Manufacturing engineering: Principles for optimization

NASA Astrophysics Data System (ADS)

Koenig, Daniel T.

Various subjects in the area of manufacturing engineering are addressed. The topics considered include: manufacturing engineering organization concepts and management techniques, factory capacity and loading techniques, capital equipment programs, machine tool and equipment selection and implementation, producibility engineering, methods, planning and work management, and process control engineering in job shops. Also discussed are: maintenance engineering, numerical control of machine tools, fundamentals of computer-aided design/computer-aided manufacture, computer-aided process planning and data collection, group technology basis for plant layout, environmental control and safety, and the Integrated Productivity Improvement Program.

Implementing Lean Six Sigma to achieve inventory control in supply chain management

NASA Astrophysics Data System (ADS)

Hong, Chen

2017-11-01

The inventory cost has important impact on the production cost. In order to get the maximum circulation of funds of enterprise with minimum inventory cost, the inventory control with Lean Six Sigma is presented in supply chain management. The inventory includes both the raw material and the semi-finished parts in manufacturing process. Though the inventory is often studied, the inventory control in manufacturing process is seldom mentioned. This paper reports the inventory control from the perspective of manufacturing process by using statistical techniques including DMAIC, Control Chart, and Statistical Process Control. The process stability is evaluated and the process capability is verified with Lean Six Sigma philosophy. The demonstration in power meter production shows the inventory is decreased from 25% to 0.4%, which indicates the inventory control can be achieved with Lean Six Sigma philosophy and the inventory cost in production can be saved for future sustainable development in supply chain management.

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

NASA Astrophysics Data System (ADS)

Beaman, Joseph

2015-03-01

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

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.

Large-area copper indium diselenide (CIS) process, control and manufacturing

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

Gillespie, T.J.; Lanning, B.R.; Marshall, C.H.

1997-12-31

Lockheed Martin Astronautics (LMA) has developed a large-area (30x30cm) sequential CIS manufacturing approach amenable to low-cost photovoltaics (PV) production. A prototype CIS manufacturing system has been designed and built with compositional uniformity (Cu/In ratio) verified within {+-}4 atomic percent over the 30x30cm area. CIS device efficiencies have been measured by the National Renewable Energy Laboratory (NREL) at 7% on a flexible non-sodium-containing substrate and 10% on a soda-lime-silica (SLS) glass substrate. Critical elements of the manufacturing capability include the CIS sequential process selection, uniform large-area material deposition, and in-situ process control. Details of the process and large-area manufacturing approach aremore » discussed and results presented.« less

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

NASA Astrophysics Data System (ADS)

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

2000-10-01

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

76 FR 21652 - Oil Pollution Prevention; Spill Prevention, Control, and Countermeasure (SPCC) Rule-Amendments...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-18

... of Agriculture (USDA) Recommended Requirements for Milk for Manufacturing Purposes and its Production and Processing (Milk for Manufacturing Purposes and Its Production and Processing; Requirements... for Manufacturing Purposes and its Production and Processing, or equivalent State dairy regulatory...

Intelligent Weld Manufacturing: Role of Integrated Computational Welding Engineering

DOE PAGES

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

2017-12-02

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

Intelligent Weld Manufacturing: Role of Integrated Computational Welding Engineering

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

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

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

21 CFR 820.70 - Production and process controls.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Production and process controls. 820.70 Section 820.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... could occur as a result of the manufacturing process, the manufacturer shall establish and maintain...

MapReduce Based Parallel Bayesian Network for Manufacturing Quality Control

NASA Astrophysics Data System (ADS)

Zheng, Mao-Kuan; Ming, Xin-Guo; Zhang, Xian-Yu; Li, Guo-Ming

2017-09-01

Increasing complexity of industrial products and manufacturing processes have challenged conventional statistics based quality management approaches in the circumstances of dynamic production. A Bayesian network and big data analytics integrated approach for manufacturing process quality analysis and control is proposed. Based on Hadoop distributed architecture and MapReduce parallel computing model, big volume and variety quality related data generated during the manufacturing process could be dealt with. Artificial intelligent algorithms, including Bayesian network learning, classification and reasoning, are embedded into the Reduce process. Relying on the ability of the Bayesian network in dealing with dynamic and uncertain problem and the parallel computing power of MapReduce, Bayesian network of impact factors on quality are built based on prior probability distribution and modified with posterior probability distribution. A case study on hull segment manufacturing precision management for ship and offshore platform building shows that computing speed accelerates almost directly proportionally to the increase of computing nodes. It is also proved that the proposed model is feasible for locating and reasoning of root causes, forecasting of manufacturing outcome, and intelligent decision for precision problem solving. The integration of bigdata analytics and BN method offers a whole new perspective in manufacturing quality control.

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

PubMed

Singh, Ravendra; Ierapetritou, Marianthi; Ramachandran, Rohit

2013-11-01

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

Analytical method for promoting process capability of shock absorption steel.

PubMed

Sung, Wen-Pei; Shih, Ming-Hsiang; Chen, Kuen-Suan

2003-01-01

Mechanical properties and low cycle fatigue are two factors that must be considered in developing new type steel for shock absorption. Process capability and process control are significant factors in achieving the purpose of research and development programs. Often-used evaluation methods failed to measure process yield and process centering; so this paper uses Taguchi loss function as basis to establish an evaluation method and the steps for assessing the quality of mechanical properties and process control of an iron and steel manufacturer. The establishment of this method can serve the research and development and manufacturing industry and lay a foundation in enhancing its process control ability to select better manufacturing processes that are more reliable than decision making by using the other commonly used methods.

Method and apparatus for manufacturing gas tags

DOEpatents

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

1996-12-17

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

Method and apparatus for manufacturing gas tags

DOEpatents

Gross, Kenny C.; Laug, Matthew T.

1996-01-01

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

Intelligent Processing Equipment Projects at DLA

NASA Technical Reports Server (NTRS)

Obrien, Donald F.

1992-01-01

The Defense Logistics Agency is successfully incorporating Intelligent Processing Equipment (IPE) into each of its Manufacturing Technology thrust areas. Several IPE applications are addressed in the manufacturing of two 'soldier support' items: combat rations and military apparel. In combat rations, in-line sensors for food processing are being developed or modified from other industries. In addition, many process controls are being automated to achieve better quality and to gain higher use (soldier) acceptance. IPE applications in military apparel include: in-process quality controls for identification of sewing defects, use of robots in the manufacture of shirt collars, and automated handling of garments for pressing.

Manufacturing processes for fabricating graphite/PMR 15 polyimide structural elements

NASA Technical Reports Server (NTRS)

Sheppard, C. H.; Hoggatt, J. T.; Symonds, W. A.

1979-01-01

Investigations were conducted to obtain commercially available graphite/PMR-15 polyimide prepreg, develop an autoclave manufacturing process, and demonstrate the process by manufacturing structural elements. Controls were established on polymer, prepreg, composite fabrication, and quality assurance, Successful material quality control and processes were demonstrated by fabricating major structural elements including flat laminates, hat sections, I beam sections, honeycomb sandwich structures, and molded graphite reinforced fittings. Successful fabrication of structural elements and simulated section of the space shuttle aft body flap shows that the graphite/PMR-15 polyimide system and the developed processes are ready for further evaluation in flight test hardware.

Intelligent processing equipment projects at DLA

NASA Astrophysics Data System (ADS)

Obrien, Donald F.

1992-04-01

The Defense Logistics Agency is successfully incorporating Intelligent Processing Equipment (IPE) into each of its Manufacturing Technology thrust areas. Several IPE applications are addressed in the manufacturing of two 'soldier support' items: combat rations and military apparel. In combat rations, in-line sensors for food processing are being developed or modified from other industries. In addition, many process controls are being automated to achieve better quality and to gain higher use (soldier) acceptance. IPE applications in military apparel include: in-process quality controls for identification of sewing defects, use of robots in the manufacture of shirt collars, and automated handling of garments for pressing.

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...

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

PubMed

Tulina, M A; Pyatigorskaya, N V

2018-03-01

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

Closing the Gap Between Process Control Theory and Practice

ERIC Educational Resources Information Center

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

2010-01-01

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

Modeling of feed-forward control using the partial least squares regression method in the tablet compression process.

PubMed

Hattori, Yusuke; Otsuka, Makoto

2017-05-30

In the pharmaceutical industry, the implementation of continuous manufacturing has been widely promoted in lieu of the traditional batch manufacturing approach. More specially, in recent years, the innovative concept of feed-forward control has been introduced in relation to process analytical technology. In the present study, we successfully developed a feed-forward control model for the tablet compression process by integrating data obtained from near-infrared (NIR) spectra and the physical properties of granules. In the pharmaceutical industry, batch manufacturing routinely allows for the preparation of granules with the desired properties through the manual control of process parameters. On the other hand, continuous manufacturing demands the automatic determination of these process parameters. Here, we proposed the development of a control model using the partial least squares regression (PLSR) method. The most significant feature of this method is the use of dataset integrating both the NIR spectra and the physical properties of the granules. Using our model, we determined that the properties of products, such as tablet weight and thickness, need to be included as independent variables in the PLSR analysis in order to predict unknown process parameters. Copyright © 2017 Elsevier B.V. All rights reserved.

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.

Metrology for Fuel Cell Manufacturing

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

Stocker, Michael; Stanfield, Eric

2015-02-04

The project was divided into three subprojects. The first subproject is Fuel Cell Manufacturing Variability and Its Impact on Performance. The objective was to determine if flow field channel dimensional variability has an impact on fuel cell performance. The second subproject is Non-contact Sensor Evaluation for Bipolar Plate Manufacturing Process Control and Smart Assembly of Fuel Cell Stacks. The objective was to enable cost reduction in the manufacture of fuel cell plates by providing a rapid non-contact measurement system for in-line process control. The third subproject is Optical Scatterfield Metrology for Online Catalyst Coating Inspection of PEM Soft Goods. Themore » objective was to evaluate the suitability of Optical Scatterfield Microscopy as a viable measurement tool for in situ process control of catalyst coatings.« less

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.

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.

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

NASA Astrophysics Data System (ADS)

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

2017-12-01

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

A practical discussion of risk management for manufacturing of pharmaceutical products.

PubMed

Mollah, A Hamid; Baseman, Harold S; Long, Mike; Rathore, Anurag S

2014-01-01

Quality risk management (QRM) is now a regulatory expectation, and it makes good business sense. The goal of the risk assessment is to increase process understanding and deliver safe and effective product to the patients. Risk analysis and management is an acceptable and effective way to minimize patient risk and determine the appropriate level of controls in manufacturing. While understanding the elements of QRM is important, knowing how to apply them in the manufacturing environment is essential for effective process performance and control. This article will preview application of QRM in pharmaceutical and biopharmaceutical manufacturing to illustrate how QRM can help the reader achieve that objective. There are several areas of risk that a drug company may encounter in pharmaceutical manufacturing, specifically addressing oral solid and liquid formulations. QRM tools can be used effectively to identify the risks and develop strategy to minimize or control them. Risks are associated throughout the biopharmaceutical manufacturing process-from raw material supply through manufacturing and filling operations to final distribution via a controlled cold chain process. Assessing relevant attributes and risks for biotechnology-derived products is more complicated and challenging for complex pharmaceuticals. This paper discusses key risk factors in biopharmaceutical manufacturing. Successful development and commercialization of pharmaceutical products is all about managing risks. If a company was to take zero risk, most likely the path to commercialization would not be commercially viable. On the other hand, if the risk taken was too much, the product is likely to have a suboptimal safety and efficacy profile and thus is unlikely to be a successful product. This article addresses the topic of quality risk management with the key objective of minimizing patient risk while creating an optimal process and product. Various tools are presented to aid implementation of these concepts. © PDA, Inc. 2014.

Embedded spacecraft thermal control using ultrasonic consolidation

NASA Astrophysics Data System (ADS)

Clements, Jared W.

Research has been completed in order to rapidly manufacture spacecraft thermal control technologies embedded in spacecraft structural panels using ultrasonic consolidation. This rapid manufacturing process enables custom thermal control designs in the time frame necessary for responsive space. Successfully embedded components include temperature sensors, heaters, wire harnessing, pre-manufactured heat pipes, and custom integral heat pipes. High conductivity inserts and custom integral pulsating heat pipes were unsuccessfully attempted. This research shows the viability of rapid manufacturing of spacecraft structures with embedded thermal control using ultrasonic consolidation.

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...

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

PubMed

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

2015-05-01

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

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

PubMed

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

2017-03-01

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

Transforming nanomedicine manufacturing toward Quality by Design and microfluidics.

PubMed

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

2018-04-05

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

Development and implementation of an automatic integration system for fibre optic sensors in the braiding process with the objective of online-monitoring of composite structures

NASA Astrophysics Data System (ADS)

Hufenbach, W.; Gude, M.; Czulak, A.; Kretschmann, Martin

2014-04-01

Increasing economic, political and ecological pressure leads to steadily rising percentage of modern processing and manufacturing processes for fibre reinforced polymers in industrial batch production. Component weights beneath a level achievable by classic construction materials, which lead to a reduced energy and cost balance during product lifetime, justify the higher fabrication costs. However, complex quality control and failure prediction slow down the substitution by composite materials. High-resolution fibre-optic sensors (FOS), due their low diameter, high measuring point density and simple handling, show a high applicability potential for an automated sensor-integration in manufacturing processes, and therefore the online monitoring of composite products manufactured in industrial scale. Integrated sensors can be used to monitor manufacturing processes, part tests as well as the component structure during product life cycle, which simplifies allows quality control during production and the optimization of single manufacturing processes.[1;2] Furthermore, detailed failure analyses lead to a enhanced understanding of failure processes appearing in composite materials. This leads to a lower wastrel number and products of a higher value and longer product life cycle, whereby costs, material and energy are saved. This work shows an automation approach for FOS-integration in the braiding process. For that purpose a braiding wheel has been supplemented with an appliance for automatic sensor application, which has been used to manufacture preforms of high-pressure composite vessels with FOS-networks integrated between the fibre layers. All following manufacturing processes (vacuum infiltration, curing) and component tests (quasi-static pressure test, programmed delamination) were monitored with the help of the integrated sensor networks. Keywords: SHM, high-pressure composite vessel, braiding, automated sensor integration, pressure test, quality control, optic-fibre sensors, Rayleigh, Luna Technologies

Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing.

PubMed

Esmonde-White, Karen A; Cuellar, Maryann; Uerpmann, Carsten; Lenain, Bruno; Lewis, Ian R

2017-01-01

Adoption of Quality by Design (QbD) principles, regulatory support of QbD, process analytical technology (PAT), and continuous manufacturing are major factors effecting new approaches to pharmaceutical manufacturing and bioprocessing. In this review, we highlight new technology developments, data analysis models, and applications of Raman spectroscopy, which have expanded the scope of Raman spectroscopy as a process analytical technology. Emerging technologies such as transmission and enhanced reflection Raman, and new approaches to using available technologies, expand the scope of Raman spectroscopy in pharmaceutical manufacturing, and now Raman spectroscopy is successfully integrated into real-time release testing, continuous manufacturing, and statistical process control. Since the last major review of Raman as a pharmaceutical PAT in 2010, many new Raman applications in bioprocessing have emerged. Exciting reports of in situ Raman spectroscopy in bioprocesses complement a growing scientific field of biological and biomedical Raman spectroscopy. Raman spectroscopy has made a positive impact as a process analytical and control tool for pharmaceutical manufacturing and bioprocessing, with demonstrated scientific and financial benefits throughout a product's lifecycle.

Manufacturing Cell Therapies Using Engineered Biomaterials.

PubMed

Abdeen, Amr A; Saha, Krishanu

2017-10-01

Emerging manufacturing processes to generate regenerative advanced therapies can involve extensive genomic and/or epigenomic manipulation of autologous or allogeneic cells. These cell engineering processes need to be carefully controlled and standardized to maximize safety and efficacy in clinical trials. Engineered biomaterials with smart and tunable properties offer an intriguing tool to provide or deliver cues to retain stemness, direct differentiation, promote reprogramming, manipulate the genome, or select functional phenotypes. This review discusses the use of engineered biomaterials to control human cell manufacturing. Future work exploiting engineered biomaterials has the potential to generate manufacturing processes that produce standardized cells with well-defined critical quality attributes appropriate for clinical testing. Copyright © 2017 Elsevier Ltd. All rights reserved.

Manufacturing Execution Systems: Examples of Performance Indicator and Operational Robustness Tools.

PubMed

Gendre, Yannick; Waridel, Gérard; Guyon, Myrtille; Demuth, Jean-François; Guelpa, Hervé; Humbert, Thierry

Manufacturing Execution Systems (MES) are computerized systems used to measure production performance in terms of productivity, yield, and quality. In the first part, performance indicator and overall equipment effectiveness (OEE), process robustness tools and statistical process control are described. The second part details some tools to help process robustness and control by operators by preventing deviations from target control charts. MES was developed by Syngenta together with CIMO for automation.

Control of microstructure in soldered, brazed, welded, plated, cast or vapor deposited manufactured components

DOEpatents

Ripley, Edward B.; Hallman, Russell L.

2015-11-10

Disclosed are methods and systems for controlling of the microstructures of a soldered, brazed, welded, plated, cast, or vapor deposited manufactured component. The systems typically use relatively weak magnetic fields of either constant or varying flux to affect material properties within a manufactured component, typically without modifying the alloy, or changing the chemical composition of materials or altering the time, temperature, or transformation parameters of a manufacturing process. Such systems and processes may be used with components consisting of only materials that are conventionally characterized as be uninfluenced by magnetic forces.

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

PubMed

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

2017-11-01

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

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

PubMed

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

2014-12-30

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

Controlling high-throughput manufacturing at the nano-scale

NASA Astrophysics Data System (ADS)

Cooper, Khershed P.

2013-09-01

Interest in nano-scale manufacturing research and development is growing. The reason is to accelerate the translation of discoveries and inventions of nanoscience and nanotechnology into products that would benefit industry, economy and society. Ongoing research in nanomanufacturing is focused primarily on developing novel nanofabrication techniques for a variety of applications—materials, energy, electronics, photonics, biomedical, etc. Our goal is to foster the development of high-throughput methods of fabricating nano-enabled products. Large-area parallel processing and highspeed continuous processing are high-throughput means for mass production. An example of large-area processing is step-and-repeat nanoimprinting, by which nanostructures are reproduced again and again over a large area, such as a 12 in wafer. Roll-to-roll processing is an example of continuous processing, by which it is possible to print and imprint multi-level nanostructures and nanodevices on a moving flexible substrate. The big pay-off is high-volume production and low unit cost. However, the anticipated cost benefits can only be realized if the increased production rate is accompanied by high yields of high quality products. To ensure product quality, we need to design and construct manufacturing systems such that the processes can be closely monitored and controlled. One approach is to bring cyber-physical systems (CPS) concepts to nanomanufacturing. CPS involves the control of a physical system such as manufacturing through modeling, computation, communication and control. Such a closely coupled system will involve in-situ metrology and closed-loop control of the physical processes guided by physics-based models and driven by appropriate instrumentation, sensing and actuation. This paper will discuss these ideas in the context of controlling high-throughput manufacturing at the nano-scale.

Additive Manufacturing: Ensuring Quality for Spacecraft Applications

NASA Technical Reports Server (NTRS)

Swanson, Theodore; Stephenson, Timothy

2014-01-01

Reliable manufacturing requires that material properties and fabrication processes be well defined in order to insure that the manufactured parts meet specified requirements. While this issue is now relatively straightforward for traditional processes such as subtractive manufacturing and injection molding, this capability is still evolving for AM products. Hence, one of the principal challenges within AM is in qualifying and verifying source material properties and process control. This issue is particularly critical for applications in harsh environments and demanding applications, such as spacecraft.

Evaluation of strength-controlling defects in paper by stress concentration analyses

Treesearch

John M. Considine; David W. Vahey; James W. Evans; Kevin T. Turner; Robert E. Rowlands

2011-01-01

Cellulosic webs, such as paper materials, are composed of an interwoven, bonded network of cellulose fibers. Strength-controlling parameters in these webs are influenced by constituent fibers and method of processing and manufacture. Instead of estimating the effect on tensile strength of each processing/manufacturing variable, this study modifies and compares the...

Microeconomics of advanced process window control for 50-nm gates

NASA Astrophysics Data System (ADS)

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

2002-07-01

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

40 CFR 763.165 - Manufacture and importation prohibitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

78 FR 34156 - Hazardous Materials: Emergency Recall Order

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-06

... unilateral changes to its manufacturing process, quality control oversight, and cylinder designs without... never functioned as designed, and indicated that the shutdown device had not stopped the manufacturing... 33-pound cylinders. Jurisdiction Lite Cylinder manufactures or has manufactured, marked, certified...

Grain Structure Control of Additively Manufactured Metallic Materials

PubMed Central

Faierson, Eric J.

2017-01-01

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

NIST: Information Management in the AMRF

NASA Technical Reports Server (NTRS)

Callaghan, George (Editor)

1991-01-01

The information management strategies developed for the NIST Automated Manufacturing Research Facility (AMRF) - a prototype small batch manufacturing facility used for integration and measurement related standards research are outlined in this video. The five major manufacturing functions - design, process planning, off-line programming, shop floor control, and materials processing are explained and their applications demonstrated.

78 FR 32427 - Notice of Issuance of Final Determination Concerning Multifunctional Digital Imaging Systems

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-30

... manufacture different types of Controller units. Ricoh considers the manufacturing of the Controller unit... components and subassemblies of the MFPs from China and the Philippines for manufacture in the U.S. and..., and that the entire engineering, development, design and artwork processes for the MFPs took place in...

Virtual manufacturing work cell for engineering

NASA Astrophysics Data System (ADS)

Watanabe, Hideo; Ohashi, Kazushi; Takahashi, Nobuyuki; Kato, Kiyotaka; Fujita, Satoru

1997-12-01

The life cycles of products have been getting shorter. To meet this rapid turnover, manufacturing systems must be frequently changed as well. In engineering to develop manufacturing systems, there are several tasks such as process planning, layout design, programming, and final testing using actual machines. This development of manufacturing systems takes a long time and is expensive. To aid the above engineering process, we have developed the virtual manufacturing workcell (VMW). This paper describes a concept of VMW and design method through computer aided manufacturing engineering using VMW (CAME-VMW) related to the above engineering tasks. The VMW has all design data, and realizes a behavior of equipment and devices using a simulator. The simulator has logical and physical functionality. The one simulates a sequence control and the other simulates motion control, shape movement in 3D space. The simulator can execute the same control software made for actual machines. Therefore we can verify the behavior precisely before the manufacturing workcell will be constructed. The VMW creates engineering work space for several engineers and offers debugging tools such as virtual equipment and virtual controllers. We applied this VMW to development of a transfer workcell for vaporization machine in actual manufacturing system to produce plasma display panel (PDP) workcell and confirmed its effectiveness.

Study of process variables associated with manufacturing hermetically-sealed nickel-cadmium cells

NASA Technical Reports Server (NTRS)

Miller, L.

1974-01-01

A two year study of the major process variables associated with the manufacturing process for sealed, nickel-cadmium, areospace cells is summarized. Effort was directed toward identifying the major process variables associated with a manufacturing process, experimentally assessing each variable's effect, and imposing the necessary changes (optimization) and controls for the critical process variables to improve results and uniformity. A critical process variable associated with the sintered nickel plaque manufacturing process was identified as the manual forming operation. Critical process variables identified with the positive electrode impregnation/polarization process were impregnation solution temperature, free acid content, vacuum impregnation, and sintered plaque strength. Positive and negative electrodes were identified as a major source of carbonate contamination in sealed cells.

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

PubMed

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

2017-11-01

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

Five-Axis Ultrasonic Additive Manufacturing for Nuclear Component Manufacture

NASA Astrophysics Data System (ADS)

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

2017-03-01

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

Five-axis ultrasonic additive manufacturing for nuclear component manufacture

DOE PAGES

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

2016-01-01

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

76 FR 29767 - Preventive Controls for Registered Human Food and Animal Food/Feed Facilities; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-23

... associated with specific types of food or specific methods of manufacturing, processing, packing, or holding... specific methods of manufacturing, processing, packing, or holding food. In particular, we welcome input on... controls (e.g., procedures and practices utilized to minimize the risk of contamination) for human food and...

40 CFR 763.175 - Enforcement.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT ASBESTOS Prohibition of the Manufacture, Importation, Processing, and Distribution in Commerce of Certain Asbestos... the manufacture, import, processing, or distribution in commerce of asbestos-containing products in...

Adaptive Process Controls and Ultrasonics for High Temperature PEM MEA Manufacture

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

Walczyk, Daniel F.

2015-08-26

The purpose of this 5-year DOE-sponsored project was to address major process bottlenecks associated with fuel cell manufacturing. New technologies were developed to significantly reduce pressing cycle time for high temperature PEM membrane electrode assembly (MEA) through the use of novel, robust ultrasonic (U/S) bonding processes along with low temperature (<100°C) PEM MEAs. In addition, greater manufacturing uniformity and performance was achieved through (a) an investigation into the causes of excessive variation in ultrasonically and thermally bonded MEAs using more diagnostics applied during the entire fabrication and cell build process, and (b) development of rapid, yet simple quality control measurementmore » techniques for use by industry.« less

Computerized Manufacturing Automation. Employment, Education, and the Workplace. Summary.

ERIC Educational Resources Information Center

Congress of the U.S., Washington, DC. Office of Technology Assessment.

The application of programmable automation (PA) offers new opportunities to enhance and streamline manufacturing processes. Five PA technologies are examined in this report: computer-aided design, robots, numerically controlled machine tools, flexible manufacturing systems, and computer-integrated manufacturing. Each technology is in a relatively…

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

NASA Astrophysics Data System (ADS)

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

2015-03-01

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

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

Code of Federal Regulations, 2010 CFR

2010-04-01

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

21 CFR 225.1 - Current good manufacturing practice.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or...

21 CFR 225.1 - Current good manufacturing practice.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or...

21 CFR 225.1 - Current good manufacturing practice.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or...

21 CFR 225.1 - Current good manufacturing practice.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or...

Vacuum mechatronics

NASA Technical Reports Server (NTRS)

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

1989-01-01

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

Solidification and solid-state transformation sciences in metals additive manufacturing

DOE PAGES

Kirka, Michael M.; Nandwana, Peeyush; Lee, Yousub; ...

