in the current LCEA process is on manufacturing. A review of recent LCE...

Spraying Techniques for Large Scale Manufacturing of PEM-FC Electrodes

NASA Astrophysics Data System (ADS)

Hoffman, Casey J.

Fuel cells are highly efficient energy conversion devices that represent one part of the solution to the world's current energy crisis in the midst of global climate change. When supplied with the necessary reactant gasses, fuel cells produce only electricity, heat, and water. The fuel used, namely hydrogen, is available from many sources including natural gas and the electrolysis of water. If the electricity for electrolysis is generated by renewable energy (e.g., solar and wind power), fuel cells represent a completely 'green' method of producing electricity. The thought of being able to produce electricity to power homes, vehicles, and other portable or stationary equipment with essentially zero environmentally harmful emissions has been driving academic and industrial fuel cell research and development with the goal of successfully commercializing this technology. Unfortunately, fuel cells cannot achieve any appreciable market penetration at their current costs. The author's hypothesis is that: the development of automated, non-contact deposition methods for electrode manufacturing will improve performance and process flexibility, thereby helping to accelerate the commercialization of PEMFC technology. The overarching motivation for this research was to lower the cost of manufacturing fuel cell electrodes and bring the technology one step closer to commercial viability. The author has proven this hypothesis through a detailed study of two non-contact spraying methods. These scalable deposition systems were incorporated into an automated electrode manufacturing system that was designed and built by the author for this research. The electrode manufacturing techniques developed by the author have been shown to produce electrodes that outperform a common lab-scale contact method that was studied as a baseline, as well as several commercially available electrodes. In addition, these scalable, large scale electrode manufacturing processes developed by the author are also flexible and can be used to fabricate almost any fuel cell electrodes on the market today. This dissertation provides a description of the entire electrode manufacturing process as well as an analysis of the accuracy, performance and repeatability of the methods.

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

NASA Astrophysics Data System (ADS)

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

2015-12-01

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

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.

Adapting viral safety assurance strategies to continuous processing of biological products.

PubMed

Johnson, Sarah A; Brown, Matthew R; Lute, Scott C; Brorson, Kurt A

2017-01-01

There has been a recent drive in commercial large-scale production of biotechnology products to convert current batch mode processing to continuous processing manufacturing. There have been reports of model systems capable of adapting and linking upstream and downstream technologies into a continuous manufacturing pipeline. However, in many of these proposed continuous processing model systems, viral safety has not been comprehensively addressed. Viral safety and detection is a highly important and often expensive regulatory requirement for any new biological product. To ensure success in the adaption of continuous processing to large-scale production, there is a need to consider the development of approaches that allow for seamless incorporation of viral testing and clearance/inactivation methods. In this review, we outline potential strategies to apply current viral testing and clearance/inactivation technologies to continuous processing, as well as modifications of existing unit operations to ensure the successful integration of viral clearance into the continuous processing of biological products. Biotechnol. Bioeng. 2017;114: 21-32. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Developing the revised NICE appraisal technical guidance to manufacturers and sponsors: opportunity or threat?

PubMed

Taylor, Rod S; Hutton, John; Culyer, Anthony J

2002-01-01

One of the principal roles of the National Institute for Clinical Excellence (NICE) is to appraise selected existing and emerging healthcare technologies and, as a result, produce guidance for the National Health Service (NHS) in England and Wales. A central part of this appraisal is the potential for manufacturers and sponsors to make a data submission. This paper describes the process of development of the second edition of technical guidance to manufacturers and sponsors for submission to NICE. The revision process took place during the period May 2000 and January 2001 and involved a number of key steps -- establishment of a guidance steering committee, review of current international guidelines of clinical and cost effectiveness, drafting of the guidance, detailed consultation with stakeholders, revision of the guidance and, finally, publication. The lessons learnt from revision of the NICE guidance for manufacturers and sponsors and some main issues for its future development are discussed.

Technology transfer into the solid propulsion industry

NASA Technical Reports Server (NTRS)

Campbell, Ralph L.; Thomson, Lawrence J.

1995-01-01

This paper is a survey of the waste minimization efforts of industries outside of aerospace for possible applications in the manufacture of solid rocket motors (SRM) for NASA. The Redesigned Solid Rocket Motor (RSRM) manufacturing plan was used as the model for processes involved in the production of an SRM. A literature search was conducted to determine the recycling, waste minimization, and waste treatment methods used in the commercial sector that might find application in SRM production. Manufacturers, trade organizations, and professional associations were also contacted. Waste minimization efforts for current processes and replacement technologies, which might reduce the amount or severity of the wastes generated in SRM production, were investigated. An overview of the results of this effort are presented in this paper.

Additive Manufacturing in the Marine Corps

DTIC Science & Technology

2015-06-01

commonly referred to as 3D printing. This thesis answers the question of how additive manufacturing can improve the effectiveness of Marine Corps...analysis of current and future 3D -printing processes, examination of several civilian and military examples, and examination of the impact across...fully integrating 3D printers, such as the lack of certification and qualification standards, unreliable end product results, and determining ownership

21 CFR 211.188 - Batch production and control records.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and... percentage of theoretical yield at appropriate phases of processing; (8) Complete labeling control records...

21 CFR 211.188 - Batch production and control records.

Code of Federal Regulations, 2011 CFR

2011-04-01

... (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and... percentage of theoretical yield at appropriate phases of processing; (8) Complete labeling control records...

A Review of the Fatigue Properties of Additively Manufactured Ti-6Al-4V

NASA Astrophysics Data System (ADS)

Cao, Fei; Zhang, Tiantian; Ryder, Matthew A.; Lados, Diana A.

2018-03-01

Various additive manufacturing (AM) technologies have been used to fabricate Ti-6Al-4V. The fatigue performance of Ti-6Al-4V varies from process to process. In this review, fatigue properties of Ti-6Al-4V alloys made by different AM technologies and post-fabrication treatments were compiled and discussed to correlate with the materials' characteristic features, primarily surface roughness and porosity. Microstructure anisotropy and porosity effects on fatigue crack growth and fatigue life are also presented and discussed. A modified Kitagawa-Takahashi diagram developed from current available fatigue data was used to quantify the influence of defects on fatigue strength. This review aims to assist in selecting/optimizing AM processes to achieve high fatigue resistance in Ti-6Al-4V, as well as provide a better understanding of the advantages and limitations of current AM techniques in producing titanium alloys.

Trends in Process Analytical Technology: Present State in Bioprocessing.

PubMed

Jenzsch, Marco; Bell, Christian; Buziol, Stefan; Kepert, Felix; Wegele, Harald; Hakemeyer, Christian

2017-08-04

Process analytical technology (PAT), the regulatory initiative for incorporating quality in pharmaceutical manufacturing, is an area of intense research and interest. If PAT is effectively applied to bioprocesses, this can increase process understanding and control, and mitigate the risk from substandard drug products to both manufacturer and patient. To optimize the benefits of PAT, the entire PAT framework must be considered and each elements of PAT must be carefully selected, including sensor and analytical technology, data analysis techniques, control strategies and algorithms, and process optimization routines. This chapter discusses the current state of PAT in the biopharmaceutical industry, including several case studies demonstrating the degree of maturity of various PAT tools. Graphical Abstract Hierarchy of QbD components.

Defective Reduction in Automotive Headlining Manufacturing Process

NASA Astrophysics Data System (ADS)

Rittichai, Saranya; Chutima, Parames

2016-05-01

In an automobile parts manufacturing company, currently the headlining process has a lot of wastes resulting in a high cost of quality per year. In this paper, the Six Sigma method is used to reduce the defects in the headlining process. Cause-and-effect matrix and failure mode and effect analysis (FMEA) were adopted to screen the factors that affect the quality of headlining. The 2k-1 fractional factorials design was also use to determine the potential preliminary root causes. The full factorial experiments was conducted to identify appropriate settings of the significant factors. The result showed that the process can reduce the defects of headlining from 12.21% to 6.95%

Continuous counter-current chromatography for capture and polishing steps in biopharmaceutical production.

PubMed

Steinebach, Fabian; Müller-Späth, Thomas; Morbidelli, Massimo

2016-09-01

The economic advantages of continuous processing of biopharmaceuticals, which include smaller equipment and faster, efficient processes, have increased interest in this technology over the past decade. Continuous processes can also improve quality assurance and enable greater controllability, consistent with the quality initiatives of the FDA. Here, we discuss different continuous multi-column chromatography processes. Differences in the capture and polishing steps result in two different types of continuous processes that employ counter-current column movement. Continuous-capture processes are associated with increased productivity per cycle and decreased buffer consumption, whereas the typical purity-yield trade-off of classical batch chromatography can be surmounted by continuous processes for polishing applications. In the context of continuous manufacturing, different but complementary chromatographic columns or devices are typically combined to improve overall process performance and avoid unnecessary product storage. In the following, these various processes, their performances compared with batch processing and resulting product quality are discussed based on a review of the literature. Based on various examples of applications, primarily monoclonal antibody production processes, conclusions are drawn about the future of these continuous-manufacturing technologies. Copyright © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule.

PubMed

2008-07-15

The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: CGMP for Phase 1 Investigational Drugs" dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process.

Manufacture of pooled platelets in additive solution and storage in an ELX container after an overnight warm temperature hold of platelet-rich plasma.

PubMed

Alhumaidan, Hiba; Cheves, Tracey; Holme, Stein; Sweeney, Joseph D

2011-10-01

The processing of whole blood-derived platelet-rich plasma (PRP) to a platelet concentrate and platelet-poor plasma is currently performed within 8 hours to comply with the requirements to manufacture fresh frozen plasma. Maintaining PRP at room temperature for a longer period can have the advantage of shifting the completion of component manufacture onto day shifts. Pairs of ABO-identical prepooled platelets were manufactured by the PRP method, using the current approach with platelet storage in a CLX HP container (Pall Medical, Covina, CA) and plasma, or a novel approach with an 18- to a 24-hour room temperature hold of the PRP and the manufacture of pooled platelets in a glucose-containing additive solution (AS) and storage in a new ELX container (Pall Medical). Standard in vitro assays were performed on days 2, 5, and 7. The results showed that the AS platelets in ELX have in vitro characteristics that are equivalent or superior to those of the standard product.

Intelligent Processing Equipment Research Supported by the National Science Foundation

NASA Technical Reports Server (NTRS)

Rao, Suren B.

1992-01-01

The research in progress on processes, workstations, and systems has the goal of developing a high level of understanding of the issues involved. This will enable the incorporation of a level of intelligence that will allow the creation of autonomous manufacturing systems that operate in an optimum manner, under a wide range of conditions. The emphasis of the research has been on the development of highly productive and flexible techniques to address current and future problems in manufacturing and processing. Several of these projects have resulted in well-defined and established models that can now be implemented in the application arena in the next few years.

Hot Melt Extruded and Injection Moulded Dosage Forms: Recent Research and Patents.

PubMed

Major, Ian; McConville, Christopher

2015-01-01

Hot Melt Extrusion (HME) and Injection Moulding (IM) are becoming more prevalent in the drug delivery field due to their continuous nature and advantages over current pharmaceutical manufacturing techniques. Hot melt extrusion (HME) is a process that involves the use of at least one reciprocating screw to force a thermoplastic resin along a heated barrel and through a die, while injection moulding is a forming process were molten polymer is forced at high pressure to enter a mould. HME offers a number of advantages over conventional pharmaceutical manufacturing techniques such as increased solubility and bioavailability of poorly water soluble drugs, a solvent free and continuous process, improved content uniformity and flexibility in manufacture. Injection moulding (IM) has been recognised as a rapid and versatile manufacturing technique, which has the advantages of being a continuous process, which is easily scaled up by the use of larger equipment and moulds. However, despite their advantages and the significant number of publications and patents on HME and IM drug delivery devices there are very few marketed formulations. These marketed products range from oral dosage forms which improve bioavailability and reduce pill burden to vaginal rings which provide long-term controlled release thus improving patient compliance. The patenting strategy for IM and HME seems to be focused towards patenting the finished product, more so than patenting the manufacturing process. This is probably due to the fact that the IM and HME processes have already been patented. HME is a process where raw materials (i.e. polymer, plasticizer, drug etc.) are mixed and pumped along by a rotating screw(s) at elevated temperatures through a die to produce a product of uniform shape. IM is similar to HME except that the raw materials are pushed into a mould which is set at lower temperatures. Interest in the use of HME and IM within the pharmaceutical industry is growing with as steady increase in the number of HME patents being issued and with more than 10 products, ranging from oral dosage forms to implantable devices, currently on the market. Therefore, this review of HME and IM is important to the scientific community to further understand and advance these novel and exciting manufacturing techniques.

Manufacturing Methods & Technology Project Execution Report. First CY 83.

DTIC Science & Technology

1983-11-01

UCCURRENCE. H 83 5180 MMT FOR METAL DEWAR AND UNBONDED LEADS THE GOLD WIRE BONDED CONNECTIOkS ARE MADE BY HAND WHICH IS A TEDIOUS AND EXPENSIVE PROCESS. THE...ATTACHMENTS CURRENT FILAMENT WOUND COMPOSIIE ROCKET MOTOR CASES REQUIRE FORGED METAL POLE PIECESt NOZZLE CLOSURE ATTACHMENT RINGS, AND OTHER ATTACHMENT RINGS... ELASTOMER INSULATOR PROCESS LARGE TACTICAL ROCKET MOTOR INSULATORS ARE COSTLY, LACK DESIGN CHANGE FLEXIBILITY AND SUFFER LONG LEAD TIMES. CURRENT

Intelligent Weld Manufacturing: Role of Integrated Computational Welding Engineering

DOE PAGES

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

2017-12-02

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

Additive Manufacturing of Thermoplastic Matrix Composites Using Ultrasonics

NASA Astrophysics Data System (ADS)

Olson, Meghan

Advanced composite materials have great potential for facilitating energy efficient product design and their manufacture if improvements are made to current composite manufacturing processes. This thesis focuses on the development of a novel manufacturing process for thermoplastic composite structures entitled Laser-Ultrasonic Additive Manufacturing ('LUAM'), which is intended to combine the benefits of laser processing technology, developed by Automated Dynamics Inc., with ultrasonic bonding technology that is used commercially for unreinforced polymers. These technologies used together have the potential to significantly reduce the energy consumption and void content of thermoplastic composites made using Automated Fiber Placement (AFP). To develop LUAM in a methodical manner with minimal risk, a staged approach was devised whereby coupon-level mechanical testing and prototyping utilizing existing equipment was accomplished. Four key tasks have been identified for this effort: Benchmarking, Ultrasonic Compaction, Laser Assisted Ultrasonic Compaction, and Demonstration and Characterization of LUAM. This thesis specifically addresses Tasks 1 and 2, i.e. Benchmarking and Ultrasonic Compaction, respectively. Task 1, fabricating test specimens using two traditional processes (autoclave and thermal press) and testing structural performance and dimensional accuracy, provide results of a benchmarking study by which the performance of all future phases will be gauged. Task 2, fabricating test specimens using a non-traditional process (ultrasonic conpaction) and evaluating in a similar fashion, explores the the role of ultrasonic processing parameters using three different thermoplastic composite materials. Further development of LUAM, although beyond the scope of this thesis, will combine laser and ultrasonic technology and eventually demonstrate a working system.

Intelligent Weld Manufacturing: Role of Integrated Computational Welding Engineering

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

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

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

Biological implications of lab-on-a-chip devices fabricated using multi-jet modelling and stereolithography processes

NASA Astrophysics Data System (ADS)

Zhu, Feng; Macdonald, Niall; Skommer, Joanna; Wlodkowic, Donald

2015-06-01

Current microfabrication methods are often restricted to two-dimensional (2D) or two and a half dimensional (2.5D) structures. Those fabrication issues can be potentially addressed by emerging additive manufacturing technologies. Despite rapid growth of additive manufacturing technologies in tissue engineering, microfluidics has seen relatively little developments with regards to adopting 3D printing for rapid fabrication of complex chip-based devices. This has been due to two major factors: lack of sufficient resolution of current rapid-prototyping methods (usually >100 μm ) and optical transparency of polymers to allow in vitro imaging of specimens. We postulate that adopting innovative fabrication processes can provide effective solutions for prototyping and manufacturing of chip-based devices with high-aspect ratios (i.e. above ration of 20:1). This work provides a comprehensive investigation of commercially available additive manufacturing technologies as an alternative for rapid prototyping of complex monolithic Lab-on-a-Chip devices for biological applications. We explored both multi-jet modelling (MJM) and several stereolithography (SLA) processes with five different 3D printing resins. Compared with other rapid prototyping technologies such as PDMS soft lithography and infrared laser micromachining, we demonstrated that selected SLA technologies had superior resolution and feature quality. We also for the first time optimised the post-processing protocols and demonstrated polymer features under scanning electronic microscope (SEM). Finally we demonstrate that selected SLA polymers have optical properties enabling high-resolution biological imaging. A caution should be, however, exercised as more work is needed to develop fully bio-compatible and non-toxic polymer chemistries.

Quarterly Report: Microchannel-Assisted Nanomaterial Deposition Technology for Photovoltaic Material Production

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

Palo, Daniel R.

2011-04-26

Quarterly report to ITP for Nanomanufacturing program. Report covers FY11 Q2. The primary objective of this project is to develop a nanomanufacturing process which will reduce the manufacturing energy, environmental discharge, and production cost associated with current nano-scale thin-film photovoltaic (PV) manufacturing approaches. The secondary objective is to use a derivative of this nanomanufacturing process to enable greener, more efficient manufacturing of higher efficiency quantum dot-based photovoltaic cells now under development. The work is to develop and demonstrate a scalable (pilot) microreactor-assisted nanomaterial processing platform for the production, purification, functionalization, and solution deposition of nanomaterials for photovoltaic applications. The highmore » level task duration is shown. Phase I consists of a pilot platform for Gen II PV films along with parallel efforts aimed at Gen III PV quantum dot materials. Status of each task is described.« less

Hybrid indirect/direct contactor for thermal management of counter-current processes

DOEpatents

Hornbostel, Marc D.; Krishnan, Gopala N.; Sanjurjo, Angel

2018-03-20

The invention relates to contactors suitable for use, for example, in manufacturing and chemical refinement processes. In an aspect is a hybrid indirect/direct contactor for thermal management of counter-current processes, the contactor comprising a vertical reactor column, an array of interconnected heat transfer tubes within the reactor column, and a plurality of stream path diverters, wherein the tubes and diverters are configured to block all straight-line paths from the top to bottom ends of the reactor column.

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

Ozeki, H.; Isono, T.; Uno, Y.

JAEA successfully completed the manufacture of the toroidal field (TF) insert coil (TFIC) for a performance test of the ITER TF conductor in the final design in cooperation with Hitachi, Ltd. The TFIC is a single-layer 8.875-turn solenoid coil with 1.44-m diameter. This will be tested for 68-kA current application in a 13-T external magnetic field. TFIC was manufactured in the following order: winding of the TF conductor, lead bending, fabrication of the electrical termination, heat treatment, turn insulation, installation of the coil into the support mandrel structure, vacuum pressure impregnation (VPI), structure assembly, and instrumentation. Here in this presentation,more » manufacture process and quality control status for the TFIC manufacturing are reported.« less

Additive Manufacturing Modeling and Simulation A Literature Review for Electron Beam Free Form Fabrication

NASA Technical Reports Server (NTRS)

Seufzer, William J.

2014-01-01

Additive manufacturing is coming into industrial use and has several desirable attributes. Control of the deposition remains a complex challenge, and so this literature review was initiated to capture current modeling efforts in the field of additive manufacturing. This paper summarizes about 10 years of modeling and simulation related to both welding and additive manufacturing. The goals were to learn who is doing what in modeling and simulation, to summarize various approaches taken to create models, and to identify research gaps. Later sections in the report summarize implications for closed-loop-control of the process, implications for local research efforts, and implications for local modeling efforts.

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.

Advanced Metalworking Solutions for Naval Systems That Go in Harm’s Way.

DTIC Science & Technology

2011-01-01

Cox, Titanium Fabrication Corporation, MMC, NSWCCD, ABS, and NMC. Navy Metalworking Center • Advanced Metallic Materials NMC has a successful record...Current efforts involve titanium , high-strength steel, and other alternate materials. 4 ADVANcED METALLic MATEriALS A cost-effective manufacturing solution...Manufacturing and Sustainment Technologies (iMAST). Improved shaft cladding materials and processes, which will increase the life of the main propulsion

Manufacture and Quality Control of Insert Coil with Real ITER TF Conductor

DOE PAGES

Ozeki, H.; Isono, T.; Uno, Y.; ...

2016-03-02

JAEA successfully completed the manufacture of the toroidal field (TF) insert coil (TFIC) for a performance test of the ITER TF conductor in the final design in cooperation with Hitachi, Ltd. The TFIC is a single-layer 8.875-turn solenoid coil with 1.44-m diameter. This will be tested for 68-kA current application in a 13-T external magnetic field. TFIC was manufactured in the following order: winding of the TF conductor, lead bending, fabrication of the electrical termination, heat treatment, turn insulation, installation of the coil into the support mandrel structure, vacuum pressure impregnation (VPI), structure assembly, and instrumentation. Here in this presentation,more » manufacture process and quality control status for the TFIC manufacturing are reported.« less

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

PubMed Central

Wang, Shiyong; Li, Di; Liu, Chengliang

2018-01-01

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

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

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.

Standard cell electrical and physical variability analysis based on automatic physical measurement for design-for-manufacturing purposes

NASA Astrophysics Data System (ADS)

Shauly, Eitan; Parag, Allon; Khmaisy, Hafez; Krispil, Uri; Adan, Ofer; Levi, Shimon; Latinski, Sergey; Schwarzband, Ishai; Rotstein, Israel

2011-04-01

A fully automated system for process variability analysis of high density standard cell was developed. The system consists of layout analysis with device mapping: device type, location, configuration and more. The mapping step was created by a simple DRC run-set. This database was then used as an input for choosing locations for SEM images and for specific layout parameter extraction, used by SPICE simulation. This method was used to analyze large arrays of standard cell blocks, manufactured using Tower TS013LV (Low Voltage for high-speed applications) Platforms. Variability of different physical parameters like and like Lgate, Line-width-roughness and more as well as of electrical parameters like drive current (Ion), off current (Ioff) were calculated and statistically analyzed, in order to understand the variability root cause. Comparison between transistors having the same W/L but with different layout configurations and different layout environments (around the transistor) was made in terms of performances as well as process variability. We successfully defined "robust" and "less-robust" transistors configurations, and updated guidelines for Design-for-Manufacturing (DfM).

Low-Cost Composite Materials and Structures for Aircraft Applications

NASA Technical Reports Server (NTRS)

Deo, Ravi B.; Starnes, James H., Jr.; Holzwarth, Richard C.

2003-01-01

A survey of current applications of composite materials and structures in military, transport and General Aviation aircraft is presented to assess the maturity of composites technology, and the payoffs realized. The results of the survey show that performance requirements and the potential to reduce life cycle costs for military aircraft and direct operating costs for transport aircraft are the main reasons for the selection of composite materials for current aircraft applications. Initial acquisition costs of composite airframe components are affected by high material costs and complex certification tests which appear to discourage the widespread use of composite materials for aircraft applications. Material suppliers have performed very well to date in developing resin matrix and fiber systems for improved mechanical, durability and damage tolerance performance. The next challenge for material suppliers is to reduce material costs and to develop materials that are suitable for simplified and inexpensive manufacturing processes. The focus of airframe manufacturers should be on the development of structural designs that reduce assembly costs by the use of large-scale integration of airframe components with unitized structures and manufacturing processes that minimize excessive manual labor.

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.

Recommendations regarding technical standards for follow-on biologics: comparability, similarity, interchangeability.

PubMed

Davis, Gregory C; Beals, John M; Johnson, Craig; Mayer, Mark H; Meiklejohn, Bruce I; Mitlak, Bruce H; Roth, Jody L; Towns, John K; Veenhuizen, Melissa

2009-07-01

Policy makers around the world are currently considering the creation of a regulatory pathway for follow-on biologics (FOB), which will have to account for the substantial technical challenges associated with FOB development. These challenges will likely involve more complexity than comparability assessments of process changes made by the same manufacturer. The history of industry-regulator comparability discussions helps explain why the same degree of testing and flexibility now applied to change-control within a manufacturer's own process, at this time, cannot be extrapolated to the observed and possibly unknown differences between two manufacturing processes that are independently developed by different (non-collaborating) parties. This commentary provides recommendations on the technical aspects that should be considered in the creation of an approval pathway for FOB products. In the authors' view, analytical methodology in its current state cannot alone provide full assurance that the FOB is sufficiently similar to the innovator product. Moreover, the FOB manufacturer will not have access to the extensive knowledge accumulated by the innovator manufacturer from early development through marketing. Thus, extensive clinical evaluation will likely be necessary to provide assurance that the FOB is safe and efficacious. If such testing demonstrates the FOB is safe and efficacious per existing regulatory standards, the product should receive marketing approval as a 'similar' product. Since 'similarity' is a fundamentally different determination than establishing interchangeability between the two products, an interchangeability determination must be based on additional testing and market experience to ensure patient safety. Post-marketing surveillance of the FOB should be conducted to ensure that the approved molecule has similar clinical safety and efficacy as the innovator product, prior to any consideration of interchangeability.

Solid state laser applications in photovoltaics manufacturing

NASA Astrophysics Data System (ADS)

Dunsky, Corey; Colville, Finlay

2008-02-01

Photovoltaic energy conversion devices are on a rapidly accelerating growth path driven by increasing government and societal pressure to use renewable energy as part of an overall strategy to address global warming attributed to greenhouse gas emissions. Initially supported in several countries by generous tax subsidies, solar cell manufacturers are relentlessly pushing the performance/cost ratio of these devices in a quest to reach true cost parity with grid electricity. Clearly this eventual goal will result in further acceleration in the overall market growth. Silicon wafer based solar cells are currently the mainstay of solar end-user installations with a cost up to three times grid electricity. But next-generation technology in the form of thin-film devices promises streamlined, high-volume manufacturing and greatly reduced silicon consumption, resulting in dramatically lower per unit fabrication costs. Notwithstanding the modest conversion efficiency of thin-film devices compared to wafered silicon products (around 6-10% versus 15-20%), this cost reduction is driving existing and start-up solar manufacturers to switch to thin-film production. A key aspect of these devices is patterning large panels to create a monolithic array of series-interconnected cells to form a low current, high voltage module. This patterning is accomplished in three critical scribing processes called P1, P2, and P3. Lasers are the technology of choice for these processes, delivering the desired combination of high throughput and narrow, clean scribes. This paper examines these processes and discusses the optimization of industrial lasers to meet their specific needs.

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

DOE PAGES

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

2017-09-11

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

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

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

An, Ke; Yuan, Lang; Dial, Laura

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

21 CFR 225.1 - Current good manufacturing practice.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Current good manufacturing practice. 225.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS General Provisions § 225.1 Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act...

21 CFR 226.1 - Current good manufacturing practice.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Current good manufacturing practice. 226.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES General Provisions § 226.1 Current good manufacturing practice. (a) The criteria in §§ 226.10 through 226.115, inclusive...

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.

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.

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.

Microgravity Manufacturing

NASA Technical Reports Server (NTRS)

Cooper, Ken; Munafo, Paul M. (Technical Monitor)

2002-01-01

Manufacturing capability in outer space remains one of the critical milestones to surpass to allow humans to conduct long-duration manned space exploration. The high cost-to-orbit for leaving the Earth's gravitational field continues to be the limiting factor in carrying sufficient hardware to maintain extended life support in microgravity or on other planets. Additive manufacturing techniques, or 'chipless' fabrication, like RP are being considered as the most promising technologies for achieving in situ or remote processing of hardware components, as well as for the repair of existing hardware. At least three RP technologies are currently being explored for use in microgravity and extraterrestrial fabrication.

Magnesium in North America: A Changing Landscape

NASA Astrophysics Data System (ADS)

Slade, Susan

The changing landscape of North American manufacturing in the context of global competition is impacting the market of all raw materials, including magnesium. Current automotive fuel economy legislation and pending legislation on the emissions of greenhouse gases are impacting magnesium's largest consuming industries, such as aluminum, automotive components, steel and transition metals. These industries are all considering innovative ways to efficiently incorporate the needed raw materials into their processes. The North American magnesium market differs from other regions based on maturity, supply streams, changing manufacturing capabilities and trade cases, combined with the transformation of North American manufacturing.

Application of Rapid Prototyping and Wire Arc Spray to the Fabrication of Injection Mold Tools (MSFC Center Director's Discretionary Fund)

NASA Technical Reports Server (NTRS)

Cooper, K. G.

2000-01-01

Rapid prototyping (RP) is a layer-by-layer-based additive manufacturing process for constructing three-dimensional representations of a computer design from a wax, plastic, or similar material. Wire arc spray (WAS) is a metal spray forming technique, which deposits thin layers of metal onto a substrate or pattern. Marshall Space Flight Center currently has both capabilities in-house, and this project proposed merging the two processes into an innovative manufacturing technique, in which intermediate injection molding tool halves were to be fabricated with RP and WAS metal forming.

Additive Manufacturing of Advanced High Temperature Masking Fixtures for EBPVD TBC Coating

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

List, III, Frederick Alyious; Feuerstein, Albert; Dehoff, Ryan

2016-03-30

The purpose of this Manufacturing Demonstration Facility (MDF) technical collaboration project between Praxair Surface Technologies, Inc. (PST) and Oak Ridge National Laboratory (ORNL) was to develop an additive manufacturing process to fabricate next generation high temperature masking fixtures for coating of turbine airfoils with ceramic Thermal Barrier Coatings (TBC) by the Electron Beam Physical Vapor Deposition (EBPVD) process. Typical masking fixtures are sophisticated designs and require complex part manipulation in order to achieve the desired coating distribution. Fixtures are typically fabricated from high temperature nickel (Ni) based superalloys. The fixtures are fabricated from conventional processes by welding of thin sheetmore » material into a complex geometry, to decrease the weight load for the manipulator and to reduce the thermal mass of the fixture. Recent attempts have been made in order to fabricate the fixtures through casting, but thin walled sections are difficult to cast and have high scrap rates. This project focused on understanding the potential for fabricating high temperature Ni based superalloy fixtures through additive manufacturing. Two different deposition processes; electron beam melting (EBM) and laser powder bed fusion were evaluated to determine the ideal processing route of these materials. Two different high temperature materials were evaluated. The high temperature materials evaluated were Inconel 718 and another Ni base alloy, designated throughout the remainder of this document as Alloy X, as the alloy composition is sensitive. Inconel 718 is a more widely utilized material for additive manufacturing although it is not currently the material utilized for current fixtures. Alloy X is the alloy currently used for the fixtures, but is not a commercially available alloy for additive manufacturing. Praxair determined it was possible to build the fixture using laser powder bed technology from Inconel 718. ORNL fabricated the fixture geometry using the EBM technology in order to compare deposition features such as surface roughness, geometric accuracy, deposition rate, surface and subsurface porosity, and material quality. It was determined that the laser powder bed technology was ideal for the geometry and requirements of the fixture set by Praxair, and Praxair moved forward with the purchase of a laser powder bed system. The subsequent portion of the project focused on determining the ideal processing parameters for alloy X for the laser powder bed system using ORNL’s Renishaw laser powder bed system. Praxair supplied gas atomized powders of alloy X material with properties specified by ORNL. ORNL printed text cube arrays in order to determine the ideal combination of laser powder and laser travel speed in order to maximize material density, improve surface quality, and maintain geometric accuracy. Additional powder supplied by Praxair was used to fabricate a full-scale fixture component.« less

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

A case study on Simulation and Design optimization to improve Productivity in cooling tower manufacturing industry

NASA Astrophysics Data System (ADS)

Pranav Nithin, R.; Gopikrishnan, S.; Sumesh, A.

2018-02-01

Cooling towers are the heat transfer devices commonly found in industries which are used to extract the high temperature from the coolants and make it reusable in various plants. Basically, the cooling towers has Fills made of PVC sheets stacked together to increase the surface area exposure of the cooling liquid flowing through it. This paper focuses on the study in such a manufacturing plant where fills are being manufactured. The productivity using the current manufacturing method was only 6 to 8 fills per day, where the ideal capacity was of 14 fills per day. In this plant manual labor was employed in the manufacturing process. A change in the process modification designed and implemented will help the industry to increase the productivity to 14. In this paper, initially the simulation study was done using ARENA the simulation package and later the new design was done using CAD Package and validated using Ansys Mechanical APDL. It’s found that, by the implementation of the safe design the productivity can be increased to 196 Units.

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

PubMed

2008-01-01

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

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

PubMed

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

2018-06-06

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

21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false What is current good manufacturing practice for... HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS (Eff. 12-12-2011) General Provisions § 212.2 What is current good manufacturing practice for...