2017-02-11

Additive manufacturing (AM) of metals is rapidly emerging as an established manufacturing process for metal components. Unlike traditional metals fabrication processes, metals fabricated via AM undergo localized thermal cycles during fabrication. As a result, AM presents the opportunity to control the liquid-solid phase transformation, i.e. material texture. But, thermal cycling presents challenges from the standpoint of solid-solid phase transformations. We will discuss the opportunities and challenges in metals AM in the context of texture control and associated solid-solid phase transformations in Ti-6Al-4V and Inconel 718.

Survey Available Computer Software for Automated Production Planning and Inventory Control, and Software and Hardware for Data Logging and Monitoring Shop Floor Activities

DTIC Science & Technology

1993-08-01

pricing and sales, order processing , and purchasing. The class of manufacturing planning functions include aggregate production planning, materials...level. I Depending on the application, each control level will have a number of functions associated with it. For instance, order processing , purchasing...include accounting, sales forecasting, product costing, pricing and sales, order processing , and purchasing. The class of manufacturing planning functions

Pacifichem 2000 Symposium on Plasma Chemistry and Technology for Green Manufacturing, Pollution Control and Processing Applications

DTIC Science & Technology

2001-03-19

Plasma chemistry and technology represents a significant advance and improvement for green manufacturing, pollution control, and various processing...December 14-19, 2000 in Honolulu, HI. This Congress consists of over 120 symposia. amongst them the Symposium on Plasma Chemistry and Technology for...in the plasma chemistry many field beyond the more traditional and mature fields of semiconductor and materials processing. This symposium was focus on

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.

Intelligent monitoring and control of semiconductor manufacturing equipment

NASA Technical Reports Server (NTRS)

Murdock, Janet L.; Hayes-Roth, Barbara

1991-01-01

The use of AI methods to monitor and control semiconductor fabrication in a state-of-the-art manufacturing environment called the Rapid Thermal Multiprocessor is described. Semiconductor fabrication involves many complex processing steps with limited opportunities to measure process and product properties. By applying additional process and product knowledge to that limited data, AI methods augment classical control methods by detecting abnormalities and trends, predicting failures, diagnosing, planning corrective action sequences, explaining diagnoses or predictions, and reacting to anomalous conditions that classical control systems typically would not correct. Research methodology and issues are discussed, and two diagnosis scenarios are examined.

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.

Quality control developments for graphite/PMR15 polyimide composites materials

NASA Technical Reports Server (NTRS)

Sheppard, C. H.; Hoggatt, J. T.

1979-01-01

The problem of lot-to-lot and within-lot variability of graphite/PMR-15 prepreg was investigated. The PMR-15 chemical characterization data were evaluated along with the processing conditions controlling the manufacture of PMR-15 resin and monomers. Manufacturing procedures were selected to yield a consistently reproducible graphite prepreg that could be processed into acceptable structural elements.

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

PubMed

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

2015-03-01

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

A Study on Human Oriented Autonomous Distributed Manufacturing System —Real-time Scheduling Method Based on Preference of Human Operators

NASA Astrophysics Data System (ADS)

Iwamura, Koji; Kuwahara, Shinya; Tanimizu, Yoshitaka; Sugimura, Nobuhiro

Recently, new distributed architectures of manufacturing systems are proposed, aiming at realizing more flexible control structures of the manufacturing systems. Many researches have been carried out to deal with the distributed architectures for planning and control of the manufacturing systems. However, the human operators have not yet been discussed for the autonomous components of the distributed manufacturing systems. A real-time scheduling method is proposed, in this research, to select suitable combinations of the human operators, the resources and the jobs for the manufacturing processes. The proposed scheduling method consists of following three steps. In the first step, the human operators select their favorite manufacturing processes which they will carry out in the next time period, based on their preferences. In the second step, the machine tools and the jobs select suitable combinations for the next machining processes. In the third step, the automated guided vehicles and the jobs select suitable combinations for the next transportation processes. The second and third steps are carried out by using the utility value based method and the dispatching rule-based method proposed in the previous researches. Some case studies have been carried out to verify the effectiveness of the proposed method.

21 CFR 111.355 - What are the design requirements for manufacturing operations?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What are the design requirements for manufacturing... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for Manufacturing Operations § 111.355 What are the design requirements for...

Application of ICME Methods for the Development of Rapid Manufacturing Technologies

NASA Astrophysics Data System (ADS)

Maiwald-Immer, T.; Göhler, T.; Fischersworring-Bunk, A.; Körner, C.; Osmanlic, F.; Bauereiß, A.

Rapid manufacturing technologies are lately gaining interest as alternative manufacturing method. Due to the large parameter sets applicable in these manufacturing methods and their impact on achievable material properties and quality, support of the manufacturing process development by the use of simulation is highly attractive. This is especially true for aerospace applications with their high quality demands and controlled scatter in the resulting material properties. The applicable simulation techniques to these manufacturing methods are manifold. The paper will focus on the melt pool simulation for a SLM (selective laser melting) process which was originally developed for EBM (electron beam melting). It will be discussed in the overall context of a multi-scale simulation within a virtual process chain.

Combat Ration Advanced Manufacturing Technology Demonstration (CRAMTD). ’Generic Inspection-Statistical Process Control System for a Combat Ration Manufacturing Facility’. Short Term Project (STP) Number 3.

DTIC Science & Technology

1996-01-01

failure as due to an adhesive layer between the foil and inner polypropylene layers. "* Under subcontract, NFPA provided HACCP draft manuals for the...parameters of the production process and to ensure that they are within their target values. In addition, a HACCP program was used to assure product...played an important part in implementing Hazard Analysis Critical Control Points ( HACCP ) as part of the Process and Quality Control manual. The National

Process and control systems for composites manufacturing

NASA Technical Reports Server (NTRS)

Tsiang, T. H.; Wanamaker, John L.

1992-01-01

A precise control of composite material processing would not only improve part quality, but it would also directly reduce the overall manufacturing cost. The development and incorporation of sensors will help to generate real-time information for material processing relationships and equipment characteristics. In the present work, the thermocouple, pressure transducer, and dielectrometer technologies were investigated. The monitoring sensors were integrated with the computerized control system in three non-autoclave fabrication techniques: hot-press, self contained tool (self heating and pressurizing), and pressure vessel). The sensors were implemented in the parts and tools.

21 CFR 111.80 - What representative samples must you collect?

Code of Federal Regulations, 2010 CFR

2010-04-01

... Process Control System § 111.80 What representative samples must you collect? The representative samples... unique lot within each unique shipment); (b) Representative samples of in-process materials for each manufactured batch at points, steps, or stages, in the manufacturing process as specified in the master...

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

NASA Technical Reports Server (NTRS)

Ruokangas, Corinne C.

1988-01-01

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

Case Studies in Modelling, Control in Food Processes.

PubMed

Glassey, J; Barone, A; Montague, G A; Sabou, V

This chapter discusses the importance of modelling and control in increasing food process efficiency and ensuring product quality. Various approaches to both modelling and control in food processing are set in the context of the specific challenges in this industrial sector and latest developments in each area are discussed. Three industrial case studies are used to demonstrate the benefits of advanced measurement, modelling and control in food processes. The first case study illustrates the use of knowledge elicitation from expert operators in the process for the manufacture of potato chips (French fries) and the consequent improvements in process control to increase the consistency of the resulting product. The second case study highlights the economic benefits of tighter control of an important process parameter, moisture content, in potato crisp (chips) manufacture. The final case study describes the use of NIR spectroscopy in ensuring effective mixing of dry multicomponent mixtures and pastes. Practical implementation tips and infrastructure requirements are also discussed.

75 FR 76011 - Annual Guidance Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-07

... Section 522 of the Federal Food, Drug, and Cosmetic Act Electronic Registration and Listing Manufacturing..., CFSAN (HFS- Manufacturing Process Changes, 205), Food and Drug Including Emerging Technologies, on... Chemistry, Manufacturing, Veterinary Medicine (HFV-140), and Controls Information. Food and Drug...

A DMAIC approach for process capability improvement an engine crankshaft manufacturing process

NASA Astrophysics Data System (ADS)

Sharma, G. V. S. S.; Rao, P. Srinivasa

2014-05-01

The define-measure-analyze-improve-control (DMAIC) approach is a five-strata approach, namely DMAIC. This approach is the scientific approach for reducing the deviations and improving the capability levels of the manufacturing processes. The present work elaborates on DMAIC approach applied in reducing the process variations of the stub-end-hole boring operation of the manufacture of crankshaft. This statistical process control study starts with selection of the critical-to-quality (CTQ) characteristic in the define stratum. The next stratum constitutes the collection of dimensional measurement data of the CTQ characteristic identified. This is followed by the analysis and improvement strata where the various quality control tools like Ishikawa diagram, physical mechanism analysis, failure modes effects analysis and analysis of variance are applied. Finally, the process monitoring charts are deployed at the workplace for regular monitoring and control of the concerned CTQ characteristic. By adopting DMAIC approach, standard deviation is reduced from 0.003 to 0.002. The process potential capability index ( C P) values improved from 1.29 to 2.02 and the process performance capability index ( C PK) values improved from 0.32 to 1.45, respectively.

[Chinese medicine industry 4.0：advancing digital pharmaceutical manufacture toward intelligent pharmaceutical manufacture].

PubMed

Cheng, Yi-Yu; Qu, Hai-Bin; Zhang, Bo-Li

2016-01-01

A perspective analysis on the technological innovation in pharmaceutical engineering of Chinese medicine unveils a vision on "Future Factory" of Chinese medicine industry in mind. The strategy as well as the technical roadmap of "Chinese medicine industry 4.0" is proposed, with the projection of related core technology system. It is clarified that the technical development path of Chinese medicine industry from digital manufacture to intelligent manufacture. On the basis of precisely defining technical terms such as process control, on-line detection and process quality monitoring for Chinese medicine manufacture, the technical concepts and characteristics of intelligent pharmaceutical manufacture as well as digital pharmaceutical manufacture are elaborated. Promoting wide applications of digital manufacturing technology of Chinese medicine is strongly recommended. Through completely informationized manufacturing processes and multi-discipline cluster innovation, intelligent manufacturing technology of Chinese medicine should be developed, which would provide a new driving force for Chinese medicine industry in technology upgrade, product quality enhancement and efficiency improvement. Copyright© by the Chinese Pharmaceutical Association.

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.

Statistics to the Rescue!: Using Data to Evaluate a Manufacturing Process

ERIC Educational Resources Information Center

Keithley, Michael G.

2009-01-01

The use of statistics and process controls is too often overlooked in educating students. This article describes an activity appropriate for high school students who have a background in material processing. It gives them a chance to advance their knowledge by determining whether or not a manufacturing process works well. The activity follows a…

Numerical Control/Computer Aided Manufacturing (NC/CAM), A Descom Study

DTIC Science & Technology

1979-07-01

CAM machines operate directly from computers, but most get instructions in the form of punched tape. The applications of NC/CAM are virtually...Although most NC/CAM equipment is metal working, its applications include electronics manufacturing, glass making, food processing, materiel handling...drafting, woodworking, plastics and inspection, just to name a few. Numerical control, like most technologies, is an advancing and evolutionary process

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.

21 CFR 113.5 - 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. 113.5 Section... CONTAINERS General Provisions § 113.5 Current good manufacturing practice. The criteria in §§ 113.10, 113.40..., methods, practices, and controls used by the commercial processor in the manufacture, processing, or...

Amorphous silicon photovoltaic manufacturing technology, phase 2A

NASA Astrophysics Data System (ADS)

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

1995-01-01

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

7 CFR 981.442 - Quality control.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., pieces of kernels, meal accumulated in manufacturing, or other material, to crushers, feed manufacturers... contamination in accordance with the provisions of this section. (1) Treatment process. Treatment processes... Salmonella bacteria in almonds, pursuant to a letter of determination issued by the Food and Drug...

In-situ acoustic signature monitoring in additive manufacturing processes

NASA Astrophysics Data System (ADS)

Koester, Lucas W.; Taheri, Hossein; Bigelow, Timothy A.; Bond, Leonard J.; Faierson, Eric J.

2018-04-01

Additive manufacturing is a rapidly maturing process for the production of complex metallic, ceramic, polymeric, and composite components. The processes used are numerous, and with the complex geometries involved this can make quality control and standardization of the process and inspection difficult. Acoustic emission measurements have been used previously to monitor a number of processes including machining and welding. The authors have identified acoustic signature measurement as a potential means of monitoring metal additive manufacturing processes using process noise characteristics and those discrete acoustic emission events characteristic of defect growth, including cracks and delamination. Results of acoustic monitoring for a metal additive manufacturing process (directed energy deposition) are reported. The work investigated correlations between acoustic emissions and process noise with variations in machine state and deposition parameters, and provided proof of concept data that such correlations do exist.

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

Code of Federal Regulations, 2013 CFR

2013-04-01

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

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

Code of Federal Regulations, 2014 CFR

2014-04-01

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

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

Code of Federal Regulations, 2012 CFR

2012-04-01

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

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

Code of Federal Regulations, 2011 CFR

2011-04-01

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

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

Code of Federal Regulations, 2010 CFR

2010-04-01

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

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

PubMed

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

2018-01-01

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

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

PubMed

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

2015-03-01

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

Intelligent system of coordination and control for manufacturing

NASA Astrophysics Data System (ADS)

Ciortea, E. M.

2016-08-01

This paper wants shaping an intelligent system monitoring and control, which leads to optimizing material and information flows of the company. The paper presents a model for tracking and control system using intelligent real. Production system proposed for simulation analysis provides the ability to track and control the process in real time. Using simulation models be understood: the influence of changes in system structure, commands influence on the general condition of the manufacturing process conditions influence the behavior of some system parameters. Practical character consists of tracking and real-time control of the technological process. It is based on modular systems analyzed using mathematical models, graphic-analytical sizing, configuration, optimization and simulation.

Electrical features of new DNC, CNC system viewed

NASA Astrophysics Data System (ADS)

Fritzsch, W.; Kochan, D.; Schaller, J.; Zander, H. J.

1985-03-01

Control structures capable of solving the problems of a flexible minial-labor manufacturing process are analyzed. The present state of development of equipment technology is described, and possible ways of modeling control processes are surveyed. Concepts which are frequently differently interpreted in various specialized disciplines are systematized, with a view toward creating the prerequisites for interdisciplinary cooperation. Problems and information flow during the preparatory and performance phases of manufacturing are examined with respect to coupling CAD/CAM functions. Mathematical modeling for direct numerical control is explored.

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

NASA Technical Reports Server (NTRS)

Bauer, J. L.

1979-01-01

Basic manufacturing method refinements for using graphite epoxy material for a nickel cadmium battery cell case were performed to demonstrate production feasibility. The various facets of production scale-up, i.e., process and tooling development, together with material and process control, were integrated into a comprehensive manufacturing process that assures production reproducibility and product uniformity. Test results substantiate that a battery cell case produced from graphite epoxy pre-impregnated material, utilizing the internal pressure bag fabrication method, is feasible.

49 CFR 178.70 - Approval of UN pressure receptacles.

Code of Federal Regulations, 2010 CFR

2010-10-01

... facility as specified in § 178.69. (7) Design specifications and manufacturing drawings, showing components... compliance with the applicable pressure receptacle design standard. (8) Manufacturing procedures and any applicable standards that describe in detail the manufacturing processes and control. (9) Design type...

40 CFR 763.165 - Manufacture and importation prohibitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

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

NASA Astrophysics Data System (ADS)

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

2017-08-01

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

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.

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

PubMed

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

2016-01-01

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

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

PubMed Central

Ghosh, Arup; Qin, Shiming; Lee, Jooyeoun

2016-01-01

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

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

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

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

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

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.

A senior manufacturing laboratory for determining injection molding process capability

NASA Technical Reports Server (NTRS)

Wickman, Jerry L.; Plocinski, David

1992-01-01

The following is a laboratory experiment designed to further understanding of materials science. This subject material is directed at an upper level undergraduate/graduate student in an Engineering or Engineering Technology program. It is assumed that the student has a thorough understanding of the process and quality control. The format of this laboratory does not follow that which is normally recommended because of the nature of process capability and that of the injection molding equipment and tooling. This laboratory is instead developed to be used as a point of departure for determining process capability for any process in either a quality control laboratory or a manufacturing environment where control charts, process capability, and experimental or product design are considered important topics.

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.

Manufacturing Methods and Technology Project Summary Reports

DTIC Science & Technology

1985-06-01

Computer -Aided Design (CAD)/ Computer -Aided Manufacturing (CAM) Process for the Production of Cold Forged Gears Project 483 6121 - Robotic Welding and...Caliber Projectile Bodies Project 682 8370 - Automatic Inspection and 1-I1 Process Control of Weapons Parts Manufacturing METALS Project 181 7285 - Cast...designed for use on each project. Experience suggested that a general purpose computer interface might be designed that could be used on any project

Setting new standards in MEMS

NASA Astrophysics Data System (ADS)

Rimskog, Magnus; O'Loughlin, Brian J.

2007-02-01

Silex Microsystems handles a wide range of customized MEMS components. This speech will be describing Silex's MEMS foundry work model for providing customized solutions based on MEMS in a cost effective and well controlled manner. Factors for success are the capabilities to reformulate a customer product concept to manufacturing processes in the wafer fab, using standard process modules and production equipment. A well-controlled system increases the likelihood of a first batch success and enables fast ramp-up into volume production. The following success factors can be listed: strong enduring relationships with the customers; highly qualified well-experienced specialists working close with the customer; process solutions and building blocks ready to use out of a library; addressing manufacturing issues in the early design phase; in-house know how to meet demands for volume manufacturing; access to a wafer fab with high capacity, good organization, high availability of equipment, and short lead times; process development done in the manufacturing environment using production equipment for easy ramp-up to volume production. The article covers a method of working to address these factors: to have a long and enduring relationships with customers utilizing MEMS expertise and working close with customers, to translate their product ideas to MEMS components; to have stable process solutions for features such as Low ohmic vias, Spiked electrodes, Cantilevers, Silicon optical mirrors, Micro needles, etc, which can be used and modified for the customer needs; to use a structured development and design methodology in order to handle hundreds of process modules, and setting up standard run sheets. It is also very important to do real time process development in the manufacturing line. It minimizes the lead-time for the ramp-up of production; to have access to a state of the art Wafer Fab which is well organized, controlled and flexible, with high capacity and short lead-time for prototypes. It is crucial to have intimate control of processes, equipment, organization, production flow control and WIP. This has been addressed by using a fully computerized control and reporting system.

Additive Manufacturing in Production: A Study Case Applying Technical Requirements

NASA Astrophysics Data System (ADS)

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

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

Current manufacturing processes of drug-eluting sutures.

PubMed

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

2017-11-01

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

Contamination-Free Manufacturing: Tool Component Qualification, Verification and Correlation with Wafers

NASA Astrophysics Data System (ADS)

Tan, Samantha H.; Chen, Ning; Liu, Shi; Wang, Kefei

2003-09-01

As part of the semiconductor industry "contamination-free manufacturing" effort, significant emphasis has been placed on reducing potential sources of contamination from process equipment and process equipment components. Process tools contain process chambers and components that are exposed to the process environment or process chemistry and in some cases are in direct contact with production wafers. Any contamination from these sources must be controlled or eliminated in order to maintain high process yields, device performance, and device reliability. This paper discusses new nondestructive analytical methods for quantitative measurement of the cleanliness of metal, quartz, polysilicon and ceramic components that are used in process equipment tools. The goal of these new procedures is to measure the effectiveness of cleaning procedures and to verify whether a tool component part is sufficiently clean for installation and subsequent routine use in the manufacturing line. These procedures provide a reliable "qualification method" for tool component certification and also provide a routine quality control method for reliable operation of cleaning facilities. Cost advantages to wafer manufacturing include higher yields due to improved process cleanliness and elimination of yield loss and downtime resulting from the installation of "bad" components in process tools. We also discuss a representative example of wafer contamination having been linked to a specific process tool component.

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.

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.

Study of aroma formation and transformation during the manufacturing process of Biluochun green tea in Yunnan Province by HS-SPME and GC-MS.

PubMed

Wang, Chen; Lv, Shidong; Wu, Yuanshuang; Lian, Ming; Gao, Xuemei; Meng, Qingxiong

2016-10-01

Biluochun is a typical non-fermented tea and is also famous for its unique aroma in China. Few studies have been performed to evaluate the effect of the manufacturing process on the formation and content of its aroma. The volatile components were extracted at different manufacturing process steps of Biluochun green tea using fully automated headspace solid-phase microextraction (HS-SPME) and further characterised by gas chromatography-mass spectrometry (GC-MS). Among 67 volatile components collected, the fractions of linalool oxides, β-ionone, phenylacetaldehyde, aldehydes, ketones, and nitrogen compounds were increased while alcohols and hydrocarbons declined during the manufacturing process. The aroma compounds decreased the most during the drying steps. We identified a number of significantly changed components that can be used as markers and quality control during the producing process of Biluochun. The drying step played a major role in the aroma formation of green tea products and should be the most important step for quality control. © 2016 Society of Chemical Industry. © 2016 Society of Chemical Industry.

Modelling aspects regarding the control in 13C isotope separation column

NASA Astrophysics Data System (ADS)

Boca, M. L.

2016-08-01

Carbon represents the fourth most abundant chemical element in the world, having two stable and one radioactive isotope. The 13Carbon isotopes, with a natural abundance of 1.1%, plays an important role in numerous applications, such as the study of human metabolism changes, molecular structure studies, non-invasive respiratory tests, Alzheimer tests, air pollution and global warming effects on plants [9] A manufacturing control system manages the internal logistics in a production system and determines the routings of product instances, the assignment of workers and components, the starting of the processes on not-yet-finished product instances. Manufacturing control does not control the manufacturing processes themselves, but has to cope with the consequences of the processing results (e.g. the routing of products to a repair station). In this research it was fulfilled some UML (Unified Modelling Language) diagrams for modelling the C13 Isotope Separation column, implement in STARUML program. Being a critical process and needing a good control and supervising, the critical parameters in the column, temperature and pressure was control using some PLC (Programmable logic controller) and it was made some graphic analyze for this to observe some critical situation than can affect the separation process. The main parameters that need to be control are: -The liquid nitrogen (N2) level in the condenser. -The electrical power supplied to the boiler. -The vacuum pressure.

FMS: The New Wave of Manufacturing Technology.

ERIC Educational Resources Information Center

Industrial Education, 1986

1986-01-01

Flexible manufacturing systems (FMS) are described as a marriage of all of the latest technologies--robotics, numerical control, CAD/CAM (computer-assisted design/computer-assisted manufacturing), etc.--into a cost-efficient, optimized production process yielding the greatest flexibility in making various parts. A typical curriculum to teach FMS…

Numerical modeling of heat-transfer and the influence of process parameters on tailoring the grain morphology of IN718 in electron beam additive manufacturing

DOE PAGES

Raghavan, Narendran; Dehoff, Ryan; Pannala, Sreekanth; ...

2016-04-26

The fabrication of 3-D parts from CAD models by additive manufacturing (AM) is a disruptive technology that is transforming the metal manufacturing industry. The correlation between solidification microstructure and mechanical properties has been well understood in the casting and welding processes over the years. This paper focuses on extending these principles to additive manufacturing to understand the transient phenomena of repeated melting and solidification during electron beam powder melting process to achieve site-specific microstructure control within a fabricated component. In this paper, we have developed a novel melt scan strategy for electron beam melting of nickel-base superalloy (Inconel 718) andmore » also analyzed 3-D heat transfer conditions using a parallel numerical solidification code (Truchas) developed at Los Alamos National Laboratory. The spatial and temporal variations of temperature gradient (G) and growth velocity (R) at the liquid-solid interface of the melt pool were calculated as a function of electron beam parameters. By manipulating the relative number of voxels that lie in the columnar or equiaxed region, the crystallographic texture of the components can be controlled to an extent. The analysis of the parameters provided optimum processing conditions that will result in columnar to equiaxed transition (CET) during the solidification. Furthermore, the results from the numerical simulations were validated by experimental processing and characterization thereby proving the potential of additive manufacturing process to achieve site-specific crystallographic texture control within a fabricated component.« less

Foreword

NASA Astrophysics Data System (ADS)

Bergheau, Jean-Michel; Drapier, Sylvain; Feulvarch, Éric; Ponthot, Jean-Philippe

2016-04-01

In the face of increasingly fierce global competition, industrial companies must develop products more and more quickly and cheaply. In such a context, the numerical simulation of manufacturing processes is a big challenge and a key factor for success. Indeed, numerical simulation enables the control of manufacturing processes and of the consequences that they induce on the manufactured parts in terms of material modifications, geometrical changes or residual stresses, each of them playing an important role in the lifetime of the component.

Modeling of additive manufacturing processes for metals: Challenges and opportunities

DOE PAGES

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

2017-01-09

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

Varied morphology carbon nanotubes and method for their manufacture

DOEpatents

Li, Wenzhi; Wen, Jian Guo; Ren, Zhi Feng

2007-01-02

The present invention describes the preparation of carbon nanotubes of varied morphology, catalyst materials for their synthesis. The present invention also describes reactor apparatus and methods of optimizing and controlling process parameters for the manufacture carbon nanotubes with pre-determined morphologies in relatively high purity and in high yields. In particular, the present invention provides methods for the preparation of non-aligned carbon nanotubes with controllable morphologies, catalyst materials and methods for their manufacture.

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

Simpson, L.; Britt, J.; Birkmire, R.