Solid State Lighting Program (Falcon)

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

Meeks, Steven

2012-06-30

Over the past two years, KLA-Tencor and partners successfully developed and deployed software and hardware tools that increase product yield for High Brightness LED (HBLED) manufacturing and reduce product development and factory ramp times. This report summarizes our development effort and details of how the results of the Solid State Light Program (Falcon) have started to help HBLED manufacturers optimize process control by enabling them to flag and correct identified killer defect conditions at any point of origin in the process manufacturing flow. This constitutes a quantum leap in yield management over current practice. Current practice consists of die dispositioningmore » which is just rejection of bad die at end of process based upon probe tests, loosely assisted by optical in-line monitoring for gross process deficiencies. For the first time, and as a result of our Solid State Lighting Program, our LED manufacturing partners have obtained the software and hardware tools that optimize individual process steps to control killer defects at the point in the processes where they originate. Products developed during our two year program enable optimized inspection strategies for many product lines to minimize cost and maximize yield. The Solid State Lighting Program was structured in three phases: i) the development of advanced imaging modes that achieve clear separation between LED defect types, improves signal to noise and scan rates, and minimizes nuisance defects for both front end and back end inspection tools, ii) the creation of defect source analysis (DSA) software that connect the defect maps from back-end and front-end HBLED manufacturing tools to permit the automatic overlay and traceability of defects between tools and process steps, suppress nuisance defects, and identify the origin of killer defects with process step and conditions, and iii) working with partners (Philips Lumileds) on product wafers, obtain a detailed statistical correlation of automated defect and DSA map overlay to failed die identified using end product probe test results. Results from our two year effort have led to “automated end-to-end defect detection” with full defect traceability and the ability to unambiguously correlate device killer defects to optically detected features and their point of origin within the process. Success of the program can be measured by yield improvements at our partner’s facilities and new product orders.« less

Process Evaluation Results from an Environmentally Focused Worksite Weight Management Study

ERIC Educational Resources Information Center

DeJoy, David M.; Wilson, Mark G.; Padilla, Heather M.; Goetzel, Ron Z.; Parker, Kristin B.; Della, Lindsay J.; Roemer, Enid C.

2012-01-01

There is currently much interest in exploring environmental approaches to combat weight gain and obesity. This study presents process evaluation results from a workplace-based study that tested two levels of environmentally focused weight management interventions in a manufacturing setting. The moderate treatment featured a set of relatively…

77 FR 31828 - Notice of Request for Extension of a Currently Approved Information Collection for the...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-30

... equipment used in dairy, meat or poultry industries for evaluation regarding sanitary design and... Processed Dairy Products AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice and request for... of Manufactured or Processed Dairy Products, and the Certification of Sanitary Design and Fabrication...

TSCA Chemical Substance Inventory

EPA Pesticide Factsheets

Section 8 (b) of the Toxic Substances Control Act (TSCA) requires EPA to compile, keep current, and publish a list of each chemical substance that is manufactured or processed in the United States for TSCA uses.

Process-Structure-Property Relationships for 316L Stainless Steel Fabricated by Additive Manufacturing and Its Implication for Component Engineering

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

Yang, Nancy; Yee, J.; Zheng, B.

We investigate the process-structure-property relationships for 316L stainless steel prototyping utilizing 3-D laser engineered net shaping (LENS), a commercial direct energy deposition additive manufacturing process. Our study concluded that the resultant physical metallurgy of 3-D LENS 316L prototypes is dictated by the interactive metallurgical reactions, during instantaneous powder feeding/melting, molten metal flow and liquid metal solidification. This study also showed 3-D LENS manufacturing is capable of building high strength and ductile 316L prototypes due to its fine cellular spacing from fast solidification cooling, and the well-fused epitaxial interfaces at metal flow trails and interpass boundaries. However, without further LENS processmore » control and optimization, the deposits are vulnerable to localized hardness variation attributed to heterogeneous microstructure, i.e., the interpass heat-affected zone (HAZ) from repetitive thermal heating during successive layer depositions. Most significantly, the current deposits exhibit anisotropic tensile behavior, i.e., lower strain and/or premature interpass delamination parallel to build direction (axial). This anisotropic behavior is attributed to the presence of interpass HAZ, which coexists with flying feedstock inclusions and porosity from incomplete molten metal fusion. Our current observations and findings contribute to the scientific basis for future process control and optimization necessary for material property control and defect mitigation.« less

Process-Structure-Property Relationships for 316L Stainless Steel Fabricated by Additive Manufacturing and Its Implication for Component Engineering

DOE PAGES

Yang, Nancy; Yee, J.; Zheng, B.; ...

2016-12-08

We investigate the process-structure-property relationships for 316L stainless steel prototyping utilizing 3-D laser engineered net shaping (LENS), a commercial direct energy deposition additive manufacturing process. Our study concluded that the resultant physical metallurgy of 3-D LENS 316L prototypes is dictated by the interactive metallurgical reactions, during instantaneous powder feeding/melting, molten metal flow and liquid metal solidification. This study also showed 3-D LENS manufacturing is capable of building high strength and ductile 316L prototypes due to its fine cellular spacing from fast solidification cooling, and the well-fused epitaxial interfaces at metal flow trails and interpass boundaries. However, without further LENS processmore » control and optimization, the deposits are vulnerable to localized hardness variation attributed to heterogeneous microstructure, i.e., the interpass heat-affected zone (HAZ) from repetitive thermal heating during successive layer depositions. Most significantly, the current deposits exhibit anisotropic tensile behavior, i.e., lower strain and/or premature interpass delamination parallel to build direction (axial). This anisotropic behavior is attributed to the presence of interpass HAZ, which coexists with flying feedstock inclusions and porosity from incomplete molten metal fusion. Our current observations and findings contribute to the scientific basis for future process control and optimization necessary for material property control and defect mitigation.« less

Innovative manufacturing and materials for low cost lithium ion batteries

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

Carlson, Steven

2015-12-29

This project demonstrated entirely new manufacturing process options for lithium ion batteries with major potential for improved cost and performance. These new manufacturing approaches are based on the use of the new electrode-coated separators instead of the conventional electrode-coated metal current collector foils. The key enabler to making these electrode-coated separators is a new and unique all-ceramic separator with no conventional porous plastic separator present. A simple, low cost, and high speed manufacturing process of a single coating of a ceramic pigment and polymer binder onto a re-usable release film, followed by a subsequent delamination of the all-ceramic separator andmore » any layers coated over it, such as electrodes and metal current collectors, was utilized. A suitable all-ceramic separator was developed that demonstrated the following required features needed for making electrode-coated separators: (1) no pores greater than 100 nanometer (nm) in diameter to prevent any penetration of the electrode pigments into the separator; (2) no shrinkage of the separator when heated to the high oven heats needed for drying of the electrode layer; and (3) no significant compression of the separator layer by the high pressure calendering step needed to densify the electrodes by about 30%. In addition, this nanoporous all-ceramic separator can be very thin at 8 microns thick for increased energy density, while providing all of the performance features provided by the current ceramic-coated plastic separators used in vehicle batteries: improved safety, longer cycle life, and stability to operate at voltages up to 5.0 V in order to obtain even more energy density. The thin all-ceramic separator provides a cost savings of at least 50% for the separator component and by itself meets the overall goal of this project to reduce the cell inactive component cost by at least 20%. The all-ceramic separator also enables further cost savings by its excellent heat stability with no shrinkage at up to 220oC. This allows vacuum drying of the dry cell just before filling with the electrolyte and thereby can reduce the size of the cell assembly dry room by 50%. Once the electrode-coated separator is produced, there are many different approaches for adding the metal current collector layers and making and connecting the tabs of the cells. These approaches include: (1) laminating the electrode side of the electrode-coated separator to both sides of a metal current collector; and (2) making a full coated electrode stack by coating or depositing a current collector layer on the electrode side and then coating a second electrode layer onto the current collector. Further cost savings are available from using lower cost and/or thinner and lighter current collectors and from using a separator coating manufacturing process at widths of 1.5 meters (m) or more and at high production line speeds of up to 125 meters per minute (mpm), both of which are well above the conventional coating widths and line speeds presently used in manufacturing electrodes for lithium ion batteries.« less

One-step manufacturing of innovative flat-knitted 3D net-shape preforms for composite applications

NASA Astrophysics Data System (ADS)

Bollengier, Quentin; Wieczorek, Florian; Hellmann, Sven; Trümper, Wolfgang; Cherif, Chokri

2017-10-01

Mostly due to the cost-intensive manually performed processing operations, the production of complex-shaped fibre reinforced plastic composites (FRPC) is currently very expensive and therefore either restricted to sectors with high added value or for small batch applications (e.g. in the aerospace or automotive industry). Previous works suggest that the successful integration of conventional textile manufacturing processes in the FRPC-process chain is the key to a cost-efficient manufacturing of complex three-dimensional (3D) FRPC-components with stress-oriented fibre arrangement. Therefore, this work focuses on the development of the multilayer weft knitting technology for the one-step manufacturing of complex 3D net-shaped preforms for high performance FRPC applications. In order to highlight the advantages of net-shaped multilayer weft knitted fabrics for the production of complex FRPC parts, seamless preforms such as 3D skin-stringer structures and tubular fabrics with load oriented fibre arrangement are realised. In this paper, the development of the textile bindings and performed technical modifications on flat knitting machines are presented. The results show that the multilayer weft knitting technology meets perfectly the requirements for a fully automated and reproducible manufacturing of complex 3D textile preforms with stress-oriented fibre arrangement.

Gram-scale production of plasmid pUDK-HGF with current good manufacturing practices for gene therapy of critical limb ischemia.

PubMed

Hu, ChunSheng; Cheng, XiaoChen; Lu, YuXin; Wu, ZuZe; Zhang, QingLin

2016-11-16

The demand of a plasmid encoding human hepatocyte growth factor gene (pUDK-HGF) in large quantities at high purity and concentration has increased for gene therapy of critical limb ischemia (CLI) in clinical trials. In this article, we produced pUDK-HGF in compliance with current good manufacturing practices at gram scale. The process included a 50-L batch fermentation, continuous alkaline lysis, and integrated three-step chromatography on Sepharose 6 Fast Flow, PlasmidSelect Xtra, and Source 15Q. The production process has been scaled up to yield 4.24 ± 0.41 g of pharmaceutical pUDK-HGF from 1.0 kg bacterial cell paste and the overall yield reached range from 58.37 to 66.70%. The final pUDK-HGF product exhibited high purity with supercoiled percentage of > 95.8% and undetectable residual RNA, contaminated protein, and bacterial endotoxin. The phase I clinical study indicates that intramuscular injection of pUDK-HGF is safe, well tolerated, and may provide symptomatic relief to CLI patients. These results show that our manufacturing process of pUDK-HGF is efficient in producing pharmaceutical-grade plasmid DNA and is safe for clinical applications.

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

NASA Astrophysics Data System (ADS)

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

2018-02-01

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

Solvent-Free Manufacturing of Electrodes for Lithium-ion Batteries

NASA Astrophysics Data System (ADS)

Ludwig, Brandon; Zheng, Zhangfeng; Shou, Wan; Wang, Yan; Pan, Heng

2016-03-01

Lithium ion battery electrodes were manufactured using a new, completely dry powder painting process. The solvents used for conventional slurry-cast electrodes have been completely removed. Thermal activation time has been greatly reduced due to the time and resource demanding solvent evaporation process needed with slurry-cast electrode manufacturing being replaced by a hot rolling process. It has been found that thermal activation time to induce mechanical bonding of the thermoplastic polymer to the remaining active electrode particles is only a few seconds. Removing the solvent and drying process allows large-scale Li-ion battery production to be more economically viable in markets such as automotive energy storage systems. By understanding the surface energies of various powders which govern the powder mixing and binder distribution, bonding tests of the dry-deposited particles onto the current collector show that the bonding strength is greater than slurry-cast electrodes, 148.8 kPa as compared to 84.3 kPa. Electrochemical tests show that the new electrodes outperform conventional slurry processed electrodes, which is due to different binder distribution.

Design of novel materials for additive manufacturing - Isotropic microstructure and high defect tolerance.

PubMed

Günther, J; Brenne, F; Droste, M; Wendler, M; Volkova, O; Biermann, H; Niendorf, T

2018-01-22

Electron Beam Melting (EBM) is a powder-bed additive manufacturing technology enabling the production of complex metallic parts with generally good mechanical properties. However, the performance of powder-bed based additively manufactured materials is governed by multiple factors that are difficult to control. Alloys that solidify in cubic crystal structures are usually affected by strong anisotropy due to the formation of columnar grains of preferred orientation. Moreover, processing induced defects and porosity detrimentally influence static and cyclic mechanical properties. The current study presents results on processing of a metastable austenitic CrMnNi steel by EBM. Due to multiple phase transformations induced by intrinsic heat-treatment in the layer-wise EBM process the material develops a fine-grained microstructure almost without a preferred crystallographic grain orientation. The deformation-induced phase transformation yields high damage tolerance and, thus, excellent mechanical properties less sensitive to process-induced inhomogeneities. Various scan strategies were applied to evaluate the width of an appropriate process window in terms of microstructure evolution, porosity and change of chemical composition.

High Power Laser Processing Of Materials

NASA Astrophysics Data System (ADS)

Martyr, D. R.; Holt, T.

1987-09-01

The first practical demonstration of a laser device was in 1960 and in the following years, the high power carbon dioxide laser has matured as an industrial machine tool. Modern carbon dioxide gas lasers can be used for cutting, welding, heat treatment, drilling, scribing and marking. Since their invention over 25 years ago they are now becoming recognised as highly reliable devices capable of achieving huge savings in production costs in many situations. This paper introduces the basic laser processing techniques of cutting, welding and heat treatment as they apply to the most common engineering materials. Typical processing speeds achieved with a wide range of laser powers are reported. Accuracies achievable and fit-up tolerances required are presented. Methods of integrating lasers with machine tools are described and their suitability in a wide range of manufacturing industries is described by reference to recent installations. Examples from small batch manufacturing, high volume production using dedicated laser welding equipment, and high volume manufacturing using 'flexible' automated laser welding equipment are described Future applications of laser processing are suggested by reference to current process developments.

Physical evaluations of Co-Cr-Mo parts processed using different additive manufacturing techniques

NASA Astrophysics Data System (ADS)

Ghani, Saiful Anwar Che; Mohamed, Siti Rohaida; Harun, Wan Sharuzi Wan; Noar, Nor Aida Zuraimi Md

2017-12-01

In recent years, additive manufacturing with highly design customization has gained an important technique for fabrication in aerospace and medical fields. Despite the ability of the process to produce complex components with highly controlled architecture geometrical features, maintaining the part's accuracy, ability to fabricate fully functional high density components and inferior surfaces quality are the major obstacles in producing final parts using additive manufacturing for any selected application. This study aims to evaluate the physical properties of cobalt chrome molybdenum (Co-Cr-Mo) alloys parts fabricated by different additive manufacturing techniques. The full dense Co-Cr-Mo parts were produced by Selective Laser Melting (SLM) and Direct Metal Laser Sintering (DMLS) with default process parameters. The density and relative density of samples were calculated using Archimedes' principle while the surface roughness on the top and side surface was measured using surface profiler. The roughness average (Ra) for top surface for SLM produced parts is 3.4 µm while 2.83 µm for DMLS produced parts. The Ra for side surfaces for SLM produced parts is 4.57 µm while 9.0 µm for DMLS produced parts. The higher Ra values on side surfaces compared to the top faces for both manufacturing techniques was due to the balling effect phenomenon. The yield relative density for both Co-Cr-Mo parts produced by SLM and DMLS are 99.3%. Higher energy density has influence the higher density of produced samples by SLM and DMLS processes. The findings of this work demonstrated that SLM and DMLS process with default process parameters have effectively produced full dense parts of Co-Cr-Mo with high density, good agreement of geometrical accuracy and better surface finish. Despite of both manufacturing process yield that produced components with higher density, the current finding shows that SLM technique could produce components with smoother surface quality compared to DMLS process with default parameters.

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

Facility for orbital material processing

NASA Astrophysics Data System (ADS)

Starodubov, D.; McCormick, K.; Dellosa, M.; Erdelyi, E.; Volfson, L.

2018-05-01

The sustainable orbital manufacturing with commercially viable and profitable operation has tremendous potential for driving the space exploration industry and human expansion into outer space. This highly challenging task has never been accomplished before. The current relatively high delivery cost of materials represents the business challenge of value proposition for making products in space. FOMS Inc. team identified an opportunity of fluoride optical fiber manufacturing in space that can lead to the first commercial production on orbit. To address continued cost effective International Space Station (ISS) operations FOMS Inc. has developed and demonstrated for the first time a fully operational space facility for orbital remote manufacturing with up to 50 km fiber fabrication capability and strong commercial potential for manufacturing operations on board the ISS.

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

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

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

In-Space Manufacturing Baseline Property Development

NASA Technical Reports Server (NTRS)

Stockman, Tom; Schneider, Judith; Prater, Tracie; Bean, Quincy; Werkheiser, Nicki

2016-01-01

The In-Space Manufacturing (ISM) project at NASA Marshall Space Flight Center currently operates a 3D FDM (fused deposition modeling) printer onboard the International Space Station. In order to enable utilization of this capability by designer, the project needs to establish characteristic material properties for materials produced using the process. This is difficult for additive manufacturing since standards and specifications do not yet exist for these technologies. Due to availability of crew time, there are limitations to the sample size which in turn limits the application of the traditional design allowables approaches to develop a materials property database for designers. In this study, various approaches to development of material databases were evaluated for use by designers of space systems who wish to leverage in-space manufacturing capabilities. This study focuses on alternative statistical techniques for baseline property development to support in-space manufacturing.

Additive Manufacturing of Multifunctional Components Using High Density Carbon Nanotube Yarn Filaments

NASA Technical Reports Server (NTRS)

Gardner, John M.; Sauti, Godfrey; Kim, Jae-Woo; Cano, Roberto J.; Wincheski, Russell A.; Stelter, Christopher J.; Grimsley, Brian W.; Working, Dennis C.; Siochi, Emilie J.

2016-01-01

Additive manufacturing allows for design freedom and part complexity not currently attainable using traditional manufacturing technologies. Fused Filament Fabrication (FFF), for example, can yield novel component geometries and functionalities because the method provides a high level of control over material placement and processing conditions. This is achievable by extrusion of a preprocessed filament feedstock material along a predetermined path. However if fabrication of a multifunctional part relies only on conventional filament materials, it will require a different material for each unique functionality printed into the part. Carbon nanotubes (CNTs) are an attractive material for many applications due to their high specific strength as well as good electrical and thermal conductivity. The presence of this set of properties in a single material presents an opportunity to use one material to achieve multifunctionality in an additively manufactured part. This paper describes a recently developed method for processing continuous CNT yarn filaments into three-dimensional articles, and summarizes the mechanical, electrical, and sensing performance of the components fabricated in this way.

Structural Optimisation Of Payload Fairings

NASA Astrophysics Data System (ADS)

Santschi, Y.; Eaton, N.; Verheyden, S.; Michaud, V.

2012-07-01

RUAG Space are developing materials and processing technologies for manufacture of the Next Generation Launcher (NGL) payload fairing, together with the Laboratory of Polymer and Composite Technology at the EPFL, in a project running under the ESA Future Launchers Preparatory Program (FLPP). In this paper the general aims and scope of the project are described, details of the results obtained shall be presented at a later stage. RUAG Space design, develop and manufacture fairings for the European launch vehicles Ariane 5 and VEGA using well proven composite materials and production methods which provide adequate cost/performance ratio for these applications. However, the NGL shall make full use of innovations in materials and process technologies to achieve a gain in performance at a much reduced overall manufacturing cost. NGL is scheduled to become operational in 2025, with actual development beginning in 2014. In this current project the basic technology is being developed and validated, in readiness for application in the NGL. For this new application, an entirely new approach to the fairing manufacture is evaluated.

Concise Review: Mind the Gap: Challenges in Characterizing and Quantifying Cell- and Tissue-Based Therapies for Clinical Translation

PubMed Central

Rayment, Erin A; Williams, David J

2010-01-01

There are many challenges associated with characterizing and quantifying cells for use in cell- and tissue-based therapies. From a regulatory perspective, these advanced treatments must not only be safe and effective but also be made by high-quality manufacturing processes that allow for on-time delivery of viable products. Although sterility assays can be adapted from conventional bioprocessing, cell- and tissue-based therapies require more stringent safety assessments, especially in relation to use of animal products, immune reaction, and potential instability due to extended culture times. Furthermore, cell manufacturers who plan to use human embryonic stem cells in their therapies need to be particularly stringent in their final purification steps, due to the unrestricted growth potential of these cells. This review summarizes the current issues in characterization and quantification for cell- and tissue-based therapies, dividing these challenges into the regulatory themes of safety, potency, and manufacturing quality. It outlines current assays in use, as well as highlights the limits of many of these product release tests. Mode of action is discussed, with particular reference to in vitro surrogate assays that can be used to provide information to correlate with proposed in vivo patient efficacy. Importantly, this review highlights the requirement for basic research to improve current knowledge on the in vivo fate of these treatments; as well as an improved stakeholder negotiation process to identify the measurement requirements that will ensure the manufacture of the best possible cell- and tissue-based therapies within the shortest timeframe for the most patient benefit. PMID:20333747

Inkjet printing for pharmaceutics - A review of research and manufacturing.

PubMed

Daly, Ronan; Harrington, Tomás S; Martin, Graham D; Hutchings, Ian M

2015-10-30

Global regulatory, manufacturing and consumer trends are driving a need for change in current pharmaceutical sector business models, with a specific focus on the inherently expensive research costs, high-risk capital-intensive scale-up and the traditional centralised batch manufacturing paradigm. New technologies, such as inkjet printing, are being explored to radically transform pharmaceutical production processing and the end-to-end supply chain. This review provides a brief summary of inkjet printing technologies and their current applications in manufacturing before examining the business context driving the exploration of inkjet printing in the pharmaceutical sector. We then examine the trends reported in the literature for pharmaceutical printing, followed by the scientific considerations and challenges facing the adoption of this technology. We demonstrate that research activities are highly diverse, targeting a broad range of pharmaceutical types and printing systems. To mitigate this complexity we show that by categorising findings in terms of targeted business models and Active Pharmaceutical Ingredient (API) chemistry we have a more coherent approach to comparing research findings and can drive efficient translation of a chosen drug to inkjet manufacturing. Copyright © 2015 Elsevier B.V. All rights reserved.

Microstructural evolution and mechanical property of Ti-6Al-4V wall deposited by continuous plasma arc additive manufacturing without post heat treatment.

PubMed

Lin, Jianjun; Lv, Yaohui; Liu, Yuxin; Sun, Zhe; Wang, Kaibo; Li, Zhuguo; Wu, Yixiong; Xu, Binshi

2017-05-01

Plasma arc additive manufacturing (PAM) is a novel additive manufacturing (AM) technology due to its big potential in improving efficiency, convenience and being cost-savings compared to other AM processes of high energy bea\\m. In this research, several Ti-6Al-4V thin walls were deposited by optimized weld wire-feed continuous PAM process (CPAM), in which the heat input was gradually decreased layer by layer. The deposited thin wall consisted of various morphologies, which includes epitaxial growth of prior β grains, horizontal layer bands, martensite and basket weave microstructure, that depends on the heat input, multiple thermal cycles and gradual cooling rate in the deposition process. By gradually reducing heat input of each bead and using continuous current in the PAM process, the average yield strength (YS), ultimate tensile strength (UTS) and elongation reach about 877MPa, 968MPa and 1.5%, respectively, which exceed the standard level of forging. The mechanical property was strengthened and toughened due to weakening the aspect ratio of prior β grains and separating nano-dispersoids among α lamellar. Furthermore, this research demonstrates that the CPAM process has a potential to manufacture or remanufacture in AM components of metallic biomaterials without post-processing heat treatment. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

PubMed

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

2017-01-01

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

Investigation of plasma arc welding as a method for the additive manufacturing of titanium-(6)aluminum-(4)vanadium alloy components

NASA Astrophysics Data System (ADS)

Stavinoha, Joe N.

The process of producing near net-shape components by material deposition is known as additive manufacturing. All additive manufacturing processes are based on the addition of material with the main driving forces being cost reduction and flexibility in both manufacturing and product design. With wire metal deposition, metal is deposited as beads side-by-side and layer-by-layer in a desired pattern to build a complete component or add features on a part. There are minimal waste products, low consumables, and an efficient use of energy and feedstock associated with additive manufacturing processes. Titanium and titanium alloys are useful engineering materials that possess an extraordinary combination of properties. Some of the properties that make titanium advantageous for structural applications are its high strength-to-weight ratio, low density, low coefficient of thermal expansion, and good corrosion resistance. The most commonly used titanium alloy, Ti-6Al-4V, is typically used in aerospace applications, pressure vessels, aircraft gas turbine disks, cases and compressor blades, and surgical implants. Because of the high material prices associated with titanium alloys, the production of near net-shape components by additive manufacturing is an attractive option for the manufacturing of Ti-6Al-4V alloy components. In this thesis, the manufacturing of cylindrical Ti-6Al-4V alloy specimens by wire metal deposition utilizing the plasma arc welding process was demonstrated. Plasma arc welding is a cost effective additive manufacturing technique when compared to other current additive manufacturing methods such as laser beam welding and electron beam welding. Plasma arc welding is considered a high-energy-density welding processes which is desirable for the successful welding of titanium. Metal deposition was performed using a constant current plasma arc welding power supply, flow-purged welding chamber, argon shielding and orifice gas, ERTi-5 filler metal, and Ti-6Al-4V alloy substrates. Cylindrical weld metal deposits were built by employing an automatic wire feeder, turntable positioner, and vertical torch positioner. A total of four cylindrical weld metal specimens were built with various combinations of essential plasma arc welding process parameters. The temperature of the weld metal deposit was taken with a thermocouple after allowing a specified amount of time to pass before depositing the next weld track. An analytical heat flow model was created that estimated the temperature of the weld metal deposit in relation to the number of tracks deposited. The analytical heat flow model was adjusted to match the experimental data that was obtained and revealed that the rate of production could be increased if the rate of thermal energy losses from the deposit were increased. Cross-sections of the weld metal deposits were examined to observe the effects of thermal energy input on the weld metal macrostructure, microstructure, and grain size. Results from the metallographic inspections revealed an increase in grain size and coarsening of the structure as the number of weld tracks in the deposit increased.

Industrial biomanufacturing: The future of chemical production.

PubMed

Clomburg, James M; Crumbley, Anna M; Gonzalez, Ramon

2017-01-06

The current model for industrial chemical manufacturing employs large-scale megafacilities that benefit from economies of unit scale. However, this strategy faces environmental, geographical, political, and economic challenges associated with energy and manufacturing demands. We review how exploiting biological processes for manufacturing (i.e., industrial biomanufacturing) addresses these concerns while also supporting and benefiting from economies of unit number. Key to this approach is the inherent small scale and capital efficiency of bioprocesses and the ability of engineered biocatalysts to produce designer products at high carbon and energy efficiency with adjustable output, at high selectivity, and under mild process conditions. The biological conversion of single-carbon compounds represents a test bed to establish this paradigm, enabling rapid, mobile, and widespread deployment, access to remote and distributed resources, and adaptation to new and changing markets. Copyright © 2017, American Association for the Advancement of Science.

Using Innovative Technologies for Manufacturing Rocket Engine Hardware

NASA Technical Reports Server (NTRS)

Betts, E. M.; Eddleman, D. E.; Reynolds, D. C.; Hardin, N. A.

2011-01-01

Many of the manufacturing techniques that are currently used for rocket engine component production are traditional methods that have been proven through years of experience and historical precedence. As the United States enters into the next space age where new launch vehicles are being designed and propulsion systems are being improved upon, it is sometimes necessary to adopt innovative techniques for manufacturing hardware. With a heavy emphasis on cost reduction and improvements in manufacturing time, rapid manufacturing techniques such as Direct Metal Laser Sintering (DMLS) are being adopted and evaluated for their use on NASA s Space Launch System (SLS) upper stage engine, J-2X, with hopes of employing this technology on a wide variety of future projects. DMLS has the potential to significantly reduce the processing time and cost of engine hardware, while achieving desirable material properties by using a layered powder metal manufacturing process in order to produce complex part geometries. Marshall Space Flight Center (MSFC) has recently hot-fire tested a J-2X gas generator (GG) discharge duct that was manufactured using DMLS. The duct was inspected and proof tested prior to the hot-fire test. Using a workhorse gas generator (WHGG) test fixture at MSFC's East Test Area, the duct was subjected to extreme J-2X hot gas environments during 7 tests for a total of 537 seconds of hot-fire time. The duct underwent extensive post-test evaluation and showed no signs of degradation. DMLS manufacturing has proven to be a viable option for manufacturing rocket engine hardware, and further development and use of this manufacturing method is recommended.

Advances in High Temperature Materials for Additive Manufacturing

NASA Astrophysics Data System (ADS)

Nordin, Nurul Amira Binti; Johar, Muhammad Akmal Bin; Ibrahim, Mohd Halim Irwan Bin; Marwah, Omar Mohd Faizan bin

2017-08-01

In today’s technology, additive manufacturing has evolved over the year that commonly known as 3D printing. Currently, additive manufacturing have been applied for many industries such as for automotive, aerospace, medical and other commercial product. The technologies are supported by materials for the manufacturing process to produce high quality product. Plus, additive manufacturing technologies has been growth from the lowest to moderate and high technology to fulfil manufacturing industries obligation. Initially from simple 3D printing such as fused deposition modelling (FDM), poly-jet, inkjet printing, to selective laser sintering (SLS), and electron beam melting (EBM). However, the high technology of additive manufacturing nowadays really needs high investment to carry out the process for fine products. There are three foremost type of material which is polymer, metal and ceramic used for additive manufacturing application, and mostly they were in the form of wire feedstock or powder. In circumstance, it is crucial to recognize the characteristics of each type of materials used in order to understand the behaviours of the materials on high temperature application via additive manufacturing. Therefore, this review aims to provide excessive inquiry and gather the necessary information for further research on additive material materials for high temperature application. This paper also proposed a new material based on powder glass, which comes from recycled tempered glass from automotive industry, having a huge potential to be applied for high temperature application. The technique proposed for additive manufacturing will minimize some cost of modelling with same quality of products compare to the others advanced technology used for high temperature application.

Using Innovative Techniques for Manufacturing Rocket Engine Hardware

NASA Technical Reports Server (NTRS)

Betts, Erin M.; Reynolds, David C.; Eddleman, David E.; Hardin, Andy

2011-01-01

Many of the manufacturing techniques that are currently used for rocket engine component production are traditional methods that have been proven through years of experience and historical precedence. As we enter into a new space age where new launch vehicles are being designed and propulsion systems are being improved upon, it is sometimes necessary to adopt new and innovative techniques for manufacturing hardware. With a heavy emphasis on cost reduction and improvements in manufacturing time, manufacturing techniques such as Direct Metal Laser Sintering (DMLS) are being adopted and evaluated for their use on J-2X, with hopes of employing this technology on a wide variety of future projects. DMLS has the potential to significantly reduce the processing time and cost of engine hardware, while achieving desirable material properties by using a layered powder metal manufacturing process in order to produce complex part geometries. Marshall Space Flight Center (MSFC) has recently hot-fire tested a J-2X gas generator discharge duct that was manufactured using DMLS. The duct was inspected and proof tested prior to the hot-fire test. Using the Workhorse Gas Generator (WHGG) test setup at MSFC?s East Test Area test stand 116, the duct was subject to extreme J-2X gas generator environments and endured a total of 538 seconds of hot-fire time. The duct survived the testing and was inspected after the test. DMLS manufacturing has proven to be a viable option for manufacturing rocket engine hardware, and further development and use of this manufacturing method is recommended.

Using Process Redesign and Information Technology to Improve Procurement

DTIC Science & Technology

1994-04-01

contrac- tor. Many large-volume contractors have automated order processing tied to ac- counting, manufacturing, and shipping subsystems. Currently...the contractor must receive the mailed order, analyze it, extract pertinent information, and en- ter that information into the automated order ... processing system. Almost all orders for small purchases are unilateral documents that do not require acceptance or acknowledgment by the contractor. For

Towards better process understanding: chemometrics and multivariate measurements in manufacturing of solid dosage forms.

PubMed

Matero, Sanni; van Den Berg, Frans; Poutiainen, Sami; Rantanen, Jukka; Pajander, Jari

2013-05-01

The manufacturing of tablets involves many unit operations that possess multivariate and complex characteristics. The interactions between the material characteristics and process related variation are presently not comprehensively analyzed due to univariate detection methods. As a consequence, current best practice to control a typical process is to not allow process-related factors to vary i.e. lock the production parameters. The problem related to the lack of sufficient process understanding is still there: the variation within process and material properties is an intrinsic feature and cannot be compensated for with constant process parameters. Instead, a more comprehensive approach based on the use of multivariate tools for investigating processes should be applied. In the pharmaceutical field these methods are referred to as Process Analytical Technology (PAT) tools that aim to achieve a thorough understanding and control over the production process. PAT includes the frames for measurement as well as data analyzes and controlling for in-depth understanding, leading to more consistent and safer drug products with less batch rejections. In the optimal situation, by applying these techniques, destructive end-product testing could be avoided. In this paper the most prominent multivariate data analysis measuring tools within tablet manufacturing and basic research on operations are reviewed. Copyright © 2013 Wiley Periodicals, Inc.

21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Applicability of current good manufacturing practice regulations. 210.2 Section 210.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...

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.

Manufacturing a 9-Meter Thermoplastic Composite Wind Turbine Blade: Preprint

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

Murray, Robynne; Snowberg, David R; Berry, Derek S

Currently, wind turbine blades are manufactured from a combination of glass and/or carbon fiber composite materials with a thermoset resin such as epoxy, which requires energy-intensive and expensive heating processes to cure. Newly developed in-situ polymerizing thermoplastic resin systems for composite wind turbine blades polymerize at room temperature, eliminating the heating process and significantly reducing the blade manufacturing cycle time and embodied energy, which in turn reduces costs. Thermoplastic materials can also be thermally welded, eliminating the need for adhesive bonds between blade components and increasing the overall strength and reliability of the blades. As well, thermoplastic materials enable end-of-lifemore » blade recycling by reheating and decomposing the materials, which is a limitation of existing blade technology. This paper presents a manufacturing demonstration for a 9-m-long thermoplastic composite wind turbine blade. This blade was constructed in the Composites Manufacturing Education and Technology facility at the National Wind Technology Center at the National Renewable Energy Laboratory (NREL) using a vacuum-assisted resin transfer molding process. Johns Manville fiberglass and an Arkema thermoplastic resin called Elium were used. Additional materials included Armacell-recycled polyethylene terephthalate foam from Creative Foam and low-cost carbon- fiber pultruded spar caps (manufactured in collaboration with NREL, Oak Ridge National Laboratory, Huntsman, Strongwell, and Chomarat). This paper highlights the development of the thermoplastic resin formulations, including an additive designed to control the peak exothermic temperatures. Infusion and cure times of less than 3 hours are also demonstrated, highlighting the efficiency and energy savings associated with manufacturing thermoplastic composite blades.« less

High Critical Current in Metal Organic Derived YBCO Films

DTIC Science & Technology

2010-10-31

process, particularly in reel-to- reel manufacturing equipment. During Phase I, a “three-step” conversion process was developed to de- convolute the...Task 3. After reaction, the 40-mm web was coated on both sides with a silver layer then slit into eight 4-mm width tapes which were laminated between

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...

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

PubMed

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

2017-07-01

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

Manufacturing DTaP-based combination vaccines: industrial challenges around essential public health tools.

PubMed

Vidor, Emmanuel; Soubeyrand, Benoit

2016-12-01

The manufacture of DTP-backboned combination vaccines is complex, and vaccine quality is evaluated by both batch composition and conformance of manufacturing history. Since their first availability, both the manufacturing regulations for DTP combination vaccines and their demand have evolved significantly. This has resulted in a constant need to modify manufacturing and quality control processes. Areas covered: Regulations that govern the manufacture of complex vaccines can be inconsistent between countries and need to be aligned with the regulatory requirements that apply in all countries of distribution. Changes in product mix and quantities can lead to uncertainty in vaccine supply maintenance. These problems are discussed in the context of the importance of these products as essential public health tools. Expert commentary: Increasing demand for complex vaccines globally has led to problems in supply due to intrinsically complex manufacturing and regulatory procedures. Vaccine manufacturers are fully engaged in the resolution of these challenges, but currently changes in demand need ideally to be anticipated approximately 3 years in advance due to long production cycle times.

Expression, purification, and characterization of the Necator americanus aspartic protease-1 (Na-APR-1 (M74)) antigen, a component of the bivalent human hookworm vaccine.

PubMed

Seid, Christopher A; Curti, Elena; Jones, R Mark; Hudspeth, Elissa; Rezende, Wanderson; Pollet, Jeroen; Center, Lori; Versteeg, Leroy; Pritchard, Sonya; Musiychuk, Konstantin; Yusibov, Vidadi; Hotez, Peter J; Bottazzi, Maria Elena

2015-01-01

Over 400 million people living in the world's poorest developing nations are infected with hookworms, mostly of the genus Necator americanus. A bivalent human hookworm vaccine composed of the Necator americanus Glutathione S-Transferase-1 (Na-GST-1) and the Necator americanus Aspartic Protease-1 (Na-APR-1 (M74)) is currently under development by the Sabin Vaccine Institute Product Development Partnership (Sabin PDP). Both monovalent vaccines are currently in Phase 1 trials. Both Na-GST-1 and Na-APR-1 antigens are expressed as recombinant proteins. While Na-GST-1 was found to express with high yields in Pichia pastoris, the level of expression of Na-APR-1 in this host was too low to be suitable for a manufacturing process. When the tobacco plant Nicotiana benthamiana was evaluated as an expression system, acceptable levels of solubility, yield, and stability were attained. Observed expression levels of Na-APR-1 (M74) using this system are ∼300 mg/kg. Here we describe the achievements and obstacles encountered during process development as well as characterization and stability of the purified Na-APR-1 (M74) protein and formulated vaccine. The expression, purification and analysis of purified Na-APR-1 (M74) protein obtained from representative 5 kg reproducibility runs performed to qualify the Na-APR-1 (M74) production process is also presented. This process has been successfully transferred to a pilot plant and a 50 kg scale manufacturing campaign under current Good Manufacturing Practice (cGMP) has been performed. The 50 kg run has provided a sufficient amount of protein to support the ongoing hookworm vaccine development program of the Sabin PDP.

Nondestructive evaluation of nuclear-grade graphite

NASA Astrophysics Data System (ADS)

Kunerth, D. C.; McJunkin, T. R.

2012-05-01

The material of choice for the core of the high-temperature gas-cooled reactors being developed by the U.S. Department of Energy's Next Generation Nuclear Plant Program is graphite. Graphite is a composite material whose properties are highly dependent on the base material and manufacturing methods. In addition to the material variations intrinsic to the manufacturing process, graphite will also undergo changes in material properties resulting from radiation damage and possible oxidation within the reactor. Idaho National Laboratory is presently evaluating the viability of conventional nondestructive evaluation techniques to characterize the material variations inherent to manufacturing and in-service degradation. Approaches of interest include x-ray radiography, eddy currents, and ultrasonics.

Long-term health experience of jet engine manufacturing workers: VIII. glioblastoma incidence in relation to workplace experiences with parts and processes.

PubMed

Marsh, Gary M; Youk, Ada O; Buchanich, Jeanine M; Downing, Sarah; Kennedy, Kathleen J; Esmen, Nurtan A; Hancock, Roger P; Lacey, Steven E; Pierce, Jennifer S; Fleissner, Mary Lou

2013-06-01

To determine whether glioblastoma (GB) incidence rates among jet engine manufacturing workers were associated with workplace experiences with specific parts produced and processes performed. Subjects were 210,784 workers employed between 1952 and 2001. We conducted nested case-control and cohort incidence studies with focus on 277 GB cases. We estimated time experienced with 16 part families, 4 process categories, and 32 concurrent part-process combinations with 20 or more GB cases. In both the cohort and case-control studies, none of the part families, process categories, or both considered was associated with increased GB risk. If not due to chance alone, the not statistically significantly elevated GB rates in the North Haven plant may reflect external occupational factors or nonoccupational factors unmeasured in the current evaluation.

The Generating Mechanism of Non-Sustained Disruptive Discharges in Vacuum Interrupters

NASA Astrophysics Data System (ADS)

Hara, Daisuke; Taki, Masayuki; Tanaka, Hitoshi; Okawa, Mikio; Yanabu, Satoru

To develop vacuum circuit breaker (VCB) for higher voltage application, it may be important to understand generating mechanism and its influence of non-sustained disruptive discharges (NSDD) to the systems. So, we carried out the tests using equivalent testing circuit and observed the contacts after testing, For the test, by using commercial vacuum circuit interrupters, AC voltages of 50Hz was applied between contacts for 4 seconds after current interruption, and measured generating frequencies of NSDD vs. the voltages and vs. currents. Typical contact material used in the commercial switching equipment, such as AgWC, CuW, CuCr were tested and compared. Then CuCr's of different composition and manufacturing process are investigated. And CuCr-50 (manufactured by melting process) showed the best performance in all tests. We point out that surface condition may affect the generation of NSDD and also conditioning effect is very important.

Lithographic chip identification: meeting the failure analysis challenge

NASA Astrophysics Data System (ADS)

Perkins, Lynn; Riddell, Kevin G.; Flack, Warren W.

1992-06-01

This paper describes a novel method using stepper photolithography to uniquely identify individual chips for permanent traceability. A commercially available 1X stepper is used to mark chips with an identifier or `serial number' which can be encoded with relevant information for the integrated circuit manufacturer. The permanent identification of individual chips can improve current methods of quality control, failure analysis, and inventory control. The need for this technology is escalating as manufacturers seek to provide six sigma quality control for their products and trace fabrication problems to their source. This need is especially acute for parts that fail after packaging and are returned to the manufacturer for analysis. Using this novel approach, failure analysis data can be tied back to a particular batch, wafer, or even a position within a wafer. Process control can be enhanced by identifying the root cause of chip failures. Chip identification also addresses manufacturers concerns with increasing incidences of chip theft. Since chips currently carry no identification other than the manufacturer's name and part number, recovery efforts are hampered by the inability to determine the sales history of a specific packaged chip. A definitive identifier or serial number for each chip would address this concern. The results of chip identification (patent pending) are easily viewed through a low power microscope. Batch number, wafer number, exposure step, and chip location within the exposure step can be recorded, as can dates and other items of interest. An explanation of the chip identification procedure and processing requirements are described. Experimental testing and results are presented, and potential applications are discussed.

Development and quality assessments of commercial heat production of ATF FeCrAl tubes

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

Yamamoto, Yukinori

2015-09-01

Development and quality assessment of the 2 nd generation ATF FeCrAl tube production with commercial manufacturers were conducted. The manufacturing partners include Sophisticated Alloys, Inc. (SAI), Butler, PA for FeCrAl alloy casting via vacuum induction melting, Oak Ridge National Laboratory (ORNL) for extrusion process to prepare the master bars/tubes to be tube-drawn, and Rhenium Alloys, Inc. (RAI), North Ridgeville, OH, for tube-drawing process. The masters bars have also been provided to Los Alamos National Laboratory (LANL) who works with Century Tubes, Inc., (CTI), San Diego, CA, as parallel tube production effort under the current program.

Simulation based energy-resource efficient manufacturing integrated with in-process virtual management

NASA Astrophysics Data System (ADS)

Katchasuwanmanee, Kanet; Cheng, Kai; Bateman, Richard

2016-09-01

As energy efficiency is one of the key essentials towards sustainability, the development of an energy-resource efficient manufacturing system is among the great challenges facing the current industry. Meanwhile, the availability of advanced technological innovation has created more complex manufacturing systems that involve a large variety of processes and machines serving different functions. To extend the limited knowledge on energy-efficient scheduling, the research presented in this paper attempts to model the production schedule at an operation process by considering the balance of energy consumption reduction in production, production work flow (productivity) and quality. An innovative systematic approach to manufacturing energy-resource efficiency is proposed with the virtual simulation as a predictive modelling enabler, which provides real-time manufacturing monitoring, virtual displays and decision-makings and consequentially an analytical and multidimensional correlation analysis on interdependent relationships among energy consumption, work flow and quality errors. The regression analysis results demonstrate positive relationships between the work flow and quality errors and the work flow and energy consumption. When production scheduling is controlled through optimization of work flow, quality errors and overall energy consumption, the energy-resource efficiency can be achieved in the production. Together, this proposed multidimensional modelling and analysis approach provides optimal conditions for the production scheduling at the manufacturing system by taking account of production quality, energy consumption and resource efficiency, which can lead to the key competitive advantages and sustainability of the system operations in the industry.

Novel hermetic packaging methods for MOEMS

NASA Astrophysics Data System (ADS)

Stark, David

2003-01-01

Hermetic packaging of micro-optoelectromechanical systems (MOEMS) is an immature technology, lacking industry-consensus methods and standards. Off-the-shelf, catalog window assemblies are not yet available. Window assemblies are in general custom designed and manufactured for each new product, resulting in longer than acceptable cycle times, high procurement costs and questionable reliability. There are currently two dominant window-manufacturing methods wherein a metal frame is attached to glass, as well as a third, less-used method. The first method creates a glass-to-metal seal by heating the glass above its Tg to fuse it to the frame. The second method involves first metallizing the glass where it is to be attached to the frame, and then soldering the glass to the frame. The third method employs solder-glass to bond the glass to the frame. A novel alternative with superior features compared to the three previously described window-manufacturing methods is proposed. The new approach lends itself to a plurality of glass-to-metal attachment techniques. Benefits include lower temperature processing than two of the current methods and potentially more cost-effective manufacturing than all three of today"s attachment methods.

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

NASA Astrophysics Data System (ADS)

Leino, Maija; Pekkarinen, Joonas; Soukka, Risto

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

Nanomanufacturing : nano-structured materials made layer-by-layer.

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

Cox, James V.; Cheng, Shengfeng; Grest, Gary Stephen

Large-scale, high-throughput production of nano-structured materials (i.e. nanomanufacturing) is a strategic area in manufacturing, with markets projected to exceed $1T by 2015. Nanomanufacturing is still in its infancy; process/product developments are costly and only touch on potential opportunities enabled by growing nanoscience discoveries. The greatest promise for high-volume manufacturing lies in age-old coating and imprinting operations. For materials with tailored nm-scale structure, imprinting/embossing must be achieved at high speeds (roll-to-roll) and/or over large areas (batch operation) with feature sizes less than 100 nm. Dispersion coatings with nanoparticles can also tailor structure through self- or directed-assembly. Layering films structured with thesemore » processes have tremendous potential for efficient manufacturing of microelectronics, photovoltaics and other topical nano-structured devices. This project is designed to perform the requisite R and D to bring Sandia's technology base in computational mechanics to bear on this scale-up problem. Project focus is enforced by addressing a promising imprinting process currently being commercialized.« less

Microbial transglutaminase and its application in the food industry. A review.

PubMed

Kieliszek, Marek; Misiewicz, Anna

2014-05-01

The extremely high costs of manufacturing transglutaminase from animal origin (EC 2.3.2.13) have prompted scientists to search for new sources of this enzyme. Interdisciplinary efforts have been aimed at producing enzymes synthesised by microorganisms which may have a wider scope of use. Transglutaminase is an enzyme that catalyses the formation of isopeptide bonds between proteins. Its cross-linking property is widely used in various processes: to manufacture cheese and other dairy products, in meat processing, to produce edible films and to manufacture bakery products. Transglutaminase has considerable potential to improve the firmness, viscosity, elasticity and water-binding capacity of food products. In 1989, microbial transglutaminase was isolated from Streptoverticillium sp. Its characterisation indicated that this isoform could be extremely useful as a biotechnological tool in the food industry. Currently, enzymatic preparations are used in almost all industrial branches because of their wide variety and low costs associated with their biotechnical production processes. This paper presents an overview of the literature addressing the characteristics and applications of transglutaminase.

Microstructure and Corrosion Resistance of Laser Additively Manufactured 316L Stainless Steel

NASA Astrophysics Data System (ADS)

Trelewicz, Jason R.; Halada, Gary P.; Donaldson, Olivia K.; Manogharan, Guha

2016-03-01

Additive manufacturing (AM) of metal alloys to produce complex part designs via powder bed fusion methods such as laser melting promises to be a transformative technology for advanced materials processing. However, effective implementation of AM processes requires a clear understanding of the processing-structure-properties-performance relationships in fabricated components. In this study, we report on the formation of micro and nanoscale structures in 316L stainless steel samples printed by laser AM and their implications for general corrosion resistance. A variety of techniques including x-ray diffraction, optical, scanning and transmission electron microscopy, x-ray fluorescence, and energy dispersive x-ray spectroscopy were employed to characterize the microstructure and chemistry of the laser additively manufactured 316L stainless steel, which are compared with wrought 316L coupons via electrochemical polarization. Apparent segregation of Mo has been found to contribute to a loss of passivity and an increased anodic current density. While porosity will also likely impact the environmental performance (e.g., facilitating crevice corrosion) of AM alloys, this work demonstrates the critical influence of microstructure and heterogeneous solute distributions on the corrosion resistance of laser additively manufactured 316L stainless steel.

Sensors for process control Focus Team report

NASA Astrophysics Data System (ADS)

At the Semiconductor Technology Workshop, held in November 1992, the Semiconductor Industry Association (SIA) convened 179 semiconductor technology experts to assess the 15-year outlook for the semiconductor manufacturing industry. The output of the Workshop, a document entitled 'Semiconductor Technology: Workshop Working Group Reports,' contained an overall roadmap for the technology characteristics envisioned in integrated circuits (IC's) for the period 1992-2007. In addition, the document contained individual roadmaps for numerous key areas in IC manufacturing, such as film deposition, thermal processing, manufacturing systems, exposure technology, etc. The SIA Report did not contain a separate roadmap for contamination free manufacturing (CFM). A key component of CFM for the next 15 years is the use of sensors for (1) defect reduction, (2) improved product quality, (3) improved yield, (4) improved tool utilization through contamination reduction, and (5) real time process control in semiconductor fabrication. The objective of this Focus Team is to generate a Sensors for Process Control Roadmap. Implicit in this objective is the identification of gaps in current sensor technology so that research and development activity in the sensor industry can be stimulated to develop sensor systems capable of meeting the projected roadmap needs. Sensor performance features of interest include detection limit, specificity, sensitivity, ease of installation and maintenance, range, response time, accuracy, precision, ease and frequency of calibration, degree of automation, and adaptability to in-line process control applications.

Kilogram-scale prexasertib monolactate monohydrate synthesis under continuous-flow CGMP conditions.

PubMed

Cole, Kevin P; Groh, Jennifer McClary; Johnson, Martin D; Burcham, Christopher L; Campbell, Bradley M; Diseroad, William D; Heller, Michael R; Howell, John R; Kallman, Neil J; Koenig, Thomas M; May, Scott A; Miller, Richard D; Mitchell, David; Myers, David P; Myers, Steven S; Phillips, Joseph L; Polster, Christopher S; White, Timothy D; Cashman, Jim; Hurley, Declan; Moylan, Robert; Sheehan, Paul; Spencer, Richard D; Desmond, Kenneth; Desmond, Paul; Gowran, Olivia

2017-06-16

Advances in drug potency and tailored therapeutics are promoting pharmaceutical manufacturing to transition from a traditional batch paradigm to more flexible continuous processing. Here we report the development of a multistep continuous-flow CGMP (current good manufacturing practices) process that produced 24 kilograms of prexasertib monolactate monohydrate suitable for use in human clinical trials. Eight continuous unit operations were conducted to produce the target at roughly 3 kilograms per day using small continuous reactors, extractors, evaporators, crystallizers, and filters in laboratory fume hoods. Success was enabled by advances in chemistry, engineering, analytical science, process modeling, and equipment design. Substantial technical and business drivers were identified, which merited the continuous process. The continuous process afforded improved performance and safety relative to batch processes and also improved containment of a highly potent compound. Copyright © 2017, American Association for the Advancement of Science.

Helicon wave excitation to produce energetic electrons for manufacturing semiconductors

DOEpatents

Molvik, Arthur W.; Ellingboe, Albert R.

1998-01-01

A helicon plasma source is controlled by varying the axial magnetic field or rf power controlling the formation of the helicon wave. An energetic electron current is carried on the wave when the magnetic field is 90 G; but there is minimal energetic electron current when the magnetic field is 100 G in one particular plasma source. Similar performance can be expected from other helicon sources by properly adjusting the magnetic field and power to the particular geometry. This control for adjusting the production of energetic electrons can be used in the semiconductor and thin-film manufacture process. By applying energetic electrons to the insulator layer, such as silicon oxide, etching ions are attracted to the insulator layer and bombard the insulator layer at higher energy than areas that have not accumulated the energetic electrons. Thus, silicon and metal layers, which can neutralize the energetic electron currents will etch at a slower or non-existent rate. This procedure is especially advantageous in the multilayer semiconductor manufacturing because trenches can be formed that are in the range of 0.18-0.35 mm or less.

Helicon wave excitation to produce energetic electrons for manufacturing semiconductors

DOEpatents

Molvik, A.W.; Ellingboe, A.R.

1998-10-20

A helicon plasma source is controlled by varying the axial magnetic field or rf power controlling the formation of the helicon wave. An energetic electron current is carried on the wave when the magnetic field is 90 G; but there is minimal energetic electron current when the magnetic field is 100 G in one particular plasma source. Similar performance can be expected from other helicon sources by properly adjusting the magnetic field and power to the particular geometry. This control for adjusting the production of energetic electrons can be used in the semiconductor and thin-film manufacture process. By applying energetic electrons to the insulator layer, such as silicon oxide, etching ions are attracted to the insulator layer and bombard the insulator layer at higher energy than areas that have not accumulated the energetic electrons. Thus, silicon and metal layers, which can neutralize the energetic electron currents will etch at a slower or non-existent rate. This procedure is especially advantageous in the multilayer semiconductor manufacturing because trenches can be formed that are in the range of 0.18--0.35 mm or less. 16 figs.

Assessment of an approach to printed polymer lenses

NASA Astrophysics Data System (ADS)

Marasco, Peter L.; Foote, Bob

2017-05-01

Additive manufacturing is proving its relevancy across a wide spectrum of development, prototyping and manufacturing in the US. However, there is a desire to move the capability beyond modeling and structural components. The use of additive manufacturing techniques to fabricate low-cost optics and optical systems is highly desirable in a number of markets. But processes and techniques for successfully printing an optic are currently very new. This paper discusses early advances in printing optics suitable for commercial and military applications. Data from and analysis of early prototype lenses fabricated using one possible technique will be included and discussed. The potential for additive manufacturing of optics to open the design space for complex optics and reduce development time, lowering cost and speeding up time to market, will also be discussed.

Small Scale Turbopump Manufacturing Technology and Material Processes

NASA Technical Reports Server (NTRS)

Alvarez, Erika; Morgan, Kristin; Wells, Doug; Zimmerman, Frank

2011-01-01

As part of an internal research and development project, NASA Marshall Space Flight Center (MSFC) has been developing a high specific impulse 9,000-lbf LOX/LH2 pump-fed engine testbed with the capability to throttle 10:1. A Fuel Turbopump (FTP) with the ability to operate across a speed range of 30,000-rpm to 100,000-rpm was developed and analyzed. This small size and flight-like Fuel Turbopump has completed the design and analysis phase and is currently in the manufacturing phase. This paper highlights the manufacturing and processes efforts to fabricate an approximately 20-lb turbopump with small flow passages, intricately bladed components and approximately 3-in diameter impellers. As a result of the small scale and tight tolerances of the hardware on this turbopump, several unique manufacturing and material challenges were encountered. Some of the technologies highlighted in this paper include the use of powder metallurgy technology to manufacture small impellers, electron beam welding of a turbine blisk shroud, and casting challenges. The use of risk reduction efforts such as non-destructive testing (NDT) and evaluation (NDE), fractography, material testing, and component spin testing are also discussed in this paper.

The HEALTHGRAIN definition of ‘whole grain’

PubMed Central

van der Kamp, Jan Willem; Poutanen, Kaisa; Seal, Chris J.; Richardson, David P.

2014-01-01

Most cereal products, like white bread, pasta, and biscuits, are based on flour after removal of bran and germ, the two parts of grain kernels containing most of the dietary fibre and other bioactive components. In the past decade, consumers have been rediscovering whole grain-based products and the number of wholegrain products has increased rapidly. In most countries in Europe and worldwide, however, no legally endorsed definition of wholegrain flour and products exists. Current definitions are often incomplete, lacking descriptions of the included grains and the permitted flour manufacturing processes. The consortium of the HEALTHGRAIN EU project (FP6-514008, 2005–2010) identified the need for developing a definition of whole grain with the following scope: 1) more comprehensive than current definitions in most EU countries; 2) one definition for Europe – when possible equal to definitions outside Europe; 3) reflecting current industrial practices for production of flours and consumer products; 4) useful in the context of nutritional guidelines and for labelling purposes. The definition was developed in a range of discussion meetings and consultations and was launched in 2010 at the end of the HEALTHGRAIN project. The grains included are specified: a wide range of cereal grains from the Poaceae family, and the pseudo-cereals amaranth, buckwheat, quinoa, and wild rice. The definition also describes manufacturing processes allowed for producing wholegrain flours. This paper compares the HEALTHGRAIN definition with previous definitions, provides more comprehensive explanations than in the definition itself regarding the inclusion of specific grains, and sets out the permitted flour manufacturing processes. PMID:24505218

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

PubMed

Kino-oka, Masahiro; Taya, Masahito

2009-10-01

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

Cleaning of parts for new manufacturing and parts rebuilding

NASA Astrophysics Data System (ADS)

Doherty, Jeff

1994-06-01

Parts cleaning is the largest single expense, and the most time consuming activity, in rebuilding and new manufacturing. On average, 25% to 40% of the total labor and overhead burden is spent on cleaning. EPA and OSHA pressures add to the burden by making some methods and chemicals obsolete. Some of the processes and chemicals in current use will be curtailed and or outlawed in the future. How can a shops and industries make long term decisions or capital investments in cleaning and process improvements when the government keeps changing its rules? At the MART Corporation in Saint Louis, Missouri, we manufacture a line of cabinet-style batch cleaning machines known as Power Washers. Twenty years ago MART invented and patented the Power Washer process, a cleaning method that recycles wash solution and blasts contaminates as they are washed off the more heavily contaminated parts. Since the initial invention MART has continued to R&D the washing process and develop ancillary systems that comply with EPA and OSHA regulations. For applications involving new industrial parts or items requiring specification cleaned surfaces. MART provides filtration and solution conditioning systems, part drying operations, and triple rinsing. Units are available in stainless steel or higher alloys. We are not alone in the washer manufacturing business. You have many choices of cleaning solutions (no pun intended) which will perform in your operations and yield good results. As a manufacturer, we are interested in your success with our equipment. We have all heard the horror stories of companies having selected inappropriate cleaning systems and or processes which then brought the company to its knees, production wise. Assembly, appearance, warranty, and performance shortcomings of finished products can often be directly related to the cleaning process and its shortcomings.

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

PubMed

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

2012-06-01

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

Off-target model based OPC

NASA Astrophysics Data System (ADS)

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

2005-11-01

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

Update On The Development, Testing, And Manufacture Of High Density LEU-Foil Targets For The Production Of Mo-99

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

Creasy, John T

2015-05-12

This project has the objective to reduce and/or eliminate the use of HEU in commerce. Steps in the process include developing a target testing methodology that is bounding for all Mo-99 target irradiators, establishing a maximum target LEU-foil mass, developing a LEU-foil target qualification document, developing a bounding target failure analysis methodology (failure in reactor containment), optimizing safety vs. economics (goal is to manufacture a safe, but relatively inexpensive target to offset the inherent economic disadvantage of using LEU in place of HEU), and developing target material specifications and manufacturing QC test criteria. The slide presentation is organized under themore » following topics: Objective, Process Overview, Background, Team Structure, Key Achievements, Experiment and Activity Descriptions, and Conclusions. The High Density Target project has demonstrated: approx. 50 targets irradiated through domestic and international partners; proof of concept for two front end processing methods; fabrication of uranium foils for target manufacture; quality control procedures and steps for manufacture; multiple target assembly techniques; multiple target disassembly devices; welding of targets; thermal, hydraulic, and mechanical modeling; robust target assembly parametric studies; and target qualification analysis for insertion into very high flux environment. The High Density Target project has tested and proven several technologies that will benefit current and future Mo-99 producers.« less

An analysis of variability in the manufacturing of dexosomes: implications for development of an autologous therapy.

PubMed

Patel, Sanjay; Mehta-Damani, Anita; Shu, Helen; Le Pecq, Jean-Bernard

2005-10-20

Dexosomes are nanometer-size vesicles released by dendritic-cells, possessing much of the cellular machinery required to stimulate an immune response (i.e. MHC Class I and II). The ability of patient-derived dexosomes loaded with tumor antigens to elicit anti-tumor activity is currently being evaluated in clinical trials. Unlike conventional biologics, where variability between lots of product arises mostly from the manufacturing process, an autologous product has inherent variability in the starting material due to heterogeneity in the human population. In an effort to assess the variability arising from the dexosome manufacturing process versus the human starting material, 144 dexosome preparations from normal donors (111) and cancer patients (33) from two Phase I clinical trials were analyzed. A large variability in the quantity of dexosomes (measured as the number of MHC Class II molecules) produced between individual lots was observed ( > 50-fold). An analysis of intra-lot variability shows that the manufacturing process introduces relatively little of this variability. To identify the source(s) of variability arising from the human starting material, distributions of the key parameters involved in dexosome production were established, and a model created. Computer simulations using this model were performed, and compared to the actual data observed. The main conclusion from these simulations is that the number of cells collected per individual and the productivity of these cells of are the principal sources of variability in the production of Class II. The approach described here can be extended to other autologous therapies in general to evaluate control of manufacturing processes. Moreover, this analysis of process variability is directly applicable to production at a commercial scale, since the large scale manufacture of autologous products entails an exact process replication rather than scale-up in volume, as is the case with traditional drugs or biologics. Copyright 2005 Wiley Periodicals, Inc.

Laser and electron-beam powder-bed additive manufacturing of metallic implants: A review on processes, materials and designs.

PubMed

Sing, Swee Leong; An, Jia; Yeong, Wai Yee; Wiria, Florencia Edith

2016-03-01

Additive manufacturing (AM), also commonly known as 3D printing, allows the direct fabrication of functional parts with complex shapes from digital models. In this review, the current progress of two AM processes suitable for metallic orthopaedic implant applications, namely selective laser melting (SLM) and electron beam melting (EBM) are presented. Several critical design factors such as the need for data acquisition for patient-specific design, design dependent porosity for osteo-inductive implants, surface topology of the implants and design for reduction of stress-shielding in implants are discussed. Additive manufactured biomaterials such as 316L stainless steel, titanium-6aluminium-4vanadium (Ti6Al4V) and cobalt-chromium (CoCr) are highlighted. Limitations and future potential of such technologies are also explored. © 2015 Orthopaedic Research Society. Published by Wiley Periodicals, Inc.

Recycling carbon fibre reinforced polymers for structural applications: technology review and market outlook.

PubMed

Pimenta, Soraia; Pinho, Silvestre T

2011-02-01

Both environmental and economic factors have driven the development of recycling routes for the increasing amount of carbon fibre reinforced polymer (CFRP) waste generated. This paper presents a review of the current status and outlook of CFRP recycling operations, focusing on state-of-the-art fibre reclamation and re-manufacturing processes, and on the commercialisation and potential applications of recycled products. It is shown that several recycling and re-manufacturing processes are reaching a mature stage, with implementations at commercial scales in operation, production of recycled CFRPs having competitive structural performances, and demonstrator components having been manufactured. The major challenges for the sound establishment of a CFRP recycling industry and the development of markets for the recyclates are summarised; the potential for introducing recycled CFRPs in structural components is discussed, and likely promising applications are investigated. Copyright © 2010 Elsevier Ltd. All rights reserved.

The fuzzy algorithm in the die casting mould for the application of multi-channel temperature control

NASA Astrophysics Data System (ADS)

Sun, Jin-gen; Chen, Yi; Zhang, Jia-nan

2017-01-01

Mould manufacturing is one of the most basic elements in the production chain of China. The mould manufacturing technology has become an important symbol to measure the level of a country's manufacturing industry. The die-casting mould multichannel intelligent temperature control method is studied by cooling water circulation, which uses fuzzy control to realize, aiming at solving the shortcomings of slow speed and big energy consumption during the cooling process of current die-casting mould. At present, the traditional PID control method is used to control the temperature, but it is difficult to ensure the control precision. While , the fuzzy algorithm is used to realize precise control of mould temperature in cooling process. The design is simple, fast response, strong anti-interference ability and good robustness. Simulation results show that the control method is completely feasible, which has higher control precision.