ITN Energy Systems, Inc., and Global Solar Energy, Inc., assisted by NREL's PV Manufacturing R&D program, have continued to advance CIGS production technology by developing trajectory-oriented predictive/control models, fault-tolerance control, control platform development, in-situ sensors, and process improvements. Modeling activities included developing physics-based and empirical models for CIGS and sputter-deposition processing, implementing model-based control, and applying predictive models to the construction of new evaporation sources and for control. Model-based control is enabled by implementing reduced or empirical models into a control platform. Reliability improvement activities include implementing preventive maintenance schedules; detecting failed sensors/equipment and reconfiguring to tinue processing; and systematicmore » development of fault prevention and reconfiguration strategies for the full range of CIGS PV production deposition processes. In-situ sensor development activities have resulted in improved control and indicated the potential for enhanced process status monitoring and control of the deposition processes. Substantial process improvements have been made, including significant improvement in CIGS uniformity, thickness control, efficiency, yield, and throughput. In large measure, these gains have been driven by process optimization, which in turn have been enabled by control and reliability improvements due to this PV Manufacturing R&D program.« less

A System-Oriented Approach for the Optimal Control of Process Chains under Stochastic Influences

NASA Astrophysics Data System (ADS)

Senn, Melanie; Schäfer, Julian; Pollak, Jürgen; Link, Norbert

2011-09-01

Process chains in manufacturing consist of multiple connected processes in terms of dynamic systems. The properties of a product passing through such a process chain are influenced by the transformation of each single process. There exist various methods for the control of individual processes, such as classical state controllers from cybernetics or function mapping approaches realized by statistical learning. These controllers ensure that a desired state is obtained at process end despite of variations in the input and disturbances. The interactions between the single processes are thereby neglected, but play an important role in the optimization of the entire process chain. We divide the overall optimization into two phases: (1) the solution of the optimization problem by Dynamic Programming to find the optimal control variable values for each process for any encountered end state of its predecessor and (2) the application of the optimal control variables at runtime for the detected initial process state. The optimization problem is solved by selecting adequate control variables for each process in the chain backwards based on predefined quality requirements for the final product. For the demonstration of the proposed concept, we have chosen a process chain from sheet metal manufacturing with simplified transformation functions.

Simulation of textile manufacturing processes for planning, scheduling, and quality control purposes

NASA Astrophysics Data System (ADS)

Cropper, A. E.; Wang, Z.

1995-08-01

Simulation, as a management information tool, has been applied to engineering manufacture and assembly operations. The application of the principles to textile manufacturing (fiber to fabric) is discussed. The particular problems and solutions in applying the simulation software package to the yarn production processes are discussed with an indication of how the software achieves the production schedule. The system appears to have application in planning, scheduling, and quality assurance. The latter being a result of the traceability possibilities through a process involving mixing and splitting of material.

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

NASA Technical Reports Server (NTRS)

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

1979-01-01

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

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

NASA Astrophysics Data System (ADS)

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

1993-02-01

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

21 CFR 129.1 - 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. 129.1 Section... Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as the..., methods, practices, and controls used in the processing, bottling, holding, and shipping of bottled...

Michael Ulsh | NREL

Science.gov Websites

Michael Ulsh Photo of Michael Ulsh Michael Ulsh Manufacturing R&D Project Lead Michael.Ulsh -line quality control, the study of the performance and durability effects of manufacturing defects, and lead for a multi-lab consortium on solution processing and roll-to-roll manufacturing, and is involved

Supportability Technologies for Future Exploration Missions

NASA Technical Reports Server (NTRS)

Watson, Kevin; Thompson, Karen

2007-01-01

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

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.

Process simulation for advanced composites production

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

Allendorf, M.D.; Ferko, S.M.; Griffiths, S.

1997-04-01

The objective of this project is to improve the efficiency and lower the cost of chemical vapor deposition (CVD) processes used to manufacture advanced ceramics by providing the physical and chemical understanding necessary to optimize and control these processes. Project deliverables include: numerical process models; databases of thermodynamic and kinetic information related to the deposition process; and process sensors and software algorithms that can be used for process control. Target manufacturing techniques include CVD fiber coating technologies (used to deposit interfacial coatings on continuous fiber ceramic preforms), chemical vapor infiltration, thin-film deposition processes used in the glass industry, and coatingmore » techniques used to deposit wear-, abrasion-, and corrosion-resistant coatings for use in the pulp and paper, metals processing, and aluminum industries.« less

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.

Flexible manufacturing of aircraft engine parts

NASA Astrophysics Data System (ADS)

Hassan, Ossama M.; Jenkins, Douglas M.

1992-06-01

GE Aircraft Engines, a major supplier of jet engines for commercial and military aircraft, has developed a fully integrated manufacturing facility to produce aircraft engine components in flexible manufacturing cells. This paper discusses many aspects of the implementation including process technologies, material handling, software control system architecture, socio-technical systems and lessons learned. Emphasis is placed on the appropriate use of automation in a flexible manufacturing system.

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.

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

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

PubMed

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

2018-01-01

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

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

PubMed

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

2015-01-01

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

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

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

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

2016-12-01

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

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.

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.

Patterned wafer geometry grouping for improved overlay control

NASA Astrophysics Data System (ADS)

Lee, Honggoo; Han, Sangjun; Woo, Jaeson; Park, Junbeom; Song, Changrock; Anis, Fatima; Vukkadala, Pradeep; Jeon, Sanghuck; Choi, DongSub; Huang, Kevin; Heo, Hoyoung; Smith, Mark D.; Robinson, John C.

2017-03-01

Process-induced overlay errors from outside the litho cell have become a significant contributor to the overlay error budget including non-uniform wafer stress. Previous studies have shown the correlation between process-induced stress and overlay and the opportunity for improvement in process control, including the use of patterned wafer geometry (PWG) metrology to reduce stress-induced overlay signatures. Key challenges of volume semiconductor manufacturing are how to improve not only the magnitude of these signatures, but also the wafer to wafer variability. This work involves a novel technique of using PWG metrology to provide improved litho-control by wafer-level grouping based on incoming process induced overlay, relevant for both 3D NAND and DRAM. Examples shown in this study are from 19 nm DRAM manufacturing.

Proceedings of the Solid Freeform Fabrication Symposium (3rd) Held in Austin, Texas on 3-5 August 1992

DTIC Science & Technology

1992-09-01

to accept; Manufacturing the desk could be only a very small facility for manufacturing Instant In every manufacturing process Manufacturing will be...produced " instant " parts Layer Characterized most, but not all Manufacturing of the new principles Material Deposit Includes the geometrical...using the NOODLES CAD environment [4]. Next, the CAD model is sliced, and the slices are used to generate files that control the laser mask cutting

A simple approach to industrial laser safety.

PubMed

Lewandowski, Michael A; Hinz, Michael W

2005-02-01

Industrial applications of lasers include marking, welding, cutting, and other material processing. Lasers used in these ways have significant power output but are generally designed to limit operator exposure to direct or scattered laser radiation to harmless levels in order to meet the Federal Laser Product Performance Standard (21CFR1040) for Class 1 laser products. Interesting challenges occur when companies integrate high power lasers into manufacturing or process control equipment. A significant part of the integration process is developing engineering and administrative controls to produce an acceptable level of laser safety while balancing production, maintenance, and service requirements. 3M Company uses a large number of high power lasers in numerous manufacturing processes. Whether the laser is purchased as a Class 1 laser product or whether it is purchased as a Class 4 laser and then integrated into a manufacturing application, 3M Company has developed an industrial laser safety program that maintains a high degree of laser safety while facilitating the rapid and economical integration of laser technology into the manufacturing workplace. This laser safety program is based on the requirements and recommendations contained in the American National Standard for Safe Use of Lasers, ANSI Z136.1. The fundamental components of the 3M program include hazard evaluation, engineering, administrative, and procedural controls, protective equipment, signs and labels, training, and re-evaluation upon change. This program is implemented in manufacturing facilities and has resulted in an excellent history of laser safety and an effective and efficient use of laser safety resources.

A social-level macro-governance mode for collaborative manufacturing processes

NASA Astrophysics Data System (ADS)

Gao, Ji; Lv, Hexin; Jin, Zhiyong; Xu, Ping

2017-08-01

This paper proposes the social-level macro-governance mode for innovating the popular centralized control for CoM (Collaborative Manufacturing) processes, and makes this mode depend on the support from three aspects of technologies standalone and complementary: social-level CoM process norms, CoM process supervision system, and rational agents as the brokers of enterprises. It is the close coupling of those technologies that redounds to removing effectively the uncontrollability obstacle confronted with by cross-management-domain CoM processes. As a result, this mode enables CoM applications to be implemented by uniting the centralized control of CoM partners for respective CoM activities, and therefore provides a new distributed CoM process control mode to push forward the convenient development and large-scale deployment of SME-oriented CoM applications.

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

Kirka, Michael M.; Nandwana, Peeyush; Lee, Yousub

Additive manufacturing (AM) of metals is rapidly emerging as an established manufacturing process for metal components. Unlike traditional metals fabrication processes, metals fabricated via AM undergo localized thermal cycles during fabrication. As a result, AM presents the opportunity to control the liquid-solid phase transformation, i.e. material texture. But, thermal cycling presents challenges from the standpoint of solid-solid phase transformations. We will discuss the opportunities and challenges in metals AM in the context of texture control and associated solid-solid phase transformations in Ti-6Al-4V and Inconel 718.

Process-based tolerance assessment of connecting rod machining process

NASA Astrophysics Data System (ADS)

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

2016-06-01

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

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

NASA Astrophysics Data System (ADS)

Gentry, Jeffery D.

2000-05-01

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

Multivariate statistical process control in product quality review assessment - A case study.

PubMed

Kharbach, M; Cherrah, Y; Vander Heyden, Y; Bouklouze, A

2017-11-01

According to the Food and Drug Administration and the European Good Manufacturing Practices (GMP) guidelines, Annual Product Review (APR) is a mandatory requirement in GMP. It consists of evaluating a large collection of qualitative or quantitative data in order to verify the consistency of an existing process. According to the Code of Federal Regulation Part 11 (21 CFR 211.180), all finished products should be reviewed annually for the quality standards to determine the need of any change in specification or manufacturing of drug products. Conventional Statistical Process Control (SPC) evaluates the pharmaceutical production process by examining only the effect of a single factor at the time using a Shewhart's chart. It neglects to take into account the interaction between the variables. In order to overcome this issue, Multivariate Statistical Process Control (MSPC) can be used. Our case study concerns an APR assessment, where 164 historical batches containing six active ingredients, manufactured in Morocco, were collected during one year. Each batch has been checked by assaying the six active ingredients by High Performance Liquid Chromatography according to European Pharmacopoeia monographs. The data matrix was evaluated both by SPC and MSPC. The SPC indicated that all batches are under control, while the MSPC, based on Principal Component Analysis (PCA), for the data being either autoscaled or robust scaled, showed four and seven batches, respectively, out of the Hotelling T 2 95% ellipse. Also, an improvement of the capability of the process is observed without the most extreme batches. The MSPC can be used for monitoring subtle changes in the manufacturing process during an APR assessment. Copyright © 2017 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

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

PubMed

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

2017-01-01

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

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

NASA Astrophysics Data System (ADS)

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

1995-09-01

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

Predictive modeling of solidification during laser additive manufacturing of nickel superalloys: recent developments, future directions

NASA Astrophysics Data System (ADS)

Ghosh, Supriyo

2018-01-01

Additive manufacturing (AM) processes produce parts with improved physical, chemical, and mechanical properties compared to conventional manufacturing processes. In AM processes, intricate part geometries are produced from multicomponent alloy powder, in a layer-by-layer fashion with multipass laser melting, solidification, and solid-state phase transformations, in a shorter manufacturing time, with minimal surface finishing, and at a reasonable cost. However, there is an increasing need for post-processing of the manufactured parts via, for example, stress relieving heat treatment and hot isostatic pressing to achieve homogeneous microstructure and properties at all times. Solidification in an AM process controls the size, shape, and distribution of the grains, the growth morphology, the elemental segregation and precipitation, the subsequent solid-state phase changes, and ultimately the material properties. The critical issues in this process are linked with multiphysics (such as fluid flow and diffusion of heat and mass) and multiscale (lengths, times and temperature ranges) challenges that arise due to localized rapid heating and cooling during AM processing. The alloy chemistry-process-microstructure-property-performance correlation in this process will be increasingly better understood through multiscale modeling and simulation.

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

System level analysis and control of manufacturing process variation

DOEpatents

Hamada, Michael S.; Martz, Harry F.; Eleswarpu, Jay K.; Preissler, Michael J.

2005-05-31

A computer-implemented method is implemented for determining the variability of a manufacturing system having a plurality of subsystems. Each subsystem of the plurality of subsystems is characterized by signal factors, noise factors, control factors, and an output response, all having mean and variance values. Response models are then fitted to each subsystem to determine unknown coefficients for use in the response models that characterize the relationship between the signal factors, noise factors, control factors, and the corresponding output response having mean and variance values that are related to the signal factors, noise factors, and control factors. The response models for each subsystem are coupled to model the output of the manufacturing system as a whole. The coefficients of the fitted response models are randomly varied to propagate variances through the plurality of subsystems and values of signal factors and control factors are found to optimize the output of the manufacturing system to meet a specified criterion.

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

NASA Astrophysics Data System (ADS)

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

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

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.

Licorice Production and Manufacturing: All-Sorts of Practical Applications for Statistics

ERIC Educational Resources Information Center

Watson, Jane; Skalicky, Jane; Fitzallen, Noleine; Wright, Suzie

2009-01-01

Among the practical applications of statistics is the collection of data from manufacturing processes. Often collected in the form of a time series, data collected from a series of measurements show the variation in those measurements, such as mass of a product manufactured. Limits are set for quality control and if these are exceeded then a…

Process monitoring and control with CHEMIN, a miniaturized CCD-based instrument for simultaneous XRD/XRF analysis

NASA Astrophysics Data System (ADS)

Vaniman, David T.; Bish, D.; Guthrie, G.; Chipera, S.; Blake, David E.; Collins, S. Andy; Elliott, S. T.; Sarrazin, P.

1999-10-01

There is a large variety of mining and manufacturing operations where process monitoring and control can benefit from on-site analysis of both chemical and mineralogic constituents. CHEMIN is a CCD-based instrument capable of both X-ray fluorescence (XRF; chemical) and X-ray diffraction (XRD; mineralogic) analysis. Monitoring and control with an instrument like CHEMIN can be applied to feedstocks, intermediate materials, and final products to optimize production. Examples include control of cement feedstock, of ore for smelting, and of minerals that pose inhalation hazards in the workplace. The combined XRD/XRF capability of CHEMIN can be used wherever a desired commodity is associated with unwanted constituents that may be similar in chemistry or structure but not both (e.g., Ca in both gypsum and feldspar, where only the gypsum is desired to make wallboard). In the mining industry, CHEMIN can determine mineral abundances on the spot and enable more economical mining by providing the means to assay when is being mined, quickly and frequently, at minimal cost. In manufacturing, CHEMIN could be used to spot-check the chemical composition and crystalline makeup of a product at any stage of production. Analysis by CHEMIN can be used as feedback in manufacturing processes where rates of heating, process temperature, mixture of feedstocks, and other variables must be adjusted in real time to correct structure and/or chemistry of the product (e.g., prevention of periclase and alkali sulfate coproduction in cement manufacture).

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.

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.

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

NASA Astrophysics Data System (ADS)

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

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

Materials Genome Initiative

NASA Technical Reports Server (NTRS)

Vickers, John

2015-01-01

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

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

NASA Astrophysics Data System (ADS)

Doering, Robert

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

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

NASA Astrophysics Data System (ADS)

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

2016-10-01

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

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

PubMed

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

2014-01-01

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

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

NASA Astrophysics Data System (ADS)

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

2017-12-01

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

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.

Increased Reliability of Gas Turbine Components by Robust Coatings Manufacturing

NASA Astrophysics Data System (ADS)

Sharma, A.; Dudykevych, T.; Sansom, D.; Subramanian, R.

2017-08-01

The expanding operational windows of the advanced gas turbine components demand increasing performance capability from protective coating systems. This demand has led to the development of novel multi-functional, multi-materials coating system architectures over the last years. In addition, the increasing dependency of components exposed to extreme environment on protective coatings results in more severe penalties, in case of a coating system failure. This emphasizes that reliability and consistency of protective coating systems are equally important to their superior performance. By means of examples, this paper describes the effects of scatter in the material properties resulting from manufacturing variations on coating life predictions. A strong foundation in process-property-performance correlations as well as regular monitoring and control of the coating process is essential for robust and well-controlled coating process. Proprietary and/or commercially available diagnostic tools can help in achieving these goals, but their usage in industrial setting is still limited. Various key contributors to process variability are briefly discussed along with the limitations of existing process and product control methods. Other aspects that are important for product reliability and consistency in serial manufacturing as well as advanced testing methodologies to simplify and enhance product inspection and improve objectivity are briefly described.

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.

Advances in compact manufacturing for shape and performance controllability of large-scale components-a review

NASA Astrophysics Data System (ADS)

Qin, Fangcheng; Li, Yongtang; Qi, Huiping; Ju, Li

2017-01-01

Research on compact manufacturing technology for shape and performance controllability of metallic components can realize the simplification and high-reliability of manufacturing process on the premise of satisfying the requirement of macro/micro-structure. It is not only the key paths in improving performance, saving material and energy, and green manufacturing of components used in major equipments, but also the challenging subjects in frontiers of advanced plastic forming. To provide a novel horizon for the manufacturing in the critical components is significant. Focused on the high-performance large-scale components such as bearing rings, flanges, railway wheels, thick-walled pipes, etc, the conventional processes and their developing situations are summarized. The existing problems including multi-pass heating, wasting material and energy, high cost and high-emission are discussed, and the present study unable to meet the manufacturing in high-quality components is also pointed out. Thus, the new techniques related to casting-rolling compound precise forming of rings, compact manufacturing for duplex-metal composite rings, compact manufacturing for railway wheels, and casting-extruding continuous forming of thick-walled pipes are introduced in detail, respectively. The corresponding research contents, such as casting ring blank, hot ring rolling, near solid-state pressure forming, hot extruding, are elaborated. Some findings in through-thickness microstructure evolution and mechanical properties are also presented. The components produced by the new techniques are mainly characterized by fine and homogeneous grains. Moreover, the possible directions for further development of those techniques are suggested. Finally, the key scientific problems are first proposed. All of these results and conclusions have reference value and guiding significance for the integrated control of shape and performance in advanced compact manufacturing.

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.

Foreword: Additive Manufacturing: Interrelationships of Fabrication, Constitutive Relationships Targeting Performance, and Feedback to Process Control

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

Carpenter, John S.; Beese, Allison M.; Bourell, David L.

Additive manufacturing (AM) offers distinct advantages over conventional manufacturing processes including the capability to both build and repair complex part shapes; to integrate and consolidate parts and thus overcome joining concerns; and to locally tailor material compositions as well as properties. Moreover, a variety of fields such as aerospace, military, automotive, and biomedical are employing this manufacturing technique as a way to decrease costs, increase manufacturing agility, and explore novel geometry/functionalities. In order to increase acceptance of AM as a viable processing method, pathways for qualifying both the material and the process need to be developed and, perhaps, standardized. Thismore » symposium was designed to serve as a venue for the international AM community—including government, academia, and industry—to define the fundamental interrelationships between feedstock, processing, microstructure, shape, mechanical behavior/materials properties, and function/performance. Eventually, insight into the connections between processing, microstructure, property, and performance will be achieved through experimental observations, theoretical advances, and computational modeling of physical processes. Finally, once this insight matures, AM will be able to move from the realm of making parts to making qualified materials that are certified for use with minimal need for post-fabrication characterization.« less

Foreword: Additive Manufacturing: Interrelationships of Fabrication, Constitutive Relationships Targeting Performance, and Feedback to Process Control

DOE PAGES

Carpenter, John S.; Beese, Allison M.; Bourell, David L.; ...

2015-06-26

Additive manufacturing (AM) offers distinct advantages over conventional manufacturing processes including the capability to both build and repair complex part shapes; to integrate and consolidate parts and thus overcome joining concerns; and to locally tailor material compositions as well as properties. Moreover, a variety of fields such as aerospace, military, automotive, and biomedical are employing this manufacturing technique as a way to decrease costs, increase manufacturing agility, and explore novel geometry/functionalities. In order to increase acceptance of AM as a viable processing method, pathways for qualifying both the material and the process need to be developed and, perhaps, standardized. Thismore » symposium was designed to serve as a venue for the international AM community—including government, academia, and industry—to define the fundamental interrelationships between feedstock, processing, microstructure, shape, mechanical behavior/materials properties, and function/performance. Eventually, insight into the connections between processing, microstructure, property, and performance will be achieved through experimental observations, theoretical advances, and computational modeling of physical processes. Finally, once this insight matures, AM will be able to move from the realm of making parts to making qualified materials that are certified for use with minimal need for post-fabrication characterization.« less

Soft computing in design and manufacturing of advanced materials

NASA Technical Reports Server (NTRS)

Cios, Krzysztof J.; Baaklini, George Y; Vary, Alex

1993-01-01

The potential of fuzzy sets and neural networks, often referred to as soft computing, for aiding in all aspects of manufacturing of advanced materials like ceramics is addressed. In design and manufacturing of advanced materials, it is desirable to find which of the many processing variables contribute most to the desired properties of the material. There is also interest in real time quality control of parameters that govern material properties during processing stages. The concepts of fuzzy sets and neural networks are briefly introduced and it is shown how they can be used in the design and manufacturing processes. These two computational methods are alternatives to other methods such as the Taguchi method. The two methods are demonstrated by using data collected at NASA Lewis Research Center. Future research directions are also discussed.

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

NASA Astrophysics Data System (ADS)

Xiong, Jun; Zhang, Guangjun

2013-11-01

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

Statistical tools and control of internal lubricant content of inhalation grade HPMC capsules during manufacture.

PubMed

Ayala, Guillermo; Díez, Fernando; Gassó, María T; Jones, Brian E; Martín-Portugués, Rafael; Ramiro-Aparicio, Juan

2016-04-30

The internal lubricant content (ILC) of inhalation grade HPMC capsules is a key factor to ensure good powder release when the patient inhales a medicine from a dry powder inhaler (DPI). Powder release from capsules has been shown to be influenced by the ILC. The characteristics used to measure this are the emitted dose, fine particle fraction and mass median aerodynamic diameter. In addition the ILC level is critical for capsule shell manufacture because it is an essential part of the process that cannot work without it. An experiment has been applied to the manufacture of inhalation capsules with the required ILC. A full factorial model was used to identify the controlling factors and from this a linear model has been proposed to improve control of the process. Copyright © 2016 Elsevier B.V. All rights reserved.

Integrated flexible manufacturing program for manufacturing automation and rapid prototyping

NASA Technical Reports Server (NTRS)

Brooks, S. L.; Brown, C. W.; King, M. S.; Simons, W. R.; Zimmerman, J. J.

1993-01-01

The Kansas City Division of Allied Signal Inc., as part of the Integrated Flexible Manufacturing Program (IFMP), is developing an integrated manufacturing environment. Several systems are being developed to produce standards and automation tools for specific activities within the manufacturing environment. The Advanced Manufacturing Development System (AMDS) is concentrating on information standards (STEP) and product data transfer; the Expert Cut Planner system (XCUT) is concentrating on machining operation process planning standards and automation capabilities; the Advanced Numerical Control system (ANC) is concentrating on NC data preparation standards and NC data generation tools; the Inspection Planning and Programming Expert system (IPPEX) is concentrating on inspection process planning, coordinate measuring machine (CMM) inspection standards and CMM part program generation tools; and the Intelligent Scheduling and Planning System (ISAPS) is concentrating on planning and scheduling tools for a flexible manufacturing system environment. All of these projects are working together to address information exchange, standardization, and information sharing to support rapid prototyping in a Flexible Manufacturing System (FMS) environment.

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

NASA Astrophysics Data System (ADS)

Capps, Gregory

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

Nickel-hydrogen capacity loss on storage

NASA Technical Reports Server (NTRS)

Manzo, Michelle A.

1989-01-01

A controlled experiment evaluating the capacity loss experienced by nickel electrodes stored under various conditions of temperature, hydrogen pressure, and electrolyte concentration was conducted using nickel electrodes from four different manufacturers. It was found that capacity loss varied with respect to hydrogen pressure, and storage temperature as well as with respect to electrode manufacturing processes. Impedance characteristics were monitored and found to be indicative of electrode manufacturing processes and capacity loss. Cell testing to evaluate state-of-charge effects on capacity loss were inconclusive as no loss was sustained by the cells tested in this experiment.

Chemistry, manufacturing and controls in passive transdermal drug delivery systems.

PubMed

Goswami, Tarun; Audett, Jay

2015-01-01

Transdermal drug delivery systems (TDDS) are used for the delivery of the drugs through the skin into the systemic circulation by applying them to the intact skin. The development of TDDS is a complex and multidisciplinary affair which involves identification of suitable drug, excipients and various other components. There have been numerous problems reported with respect to TDDS quality and performance. These problems can be reduced by appropriately addressing chemistry, manufacturing and controls requirements, which would thereby result in development of robust TDDS product and processes. This article provides recommendations on the chemistry, manufacturing and controls focusing on the unique technical aspects of TDDS.

A carbon dioxide stripping model for mammalian cell culture in manufacturing scale bioreactors.

PubMed

Xing, Zizhuo; Lewis, Amanda M; Borys, Michael C; Li, Zheng Jian

2017-06-01

Control of carbon dioxide within the optimum range is important in mammalian bioprocesses at the manufacturing scale in order to ensure robust cell growth, high protein yields, and consistent quality attributes. The majority of bioprocess development work is done in laboratory bioreactors, in which carbon dioxide levels are more easily controlled. Some challenges in carbon dioxide control can present themselves when cell culture processes are scaled up, because carbon dioxide accumulation is a common feature due to longer gas-residence time of mammalian cell culture in large scale bioreactors. A carbon dioxide stripping model can be used to better understand and optimize parameters that are critical to cell culture processes at the manufacturing scale. The prevailing carbon dioxide stripping models in literature depend on mass transfer coefficients and were applicable to cell culture processes with low cell density or at stationary/cell death phase. However, it was reported that gas bubbles are saturated with carbon dioxide before leaving the culture, which makes carbon dioxide stripping no longer depend on a mass transfer coefficient in the new generation cell culture processes characterized by longer exponential growth phase, higher peak viable cell densities, and higher specific production rate. Here, we present a new carbon dioxide stripping model for manufacturing scale bioreactors, which is independent of carbon dioxide mass transfer coefficient, but takes into account the gas-residence time and gas CO 2 saturation time. The model was verified by CHO cell culture processes with different peak viable cell densities (7 to 12 × 10 6  cells mL -1 ) for two products in 5,000-L and 25,000-L bioreactors. The model was also applied to a next generation cell culture process to optimize cell culture conditions and reduce carbon dioxide levels at manufacturing scale. The model provides a useful tool to understand and better control cell culture carbon dioxide profiles for process development, scale up, and characterization. Biotechnol. Bioeng. 2017;114: 1184-1194. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Assessment of the Current Level of Automation in the Manufacture of Fuel Cell Systems for Combined Heat and Power Applications

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

Ulsh, M.; Wheeler, D.; Protopappas, P.

The U.S. Department of Energy (DOE) is interested in supporting manufacturing research and development (R&D) for fuel cell systems in the 10-1,000 kilowatt (kW) power range relevant to stationary and distributed combined heat and power applications, with the intent to reduce manufacturing costs and increase production throughput. To assist in future decision-making, DOE requested that the National Renewable Energy Laboratory (NREL) provide a baseline understanding of the current levels of adoption of automation in manufacturing processes and flow, as well as of continuous processes. NREL identified and visited or interviewed key manufacturers, universities, and laboratories relevant to the study usingmore » a standard questionnaire. The questionnaire covered the current level of vertical integration, the importance of quality control developments for automation, the current level of automation and source of automation design, critical balance of plant issues, potential for continuous cell manufacturing, key manufacturing steps or processes that would benefit from DOE support for manufacturing R&D, the potential for cell or stack design changes to support automation, and the relationship between production volume and decisions on automation.« less

In vitro cytotoxicity and surface topography evaluation of additive manufacturing titanium implant materials.

PubMed

Tuomi, Jukka T; Björkstrand, Roy V; Pernu, Mikael L; Salmi, Mika V J; Huotilainen, Eero I; Wolff, Jan E H; Vallittu, Pekka K; Mäkitie, Antti A

2017-03-01

Custom-designed patient-specific implants and reconstruction plates are to date commonly manufactured using two different additive manufacturing (AM) technologies: direct metal laser sintering (DMLS) and electron beam melting (EBM). The purpose of this investigation was to characterize the surface structure and to assess the cytotoxicity of titanium alloys processed using DMLS and EBM technologies as the existing information on these issues is scarce. "Processed" and "polished" DMLS and EBM disks were assessed. Microscopic examination revealed titanium alloy particles and surface flaws on the processed materials. These surface flaws were subsequently removed by polishing. Surface roughness of EBM processed titanium was higher than that of DMLS processed. The cytotoxicity results of the DMLS and EBM discs were compared with a "gold standard" commercially available titanium mandible reconstruction plate. The mean cell viability for all discs was 82.6% (range, 77.4 to 89.7) and 83.3% for the control reconstruction plate. The DMLS and EBM manufactured titanium plates were non-cytotoxic both in "processed" and in "polished" forms.

3D Printing Polymers with Supramolecular Functionality for Biological Applications.

PubMed

Pekkanen, Allison M; Mondschein, Ryan J; Williams, Christopher B; Long, Timothy E

2017-09-11

Supramolecular chemistry continues to experience widespread growth, as fine-tuned chemical structures lead to well-defined bulk materials. Previous literature described the roles of hydrogen bonding, ionic aggregation, guest/host interactions, and π-π stacking to tune mechanical, viscoelastic, and processing performance. The versatility of reversible interactions enables the more facile manufacturing of molded parts with tailored hierarchical structures such as tissue engineered scaffolds for biological applications. Recently, supramolecular polymers and additive manufacturing processes merged to provide parts with control of the molecular, macromolecular, and feature length scales. Additive manufacturing, or 3D printing, generates customizable constructs desirable for many applications, and the introduction of supramolecular interactions will potentially increase production speed, offer a tunable surface structure for controlling cell/scaffold interactions, and impart desired mechanical properties through reinforcing interlayer adhesion and introducing gradients or self-assembled structures. This review details the synthesis and characterization of supramolecular polymers suitable for additive manufacture and biomedical applications as well as the use of supramolecular polymers in additive manufacturing for drug delivery and complex tissue scaffold formation. The effect of supramolecular assembly and its dynamic behavior offers potential for controlling the anisotropy of the printed objects with exquisite geometrical control. The potential for supramolecular polymers to generate well-defined parts, hierarchical structures, and scaffolds with gradient properties/tuned surfaces provides an avenue for developing next-generation biomedical devices and tissue scaffolds.

CONTROL TECHNOLOGY OVERVIEW REPORT: CFC (CHLOROFLUOROCARBON) EMISSIONS FROM RIGID FOAM MANUFACTURING

EPA Science Inventory

The report estimates total chlorofluorocarbon (CFC) emissions from the various rigid foam manufacturing processes and from the foam products themselves, and examines potential methods for reducing these emissions. Options studied include replacement of CFC-blown products with alt...

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...

Social and Labour Implications of Flexible Manufacturing Systems.

ERIC Educational Resources Information Center

Ebel, Karl-H.

1985-01-01

The flexible manufacturing system (FMS), a new way of organizing the production process by means of numerical control machines, robots, and computerized workstations, is described. The author examines some of the implications of FMS and the challenges it poses. (Author/CT)

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.

Integrated Process Modeling-A Process Validation Life Cycle Companion.

PubMed

Zahel, Thomas; Hauer, Stefan; Mueller, Eric M; Murphy, Patrick; Abad, Sandra; Vasilieva, Elena; Maurer, Daniel; Brocard, Cécile; Reinisch, Daniela; Sagmeister, Patrick; Herwig, Christoph

2017-10-17

During the regulatory requested process validation of pharmaceutical manufacturing processes, companies aim to identify, control, and continuously monitor process variation and its impact on critical quality attributes (CQAs) of the final product. It is difficult to directly connect the impact of single process parameters (PPs) to final product CQAs, especially in biopharmaceutical process development and production, where multiple unit operations are stacked together and interact with each other. Therefore, we want to present the application of Monte Carlo (MC) simulation using an integrated process model (IPM) that enables estimation of process capability even in early stages of process validation. Once the IPM is established, its capability in risk and criticality assessment is furthermore demonstrated. IPMs can be used to enable holistic production control strategies that take interactions of process parameters of multiple unit operations into account. Moreover, IPMs can be trained with development data, refined with qualification runs, and maintained with routine manufacturing data which underlines the lifecycle concept. These applications will be shown by means of a process characterization study recently conducted at a world-leading contract manufacturing organization (CMO). The new IPM methodology therefore allows anticipation of out of specification (OOS) events, identify critical process parameters, and take risk-based decisions on counteractions that increase process robustness and decrease the likelihood of OOS events.

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.

Investigation of compaction and permeability during the out-of-autoclave and vacuum-bag-only manufacturing of a laminate composite with aligned carbon nanofibers

NASA Astrophysics Data System (ADS)

Mann, Erin

Both industry and commercial entities are in the process of using more lightweight composites. Fillers, such as fibers, nanofibers and other nanoconstituents in polymer matrix composites have been proven to enhance the properties of composites and are still being studied in order to optimize the benefits. Further optimization can be studied during the manufacturing process. The air permeability during the out-of-autoclave-vacuum-bag-only (OOA-VBO) cure method is an important property to understand during the optimization of manufacturing processes. Changes in the manufacturing process can improve or decrease composite quality depending on the ability of the composite to evacuate gases such as air and moisture during curing. Therefore, in this study, the axial permeability of a prepreg stack was experimentally studied. Three types of samples were studied: control (no carbon nanofiber (CNF) modification), unaligned CNF modified and aligned CNF modified samples.

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

Simpson, L.

ITN Energy Systems, Inc., and Global Solar Energy, Inc., with the assistance of NREL's PV Manufacturing R&D program, have continued the advancement of CIGS production technology through the development of trajectory-oriented predictive/control models, fault-tolerance control, control-platform development, in-situ sensors, and process improvements. Modeling activities to date include the development of physics-based and empirical models for CIGS and sputter-deposition processing, implementation of model-based control, and application of predictive models to the construction of new evaporation sources and for control. Model-based control is enabled through implementation of reduced or empirical models into a control platform. Reliability improvement activities include implementation of preventivemore » maintenance schedules; detection of failed sensors/equipment and reconfiguration to continue processing; and systematic development of fault prevention and reconfiguration strategies for the full range of CIGS PV production deposition processes. In-situ sensor development activities have resulted in improved control and indicated the potential for enhanced process status monitoring and control of the deposition processes. Substantial process improvements have been made, including significant improvement in CIGS uniformity, thickness control, efficiency, yield, and throughput. In large measure, these gains have been driven by process optimization, which, in turn, have been enabled by control and reliability improvements due to this PV Manufacturing R&D program. This has resulted in substantial improvements of flexible CIGS PV module performance and efficiency.« less

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.

Utility of optical heterodyne displacement sensing and laser ultrasonics as in situ process control diagnostic for additive manufacturing

NASA Astrophysics Data System (ADS)

Manzo, Anthony J.; Helvajian, Henry

2018-04-01

An in situ process control monitor is presented by way of experimental results and simulations, which utilizes a pulsed laser ultrasonic source as a probe and an optical heterodyne displacement meter as a sensor. The intent is for a process control system that operates in near real time, is nonintrusive, and in situ: A necessary requirement for a serial manufacturing technology such as additive manufacturing (AM). We show that the diagnostic approach has utility in characterizing the local temperature, the area of the heat-affected zone, and the surface roughness (Ra ˜ 0.4 μm). We further demonstrate that it can be used to identify solitary defects (i.e., holes) on the order of 10 to 20 μm in diameter. Moreover, the technique shows promise in measuring properties of materials with features that have a small radius of curvature. We present results for a thin wire of ˜650 μm in diameter. By applying multiple pairs of probe-sensor systems, the diagnostic could also measure the local cooling rate on the scale of 1 μs. Finally, while an obvious application is used in AM technology, then all optical diagnostics could be applied to other manufacturing technologies.

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

NASA Astrophysics Data System (ADS)

Nadimpalli, Venkata K.; Nagy, Peter B.

2018-04-01

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

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

The space shuttle payload planning working groups: Volume 9: Materials processing and space manufacturing

NASA Technical Reports Server (NTRS)

1973-01-01

The findings and recommendations of the Materials Processing and Space Manufacturing group of the space shuttle payload planning activity are presented. The effects of weightlessness on the levitation processes, mixture stability, and control over heat and mass transport in fluids are considered for investigation. The research and development projects include: (1) metallurgical processes, (2) electronic materials, (3) biological applications, and (4)nonmetallic materials and processes. Additional recommendations are provided concerning the allocation of payload space, acceptance of experiments for flight, flight qualification, and private use of the space shuttle.

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.

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.

40 CFR 704.104 - Hexafluoropropylene oxide.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

Managing unexpected events in the manufacturing of biologic medicines.

PubMed

Grampp, Gustavo; Ramanan, Sundar

2013-08-01

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

A neural network controller for automated composite manufacturing

NASA Technical Reports Server (NTRS)

Lichtenwalner, Peter F.

1994-01-01

At McDonnell Douglas Aerospace (MDA), an artificial neural network based control system has been developed and implemented to control laser heating for the fiber placement composite manufacturing process. This neurocontroller learns an approximate inverse model of the process on-line to provide performance that improves with experience and exceeds that of conventional feedback control techniques. When untrained, the control system behaves as a proportional plus integral (PI) controller. However after learning from experience, the neural network feedforward control module provides control signals that greatly improve temperature tracking performance. Faster convergence to new temperature set points and reduced temperature deviation due to changing feed rate have been demonstrated on the machine. A Cerebellar Model Articulation Controller (CMAC) network is used for inverse modeling because of its rapid learning performance. This control system is implemented in an IBM compatible 386 PC with an A/D board interface to the machine.

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

PubMed

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

2015-01-01

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

21 CFR 114.80 - Processes and controls.

Code of Federal Regulations, 2010 CFR

2010-04-01

... scheduled process and maintained in all finished foods. Manufacturing shall be in accordance with the... occur often enough to ensure that the container suitably protects the food from leakage or contamination... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Processes and controls. 114.80 Section 114.80 Food...

Statistical Process Control: Going to the Limit for Quality.

ERIC Educational Resources Information Center

Training, 1987

1987-01-01

Defines the concept of statistical process control, a quality control method used especially in manufacturing. Generally, concept users set specific standard levels that must be met. Makes the point that although employees work directly with the method, management is responsible for its success within the plant. (CH)

Modelling of Robotized Manufacturing Systems Using MultiAgent Formalism

NASA Astrophysics Data System (ADS)

Foit, K.; Gwiazda, A.; Banaś, W.

2016-08-01

The evolution of manufacturing systems has greatly accelerated due to development of sophisticated control systems. On top of determined, one way production flow the need of decision making has arisen as a result of growing product range that are manufactured simultaneously, using the same resources. On the other hand, the intelligent flow control could address the “bottleneck” problem caused by the machine failure. This sort of manufacturing systems uses advanced control algorithms that are introduced by the use of logic controllers. The complex algorithms used in the control systems requires to employ appropriate methods during the modelling process, like the agent-based one, which is the subject of this paper. The concept of an agent is derived from the object-based methodology of modelling, so it meets the requirements of representing the physical properties of the machines as well as the logical form of control systems. Each agent has a high level of autonomy and could be considered separately. The multi-agent system consists of minimum two agents that can interact and modify the environment, where they act. This may lead to the creation of self-organizing structure, what could be interesting feature during design and test of manufacturing system.

Approaches to Quality Risk Management When Using Single-Use Systems in the Manufacture of Biologics.

PubMed

Ishii-Watabe, Akiko; Hirose, Akihiko; Katori, Noriko; Hashii, Norikata; Arai, Susumu; Awatsu, Hirotoshi; Eiza, Akira; Hara, Yoshiaki; Hattori, Hideshi; Inoue, Tomomi; Isono, Tetsuya; Iwakura, Masahiro; Kajihara, Daisuke; Kasahara, Nobuo; Matsuda, Hiroyuki; Murakami, Sei; Nakagawa, Taishiro; Okumura, Takehiro; Omasa, Takeshi; Takuma, Shinya; Terashima, Iyo; Tsukahara, Masayoshi; Tsutsui, Maiko; Yano, Takahiro; Kawasaki, Nana

2015-10-01

Biologics manufacturing technology has made great progress in the last decade. One of the most promising new technologies is the single-use system, which has improved the efficiency of biologics manufacturing processes. To ensure safety of biologics when employing such single-use systems in the manufacturing process, various issues need to be considered including possible extractables/leachables and particles arising from the components used in single-use systems. Japanese pharmaceutical manufacturers, together with single-use suppliers, members of the academia and regulatory authorities have discussed the risks of using single-use systems and established control strategies for the quality assurance of biologics. In this study, we describe approaches for quality risk management when employing single-use systems in the manufacturing of biologics. We consider the potential impact of impurities related to single-use components on drug safety and the potential impact of the single-use system on other critical quality attributes as well as the stable supply of biologics. We also suggest a risk-mitigating strategy combining multiple control methods which includes the selection of appropriate single-use components, their inspections upon receipt and before releasing for use and qualification of single-use systems. Communication between suppliers of single-use systems and the users, as well as change controls in the facilities both of suppliers and users, are also important in risk-mitigating strategies. Implementing these control strategies can mitigate the risks attributed to the use of single-use systems. This study will be useful in promoting the development of biologics as well as in ensuring their safety, quality and stable supply.

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.

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

NASA Astrophysics Data System (ADS)

Maneechote, T.; Luangpaiboon, P.

2010-10-01

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

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

NASA Astrophysics Data System (ADS)

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

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

Optimum processing of mammographic film.

PubMed

Sprawls, P; Kitts, E L

1996-03-01

Underprocessing of mammographic film can result in reduced contrast and visibility of breast structures and an unnecessary increase in radiation dose to the patient. Underprocessing can be caused by physical factors (low developer temperature, inadequate development time, insufficient developer agitation) or chemical factors (developer not optimized for film type; overdiluted, underreplenished, contaminated, or frequently changed developer). Conventional quality control programs are designed to produce consistent processing but do not address the issue of optimum processing. Optimum processing is defined as the level of processing that produces the film performance characteristics (contrast and sensitivity) specified by the film manufacturer. Optimum processing of mammographic film can be achieved by following a two-step protocol. The first step is to set up the processing conditions according to recommendations from the film and developer chemistry manufacturers. The second step is to verify the processing results by comparing them with sensitometric data provided by the film manufacturer.

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.

Integration of Machining and Inspection in Aerospace Manufacturing

NASA Astrophysics Data System (ADS)

Simpson, Bart; Dicken, Peter J.

2011-12-01

The main challenge for aerospace manufacturers today is to develop the ability to produce high-quality products on a consistent basis as quickly as possible and at the lowest-possible cost. At the same time, rising material prices are making the cost of scrap higher than ever so making it more important to minimise waste. Proper inspection and quality control methods are no longer a luxury; they are an essential part of every manufacturing operation that wants to grow and be successful. However, simply bolting on some quality control procedures to the existing manufacturing processes is not enough. Inspection must be fully-integrated with manufacturing for the investment to really produce significant improvements. The traditional relationship between manufacturing and inspection is that machining is completed first on the company's machine tools and the components are then transferred to dedicated inspection equipment to be approved or rejected. However, as machining techniques become more sophisticated, and as components become larger and more complex, there are a growing number of cases where closer integration is required to give the highest productivity and the biggest reductions in wastage. Instead of a simple linear progression from CAD to CAM to machining to inspection, a more complicated series of steps is needed, with extra data needed to fill any gaps in the information available at the various stages. These new processes can be grouped under the heading of "adaptive machining". The programming of most machining operations is based around knowing three things: the position of the workpiece on the machine, the starting shape of the material to be machined, and the final shape that needs to be achieved at the end of the operation. Adaptive machining techniques allow successful machining when at least one of those elements is unknown, by using in-process measurement to close the information gaps in the process chain. It also allows any errors to be spotted earlier in the manufacturing process, so helping the problems to be resolved more quickly and at lower cost.

Microprocessors: Laboratory Simulation of Industrial Control Applications.

ERIC Educational Resources Information Center

Gedeon, David V.

1981-01-01

Describes a course to make technical managers more aware of computer technology and how data loggers, programmable controllers, and larger computer systems interact in a hierarchical configuration of manufacturing process control. (SK)

42 CFR 84.2 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., or other organization that designs, manufactures, assembles, or controls the assembly of a respirator... source of production and at each step of the manufacturing process, so that departures from... respirator component designed to provide a gas-tight or dust-tight fit with the face and may include...

40 CFR 86.1825-01 - Durability demonstration procedures for refueling emissions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... shall use good engineering judgment in determining this process. (a) Service accumulation method. (1.... The manufacturer shall use good engineering judgement in developing this method. (2) The manufacturers... programs, all emission control components and systems (including both hardware and software) must be...

Can demand-side policies stop the tobacco industry's damage? Lessons from Turkey.

PubMed

Gultekin-Karakas, Derya

2015-01-01

Trade and investment liberalisation in the post-1980 period allowed the penetration of transnational tobacco companies into the Turkish market. State control over the market was gradually removed and tobacco farming, manufacturing, trade and consumption were reshaped in line with the needs of transnational tobacco companies. The resultant increase in product proliferation and aggressive marketing strategies led to a dramatic rise in cigarette consumption in the 1990s, making Turkey a market with one of the sharpest consumption increases in the world. While Turkey implemented demand-side tobacco control policies to reduce consumption after 1996, it continued to stimulate manufacturing and trade in a conflicting way. The Turkish case verifies that the liberalisation process facilitated by the state under the auspices of international institutions conflicts with tobacco control. Liberalisation paves the way for market expansions of transnational tobacco companies that resist tobacco control in their drive for profit. Current global tobacco control policies, with no interest in controlling manufacturing, have limited effect on consumption. The Turkish case indicates the necessity of establishing public control over tobacco manufacturing and trade from a public health perspective.

Bioengineering Solutions for Manufacturing Challenges in CAR T Cells

PubMed Central

Piscopo, Nicole J.; Mueller, Katherine P.; Das, Amritava; Hematti, Peiman; Murphy, William L.; Palecek, Sean P.; Capitini, Christian M.

2017-01-01

The next generation of therapeutic products to be approved for the clinic is anticipated to be cell therapies, termed “living drugs” for their capacity to dynamically and temporally respond to changes during their production ex vivo and after their administration in vivo. Genetically engineered chimeric antigen receptor (CAR) T cells have rapidly developed into powerful tools to harness the power of immune system manipulation against cancer. Regulatory agencies are beginning to approve CAR T cell therapies due to their striking efficacy in treating some hematological malignancies. However, the engineering and manufacturing of such cells remains a challenge for widespread adoption of this technology. Bioengineering approaches including biomaterials, synthetic biology, metabolic engineering, process control and automation, and in vitro disease modeling could offer promising methods to overcome some of these challenges. Here, we describe the manufacturing process of CAR T cells, highlighting potential roles for bioengineers to partner with biologists and clinicians to advance the manufacture of these complex cellular products under rigorous regulatory and quality control. PMID:28840981

Design-for-manufacture of gradient-index optical systems using time-varying boundary condition diffusion

NASA Astrophysics Data System (ADS)

Harkrider, Curtis Jason

2000-08-01

The incorporation of gradient-index (GRIN) material into optical systems offers novel and practical solutions to lens design problems. However, widespread use of gradient-index optics has been limited by poor correlation between gradient-index designs and the refractive index profiles produced by ion exchange between glass and molten salt. Previously, a design-for- manufacture model was introduced that connected the design and fabrication processes through use of diffusion modeling linked with lens design software. This project extends the design-for-manufacture model into a time- varying boundary condition (TVBC) diffusion model. TVBC incorporates the time-dependent phenomenon of melt poisoning and introduces a new index profile control method, multiple-step diffusion. The ions displaced from the glass during the ion exchange fabrication process can reduce the total change in refractive index (Δn). Chemical equilibrium is used to model this melt poisoning process. Equilibrium experiments are performed in a titania silicate glass and chemically analyzed. The equilibrium model is fit to ion concentration data that is used to calculate ion exchange boundary conditions. The boundary conditions are changed purposely to control the refractive index profile in multiple-step TVBC diffusion. The glass sample is alternated between ion exchange with a molten salt bath and annealing. The time of each diffusion step can be used to exert control on the index profile. The TVBC computer model is experimentally verified and incorporated into the design- for-manufacture subroutine that runs in lens design software. The TVBC design-for-manufacture model is useful for fabrication-based tolerance analysis of gradient-index lenses and for the design of manufactureable GRIN lenses. Several optical elements are designed and fabricated using multiple-step diffusion, verifying the accuracy of the model. The strength of multiple-step diffusion process lies in its versatility. An axicon, imaging lens, and curved radial lens, all with different index profile requirements, are designed out of a single glass composition.

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.

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

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

Pack, Seongchan; Wilson, Daniel; Aitharaju, Venkat

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

Mechanical strength of welding zones produced by material extrusion additive manufacturing.

PubMed

Davis, Chelsea S; Hillgartner, Kaitlyn E; Han, Seung Hoon; Seppala, Jonathan E

2017-08-01

As more manufacturing processes and research institutions adopt customized manufacturing as a key element in their design strategies and finished products, the resulting mechanical properties of parts produced through additive manufacturing (AM) must be characterized and understood. In material extrusion (MatEx), the most recently extruded polymer filament must bond to the previously extruded filament via polymer diffusion to form a "weld". The strength of the weld limits the performance of the manufactured part and is controlled through processing conditions. Under-standing the role of processing conditions, specifically extruder velocity and extruder temperature, on the overall strength of the weld will allow optimization of MatEx-AM parts. Here, the fracture toughness of a single weld is determined through a facile "trouser tear" Mode III fracture experiment. The actual weld thickness is observed directly by optical microscopy characterization of cross sections of MatEx-AM samples. Representative data of weld strength as a function of printing parameters on a commercial 3D printer demonstrates the robustness of the method.

Six Sigma methods applied to cryogenic coolers assembly line

NASA Astrophysics Data System (ADS)

Ventre, Jean-Marc; Germain-Lacour, Michel; Martin, Jean-Yves; Cauquil, Jean-Marc; Benschop, Tonny; Griot, René

2009-05-01

Six Sigma method have been applied to manufacturing process of a rotary Stirling cooler: RM2. Name of the project is NoVa as main goal of the Six Sigma approach is to reduce variability (No Variability). Project has been based on the DMAIC guideline following five stages: Define, Measure, Analyse, Improve, Control. Objective has been set on the rate of coolers succeeding performance at first attempt with a goal value of 95%. A team has been gathered involving people and skills acting on the RM2 manufacturing line. Measurement System Analysis (MSA) has been applied to test bench and results after R&R gage show that measurement is one of the root cause for variability in RM2 process. Two more root causes have been identified by the team after process mapping analysis: regenerator filling factor and cleaning procedure. Causes for measurement variability have been identified and eradicated as shown by new results from R&R gage. Experimental results show that regenerator filling factor impacts process variability and affects yield. Improved process haven been set after new calibration process for test bench, new filling procedure for regenerator and an additional cleaning stage have been implemented. The objective for 95% coolers succeeding performance test at first attempt has been reached and kept for a significant period. RM2 manufacturing process is now managed according to Statistical Process Control based on control charts. Improvement in process capability have enabled introduction of sample testing procedure before delivery.

The research and realization of digital management platform for ultra-precision optical elements within life-cycle

NASA Astrophysics Data System (ADS)

Wang, Juan; Wang, Jian; Li, Lijuan; Zhou, Kun

2014-08-01

In order to solve the information fusion, process integration, collaborative design and manufacturing for ultra-precision optical elements within life-cycle management, this paper presents a digital management platform which is based on product data and business processes by adopting the modern manufacturing technique, information technique and modern management technique. The architecture and system integration of the digital management platform are discussed in this paper. The digital management platform can realize information sharing and interaction for information-flow, control-flow and value-stream from user's needs to offline in life-cycle, and it can also enhance process control, collaborative research and service ability of ultra-precision optical elements.

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).