Crystal nuclei templated nanostructured membranes prepared by solvent crystallization and polymer migration

NASA Astrophysics Data System (ADS)

Wang, Bo; Ji, Jing; Li, Kang

2016-09-01

Currently, production of porous polymeric membranes for filtration is predominated by the phase-separation process. However, this method has reached its technological limit, and there have been no significant breakthrough over the last decade. Here we show, using polyvinylidene fluoride as a sample polymer, a new concept of membrane manufacturing by combining oriented green solvent crystallization and polymer migration is able to obtain high performance membranes with pure water permeation flux substantially higher than those with similar pore size prepared by conventional phase-separation processes. The new manufacturing procedure is governed by fewer operating parameters and is, thus, easier to control with reproducible results. Apart from the high water permeation flux, the prepared membranes also show excellent stable flux after fouling and superior mechanical properties of high pressure load and better abrasion resistance. These findings demonstrate the promise of a new concept for green manufacturing nanostructured polymeric membranes with high performances.

Atomic layer deposition on polymer fibers and fabrics for multifunctional and electronic textiles

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

Brozena, Alexandra H.; Oldham, Christopher J.; Parsons, Gregory N., E-mail: gnp@ncsu.edu

Textile materials, including woven cotton, polymer knit fabrics, and synthetic nonwoven fiber mats, are being explored as low-cost, flexible, and light-weight platforms for wearable electronic sensing, communication, energy generation, and storage. The natural porosity and high surface area in textiles is also useful for new applications in environmental protection, chemical decontamination, pharmaceutical and chemical manufacturing, catalytic support, tissue regeneration, and others. These applications raise opportunities for new chemistries, chemical processes, biological coupling, and nanodevice systems that can readily combine with textile manufacturing to create new “multifunctional” fabrics. Atomic layer deposition (ALD) has a unique ability to form highly uniform andmore » conformal thin films at low processing temperature on nonuniform high aspect ratio surfaces. Recent research shows how ALD can coat, modify, and otherwise improve polymer fibers and textiles by incorporating new materials for viable electronic and other multifunctional capabilities. This article provides a current overview of the understanding of ALD coating and modification of textiles, including current capabilities and outstanding problems, with the goal of providing a starting point for further research and advances in this field. After a brief introduction to textile materials and current textile treatment methods, the authors discuss unique properties of ALD-coated textiles, followed by a review of recent electronic and multifunctional textiles that use ALD coatings either as direct functional components or as critical nucleation layers for active materials integration. The article concludes with possible future directions for ALD on textiles, including the challenges in materials, manufacturing, and manufacturing integration that must be overcome for ALD to reach its full potential in electronic and other emerging multifunctional textile systems.« less

Design of an automatic production monitoring system on job shop manufacturing

NASA Astrophysics Data System (ADS)

Prasetyo, Hoedi; Sugiarto, Yohanes; Rosyidi, Cucuk Nur

2018-02-01

Every production process requires monitoring system, so the desired efficiency and productivity can be monitored at any time. This system is also needed in the job shop type of manufacturing which is mainly influenced by the manufacturing lead time. Processing time is one of the factors that affect the manufacturing lead time. In a conventional company, the recording of processing time is done manually by the operator on a sheet of paper. This method is prone to errors. This paper aims to overcome this problem by creating a system which is able to record and monitor the processing time automatically. The solution is realized by utilizing electric current sensor, barcode, RFID, wireless network and windows-based application. An automatic monitoring device is attached to the production machine. It is equipped with a touch screen-LCD so that the operator can use it easily. Operator identity is recorded through RFID which is embedded in his ID card. The workpiece data are collected from the database by scanning the barcode listed on its monitoring sheet. A sensor is mounted on the machine to measure the actual machining time. The system's outputs are actual processing time and machine's capacity information. This system is connected wirelessly to a workshop planning application belongs to the firm. Test results indicated that all functions of the system can run properly. This system successfully enables supervisors, PPIC or higher level management staffs to monitor the processing time quickly with a better accuracy.

Autonomous Agents for Dynamic Process Planning in the Flexible Manufacturing System

NASA Astrophysics Data System (ADS)

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

Rapid changes of market demands and pressures of competition require manufacturers to maintain highly flexible manufacturing systems to cope with a complex manufacturing environment. This paper deals with development of an agent-based architecture of dynamic systems for incremental process planning in the manufacturing systems. In consideration of alternative manufacturing processes and machine tools, the process plans and the schedules of the manufacturing resources are generated incrementally and dynamically. A negotiation protocol is discussed, in this paper, to generate suitable process plans for the target products real-timely and dynamically, based on the alternative manufacturing processes. The alternative manufacturing processes are presented by the process plan networks discussed in the previous paper, and the suitable process plans are searched and generated to cope with both the dynamic changes of the product specifications and the disturbances of the manufacturing resources. We initiatively combine the heuristic search algorithms of the process plan networks with the negotiation protocols, in order to generate suitable process plans in the dynamic manufacturing environment.

How Newcomers Learn the Social Norms of an Organization: A Case Study of the Socialization of Newly Hired Engineers

ERIC Educational Resources Information Center

Korte, Russell F.

2009-01-01

Current scholarship views organizational socialization as a learning process that is primarily the responsibility of the newcomer. Yet recent learning research recognizes the importance of the social interactions in the learning process. This study investigated how newly hired engineers at a large manufacturing company learned job-related tasks…

Electrocoagulation pretreatment of wet-spun acrylic fibers manufacturing wastewater to improve its biodegradability.

PubMed

Gong, Chenhao; Zhang, Zhongguo; Li, Haitao; Li, Duo; Wu, Baichun; Sun, Yuwei; Cheng, Yanjun

2014-06-15

The electrocoagulation (EC) process was used to pretreat wastewater from the manufacture of wet-spun acrylic fibers, and the effects of varying the operating parameters, including the electrode area/wastewater volume (A/V) ratio, current density, interelectrode distance and pH, on the EC treatment process were investigated. About 44% of the total organic carbon was removed using the optimal conditions in a 100 min procedure. The optimal conditions were a current density of 35.7 mA cm(-2), an A/V ratio of 0.28 cm(-1), a pH of 5, and an interelectrode distance of 0.8 cm. The biodegradability of the contaminants in the treated water was improved by the EC treatment (using the optimal conditions), increasing the five-day biological oxygen demand/chemical oxygen demand ratio to 0.35, which could improve the effectiveness of subsequent biological treatments. The improvement in the biodegradability of the contaminants in the wastewater was attributed to the removal and degradation of aromatic organic compounds, straight-chain paraffins, and other organic compounds, which we identified using gas chromatography-mass spectrometry and Fourier transform infrared spectroscopy. The EC process was proven to be an effective alternative pretreatment for wastewater from the manufacture of wet-spun acrylic fibers, prior to biological treatments. Copyright © 2014 Elsevier B.V. All rights reserved.

Progress in second-generation HTS wire development and manufacturing

NASA Astrophysics Data System (ADS)

Selvamanickam, V.; Chen, Y.; Xiong, X.; Xie, Y.; Zhang, X.; Rar, A.; Martchevskii, M.; Schmidt, R.; Lenseth, K.; Herrin, J.

2008-09-01

2007 has marked yet another year of continued rapid progress in developing and manufacturing high-performance, long-length second-generation (2G) HTS wires at high speeds. Using ion beam assisted deposition (IBAD) MgO and associated buffer sputtering processes, SuperPower has now exceeded piece lengths of 1000 m of fully buffered tape reproducibly with excellent in-plane texture of 6-7 degrees and uniformity of about 2%. These kilometer lengths are produced at high speeds of about 350 m/h of 4 mm wide tape. In combination with metal organic chemical vapor deposition (MOCVD), 2G wires up to single piece lengths to 790 m with a minimum critical current value of 190 A/cm corresponding to a Critical current × Length performance of 150,100 Am have been achieved. Tape speeds up to 180 m/h have been reached MOCVD while maintaining critical currents above 200 A/cm in 100+ m lengths. Thick film MOCVD technology has been transitioned to Pilot manufacturing system where a minimum critical current of 320 A/cm has been demonstrated over a length of 155 m processed at a speed of 70 m/h in 4 mm width. Finally, nearly 10,000 m of 2G wire has been produced, exhaustively tested, and delivered to the Albany Cable project. The average minimum critical current of the wire delivered in 225 segments of 43-44 m is 70 A in 4 mm widths. A 30 m cable has been fabricated with this wire by Sumitomo Electric and has been installed in the power grid of National Grid in downtown Albany and is the world’s first 2G device installed in the grid.

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

NASA Astrophysics Data System (ADS)

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

2017-06-01

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

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

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.

Sterilization processes. Meeting the demands of today's health care technology.

PubMed

Crow, S

1993-09-01

Universal Precautions dictate sterilization for all invasive equipment that break the blood barrier; however, current methods of sterilization, such as steam and ethylene oxide gas (ETO), are not compatible with many of the delicate, heat-sensitive surgical instruments used in modern health care. In addition, traditional sterilization methods are often too time consuming for practical use in the operating room. Clearly, new sterilization processes need to be developed. In this article, the criteria modern sterilization processes must meet and how some manufacturers plan to meet this challenge are discussed. In addition, the pros and cons of using peracetic acid (the newest sterilization process currently available) are examined.

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

NASA Astrophysics Data System (ADS)

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

2018-05-01

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

40 CFR 52.777 - Control strategy: photochemical oxidants (hydrocarbons).

Code of Federal Regulations, 2014 CFR

2014-07-01

... plastics, automotive plastics, and synthetic organic chemical manufacturing industries (SOCMI) batch... wastewater processes, offset lithography operations, business plastics, automotive plastics, and synthetic... order between U.S. Steel (currently USX Corporation) and the IDEM signed by IDEM on March 22, 1996...

40 CFR 52.777 - Control strategy: photochemical oxidants (hydrocarbons).

Code of Federal Regulations, 2010 CFR

2010-07-01

... plastics, automotive plastics, and synthetic organic chemical manufacturing industries (SOCMI) batch... wastewater processes, offset lithography operations, business plastics, automotive plastics, and synthetic... order between U.S. Steel (currently USX Corporation) and the IDEM signed by IDEM on March 22, 1996...

40 CFR 52.777 - Control strategy: photochemical oxidants (hydrocarbons).

Code of Federal Regulations, 2011 CFR

2011-07-01

... plastics, automotive plastics, and synthetic organic chemical manufacturing industries (SOCMI) batch... wastewater processes, offset lithography operations, business plastics, automotive plastics, and synthetic... order between U.S. Steel (currently USX Corporation) and the IDEM signed by IDEM on March 22, 1996...

Forming Mandrels for X-Ray Mirror Substrates

NASA Technical Reports Server (NTRS)

Blake, Peter N.; Saha. To,p; Zhang, Will; O'Dell, Stephen; Kester, Thomas; Jones, William

2011-01-01

Precision forming mandrels are one element in X-ray mirror development at NASA. Current mandrel fabrication process is capable of meeting the allocated precision requirements for a 5 arcsec telescope. A manufacturing plan is outlined for a large IXO-scale program.

Manufacturing Process Developments for Regeneratively-Cooled Channel Wall Rocket Nozzles

NASA Technical Reports Server (NTRS)

Gradl, Paul; Brandsmeier, Will

2016-01-01

Regeneratively cooled channel wall nozzles incorporate a series of integral coolant channels to contain the coolant to maintain adequate wall temperatures and expand hot gas providing engine thrust and specific impulse. NASA has been evaluating manufacturing techniques targeting large scale channel wall nozzles to support affordability of current and future liquid rocket engine nozzles and thrust chamber assemblies. The development of these large scale manufacturing techniques focus on the liner formation, channel slotting with advanced abrasive water-jet milling techniques and closeout of the coolant channels to replace or augment other cost reduction techniques being evaluated for nozzles. NASA is developing a series of channel closeout techniques including large scale additive manufacturing laser deposition and explosively bonded closeouts. A series of subscale nozzles were completed evaluating these processes. Fabrication of mechanical test and metallography samples, in addition to subscale hardware has focused on Inconel 625, 300 series stainless, aluminum alloys as well as other candidate materials. Evaluations of these techniques are demonstrating potential for significant cost reductions for large scale nozzles and chambers. Hot fire testing is planned using these techniques in the future.

Additive Manufacturing in Offsite Repair of Consumer Electronics

NASA Astrophysics Data System (ADS)

Chekurov, Sergei; Salmi, Mika

Spare parts for products that are at the end of their life cycles, but still under warranty, are logistically difficult because they are commonly not stored in the central warehouse. These uncommon spare parts occupy valuable space in smaller inventories and take a long time to be transported to the point of need, thus delaying the repair process. This paper proposes that storing the spare parts on a server and producing them with additive manufacturing (AM) on demand can shorten the repair cycle by simplifying the logistics. Introducing AM in the repair supply chain lowers the number of products that need to be reimbursed to the customer due to lengthy repairs, improves the repair statistics of the repair shops, and reduces the number of items that are held in stock. For this paper, the functionality of the concept was verified by reverse engineering a memory cover of a portable computer and laser sintering it from polyamide 12. The additively manufactured component fit well and the computer operated normally after the replacement. The current spare part supply chain model and models with AM machinery located at the repair shop, the centralized spare part provider, and the original equipment manufacturer were provided. The durations of the repair process in the models were compared by simulating two scenarios with the Monte Carlo method. As the biggest improvement, the model with the AM machine in the repair shop reduced the duration of the repair process from 14 days to three days. The result points to the conclusion that placing the machine as close to the need as possible is the best option, if there is enough demand. The spare parts currently compatible with AM are plastic components without strict surface roughness requirements, but more spare parts will become compatible with the development of AM.

2015 Summer Design Challenge: Team A&E (2241) Additively Manufactured Discriminator.

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

Miller, Sarah E.; Moore, Brandon James

Current discriminator designs are based on historical designs and traditional manufacturing methods. The goal of this project was to form non-traditional groups to create novel discriminator designs by taking advantage of additive manufacturing. These designs would expand current discriminator designs and provide insight on the applicability of additive manufacturing for future projects. Our design stretched the current abilities of additive manufacturing and noted desired improvements for the future. Through collaboration with NSC, we noted several additional technologies which work well with additive manufacturing such as topology optimization and CT scanning and determined how these technologies could be improved to bettermore » combine with additive manufacturing.« less

A testpart for interdisciplinary analyses in micro production engineering

DOE PAGES

Möhring, H. -C.; Kersting, P.; Carmignato, S.; ...

2015-04-26

In 2011, a round robin test was initiated within the group of CIRP Research Affiliates. The aim was to establish a platform for linking interdisciplinary research in order to share the expertise and experiences of participants all over the world. This paper introduces a testpart which has been designed to allow an analysis of different manufacturing technologies, simulation methods, machinery and metrology as well as process and production planning aspects. Current investigations are presented focusing on the machining and additive processes to produce the geometry, simulation approaches, machine analysis, and a comparison of measuring technologies. Challenges and limitations regarding themore » manufacturing and evaluation of the testpart features by the applied methods are discussed.« less

Laser powder bed fusion additive manufacturing of metals; physics, computational, and materials challenges

NASA Astrophysics Data System (ADS)

King, W. E.; Anderson, A. T.; Ferencz, R. M.; Hodge, N. E.; Kamath, C.; Khairallah, S. A.; Rubenchik, A. M.

2015-12-01

The production of metal parts via laser powder bed fusion additive manufacturing is growing exponentially. However, the transition of this technology from production of prototypes to production of critical parts is hindered by a lack of confidence in the quality of the part. Confidence can be established via a fundamental understanding of the physics of the process. It is generally accepted that this understanding will be increasingly achieved through modeling and simulation. However, there are significant physics, computational, and materials challenges stemming from the broad range of length and time scales and temperature ranges associated with the process. In this paper, we review the current state of the art and describe the challenges that need to be met to achieve the desired fundamental understanding of the physics of the process.

Continuous and pulsed laser high power beam combiner for additive manufacturing applications

NASA Astrophysics Data System (ADS)

Bassignana, Marta; Califano, Alessio; Pescarmona, Francesco; Braglia, Andrea; Perrone, Guido

2018-02-01

Laser-based additive manufacturing (AM) from metal powders is emerging as the new industrial revolution, although current fabrication approaches still require long mechanical post-processing to improve the final surface quality and meet the design tolerances. To overcome this limitation, the next generation machines are expected to complement laser AM with laser ablation (LA) to implement surface finishing and micro texturing already during the device growth process. With this aim, a new beam combiner to allow the real-time interchange of additive and subtractive processes using the same scanner head has been designed. Extensive tests have been carried out using a 6 kW continuous-wave laser similar to that used for the metal powder fusion and a nanosecond 100W pulsed source similar to that used for laser ablation.

Risks and reliability of manufacturing processes as related to composite materials for spacecraft structures

NASA Technical Reports Server (NTRS)

Bao, Han P.

1995-01-01

Fabricating primary aircraft and spacecraft structures using advanced composite materials entail both benefits and risks. The benefits come from much improved strength-to-weight ratios and stiffness-to-weight ratios, potential for less part count, ability to tailor properties, chemical and solvent resistance, and superior thermal properties. On the other hand, the risks involved include high material costs, lack of processing experience, expensive labor, poor reproducibility, high toxicity for some composites, and a variety of space induced risks. The purpose of this project is to generate a manufacturing database for a selected number of materials with potential for space applications, and to rely on this database to develop quantitative approaches to screen candidate materials and processes for space applications on the basis of their manufacturing risks including costs. So far, the following materials have been included in the database: epoxies, polycyanates, bismalemides, PMR-15, polyphenylene sulfides, polyetherimides, polyetheretherketone, and aluminum lithium. The first four materials are thermoset composites; the next three are thermoplastic composites, and the last one is is a metal. The emphasis of this database is on factors affecting manufacturing such as cost of raw material, handling aspects which include working life and shelf life of resins, process temperature, chemical/solvent resistance, moisture resistance, damage tolerance, toxicity, outgassing, thermal cycling, and void content, nature or type of process, associate tooling, and in-process quality assurance. Based on industry experience and published literature, a relative ranking was established for each of the factors affecting manufacturing as listed above. Potential applications of this database include the determination of a delta cost factor for specific structures with a given process plan and a general methodology to screen materials and processes for incorporation into the current conceptual design optimization of future spacecrafts as being coordinated by the Vehicle Analysis Branch where this research is being conducted.

Intelligent manufacturing: the challenge for manufacturing strategy in China in the 21st century--what we will do

NASA Astrophysics Data System (ADS)

Yang, Shuzi; Lei, Ming; Guan, Zai-Lin; Xiong, Youlun

1995-08-01

This paper first introduces the project of intelligent manufacturing in China and the research state of the IIMRC (Intelligent and Integrated Manufacturing Research Centre) of HUST (Huazhong University of Science and Technology), then reviews the recent advances in object- oriented and distributed artificial intelligence and puts forth the view that these advances open up the prospect of systems that will enable the true integration of enterprises. In an attempt to identify domain requirements and match them with research achievements, the paper examines the current literature and distinguishes 14 features that are common. It argues that effective enterprise-wide support could be greatly facilitated by the existence of intelligent software entities with autonomous processing capabilities, that possess coordination and negotiation facilities and are organized in distributed hierarchical states.

Residual stress prediction in a powder bed fusion manufactured Ti6Al4V hip stem

NASA Astrophysics Data System (ADS)

Barrett, Richard A.; Etienne, Titouan; Duddy, Cormac; Harrison, Noel M.

2017-10-01

Powder bed fusion (PBF) is a category of additive manufacturing (AM) that is particularly suitable for the production of 3D metallic components. In PBF, only material in the current build layer is at the required melt temperature, with the previously melted and solidified layers reducing in temperature, thus generating a significant thermal gradient within the metallic component, particularly for laser based PBF components. The internal thermal stresses are subsequently relieved in a post-processing heat-treatment step. Failure to adequately remove these stresses can result in cracking and component failure. A prototype hip stem was manufactured from Ti6Al4V via laser PBF but was found to have fractured during over-seas shipping. This study examines the evolution of thermal stresses during the laser PBF manufacturing and heat treatment processes of the hip stem in a 2D finite element analysis (FEA) and compares it to an electron beam PBF process. A custom written script for the automatic conversion of a gross geometry finite element model into a thin layer- by-layer finite element model was developed. The build process, heat treatment (for laser PBF) and the subsequent cooling were simulated at the component level. The results demonstrate the effectiveness of the heat treatment in reducing PBF induced thermal stresses, and the concentration of stresses in the region that fractured.

Fabricating specialised orthopaedic implants using additive manufacturing

NASA Astrophysics Data System (ADS)

Unwin, Paul

2014-03-01

It has been hypothesised that AM is ideal for patient specific orthopaedic implants such as those used in bone cancer treatment, that can rapidly build structures such as lattices for bone and tissues to in-grow, that would be impossible using current conventional subtractive manufacturing techniques. The aim of this study was to describe the adoption of AM (direct metal laser sintering and electron beam melting) into the design manufacturing and post-manufacturing processes and the early clinical use. Prior to the clinical use of AM implants, extensive metallurgical and mechanical testing of both laser and electron beam fabrications were undertaken. Concurrently, post-manufacturing processes evaluated included hipping, cleaning and coating treatments. The first clinical application of a titanium alloy mega-implant was undertaken in November 2010. A 3D model of the pelvic wing implant was designed from CT scans. Novel key features included extensive lattice structures at the bone interfaces and integral flanges to fix the implant to the bone. The pelvic device was implanted with the aid of navigation and to date the patient remains active. A further 18 patient specific mega-implants have now been implanted. The early use of this advanced manufacturing route for patient specific implants has been very encouraging enabling the engineer to produce more advanced and anatomical conforming implants. However, there are a new set of design, manufacturing and regulatory challenges that require addressing to permit this technique to be used more widely. This technology is changing the design and manufacturing paradigm for the fabrication of specialised orthopaedic implants.

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.

75 FR 40840 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-14

... Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements... regulations regarding current good manufacturing practice (CGMP) for dietary supplements. DATES: Submit either... in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements--21 CFR Part 111...

CARBON BLACK DISPERSION PRE-PLATING TECHNOLOGY FOR PRINTED WIRE BOARD MANUFACTURING

EPA Science Inventory

This evaluation addresses the product quality, waste reduction, and economic issues involved in replacing electroless copper with a carbon black dispersion technology. McCurdy Circuits of Orange County, California, currently has both processes in operation. McCurdy has found that...

Imaging-based optical caliper for objects in hot manufacturing processes

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

Huang, Howard

OG Technologies, Inc. (OGT), in conjunction with its industrial and academic partners, proposes to develop an Imaging-Based Optical Caliper (hereafter referred to as OC) for Objects in Hot Manufacturing Processes. The goal is to develop and demonstrate the OC with the synergy of OGT's current technological pool and other innovations to provide a light weight, robust, safe and accurate portable dimensional measurement device for hot objects with integrated wireless communication capacity to enable real time process control. The technical areas of interest in this project are the combination of advanced imaging, Sensor Fusion, and process control. OGT believes that themore » synergistic interactions between its current set of technologies and other innovations could deliver products that are viable and have high impact in the hot manufacture processes, such as steel making, steel rolling, open die forging, and glass industries, resulting in a new energy efficient control paradigm in the operations through improved yield, prolonged tool life and improved quality. In-line dimension measurement and control is of interest to the steel makers, yet current industry focus is on the final product dimension only instead of whole process due to the limit of man power, system cost and operator safety concerns. As sensor technologies advances, the industry started to see the need to enforce better dimensional control throughout the process, but lack the proper tools to do so. OGT along with its industrial partners represent the indigenous effort of technological development to serve the US steel industry. The immediate market that can use and get benefited from the proposed OC is the Steel Industry. The deployment of the OC has the potential to provide benefits in reduction of energy waste, CO2 emission, waste water amount, toxic waste, and so forth. The potential market after further expended function includes Hot Forging and Freight Industries. The OC prototypes were fabricated, and were progressively tested on-site in several steel mill and hot forging facilities for evaluation. Software refinements and new calibration procedures were also carried out to overcome the discovered glitches. Progress was presented to the hot manufacture facilities worldwide. Evidence showed a great interest and practical need for this product. OGT is in the pilot commercialization mode for this new development. The R&D team also successfully developed a 3D measurement function with no additional investment of hardware or equipment to measure low or room temperature object dimensions. Several tests were conducted in the reality environment to evaluate the measurement results. This new application will require additional development in product design.« less

COMMERCIAL DEMONSTRATION OF THE MANUFACTURED AGGREGATE PROCESSING TECHNOLOGY UTILIZING SPRAY DRYER ASH

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

Roy Scandrol

2003-04-01

Universal Aggregates, LLC proposes to design, construct and operate a lightweight aggregate manufacturing plant at the Birchwood Power Facility in King George, Virginia. The installation and start-up expenses for the Birchwood Aggregate Facility are $19.5 million. The DOE share is $7.2 million (37%) and the Universal Aggregates share is $12.3 (63%). The project team consists of CONSOL Energy Inc., P.J. Dick, Inc., SynAggs, LLC, and Universal Aggregates, LLC. The Birchwood Facility will transform 115,000 tons per year of spray dryer by-products that are currently being disposed of in an offsite landfill into 167,000 tons of a useful product, lightweight aggregatesmore » that can be used to manufacture lightweight aggregates that can be used to manufacture lightweight and medium weight masonry blocks. In addition to the environmental benefits, the Birchwood Facility will create eight (8) manufacturing jobs plus additional employment in the local trucking industry to deliver the aggregate to customers or reagents to the facility. A successful demonstration would lead to additional lightweight aggregate manufacturing facilities in the United States. There are currently twenty-one (21) spray dryer facilities operating in the United States that produce an adequate amount of spray dryer by-product to economically justify the installation of a lightweight aggregate manufacturing facility. Industry sources believe that as additional scrubbing is required, dry flue gas desulfurization (FGD) technologies will be the technology of choice. Letters from potential lightweight aggregate customers indicate that there is a market for the product once the commercialization barriers are eliminated by this demonstration project.« less

COMMERCIAL DEMONSTRATION OF THE MANUFACTURED AGGREGATE PROCESSING TECHNOLOGY UTILIZING SPRAY DRYER ASH

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

Roy Scandrol

2003-10-01

Universal Aggregates, LLC proposes to design, construct and operate a lightweight aggregate manufacturing plant at the Birchwood Power Facility in King George, Virginia. The installation and start-up expenses for the Birchwood Aggregate Facility are $19.5 million. The DOE share is $7.2 million (37%) and the Universal Aggregates share is $12.3 (63%). The project team consists of CONSOL Energy Inc., P.J. Dick, Inc., SynAggs, LLC, and Universal Aggregates, LLC. The Birchwood Facility will transform 115,000 tons per year of spray dryer by-products that are currently being disposed of in an offsite landfill into 167,000 tons of a useful product, lightweight aggregatesmore » that can be used to manufacture lightweight aggregates that can be used to manufacture lightweight and medium weight masonry blocks. In addition to the environmental benefits, the Birchwood Facility will create nine (9) manufacturing jobs plus additional employment in the local trucking industry to deliver the aggregate to customers or reagents to the facility. A successful demonstration would lead to additional lightweight aggregate manufacturing facilities in the United States. There are currently twenty-one (21) spray dryer facilities operating in the United States that produce an adequate amount of spray dryer by-product to economically justify the installation of a lightweight aggregate manufacturing facility. Industry sources believe that as additional scrubbing is required, dry FGD technologies will be the technology of choice. Letters from potential lightweight aggregate customers indicate that there is a market for the product once the commercialization barriers are eliminated by this demonstration project.« less

In Situ Fringe Projection Profilometry for Laser Power Bed Fusion Process

NASA Astrophysics Data System (ADS)

Zhang, Bin

Additive manufacturing (AM) offers an industrial solution to produce parts with complex geometries and internal structures that conventional manufacturing techniques cannot produce. However, current metal additive process, particularly the laser powder bed fusion (LPBF) process, suffers from poor surface finish and various material defects which hinder its wide applications. One way to solve this problem is by adding in situ metrology sensor onto the machine chamber. Matured manufacturing processes are tightly monitored and controlled, and instrumentation advances are needed to realize this same advantage for metal additive process. This encourages us to develop an in situ fringe projection system for the LPBF process. The development of such a system and the measurement capability are demonstrated in this dissertation. We show that this system can measure various powder bed signatures including powder layer variations, the average height drop between fused metal and unfused powder, and the height variations on the fused surfaces. The ability to measure textured surface is also evaluated through the instrument transfer function (ITF). We analyze the mathematical model of the proposed fringe projection system, and prove the linearity of the system through simulations. A practical ITF measurement technique using a stepped surface is also demonstrated. The measurement results are compared with theoretical predictions generated through the ITF simulations.

Optimising the design and operation of semi-continuous affinity chromatography for clinical and commercial manufacture.

PubMed

Pollock, James; Bolton, Glen; Coffman, Jon; Ho, Sa V; Bracewell, Daniel G; Farid, Suzanne S

2013-04-05

This paper presents an integrated experimental and modelling approach to evaluate the potential of semi-continuous chromatography for the capture of monoclonal antibodies (mAb) in clinical and commercial manufacture. Small-scale single-column experimental breakthrough studies were used to derive design equations for the semi-continuous affinity chromatography system. Verification runs with the semi-continuous 3-column and 4-column periodic counter current (PCC) chromatography system indicated the robustness of the design approach. The product quality profiles and step yields (after wash step optimisation) achieved were comparable to the standard batch process. The experimentally-derived design equations were incorporated into a decisional tool comprising dynamic simulation, process economics and sizing optimisation. The decisional tool was used to evaluate the economic and operational feasibility of whole mAb bioprocesses employing PCC affinity capture chromatography versus standard batch chromatography across a product's lifecycle from clinical to commercial manufacture. The tool predicted that PCC capture chromatography would offer more significant savings in direct costs for early-stage clinical manufacture (proof-of-concept) (∼30%) than for late-stage clinical (∼10-15%) or commercial (∼5%) manufacture. The evaluation also highlighted the potential facility fit issues that could arise with a capture resin (MabSelect) that experiences losses in binding capacity when operated in continuous mode over lengthy commercial campaigns. Consequently, the analysis explored the scenario of adopting the PCC system for clinical manufacture and switching to the standard batch process following product launch. The tool determined the PCC system design required to operate at commercial scale without facility fit issues and with similar costs to the standard batch process whilst pursuing a process change application. A retrofitting analysis established that the direct cost savings obtained by 8 proof-of-concept batches would be sufficient to pay back the investment cost of the pilot-scale semi-continuous chromatography system. Copyright © 2013 Elsevier B.V. All rights reserved.

Splendidly blended: a machine learning set up for CDU control

NASA Astrophysics Data System (ADS)

Utzny, Clemens

2017-06-01

As the concepts of machine learning and artificial intelligence continue to grow in importance in the context of internet related applications it is still in its infancy when it comes to process control within the semiconductor industry. Especially the branch of mask manufacturing presents a challenge to the concepts of machine learning since the business process intrinsically induces pronounced product variability on the background of small plate numbers. In this paper we present the architectural set up of a machine learning algorithm which successfully deals with the demands and pitfalls of mask manufacturing. A detailed motivation of this basic set up followed by an analysis of its statistical properties is given. The machine learning set up for mask manufacturing involves two learning steps: an initial step which identifies and classifies the basic global CD patterns of a process. These results form the basis for the extraction of an optimized training set via balanced sampling. A second learning step uses this training set to obtain the local as well as global CD relationships induced by the manufacturing process. Using two production motivated examples we show how this approach is flexible and powerful enough to deal with the exacting demands of mask manufacturing. In one example we show how dedicated covariates can be used in conjunction with increased spatial resolution of the CD map model in order to deal with pathological CD effects at the mask boundary. The other example shows how the model set up enables strategies for dealing tool specific CD signature differences. In this case the balanced sampling enables a process control scheme which allows usage of the full tool park within the specified tight tolerance budget. Overall, this paper shows that the current rapid developments off the machine learning algorithms can be successfully used within the context of semiconductor manufacturing.

How Newcomers Learn the Social Norms of an Organization: A Case Study of the Socialization of Newly Hired Engineers. Research Brief

ERIC Educational Resources Information Center

Korte, Russel

2009-01-01

Current scholarship views organizational socialization as a learning process that is primarily the responsibility of the newcomer. Yet recent learning research recognizes the importance of the social interactions in the learning process. This study investigated how newly hired engineers at a large manufacturing company learned job-related tasks…

Continuous manufacturing of extended release tablets via powder mixing and direct compression.

PubMed

Ervasti, Tuomas; Simonaho, Simo-Pekka; Ketolainen, Jarkko; Forsberg, Peter; Fransson, Magnus; Wikström, Håkan; Folestad, Staffan; Lakio, Satu; Tajarobi, Pirjo; Abrahmsén-Alami, Susanna

2015-11-10

The aim of the current work was to explore continuous dry powder mixing and direct compression for manufacturing of extended release (ER) matrix tablets. The study was span out with a challenging formulation design comprising ibuprofen compositions with varying particle size and a relatively low amount of the matrix former hydroxypropyl methylcellulose (HPMC). Standard grade HPMC (CR) was compared to a recently developed direct compressible grade (DC2). The work demonstrate that ER tablets with desired quality attributes could be manufactured via integrated continuous mixing and direct compression. The most robust tablet quality (weight, assay, tensile strength) was obtained using high mixer speed and large particle size ibuprofen and HPMC DC2 due to good powder flow. At low mixer speed it was more difficult to achieve high quality low dose tablets. Notably, with HPMC DC2 the processing conditions had a significant effect on drug release. Longer processing time and/or faster mixer speed was needed to achieve robust release with compositions containing DC2 compared with those containing CR. This work confirms the importance of balancing process parameters and material properties to find consistent product quality. Also, adaptive control is proven a pivotal means for control of continuous manufacturing systems. Copyright © 2015 Elsevier B.V. All rights reserved.

78 FR 31863 - Airworthiness Directives; Sikorsky Aircraft Corporation-Manufactured (Sikorsky) Model Helicopters...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-28

... Corporation- Manufactured (Sikorsky) Model Helicopters (type certificate currently held by Erickson Air-Crane... Corporation-manufactured Model S-64E helicopters (type certificate currently held by Erickson Air-Crane Incorporated (Erickson)). That AD currently requires inspecting and reworking the main gearbox (MGB) assembly...

21 CFR 184.1452 - Manganese gluconate.

Code of Federal Regulations, 2012 CFR

2012-04-01

....1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing... ingredient is based upon the following current good manufacturing practice conditions of use: (1) The... is used in the following foods at levels not to exceed current good manufacturing practice: baked...

21 CFR 184.1452 - Manganese gluconate.

Code of Federal Regulations, 2013 CFR

2013-04-01

....1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing... ingredient is based upon the following current good manufacturing practice conditions of use: (1) The... is used in the following foods at levels not to exceed current good manufacturing practice: baked...

21 CFR 184.1452 - Manganese gluconate.

Code of Federal Regulations, 2011 CFR

2011-04-01

....1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing... ingredient is based upon the following current good manufacturing practice conditions of use: (1) The... is used in the following foods at levels not to exceed current good manufacturing practice: baked...

21 CFR 184.1452 - Manganese gluconate.

Code of Federal Regulations, 2010 CFR

2010-04-01

....1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing... ingredient is based upon the following current good manufacturing practice conditions of use: (1) The... is used in the following foods at levels not to exceed current good manufacturing practice: baked...

ILT optimization of EUV masks for sub-7nm lithography

NASA Astrophysics Data System (ADS)

Hooker, Kevin; Kuechler, Bernd; Kazarian, Aram; Xiao, Guangming; Lucas, Kevin

2017-06-01

The 5nm and 7nm technology nodes will continue recent scaling trends and will deliver significantly smaller minimum features, standard cell areas and SRAM cell areas vs. the 10nm node. There are tremendous economic pressures to shrink each subsequent technology, though in a cost-effective and performance enhancing manner. IC manufacturers are eagerly awaiting EUV so that they can more aggressively shrink their technology than they could by using complicated MPT. The current 0.33NA EUV tools and processes also have their patterning limitations. EUV scanner lenses, scanner sources, masks and resists are all relatively immature compared to the current lithography manufacturing baseline of 193i. For example, lens aberrations are currently several times larger (as a function of wavelength) in EUV scanners than for 193i scanners. Robustly patterning 16nm L/S fully random logic metal patterns and 40nm pitch random logic rectangular contacts with 0.33NA EUV are tough challenges that will benefit from advanced OPC/RET. For example, if an IC manufacturer can push single exposure device layer resolution 10% tighter using improved ILT to avoid using DPT, there will be a significant cost and process complexity benefit to doing so. ILT is well known to have considerable benefits in finding flexible 193i mask pattern solutions to improve process window, improve 2D CD control, improve resolution in low K1 lithography regime and help to delay the introduction of DPT. However, ILT has not previously been applied to EUV lithography. In this paper, we report on new developments which extend ILT method to EUV lithography and we characterize the benefits seen vs. traditional EUV OPC/RET methods.

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

Rupich, Martin W.; Sathyamurthy, Srivatsan; Fleshler, Steven

We demonstrate a twofold increase in the in-field critical current of AMSC's standard 2G coil wire by irradiation with 18-MeV Au ions. The optimum pinning enhancement is achieved with a dose of 6 × 10 11 Au ions/cm 2. Although the 77 K, self-field critical current is reduced by about 35%, the in-field critical current (H//c) shows a significant enhancement between 4 and 50 K in fields > 1 T. The process was used for the roll-to-roll irradiation of AMSC's standard 46-mm-wide production coated conductor strips, which were further processed into standard copper laminated coil wire. The long-length wires showmore » the same enhancement as attained with short static irradiated samples. The roll-to-roll irradiation process can be incorporated in the standard 2G wire manufacturing, with no modifications to the current process. In conclusion, the enhanced performance of the wire will benefit rotating machine and magnet applications.« less

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

Rupich, Martin W.; Sathyamurthy, Srivatsan; Fleshler, Steven

We demonstrate a twofold increase in the in-field critical current of AMSC's standard 2G coil wire by irradiation with 18-MeV Au ions. The optimum pinning enhancement is achieved with a dose of 6 x 10(11) Au ions/cm(2). Although the 77 K, self-field critical current is reduced by about 35%, the in-field critical current (H//c) shows a significant enhancement between 4 and 50 K in fields > 1 T. The process was used for the roll-to-roll irradiation of AMSC's standard 46-mm-wide production coated conductor strips, which were further processed into standard copper laminated coil wire. The long-length wires show the samemore » enhancement as attained with short static irradiated samples. The roll-to-roll irradiation process can be incorporated in the standard 2G wire manufacturing, with no modifications to the current process. The enhanced performance of the wire will benefit rotating machine and magnet applications.« less

The Healthy Eating Agenda in Australia. Is Salt a Priority for Manufacturers?

PubMed Central

Nichols, Tyler; Yam, Chrystal

2017-01-01

Many nation states have endorsed and acted on the World Health Organization’s target of a 30% reduction in global salt consumption by 2025. In Australia, new government-led voluntary measures were initiated in 2009, consisting of public–private partnerships, front-of-pack labelling, and food reformulation targets (which include reduced salt). How Australia’s private sector has responded to this healthy eating agenda has been investigated in a limited way, particularly with regards to manufacturers which produce processed foods considered significant sources of sodium. In this study we asked: have Australia’s largest food manufacturers made “…positive (nutrition) changes to their product portfolios” as disclosed in their public policies, priorities, and communications? And, is salt reduction a priority for processed food manufacturers? A systematic search and critical content-analysis of grey literature published by food manufacturers was conducted. The results suggest half of the sample publically describe some salt reduction activities but the scale and efficacy of these changes is unclear from the available literature. The Australian Government’s Healthy Food Partnership could capitalise on current documented activities in salt reduction, and implement a more comprehensive healthy eating agenda moving forward. In light of the increasing rates of hypertension, population salt consumption and diet-related disease, more could be done. PMID:28809812

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

Quality Risk Management: Putting GMP Controls First.

PubMed

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

2012-01-01

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

Assessment of a virtual functional prototyping process for the rapid manufacture of passive-dynamic ankle-foot orthoses.

PubMed

Schrank, Elisa S; Hitch, Lester; Wallace, Kevin; Moore, Richard; Stanhope, Steven J

2013-10-01

Passive-dynamic ankle-foot orthosis (PD-AFO) bending stiffness is a key functional characteristic for achieving enhanced gait function. However, current orthosis customization methods inhibit objective premanufacture tuning of the PD-AFO bending stiffness, making optimization of orthosis function challenging. We have developed a novel virtual functional prototyping (VFP) process, which harnesses the strengths of computer aided design (CAD) model parameterization and finite element analysis, to quantitatively tune and predict the functional characteristics of a PD-AFO, which is rapidly manufactured via fused deposition modeling (FDM). The purpose of this study was to assess the VFP process for PD-AFO bending stiffness. A PD-AFO CAD model was customized for a healthy subject and tuned to four bending stiffness values via VFP. Two sets of each tuned model were fabricated via FDM using medical-grade polycarbonate (PC-ISO). Dimensional accuracy of the fabricated orthoses was excellent (average 0.51 ± 0.39 mm). Manufacturing precision ranged from 0.0 to 0.74 Nm/deg (average 0.30 ± 0.36 Nm/deg). Bending stiffness prediction accuracy was within 1 Nm/deg using the manufacturer provided PC-ISO elastic modulus (average 0.48 ± 0.35 Nm/deg). Using an experimentally derived PC-ISO elastic modulus improved the optimized bending stiffness prediction accuracy (average 0.29 ± 0.57 Nm/deg). Robustness of the derived modulus was tested by carrying out the VFP process for a disparate subject, tuning the PD-AFO model to five bending stiffness values. For this disparate subject, bending stiffness prediction accuracy was strong (average 0.20 ± 0.14 Nm/deg). Overall, the VFP process had excellent dimensional accuracy, good manufacturing precision, and strong prediction accuracy with the derived modulus. Implementing VFP as part of our PD-AFO customization and manufacturing framework, which also includes fit customization, provides a novel and powerful method to predictably tune and precisely manufacture orthoses with objectively customized fit and functional characteristics.

Contributions for the next generation of 3D metal printing machines

NASA Astrophysics Data System (ADS)

Pereira, M.; Thombansen, U.

2015-03-01

The 3D metal printing processes are key technologies for the new industry manufacturing requirements, as small lot production associated with high design complexity and high flexibility are needed towards personalization and customization. The main challenges for these processes are associated to increasing printing volumes, maintaining the relative accuracy level and reducing the global manufacturing time. Through a review on current technologies and solutions proposed by global patents new design solutions for 3D metal printing machines can be suggested. This paper picks up current technologies and trends in SLM and suggests some design approaches to overcome these challenges. As the SLM process is based on laser scanning, an increase in printing volume requires moving the scanner over the work surface by motion systems if printing accuracy has to be kept constant. This approach however does not contribute to a reduction in manufacturing time, as only one laser source will be responsible for building the entire work piece. With given technology limits in galvo based laser scanning systems, the most obvious solution consists in using multiple beam delivery systems in series, in parallel or both. Another concern is related to the weight of large work pieces. A new powder recoater can control the layer thickness and uniformity and eliminate or diminish fumes. To improve global accuracy, the use of a pair of high frequency piezoelectric actuators can help in positioning the laser beam. The implementation of such suggestions can contribute to SLM productivity. To do this, several research activities need to be accomplished in areas related to design, control, software and process fundamentals.

Future Supply Chains Enabled by Continuous Processing-Opportunities Challenges May 20-21 2014 Continuous Manufacturing Symposium.

PubMed

Srai, Jagjit Singh; Badman, Clive; Krumme, Markus; Futran, Mauricio; Johnston, Craig

2015-03-01

This paper examines the opportunities and challenges facing the pharmaceutical industry in moving to a primarily "continuous processing"-based supply chain. The current predominantly "large batch" and centralized manufacturing system designed for the "blockbuster" drug has driven a slow-paced, inventory heavy operating model that is increasingly regarded as inflexible and unsustainable. Indeed, new markets and the rapidly evolving technology landscape will drive more product variety, shorter product life-cycles, and smaller drug volumes, which will exacerbate an already unsustainable economic model. Future supply chains will be required to enhance affordability and availability for patients and healthcare providers alike despite the increased product complexity. In this more challenging supply scenario, we examine the potential for a more pull driven, near real-time demand-based supply chain, utilizing continuous processing where appropriate as a key element of a more "flow-through" operating model. In this discussion paper on future supply chain models underpinned by developments in the continuous manufacture of pharmaceuticals, we have set out; The paper recognizes that although current batch operational performance in pharma is far from optimal and not necessarily an appropriate end-state benchmark for batch technology, the adoption of continuous supply chain operating models underpinned by continuous production processing, as full or hybrid solutions in selected product supply chains, can support industry transformations to deliver right-first-time quality at substantially lower inventory profiles. © 2015 The Authors. Journal of Pharmaceutical Sciences published by Wiley Periodicals, Inc. and the American Pharmacists Association. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Digital fabrication of textiles: an analysis of electrical networks in 3D knitted functional fabrics

NASA Astrophysics Data System (ADS)

Vallett, Richard; Knittel, Chelsea; Christe, Daniel; Castaneda, Nestor; Kara, Christina D.; Mazur, Krzysztof; Liu, Dani; Kontsos, Antonios; Kim, Youngmoo; Dion, Genevieve

2017-05-01

Digital fabrication methods are reshaping design and manufacturing processes through the adoption of pre-production visualization and analysis tools, which help minimize waste of materials and time. Despite the increasingly widespread use of digital fabrication techniques, comparatively few of these advances have benefited the design and fabrication of textiles. The development of functional fabrics such as knitted touch sensors, antennas, capacitors, and other electronic textiles could benefit from the same advances in electrical network modeling that revolutionized the design of integrated circuits. In this paper, the efficacy of using current state-of-the-art digital fabrication tools over the more common trialand- error methods currently used in textile design is demonstrated. Gaps are then identified in the current state-of-the-art tools that must be resolved to further develop and streamline the rapidly growing field of smart textiles and devices, bringing textile production into the realm of 21st century manufacturing.

21 CFR 123.5 - Current good manufacturing practice.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 123.5 Section...) FOOD FOR HUMAN CONSUMPTION FISH AND FISHERY PRODUCTS General Provisions § 123.5 Current good manufacturing practice. (a) Part 110 of this chapter applies in determining whether the facilities, methods...

76 FR 47593 - Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-05

...] Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission... entitled ``PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide.'' FDA has... consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency...

21 CFR 184.1452 - Manganese gluconate.

Code of Federal Regulations, 2014 CFR

2014-04-01

... used in food with no limitation other than current good manufacturing practice. The affirmation of this... following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient... levels not to exceed current good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this...

21 CFR 184.1449 - Manganese citrate.

Code of Federal Regulations, 2014 CFR

2014-04-01

... § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing... ingredient is based upon the following current good manufacturing practice conditions of use: (1) The... is used in the following foods at levels not to exceed current good manufacturing practice: baked...

Streamlining the Design-to-Build Transition with Build-Optimization Software Tools.

PubMed

Oberortner, Ernst; Cheng, Jan-Fang; Hillson, Nathan J; Deutsch, Samuel

2017-03-17

Scaling-up capabilities for the design, build, and test of synthetic biology constructs holds great promise for the development of new applications in fuels, chemical production, or cellular-behavior engineering. Construct design is an essential component in this process; however, not every designed DNA sequence can be readily manufactured, even using state-of-the-art DNA synthesis methods. Current biological computer-aided design and manufacture tools (bioCAD/CAM) do not adequately consider the limitations of DNA synthesis technologies when generating their outputs. Designed sequences that violate DNA synthesis constraints may require substantial sequence redesign or lead to price-premiums and temporal delays, which adversely impact the efficiency of the DNA manufacturing process. We have developed a suite of build-optimization software tools (BOOST) to streamline the design-build transition in synthetic biology engineering workflows. BOOST incorporates knowledge of DNA synthesis success determinants into the design process to output ready-to-build sequences, preempting the need for sequence redesign. The BOOST web application is available at https://boost.jgi.doe.gov and its Application Program Interfaces (API) enable integration into automated, customized DNA design processes. The herein presented results highlight the effectiveness of BOOST in reducing DNA synthesis costs and timelines.

Macro-/Micro-Controlled 3D Lithium-Ion Batteries via Additive Manufacturing and Electric Field Processing.

PubMed

Li, Jie; Liang, Xinhua; Liou, Frank; Park, Jonghyun

2018-01-30

This paper presents a new concept for making battery electrodes that can simultaneously control macro-/micro-structures and help address current energy storage technology gaps and future energy storage requirements. Modern batteries are fabricated in the form of laminated structures that are composed of randomly mixed constituent materials. This randomness in conventional methods can provide a possibility of developing new breakthrough processing techniques to build well-organized structures that can improve battery performance. In the proposed processing, an electric field (EF) controls the microstructures of manganese-based electrodes, while additive manufacturing controls macro-3D structures and the integration of both scales. The synergistic control of micro-/macro-structures is a novel concept in energy material processing that has considerable potential for providing unprecedented control of electrode structures, thereby enhancing performance. Electrochemical tests have shown that these new electrodes exhibit superior performance in their specific capacity, areal capacity, and life cycle.

Fabrication of Circuit QED Quantum Processors, Part 2: Advanced Semiconductor Manufacturing Perspectives

NASA Astrophysics Data System (ADS)

Michalak, D. J.; Bruno, A.; Caudillo, R.; Elsherbini, A. A.; Falcon, J. A.; Nam, Y. S.; Poletto, S.; Roberts, J.; Thomas, N. K.; Yoscovits, Z. R.; Dicarlo, L.; Clarke, J. S.

Experimental quantum computing is rapidly approaching the integration of sufficient numbers of quantum bits for interesting applications, but many challenges still remain. These challenges include: realization of an extensible design for large array scale up, sufficient material process control, and discovery of integration schemes compatible with industrial 300 mm fabrication. We present recent developments in extensible circuits with vertical delivery. Toward the goal of developing a high-volume manufacturing process, we will present recent results on a new Josephson junction process that is compatible with current tooling. We will then present the improvements in NbTiN material uniformity that typical 300 mm fabrication tooling can provide. While initial results on few-qubit systems are encouraging, advanced processing control is expected to deliver the improvements in qubit uniformity, coherence time, and control required for larger systems. Research funded by Intel Corporation.

Computer Simulation of Replaceable Many Sider Plates (RMSP) with Enhanced Chip-Breaking Characteristics

NASA Astrophysics Data System (ADS)

Korchuganova, M.; Syrbakov, A.; Chernysheva, T.; Ivanov, G.; Gnedasch, E.

2016-08-01

Out of all common chip curling methods, a special tool face form has become the most widespread which is developed either by means of grinding or by means of profile pressing in the production process of RMSP. Currently, over 15 large tool manufacturers produce tools using instrument materials of over 500 brands. To this, we must add a large variety of tool face geometries, which purpose includes the control over form and dimensions of the chip. Taking into account all the many processed materials, specific tasks of the process planner, requirements to the quality of manufactured products, all this makes the choice of a proper tool which can perform the processing in the most effective way significantly harder. Over recent years, the nomenclature of RMSP for lathe tools with mechanical mounting has been considerably broadened by means of diversification of their faces

Energy absorption capabilities of complex thin walled structures

NASA Astrophysics Data System (ADS)

Tarlochan, F.; AlKhatib, Sami

2017-10-01

Thin walled structures have been used in the area of energy absorption during an event of a crash. A lot of work has been done on tubular structures. Due to limitation of manufacturing process, complex geometries were dismissed as potential solutions. With the advancement in metal additive manufacturing, complex geometries can be realized. As a motivation, the objective of this study is to investigate computationally the crash performance of complex tubular structures. Five designs were considered. In was found that complex geometries have better crashworthiness performance than standard tubular structures used currently.

3D-additive manufactured optical mount

NASA Astrophysics Data System (ADS)

Mammini, Paul V.; Ciscel, David; Wooten, John

2015-09-01

The Area Defense Anti-Munitions (ADAM) is a low cost and effective high power laser weapon system. It's designed to address and negate important threats such as short-range rockets, UAVs, and small boats. Many critical optical components operate in the system. The optics and mounts must accommodate thermal and mechanical stresses, plus maintain an exceptional wave front during operation. Lockheed Martin Space Systems Company (LMSSC) developed, designed, and currently operates ADAM. This paper covers the design and development of a key monolithic, flexured, titanium mirror mount that was manufactured by CalRAM using additive processes.

Manufacturing technology methodology for propulsion system parts

NASA Astrophysics Data System (ADS)

McRae, M. M.

1992-07-01

A development history and a current status evaluation are presented for lost-wax casting of such gas turbine engine components as turbine vanes and blades. The most advanced such systems employ computer-integrated manufacturing methods for high process repeatability, reprogramming versatility, and feedback monitoring. Stereolithography-based plastic model 3D prototyping has also been incorporated for the wax part of the investment casting; it may ultimately be possible to produce the 3D prototype in wax directly, or even to create a ceramic mold directly. Nonintrusive inspections are conducted by X-radiography and neutron radiography.

Monodisperse Latex Reactor (MLR): A materials processing space shuttle mid-deck payload

NASA Technical Reports Server (NTRS)

Kornfeld, D. M.

1985-01-01

The monodisperse latex reactor experiment has flown five times on the space shuttle, with three more flights currently planned. The objectives of this project is to manufacture, in the microgravity environment of space, large particle-size monodisperse polystyrene latexes in particle sizes larger and more uniform than can be manufactured on Earth. Historically it has been extremely difficult, if not impossible to manufacture in quantity very high quality monodisperse latexes on Earth in particle sizes much above several micrometers in diameter due to buoyancy and sedimentation problems during the polymerization reaction. However the MLR project has succeeded in manufacturing in microgravity monodisperse latex particles as large as 30 micrometers in diameter with a standard deviation of 1.4 percent. It is expected that 100 micrometer particles will have been produced by the completion of the the three remaining flights. These tiny, highly uniform latex microspheres have become the first material to be commercially marketed that was manufactured in space.

21 CFR 211.115 - Reprocessing.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Reprocessing. 211.115 Section 211.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls § 211.115...

21 CFR 211.115 - Reprocessing.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Reprocessing. 211.115 Section 211.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls § 211.115...

21 CFR 211.105 - Equipment identification.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Equipment identification. 211.105 Section 211.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.115 - Reprocessing.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Reprocessing. 211.115 Section 211.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls § 211.115...

21 CFR 211.105 - Equipment identification.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Equipment identification. 211.105 Section 211.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.115 - Reprocessing.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Reprocessing. 211.115 Section 211.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls § 211.115...

21 CFR 211.115 - Reprocessing.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Reprocessing. 211.115 Section 211.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls § 211.115...

21 CFR 211.105 - Equipment identification.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Equipment identification. 211.105 Section 211.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

Agent-based services for B2B electronic commerce

NASA Astrophysics Data System (ADS)

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

2000-12-01

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

2D net shape weaving for cost effective manufacture of textile reinforced composites

NASA Astrophysics Data System (ADS)

Vo, D. M. P.; Kern, M.; Hoffmann, G.; Cherif, C.

2017-10-01

Despite significant weight and performance advantages over metal parts, the today’s demand for fibre-reinforced polymer composites (FRPC) has been limited mainly by their large manufacturing cost. The combination of dry textile preforms and low-cost consolidation processes such as resin transfer molding (RTM) has been appointed as a promising approach to low-cost FRPC manufacture. At the current state of the art, tooling and impregnation technology is well understood whereas preform fabrication technology has not been developed effectively. This paper presents an advanced 2D net shape weaving technology developed with the aim to establish a more cost effective system for the manufacture of dry textile preforms for FRPC. 2D net shape weaving is developed based on open reed weave (ORW) technology and enables the manufacture of 2D contoured woven fabrics with firm edge, so that oversize cutting and hand trimming after molding are no longer required. The introduction of 2D net shape woven fabrics helps to reduce material waste, cycle time and preform manufacturing cost significantly. Furthermore, higher grade of automation in preform fabrication can be achieved.

Fine-Filament MgB2 Superconductor Wire

NASA Technical Reports Server (NTRS)

Cantu, Sherrie

2015-01-01

Hyper Tech Research, Inc., has developed fine-filament magnesium diboride (MgB2) superconductor wire for motors and generators used in turboelectric aircraft propulsion systems. In Phase I of the project, Hyper Tech demonstrated that MgB2 multifilament wires (<10 micrometers) could reduce alternating current (AC) losses that occur due to hysteresis, eddy currents, and coupling losses. The company refined a manufacturing method that incorporates a magnesium-infiltration process and provides a tenfold enhancement in critical current density over wire made by a conventional method involving magnesium-boron powder mixtures. Hyper Tech also improved its wire-drawing capability to fabricate fine multifilament strands. In Phase II, the company developed, manufactured, and tested the wire for superconductor and engineering current density and AC losses. Hyper Tech also fabricated MgB2 rotor coil packs for a superconducting generator. The ultimate goal is to enable low-cost, round, lightweight, low-AC-loss superconductors for motor and generator stator coils operating at 25 K in next-generation turboelectric aircraft propulsion systems.

Commercial and PET radioisotope manufacturing with a medical cyclotron

NASA Astrophysics Data System (ADS)

Boothe, T. E.; McLeod, T. F.; Plitnikas, M.; Kinney, D.; Tavano, E.; Feijoo, Y.; Smith, P.; Szelecsényi, F.

1993-06-01

Mount Sinai has extensive experience in producing radionuclides for commercial sales and for incorporation into radiopharmaceuticals, including PET. Currently, an attempt is being made to supply radiochemicals to radiopharmaceutical manufacturers outside the hospital, to prepare radiopharmaceuticals for in-house use, and to prepare PET radiopharmaceuticals, such as 2-[F-18] FDG, for outside sales. This use for both commercial and PET manufacturing is atypical for a hospital-based cyclotron. To accomplish PET radiopharmaceutical sales, the hospital operates a nuclear pharmacy. A review of operational details for the past several years shows a continuing dependence on commercial sales which is reflected in research and developmental aspects and in staffing. Developmental efforts have centered primarily on radionuclide production, target development, and radiochemical processing optimization.

Evaluation of a Novel Approach for Reducing Emissions of Pharmaceuticals to the Environment

NASA Astrophysics Data System (ADS)

Bean, Thomas G.; Bergstrom, Ed; Thomas-Oates, Jane; Wolff, Amy; Bartl, Peter; Eaton, Bob; Boxall, Alistair B. A.

2016-10-01

Increased interest over the levels of pharmaceuticals detected in the environment has led to the need for new approaches to manage their emissions. Inappropriate disposal of unused and waste medicines and release from manufacturing plants are believed to be important pathways for pharmaceuticals entering the environment. In situ treatment technologies, which can be used on-site in pharmacies, hospitals, clinics, and at manufacturing plants, might provide a solution. In this study we explored the use of Pyropure, a microscale combined pyrolysis and gasification in situ treatment system for destroying pharmaceutical wastes. This involved selecting 17 pharmaceuticals, including 14 of the most thermally stable compounds currently in use and three of high environmental concern to determine the technology's success in waste destruction. Treatment simulation studies were done on three different waste types and liquid, solid, and gaseous emissions from the process were analyzed for parent pharmaceutical and known active transformation products. Gaseous emissions were also analyzed for NOx, particulates, dioxins, furans, and metals. Results suggest that Pyropure is an effective treatment process for pharmaceutical wastes: over 99 % of each study pharmaceutical was destroyed by the system without known active transformation products being formed during the treatment process. Emissions of the other gaseous air pollutants were within acceptable levels. Future uptake of the system, or similar in situ treatment approaches, by clinics, pharmacists, and manufacturers could help to reduce the levels of pharmaceuticals in the environment and reduce the economic and environmental costs of current waste management practices.

Tunable mega-ampere electron current propagation in solids by dynamic control of lattice melt

DOE PAGES

MacLellan, D.  A.; Carroll, D.  C.; Gray, R.  J.; ...

2014-10-31

The influence of lattice-melt-induced resistivity gradients on the transport of mega-ampere currents of fast electrons in solids is investigated numerically and experimentally using laser-accelerated protons to induce isochoric heating. Tailoring the heating profile enables the resistive magnetic fields which strongly influence the current propagation to be manipulated. This tunable laser-driven process enables important fast electron beam properties, including the beam divergence, profile, and symmetry to be actively tailored, and without recourse to complex target manufacture.

The impact of manufacturing complexity drivers on performance-a preliminary study

NASA Astrophysics Data System (ADS)

Huah Leang, Suh; Mahmood, Wan Hasrulnizzam Wan; Rahman, Muhamad Arfauz A.

2018-03-01

Manufacturing systems, in pursuit of cost, time and flexibility optimisation are becoming more and more complex, exhibiting a dynamic and nonlinear behaviour. Unpredictability is a distinct characteristic of such behaviour and effects production planning significantly. Therefore, this study was undertaken to investigate the priority level and current achievement of manufacturing performance in Malaysia’s manufacturing industry and the complexity drivers on manufacturing productivity performance. The results showed that Malaysia’s manufacturing industry prioritised product quality and they managed to achieve a good on time delivery performance. However, for other manufacturing performance, there was a difference where the current achievement of manufacturing performances in Malaysia’s manufacturing industry is slightly lower than the priority given to them. The strong correlation of significant value for priority status was observed between efficient production levelling (finished goods) and finish product management while the strong correlation of significant value for current achievement was minimised the number of workstation and factory transportation system. This indicates that complexity drivers have an impact towards manufacturing performance. Consequently, it is necessary to identify complexity drivers to achieve well manufacturing performance.

Using Laser Ultrasound to Detect Subsurface Defects in Metal Laser Powder Bed Fusion Components

NASA Astrophysics Data System (ADS)

Everton, Sarah; Dickens, Phill; Tuck, Chris; Dutton, Ben

2018-03-01

Laser powder bed fusion offers many advantages over conventional manufacturing methods, such as the integration of multiple parts that can result in significant weight-savings. The increased design freedom that layer-wise manufacture allows has also been seen to enhance component performance at little or no added cost. For such benefits to be realized, however, the material quality must first be assured. Laser ultrasonic testing is a noncontact inspection technique that has been proposed as suitable for in situ monitoring of metal additive manufacturing processes. This article explores the current capability of this technique to detect manufactured, subsurface defects in Ti-6Al-4V samples, ex situ. The results are compared with x-ray computed tomography reconstructions and focus variation microscopy. Although laser ultrasound has been used to identify material discontinuities, further work is required before this technique could be implemented in situ.

Computer-aided design and manufacturing of surgical templates and their clinical applications: a review.

PubMed

Chen, Xiaojun; Xu, Lu; Wang, Wei; Li, Xing; Sun, Yi; Politis, Constantinus

2016-09-01

The surgical template is a guide aimed at directing the implant placement, tumor resection, osteotomy and bone repositioning. Using it, preoperative planning can be transferred to the actual surgical site, and the precision, safety and reliability of the surgery can be improved. However, the actual workflow of the surgical template design and manufacturing is quite complicated before the final clinical application. The major goal of the paper is to provide a comprehensive reference source of the current and future development of the template design and manufacturing for relevant researchers. Expert commentary: This paper aims to present a review of the necessary procedures in the template-guided surgery including the image processing, 3D visualization, preoperative planning, surgical guide design and manufacturing. In addition, the template-guided clinical applications for various kinds of surgeries are reviewed, and it demonstrated that the precision of the surgery has been improved compared with the non-guided operations.

Laser powder bed fusion additive manufacturing of metals; physics, computational, and materials challenges

DOE PAGES

King, W. E.; Anderson, A. T.; Ferencz, R. M.; ...

2015-12-29

The production of metal parts via laser powder bed fusion additive manufacturing is growing exponentially. However, the transition of this technology from production of prototypes to production of critical parts is hindered by a lack of confidence in the quality of the part. Confidence can be established via a fundamental understanding of the physics of the process. It is generally accepted that this understanding will be increasingly achieved through modeling and simulation. However, there are significant physics, computational, and materials challenges stemming from the broad range of length and time scales and temperature ranges associated with the process. In thismore » study, we review the current state of the art and describe the challenges that need to be met to achieve the desired fundamental understanding of the physics of the process.« less

Spectral imaging applications: Remote sensing, environmental monitoring, medicine, military operations, factory automation and manufacturing

NASA Technical Reports Server (NTRS)

Gat, N.; Subramanian, S.; Barhen, J.; Toomarian, N.

1996-01-01

This paper reviews the activities at OKSI related to imaging spectroscopy presenting current and future applications of the technology. The authors discuss the development of several systems including hardware, signal processing, data classification algorithms and benchmarking techniques to determine algorithm performance. Signal processing for each application is tailored by incorporating the phenomenology appropriate to the process, into the algorithms. Pixel signatures are classified using techniques such as principal component analyses, generalized eigenvalue analysis and novel very fast neural network methods. The major hyperspectral imaging systems developed at OKSI include the Intelligent Missile Seeker (IMS) demonstration project for real-time target/decoy discrimination, and the Thermal InfraRed Imaging Spectrometer (TIRIS) for detection and tracking of toxic plumes and gases. In addition, systems for applications in medical photodiagnosis, manufacturing technology, and for crop monitoring are also under development.

15 CFR 400.33 - Restrictions on manufacturing and processing activity.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

21 CFR 1005.25 - Service of process on manufacturers.

Code of Federal Regulations, 2010 CFR

2010-04-01

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

21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false What is current good manufacturing practice for PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION...

21 CFR 184.1101 - Diacetyl tartaric acid esters of mono- and diglycerides.

Code of Federal Regulations, 2010 CFR

2010-04-01

... used in food with no limitation other than current good manufacturing practice. The affirmation of this... following current good manufacturing practice conditions of use: (1) The ingredient is used in food as an... levels not to exceed current good manufacturing practice: baked goods and baking mixes as defined in...