A preliminary investigation of the Environmental Control and Life Support Subsystem (EC/LSS) for the space construction base manufacturing modules

NASA Technical Reports Server (NTRS)

Wells, H. B.

1977-01-01

The preliminary data of the environmental control and life support subsystem for a space construction base manufacturing module was reported. A space processing module, which is capable of performing production biological experiments, was chosen as a baseline configuration. The primary assemblies and components considered for use were humidity and temperature control, ventilation fan, cabin fan, water separator, condensate storage, overboard dumping, distribution system, contaminant monitoring, cabin sensors, and fire and smoke detection.

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

Manufacturing Diamond Under Very High Pressure

NASA Technical Reports Server (NTRS)

Voronov, Oleg

2007-01-01

A process for manufacturing bulk diamond has been made practical by the invention of the High Pressure and Temperature Apparatus capable of applying the combination of very high temperature and high pressure needed to melt carbon in a sufficiently large volume. The apparatus includes a reaction cell wherein a controlled static pressure as high as 20 GPa and a controlled temperature as high as 5,000 C can be maintained.

Problems of Automation and Management Principles Information Flow in Manufacturing

NASA Astrophysics Data System (ADS)

Grigoryuk, E. N.; Bulkin, V. V.

2017-07-01

Automated control systems of technological processes are complex systems that are characterized by the presence of elements of the overall focus, the systemic nature of the implemented algorithms for the exchange and processing of information, as well as a large number of functional subsystems. The article gives examples of automatic control systems and automated control systems of technological processes held parallel between them by identifying strengths and weaknesses. Other proposed non-standard control system of technological process.

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.

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.

Statistical process control for residential treated wood

Treesearch

Patricia K. Lebow; Timothy M. Young; Stan Lebow

2017-01-01

This paper is the first stage of a study that attempts to improve the process of manufacturing treated lumber through the use of statistical process control (SPC). Analysis of industrial and auditing agency data sets revealed there are differences between the industry and agency probability density functions (pdf) for normalized retention data. Resampling of batches of...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-18

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

40 CFR 704.25 - 11-Aminoundecanoic acid.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

40 CFR 86.1825-01 - Durability demonstration procedures for refueling emissions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... life. The manufacturer shall use good engineering judgment in determining this process. (a) Service... full useful life. The manufacturer shall use good engineering judgement in developing this method. (2... accumulation programs, all emission control components and systems (including both hardware and software) must...

40 CFR 86.1825-01 - Durability demonstration procedures for refueling emissions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... life. The manufacturer shall use good engineering judgment in determining this process. (a) Service... full useful life. The manufacturer shall use good engineering judgement in developing this method. (2... accumulation programs, all emission control components and systems (including both hardware and software) must...

40 CFR 86.1825-01 - Durability demonstration procedures for refueling emissions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... life. The manufacturer shall use good engineering judgment in determining this process. (a) Service... full useful life. The manufacturer shall use good engineering judgement in developing this method. (2... accumulation programs, all emission control components and systems (including both hardware and software) must...

Material Stream Strategy for Lithium and Inorganics (U)

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

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

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

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

PubMed Central

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

2016-01-01

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

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

PubMed

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

2016-03-17

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

The Future of Pharmaceutical Manufacturing Sciences

PubMed Central

2015-01-01

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

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.

The Future of Pharmaceutical Manufacturing Sciences.

PubMed

Rantanen, Jukka; Khinast, Johannes

2015-11-01

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

Automated solar cell assembly team process research

NASA Astrophysics Data System (ADS)

Nowlan, M. J.; Hogan, S. J.; Darkazalli, G.; Breen, W. F.; Murach, J. M.; Sutherland, S. F.; Patterson, J. S.

1994-06-01

This report describes work done under the Photovoltaic Manufacturing Technology (PVMaT) project, Phase 3A, which addresses problems that are generic to the photovoltaic (PV) industry. Spire's objective during Phase 3A was to use its light soldering technology and experience to design and fabricate solar cell tabbing and interconnecting equipment to develop new, high-yield, high-throughput, fully automated processes for tabbing and interconnecting thin cells. Areas that were addressed include processing rates, process control, yield, throughput, material utilization efficiency, and increased use of automation. Spire teamed with Solec International, a PV module manufacturer, and the University of Massachusetts at Lowell's Center for Productivity Enhancement (CPE), automation specialists, who are lower-tier subcontractors. A number of other PV manufacturers, including Siemens Solar, Mobil Solar, Solar Web, and Texas instruments, agreed to evaluate the processes developed under this program.

Fuzzy control of burnout of multilayer ceramic actuators

NASA Astrophysics Data System (ADS)

Ling, Alice V.; Voss, David; Christodoulou, Leo

1996-08-01

To improve the yield and repeatability of the burnout process of multilayer ceramic actuators (MCAs), an intelligent processing of materials (IPM-based) control system has been developed for the manufacture of MCAs. IPM involves the active (ultimately adaptive) control of a material process using empirical or analytical models and in situ sensing of critical process states (part features and process parameters) to modify the processing conditions in real time to achieve predefined product goals. Thus, the three enabling technologies for the IPM burnout control system are process modeling, in situ sensing and intelligent control. This paper presents the design of an IPM-based control strategy for the burnout process of MCAs.

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...

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...

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.

Modelling and control for laser based welding processes: modern methods of process control to improve quality of laser-based joining methods

NASA Astrophysics Data System (ADS)

Zäh, Ralf-Kilian; Mosbach, Benedikt; Hollwich, Jan; Faupel, Benedikt

2017-02-01

To ensure the competitiveness of manufacturing companies it is indispensable to optimize their manufacturing processes. Slight variations of process parameters and machine settings have only marginally effects on the product quality. Therefore, the largest possible editing window is required. Such parameters are, for example, the movement of the laser beam across the component for the laser keyhole welding. That`s why it is necessary to keep the formation of welding seams within specified limits. Therefore, the quality of laser welding processes is ensured, by using post-process methods, like ultrasonic inspection, or special in-process methods. These in-process systems only achieve a simple evaluation which shows whether the weld seam is acceptable or not. Furthermore, in-process systems use no feedback for changing the control variables such as speed of the laser or adjustment of laser power. In this paper the research group presents current results of the research field of Online Monitoring, Online Controlling and Model predictive controlling in laser welding processes to increase the product quality. To record the characteristics of the welding process, tested online methods are used during the process. Based on the measurement data, a state space model is ascertained, which includes all the control variables of the system. Depending on simulation tools the model predictive controller (MPC) is designed for the model and integrated into an NI-Real-Time-System.

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

NASA Astrophysics Data System (ADS)

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

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

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.

Modelling of human-machine interaction in equipment design of manufacturing cells

NASA Astrophysics Data System (ADS)

Cochran, David S.; Arinez, Jorge F.; Collins, Micah T.; Bi, Zhuming

2017-08-01

This paper proposes a systematic approach to model human-machine interactions (HMIs) in supervisory control of machining operations; it characterises the coexistence of machines and humans for an enterprise to balance the goals of automation/productivity and flexibility/agility. In the proposed HMI model, an operator is associated with a set of behavioural roles as a supervisor for multiple, semi-automated manufacturing processes. The model is innovative in the sense that (1) it represents an HMI based on its functions for process control but provides the flexibility for ongoing improvements in the execution of manufacturing processes; (2) it provides a computational tool to define functional requirements for an operator in HMIs. The proposed model can be used to design production systems at different levels of an enterprise architecture, particularly at the machine level in a production system where operators interact with semi-automation to accomplish the goal of 'autonomation' - automation that augments the capabilities of human beings.

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.

Development of Process Analytical Technology (PAT) methods for controlled release pellet coating.

PubMed

Avalle, P; Pollitt, M J; Bradley, K; Cooper, B; Pearce, G; Djemai, A; Fitzpatrick, S

2014-07-01

This work focused on the control of the manufacturing process for a controlled release (CR) pellet product, within a Quality by Design (QbD) framework. The manufacturing process was Wurster coating: firstly layering active pharmaceutical ingredient (API) onto sugar pellet cores and secondly a controlled release (CR) coating. For each of these two steps, development of a Process Analytical Technology (PAT) method is discussed and also a novel application of automated microscopy as the reference method. Ultimately, PAT methods should link to product performance and the two key Critical Quality Attributes (CQAs) for this CR product are assay and release rate, linked to the API and CR coating steps respectively. In this work, the link between near infra-red (NIR) spectra and those attributes was explored by chemometrics over the course of the coating process in a pilot scale industrial environment. Correlations were built between the NIR spectra and coating weight (for API amount), CR coating thickness and dissolution performance. These correlations allow the coating process to be monitored at-line and so better control of the product performance in line with QbD requirements. Copyright © 2014 Elsevier B.V. All rights reserved.

The application of virtual reality systems as a support of digital manufacturing and logistics

NASA Astrophysics Data System (ADS)

Golda, G.; Kampa, A.; Paprocka, I.

2016-08-01

Modern trends in development of computer aided techniques are heading toward the integration of design competitive products and so-called "digital manufacturing and logistics", supported by computer simulation software. All phases of product lifecycle: starting from design of a new product, through planning and control of manufacturing, assembly, internal logistics and repairs, quality control, distribution to customers and after-sale service, up to its recycling or utilization should be aided and managed by advanced packages of product lifecycle management software. Important problems for providing the efficient flow of materials in supply chain management of whole product lifecycle, using computer simulation will be described on that paper. Authors will pay attention to the processes of acquiring relevant information and correct data, necessary for virtual modeling and computer simulation of integrated manufacturing and logistics systems. The article describes possibilities of use an applications of virtual reality software for modeling and simulation the production and logistics processes in enterprise in different aspects of product lifecycle management. The authors demonstrate effective method of creating computer simulations for digital manufacturing and logistics and show modeled and programmed examples and solutions. They pay attention to development trends and show options of the applications that go beyond enterprise.

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

Code of Federal Regulations, 2014 CFR

2014-04-01

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

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

Code of Federal Regulations, 2013 CFR

2013-04-01

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

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

Code of Federal Regulations, 2013 CFR

2013-04-01

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

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

Code of Federal Regulations, 2014 CFR

2014-04-01

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

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

Code of Federal Regulations, 2012 CFR

2012-04-01

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

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

Code of Federal Regulations, 2014 CFR

2014-04-01

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

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

Code of Federal Regulations, 2011 CFR

2011-04-01

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

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

Code of Federal Regulations, 2011 CFR

2011-04-01

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

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

Code of Federal Regulations, 2012 CFR

2012-04-01

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

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

Code of Federal Regulations, 2012 CFR

2012-04-01

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

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

Code of Federal Regulations, 2013 CFR

2013-04-01

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

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

Code of Federal Regulations, 2011 CFR

2011-04-01

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

Additive Manufacturing: From Rapid Prototyping to Flight

NASA Technical Reports Server (NTRS)

Prater, Tracie

2015-01-01

Additive manufacturing (AM) offers tremendous promise for the rocket propulsion community. Foundational work must be performed to ensure the safe performance of AM parts. Government, industry, and academia must collaborate in the characterization, design, modeling, and process control to accelerate the certification of AM parts for human-rated flight.

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

Code of Federal Regulations, 2010 CFR

2010-04-01

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

Aerospace System Unified Life Cycle Engineering Producibility Measurement Issues

DTIC Science & Technology

1989-05-01

Control .................................................................. 11-9 5 . C o st...in the development process; these computer -aided models offer clarity approaching that of a prototype model. Once a part geometry is represented...of part geometry , allowing manufacturability evaluation and possibly other computer -integrated manufacturing (CIM) tasks. (Other papers that discuss

19 CFR 19.14 - Materials for use in manufacturing warehouse.

Code of Federal Regulations, 2010 CFR

2010-04-01

...; DEPARTMENT OF THE TREASURY CUSTOMS WAREHOUSES, CONTAINER STATIONS AND CONTROL OF MERCHANDISE THEREIN... statistical information as provided in § 141.61(e) of this chapter. If the merchandise has been imported or... report this information for each warehouse entry represented in the manufacturing process. [28 FR 14763...

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.

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.

Robotics in space-age manufacturing

NASA Technical Reports Server (NTRS)

Jones, Chip

1991-01-01

Robotics technologies are developed to improve manufacturing of space hardware. The following applications of robotics are covered: (1) welding for the space shuttle and space station Freedom programs; (2) manipulation of high-pressure water for shuttle solid rocket booster refurbishment; (3) automating the application of insulation materials; (4) precision application of sealants; and (5) automation of inspection procedures. Commercial robots are used for these development programs, but they are teamed with advanced sensors, process controls, and computer simulation to form highly productive manufacturing systems. Many of the technologies are also being actively pursued in private sector manufacturing operations.

Logic gate scanner focus control in high-volume manufacturing using scatterometry

NASA Astrophysics Data System (ADS)

Dare, Richard J.; Swain, Bryan; Laughery, Michael

2004-05-01

Tool matching and optimal process control are critical requirements for success in semiconductor manufacturing. It is imperative that a tool"s operating conditions are understood and controlled in order to create a process that is repeatable and produces devices within specifications. Likewise, it is important where possible to match multiple systems using some methodology, so that regardless of which tool is used the process remains in control. Agere Systems is currently using Timbre Technologies" Optical Digital Profilometry (ODP) scatterometry for controlling Nikon scanner focus at the most critical lithography layer; logic gate. By adjusting focus settings and verifying the resultant changes in resist profile shape using ODP, it becomes possible to actively control scanner focus to achieve a desired resist profile. Since many critical lithography processes are designed to produce slightly re-entrant resist profiles, this type of focus control is not possible via Critical Dimension Scanning Electron Microscopy (CDSEM) where reentrant profiles cannot be accurately determined. Additionally, the high throughput and non-destructive nature of this measurement technique saves both cycle time and wafer costs compared to cross-section SEM. By implementing an ODP daily process check and after any maintenance on a scanner, Agere successfully enabled focus drift control, i.e. making necessary focus or equipment changes in order to maintain a desired resist profile.

Process and assembly plans for low cost commercial fuselage structure

NASA Technical Reports Server (NTRS)

Willden, Kurtis; Metschan, Stephen; Starkey, Val

1991-01-01

Cost and weight reduction for a composite structure is a result of selecting design concepts that can be built using efficient low cost manufacturing and assembly processes. Since design and manufacturing are inherently cost dependent, concurrent engineering in the form of a Design-Build Team (DBT) is essential for low cost designs. Detailed cost analysis from DBT designs and hardware verification must be performed to identify the cost drivers and relationships between design and manufacturing processes. Results from the global evaluation are used to quantitatively rank design, identify cost centers for higher ranking design concepts, define and prioritize a list of technical/economic issues and barriers, and identify parameters that control concept response. These results are then used for final design optimization.

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.

Advanced process control framework initiative

NASA Astrophysics Data System (ADS)

Hill, Tom; Nettles, Steve

1997-01-01

The semiconductor industry, one the world's most fiercely competitive industries, is driven by increasingly complex process technologies and global competition to improve cycle time, quality, and process flexibility. Due to the complexity of these problems, current process control techniques are generally nonautomated, time-consuming, reactive, nonadaptive, and focused on individual fabrication tools and processes. As the semiconductor industry moves into higher density processes, radical new approaches are required. To address the need for advanced factory-level process control in this environment, Honeywell, Advanced Micro Devices (AMD), and SEMATECH formed the Advanced Process Control Framework Initiative (APCFI) joint research project. The project defines and demonstrates an Advanced Process Control (APC) approach based on SEMATECH's Computer Integrated Manufacturing (CIM) Framework. Its scope includes the coordination of Manufacturing Execution Systems, process control tools, and wafer fabrication equipment to provide necessary process control capabilities. Moreover, it takes advantage of the CIM Framework to integrate and coordinate applications from other suppliers that provide services necessary for the overall system to function. This presentation discusses the key concept of model-based process control that differentiates the APC Framework. This major improvement over current methods enables new systematic process control by linking the knowledge of key process settings to desired product characteristics that reside in models created with commercial model development tools The unique framework-based approach facilitates integration of commercial tools and reuse of their data by tying them together in an object-based structure. The presentation also explores the perspective of each organization's involvement in the APCFI project. Each has complementary goals and expertise to contribute; Honeywell represents the supplier viewpoint, AMD represents the user with 'real customer requirements', and SEMATECH provides a consensus-building organization that widely disseminates technology to suppliers and users in the semiconductor industry that face similar equipment and factory control systems challenges.

Prevention of Salmonella cross-contamination in an oilmeal manufacturing plant.

PubMed

Morita, T; Kitazawa, H; Iida, T; Kamata, S

2006-08-01

The mechanisms of Salmonella contamination in an oilmeal plant were investigated and the basic data were collected in order to achieve control of Salmonella in oilmeal. Salmonella was detected in all contamination vectors and environmental factors investigated, namely: operators, processing floor, dust in the air and rodents. In particular, high concentrations of Salmonella were detected on the processing floor of the manufacturing area, which has high oil content. Steam was the most effective disinfection method used for the processing floor, as the effects of heat sterilization and disinfection may work in tandem. In addition, restricting the movement of operators of the production chain remarkably reduced Salmonella contamination, even in areas of otherwise high contamination. Within the oilmeal plant, high Salmonella contamination rates for the processing floor represent the greatest risk of contamination of oilmeal via operators, dust in the air and rodents. Therefore, control of the processing floor is the most important means for reducing the oilmeal contamination rate. Specific Salmonella control methods for oilmeal plants have been established.

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

NASA Astrophysics Data System (ADS)

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

2018-04-01

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

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

NASA Astrophysics Data System (ADS)

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

2012-09-01

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

Additive Manufacturing of Fuel Injectors

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

Sadek Tadros, Dr. Alber Alphonse; Ritter, Dr. George W.; Drews, Charles Donald

Additive manufacturing (AM), also known as 3D-printing, has been shifting from a novelty prototyping paradigm to a legitimate manufacturing tool capable of creating components for highly complex engineered products. An emerging AM technology for producing metal parts is the laser powder bed fusion (L-PBF) process; however, industry manufacturing specifications and component design practices for L-PBF have not yet been established. Solar Turbines Incorporated (Solar), an industrial gas turbine manufacturer, has been evaluating AM technology for development and production applications with the desire to enable accelerated product development cycle times, overall turbine efficiency improvements, and supply chain flexibility relative to conventionalmore » manufacturing processes (casting, brazing, welding). Accordingly, Solar teamed with EWI on a joint two-and-a-half-year project with the goal of developing a production L-PBF AM process capable of consistently producing high-nickel alloy material suitable for high temperature gas turbine engine fuel injector components. The project plan tasks were designed to understand the interaction of the process variables and their combined impact on the resultant AM material quality. The composition of the high-nickel alloy powders selected for this program met the conventional cast Hastelloy X compositional limits and were commercially available in different particle size distributions (PSD) from two suppliers. Solar produced all the test articles and both EWI and Solar shared responsibility for analyzing them. The effects of powder metal input stock, laser parameters, heat treatments, and post-finishing methods were evaluated. This process knowledge was then used to generate tensile, fatigue, and creep material properties data curves suitable for component design activities. The key process controls for ensuring consistent material properties were documented in AM powder and process specifications. The basic components of the project were: • Powder metal input stock: Powder characterization, dimensional accuracy, metallurgical characterization, and mechanical properties evaluation. • Process parameters: Laser parameter effects, post-printing heat-treatment development, mechanical properties evaluation, and post-finishing technique. • Material design curves: Room and elevated temperature tensiles, low cycle fatigue, and creep rupture properties curves generated. • AM specifications: Key metal powder characteristics, laser parameters, and heat-treatment controls identified.« less

Process development for green part printing using binder jetting additive manufacturing

NASA Astrophysics Data System (ADS)

Miyanaji, Hadi; Orth, Morgan; Akbar, Junaid Muhammad; Yang, Li

2018-05-01

Originally developed decades ago, the binder jetting additive manufacturing (BJ-AM) process possesses various advantages compared to other additive manufacturing (AM) technologies such as broad material compatibility and technological expandability. However, the adoption of BJ-AM has been limited by the lack of knowledge with the fundamental understanding of the process principles and characteristics, as well as the relatively few systematic design guideline that are available. In this work, the process design considerations for BJ-AM in green part fabrication were discussed in detail in order to provide a comprehensive perspective of the design for additive manufacturing for the process. Various process factors, including binder saturation, in-process drying, powder spreading, powder feedstock characteristics, binder characteristics and post-process curing, could significantly affect the printing quality of the green parts such as geometrical accuracy and part integrity. For powder feedstock with low flowability, even though process parameters could be optimized to partially offset the printing feasibility issue, the qualities of the green parts will be intrinsically limited due to the existence of large internal voids that are inaccessible to the binder. In addition, during the process development, the balanced combination between the saturation level and in-process drying is of critical importance in the quality control of the green parts.

Drop-on-Demand System for Manufacturing of Melt-based Solid Oral Dosage: Effect of Critical Process Parameters on Product Quality.

PubMed

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

2016-04-01

The features of a drop-on-demand-based system developed for the manufacture of melt-based pharmaceuticals have been previously reported. In this paper, a supervisory control system, which is designed to ensure reproducible production of high quality of melt-based solid oral dosages, is presented. This control system enables the production of individual dosage forms with the desired critical quality attributes: amount of active ingredient and drug morphology by monitoring and controlling critical process parameters, such as drop size and product and process temperatures. The effects of these process parameters on the final product quality are investigated, and the properties of the produced dosage forms characterized using various techniques, such as Raman spectroscopy, optical microscopy, and dissolution testing. A crystallization temperature control strategy, including controlled temperature cycles, is presented to tailor the crystallization behavior of drug deposits and to achieve consistent drug morphology. This control strategy can be used to achieve the desired bioavailability of the drug by mitigating variations in the dissolution profiles. The supervisor control strategy enables the application of the drop-on-demand system to the production of individualized dosage required for personalized drug regimens.

The implementation of a Hazard Analysis and Critical Control Point management system in a peanut butter ice cream plant.

PubMed

Hung, Yu-Ting; Liu, Chi-Te; Peng, I-Chen; Hsu, Chin; Yu, Roch-Chui; Cheng, Kuan-Chen

2015-09-01

To ensure the safety of the peanut butter ice cream manufacture, a Hazard Analysis and Critical Control Point (HACCP) plan has been designed and applied to the production process. Potential biological, chemical, and physical hazards in each manufacturing procedure were identified. Critical control points for the peanut butter ice cream were then determined as the pasteurization and freezing process. The establishment of a monitoring system, corrective actions, verification procedures, and documentation and record keeping were followed to complete the HACCP program. The results of this study indicate that implementing the HACCP system in food industries can effectively enhance food safety and quality while improving the production management. Copyright © 2015. Published by Elsevier B.V.

Control of three different continuous pharmaceutical manufacturing processes: Use of soft sensors.

PubMed

Rehrl, Jakob; Karttunen, Anssi-Pekka; Nicolaï, Niels; Hörmann, Theresa; Horn, Martin; Korhonen, Ossi; Nopens, Ingmar; De Beer, Thomas; Khinast, Johannes G

2018-05-30

One major advantage of continuous pharmaceutical manufacturing over traditional batch manufacturing is the possibility of enhanced in-process control, reducing out-of-specification and waste material by appropriate discharge strategies. The decision on material discharge can be based on the measurement of active pharmaceutical ingredient (API) concentration at specific locations in the production line via process analytic technology (PAT), e.g. near-infrared (NIR) spectrometers. The implementation of the PAT instruments is associated with monetary investment and the long term operation requires techniques avoiding sensor drifts. Therefore, our paper proposes a soft sensor approach for predicting the API concentration from the feeder data. In addition, this information can be used to detect sensor drift, or serve as a replacement/supplement of specific PAT equipment. The paper presents the experimental determination of the residence time distribution of selected unit operations in three different continuous processing lines (hot melt extrusion, direct compaction, wet granulation). The mathematical models describing the soft sensor are developed and parameterized. Finally, the suggested soft sensor approach is validated on the three mentioned, different continuous processing lines, demonstrating its versatility. Copyright © 2018 Elsevier B.V. All rights reserved.

Continuous powder feeding for pharmaceutical solid dosage form manufacture: a short review.

PubMed

Blackshields, Caroline A; Crean, Abina M

2018-07-01

There has been a noticeable shift from pharmaceutical batch processing towards a more continuous mode of manufacture for solid oral dosage forms. Continuous solid oral dose processes would not be possible in the absence of a highly accurate feeding system. The performance of feeders defines the content of formulations and is therefore a critical operation in continuous manufacturing of solid dosage forms. It was the purpose of this review to review the role of the initial powder feeding step in a continuous manufacturing process. Different feeding mechanisms are discussed with a particular emphasis on screw controlled loss in weight (LIW) feeding. The importance of understanding the physical properties of the raw materials and its impact on the feeding process is reviewed. Prior knowledge of materials provides an initial indication of how the powders will behave through processing and facilitates in the selection of the most suitable (i) feeder (capacity), (ii) feeding mechanism, and (iii) in the case of screw feeder - screw type. The studies identified in this review focus on the impact of material on powder feeding performance.

Assessing the influence of component processing and donor characteristics on quality of red cell concentrates using quality control data.

PubMed

Jordan, A; Chen, D; Yi, Q-L; Kanias, T; Gladwin, M T; Acker, J P

2016-07-01

Quality control (QC) data collected by blood services are used to monitor production and to ensure compliance with regulatory standards. We demonstrate how analysis of quality control data can be used to highlight the sources of variability within red cell concentrates (RCCs). We merged Canadian Blood Services QC data with manufacturing and donor records for 28 227 RCC between June 2011 and October 2014. Units were categorized based on processing method, bag manufacturer, donor age and donor sex, then assessed based on product characteristics: haemolysis and haemoglobin levels, unit volume, leucocyte count and haematocrit. Buffy-coat method (top/bottom)-processed units exhibited lower haemolysis than units processed using the whole-blood filtration method (top/top). Units from female donors exhibited lower haemolysis than male donations. Processing method influenced unit volume and the ratio of additive solution to residual plasma. Stored red blood cell characteristics are influenced by prestorage processing and donor factors. Understanding the relationship between processing, donors and RCC quality will help blood services to ensure the safety of transfused products. © 2016 International Society of Blood Transfusion.

Statistical Process Control in the Practice of Program Evaluation.