21 CFR 184.1101 - Diacetyl tartaric acid esters of mono- and diglycerides.

Code of Federal Regulations, 2011 CFR

2011-04-01

... used in food with no limitation other than current good manufacturing practice. The affirmation of this... following current good manufacturing practice conditions of use: (1) The ingredient is used in food as an... levels not to exceed current good manufacturing practice: baked goods and baking mixes as defined in...

[Applications and prospects of on-line near infrared spectroscopy technology in manufacturing of Chinese materia medica].

PubMed

Li, Yang; Wu, Zhi-Sheng; Pan, Xiao-Ning; Shi, Xin-Yuan; Guo, Ming-Ye; Xu, Bing; Qiao, Yan-Jiang

2014-10-01

The quality of Chinese materia medica (CMM) is affected by every process in CMM manufacturing. According to multi-unit complex features in the production of CMM, on-line near infrared spectroscopy (NIR) is used as an evaluating technology with its rapid, non-destructive and non-pollution etc. advantages. With the research in institutions, the on-line NIR applied in process analysis and control of CMM was described systematically, and the on-line NIR platform building was used as an example to clarify the feasibility of on-line NIR technology in CMM manufacturing process. Then, from the point of application by pharmaceutical companies, the current on-line NIR research on CMM and its production in pharmaceutical companies was relatively comprehensively summarized. Meanwhile, the types of CMM productions were classified in accordance with two formulations (liquid and solid dosage formulations). The different production processes (extraction, concentration and alcohol precipitation, etc. ) were used as liquid formulation diacritical points; the different types (tablets, capsules and plasters, etc.) were used as solid dosage formulation diacritical points, and the reliability of on-line NIR used in the whole process in CMM production was proved in according to the summary of literatures in recent 10 years, which could support the modernization of CMM production.

The vital role of manufacturing quality in the reliability of PV modules

NASA Astrophysics Data System (ADS)

Rusch, Peter

2014-10-01

The influence of manufacturing quality on the reliability of PV modules coming out of today's factories has been, and is still, under estimated among investors and buyers. The main reason is perception. Contrary to popular belief, PV modules are not a commodity. Module quality does differ among module brands. Certification alone does not guarantee the quality or reliability of a module. Cost reductions in manufacturing have unequivocally affected module quality. And the use of new, cheaper materials has had a measureable impact on module reliability. The need for meaningful manufacturing quality standards has been understood by the leading technical institutions and important industry players. The fact that most leading PV panel manufacturers have been certified according to ISO 9001 has led to some level of improvement and higher effectiveness. The new ISO 9001 PV QMS standards will be a major step in providing a tool to assess PV manufacturers' quality management systems. The current lack of sufficient standards has still got a negative influence on the quality of modules being installed today. Today every manufacturer builds their modules in their own way with little standardization or adherence to quality processes and methods, which are commonplace in other manufacturing industries. Although photovoltaic technology is to a great extent mature, the way modules are being produced has changed significantly over the past few years and it continues to change at a rapid pace. Investors, financiers and lenders stand the most to gain from PV systems over the long-term, but also the most to lose. Investors, developers, EPC, O&M and solar asset management companies must all manage manufacturing quality more proactively or they will face unexpected risks and failures down the road. Manufacturing quality deserves more transparency and attention, as it is a major driver of module performance and reliability. This paper will explain the benefits of good manufacturing quality and the dangers in poor manufacturing quality. The paper also explains why buyers and long-term investors need to pay close attention to the day-to-day manufacturing quality of module manufacturers. We demonstrate how these quality risks can be assessed and mitigated by independent diligence, professional contracting and smart quality assurance processes that can be easily built into any module procurement process. We highlight the steps to ensure that every module used in a PV system is built to quality standards that support the long-term reliability of a PV system.

Optimized Gen-II FeCrAl cladding production in large quantity for campaign testing

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

Yamamoto, Yukinori; Sun, Zhiqian; Pint, Bruce A.

2016-06-03

There are two major objectives in this report; (1) to optimize microstructure control of ATF FeCrAl alloys during tube drawing processes, and (2) to provide an update on the progress of ATF FeCrAl tube production via commercial manufacturers. Experimental efforts have been made to optimize the process parameters balancing the tube fabricability, especially for tube drawing processes, and microstructure control of the final tube products. Lab-scale sheet materials of Gen II FeCrAl alloys (Mo-containing and Nb-containing FeCrAl alloys) were used in the study, combined with a stepwise warm-rolling process and intermediate annealing, aiming to simulate the tube drawing process inmore » a commercial tube manufacturer. The intermediate annealing at 650ºC for 1h was suggested for the tube-drawing process of Mo-containing FeCrAl alloys because it successfully softened the material by recovering the work hardening introduced through the rolling step, without inducing grain coarsening due to recrystallization. The final tube product is expected to have stabilized deformed microstructure providing the improved tensile properties with sufficient ductility. Optimization efforts on Nb-containing FeCrAl alloys focused on the effect of alloying additions and annealing conditions on the stability of deformed microstructure. Relationships between the second-phase precipitates (Fe 2Nb-Laves phase) and microstructure stability are discussed. FeCrAl tube production through commercial tube manufacturers is currently in progress. Three different manufacturers, Century Tubes, Inc. (CTI), Rhenium Alloys, Inc. (RAI), and Superior Tube Company, Inc. (STC), are providing capabilities for cold-drawing, warm-drawing, and HPTR cold-pilgering, respectively. The first two companies are currently working on large quantity tube production (expected 250 ft length) of Gen I model FeCrAl alloy (B136Y3, at CTI) and Gen II (C35M4, at RAI), with the process parameters obtained from the experimental efforts. The expected delivery dates are at the end of July, 2016, and the middle of June, 2016, respectively. Tube production at STC would be the first attempt to apply cold-pilgering to the FeCrAl alloys. Communication has been initiated, and the materials have been machined for the cold-pilgering process.« less

Inspection of cup-shaped steel parts from the I.D. side using eddy current

NASA Astrophysics Data System (ADS)

Griffiths, Erick W.; Pearson, Lee H.

2018-04-01

An eddy current method was developed to inspect cup-shaped steel parts from the I.D. side. During the manufacturing process of these parts, a thin Al tape foil is applied to the I.D. side of the part. One of the critical process parameters is that only one foil layer can be applied. An eddy current inspection system was developed to reject parts with more than one foil layer. The Al tape foil is cut to length to fit the inner diameter, however, after application of the foil there is a gap created between the beginning and end of the foil. It was found that this gap interfered with the eddy current inspection causing a false positive indication. To solve this problem a sensor design and data analysis process were developed to overcome the effects of these gaps. The developed system incorporates simultaneous measurements from multiple eddy current sensors and signal processing to achieve a reliable inspection.

Drug delivery system innovation and Health Technology Assessment: Upgrading from Clinical to Technological Assessment.

PubMed

Panzitta, Michele; Bruno, Giorgio; Giovagnoli, Stefano; Mendicino, Francesca R; Ricci, Maurizio

2015-11-30

Health Technology Assessment (HTA) is a multidisciplinary health political instrument that evaluates the consequences, mainly clinical and economical, of a health care technology; the HTA aim is to produce and spread information on scientific and technological innovation for health political decision making process. Drug delivery systems (DDS), such as nanocarriers, are technologically complex but they have pivotal relevance in therapeutic innovation. The HTA process, as commonly applied to conventional drug evaluation, should upgrade to a full pharmaceutical assessment, considering the DDS complexity. This is useful to study more in depth the clinical outcome and to broaden its critical assessment toward pharmaceutical issues affecting the patient and not measured by the current clinical evidence approach. We draw out the expertise necessary to perform the pharmaceutical assessment and we propose a format to evaluate the DDS technological topics such as formulation and mechanism of action, physicochemical characteristics, manufacturing process. We integrated the above-mentioned three points in the Evidence Based Medicine approach, which is data source for any HTA process. In this regard, the introduction of a Pharmaceutics Expert figure in the HTA could be fundamental to grant a more detailed evaluation of medicine product characteristics and performances and to help optimizing DDS features to overcome R&D drawbacks. Some aspects of product development, such as manufacturing processes, should be part of the HTA as innovative manufacturing processes allow new products to reach more effectively patient bedside. HTA so upgraded may encourage resource allocating payers to invest in innovative technologies and providers to focus on innovative material properties and manufacturing processes, thus contributing to bring more medicines in therapy in a sustainable manner. Copyright © 2015 Elsevier B.V. All rights reserved.

Towards the implementation of quality by design to the production of therapeutic monoclonal antibodies with desired glycosylation patterns.

PubMed

del Val, Ioscani Jimenez; Kontoravdi, Cleo; Nagy, Judit M

2010-01-01

Quality by design (QbD) is a scheme for the development, manufacture, and approval of pharmaceutical products. The end goal of QbD is to ensure product quality by building it into the manufacturing process. The main regulatory bodies are encouraging its implementation to the manufacture of all new pharmaceuticals including biological products. Monoclonal antibodies (mAbs) are currently the leading products of the biopharmaceutical industry. It has been widely reported that glycosylation directly influences the therapeutic mechanisms by which mAbs function in vivo. In addition, glycosylation has been identified as one of the main sources of monoclonal antibody heterogeneity, and thus, a critical parameter to follow during mAb manufacture. This article reviews the research on glycosylation of mAbs over the past 2 decades under the QbD scope. The categories presented under this scope are: (a) definition of the desired clinical effects of mAbs, (b) definition of the glycosylation-associated critical quality attributes (glycCQAs) of mAbs, (c) assessment of process parameters that pose a risk for mAb glycCQAs, and (d) methods for accurately quantifying glycCQAs of mAbs. The information available in all four areas leads us to conclude that implementation of QbD to the manufacture of mAbs with specific glycosylation patterns will be a reality in the near future. We also foresee that the implementation of QbD will lead to the development of more robust and efficient manufacturing processes and to a new generation of mAbs with increased clinical efficacy. Copyright © 2010 American Institute of Chemical Engineers (AIChE).

21 CFR 211.103 - Calculation of yield.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Calculation of yield. 211.103 Section 211.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.103 - Calculation of yield.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Calculation of yield. 211.103 Section 211.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.103 - Calculation of yield.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Calculation of yield. 211.103 Section 211.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

Gene disruption technologies have the potential to transform stored product insect pest control

USDA-ARS?s Scientific Manuscript database

Stored product insects feed on grains and processed commodities manufactured from grain post-harvest, reducing the nutritional value and contaminating food. Currently, the main defense against stored product insect pests is the pesticide fumigant phosphine. Phosphine is highly toxic to all animals, ...

Development of Specialized Advanced Materials Curriculum.

ERIC Educational Resources Information Center

Malmgren, Thomas; And Others

This course is intended to give students a comprehensive experience in current and future manufacturing materials and processes. It familiarizes students with: (1) base of composite materials; (2) composites--a very light, strong material used in spacecraft and stealth aircraft; (3) laminates; (4) advanced materials--especially aluminum alloys;…

The Current Status of Behaviorism and Neurofeedback

ERIC Educational Resources Information Center

Fultz, Dwight E.

2009-01-01

There appears to be no dominant conceptual model for the process and outcomes of neurofeedback among practitioners or manufacturers. Behaviorists are well-positioned to develop a neuroscience-based source code in which neural activity is described in behavioral terms, providing a basis for behavioral conceptualization and education of…

Bio-composites from mycelium reinforced agricultural substrates

USDA-ARS?s Scientific Manuscript database

There is a need for biodegradable alternatives to the inert plastics and expanded foams currently used in in manufacturing processes and device components. The material focused on in this report is a bio-composite patented by Ecovative Design, LLC. The bio-composite utilizes the fungus mycelium to i...

Using NASA and the Space Program to Help High School and College Students Learn Chemistry.

ERIC Educational Resources Information Center

Kelter, Paul B.; And Others

1987-01-01

Discusses the current state of space-related research and manufacturing techniques. Focuses on the areas of spectroscopy, materials processing, electrochemistry, and analysis. Provides examples and classroom application for using these aspects of the space program to teach chemistry. (TW)

Production of polyol oils from soybean oil through bioprocess

USDA-ARS?s Scientific Manuscript database

Soy-polyol oils (oxygenated acylglycerols) are important starting materials for the manufacture of polymers such as polyurethane. Currently, they are produced by a two-step chemical process involving epoxidation and then the subsequent opening of the oxirane ring. The objective of this study is to d...

Eddy Current Assessment of Engineered Components Containing Nanofibers

NASA Astrophysics Data System (ADS)

Ko, Ray T.; Hoppe, Wally; Pierce, Jenny

2009-03-01

The eddy current approach has been used to assess engineered components containing nanofibers. Five specimens with different programmed defects were fabricated. A 4-point collinear probe was used to verify the electrical resistivity of each specimen. The liftoff component of the eddy current signal was used to test two extreme cases with different nano contents. Additional eddy current measurements were also used in detecting a missing nano layer simulating a manufacturing process error. The results of this assessment suggest that eddy current liftoff measurement can be a useful tool in evaluating the electrical properties of materials containing nanofibers.

Quality management of manufacturing process based on manufacturing execution system

NASA Astrophysics Data System (ADS)

Zhang, Jian; Jiang, Yang; Jiang, Weizhuo

2017-04-01

Quality control elements in manufacturing process are elaborated. And the approach of quality management of manufacturing process based on manufacturing execution system (MES) is discussed. The functions of MES for a microcircuit production line are introduced conclusively.

Development of a method to manufacture uncured, no-nitrate/nitrite-added whole muscle jerky.

PubMed

Sindelar, Jeffrey J; Terns, Matthew J; Meyn, Elizabeth; Boles, Jane A

2010-10-01

"Natural curing" is accomplished by use of vegetable juice/powder high in naturally occurring nitrates combined with a nitrate reducing starter culture to result in indirectly "cured" products. Since the starter culture used is not water soluble, making "naturally cured" whole muscle jerky with current manufacturing techniques has been found ineffective. The objective was to investigate processes for whole muscle beef jerky that might provide cured meat characteristics similar to those of a nitrite-added control. Treatments where jerky was placed in a barrier bag during incubation were found to be the least similar to the nitrite-added control. Jerky placed in a 40.6 degrees C smokehouse during incubation resulted in significantly more (P<0.05) converted cured pigment than the barrier bag treatments but less (P<0.05) than the control. The processing methods investigated to manufacture "naturally cured" whole muscle jerky in this study were ineffective in resulting in products similar to those cured with sodium nitrite. Published by Elsevier Ltd.

Low-Cost Manufacturing of Bioresorbable Conductors by Evaporation-Condensation-Mediated Laser Printing and Sintering of Zn Nanoparticles.

PubMed

Shou, Wan; Mahajan, Bikram K; Ludwig, Brandon; Yu, Xiaowei; Staggs, Joshua; Huang, Xian; Pan, Heng

2017-07-01

Currently, bioresorbable electronic devices are predominantly fabricated by complex and expensive vacuum-based integrated circuit (IC) processes. Here, a low-cost manufacturing approach for bioresorbable conductors on bioresorbable polymer substrates by evaporation-condensation-mediated laser printing and sintering of Zn nanoparticle is reported. Laser sintering of Zn nanoparticles has been technically difficult due to the surface oxide on nanoparticles. To circumvent the surface oxide, a novel approach is discovered to print and sinter Zn nanoparticle facilitated by evaporation-condensation in confined domains. The printing process can be performed on low-temperature substrates in ambient environment allowing easy integration on a roll-to-roll platform for economical manufacturing of bioresorbable electronics. The fabricated Zn conductors show excellent electrical conductivity (≈1.124 × 10 6 S m -1 ), mechanical durability, and water dissolvability. Successful demonstration of strain gauges confirms the potential application in various environmentally friendly sensors and circuits. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Fine pitch thermosonic wire bonding: analysis of state-of-the-art manufacturing capability

NASA Astrophysics Data System (ADS)

Cavasin, Daniel

1995-09-01

A comprehensive process characterization was performed at the Motorola plastic package assembly site in Selangor, Malaysia, to document the current fine pitch wire bond process capability, using state-of-the-art equipment, in an actual manufacturing environment. Two machines, representing the latest technology from two separate manufacturers, were operated one shift per day for five days, bonding a 132 lead Plastic Quad Flat Pack. Using a test device specifically designed for fine pitch wire bonding, the bonding programs were alternated between 107 micrometers and 92 micrometers pad pitch, running each pitch for a total of 1600 units per machine. Wire, capillary type, and related materials were standardized and commercially available. A video metrology measurement system, with a demonstrated six sigma repeatability band width of 0.51 micrometers , was utilized to measure the bonded units for bond dimensions and placement. Standard Quality Assurance (QA) metrics were also performed. Results indicate that state-of-the-art thermosonic wire bonding can achieve acceptable assembly yields at these fine pad pitches.

The Rare Earth Magnet Industry and Rare Earth Price in China

NASA Astrophysics Data System (ADS)

Ding, Kaihong

2014-07-01

In the past four years, the price of rare earth metal fluctuates sharply for many reasons. Currently, it has become more stable and more reasonable. This presentation is focused on the effect about the rare earth metal price. Some motor manufacturers have shifted from rare earth permanent magnet to ferrite magnet. Many motor manufacturers changed the design for the motor cooling system to make the motor function at a lower temperature. Thus the consumption of Dy can be markedly reduced. As for manufacturer of NdFeB magnet, we are also trying to optimize our process to reduce to dependence of HREE such as Dy and Tb. HS process have been introduced to solve the problem. With more and more people focusing and engaging on the REE industry, the price of REE will be more transparent without too many fluctuations. China is considering the problems of balancing the environment, energy sources, and labor sources. The application field about NdFeB such as wind turbine generator, HEV/EV, FA /OA is flourishing.

Mechanical design implementation and mathematical considerations for ultra precise diamond turning of multiple freeform mirrors on a common substrate

NASA Astrophysics Data System (ADS)

Hartung, Johannes; Beier, Matthias; Peschel, Thomas; Gebhardt, Andreas; Risse, Stefan

2015-09-01

For optical systems consisting of metal (in general freeform) mirrors there exist several diamond turning fabrication approaches. These are distuingished by the effort in manufacturing and integration of the later system. The more work one puts into the manufacturing stage the less complicated is the alignment and integration afterwards. For example the most degrees of freedom have to be aligned in integration phase if every mirror of the system is fabricated as a single optical component. For a three mirror anastigmat with three freeform mirrors the degrees of freedom sum up to 18. Therefore the mirror fabrication itself is more or less easy, but the integration is very difficult. There are three major parts in the design and manufacturing process chain to be considered for tackling this integration problem. At the first position in the process chain there is the optical design occuring. At this stage a negotiation between manufacturing and design could improve manufacturability because of more possible integration approaches. The second stage is the mechanical design. Here the appropriate manufacturing approach is already chosen, but may be revisited due to incompatiblities with, e.g., stress specifications. The third level is the manufacturing stage. Here are different clamping approaches and fabrication methods possible. The current article will focus on an approach ("snap-together") where two mirrors are fabricated on one substrate and therefore a reduction of the number of degrees of freedom to be aligned are reduced to six. This improves the amount of time needed for the system integration significantly in contrast to a single mirror fabrication.

Preventing type 2 diabetes: Changing the food industry

PubMed Central

Popkin, Barry M.; Kenan, W. R.

2016-01-01

Improving our global diet by working with the food industry is a fairly complex task. Previously the global food manufacturing companies and governments were the major players. However, matters have shifted rapidly so that food retailers, food manufacturers, the restaurant–food service sector, and agribusinesses are now the major players. The current modern system of packaged processed food has now penetrated the globe—rich and poor, rural and urban are all in reach of this food system. Consequently, working with this complex sector when possible and an array of governmental regulatory large-scale options to improve our diet have increased in importance. Taxation of unhealthy foods and beverages, marketing controls, and front of the package labeling are the primary current options. Evaluations of the impacts of both public and industry initiatives are needed. PMID:27432072

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

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

von Kuegelgen, T.

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

Measurement Science for Prognostics and Health Management for Smart Manufacturing Systems: Key Findings from a Roadmapping Workshop

PubMed Central

Weiss, Brian A.; Vogl, Gregory; Helu, Moneer; Qiao, Guixiu; Pellegrino, Joan; Justiniano, Mauricio; Raghunathan, Anand

2017-01-01

The National Institute of Standards and Technology (NIST) hosted the Roadmapping Workshop – Measurement Science for Prognostics and Health Management for Smart Manufacturing Systems (PHM4SMS) in Fall 2014 to discuss the needs and priorities of stakeholders in the PHM4SMS technology area. The workshop brought together over 70 members of the PHM community. The attendees included representatives from small, medium, and large manufacturers; technology developers and integrators; academic researchers; government organizations; trade associations; and standards bodies. The attendees discussed the current and anticipated measurement science challenges to advance PHM methods and techniques for smart manufacturing systems; the associated research and development needed to implement condition monitoring, diagnostic, and prognostic technologies within manufacturing environments; and the priorities to meet the needs of PHM in manufacturing. This paper will summarize the key findings of this workshop, and present some of the critical measurement science challenges and corresponding roadmaps, i.e., suggested courses of action, to advance PHM for manufacturing. Milestones and targeted capabilities will be presented for each roadmap across three areas: PHM Manufacturing Process Techniques; PHM Performance Assessment; and PHM Infrastructure – Hardware, Software, and Integration. An analysis of these roadmaps and crosscutting themes seen across the breakout sessions is also discussed. PMID:28664163

Factors that affect micro-tooling features created by direct printing approach

NASA Astrophysics Data System (ADS)

Kumbhani, Mayur N.

Current market required faster pace production of smaller, better, and improved products in shorter amount of time. Traditional high-rate manufacturing process such as hot embossing, injection molding, compression molding, etc. use tooling to replicate feature on a products. Miniaturization of many product in the field of biomedical, electronics, optical, and microfluidic is occurring on a daily bases. There is a constant need to produce cheaper, and faster tooling, which can be utilize by existing manufacturing processes. Traditionally, in order to manufacture micron size tooling features processes such as micro-machining, Electrical Discharge Machining (EDM), etc. are utilized. Due to a higher difficulty to produce smaller size features, and longer production cycle time, various additive manufacturing approaches are proposed, e.g. selective laser sintering (SLS), inkjet printing (3DP), fused deposition modeling (FDM), etc. were proposed. Most of these approaches can produce net shaped products from different materials such as metal, ceramic, or polymers. Several attempts were made to produce tooling features using additive manufacturing approaches. Most of these produced tooling were not cost effective, and the life cycle of these tooling was reported short. In this research, a method to produce tooling features using direct printing approach, where highly filled feedstock was dispensed on a substrate. This research evaluated different natural binders, such as guar gum, xanthan gum, and sodium carboxymethyl cellulose (NaCMC) and their combinations were evaluated. The best binder combination was then use to evaluate effect of different metal (316L stainless steel (3 mum), 316 stainless steel (45 mum), and 304 stainless steel (45 mum)) particle size on feature quality. Finally, the effect of direct printing process variables such as dispensing tip internal diameter (500 mum, and 333 mum) at different printing speeds were evaluated.

Department of Energy. Jobs and Innovation Accelerator Challenge (JIAC) Program

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

Riley, Jon

1.1 NCMS Digital Manufacturing Initiative The people and businesses of Southeast Michigan have long been known for their prowess in the automotive industry, a sector built on the innovation of the assembly line and the rise of mass production as a manufacturing model. Just as the assembly line was the key to a strong manufacturing base a century ago, a digital manufacturing infrastructure is critical to the future of industry. Economic uncertainty has slowed innovation, but access to cutting-edge tools such as high performance modeling, simulation and analysis (MSA) provides a bold path forward, ensuring global competitiveness and transforming ourmore » manufacturing processes. Digital manufacturing is, essentially, the virtualization of processes that had been physical. Many larger manufacturers have embraced it, but the majority of small and medium-sized manufacturers (SMMs) have not. The Digital Manufacturing Initiative is a bold, national effort by the National Center for Manufacturing Sciences (NCMS) to put manufacturing innovation on fast forward, and bring the future of industry into the present. SMMs need a broader array of access options, training, support, and guidance. Providing access will supercharge any organization with tomorrow’s tools, as positively disruptive and potential-laden as the assembly line once was. Sustainable success in the State of Michigan requires the development of foundational infrastructure, the exploration of initial inroads with various manufacturers of all sizes, and the initiation of a prototype engagement mechanism applicable for other future regional efforts. To accomplish this NCMS leveraged complimen-tary State and Federal funding opportunities (shown in Figure 1) along with a coupled voice of industry market research study. A brief summary of each opportunity is found in Appendix A. At the heart of the Michigan effort was the development of an access portal (www.doitindigital.com) and the development of partnerships with local large manufacturers (OEMs) who could provide pull to encourage SMMs (current and future suppliers) to participate. Central to this entire effort was the opportunity that this Final Report documents corresponding to the specific tasks associated with the U.S. Department of Energy (DOE) funded component of the InnoState Jobs Innovation Accelerator Challenge (JIAC) Program.« less

The Evolution of Process Safety: Current Status and Future Direction.

PubMed

Mannan, M Sam; Reyes-Valdes, Olga; Jain, Prerna; Tamim, Nafiz; Ahammad, Monir

2016-06-07

The advent of the industrial revolution in the nineteenth century increased the volume and variety of manufactured goods and enriched the quality of life for society as a whole. However, industrialization was also accompanied by new manufacturing and complex processes that brought about the use of hazardous chemicals and difficult-to-control operating conditions. Moreover, human-process-equipment interaction plus on-the-job learning resulted in further undesirable outcomes and associated consequences. These problems gave rise to many catastrophic process safety incidents that resulted in thousands of fatalities and injuries, losses of property, and environmental damages. These events led eventually to the necessity for a gradual development of a new multidisciplinary field, referred to as process safety. From its inception in the early 1970s to the current state of the art, process safety has come to represent a wide array of issues, including safety culture, process safety management systems, process safety engineering, loss prevention, risk assessment, risk management, and inherently safer technology. Governments and academic/research organizations have kept pace with regulatory programs and research initiatives, respectively. Understanding how major incidents impact regulations and contribute to industrial and academic technology development provides a firm foundation to address new challenges, and to continue applying science and engineering to develop and implement programs to keep hazardous materials within containment. Here the most significant incidents in terms of their impact on regulations and the overall development of the field of process safety are described.

Network-based production quality control

NASA Astrophysics Data System (ADS)

Kwon, Yongjin; Tseng, Bill; Chiou, Richard

2007-09-01

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

Measurement framework for product service system performance of generator set distributors

NASA Astrophysics Data System (ADS)

Sofianti, Tanika D.

2017-11-01

Selling Generator Set (Genset) in B2B market, distributors assisted manufacturers to sell products. This is caused by the limited resources owned by the manufacturer for adding service elements. These service elements are needed to enhance the competitiveness of the generator sets. Some genset distributors often sell products together with supports to their customers. Industrial distributor develops services to meet the needs of the customer. Generator set distributors support machines and equipment produced by manufacturer. The services delivered by the distributors could enhance value obtained by the customers from the equipment. Services provided to customers in bidding process, ordering process of the equipment from the manufacturer, equipment delivery, installations, and the after sales stage. This paper promotes framework to measure Product Service System (PSS) of Generator Set distributors in delivering their products and services for the customers. The methodology of conducting this research is by adopting the perspective of the providers and customers and by taking into account the tangible and intangible products. This research leads to the idea of improvement of current Product Service System of a Genset distributor. This research needs further studies in more detailed measures and the implementation of measurement tools.

Availability and use of essential medicines in China: manufacturing, supply, and prescribing in Shandong and Gansu provinces

PubMed Central

2010-01-01

Background The current health care reform in China launched in 2009 tackles the problem of access to appropriate medicines for its 1.3 billion people by focusing on providing essential medicines to all. To provide evidence for the reform process, we investigated the manufacturing, purchasing, and prescribing of essential medicines in two provinces. Methods We conducted surveys in 2007 of all manufacturers (n = 253) and of 59 purposively selected retail and 63 hospital pharmacies in Shandong and Gansu provinces to assess production and supply of products on the 2004 National Essential Medicines List (NEML), as well as factors underlying decision making about production and supply. We also reviewed prescriptions (n = 5456) in health facilities to calculate standard indicators of appropriate medicines use. Results Overall, manufacturers in Shandong and Gansu produced only 62% and 50%, respectively, of the essential medicines they were licensed to produce. Of a randomly selected 10% of NEML products, retail pharmacies stocked up to 60% of Western products. Median availability in hospital pharmacies ranged from 19% to 69%. Manufacturer and retail pharmacy managers based decisions on medicines production and stocking on economic considerations, while hospital pharmacy managers cited clinical need. Between 64% and 86% of prescriptions contained an essential medicine. However, overprescribing of antibiotics (34%-77% of prescriptions) and injectables (22%-61%) for adult non-infectious outpatient consultations was common. Conclusions We found that manufacturers, retail pharmacies, and hospital pharmacies paid limited attention to China's 2004 NEML in their decisions to manufacture, purchase, and stock essential medicines. We also found that prescribing of essential medicines was frequently inappropriate. These results should inform strategies to improve affordable access to essential medicines under the current health care reform. PMID:20637116

Availability and use of essential medicines in China: manufacturing, supply, and prescribing in Shandong and Gansu provinces.

PubMed

Chen, Wen; Tang, Shenglan; Sun, Jing; Ross-Degnan, Dennis; Wagner, Anita K

2010-07-17

The current health care reform in China launched in 2009 tackles the problem of access to appropriate medicines for its 1.3 billion people by focusing on providing essential medicines to all. To provide evidence for the reform process, we investigated the manufacturing, purchasing, and prescribing of essential medicines in two provinces. We conducted surveys in 2007 of all manufacturers (n = 253) and of 59 purposively selected retail and 63 hospital pharmacies in Shandong and Gansu provinces to assess production and supply of products on the 2004 National Essential Medicines List (NEML), as well as factors underlying decision making about production and supply. We also reviewed prescriptions (n = 5456) in health facilities to calculate standard indicators of appropriate medicines use. Overall, manufacturers in Shandong and Gansu produced only 62% and 50%, respectively, of the essential medicines they were licensed to produce. Of a randomly selected 10% of NEML products, retail pharmacies stocked up to 60% of Western products. Median availability in hospital pharmacies ranged from 19% to 69%. Manufacturer and retail pharmacy managers based decisions on medicines production and stocking on economic considerations, while hospital pharmacy managers cited clinical need. Between 64% and 86% of prescriptions contained an essential medicine. However, overprescribing of antibiotics (34%-77% of prescriptions) and injectables (22%-61%) for adult non-infectious outpatient consultations was common. We found that manufacturers, retail pharmacies, and hospital pharmacies paid limited attention to China's 2004 NEML in their decisions to manufacture, purchase, and stock essential medicines. We also found that prescribing of essential medicines was frequently inappropriate. These results should inform strategies to improve affordable access to essential medicines under the current health care reform.

21 CFR 114.5 - Current good manufacturing practice.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 114.5 Section...) FOOD FOR HUMAN CONSUMPTION ACIDIFIED FOODS General Provisions § 114.5 Current good manufacturing practice. The criteria in §§ 114.10, 114.80, 114.83, 114.89, and 114.100, as well as the criteria in part...

21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

Code of Federal Regulations, 2013 CFR

2013-04-01

... PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... TOMOGRAPHY DRUGS General Provisions § 212.2 What is current good manufacturing practice for PET drugs? Current good manufacturing practice for PET drugs is the minimum requirements for the methods to be used...

21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

Code of Federal Regulations, 2014 CFR

2014-04-01

... PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... TOMOGRAPHY DRUGS General Provisions § 212.2 What is current good manufacturing practice for PET drugs? Current good manufacturing practice for PET drugs is the minimum requirements for the methods to be used...

21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

Code of Federal Regulations, 2012 CFR

2012-04-01

... PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... TOMOGRAPHY DRUGS General Provisions § 212.2 What is current good manufacturing practice for PET drugs? Current good manufacturing practice for PET drugs is the minimum requirements for the methods to be used...