ERIC Educational Resources Information Center

Posavac, Emil J.

1995-01-01

A technique developed to monitor the quality of manufactured products, statistical process control (SPC), incorporates several features that may prove attractive to evaluators. This paper reviews the history of SPC, suggests how the approach can enrich program evaluation, and illustrates its use in a hospital-based example. (SLD)

A Review of International Space Station Habitable Element Equipment Offgassing Characteristics

NASA Technical Reports Server (NTRS)

Perry, Jay L.

2010-01-01

Crewed spacecraft trace contaminant control employs both passive and active methods to achieve acceptable cabin atmospheric quality. Passive methods include carefully selecting materials of construction, employing clean manufacturing practices, and minimizing systems and payload operational impacts to the cabin environment. Materials selection and manufacturing processes constitute the first level of equipment offgassing control. An element-level equipment offgassing test provides preflight verification that passive controls have been successful. Offgassing test results from multiple International Space Station (ISS) habitable elements and cargo vehicles are summarized and implications for active contamination control equipment design are discussed

At-line validation of a process analytical technology approach for quality control of melamine-urea-formaldehyde resin in composite wood-panel production using near infrared spectroscopy.

PubMed

Meder, Roger; Stahl, Wolfgang; Warburton, Paul; Woolley, Sam; Earnshaw, Scott; Haselhofer, Klaus; van Langenberg, Ken; Ebdon, Nick; Mulder, Roger

2017-01-01

The reactivity of melamine-urea-formaldehyde resins is of key importance in the manufacture of engineered wood products such as medium density fibreboard (MDF) and other wood composite products. Often the MDF manufacturing plant has little available information on the resin reactivity other than details of the resin specification at the time of batch manufacture, which often occurs off-site at a third-party resin plant. Often too, fresh resin on delivery at the MDF plant is mixed with variable volume of aged resin in storage tanks, thereby rendering any specification of the fresh resin batch obsolete. It is therefore highly desirable to develop a real-time, at-line or on-line, process analytical technology to monitor the quality of the resin prior to MDF panel manufacture. Near infrared (NIR) spectroscopy has been calibrated against standard quality methods and against 13 C nuclear magnetic resonance (NMR) measures of molecular composition in order to provide at-line process analytical technology (PAT), to monitor the resin quality, particularly the formaldehyde content of the resin. At-line determination of formaldehyde content in the resin was made possible using a six-factor calibration with an R 2 (cal) value of 0.973, and R 2 (CV) value of 0.929 and a root-mean-square error of cross-validation of 0.01. This calibration was then used to generate control charts of formaldehyde content at regular four-hourly periods during MDF panel manufacture in a commercial MDF manufacturing plant.

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.

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.

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.

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

NASA Technical Reports Server (NTRS)

Oravec, Heather Ann; Daniels, Christopher C.

2014-01-01

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

Intelligent Manufacturing of Commercial Optics Final Report CRADA No. TC-0313-92

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

Taylor, J. S.; Pollicove, H.

The project combined the research and development efforts of LLNL and the University of Rochester Center for Manufacturing Optics (COM), to develop a new generation of flexible computer controlled optics· grinding machines. COM's principal near term development effort is to commercialize the OPTICAM-SM, a new prototype spherical grinding machine. A crucial requirement for commercializing the OPTICAM-SM is the development of a predictable and repeatable material removal process ( deterministic micro-grinding) that yields high quality surfaces that minimize non-deterministic polishing. OPTICAM machine tools and the fabrication process development studies are part of COM' s response to the DOD (ARPA) request tomore » implement a modernization strategy for revitalizing the U.S. optics manufacturing base. This project was entered into in order to develop a new generation of :flexible, computer-controlled optics grinding machines.« less

Reusable Solid Rocket Motor - Accomplishments, Lessons, and a Culture of Success

NASA Technical Reports Server (NTRS)

Moore, Dennis R.; Phelps, Willie J.

2011-01-01

The Reusable Solid Rocket Motor represents the largest solid rocket motor ever flown and the only human rated solid motor. Each Reusable Solid Rocket Motor (RSRM) provides approximately 3-million lb of thrust to lift the integrated Space Shuttle vehicle from the launch pad. The motors burn out approximately 2 minutes later, separate from the vehicle and are recovered and refurbished. The size of the motor and the need for high reliability were challenges. Thrust shaping, via shaping of the propellant grain, was needed to limit structural loads during ascent. The motor design evolved through several block upgrades to increase performance and to increase safety and reliability. A major redesign occurred after STS-51L with the Redesigned Solid Rocket Motor. Significant improvements in the joint sealing systems were added. Design improvements continued throughout the Program via block changes with a number of innovations including development of low temperature o-ring materials and incorporation of a unique carbon fiber rope thermal barrier material. Recovery of the motors and post flight inspection improved understanding of hardware performance, and led to key design improvements. Because of the multidecade program duration material obsolescence was addressed, and requalification of materials and vendors was sometimes needed. Thermal protection systems and ablatives were used to protect the motor cases and nozzle structures. Significant understanding of design and manufacturing features of the ablatives was developed during the program resulting in optimization of design features and processing parameters. The project advanced technology in eliminating ozone-depleting materials in manufacturing processes and the development of an asbestos-free case insulation. Manufacturing processes for the large motor components were unique and safety in the manufacturing environment was a special concern. Transportation and handling approaches were also needed for the large hardware segments. The reusable solid rocket motor achieved significant reliability via process control, ground test programs, and postflight assessment. Process control is mandatory for a solid rocket motor as an acceptance test of the delivered product is not feasible. Process control included process failure modes and effects analysis, statistical process control, witness panels, and process product integrity audits. Material controls and inspections were maintained throughout the sub tier vendors. Material fingerprinting was employed to assess any drift in delivered material properties. The RSRM maintained both full scale and sub-scale test articles. These enabled continuous improvement of design and evaluation of process control and material behavior. Additionally RSRM reliability was achieved through attention to detail in post flight assessment to observe any shift in performance. The postflight analysis and inspections provided invaluable reliability data as it enables observation of actual flight performance, most of which would not be available if the motors were not recovered. These unique challenges, features of the reusable solid rocket motor, materials and manufacturing issues, and design improvements will be discussed in the paper.

Stochastic Adaptive Estimation and Control.

DTIC Science & Technology

1994-10-26

Marcus, "Language Stability and Stabilizability of Discrete Event Dynamical Systems ," SIAM Journal on Control and Optimization, 31, September 1993...in the hierarchical control of flexible manufacturing systems ; in this problem, the model involves a hybrid process in continuous time whose state is...of the average cost control problem for discrete- time Markov processes. Our exposition covers from finite to Borel state and action spaces and

Development and manufacture of reactive-transfer-printed CIGS photovoltaic modules

NASA Astrophysics Data System (ADS)

Eldada, Louay; Sang, Baosheng; Lu, Dingyuan; Stanbery, Billy J.

2010-09-01

In recent years, thin-film photovoltaic (PV) companies started realizing their low manufacturing cost potential, and grabbing an increasingly larger market share from multicrystalline silicon companies. Copper Indium Gallium Selenide (CIGS) is the most promising thin-film PV material, having demonstrated the highest energy conversion efficiency in both cells and modules. However, most CIGS manufacturers still face the challenge of delivering a reliable and rapid manufacturing process that can scale effectively and deliver on the promise of this material system. HelioVolt has developed a reactive transfer process for CIGS absorber formation that has the benefits of good compositional control, high-quality CIGS grains, and a fast reaction. The reactive transfer process is a two stage CIGS fabrication method. Precursor films are deposited onto substrates and reusable print plates in the first stage, while in the second stage, the CIGS layer is formed by rapid heating with Se confinement. High quality CIGS films with large grains were produced on a full-scale manufacturing line, and resulted in high-efficiency large-form-factor modules. With 14% cell efficiency and 12% module efficiency, HelioVolt started to commercialize the process on its first production line with 20 MW nameplate capacity.

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.

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.

Automated plasma control with optical emission spectroscopy

NASA Astrophysics Data System (ADS)

Ward, P. P.

Plasma etching and desmear processes for printed wiring board (PWB) manufacture are difficult to predict and control. Non-uniformity of most plasma processes and sensitivity to environmental changes make it difficult to maintain process stability from day to day. To assure plasma process performance, weight loss coupons or post-plasma destructive testing must be used. These techniques are not real-time methods however, and do not allow for immediate diagnosis and process correction. These tests often require scrapping some fraction of a batch to insure the integrity of the rest. Since these tests verify a successful cycle with post-plasma diagnostics, poor test results often determine that a batch is substandard and the resulting parts unusable. These tests are a costly part of the overall fabrication cost. A more efficient method of testing would allow for constant monitoring of plasma conditions and process control. Process anomalies should be detected and corrected before the parts being treated are damaged. Real time monitoring would allow for instantaneous corrections. Multiple site monitoring would allow for process mapping within one system or simultaneous monitoring of multiple systems. Optical emission spectroscopy conducted external to the plasma apparatus would allow for this sort of multifunctional analysis without perturbing the glow discharge. In this paper, optical emission spectroscopy for non-intrusive, in situ process control will be explored along with applications of this technique to for process control, failure analysis and endpoint determination in PWB manufacture.

Control of formaldehyde and TVOC emission from wood-based flooring composites at various manufacturing processes by surface finishing.

PubMed

Kim, Sumin

2010-04-15

This paper assesses the reproducibility of testing formaldehyde and TVOC emission behavior from wood flooring composites bonded by urea-formaldehyde resin at various manufacturing steps for surface finishing materials. The surface adhesion step of laminate flooring for this research was divided into two steps; HDF only and HDF with LPMs. In the case of engineered flooring, the manufacturing steps were divided into three steps; plywood only, fancy veneer bonded on plywood and UV coated on fancy veneer with plywood. Formaldehyde and VOCs emission decreased at the process of final surface finishing materials; LPMs were applied on the surface of HDF for laminate flooring. Although emissions increased when fancy veneer was bonded onto plywood in the case of engineered flooring, emission was dramatically reduced up to similar level with plywood only when final surface finishing; UV-curable coating was applied on fancy veneer. This study suggests that formaldehyde and VOCs emission from floorings can be controlled at manufacturing steps for surface finishing. 2009 Elsevier B.V. All rights reserved.

Application of terahertz pulse imaging as PAT tool for non-destructive evaluation of film-coated tablets under different manufacturing conditions.

PubMed

Dohi, Masafumi; Momose, Wataru; Yoshino, Hiroyuki; Hara, Yuko; Yamashita, Kazunari; Hakomori, Tadashi; Sato, Shusaku; Terada, Katsuhide

2016-02-05

Film-coated tablets (FCTs) are a popular solid dosage form in pharmaceutical industry. Manufacturing conditions during the film-coating process affect the properties of the film layer, which might result in critical quality problems. Here, we analyzed the properties of the film layer using a non-destructive approach with terahertz pulsed imaging (TPI). Hydrophilic tablets that become distended upon water absorption were used as core tablets and coated with film under different manufacturing conditions. TPI-derived parameters such as film thickness (FT), film surface reflectance (FSR), and interface density difference (IDD) between the film layer and core tablet were affected by manufacturing conditions and influenced critical quality attributes of FCTs. Relative standard deviation of FSR within tablets correlated well with surface roughness. Tensile strength could be predicted in a non-destructive manner using the multivariate regression equation to estimate the core tablet density by film layer density and IDD. The absolute value of IDD (Lateral) correlated with the risk of cracking on the lateral film layer when stored in a high-humidity environment. Further, in-process control was proposed for this value during the film-coating process, which will enable a feedback control system to be applied to process parameters and reduced risk of cracking without a stability test. Copyright © 2015 Elsevier B.V. All rights reserved.

Materials processing in zero gravity. [space manufacturing

NASA Technical Reports Server (NTRS)

Wuenscher, H. F.

1973-01-01

Manufacturing processes which are expected to show drastic changes in a space environment due to the absence of earth gravity are classified according to (1) buoyancy and thermal convection sensitive processes and (2) processes where molecular forces like cohesion and adhesion remain as the relatively strongest and hence controlling factors. Some specific process demonstration experiments carried out during the Apollo 14 mission and in the Skylab program are described. These include chemical separation by electrophoresis, the M551 metals melting experiment, the M552 exothermic brazing experiment, the M553 sphere forming experiment, the M554 composite casting experiment, and the M555 gallium arsenide crystal growth experiment.

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

PubMed

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

2015-01-01

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

Freeform Fluidics

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

Dehoff, Ryan R; Love, Lonnie J; Lind, Randall F

This work explores the integration of miniaturized fluid power and additive manufacturing. Oak Ridge National Laboratory (ORNL) has been developing an approach to miniaturized fluidic actuation and control that enables high dexterity, low cost and a pathway towards energy efficiency. Previous work focused on mesoscale digital control valves (high pressure, low flow) and the integration of actuation and fluid passages directly with the structure, the primary application being fluid powered robotics. The fundamental challenge was part complexity. ORNL s new additive manufacturing technologies (e-beam, laser and ultrasonic deposition) enables freeform manufacturing using conventional metal alloys with excellent mechanical properties. Themore » combination of these two technologies, miniaturized fluid power and additive manufacturing, can enable a paradigm shift in fluid power, increasing efficiency while simultaneously reducing weight, size, complexity and cost. This paper focuses on the impact additive manufacturing can have on new forms of fluid power components and systems. We begin with a description of additive manufacturing processes, highlighting the strengths and weaknesses of each technology. Next we describe fundamental results of material characterization to understand the design and mechanical limits of parts made with the e-beam process. A novel design approach is introduced that enables integration of fluid powered actuation with mechanical structure. Finally, we describe a proof-of-principle demonstration: an anthropomorphic (human-like) hydraulically powered hand with integrated power supply and actuation.« less

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.

Improving overly manufacturing metrics through application of feedforward mask-bias

NASA Astrophysics Data System (ADS)

Joubert, Etienne; Pellegrini, Joseph C.; Misra, Manish; Sturtevant, John L.; Bernhard, John M.; Ong, Phu; Crawshaw, Nathan K.; Puchalski, Vern

2003-06-01

Traditional run-to-run controllers that rely on highly correlated historical events to forecast process corrections have been shown to provide substantial benefit over manual control in the case of a fab that is primarily manufacturing high volume, frequent running parts (i.e., DRAM, MPU, and similar operations). However, a limitation of the traditional controller emerges when it is applied to a fab whose work in process (WIP) is composed of primarily short-running, high part count products (typical of foundries and ASIC fabs). This limitation exists because there is a strong likelihood that each reticle has a unique set of process corrections different from other reticles at the same process layer. Further limitations exist when it is realized that each reticle is loaded and aligned differently on multiple exposure tools.A structural change in how the run-to-run controller manages the frequent reticle changes associated with the high part count environment has allowed for breakthrough performance to be achieved. This breakthrough was mad possible by the realization that; 1. Reticle sourced errors were highly stable over long periods of time, thus allowing them to be deconvolved from the day to day tool and process drifts. 2. Reticle sourced errors can be modeled as a feedforward disturbance rather than as discriminates in defining and dividing process streams. In this paper, we show how to deconvolve the static (reticle) and dynamic (day to day tool and process) components from the overall error vector to better forecast feedback for existing products as well as how to compute or learn these values for new product introductions - or new tool startups. Manufacturing data will presented to support this discussion with some real world success stories.

Decision support tool for diagnosing the source of variation

NASA Astrophysics Data System (ADS)

Masood, Ibrahim; Azrul Azhad Haizan, Mohamad; Norbaya Jumali, Siti; Ghazali, Farah Najihah Mohd; Razali, Hazlin Syafinaz Md; Shahir Yahya, Mohd; Azlan, Mohd Azwir bin

2017-08-01

Identifying the source of unnatural variation (SOV) in manufacturing process is essential for quality control. The Shewhart control chart patterns (CCPs) are commonly used to monitor the SOV. However, a proper interpretation of CCPs associated to its SOV requires a high skill industrial practitioner. Lack of knowledge in process engineering will lead to erroneous corrective action. The objective of this study is to design the operating procedures of computerized decision support tool (DST) for process diagnosis. The DST is an embedded tool in CCPs recognition scheme. Design methodology involves analysis of relationship between geometrical features, manufacturing process and CCPs. The DST contents information about CCPs and its possible root cause error and description on SOV phenomenon such as process deterioration in tool bluntness, offsetting tool, loading error, and changes in materials hardness. The DST will be useful for an industrial practitioner in making effective troubleshooting.

Design of forging process variables under uncertainties

NASA Astrophysics Data System (ADS)

Repalle, Jalaja; Grandhi, Ramana V.

2005-02-01

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

Manufacturing of tailored tubes with a process integrated heat treatment

NASA Astrophysics Data System (ADS)

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

2017-10-01

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

Experimental research on mathematical modelling and unconventional control of clinker kiln in cement plants

NASA Astrophysics Data System (ADS)

Rusu-Anghel, S.

2017-01-01

Analytical modeling of the flow of manufacturing process of the cement is difficult because of their complexity and has not resulted in sufficiently precise mathematical models. In this paper, based on a statistical model of the process and using the knowledge of human experts, was designed a fuzzy system for automatic control of clinkering process.

Optimization of Process Parameters of Edge Robotic Deburring with Force Control

NASA Astrophysics Data System (ADS)

Burghardt, A.; Szybicki, D.; Kurc, K.; Muszyńska, M.

2016-12-01

The issues addressed in the paper present a part of the scientific research conducted within the framework of the automation of the aircraft engine part manufacturing processes. The results of the research presented in the article provided information in which tolerances while using a robotic control station with the option of force control we can make edge deburring.

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.

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

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

Liddell, Heather; Brueske, Sabine; Carpenter, Alberta

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

Process monitoring and visualization solutions for hot-melt extrusion: a review.

PubMed

Saerens, Lien; Vervaet, Chris; Remon, Jean Paul; De Beer, Thomas

2014-02-01

Hot-melt extrusion (HME) is applied as a continuous pharmaceutical manufacturing process for the production of a variety of dosage forms and formulations. To ensure the continuity of this process, the quality of the extrudates must be assessed continuously during manufacturing. The objective of this review is to provide an overview and evaluation of the available process analytical techniques which can be applied in hot-melt extrusion. Pharmaceutical extruders are equipped with traditional (univariate) process monitoring tools, observing barrel and die temperatures, throughput, screw speed, torque, drive amperage, melt pressure and melt temperature. The relevance of several spectroscopic process analytical techniques for monitoring and control of pharmaceutical HME has been explored recently. Nevertheless, many other sensors visualizing HME and measuring diverse critical product and process parameters with potential use in pharmaceutical extrusion are available, and were thoroughly studied in polymer extrusion. The implementation of process analytical tools in HME serves two purposes: (1) improving process understanding by monitoring and visualizing the material behaviour and (2) monitoring and analysing critical product and process parameters for process control, allowing to maintain a desired process state and guaranteeing the quality of the end product. This review is the first to provide an evaluation of the process analytical tools applied for pharmaceutical HME monitoring and control, and discusses techniques that have been used in polymer extrusion having potential for monitoring and control of pharmaceutical HME. © 2013 Royal Pharmaceutical Society.

Performance Optimization Control of ECH using Fuzzy Inference Application

NASA Astrophysics Data System (ADS)

Dubey, Abhay Kumar

Electro-chemical honing (ECH) is a hybrid electrolytic precision micro-finishing technology that, by combining physico-chemical actions of electro-chemical machining and conventional honing processes, provides the controlled functional surfaces-generation and fast material removal capabilities in a single operation. Process multi-performance optimization has become vital for utilizing full potential of manufacturing processes to meet the challenging requirements being placed on the surface quality, size, tolerances and production rate of engineering components in this globally competitive scenario. This paper presents an strategy that integrates the Taguchi matrix experimental design, analysis of variances and fuzzy inference system (FIS) to formulate a robust practical multi-performance optimization methodology for complex manufacturing processes like ECH, which involve several control variables. Two methodologies one using a genetic algorithm tuning of FIS (GA-tuned FIS) and another using an adaptive network based fuzzy inference system (ANFIS) have been evaluated for a multi-performance optimization case study of ECH. The actual experimental results confirm their potential for a wide range of machining conditions employed in ECH.

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

PubMed

van den Ban, Sander; Goodwin, Daniel J

2017-05-01

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

Stereolithography: A new method for processing dental ceramics by additive computer-aided manufacturing.

PubMed

Dehurtevent, Marion; Robberecht, Lieven; Hornez, Jean-Christophe; Thuault, Anthony; Deveaux, Etienne; Béhin, Pascal

2017-05-01

The aim of this study was to compare the physical and mechanical properties of stereolithography (SLA)- manufactured alumina ceramics of different composition to those of subtractive- manufactured ceramics and to produce suitable dental crown frameworks. The physical and mechanical properties of a control and six experimental SLA ceramics prepared from slurries with small (S) and large (L) particles (0.46±0.03 and 1.56±0.04μm, respectively) and three dry matter contents (70%, 75%, 80%) were evaluated by dynamic rheometry, hydrostatic weighing, three3-point flexural strength measurements, and Weibull analyses, and by the micrometrics measurement of shrinkage ratio before and after the heat treatments. S75 was the only small particle slurry with a significantly higher viscosity than L70. The viscosity of the S80 slurry made it impossible to take rheological measurements. The viscosities of the S75 and S80 slurries caused deformations in the printed layers during SLA manufacturing and were excluded from further consideration. SLA samples with low dry matter content had significantly lower and densityflexural strengths. Only SLA samples with a large particle size and high dry matter content (L75 and L80) were similar in density and flexural strength to the subtractive- manufactured samples. The 95% confidence intervals of the Weibull modulus of the L80 ceramic were higher (no overlap fraction) than those of the L75 ceramic and were similar to the control (overlap fraction). The Weibull characteristics of L80 ceramic were higher than those of L75 ceramic and the control. SLA can be used to process suitable crown frameworks but shows results in anisotropic shrinkage. The hH High particle size and dry matter content of the L80 slurry allowed made it possible to produce a reliable ceramic by SLA manufacturing with an anisotropic shrinkage, and a density, and flexural strength similar to those of a subtractive-manufactured ceramic. SLA allowed made it possible to build up a dense 3D alumina crown framework with controlled shape. Further studies on the marginal adaptation and shrinkage model of alumina crown frameworks will be required to optimize the process. Copyright © 2017 The Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

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

NASA Technical Reports Server (NTRS)

Kayton, M.; Smith, A. G.

1974-01-01

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

Manufacturing Research: Self-Directed Control

DTIC Science & Technology

1991-01-01

reduce this sensitivity. SDO is performing Taguchi’s parameter design . 1-13 Statistical Process Control SPC techniques will be used to monitor the process...Florida,R.E. Krieger Pub. Co., 1988. Dehnad, Khowrow, Quality Control . Robust Design . and the Taguchi Method, Pacific Grove, California, Wadsworth... control system. This turns out to be a non -trivial exercise. A human operator can see an event occur (such as the vessel pressurizing above its setpoint

Quality control troubleshooting tools for the mill floor

Treesearch

John Dramm

2000-01-01

Statistical Process Control (SPC) provides effective tools for improving process quality in the forest products industry resulting in reduced costs and improved productivity. Implementing SPC helps identify and locate problems that occur in wood products manufacturing. SPC tools achieve their real value when applied on the mill floor for monitoring and troubleshooting...

40 CFR 60.562-1 - Standards: Process emissions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Compound (VOC) Emissions from the Polymer Manufacturing Industry § 60.562-1 Standards: Process emissions... vent stream from a control device shall have car-sealed opened all valves in the vent system from the emission source to the control device and car-sealed closed all valves in vent system that would lead the...

Continuous processing and the applications of online tools in pharmaceutical product manufacture: developments and examples.

PubMed

Ooi, Shing Ming; Sarkar, Srimanta; van Varenbergh, Griet; Schoeters, Kris; Heng, Paul Wan Sia

2013-04-01

Continuous processing and production in pharmaceutical manufacturing has received increased attention in recent years mainly due to the industries' pressing needs for more efficient, cost-effective processes and production, as well as regulatory facilitation. To achieve optimum product quality, the traditional trial-and-error method for the optimization of different process and formulation parameters is expensive and time consuming. Real-time evaluation and the control of product quality using an online process analyzer in continuous processing can provide high-quality production with very high-throughput at low unit cost. This review focuses on continuous processing and the application of different real-time monitoring tools used in the pharmaceutical industry for continuous processing from powder to tablets.

Evaluation of the quality of generic polymethylmethacrylate intraocular lenses marketed in India.

PubMed

Combe, R; Watkins, R; Brian, G

2001-04-01

To determine the quality of single-piece, allpolymethylmethacrylate (PMMA) Intraocular lenses (IOLs) from eght generic manufacturers marketing their product in India. This assessment of quality was made with respect to compliance with internationa standards for the manufacture of IOLs, specifically those parameters most likely to affect patient postoperat ve visual acuity and the long-term biocompatibility of the implanted lens. Ten IOLs from each of eight manufacturers were purchased randomly from commercial retail outlets in India. Each IOL, in a masked fashion, had its physical dimensions, optical performance and cosmetic appearance assessed, using the methods prescribed in ISO 11979-2 and 11979-3. Validation of manufacturing process controls were determined by statistical process contro techniques. Four IOLs from each manufacturer were also tested for the presence of unpolymerized PMMA using gas chromatography. Only lenses from two IOL manufacturers complied with the optical and mechanical standards. All other manufacturers' lenses failed one or more of these tests. Intraocular lenses from only two producers met with surface quality and bulk homogeneity standards. All others exhibited defects such as surface contamination and scratches, poor polishing, and chipped or rough positioning holes. Lenses from two producers exhibited high levels of methylmethacrylate monomer (MMA). Non-clinical grade PMMA starting material may have been used in the manufacture of IOLs by some producers. Critical manufacturing defects occurred in the IOLs from five of the eight producers tested. Only one manufacturer's IOLs met all specifications, and on statistical analysis demonstrated good manufacturing process contro with respect to the properties tested. With the widespread acceptance of IOL implantation in developing countries, such as India, it is essential that in the rush to make this the norm, the quality of implants used not be overlooked.

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.

Progress in nanoscale dry processes for fabrication of high-aspect-ratio features: How can we control critical dimension uniformity at the bottom?

NASA Astrophysics Data System (ADS)

Ishikawa, Kenji; Karahashi, Kazuhiro; Ishijima, Tatsuo; Cho, Sung Il; Elliott, Simon; Hausmann, Dennis; Mocuta, Dan; Wilson, Aaron; Kinoshita, Keizo

2018-06-01

In this review, we discuss the progress of emerging dry processes for nanoscale fabrication of high-aspect-ratio features, including emerging design technology for manufacturability. Experts in the fields of plasma processing have contributed to addressing the increasingly challenging demands of nanoscale deposition and etching technologies for high-aspect-ratio features. The discussion of our atomic-scale understanding of physicochemical reactions involving ion bombardment and neutral transport presents the major challenges shared across the plasma science and technology community. Focus is placed on advances in fabrication technology that control surface reactions on three-dimensional features, as well as state-of-the-art techniques used in semiconductor manufacturing with a brief summary of future challenges.

Direct metal writing: Controlling the rheology through microstructure

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

Chen, Wen; Thornley, Luke; Coe, Hannah G.

Most metal additive manufacturing approaches are based on powder-bed melting techniques such as laser selective melting or electron beam melting, which often yield uncontrolled microstructures with defects (e.g., pores or microcracks) and residual stresses. Here, we introduce a proof-of-concept prototype of a 3D metal freeform fabrication process by direct writing of metallic alloys in the semi-solid regime. This process is achieved through controlling the particular microstructure and the rheological behavior of semi-solid alloy slurries, which demonstrate a well suited viscosity and a shear thinning property to retain the shape upon printing. Furthermore, the ability to control the microstructure through thismore » method yields a flexible manufacturing route to fabricating 3D metal parts with full density and complex geometries.« less

Direct metal writing: Controlling the rheology through microstructure

DOE PAGES

Chen, Wen; Thornley, Luke; Coe, Hannah G.; ...

2017-02-27

Most metal additive manufacturing approaches are based on powder-bed melting techniques such as laser selective melting or electron beam melting, which often yield uncontrolled microstructures with defects (e.g., pores or microcracks) and residual stresses. Here, we introduce a proof-of-concept prototype of a 3D metal freeform fabrication process by direct writing of metallic alloys in the semi-solid regime. This process is achieved through controlling the particular microstructure and the rheological behavior of semi-solid alloy slurries, which demonstrate a well suited viscosity and a shear thinning property to retain the shape upon printing. Furthermore, the ability to control the microstructure through thismore » method yields a flexible manufacturing route to fabricating 3D metal parts with full density and complex geometries.« less

21 CFR 111.103 - What are the requirements under this subpart F for written procedures?

Code of Federal Regulations, 2010 CFR

2010-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... quality control operations, including written procedures for conducting a material review and making a...

Development of Space Station strut design

NASA Technical Reports Server (NTRS)

Johnson, R. R.; Bluck, R. M.; Holmes, A. M. C.; Kural, M. H.

1986-01-01

Candidate Space Station struts exhibiting high stiffness (38-40 msi modulus of elasticity) were manufactured and experimentally evaluated. One and two inch diameter aluminum-clad evaluation specimens were manufactured using a unique dry fiber resin injection process. Preliminary tests were performed on strut elements having 80 percent high-modulus graphite epoxy and 20 percent aluminum. Performed tests included modulus of elasticity, thermal cycling, and coefficient of thermal expansion. The paper describes the design approach, including an analytical assessment of strut thermal deformation behavior. The major thrust of this paper is the manufacturing process which produces aluminum-clad struts with precisely controlled properties which can be fine-tuned after fabrication. An impact test and evaluation procedure for evaluating toughness is described.

Integrated manufacturing approach to attain benchmark team performance

NASA Astrophysics Data System (ADS)

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

1994-09-01

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

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.

Design and Manufacture of Conical Shell Structures Using Prepreg Laminates

NASA Astrophysics Data System (ADS)

Khakimova, Regina; Burau, Florian; Degenhardt, Richard; Siebert, Mark; Castro, Saullo G. P.

2016-06-01

The design and manufacture of unstiffened composite conical structures is very challenging, as the variation of the fiber orientations, lay-up and the geometry of the ply pieces have a significant influence on the thickness imperfections and ply angle deviations imprinted to the final part. This paper deals with the manufacture of laminated composite cones through the prepeg/autoclave process. The cones are designed to undergo repetitive buckling tests without accumulating permanent damage. The aim is to define a process that allows the control of fiber angle deviations and the removal of thickness imperfections generated from gaps and overlaps between ply pieces. Ultrasonic scan measurements are used to proof the effectiveness of the proposed method.

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

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

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

2000-09-13

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

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

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

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

2000-07-14

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

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

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

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

2000-08-18

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

Configuration of management accounting information system for multi-stage manufacturing

NASA Astrophysics Data System (ADS)

Mkrtychev, S. V.; Ochepovsky, A. V.; Enik, O. A.

2018-05-01

The article presents an approach to configuration of a management accounting information system (MAIS) that provides automated calculations and the registration of normative production losses in multi-stage manufacturing. The use of MAIS with the proposed configuration at the enterprises of textile and woodworking industries made it possible to increase the accuracy of calculations for normative production losses and to organize accounting thereof with the reference to individual stages of the technological process. Thus, high efficiency of multi-stage manufacturing control is achieved.

The AMTEX Partnership{trademark}. First quarter report, Fiscal year 1996

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

NONE

1995-12-01

The AMTEX Partnership is a collaborative research and development program among the US Integrated Textile Industry, DOE, the National Laboratories, other federal agencies and laboratories, and universities. The goal of AMTEX is to strengthen the competitiveness of this vital industry, thereby preserving and creating US jobs. Topics in this quarters report include: computer-aided fabric evaluation, cotton biotechnology, demand activated manufacturing architecture, electronic embedded fingerprints, on-line process control in flexible fiber manufacturing, rapid cutting, sensors for agile manufacturing, and textile resource conservation.

Dynamic control of moisture during hot pressing of wood composites

Treesearch

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

2006-01-01

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

77 FR 11390 - Delegation of National Emission Standards for Hazardous Air Pollutants for Source Categories; Nevada

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-27

... Tanks. O Ethylene Oxide X X X Sterilization Facilities. Q Industrial Process Cooling X X Towers. R... Organic-Water Separators. WW Storage Vessels (Tanks)-- X X Control Level 2. XX Ethylene Manufacturing X X... Refractory Products X X Manufacturing. TTTTT Primary Magnesium Refining. X WWWWW Hospital Ethylene Oxide X X...

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

PubMed

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

2016-08-01

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

Spacesuit glove manufacturing enhancements through the use of advanced technologies

NASA Astrophysics Data System (ADS)

Cadogan, David; Bradley, David; Kosmo, Joseph

The sucess of astronauts performing extravehicular activity (EVA) on orbit is highly dependent upon the performance of their spacesuit gloves.A study has recently been conducted to advance the development and manufacture of spacesuit gloves. The process replaces the manual techniques of spacesuit glove manufacture by utilizing emerging technologies such as laser scanning, Computer Aided Design (CAD), computer generated two-dimensional patterns from three-dimensionl surfaces, rapid prototyping technology, and laser cutting of materials, to manufacture the new gloves. Results of the program indicate that the baseline process will not increase the cost of the gloves as compared to the existing styles, and in production, may reduce the cost of the gloves. perhaps the most important outcome of the Laserscan process is that greater accuracy and design control can be realized. Greater accuracy was achieved in the baseline anthropometric measurement and CAD data measurement which subsequently improved the design feature. This effectively enhances glove performance through better fit and comfort.

Validation of Contamination Control in Rapid Transfer Port Chambers for Pharmaceutical Manufacturing Processes

PubMed Central

Hu, Shih-Cheng; Shiue, Angus; Liu, Han-Yang; Chiu, Rong-Ben

2016-01-01

There is worldwide concern with regard to the adverse effects of drug usage. However, contaminants can gain entry into a drug manufacturing process stream from several sources such as personnel, poor facility design, incoming ventilation air, machinery and other equipment for production, etc. In this validation study, we aimed to determine the impact and evaluate the contamination control in the preparation areas of the rapid transfer port (RTP) chamber during the pharmaceutical manufacturing processes. The RTP chamber is normally tested for airflow velocity, particle counts, pressure decay of leakage, and sterility. The air flow balance of the RTP chamber is affected by the airflow quantity and the height above the platform. It is relatively easy to evaluate the RTP chamber′s leakage by the pressure decay, where the system is charged with the air, closed, and the decay of pressure is measured by the time period. We conducted the determination of a vaporized H2O2 of a sufficient concentration to complete decontamination. The performance of the RTP chamber will improve safety and can be completely tested at an ISO Class 5 environment. PMID:27845748

Validation of Contamination Control in Rapid Transfer Port Chambers for Pharmaceutical Manufacturing Processes.

PubMed

Hu, Shih-Cheng; Shiue, Angus; Liu, Han-Yang; Chiu, Rong-Ben

2016-11-12

There is worldwide concern with regard to the adverse effects of drug usage. However, contaminants can gain entry into a drug manufacturing process stream from several sources such as personnel, poor facility design, incoming ventilation air, machinery and other equipment for production, etc. In this validation study, we aimed to determine the impact and evaluate the contamination control in the preparation areas of the rapid transfer port (RTP) chamber during the pharmaceutical manufacturing processes. The RTP chamber is normally tested for airflow velocity, particle counts, pressure decay of leakage, and sterility. The air flow balance of the RTP chamber is affected by the airflow quantity and the height above the platform. It is relatively easy to evaluate the RTP chamber's leakage by the pressure decay, where the system is charged with the air, closed, and the decay of pressure is measured by the time period. We conducted the determination of a vaporized H₂O₂ of a sufficient concentration to complete decontamination. The performance of the RTP chamber will improve safety and can be completely tested at an ISO Class 5 environment.

Wafer-shape metrics based foundry lithography

NASA Astrophysics Data System (ADS)

Kim, Sungtae; Liang, Frida; Mileham, Jeffrey; Tsai, Damon; Bouche, Eric; Lee, Sean; Huang, Albert; Hua, C. F.; Wei, Ming Sheng

2017-03-01

As device shrink, there are many difficulties with process integration and device yield. Lithography process control is expected to be a major challenge due to tighter overlay and focus control requirement. The understanding and control of stresses accumulated during device fabrication has becoming more critical at advanced technology nodes. Within-wafer stress variations cause local wafer distortions which in turn present challenges for managing overlay and depth of focus during lithography. A novel technique for measuring distortion is Coherent Gradient Sensing (CGS) interferometry, which is capable of generating a high-density distortion data set of the full wafer within a time frame suitable for a high volume manufacturing (HVM) environment. In this paper, we describe the adoption of CGS (Coherent Gradient Sensing) interferometry into high volume foundry manufacturing to overcome these challenges. Leveraging this high density 3D metrology, we characterized its In-plane distortion as well as its topography capabilities applied to the full flow of an advanced foundry manufacturing. Case studies are presented that summarize the use of CGS data to reveal correlations between in-plane distortion and overlay variation as well as between topography and device yield.

40 CFR 763.167 - Processing prohibitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

Performance analysis of Integrated Communication and Control System networks

NASA Technical Reports Server (NTRS)

Halevi, Y.; Ray, A.

1990-01-01

This paper presents statistical analysis of delays in Integrated Communication and Control System (ICCS) networks that are based on asynchronous time-division multiplexing. The models are obtained in closed form for analyzing control systems with randomly varying delays. The results of this research are applicable to ICCS design for complex dynamical processes like advanced aircraft and spacecraft, autonomous manufacturing plants, and chemical and processing plants.

Biosimilarity Versus Manufacturing Change: Two Distinct Concepts.

PubMed

Declerck, Paul; Farouk-Rezk, Mourad; Rudd, Pauline M

2016-02-01

As products of living cells, biologics are far more complicated than small molecular-weight drugs not only with respect to size and structural complexity but also their sensitivity to manufacturing processes and post-translational changes. Most of the information on the manufacturing process of biotherapeutics is proprietary and hence not fully accessible to the public. This information gap represents a key challenge for biosimilar developers and plays a key role in explaining the differences in regulatory pathways required to demonstrate biosimilarity versus those required to ensure that a change in manufacturing process did not have implications on safety and efficacy. Manufacturing process changes are frequently needed for a variety of reasons including response to regulatory requirements, up scaling production, change in facility, change in raw materials, improving control of quality (consistency) or optimising production efficiency. The scope of the change is usually a key indicator of the scale of analysis required to evaluate the quality. In most cases, where the scope of the process change is limited, only quality and analytical studies should be sufficient while comparative clinical studies can be required in case of major changes (e.g., cell line changes). Biosimilarity exercises have been addressed differently by regulators on the understanding that biosimilar developers start with fundamental differences being a new cell line and also a knowledge gap of the innovator's processes, including culture media, purification processes, and potentially different formulations, and are thus required to ensure that differences from innovators do not result in differences in efficacy and safety.

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

NASA Astrophysics Data System (ADS)

Li, Leihong

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

Process-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

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

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

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

2008-09-01

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

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

NASA Astrophysics Data System (ADS)

Bickerton, Simon

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

Six sigma: process of understanding the control and capability of ranitidine hydrochloride tablet.

PubMed

Chabukswar, Ar; Jagdale, Sc; Kuchekar, Bs; Joshi, Vd; Deshmukh, Gr; Kothawade, Hs; Kuckekar, Ab; Lokhande, Pd

2011-01-01

The process of understanding the control and capability (PUCC) is an iterative closed loop process for continuous improvement. It covers the DMAIC toolkit in its three phases. PUCC is an iterative approach that rotates between the three pillars of the process of understanding, process control, and process capability, with each iteration resulting in a more capable and robust process. It is rightly said that being at the top is a marathon and not a sprint. The objective of the six sigma study of Ranitidine hydrochloride tablets is to achieve perfection in tablet manufacturing by reviewing the present robust manufacturing process, to find out ways to improve and modify the process, which will yield tablets that are defect-free and will give more customer satisfaction. The application of six sigma led to an improved process capability, due to the improved sigma level of the process from 1.5 to 4, a higher yield, due to reduced variation and reduction of thick tablets, reduction in packing line stoppages, reduction in re-work by 50%, a more standardized process, with smooth flow and change in coating suspension reconstitution level (8%w/w), a huge cost reduction of approximately Rs.90 to 95 lakhs per annum, an improved overall efficiency by 30% approximately, and improved overall quality of the product.

Six Sigma: Process of Understanding the Control and Capability of Ranitidine Hydrochloride Tablet

PubMed Central

Chabukswar, AR; Jagdale, SC; Kuchekar, BS; Joshi, VD; Deshmukh, GR; Kothawade, HS; Kuckekar, AB; Lokhande, PD

2011-01-01

The process of understanding the control and capability (PUCC) is an iterative closed loop process for continuous improvement. It covers the DMAIC toolkit in its three phases. PUCC is an iterative approach that rotates between the three pillars of the process of understanding, process control, and process capability, with each iteration resulting in a more capable and robust process. It is rightly said that being at the top is a marathon and not a sprint. The objective of the six sigma study of Ranitidine hydrochloride tablets is to achieve perfection in tablet manufacturing by reviewing the present robust manufacturing process, to find out ways to improve and modify the process, which will yield tablets that are defect-free and will give more customer satisfaction. The application of six sigma led to an improved process capability, due to the improved sigma level of the process from 1.5 to 4, a higher yield, due to reduced variation and reduction of thick tablets, reduction in packing line stoppages, reduction in re-work by 50%, a more standardized process, with smooth flow and change in coating suspension reconstitution level (8%w/w), a huge cost reduction of approximately Rs.90 to 95 lakhs per annum, an improved overall efficiency by 30% approximately, and improved overall quality of the product. PMID:21607050

Multicenter Cell Processing for Cardiovascular Regenerative Medicine Applications - The Cardiovascular Cell Therapy Research Network (CCTRN) Experience

PubMed Central

Gee, Adrian P.; Richman, Sara; Durett, April; McKenna, David; Traverse, Jay; Henry, Timothy; Fisk, Diann; Pepine, Carl; Bloom, Jeannette; Willerson, James; Prater, Karen; Zhao, David; Koç, Jane Reese; Ellis, Steven; Taylor, Doris; Cogle, Christopher; Moyé, Lemuel; Simari, Robert; Skarlatos, Sonia

2013-01-01

Background Aims Multi-center cellular therapy clinical trials require the establishment and implementation of standardized cell processing protocols and associated quality control mechanisms. The aims here were to develop such an infrastructure in support of the Cardiovascular Cell Therapy Research Network (CCTRN) and to report on the results of processing for the first 60 patients. Methods Standardized cell preparations, consisting of autologous bone marrow mononuclear cells, prepared using the Sepax device were manufactured at each of the five processing facilities that supported the clinical treatment centers. Processing staff underwent centralized training that included proficiency evaluation. Quality was subsequently monitored by a central quality control program that included product evaluation by the CCTRN biorepositories. Results Data from the first 60 procedures demonstrate that uniform products, that met all release criteria, could be manufactured at all five sites within 7 hours of receipt of the bone marrow. Uniformity was facilitated by use of the automated systems (the Sepax for processing and the Endosafe device for endotoxin testing), standardized procedures and centralized quality control. Conclusions Complex multicenter cell therapy and regenerative medicine protocols can, where necessary, successfully utilize local processing facilities once an effective infrastructure is in place to provide training, and quality control. PMID:20524773

40 CFR 63.140 - Process wastewater provisions-delay of repair.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 10 2014-07-01 2014-07-01 false Process wastewater provisions-delay of... Manufacturing Industry for Process Vents, Storage Vessels, Transfer Operations, and Wastewater § 63.140 Process wastewater provisions—delay of repair. (a) Delay of repair of equipment for which a control equipment failure...

40 CFR 63.140 - Process wastewater provisions-delay of repair.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 10 2012-07-01 2012-07-01 false Process wastewater provisions-delay of... Manufacturing Industry for Process Vents, Storage Vessels, Transfer Operations, and Wastewater § 63.140 Process wastewater provisions—delay of repair. (a) Delay of repair of equipment for which a control equipment failure...

40 CFR 63.140 - Process wastewater provisions-delay of repair.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 9 2011-07-01 2011-07-01 false Process wastewater provisions-delay of... Manufacturing Industry for Process Vents, Storage Vessels, Transfer Operations, and Wastewater § 63.140 Process wastewater provisions—delay of repair. (a) Delay of repair of equipment for which a control equipment failure...

40 CFR 63.140 - Process wastewater provisions-delay of repair.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 10 2013-07-01 2013-07-01 false Process wastewater provisions-delay of... Manufacturing Industry for Process Vents, Storage Vessels, Transfer Operations, and Wastewater § 63.140 Process wastewater provisions—delay of repair. (a) Delay of repair of equipment for which a control equipment failure...

Traceability of On-Machine Tool Measurement: A Review.

PubMed

Mutilba, Unai; Gomez-Acedo, Eneko; Kortaberria, Gorka; Olarra, Aitor; Yagüe-Fabra, Jose A

2017-07-11

Nowadays, errors during the manufacturing process of high value components are not acceptable in driving industries such as energy and transportation. Sectors such as aerospace, automotive, shipbuilding, nuclear power, large science facilities or wind power need complex and accurate components that demand close measurements and fast feedback into their manufacturing processes. New measuring technologies are already available in machine tools, including integrated touch probes and fast interface capabilities. They provide the possibility to measure the workpiece in-machine during or after its manufacture, maintaining the original setup of the workpiece and avoiding the manufacturing process from being interrupted to transport the workpiece to a measuring position. However, the traceability of the measurement process on a machine tool is not ensured yet and measurement data is still not fully reliable enough for process control or product validation. The scientific objective is to determine the uncertainty on a machine tool measurement and, therefore, convert it into a machine integrated traceable measuring process. For that purpose, an error budget should consider error sources such as the machine tools, components under measurement and the interactions between both of them. This paper reviews all those uncertainty sources, being mainly focused on those related to the machine tool, either on the process of geometric error assessment of the machine or on the technology employed to probe the measurand.

Application of the quality by design approach to the drug substance manufacturing process of an Fc fusion protein: towards a global multi-step design space.

PubMed

Eon-duval, Alex; Valax, Pascal; Solacroup, Thomas; Broly, Hervé; Gleixner, Ralf; Strat, Claire L E; Sutter, James

2012-10-01

The article describes how Quality by Design principles can be applied to the drug substance manufacturing process of an Fc fusion protein. First, the quality attributes of the product were evaluated for their potential impact on safety and efficacy using risk management tools. Similarly, process parameters that have a potential impact on critical quality attributes (CQAs) were also identified through a risk assessment. Critical process parameters were then evaluated for their impact on CQAs, individually and in interaction with each other, using multivariate design of experiment techniques during the process characterisation phase. The global multi-step Design Space, defining operational limits for the entire drug substance manufacturing process so as to ensure that the drug substance quality targets are met, was devised using predictive statistical models developed during the characterisation study. The validity of the global multi-step Design Space was then confirmed by performing the entire process, from cell bank thawing to final drug substance, at its limits during the robustness study: the quality of the final drug substance produced under different conditions was verified against predefined targets. An adaptive strategy was devised whereby the Design Space can be adjusted to the quality of the input material to ensure reliable drug substance quality. Finally, all the data obtained during the process described above, together with data generated during additional validation studies as well as manufacturing data, were used to define the control strategy for the drug substance manufacturing process using a risk assessment methodology. Copyright © 2012 Wiley-Liss, Inc.

Research on width control of Metal Fused-coating Additive Manufacturing based on active control

NASA Astrophysics Data System (ADS)

Ren, Chuan qi; Wei, Zheng ying; Wang, Xin; Du, Jun; Zhang, Shan; Zhang, Zhitong; Bai, Hao

2017-12-01

Given the stability of the shape of the forming layer is one of the key problems that affect the final quality of the sample morphology, taking a study on the forming process and the control method of morphology make a significant difference to metal fused-coating additive manufacturing (MFCAM) in achieving the efficient and stable forming. To improve the quality and precision of the samples of single-layer single pass, a control method of morphology based on active control was established by this paper. The real-time acquisition of image was realized by CCD and the characteristics of morphology of the forming process were simultaneously extracted. Making analysis of the characteristics of the width during the process, the relationship between the relative difference of different frames and moving speed was given. A large number of experiments are used to verify the response speed and accuracy of the system. The results show that the active system can improve the morphology of the sample and the smoothness of the width of the single channel, and increase the uniformity of width by 55.16%.

Collaborative Manufacturing for Small-Medium Enterprises

NASA Astrophysics Data System (ADS)

Irianto, D.

2016-02-01

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

In-vitro evaluation of Polylactic acid (PLA) manufactured by fused deposition modeling.

PubMed

Wurm, Matthias C; Möst, Tobias; Bergauer, Bastian; Rietzel, Dominik; Neukam, Friedrich Wilhelm; Cifuentes, Sandra C; Wilmowsky, Cornelius von

2017-01-01

With additive manufacturing (AM) individual and biocompatible implants can be generated by using suitable materials. The aim of this study was to investigate the biological effects of polylactic acid (PLA) manufactured by Fused Deposition Modeling (FDM) on osteoblasts in vitro according to European Norm / International Organization for Standardization 10,993-5. Human osteoblasts (hFOB 1.19) were seeded onto PLA samples produced by FDM and investigated for cell viability by fluorescence staining after 24 h. Cell proliferation was measured after 1, 3, 7 and 10 days by cell-counting and cell morphology was evaluated by scanning electron microscopy. For control, we used titanium samples and polystyrene (PS). Cell viability showed higher viability on PLA (95,3% ± 2.1%) than in control (91,7% ±2,7%). Cell proliferation was highest in the control group (polystyrene) and higher on PLA samples compared to the titanium samples. Scanning electron microscopy revealed homogenous covering of sample surface with regularly spread cells on PLA as well as on titanium. The manufacturing of PLA discs from polylactic acid using FDM was successful. The in vitro investigation with human fetal osteoblasts showed no cytotoxic effects. Furthermore, FDM does not seem to alter biocompatibility of PLA. Nonetheless osteoblasts showed reduced growth on PLA compared to the polystyrene control within the cell experiments. This could be attributed to surface roughness and possible release of residual monomers. Those influences could be investigated in further studies and thus lead to improvement in the additive manufacturing process. In addition, further research focused on the effect of PLA on bone growth should follow. In summary, PLA processed in Fused Deposition Modelling seems to be an attractive material and method for reconstructive surgery because of their biocompatibility and the possibility to produce individually shaped scaffolds.

Metrological assurance and traceability for Industry 4.0 and additive manufacturing in Ukraine

NASA Astrophysics Data System (ADS)

Skliarov, Volodymyr; Neyezhmakov, Pavel; Prokopov, Alexander

2018-03-01

The national measurement standards from the point of view of traceability of the results of measurement in additive manufacturing in Ukraine are considered in the paper. The metrological characteristics of the national primary measurement standards in the field of geometric, temperature, optical-physical and time-frequency measurements, which took part in international comparisons within COOMET projects, are presented. The accurate geometric, temperature, optical-physical and time-frequency measurements are the key ones in controlling the quality of additive manufacturing. The use of advanced CAD/CAE/CAM systems allows to simulate the process of additive manufacturing at each stage. In accordance with the areas of the technology of additive manufacturing, the ways of improving the national measurement standards of Ukraine for the growing needs of metrology of additive manufacturing are considered.

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

PubMed

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

2002-03-01

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

The specification of personalised insoles using additive manufacturing.

PubMed

Salles, André S; Gyi, Diane E

2012-01-01

Research has been conducted to explore a process that delivers insoles for personalised footwear for the high street using additive manufacturing (AM) and to evaluate the use of such insoles in terms of discomfort. Therefore, the footwear personalisation process was first identified: (1) foot capture; (2) anthropometric measurements; (3) insole design; and (4) additive manufacturing. In order to explore and evaluate this process, recreational runners were recruited. They had both feet scanned and 15 anthropometric measurements taken. Personalised insoles were designed from the scans and manufactured using AM. Participants were fitted with footwear under two experimental conditions: personalised and control, which were compared in terms of discomfort. The mean ratings for discomfort variables were generally low for both conditions and no significant differences were detected between conditions. In general, the personalisation process showed promise in terms of the scan data, although the foot capture position may not be considered 'gold standard'. Polyamide, the material used for the insoles, demonstrated positive attributes: visual inspection revealed no signs of breaking. The footwear personalisation process described and explored in this study shows potential and can be considered a good starting point for designer and researchers.