Advances in Neutron Radiography: Application to Additive Manufacturing Inconel 718

DOE PAGES

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

2016-01-01

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

Process monitoring of additive manufacturing by using optical tomography

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

Zenzinger, Guenter, E-mail: guenter.zenzinger@mtu.de, E-mail: alexander.ladewig@mtu.de; Bamberg, Joachim, E-mail: guenter.zenzinger@mtu.de, E-mail: alexander.ladewig@mtu.de; Ladewig, Alexander, E-mail: guenter.zenzinger@mtu.de, E-mail: alexander.ladewig@mtu.de

2015-03-31

Parts fabricated by means of additive manufacturing are usually of complex shape and owing to the fabrication procedure by using selective laser melting (SLM), potential defects and inaccuracies are often very small in lateral size. Therefore, an adequate quality inspection of such parts is rather challenging, while non-destructive-techniques (NDT) are difficult to realize, but considerable efforts are necessary in order to ensure the quality of SLM-parts especially used for aerospace components. Thus, MTU Aero Engines is currently focusing on the development of an Online Process Control system which monitors and documents the complete welding process during the SLM fabrication procedure.more » A high-resolution camera system is used to obtain images, from which tomographic data for a 3dim analysis of SLM-parts are processed. From the analysis, structural irregularities and structural disorder resulting from any possible erroneous melting process become visible and may be allocated anywhere within the 3dim structure. Results of our optical tomography (OT) method as obtained on real defects are presented.« less

FDA, CE mark or something else?-Thinking fast and slow.

PubMed

Mishra, Sundeep

There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: "substantial equivalence," "PMDA," "CE mark," "Notified body," "510K" and "PMA" but the actual approval process can also be very tardy, inconsistent and expensive. Copyright © 2016 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

Interaction of preservation methods and radiation sterilization in human skin processing, with particular insight on the impact of the final water content and collagen disruption. Part I: process validation, water activity and collagen changes in tissues cryopreserved or processed using 50, 85 or 98% glycerol solutions.

PubMed

Herson, M R; Hamilton, K; White, J; Alexander, D; Poniatowski, S; O'Connor, A J; Werkmeister, J A

2018-04-25

Current regulatory requirements demand an in-depth understanding and validation of protocols used in tissue banking. The aim of this work was to characterize the quality of split thickness skin allografts cryopreserved or manufactured using highly concentrated solutions of glycerol (50, 85 or 98%), where tissue water activity (a w ), histology and birefringence changes were chosen as parameters. Consistent a w outcomes validated the proposed processing protocols. While no significant changes in tissue quality were observed under bright-field microscopy or in collagen birefringence, in-process findings can be harnessed to fine-tune and optimize manufacturing outcomes in particular when further radiation sterilization is considered. Furthermore, exposing the tissues to 85% glycerol seems to derive the most efficient outcomes as far as a w and control of microbiological growth.

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

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

NASA Astrophysics Data System (ADS)

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

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

21 CFR 211.101 - Charge-in of components.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Charge-in of components. 211.101 Section 211.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.101 - Charge-in of components.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Charge-in of components. 211.101 Section 211.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.101 - Charge-in of components.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Charge-in of components. 211.101 Section 211.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.101 - Charge-in of components.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Charge-in of components. 211.101 Section 211.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.101 - Charge-in of components.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Charge-in of components. 211.101 Section 211.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

Novel storage technologies for raw and clarified syrup biomass feedstocks from sweet sorghum (Sorghum bicolor L. Moench)

USDA-ARS?s Scientific Manuscript database

Attention is currently focused on developing sustainable supply chains of sugar feedstocks for new, flexible biorefineries. Fundamental processing needs identified by industry for the large-scale manufacture of biofuels and bioproducts from sweet sorghum (Sorghum bicolor L. Moench) include stabiliz...

Industry technology assessment of graphite-polymide composite materials. [conferences

NASA Technical Reports Server (NTRS)

1975-01-01

An assessment of the current state of the art and the future prospects for graphite polyimide composite material technology is presented. Presentations and discussions given at a minisymposium of major issues on the present and future use, availability, processing, manufacturing, and testing of graphite polyimide composite materials are summarized.

76 FR 31342 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-31

... product requirements are set forth. Section 211.173--Animals used in testing components, in-process... drug is adulterated if the methods used in, or the facilities or controls used for, its manufacture... can be used for evaluating, at least annually, the quality [[Page 31343

Production of Microchips from Polystyrene Plates

ERIC Educational Resources Information Center

Pace, Sarah Lindsey

2009-01-01

Currently manufactured microchips are expensive to make, require specialized equipment, and leave a large environmental footprint. To counter this, an alternative procedure that is cheaper and leaves a smaller environmental footprint should be made. The goal of this research project is to develop a process that creates microchips from polystyrene…

Nano Titanium Dioxide Environmental Matters: State of the Science Literature Review

EPA Science Inventory

The purpose of this report is to compile and summarize currently-available information pertaining to the manufacturing, processing, use, and end-of-life for nanoscale titanium dioxide (nano-TiO₂). The focus of the report is to identify, summarize, and present informat...

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

NASA Astrophysics Data System (ADS)

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

2016-08-01

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

Face Gear Technology for Aerospace Power Transmission Progresses

NASA Technical Reports Server (NTRS)

2005-01-01

The use of face gears in an advanced rotorcraft transmission design was first proposed by the McDonnell Douglas Helicopter Company during their contracted effort with the U.S. Army under the Advanced Rotorcraft Transmission (ART) program. Face gears would be used to turn the corner between the horizontal gas turbine engine and the vertical output rotor shaft--a function currently done by spiral bevel gears. This novel gearing arrangement would substantially lower the drive system weight partly because a face gear mesh would be used to split the input power between two output gears. However, the use of face gears and their ability to operate successfully at the speeds and loads required for an aerospace environment was unknown. Therefore a proof-of-concept phase with an existing test stand at the NASA Lewis Research Center was pursued. Hardware was designed that could be tested in Lewis' Spiral Bevel Gear Test Rig. The initial testing indicated that the face gear mesh was a feasible design that could be used at high speeds and load. Surface pitting fatigue was the typical failure mode, and that could lead to tooth fracture. An interim project was conducted to see if slight modifications to the gear tooth geometry or an alternative heat treating process could overcome the surface fatigue problems. From the initial and interim tests, it was apparent that for the surface fatigue problems to be overcome the manufacturing process used for this component would have to be developed to the level used for spiral bevel gears. The current state of the art for face gear manufacturing required using less than optimal gear materials and manufacturing techniques because the surface of the tooth form does not receive final finishing after heat treatment as it does for spiral bevel gears. This resulted in less than desirable surface hardness and manufacturing tolerances. An Advanced Research and Projects Agency (ARPA) Technology Reinvestment Project has been funded to investigate the effects of manufacturing process improvements on the operating characteristics of face gears. The program is being conducted with McDonnell Douglas Helicopter Co., Lucas Western Inc., the University of Illinois at Chicago, and a NASA/U.S. Army team. The goal of the project is develop the grinding process, experimentally verify the improvement in face gear fatigue life, and conduct a full-scale helicopter transmission test. The theory and methodology to grind face gears has been completed, and manufacture of the test hardware is ongoing. Experimental verification on test hardware is scheduled to begin in fiscal 1996.

Control Systems Engineering in Continuous Pharmaceutical Manufacturing May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Myerson, Allan S; Krumme, Markus; Nasr, Moheb; Thomas, Hayden; Braatz, Richard D

2015-03-01

This white paper provides a perspective of the challenges, research needs, and future directions for control systems engineering in continuous pharmaceutical processing. The main motivation for writing this paper is to facilitate the development and deployment of control systems technologies so as to ensure quality of the drug product. Although the main focus is on small-molecule pharmaceutical products, most of the same statements apply to biological drug products. An introduction to continuous manufacturing and control systems is followed by a discussion of the current status and technical needs in process monitoring and control, systems integration, and risk analysis. Some key points are that: (1) the desired objective in continuous manufacturing should be the satisfaction of all critical quality attributes (CQAs), not for all variables to operate at steady-state values; (2) the design of start-up and shutdown procedures can significantly affect the economic operation of a continuous manufacturing process; (3) the traceability of material as it moves through the manufacturing facility is an important consideration that can at least in part be addressed using residence time distributions; and (4) the control systems technologies must assure quality in the presence of disturbances, dynamics, uncertainties, nonlinearities, and constraints. Direct measurement, first-principles and empirical model-based predictions, and design space approaches are described for ensuring that CQA specifications are met. Ways are discussed for universities, regulatory bodies, and industry to facilitate working around or through barriers to the development of control systems engineering technologies for continuous drug manufacturing. Industry and regulatory bodies should work with federal agencies to create federal funding mechanisms to attract faculty to this area. Universities should hire faculty interested in developing first-principles models and control systems technologies for drug manufacturing that are easily transportable to industry. Industry can facilitate the move to continuous manufacturing by working with universities on the conception of new continuous pharmaceutical manufacturing process unit operations that have the potential to make major improvements in product quality, controllability, or reduced capital and/or operating costs. Regulatory bodies should ensure that: (1) regulations and regulatory practices promote, and do not derail, the development and implementation of continuous manufacturing and control systems engineering approaches; (2) the individuals who approve specific regulatory filings are sufficiently trained to make good decisions regarding control systems approaches; (3) provide regulatory clarity and eliminate/reduce regulatory risks; (4) financially support the development of high-quality training materials for use of undergraduate students, graduate students, industrial employees, and regulatory staff; (5) enhance the training of their own technical staff by financially supporting joint research projects with universities in the development of continuous pharmaceutical manufacturing processes and the associated control systems engineering theory, numerical algorithms, and software; and (6) strongly encourage the federal agencies that support research to fund these research areas. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Control systems engineering in continuous pharmaceutical manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Myerson, Allan S; Krumme, Markus; Nasr, Moheb; Thomas, Hayden; Braatz, Richard D

2015-03-01

This white paper provides a perspective of the challenges, research needs, and future directions for control systems engineering in continuous pharmaceutical processing. The main motivation for writing this paper is to facilitate the development and deployment of control systems technologies so as to ensure quality of the drug product. Although the main focus is on small-molecule pharmaceutical products, most of the same statements apply to biological drug products. An introduction to continuous manufacturing and control systems is followed by a discussion of the current status and technical needs in process monitoring and control, systems integration, and risk analysis. Some key points are that: (1) the desired objective in continuous manufacturing should be the satisfaction of all critical quality attributes (CQAs), not for all variables to operate at steady-state values; (2) the design of start-up and shutdown procedures can significantly affect the economic operation of a continuous manufacturing process; (3) the traceability of material as it moves through the manufacturing facility is an important consideration that can at least in part be addressed using residence time distributions; and (4) the control systems technologies must assure quality in the presence of disturbances, dynamics, uncertainties, nonlinearities, and constraints. Direct measurement, first-principles and empirical model-based predictions, and design space approaches are described for ensuring that CQA specifications are met. Ways are discussed for universities, regulatory bodies, and industry to facilitate working around or through barriers to the development of control systems engineering technologies for continuous drug manufacturing. Industry and regulatory bodies should work with federal agencies to create federal funding mechanisms to attract faculty to this area. Universities should hire faculty interested in developing first-principles models and control systems technologies for drug manufacturing that are easily transportable to industry. Industry can facilitate the move to continuous manufacturing by working with universities on the conception of new continuous pharmaceutical manufacturing process unit operations that have the potential to make major improvements in product quality, controllability, or reduced capital and/or operating costs. Regulatory bodies should ensure that: (1) regulations and regulatory practices promote, and do not derail, the development and implementation of continuous manufacturing and control systems engineering approaches; (2) the individuals who approve specific regulatory filings are sufficiently trained to make good decisions regarding control systems approaches; (3) provide regulatory clarity and eliminate/reduce regulatory risks; (4) financially support the development of high-quality training materials for use of undergraduate students, graduate students, industrial employees, and regulatory staff; (5) enhance the training of their own technical staff by financially supporting joint research projects with universities in the development of continuous pharmaceutical manufacturing processes and the associated control systems engineering theory, numerical algorithms, and software; and (6) strongly encourage the federal agencies that support research to fund these research areas. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Laboratory considerations of United States Pharmacopeia Chapter <71> sterility tests and its application to pharmaceutical compounding.

PubMed

Hyde, Tiffany D

2014-01-01

The purpose of this article is to describe United States Pharmacopeia Chapter <71> Sterility Tests from the perspective of Current Good Manufacturing Practices in order to aid compounding pharmacists in understanding the details and complexities that are required. Compounding pharmacists face a unique challenge in the industry today, with their compounding practice and the U.S. Food and Drug Administration trying to impose Current Good Manufacturing Practices guidelines. Naturally, this becomes a challenge to contract testing laboratories as well, as they are caught between the testing for non-Current Good Manufacturing Practices compounding standards and Current Good Manufacturing Practices manufacturing. It is important that the compounding pharmacist and their partner testing laboratory work closely together to ensure appropriate requirements are being met.

Topological design and additive manufacturing of porous metals for bone scaffolds and orthopaedic implants: A review.

PubMed

Wang, Xiaojian; Xu, Shanqing; Zhou, Shiwei; Xu, Wei; Leary, Martin; Choong, Peter; Qian, M; Brandt, Milan; Xie, Yi Min

2016-03-01

One of the critical issues in orthopaedic regenerative medicine is the design of bone scaffolds and implants that replicate the biomechanical properties of the host bones. Porous metals have found themselves to be suitable candidates for repairing or replacing the damaged bones since their stiffness and porosity can be adjusted on demands. Another advantage of porous metals lies in their open space for the in-growth of bone tissue, hence accelerating the osseointegration process. The fabrication of porous metals has been extensively explored over decades, however only limited controls over the internal architecture can be achieved by the conventional processes. Recent advances in additive manufacturing have provided unprecedented opportunities for producing complex structures to meet the increasing demands for implants with customized mechanical performance. At the same time, topology optimization techniques have been developed to enable the internal architecture of porous metals to be designed to achieve specified mechanical properties at will. Thus implants designed via the topology optimization approach and produced by additive manufacturing are of great interest. This paper reviews the state-of-the-art of topological design and manufacturing processes of various types of porous metals, in particular for titanium alloys, biodegradable metals and shape memory alloys. This review also identifies the limitations of current techniques and addresses the directions for future investigations. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

PubMed

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

2005-11-15

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

Assessment of an optimized manufacturing process for inactivated quadrivalent influenza vaccine: a phase III, randomized, double-blind, safety and immunogenicity study in children and adults.

PubMed

Claeys, Carine; Drame, Mamadou; García-Sicilia, José; Zaman, Khalequ; Carmona, Alfonso; Tran, Phu My; Miranda, Mariano; Martinón-Torres, Federico; Thollot, Franck; Horn, Michael; Schwarz, Tino F; Behre, Ulrich; Merino, José M; Sadowska-Krawczenko, Iwona; Szymański, Henryk; Schu, Peter; Neumeier, Elisabeth; Li, Ping; Jain, Varsha K; Innis, Bruce L

2018-04-18

GSK has modified the licensed monovalent bulk manufacturing process for its split-virion inactivated quadrivalent influenza vaccine (IIV4) to harmonize the process among different strains, resulting in an increased number of finished vaccine doses, while compensating for the change from inactivated trivalent influenza vaccine (IIV3) to IIV4. To confirm the manufacturing changes do not alter the profile of the vaccine, a clinical trial was conducted to compare IIV4 made by the currently licensed process with a vaccine made by the new (investigational) process (IIV4-I). The main objectives were to compare the reactogenicity and safety of IIV4-I versus IIV4 in all age groups, and to demonstrate the non-inferiority of the hemagglutination-inhibition (HI) antibody responses based on the geometric mean titer ratio of IIV4-I versus IIV4 in children. The Phase III, randomized, double-blind, multinational study included three cohorts: adults (18-49 years; N = 120), children (3-17 years; N = 821), and infants (6-35 months; N = 940). Eligible subjects in each cohort were randomized 1:1 to receive IIV4-I or IIV4. Both vaccines contained 15 μg of hemagglutinin antigen for each of the four seasonal virus strains. Adults and vaccine-primed children received one dose of vaccine, and vaccine-unprimed children received two doses of vaccine 28 days apart. All children aged ≥9 years were considered to be vaccine-primed and received one dose of vaccine. The primary immunogenicity objective of the study was met in demonstrating immunogenic non-inferiority of IIV4-I versus IIV4 in children. The IIV4-I was immunogenic against all four vaccine strains in each age cohort. The reactogenicity and safety profile of IIV4-I was similar to IIV4 in each age cohort, and there was no increase in the relative risk of fever (≥38 °C) with IIV4-I versus IIV4 within the 7-day post-vaccination period in infants (1.06; 95% Confidence Interval: 0.75, 1.50; p = 0.786). The study demonstrated that in adults, children, and infants, the IIV4-I made using an investigational manufacturing process was immunogenic with a reactogenicity and safety profile that was similar to licensed IIV4. These results support that the investigational process used to manufacture IIV4-I is suitable to replace the current licensed process. ClinicalTrials.gov: NCT02207413 ; trial registration date: August 4, 2014.

Monitoring the quality of welding based on welding current and ste analysis

NASA Astrophysics Data System (ADS)

Mazlan, Afidatusshimah; Daniyal, Hamdan; Izzani Mohamed, Amir; Ishak, Mahadzir; Hadi, Amran Abdul

2017-10-01

Qualities of welding play an important part in industry especially in manufacturing field. Post-welding non-destructive test is one of the importance process to ensure the quality of welding but it is time consuming and costly. To reduce the chance of defects, online monitoring had been utilized by continuously sense some of welding parameters and predict welding quality. One of the parameters is welding current, which is rich of information but lack of study focus on extract them at signal analysis level. This paper presents the analysis of welding current using Short Time Energy (STE) signal processing to quantify the pattern of the current. GMAW set with carbon steel specimens are used in this experimental study with high-bandwidth and high sampling rate oscilloscope capturing the welding current. The results indicate welding current as signatures have high correlation with the welding process. Continue with STE analysis, the value below 5000 is declare as good welding, meanwhile the STE value more than 6000 is contained defect.

3D printing of high-strength aluminium alloys

NASA Astrophysics Data System (ADS)

Martin, John H.; Yahata, Brennan D.; Hundley, Jacob M.; Mayer, Justin A.; Schaedler, Tobias A.; Pollock, Tresa M.

2017-09-01

Metal-based additive manufacturing, or three-dimensional (3D) printing, is a potentially disruptive technology across multiple industries, including the aerospace, biomedical and automotive industries. Building up metal components layer by layer increases design freedom and manufacturing flexibility, thereby enabling complex geometries, increased product customization and shorter time to market, while eliminating traditional economy-of-scale constraints. However, currently only a few alloys, the most relevant being AlSi10Mg, TiAl6V4, CoCr and Inconel 718, can be reliably printed; the vast majority of the more than 5,500 alloys in use today cannot be additively manufactured because the melting and solidification dynamics during the printing process lead to intolerable microstructures with large columnar grains and periodic cracks. Here we demonstrate that these issues can be resolved by introducing nanoparticles of nucleants that control solidification during additive manufacturing. We selected the nucleants on the basis of crystallographic information and assembled them onto 7075 and 6061 series aluminium alloy powders. After functionalization with the nucleants, we found that these high-strength aluminium alloys, which were previously incompatible with additive manufacturing, could be processed successfully using selective laser melting. Crack-free, equiaxed (that is, with grains roughly equal in length, width and height), fine-grained microstructures were achieved, resulting in material strengths comparable to that of wrought material. Our approach to metal-based additive manufacturing is applicable to a wide range of alloys and can be implemented using a range of additive machines. It thus provides a foundation for broad industrial applicability, including where electron-beam melting or directed-energy-deposition techniques are used instead of selective laser melting, and will enable additive manufacturing of other alloy systems, such as non-weldable nickel superalloys and intermetallics. Furthermore, this technology could be used in conventional processing such as in joining, casting and injection moulding, in which solidification cracking and hot tearing are also common issues.

3D printing of high-strength aluminium alloys.

PubMed

Martin, John H; Yahata, Brennan D; Hundley, Jacob M; Mayer, Justin A; Schaedler, Tobias A; Pollock, Tresa M

2017-09-20

Metal-based additive manufacturing, or three-dimensional (3D) printing, is a potentially disruptive technology across multiple industries, including the aerospace, biomedical and automotive industries. Building up metal components layer by layer increases design freedom and manufacturing flexibility, thereby enabling complex geometries, increased product customization and shorter time to market, while eliminating traditional economy-of-scale constraints. However, currently only a few alloys, the most relevant being AlSi10Mg, TiAl6V4, CoCr and Inconel 718, can be reliably printed; the vast majority of the more than 5,500 alloys in use today cannot be additively manufactured because the melting and solidification dynamics during the printing process lead to intolerable microstructures with large columnar grains and periodic cracks. Here we demonstrate that these issues can be resolved by introducing nanoparticles of nucleants that control solidification during additive manufacturing. We selected the nucleants on the basis of crystallographic information and assembled them onto 7075 and 6061 series aluminium alloy powders. After functionalization with the nucleants, we found that these high-strength aluminium alloys, which were previously incompatible with additive manufacturing, could be processed successfully using selective laser melting. Crack-free, equiaxed (that is, with grains roughly equal in length, width and height), fine-grained microstructures were achieved, resulting in material strengths comparable to that of wrought material. Our approach to metal-based additive manufacturing is applicable to a wide range of alloys and can be implemented using a range of additive machines. It thus provides a foundation for broad industrial applicability, including where electron-beam melting or directed-energy-deposition techniques are used instead of selective laser melting, and will enable additive manufacturing of other alloy systems, such as non-weldable nickel superalloys and intermetallics. Furthermore, this technology could be used in conventional processing such as in joining, casting and injection moulding, in which solidification cracking and hot tearing are also common issues.

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

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

Fullenkamp, Patrick H; Holody, Diane S

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

The current status of the mission instruments of GOSAT-2

NASA Astrophysics Data System (ADS)

Nakajima, Masakatsu; Yajima, Yukie; Hashimoto, Makiko; Shiomi, Kei; Suto, Hiroshi; Imai, Hiroko

2017-04-01

The GOSAT-2 is the successor satellite to the GOSAT which is the satellite dedicated to the measurements of the greenhouse gases such as carbon dioxide and methane. GOSAT was launched in January of 2009 and has been operated for about seven years. The development of the GOSAT-2 has been continued for three years, and currently the proto-flight model is under manufacturing. The mission instruments of the GOSAT-2 are TANSO-FTS-2 and TANSO-CAI-2. TANSO-FTS-2 is the Fourier Transform Spectrometer observing greenhouse gases such as Carbon Dioxide and Methane and TANSO-CAI-2 is the imager observing the aerosols and clouds to compensate the TANSO-FTS-2 data and to grasp the movements of the aerosols such as PM2.5. The mission instruments will adopt the same kinds of instruments as GOSAT. But some improvements will be carried. Based on the results of the critical design, the manufacturing of the proto-flight model was started and through the manufacturing, the gap has emerged between the design and manufacturing. Especially, the results of the polarization sensitivity of the TANSO-CAI-2 was lower than 3% which is the requirements and the results of the test manufacturing has shown that it has been over than 40%. The root cause of this anomaly was that the thickness of the anti-reflecting coating had varied from place to place. Therefore the design of the thickness of the anti-reflecting coating has been changed with consideration for the difference of the thickness of the coat between the center and edge of the lens. And we could meet the polarization sensitivity requirement. In this presentation, the root cause and the investigation process of the polarization sensitivity anomaly will be presented as well as the current status of the manufacturing of the mission instruments of GOSAT-2.

Demonstration of array eddy current technology for real-time monitoring of laser powder bed fusion additive manufacturing process

NASA Astrophysics Data System (ADS)

Todorov, Evgueni; Boulware, Paul; Gaah, Kingsley

2018-03-01

Nondestructive evaluation (NDE) at various fabrication stages is required to assure quality of feedstock and solid builds. Industry efforts are shifting towards solutions that can provide real-time monitoring of additive manufacturing (AM) fabrication process layer-by-layer while the component is being built to reduce or eliminate dependence on post-process inspection. Array eddy current (AEC), electromagnetic NDE technique was developed and implemented to directly scan the component without physical contact with the powder and fused layer surfaces at elevated temperatures inside a LPBF chamber. The technique can detect discontinuities, surface irregularities, and undesirable metallurgical phase transformations in magnetic and nonmagnetic conductive materials used for laser fusion. The AEC hardware and software were integrated with the L-PBF test bed. Two layer-by-layer tests of Inconel 625 coupons with AM built discontinuities and lack of fusion were conducted inside the L-PBF chamber. The AEC technology demonstrated excellent sensitivity to seeded, natural surface, and near-surface-embedded discontinuities, while also detecting surface topography. The data was acquired and imaged in a layer-by-layer sequence demonstrating the real-time monitoring capabilities of this new technology.

Adsorption treatment of oxide chemical mechanical polishing wastewater from a semiconductor manufacturing plant by electrocoagulation.

PubMed

Chou, Wei-Lung; Wang, Chih-Ta; Chang, Wen-Chun; Chang, Shih-Yu

2010-08-15

In this study, metal hydroxides generated during electrocoagulation (EC) were used to remove the chemical oxygen demand (COD) of oxide chemical mechanical polishing (oxide-CMP) wastewater from a semiconductor manufacturing plant by EC. Adsorption studies were conducted in a batch system for various current densities and temperatures. The COD concentration in the oxide-CMP wastewater was effectively removed and decreased by more than 90%, resulting in a final wastewater COD concentration that was below the Taiwan discharge standard (100 mg L(-1)). Since the processed wastewater quality exceeded the direct discharge standard, the effluent could be considered for reuse. The adsorption kinetic studies showed that the EC process was best described using the pseudo-second-order kinetic model at the various current densities and temperatures. The experimental data were also tested against different adsorption isotherm models to describe the EC process. The Freundlich adsorption isotherm model predictions matched satisfactorily with the experimental observations. Thermodynamic parameters, including the Gibbs free energy, enthalpy, and entropy, indicated that the COD adsorption of oxide-CMP wastewater on metal hydroxides was feasible, spontaneous and endothermic in the temperature range of 288-318 K. Copyright 2010 Elsevier B.V. All rights reserved.

Surface Coating of Oxide Powders: A New Synthesis Method to Process Biomedical Grade Nano-Composites

PubMed Central

Palmero, Paola; Montanaro, Laura; Reveron, Helen; Chevalier, Jérôme

2014-01-01

Composite and nanocomposite ceramics have achieved special interest in recent years when used for biomedical applications. They have demonstrated, in some cases, increased performance, reliability, and stability in vivo, with respect to pure monolithic ceramics. Current research aims at developing new compositions and architectures to further increase their properties. However, the ability to tailor the microstructure requires the careful control of all steps of manufacturing, from the synthesis of composite nanopowders, to their processing and sintering. This review aims at deepening understanding of the critical issues associated with the manufacturing of nanocomposite ceramics, focusing on the key role of the synthesis methods to develop homogeneous and tailored microstructures. In this frame, the authors have developed an innovative method, named “surface-coating process”, in which matrix oxide powders are coated with inorganic precursors of the second phase. The method is illustrated into two case studies; the former, on Zirconia Toughened Alumina (ZTA) materials for orthopedic applications, and the latter, on Zirconia-based composites for dental implants, discussing the advances and the potential of the method, which can become a valuable alternative to the current synthesis process already used at a clinical and industrial scale. PMID:28788117

Asphalt fume exposure levels in North American asphalt production and roofing manufacturing operations.

PubMed

Axten, Charles W; Fayerweather, William E; Trumbore, David C; Mueller, Dennis J; Sampson, Arthur F

2012-01-01

This study extends by 8 years (1998-2005) a previous survey of asphalt fume exposures within North American asphalt processing and roofing product manufacturing workers. It focuses on characterizing personal, full-shift samples and seeks to address several limitations of the previous survey. Five major roofing manufacturers with established occupational health programs submitted workplace asphalt fume sampling results to a central repository for review and analysis. A certified industrial hygienist-led quality assurance team oversaw the data collection, consolidation, and analysis efforts. The analysis dataset consisted of 1261 personal exposure samples analyzed for total particulate (TP) and benzene soluble fraction (BSF) using existing NIOSH methods. For BSF, the survey's arithmetic (0.25 mg/m(3), SD = 0.62) and geometric (0.12 mg/m(3), GSD = 2.88) means indicate that the industry has sustained the control levels achieved in the late 1980s, early 1990s. Similar results were found for TP. The survey-wide summary statistics are consistent with other post-1990 multi-company exposure studies. Although these findings indicate that currently available controls are capable of achieving substantial (95%) compliance with the current threshold limit value in asphalt processing and inorganic shingle and roll plants, they also show that the majority of plants are not achieving this level of exposure control, and that exposures are significantly higher in plants making other product lines, particularly organic felt products. The current retrospective survey of existing company exposure data, like its predecessor, has several important limitations. These include lack of data on smaller manufacturers and on several commercially important product lines; insufficient information on the prevalence and effectiveness of engineering controls; no standard criteria by which to define and assess exposures in non-routine operations; and a paucity of exposure data collected as part of a random sampling strategy. To improve efforts to characterize exposures and potential health risks in roofing plants, a prospective program is currently being developed and piloted with the aim of building a more complete, higher-quality database based on a common industrial hygiene protocol.

Electron-processing technology: A promising application for the viscose industry

NASA Astrophysics Data System (ADS)

Stepanik, T. M.; Rajagopal, S.; Ewing, D.; Whitehouse, R.

1998-06-01

In marketing its IMPELA ® line of high power, high-throughput industrial accelerators, Atomic Energy of Canada Limited (AECL) is working with viscose (rayon) companies world-wide to integrate electron-processing technology as part of the viscose manufacturing process. The viscose industry converts cellulose wood pulp into products such as staple fiber, filament, cord, film, packaging, and non-edible sausage casings. This multibillion dollar industry is currently suffering from high production costs, and is facing increasingly stringent environmental regulations. The use of electron-treated pulp can significantly lower production costs and can provide equally significant environmental benefits. This paper describes our current understanding of the benefits of using electron-treated pulp in this process, and AECL's efforts in developing this technology.

Klystron Manufacturing Technology Program.

DTIC Science & Technology

1983-09-01

processes, and methodology used on the current production tube, VKU-7735E, and the new methods and techniques used to improve and reduce the cost of...the bellows. This alignment is c~tclto the smoothi operation of the internal tuniing mezhanism. IT METR𔃼D - VKCU-7795F The new assembly method changes...Varian, the MT contractor that the new methodology , technologies and process changes introduced into the MT power klystron and autotuner assembly - VKU

Computer-aided design development transition for IPAD environment

NASA Technical Reports Server (NTRS)

Owens, H. G.; Mock, W. D.; Mitchell, J. C.

1980-01-01

The relationship of federally sponsored computer-aided design/computer-aided manufacturing (CAD/CAM) programs to the aircraft life cycle design process, an overview of NAAD'S CAD development program, an evaluation of the CAD design process, a discussion of the current computing environment within which NAAD is developing its CAD system, some of the advantages/disadvantages of the NAAD-IPAD approach, and CAD developments during transition into the IPAD system are discussed.

Advanced optical manufacturing digital integrated system

NASA Astrophysics Data System (ADS)

Tao, Yizheng; Li, Xinglan; Li, Wei; Tang, Dingyong

2012-10-01

It is necessarily to adapt development of advanced optical manufacturing technology with modern science technology development. To solved these problems which low of ration, ratio of finished product, repetition, consistent in big size and high precision in advanced optical component manufacturing. Applied business driven and method of Rational Unified Process, this paper has researched advanced optical manufacturing process flow, requirement of Advanced Optical Manufacturing integrated System, and put forward architecture and key technology of it. Designed Optical component core and Manufacturing process driven of Advanced Optical Manufacturing Digital Integrated System. the result displayed effective well, realized dynamic planning Manufacturing process, information integration improved ratio of production manufactory.

High-throughput electrical characterization for robust overlay lithography control

NASA Astrophysics Data System (ADS)

Devender, Devender; Shen, Xumin; Duggan, Mark; Singh, Sunil; Rullan, Jonathan; Choo, Jae; Mehta, Sohan; Tang, Teck Jung; Reidy, Sean; Holt, Jonathan; Kim, Hyung Woo; Fox, Robert; Sohn, D. K.

2017-03-01

Realizing sensitive, high throughput and robust overlay measurement is a challenge in current 14nm and advanced upcoming nodes with transition to 300mm and upcoming 450mm semiconductor manufacturing, where slight deviation in overlay has significant impact on reliability and yield1). Exponentially increasing number of critical masks in multi-patterning lithoetch, litho-etch (LELE) and subsequent LELELE semiconductor processes require even tighter overlay specification2). Here, we discuss limitations of current image- and diffraction- based overlay measurement techniques to meet these stringent processing requirements due to sensitivity, throughput and low contrast3). We demonstrate a new electrical measurement based technique where resistance is measured for a macro with intentional misalignment between two layers. Overlay is quantified by a parabolic fitting model to resistance where minima and inflection points are extracted to characterize overlay control and process window, respectively. Analyses using transmission electron microscopy show good correlation between actual overlay performance and overlay obtained from fitting. Additionally, excellent correlation of overlay from electrical measurements to existing image- and diffraction- based techniques is found. We also discuss challenges of integrating electrical measurement based approach in semiconductor manufacturing from Back End of Line (BEOL) perspective. Our findings open up a new pathway for accessing simultaneous overlay as well as process window and margins from a robust, high throughput and electrical measurement approach.

Trends in capacity utilization for therapeutic monoclonal antibody production.

PubMed

Langer, Eric S

2009-01-01

The administration of high doses of therapeutic antibodies requires large-scale, efficient, cost effective manufacturing processes. An understanding of how the industry is using its available production capacity is important for production planning, and facility expansion analysis. Inaccurate production planning for therapeutic antibodies can have serious financial ramifications. In the recent 5(th) Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, 434 qualified respondents from 39 countries were asked to indicate, among other manufacturing issues, their current trends and future predictions with respect to the production capacity utilization of monoclonal antibodies in mammalian cell culture systems. While overall production of monoclonals has expanded dramatically since 2003, the average capacity utilization for mammalian cell culture systems, has decreased each year since 2003. Biomanufacturers aggressively attempt to avoid unanticipated high production demands that can create a capacity crunch. We summarize trends associated with capacity utilization and capacity constraints which indicate that biopharmaceutical manufacturers are doing a better job planning for capacity. The results have been a smoothing of capacity use shifts and an improved ability to forecast capacity and outsourcing needs. Despite these data, today, the instability and financial constraints caused by the current global economic crisis are likely to create unforeseen shifts in our capacity utilization and capacity expansion trends. These shifts will need to be measured in subsequent studies.

Processing of continuous fiber reinforced ceramic composites for ultra high temperature applications using organosilicon polymer precursors

NASA Astrophysics Data System (ADS)

Nicholas, James Robert

The current work is on the development of continuous fiber reinforced ceramic materials (CFCCs) for use in ultra high temperature applications. These applications subject materials to extremely high temperatures(> 2000°C). Monolithic ceramics are currently being used for these applications, but the tendency to fail catastrophically has driven the need for the next generation of material. Reinforcing with continuous fibers significantly improves the toughness of the monolithic materials; however, this is a manufacturing challenge. The development of commercial, low-viscosity preceramic polymers provides new opportunities to fabricate CFCCs. Preceramic polymers behave as polymers at low temperatures and are transformed into ceramics upon heating to high temperatures. The polymer precursors enable the adaptation of well-established polymer processing techniques to produce high quality materials at relatively low cost. In the present work, SMP-10 from Starfire Systems, and PURS from KiON Corp. were used to manufacture ZrB2-SiC/SiC CFCCs using low cost vacuum bagging process in conjunction with the polymer infiltration and pyrolysis process. The microstructure was investigated using scanning electron microscopy and it was determined that the initial greenbody cure produced porosity of both closed and open pores. The open pores were found to be more successfully re-infiltrated using neat resin compared to slurry reinfiltrate; however, the closed pores were found to be impenetrable during subsequent reinfiltrations. The mechanical performance of the manufactured samples was evaluated using flexure tests and found the fiber reinforcement prevented catastrophic failure behavior by increasing fracture toughness. Wedge sample were fabricated and evaluated to demonstrate the ability to produce CFCC of complex geometry.

Printing Outside the Box: Additive Manufacturing Processes for Fabrication of Large Aerospace Structures

NASA Technical Reports Server (NTRS)

Babai, Majid; Peters, Warren

2015-01-01

To achieve NASA's mission of space exploration, innovative manufacturing processes are being applied to the fabrication of propulsion elements. Liquid rocket engines (LREs) are comprised of a thrust chamber and nozzle extension as illustrated in figure 1 for the J2X upper stage engine. Development of the J2X engine, designed for the Ares I launch vehicle, is currently being incorporated on the Space Launch System. A nozzle extension is attached to the combustion chamber to obtain the expansion ratio needed to increase specific impulse. If the nozzle extension could be printed as one piece using free-form additive manufacturing (AM) processes, rather than the current method of forming welded parts, a considerable time savings could be realized. Not only would this provide a more homogenous microstructure than a welded structure, but could also greatly shorten the overall fabrication time. The main objective of this study is to fabricate test specimens using a pulsed arc source and solid wire as shown in figure 2. The mechanical properties of these specimens will be compared with those fabricated using the powder bed, selective laser melting technology at NASA Marshall Space Flight Center. As printed components become larger, maintaining a constant temperature during the build process becomes critical. This predictive capability will require modeling of the moving heat source as illustrated in figure 3. Predictive understanding of the heat profile will allow a constant temperature to be maintained as a function of height from substrate while printing complex shapes. In addition, to avoid slumping, this will also allow better control of the microstructural development and hence the properties. Figure 4 shows a preliminary comparison of the mechanical properties obtained.

Development of Aluminum-Lithium 2195 Gores by the Stretch Forming Process

NASA Technical Reports Server (NTRS)

Volz, M. P.; Chen, P. S.; Gorti, S.; Salvail, P.

2014-01-01

Aluminum-Lithium alloy 2195 exhibits higher mechanical properties and lower density than aluminum alloy 2219, which is the current baseline material for Space Launch System (SLS) cryogenic tank components. Replacement of Al 2219 with Al-Li 2195 would result in substantial weight savings, as was the case when this replacement was made on the shuttle external tank. A key component of cryogenic tanks are the gores, which are welded together to make the rounded ends of the tanks. The required thicknesses of these gores depend on the specific SLS configuration and may exceed the current experience base in the manufacture of such gores by the stretch forming process. Here we describe the steps taken to enhance the formability of Al-Li 2195 by optimizing the heat treatment and stretch forming processes for gore thicknesses up to 0.75", which envelopes the maximum expected gore thicknesses for SLS tanks. An annealing treatment, developed at Marshall Space Flight Center, increased the forming range and strain hardening exponent of Al-Li 2195 plates. Using this annealing treatment, one 0.525" thick and two 0.75" thick gores were manufactured by the stretch forming process. The annealing treatment enabled the stretch forming of the largest ever cross sectional area (thickness x width) of an Al-Li 2195 plate achieved by the manufacturer. Mechanical testing of the gores showed greater than expected ultimate tensile strength, yield strength, modulus, and elongation values. The gores also exhibited acceptable fracture toughness at room and LN2 temperatures. All of the measured data indicate that the stretch formed gores have sufficient material properties to be used in flight domes.

Re-manufacture of cobalt-manganese-bromide as a liquid catalyst from spent catalyst containing cobalt generated from petrochemical processes via hydrometallurgy.

PubMed

Joo, Sung-Ho; Shin, Dong Ju; Oh, Chang Hyun; Wang, Jei-Pil; Shin, Shun Myung

2016-11-15

Cobalt and manganese have been the subject of individual separation studies because their fields of application are different. However, this study shows that high-value products can be manufactured in the form of a cobalt-manganese-bromide (CMB) liquid catalyst by simultaneously recovering cobalt and manganese. Na-bis-(2,4,4-tri-methyl-pentyl)phosphinic acid was employed in order to manufacture the CMB liquid catalyst from the spent catalyst generated from petroleum chemistry processes. The pH-isotherm, degree of saponification of solvent and separation factor values were investigated. ΔpH50 and separation factor values show that Co and Mn can be separated from impurities such as Mg and Ca. Further, the extraction stages and organic/aqueous ratio isotherms were investigated using counter-current simulation extraction batch tests. To prepare CMB from a loaded organic phase obtained in a stripping study using hydrogen bromide, the Co and Mn were completely stripped and concentrated by a factor of 6 using a 2M hydrogen bromide solution. When compared with manufactured and commercial CMB, the CMB liquid catalyst could be produced by supplying a shortage of Mn in the form of manganese bromide. Finally, the method of manufacture of CMB was subjected to a real pilot plant test. Copyright © 2016. Published by Elsevier B.V.

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

Horowitz, Kelsey A. W.; Fu, Ran; Woodhouse, Michael

This article examines current cost drivers and potential avenues to reduced cost for monolithic, glass-glass Cu(In,Ga)(Se,S)2 (CIGS) modules by constructing a comprehensive bottom-up cost model. For a reference case where sputtering plus batch sulfurization after selenization (SAS) is employed, we compute a manufacturing cost of $69/m2 if the modules are made in the United States at a 1 GW/year production volume. At 14% module efficiency, this corresponds to a manufacturing cost of $0.49/WDC and a minimum sustainable price (MSP) of $0.67/WDC. We estimate that MSP could vary within +/-20% of this value given the range of quoted input prices, andmore » existing variations in module design, manufacturing processes, and manufacturing location. Potential for reduction in manufacturing costs to below $0.40/WDC may be possible if average production module efficiencies can be increased above 17% without increasing $/m2 costs; even lower costs could be achieved if $/m2 costs could be reduced, particularly via innovations in the CIGS deposition process or balance-of-module elements. We present the impact on cost of regional factors, CIGS deposition method, device design, and price fluctuations. One metric of competitiveness-levelized cost of energy (LCOE) -- is also assessed for several U.S. locations and compared to that of standard multi-crystalline silicon (m(c-Si)) and cadmium telluride (CdTe).« less

Printed polymer photonic devices for optical interconnect systems

NASA Astrophysics Data System (ADS)

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

2016-03-01

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

Costs, Benefits, and Adoption of Additive Manufacturing: A Supply Chain Perspective

PubMed Central

Thomas, Douglas

2017-01-01

There are three primary aspects to the economics of additive manufacturing: measuring the value of goods produced, measuring the costs and benefits of using the technology, and estimating the adoption and diffusion of the technology. This paper provides an updated estimate of the value of goods produced. It then reviews the literature on additive manufacturing costs and identifies those instances in the literature where this technology is cost effective. The paper then goes on to propose an approach for examining and understanding the societal costs and benefits of this technology both from a monetary viewpoint and a resource consumption viewpoint. The final section discusses the trends in the adoption of additive manufacturing. Globally, there is an estimated $667 million in value added produced using additive manufacturing, which equates to 0.01 % of total global manufacturing value added. US value added is estimated as $241 million. Current research on additive manufacturing costs reveals that it is cost effective for manufacturing small batches with continued centralized production; however, with increased automation distributed production may become cost effective. Due to the complexities of measuring additive manufacturing costs and data limitations, current studies are limited in their scope. Many of the current studies examine the production of single parts and those that examine assemblies tend not to examine supply chain effects such as inventory and transportation costs along with decreased risk to supply disruption. The additive manufacturing system and the material costs constitute a significant portion of an additive manufactured product; however, these costs are declining over time. The current trends in costs and benefits have resulted in this technology representing 0.02 % of the relevant manufacturing industries in the US; however, as the costs of additive manufacturing systems decrease, this technology may become widely adopted and change the supplier, manufacturer, and consumer interactions. An examination in the adoption of additive manufacturing reveals that for this technology to exceed $4.4 billion in 2020, $16.0 billion in 2025, and $196.8 billion in 2035 it would need to deviate from its current trends of adoption. PMID:28747809

Costs, Benefits, and Adoption of Additive Manufacturing: A Supply Chain Perspective.

PubMed

Thomas, Douglas

2016-07-01

There are three primary aspects to the economics of additive manufacturing: measuring the value of goods produced, measuring the costs and benefits of using the technology, and estimating the adoption and diffusion of the technology. This paper provides an updated estimate of the value of goods produced. It then reviews the literature on additive manufacturing costs and identifies those instances in the literature where this technology is cost effective. The paper then goes on to propose an approach for examining and understanding the societal costs and benefits of this technology both from a monetary viewpoint and a resource consumption viewpoint. The final section discusses the trends in the adoption of additive manufacturing. Globally, there is an estimated $667 million in value added produced using additive manufacturing, which equates to 0.01 % of total global manufacturing value added. US value added is estimated as $241 million. Current research on additive manufacturing costs reveals that it is cost effective for manufacturing small batches with continued centralized production; however, with increased automation distributed production may become cost effective. Due to the complexities of measuring additive manufacturing costs and data limitations, current studies are limited in their scope. Many of the current studies examine the production of single parts and those that examine assemblies tend not to examine supply chain effects such as inventory and transportation costs along with decreased risk to supply disruption. The additive manufacturing system and the material costs constitute a significant portion of an additive manufactured product; however, these costs are declining over time. The current trends in costs and benefits have resulted in this technology representing 0.02 % of the relevant manufacturing industries in the US; however, as the costs of additive manufacturing systems decrease, this technology may become widely adopted and change the supplier, manufacturer, and consumer interactions. An examination in the adoption of additive manufacturing reveals that for this technology to exceed $4.4 billion in 2020, $16.0 billion in 2025, and $196.8 billion in 2035 it would need to deviate from its current trends of adoption.

Electrochemical Solution Growth of Magnetic Nitrides

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

Monson, Todd C.; Pearce, Charles

Magnetic nitrides, if manufactured in bulk form, would provide designers of transformers and inductors with a new class of better performing and affordable soft magnetic materials. According to experimental results from thin films and/or theoretical calculations, magnetic nitrides would have magnetic moments well in excess of current state of the art soft magnets. Furthermore, magnetic nitrides would have higher resistivities than current transformer core materials and therefore not require the use of laminates of inactive material to limit eddy current losses. However, almost all of the magnetic nitrides have been elusive except in difficult to reproduce thin films or asmore » inclusions in another material. Now, through its ability to reduce atmospheric nitrogen, the electrochemical solution growth (ESG) technique can bring highly sought after (and previously inaccessible) new magnetic nitrides into existence in bulk form. This method utilizes a molten salt as a solvent to solubilize metal cations and nitrogen ions produced electrochemically and form nitrogen compounds. Unlike other growth methods, the scalable ESG process can sustain high growth rates (~mm/hr) even under reasonable operating conditions (atmospheric pressure and 500 °C). Ultimately, this translates into a high throughput, low cost, manufacturing process. The ESG process has already been used successfully to grow high quality GaN. Below, the experimental results of an exploratory express LDRD project to access the viability of the ESG technique to grow magnetic nitrides will be presented.« less

Construction of negative images of menstruation in Indian TV commercials.

PubMed

Yagnik, Arpan Shailesh

2012-01-01

Menstruation is a perfectly normal physiological process; however, it is problematized in TV commercials. In the current study, a thematic analysis of 50 Indian TV commercials was conducted to identify the latent themes. Social captivity, restrictions, professional inefficiency, and physical and mental discomfort emerged as major themes after the analysis. The knowledge that manufacturers use such themes for image building and creating a conducive buying environment may prevent the reinforcement of menstrual taboos in Indian society. It can also guide the manufacturers in ideating and creating positive and healthier ways of advertising female hygiene products.

Manufacturing waste disposal practices of the chemical propulsion industry

NASA Technical Reports Server (NTRS)

Goldberg, Benjamin E.; Adams, Daniel E.; Schutzenhofer, Scott A.

1995-01-01

The waste production, mitigation and disposal practices of the United States chemical propulsion industry have been investigated, delineated, and comparatively assessed to the U.S. industrial base. Special emphasis has been placed on examination of ozone depleting chemicals (ODC's). The research examines present and anticipated future practices and problems encountered in the manufacture of solid and liquid propulsion systems. Information collected includes current environmental laws and regulations that guide the industry practices, processes in which ODC's are or have been used, quantities of waste produced, funding required to maintain environmentally compliant practices, and preventive efforts.

A novel design solution to the fraenal notch of maxillary dentures.

PubMed

White, J A P; Bond, I P; Jagger, D C

2013-09-01

This study investigates a novel design feature for the fraenal notch of maxillary dentures, using computational and experimental methods, and shows that its use could significantly increase the longevity of the prosthesis. A two-step process can be used to create the design feature with current denture base materials, but would be highly dependent on the individual skill of the dental technician. Therefore, an alternative form of manufacture, multi-material additive layer manufacture (or '3D printing'), has been proposed as a future method for the direct production of complete dentures with multi-material design features.

Recent advances in the biological production of mannitol.

PubMed

Song, Seung Hoon; Vieille, Claire

2009-08-01

Mannitol is a fructose-derived, 6-carbon sugar alcohol that is widely found in bacteria, yeasts, fungi, and plants. Because of its desirable properties, mannitol has many applications in pharmaceutical products, in the food industry, and in medicine. The current mannitol chemical manufacturing process yields crystalline mannitol in yields below 20 mol% from 50% glucose/50% fructose syrups. Thus, microbial and enzymatic mannitol manufacturing methods have been actively investigated, in particular in the last 10 years. This review summarizes the most recent advances in biological mannitol production, including the development of bacterial-, yeast-, and enzyme-based transformations.

Manufacturing Process Selection of Composite Bicycle’s Crank Arm using Analytical Hierarchy Process (AHP)

NASA Astrophysics Data System (ADS)

Luqman, M.; Rosli, M. U.; Khor, C. Y.; Zambree, Shayfull; Jahidi, H.

2018-03-01

Crank arm is one of the important parts in a bicycle that is an expensive product due to the high cost of material and production process. This research is aimed to investigate the potential type of manufacturing process to fabricate composite bicycle crank arm and to describe an approach based on analytical hierarchy process (AHP) that assists decision makers or manufacturing engineers in determining the most suitable process to be employed in manufacturing of composite bicycle crank arm at the early stage of the product development process to reduce the production cost. There are four types of processes were considered, namely resin transfer molding (RTM), compression molding (CM), vacuum bag molding and filament winding (FW). The analysis ranks these four types of process for its suitability in the manufacturing of bicycle crank arm based on five main selection factors and 10 sub factors. Determining the right manufacturing process was performed based on AHP process steps. Consistency test was performed to make sure the judgements are consistent during the comparison. The results indicated that the compression molding was the most appropriate manufacturing process because it has the highest value (33.6%) among the other manufacturing processes.

Development of the antimicrobial effectiveness test as USP chapter <51>.

PubMed

Sutton, Scott V W; Porter, David

2002-01-01

The antimicrobial effectiveness test first appeared as a USP General Chapter in the 18th revision, official September 1, 1970. This chapter, at the beginning, was designed to evaluate the performance of antimicrobials added to inhibit the growth of microorganisms that might be introduced during or subsequent to the manufacturing process. As Good Manufacturing Practices (GMPs) became a governing principal in pharmaceutical manufacturing, the purpose of the test was refined to focus on activity of the preservative system as a protection against inadvertent contamination during storage and usage of the product. This article will review the history of the antimicrobial test; its function, technique, and the background discussions that resulted in the changes from the test that appeared in USP XVIII to that of the current USP 25.

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.

Cost of ownership for inspection equipment

NASA Astrophysics Data System (ADS)

Dance, Daren L.; Bryson, Phil

1993-08-01

Cost of Ownership (CoO) models are increasingly a part of the semiconductor equipment evaluation and selection process. These models enable semiconductor manufacturers and equipment suppliers to quantify a system in terms of dollars per wafer. Because of the complex nature of the semiconductor manufacturing process, there are several key attributes that must be considered in order to accurately reflect the true 'cost of ownership'. While most CoO work to date has been applied to production equipment, the need to understand cost of ownership for inspection and metrology equipment presents unique challenges. Critical parameters such as detection sensitivity as a function of size and type of defect are not included in current CoO models yet are, without question, major factors in the technical evaluation process and life-cycle cost. This paper illustrates the relationship between these parameters, as components of the alpha and beta risk, and cost of ownership.

Tapping the Value Potential of Extended Asset Services - Experiences from Finnish Companies

NASA Astrophysics Data System (ADS)

Kortelainen, Helena; Hanski, Jyri; Valkokari, Pasi; Ahonen, Toni

2017-09-01

Recent developments in information technology and business models enable a wide variety of new services for companies looking for growth in services. Currently, manufacturing companies have been actively developing and providing novel asset based services such as condition monitoring and remote control. However, there is still untapped potential in extending the service delivery to the long-term co-operative development of physical assets over the whole lifecycle. Close collaboration with the end-customer and other stakeholders is needed in order to understand the value generation options. In this paper, we assess some of the asset services manufacturing companies are currently developing. The descriptions of the asset services are based on the results of an industrial workshop in which the companies presented their service development plans. The service propositions are compared with the Total Cost of Ownership and the closed loop life cycle frameworks. Based on the comparison, gaps that indicate potential for extended asset service concepts are recognised. In conclusion, we argue that the manufacturing companies do not recognise the whole potential for asset based services and for optimizing the performance of the end customers' processes.

Intelligent technologies in process of highly-precise products manufacturing

NASA Astrophysics Data System (ADS)

Vakhidova, K. L.; Khakimov, Z. L.; Isaeva, M. R.; Shukhin, V. V.; Labazanov, M. A.; Ignatiev, S. A.

2017-10-01

One of the main control methods of the surface layer of bearing parts is the eddy current testing method. Surface layer defects of bearing parts, like burns, cracks and some others, are reflected in the results of the rolling surfaces scan. The previously developed method for detecting defects from the image of the raceway was quite effective, but the processing algorithm is complicated and lasts for about 12 ... 16 s. The real non-stationary signals from an eddy current transducer (ECT) consist of short-time high-frequency and long-time low-frequency components, therefore a transformation is used for their analysis, which provides different windows for different frequencies. The wavelet transform meets these conditions. Based on aforesaid, a methodology for automatically detecting and recognizing local defects in bearing parts surface layer has been developed on the basis of wavelet analysis using integral estimates. Some of the defects are recognized by the amplitude component, otherwise an automatic transition to recognition by the phase component of information signals (IS) is carried out. The use of intelligent technologies in the manufacture of bearing parts will, firstly, significantly improve the quality of bearings, and secondly, significantly improve production efficiency by reducing (eliminating) rejections in the manufacture of products, increasing the period of normal operation of the technological equipment (inter-adjustment period), the implementation of the system of Flexible facilities maintenance, as well as reducing production costs.

Chitosan scaffolds containing calcium phosphate salts and rhBMP-2: in vitro and in vivo testing for bone tissue regeneration.

PubMed

Guzmán, Rodrigo; Nardecchia, Stefania; Gutiérrez, María C; Ferrer, María Luisa; Ramos, Viviana; del Monte, Francisco; Abarrategi, Ander; López-Lacomba, José Luis

2014-01-01

Numerous strategies that are currently used to regenerate bone depend on employing biocompatible materials exhibiting a scaffold structure. These scaffolds can be manufactured containing particular active compounds, such as hydroxyapatite precursors and/or different growth factors to enhance bone regeneration process. Herein, we have immobilized calcium phosphate salts (CPS) and bone morphogenetic protein 2 (BMP-2)--combined or alone--into chitosan scaffolds using ISISA process. We have analyzed whether the immobilized bone morphogenetic protein preserved its osteoinductive capability after manufacturing process as well as BMP-2 in vitro release kinetic. We have also studied both the in vitro and in vivo biocompatibility of the resulting scaffolds using a rabbit model. Results indicated that rhBMP-2 remained active in the scaffolds after the manufacturing process and that its release kinetic was different depending on the presence of CPS. In vitro and in vivo findings showed that cells grew more in scaffolds with both CPS and rhBMP-2 and that these scaffolds induced more bone formation in rabbit tibia. Thus chitosan scaffolds containing both CPS and rhBMP-2 were more osteoinductive than their counterparts alone indicating that could be useful for bone regeneration purposes, such as some applications in dentistry.

Concepts for the development of nanoscale stable precipitation-strengthened steels manufactured by conventional methods

DOE PAGES

Yablinsky, C. A.; Tippey, K. E.; Vaynman, S.; ...

2014-11-11

In this study, the development of oxide dispersion strengthened ferrous alloys has shown that microstructures designed for excellent irradiation resistance and thermal stability ideally contain stable nanoscale precipitates and dislocation sinks. Based upon this understanding, the microstructures of conventionally manufactured ferritic and ferritic-martensitic steels can be designed to include controlled volume fractions of fine, stable precipitates and dislocation sinks via specific alloying and processing paths. The concepts proposed here are categorized as advanced high-Cr ferritic-martensitic (AHCr-FM) and novel tailored precipitate ferritic (TPF) steels, which have the potential to improve the in-reactor performance of conventionally manufactured alloys. AHCr-FM steels have modifiedmore » alloy content relative to current reactor materials (such as alloy NF616/P92) to maximize desirable precipitates and control phase stability. TPF steels are designed to incorporate nickel aluminides, in addition to microalloy carbides, in a ferritic matrix to produce fine precipitate arrays with good thermal stability. Both alloying concepts may also benefit from thermomechanical processing to establish dislocation sinks and modify phase transformation behaviors. Alloying and processing paths toward designed microstructures are discussed for both AHCr-FM and TPF material classes.« less

Impact of Electrostatics on Processing and Product Performance of Pharmaceutical Solids.

PubMed

Desai, Parind Mahendrakumar; Tan, Bernice Mei Jin; Liew, Celine Valeria; Chan, Lai Wah; Heng, Paul Wan Sia

2015-01-01

Manufacturing of pharmaceutical solids involves different unit operations and processing steps such as powder blending, fluidization, sieving, powder coating, pneumatic conveying and spray drying. During these operations, particles come in contact with other particles, different metallic, glass or polymer surfaces and can become electrically charged. Electrostatic charging often gives a negative connotation as it creates sticking, jamming, segregation or other issues during tablet manufacturing, capsule filling, film packaging and other pharmaceutical operations. A thorough and fundamental appreciation of the current knowledge of mechanisms and the potential outcomes is essential in order to minimize potential risks resulting from this phenomenon. The intent of this review is to discuss the electrostatic properties of pharmaceutical powders, equipment surfaces and devices affecting pharmaceutical processing and product performance. Furthermore, the underlying mechanisms responsible for the electrostatic charging are described and factors affecting electrostatic charging have been reviewed in detail. Feasibility of different methods used in the laboratory and pharmaceutical industry to measure charge propensity and decay has been summarized. Different computational and experimental methods studied have proven that the particle charging is a very complex phenomenon and control of particle charging is extremely important to achieve reliable manufacturing and reproducible product performance.

Review of bilayer tablet technology.

PubMed

Abebe, Admassu; Akseli, Ilgaz; Sprockel, Omar; Kottala, Niranjan; Cuitiño, Alberto M

2014-01-30

Therapeutic strategies based on oral delivery of bilayer (and multilayer) tablets are gaining more acceptance among brand and generic products due to a confluence of factors including advanced delivery strategies, patient compliance and combination therapy. Successful manufacturing of these ever more complex systems needs to overcome a series of challenges from formulation design to tablet press monitoring and control. This article provides an overview of the state-of-the-art of bilayer tablet technology, highlighting the main benefits of this type of oral dosage forms while providing a description of current challenges and advances toward improving manufacturing practices and product quality. Several aspects relevant to bilayer tablet manufacturing are addressed including material properties, lubrication, layer ordering, layer thickness, layer weight control, as well as first and final compression forces. A section is also devoted to bilayer tablet characterization that present additional complexities associated with interfaces between layers. The available features of the manufacturing equipment for bilayer tablet production are also described indicating the different strategies for sensing and controls offered by bilayer tablet press manufacturers. Finally, a roadmap for bilayer tablet manufacturing is advanced as a guideline to formulation design and selection of process parameters and equipment. Copyright © 2013 Elsevier B.V. All rights reserved.

Knowledge management performance methodology regarding manufacturing organizations

NASA Astrophysics Data System (ADS)

Istrate, C.; Herghiligiu, I. V.

2016-08-01

The current business situation is extremely complicated. Business must adapt to the changes in order (a) to survive on the increasingly dynamic markets, (b) to meet customers’ new request for complex, customized and innovative products. In modern manufacturing organizations it can be seen a substantial improvement regarding the management of knowledge. This occurs due to the fact that organizations realized that knowledge and an efficient management of knowledge generates the highest value. Even it could be said that the manufacturing organizations were and are the biggest beneficiary of KM science. Knowledge management performance (KMP) evaluation in manufacturing organizations can be considered as extremely important because without measuring it, they are unable to properly assess (a) what goals, targets and activities must have continuity, (b) what must be improved and (c) what must be completed. Therefore a proper KM will generate multiple competitive advantages for organizations. This paper presents a developed methodological framework regarding the KMP importance regarding manufacturing organizations. This methodological framework was developed using as research methods: bibliographical research and a panel of specialists. The purpose of this paper is to improve the evaluation process of KMP and to provide a viable tool for manufacturing organizations managers.

78 FR 76836 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-19

... Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements... of FDA's regulations regarding current good manufacturing practice (CGMP) for dietary supplements..., or Holding Operations for Dietary Supplements--21 CFR Part 111 (OMB Control Number 0910-0606...

21 CFR 184.1449 - Manganese citrate.

Code of Federal Regulations, 2012 CFR

2012-04-01

... than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing... good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic...

21 CFR 184.1449 - Manganese citrate.

Code of Federal Regulations, 2010 CFR

2010-04-01

... than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing... good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic...

21 CFR 184.1449 - Manganese citrate.

Code of Federal Regulations, 2011 CFR

2011-04-01

... than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing... good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic...

21 CFR 184.1449 - Manganese citrate.

Code of Federal Regulations, 2013 CFR

2013-04-01

... than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing... good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic...

Aberrations in square pore micro-channel optics used for x-ray lobster eye telescopes

NASA Astrophysics Data System (ADS)

Willingale, R.; Pearson, J. F.; Martindale, A.; Feldman, C. H.; Fairbend, R.; Schyns, E.; Petit, S.; Osborne, J. P.; O'Brien, P. T.

2016-07-01

We identify all the significant aberrations that limit the performance of square pore micro-channel plate optics (MPOs) used as an X-ray lobster eye. These include aberrations intrinsic to the geometry, intrinsic errors associated with the slumping process used to introduce a spherical form to the plates and imperfections associated with the plate manufacturing process. The aberrations are incorporated into a comprehensive software model of the X-ray response of the optics and the predicted imaging response is compared with the measured X-ray performance obtained from a breadboard lobster eye. The results reveal the manufacturing tolerances which limit the current performance of MPOs and enable us to identify particular intrinsic aberrations which will limit the ultimate performance we can expect from MPO-lobster eye telescopes.

Development of Integrated Programs for Aerospace-vehicle Design (IPAD): Product manufacture interactions with the design process

NASA Technical Reports Server (NTRS)

Crowell, H. A.

1979-01-01

The product manufacturing interactions with the design process and the IPAD requirements to support the interactions are described. The data requirements supplied to manufacturing by design are identified and quantified. Trends in computer-aided manufacturing are discussed and the manufacturing process of the 1980's is anticipated.

Engineered pinning landscapes for enhanced 2G coil wire

DOE PAGES

Rupich, Martin W.; Sathyamurthy, Srivatsan; Fleshler, Steven; ...

2016-04-01

We demonstrate a twofold increase in the in-field critical current of AMSC's standard 2G coil wire by irradiation with 18-MeV Au ions. The optimum pinning enhancement is achieved with a dose of 6 × 10 11 Au ions/cm 2. Although the 77 K, self-field critical current is reduced by about 35%, the in-field critical current (H//c) shows a significant enhancement between 4 and 50 K in fields > 1 T. The process was used for the roll-to-roll irradiation of AMSC's standard 46-mm-wide production coated conductor strips, which were further processed into standard copper laminated coil wire. The long-length wires showmore » the same enhancement as attained with short static irradiated samples. The roll-to-roll irradiation process can be incorporated in the standard 2G wire manufacturing, with no modifications to the current process. In conclusion, the enhanced performance of the wire will benefit rotating machine and magnet applications.« less

Effects of Processing Parameters on Surface Roughness of Additive Manufactured Ti-6Al-4V via Electron Beam Melting

PubMed Central

Sin, Wai Jack; Nai, Mui Ling Sharon; Wei, Jun

2017-01-01

As one of the powder bed fusion additive manufacturing technologies, electron beam melting (EBM) is gaining more and more attention due to its near-net-shape production capacity with low residual stress and good mechanical properties. These characteristics also allow EBM built parts to be used as produced without post-processing. However, the as-built rough surface introduces a detrimental influence on the mechanical properties of metallic alloys. Thereafter, understanding the effects of processing parameters on the part’s surface roughness, in turn, becomes critical. This paper has focused on varying the processing parameters of two types of contouring scanning strategies namely, multispot and non-multispot, in EBM. The results suggest that the beam current and speed function are the most significant processing parameters for non-multispot contouring scanning strategy. While for multispot contouring scanning strategy, the number of spots, spot time, and spot overlap have greater effects than focus offset and beam current. The improved surface roughness has been obtained in both contouring scanning strategies. Furthermore, non-multispot contouring scanning strategy gives a lower surface roughness value and poorer geometrical accuracy than the multispot counterpart under the optimized conditions. These findings could be used as a guideline for selecting the contouring type used for specific industrial parts that are built using EBM. PMID:28937638

40 CFR 761.193 - Maintenance of monitoring records by persons who import, manufacture, process, distribute in...

Code of Federal Regulations, 2013 CFR

2013-07-01

... persons who import, manufacture, process, distribute in commerce, or use chemicals containing... records by persons who import, manufacture, process, distribute in commerce, or use chemicals containing inadvertently generated PCBs. (a) Persons who import, manufacture, process, distribute in commerce, or use...