40 CFR 763.160 - Scope.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT ASBESTOS Prohibition of the Manufacture, Importation, Processing, and Distribution in Commerce of Certain Asbestos..., importation, processing, and distribution in commerce of the asbestos-containing products identified and at...

40 CFR 763.160 - Scope.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT ASBESTOS Prohibition of the Manufacture, Importation, Processing, and Distribution in Commerce of Certain Asbestos..., importation, processing, and distribution in commerce of the asbestos-containing products identified and at...

40 CFR 763.160 - Scope.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT ASBESTOS Prohibition of the Manufacture, Importation, Processing, and Distribution in Commerce of Certain Asbestos..., importation, processing, and distribution in commerce of the asbestos-containing products identified and at...

40 CFR 763.160 - Scope.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT ASBESTOS Prohibition of the Manufacture, Importation, Processing, and Distribution in Commerce of Certain Asbestos..., importation, processing, and distribution in commerce of the asbestos-containing products identified and at...

Trends in Solidification Grain Size and Morphology for Additive Manufacturing of Ti-6Al-4V

NASA Astrophysics Data System (ADS)

Gockel, Joy; Sheridan, Luke; Narra, Sneha P.; Klingbeil, Nathan W.; Beuth, Jack

2017-12-01

Metal additive manufacturing (AM) is used for both prototyping and production of final parts. Therefore, there is a need to predict and control the microstructural size and morphology. Process mapping is an approach that represents AM process outcomes in terms of input variables. In this work, analytical, numerical, and experimental approaches are combined to provide a holistic view of trends in the solidification grain structure of Ti-6Al-4V across a wide range of AM process input variables. The thermal gradient is shown to vary significantly through the depth of the melt pool, which precludes development of fully equiaxed microstructure throughout the depth of the deposit within any practical range of AM process variables. A strategy for grain size control is demonstrated based on the relationship between melt pool size and grain size across multiple deposit geometries, and additional factors affecting grain size are discussed.

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

Code of Federal Regulations, 2010 CFR

2010-04-01

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

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

Code of Federal Regulations, 2010 CFR

2010-04-01

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

An intelligent CNC machine control system architecture

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

Miller, D.J.; Loucks, C.S.

1996-10-01

Intelligent, agile manufacturing relies on automated programming of digitally controlled processes. Currently, processes such as Computer Numerically Controlled (CNC) machining are difficult to automate because of highly restrictive controllers and poor software environments. It is also difficult to utilize sensors and process models for adaptive control, or to integrate machining processes with other tasks within a factory floor setting. As part of a Laboratory Directed Research and Development (LDRD) program, a CNC machine control system architecture based on object-oriented design and graphical programming has been developed to address some of these problems and to demonstrate automated agile machining applications usingmore » platform-independent software.« less

Cellulose nanocrystals the next big nano-thing?

NASA Astrophysics Data System (ADS)

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

2008-08-01

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

Standard Reference Specimens in Quality Control of Engineering Surfaces

PubMed Central

Song, J. F.; Vorburger, T. V.

1991-01-01

In the quality control of engineering surfaces, we aim to understand and maintain a good relationship between the manufacturing process and surface function. This is achieved by controlling the surface texture. The control process involves: 1) learning the functional parameters and their control values through controlled experiments or through a long history of production and use; 2) maintaining high accuracy and reproducibility with measurements not only of roughness calibration specimens but also of real engineering parts. In this paper, the characteristics, utilizations, and limitations of different classes of precision roughness calibration specimens are described. A measuring procedure of engineering surfaces, based on the calibration procedure of roughness specimens at NIST, is proposed. This procedure involves utilization of check specimens with waveform, wavelength, and other roughness parameters similar to functioning engineering surfaces. These check specimens would be certified under standardized reference measuring conditions, or by a reference instrument, and could be used for overall checking of the measuring procedure and for maintaining accuracy and agreement in engineering surface measurement. The concept of “surface texture design” is also suggested, which involves designing the engineering surface texture, the manufacturing process, and the quality control procedure to meet the optimal functional needs. PMID:28184115

Prevalence of Listeria monocytogenes in Retail Lightly Pickled Vegetables and Its Successful Control at Processing Plants.

PubMed

Taguchi, Masumi; Kanki, Masashi; Yamaguchi, Yuko; Inamura, Hideichi; Koganei, Yosuke; Sano, Tetsuya; Nakamura, Hiromi; Asakura, Hiroshi

2017-03-01

Incidences of food poisoning traced to nonanimal food products have been increasingly reported. One of these was a recent large outbreak of Shiga toxin-producing Escherichia coli (STEC) O157 infection from the consumption of lightly pickled vegetables, indicating the necessity of imposing hygienic controls during manufacturing. However, little is known about the bacterial contamination levels in these minimally processed vegetables. Here we examined the prevalence of STEC, Salmonella spp., and Listeria monocytogenes in 100 lightly pickled vegetable products manufactured at 55 processing factories. Simultaneously, we also performed quantitative measurements of representative indicator bacteria (total viable counts, coliform counts, and β-glucuronidase-producing E. coli counts). STEC and Salmonella spp. were not detected in any of the samples; L. monocytogenes was detected in 12 samples manufactured at five of the factories. Microbiological surveillance at two factories (two surveys at factory A and three surveys at factory B) between June 2014 and January 2015 determined that the areas predominantly contaminated with L. monocytogenes included the refrigerators and packaging rooms. Genotyping provided further evidence that the contaminants found in these areas were linked to those found in the final products. Taken together, we demonstrated the prevalence of L. monocytogenes in lightly pickled vegetables sold at the retail level. Microbiological surveillance at the manufacturing factories further clarified the sources of the contamination in the retail products. These data indicate the necessity of implementing adequate monitoring programs to minimize health risks attributable to the consumption of these minimally processed vegetables.

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

NASA Astrophysics Data System (ADS)

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

2016-08-01

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

Process and product development in the manufacturing of molecular therapeutics.

PubMed

Atkinson, E M; Christensen, J R

1999-08-01

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

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.

FDA 2011 process validation guidance: lifecycle compliance model.

PubMed

Campbell, Cliff

2014-01-01

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

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

Fieldcrest Cannon, Inc. Advanced Technical Preparation. Statistical Process Control (SPC). PRE-SPC I. Instructor Book.

ERIC Educational Resources Information Center

Averitt, Sallie D.

This instructor guide, which was developed for use in a manufacturing firm's advanced technical preparation program, contains the materials required to present a learning module that is designed to prepare trainees for the program's statistical process control module by improving their basic math skills and instructing them in basic calculator…

Furnace and support equipment for space processing. [space manufacturing - Czochralski method

NASA Technical Reports Server (NTRS)

Mazelsky, R.; Duncan, C. S.; Seidensticker, R. G.; Johnson, R. A.; Hopkins, R. H.; Roland, G. W.

1975-01-01

A core facility capable of performing a majority of materials processing experiments is discussed. Experiment classes are described, the needs peculiar to each experiment type are outlined, and projected facility requirements to perform the experiments are treated. Control equipment (automatic control) and variations of the Czochralski method for use in space are discussed.

Six-sigma application in tire-manufacturing company: a case study

NASA Astrophysics Data System (ADS)

Gupta, Vikash; Jain, Rahul; Meena, M. L.; Dangayach, G. S.

2017-09-01

Globalization, advancement of technologies, and increment in the demand of the customer change the way of doing business in the companies. To overcome these barriers, the six-sigma define-measure-analyze-improve-control (DMAIC) method is most popular and useful. This method helps to trim down the wastes and generating the potential ways of improvement in the process as well as service industries. In the current research, the DMAIC method was used for decreasing the process variations of bead splice causing wastage of material. This six-sigma DMAIC research was initiated by problem identification through voice of customer in the define step. The subsequent step constitutes of gathering the specification data of existing tire bead. This step was followed by the analysis and improvement steps, where the six-sigma quality tools such as cause-effect diagram, statistical process control, and substantial analysis of existing system were implemented for root cause identification and reduction in process variation. The process control charts were used for systematic observation and control the process. Utilizing DMAIC methodology, the standard deviation was decreased from 2.17 to 1.69. The process capability index (C p) value was enhanced from 1.65 to 2.95 and the process performance capability index (C pk) value was enhanced from 0.94 to 2.66. A DMAIC methodology was established that can play a key role for reducing defects in the tire-manufacturing process in India.

[Emission characteristics and safety evaluation of volatile organic compounds in manufacturing processes of automotive coatings].

PubMed

Zeng, Pei-Yuan; Li, Jian-Jun; Liao, Dong-Qi; Tu, Xiang; Xu, Mei-Ying; Sun, Guo-Ping

2013-12-01

Emission characteristics of volatile organic compounds (VOCs) were investigated in an automotive coating manufacturing enterprise. Air samples were taken from eight different manufacturing areas in three workshops, and the species of VOCs and their concentrations were measured by gas chromatography-mass spectrometry (GC-MS). Safety evaluation was also conducted by comparing the concentration of VOCs with the permissible concentration-short term exposure limit (PC-STEL) regulated by the Ministry of Health. The results showed that fifteen VOCs were detected in the indoor air of the automotive coatings workshop, including benzene, toluene, ethylbenzene, xylene, ethyl acetate, butyl acetate, methyl isobutyl ketone, propylene glycol monomethyl ether acetate, trimethylbenzene and ethylene glycol monobutyl ether, Their concentrations widely ranged from 0.51 to 593.14 mg x m(-3). The concentrations of TVOCs were significantly different among different manufacturing processes. Even in the same manufacturing process, the concentrations of each component measured at different times were also greatly different. The predominant VOCs of indoor air in the workshop were identified to be ethylbenzene and butyl acetate. The concentrations of most VOCs exceeded the occupational exposure limits, so the corresponding control measures should be taken to protect the health of the workers.

Transistor step stress testing program for JANTX2N2484

NASA Technical Reports Server (NTRS)

1979-01-01

The effect of power/temperature step stress when applied to the transistor JANTX2N2484, manufactured by Raytheon and Teledyne was evaluated. Forty-eight samples from each manufacturer were divided equally (16 per group) into three groups and submitted to the processes outlined. In addition, two control sample units were maintained for verification of the electrical parametric testing.

Emission factors of air toxics from semiconductor manufacturing in Korea.

PubMed

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

2006-11-01

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

77 FR 23618 - Authority To Manufacture and Distribute Postage Evidencing Systems

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-20

... revision of the rules concerning inventory controls for Postage Evidencing Systems (PES). These changes are... System inventory control processes. (a) Each authorized provider of Postage Evidencing Systems must... custody and control of Postage Evidencing Systems and must specifically authorize in writing the proposed...

It Systems Supporting the Management of Production Capacity

NASA Astrophysics Data System (ADS)

Milewska, Elżbieta

2017-03-01

The paper presents the problem of manufacturing process flexibility in view of a company's material and information flow stream management. The author of the article has described the functions of a production process control system and presented the characteristics of production capacity intensive and extensive reserves. The MRP II/ERP, MES and APS class IT tools supporting the process of production planning, organization and control have also been discussed.

OAO battery data analysis

NASA Technical Reports Server (NTRS)

Gaston, S.; Wertheim, M.; Orourke, J. A.

1973-01-01

Summary, consolidation and analysis of specifications, manufacturing process and test controls, and performance results for OAO-2 and OAO-3 lot 20 Amp-Hr sealed nickel cadmium cells and batteries are reported. Correlation of improvements in control requirements with performance is a key feature. Updates for a cell/battery computer model to improve performance prediction capability are included. Applicability of regression analysis computer techniques to relate process controls to performance is checked.

A modular assembling platform for manufacturing of microsystems by optical tweezers

NASA Astrophysics Data System (ADS)

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

2013-09-01

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

Cyber physical systems role in manufacturing technologies

NASA Astrophysics Data System (ADS)

Al-Ali, A. R.; Gupta, Ragini; Nabulsi, Ahmad Al

2018-04-01

Empowered by the recent development in single System-on-Chip, Internet of Things, and cloud computing technologies, cyber physical systems are evolving as a major controller during and post the manufacturing products process. In additional to their real physical space, cyber products nowadays have a virtual space. A product virtual space is a digital twin that is attached to it to enable manufacturers and their clients to better manufacture, monitor, maintain and operate it throughout its life time cycles, i.e. from the product manufacturing date, through operation and to the end of its lifespan. Each product is equipped with a tiny microcontroller that has a unique identification number, access code and WiFi conductivity to access it anytime and anywhere during its life cycle. This paper presents the cyber physical systems architecture and its role in manufacturing. Also, it highlights the role of Internet of Things and cloud computing in industrial manufacturing and factory automation.

Smart manufacturing of complex shaped pipe components

NASA Astrophysics Data System (ADS)

Salchak, Y. A.; Kotelnikov, A. A.; Sednev, D. A.; Borikov, V. N.

2018-03-01

Manufacturing industry is constantly improving. Nowadays the most relevant trend is widespread automation and optimization of the production process. This paper represents a novel approach for smart manufacturing of steel pipe valves. The system includes two main parts: mechanical treatment and quality assurance units. Mechanical treatment is performed by application of the milling machine with implementation of computerized numerical control, whilst the quality assurance unit contains three testing modules for different tasks, such as X-ray testing, optical scanning and ultrasound testing modules. The advances of each of them provide reliable results that contain information about any failures of the technological process, any deviations of geometrical parameters of the valves. The system also allows detecting defects on the surface or in the inner structure of the component.

Research development of thermal aberration in 193nm lithography exposure system

NASA Astrophysics Data System (ADS)

Wang, Yueqiang; Liu, Yong

2014-08-01

Lithographic exposure is the key process in the manufacture of the integrated circuit, and the performance of exposure system decides the level of microelectronic manufacture technology. Nowadays, the 193nm ArF immersion exposure tool is widely used by the IC manufacturer. With the uniformity of critical dimension (CDU) and overlay become tighter and the requirement for throughput become higher, the thermal aberration caused by lens material and structure absorbing the laser energy cannot be neglected. In this paper, we introduce the efforts and methods that researcher on thermal aberration and its control. Further, these methods were compared to show their own pros and cons. Finally we investigated the challenges of thermal aberration control for state of the art technologies.

[Quality control in herbal supplements].

PubMed

Oelker, Luisa

2005-01-01

Quality and safety of food and herbal supplements are the result of a whole of different elements as good manufacturing practice and process control. The process control must be active and able to individuate and correct all possible hazards. The main and most utilized instrument is the hazard analysis critical control point (HACCP) system the correct application of which can guarantee the safety of the product. Herbal supplements need, in addition to standard quality control, a set of checks to assure the harmlessness and safety of the plants used.

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.

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.

11 CFR 9405.5 - Categories of exemptions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... descriptions of manufacturing process, quality control methodology, and test results. The following procedures... lawful national security intelligence investigation, information furnished by a confidential source; (v...

11 CFR 9405.5 - Categories of exemptions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... descriptions of manufacturing process, quality control methodology, and test results. The following procedures... lawful national security intelligence investigation, information furnished by a confidential source; (v...

11 CFR 9405.5 - Categories of exemptions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... descriptions of manufacturing process, quality control methodology, and test results. The following procedures... lawful national security intelligence investigation, information furnished by a confidential source; (v...

11 CFR 9405.5 - Categories of exemptions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... descriptions of manufacturing process, quality control methodology, and test results. The following procedures... lawful national security intelligence investigation, information furnished by a confidential source; (v...

Development and characterization of an IPMC hair-like transducer

NASA Astrophysics Data System (ADS)

Akle, Barbar J.; Challita, Elio; Khairalah, Nady

2015-04-01

Hair-like sensors are very common in natural and biological systems. Such sensors are used to measure acoustic pressures, fluid flows, and chemical concentrations among others. Hair-like actuators are also used to control fluid flows and perform temperature management. This study presents a manufacturing technique for a hair-like IPMC transducer. A thorough study is presented on the building process of the sensor. The method used to control the diameter and the electrodes thickness of the transducer is developed. The sensing behavior of the manufactured transducers is experimentally characterized.

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

PubMed

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

2018-01-31

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

Effect of Chemical and Physical Properties on the In Vitro Degradation of 3D Printed High Resolution Poly(propylene fumarate) Scaffolds.

PubMed

Walker, Jason M; Bodamer, Emily; Krebs, Olivia; Luo, Yuanyuan; Kleinfehn, Alex; Becker, Matthew L; Dean, David

2017-04-10

Two distinct molecular masses of poly(propylene fumarate) (PPF) are combined with an additive manufacturing process to fabricate highly complex scaffolds possessing controlled chemical properties and porous architecture. Scaffolds were manufactured with two polymer molecular masses and two architecture styles. Degradation was assessed in an accelerated in vitro environment. The purpose of the degradation study is not to model or mimic in vivo degradation, but to efficiently compare the effect of modulating scaffold properties. This is the first study addressing degradation of chain-growth synthesized PPF, a process that allows for considerably more control over molecular mass distribution. It demonstrates that, with greater process control, not only is scaffold fabrication reproducible, but the mechanical properties and degradation kinetics can be tailored by altering the physical properties of the scaffold. This is a clear step forward in using PPF to address unmet medical needs while meeting regulatory demands and ultimately obtaining clinical relevancy.

EVALUATION OF THE POLYAD FB AIR PURIFICATION AND SOLVENT RECOVERY PROCESS FOR STYRENE REMOVAL

EPA Science Inventory

The report gives results of a study evaluating the Polyad fluidized-bed (FB) process for controlling styrene emissions at a representative fiberglass shower stall and bath tub manufacturing plan*t. he process was evaluated using a transport able unit supplied by Weatherly, Inc., ...

40 CFR 63.7143 - What definitions apply to this subpart?

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Lime Manufacturing Plants Other... capture and transport PM to a control device. Control device means the air pollution control equipment used to reduce PM emissions released to the atmosphere from one or more process operations at an LMP...

40 CFR 63.7143 - What definitions apply to this subpart?

Code of Federal Regulations, 2012 CFR

2012-07-01

... (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Lime Manufacturing Plants Other... capture and transport PM to a control device. Control device means the air pollution control equipment used to reduce PM emissions released to the atmosphere from one or more process operations at an LMP...

40 CFR 63.7143 - What definitions apply to this subpart?

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Lime Manufacturing Plants Other... capture and transport PM to a control device. Control device means the air pollution control equipment used to reduce PM emissions released to the atmosphere from one or more process operations at an LMP...

40 CFR 63.7143 - What definitions apply to this subpart?

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Lime Manufacturing Plants Other... capture and transport PM to a control device. Control device means the air pollution control equipment used to reduce PM emissions released to the atmosphere from one or more process operations at an LMP...

40 CFR 63.7143 - What definitions apply to this subpart?

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Lime Manufacturing Plants Other... capture and transport PM to a control device. Control device means the air pollution control equipment used to reduce PM emissions released to the atmosphere from one or more process operations at an LMP...

Breakthrough Performance: Creating the Innovative Enterprise.

ERIC Educational Resources Information Center

Hanson, Diane; Bapst, Jerry

1998-01-01

Illustrates a new model for innovative enterprises by reviewing the process an instruments and control systems manufacturer used to implement changes in its corporate operating philosophy. Outlines the "Quantum Model": spheres of control, influence, interest, and UNs (unknown, unpredictable, uncontrollable, uncomfortable). Discusses…

Fieldcrest Cannon, Inc. Advanced Technical Preparation. Statistical Process Control (SPC). PRE-SPC 11: SPC & Graphs. Instructor Book.

ERIC Educational Resources Information Center

Averitt, Sallie D.

This instructor guide, which was developed for use in a manufacturing firm's advanced technical preparation program, contains the materials required to present a learning module that is designed to prepare trainees for the program's statistical process control module by improving their basic math skills in working with line graphs and teaching…

From chaos to control: winning the war.

PubMed

Wojciak, P J

1994-08-01

This article illustrates how a small manufacturing facility in the Midwest undertook the process of an MRP II implementation and ultimately gained class A status at a true make-or-break time in its history. The control that was gained throughout the entire process has helped create a winning environment and will continue to strengthen our position as we move toward world-class excellence.

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

NASA Astrophysics Data System (ADS)

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

2018-07-01

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

ProSens: integrated production control by automated inspection planning and efficient multisensor metrology

NASA Astrophysics Data System (ADS)

Glaser, Ulf; Li, Zhichao; Bichmann, Stephan, II; Pfeifer, Tilo

2003-05-01

By China's entry into the WTO, Chinese as well as German companies are facing the question, how to minimize the risk of unfamiliar cooperation partners when developing products. The rise of customer demands concerning quality, product diversity and the reduction of expenses require flexibility and efficiency with reliable component suppliers. In order to build and strengthen sino-german cooperations, a manufacturing control using homogenized and efficient measures to assure high quality is of vital importance. Lack of unifications may cause identical measurements conducted at subcontractors or customers to be carried out with different measurement processes which leads to incomparable results. Rapidly growing company cooperations and simultaneously decreasing of manufacturing scope cause substantial difficulties when coordinating joint quality control activities. "ProSens," a sino-german project consortium consisting of industrial users, technology producers and research institutes, aims at improving selected production processes by: Creation of a homogeneous quality awareness in sino-german cooperations. Sensitization for process accompanying metrology at an early stage of product development. Increase of the process performance by the use of integrated metrology. Reduction of production time and cost. Unification of quality control of complex products by means of efficient measurement strategies and CAD-based inspection planning.

Recursive least squares estimation and its application to shallow trench isolation

NASA Astrophysics Data System (ADS)

Wang, Jin; Qin, S. Joe; Bode, Christopher A.; Purdy, Matthew A.

2003-06-01

In recent years, run-to-run (R2R) control technology has received tremendous interest in semiconductor manufacturing. One class of widely used run-to-run controllers is based on the exponentially weighted moving average (EWMA) statistics to estimate process deviations. Using an EWMA filter to smooth the control action on a linear process has been shown to provide good results in a number of applications. However, for a process with severe drifts, the EWMA controller is insufficient even when large weights are used. This problem becomes more severe when there is measurement delay, which is almost inevitable in semiconductor industry. In order to control drifting processes, a predictor-corrector controller (PCC) and a double EWMA controller have been developed. Chen and Guo (2001) show that both PCC and double-EWMA controller are in effect Integral-double-Integral (I-II) controllers, which are able to control drifting processes. However, since offset is often within the noise of the process, the second integrator can actually cause jittering. Besides, tuning the second filter is not as intuitive as a single EWMA filter. In this work, we look at an alternative way Recursive Least Squares (RLS), to estimate and control the drifting process. EWMA and double-EWMA are shown to be the least squares estimate for locally constant mean model and locally constant linear trend model. Then the recursive least squares with exponential factor is applied to shallow trench isolation etch process to predict the future etch rate. The etch process, which is a critical process in the flash memory manufacturing, is known to suffer from significant etch rate drift due to chamber seasoning. In order to handle the metrology delay, we propose a new time update scheme. RLS with the new time update method gives very good result. The estimate error variance is smaller than that from EWMA, and mean square error decrease more than 10% compared to that from EWMA.

The need for artificial intelligence as an aid in controlling a manufacturing operation

NASA Astrophysics Data System (ADS)

Weyand, J.

AI applications to industrial production and planning are discussed and illustrated with diagrams and drawings. Applications examined include flexible automation of manufacturing processes (robots with open manual control, robots programmable to meet product specifications, self-regulated robots, and robots capable of learning), flexible fault detection and diagnostics, production control, and overall planning and management (product strategies, marketing, determination of development capacity, site selection, project organization, and technology investment strategies). For the case of robots, problems in the design and operation of a state-of-the-art machine-tool cell (for hole boring, milling, and joining) are analyzed in detail.

Survey of the US materials processing and manufacturing in space program

NASA Technical Reports Server (NTRS)

Mckannan, E. C.

1981-01-01

To promote potential commercial applications of low-g technology, the materials processing and manufacturing in space program is structured to: (1) analyze the scientific principles of gravitational effects on processes used in producing materials; (2) apply the research toward the technology used to control production process (on Earth or in space, as appropriate); and (3) establish the legal and managerial framework for commercial ventures. Presently federally funded NASA research is described as well as agreements for privately funded commercial activity, and a proposed academic participation process. The future scope of the program and related capabilities using ground based facilities, aircraft, sounding rockets, and space shuttles are discussed. Areas of interest described include crystal growth; solidification of metals and alloys; containerless processing; fluids and chemical processes (including biological separation processes); and processing extraterrestrial materials.

Monitoring system for the quality assessment in additive manufacturing

NASA Astrophysics Data System (ADS)

Carl, Volker

2015-03-01

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

Monitoring system for the quality assessment in additive manufacturing

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

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

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

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.

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

Bates, Robert; McConnell, Elizabeth

Machining methods across many industries generally require multiple operations to machine and process advanced materials, features with micron precision, and complex shapes. The resulting multiple machining platforms can significantly affect manufacturing cycle time and the precision of the final parts, with a resultant increase in cost and energy consumption. Ultrafast lasers represent a transformative and disruptive technology that removes material with micron precision and in a single step manufacturing process. Such precision results from athermal ablation without modification or damage to the remaining material which is the key differentiator between ultrafast laser technologies and traditional laser technologies or mechanical processes.more » Athermal ablation without modification or damage to the material eliminates post-processing or multiple manufacturing steps. Combined with the appropriate technology to control the motion of the work piece, ultrafast lasers are excellent candidates to provide breakthrough machining capability for difficult-to-machine materials. At the project onset in early 2012, the project team recognized that substantial effort was necessary to improve the application of ultrafast laser and precise motion control technologies (for micromachining difficult-to-machine materials) to further the aggregate throughput and yield improvements over conventional machining methods. The project described in this report advanced these leading-edge technologies thru the development and verification of two platforms: a hybrid enhanced laser chassis and a multi-application testbed.« less

Equilibrium moisture content during storage, manufacturing, and shipping of Bolivian wood products

Treesearch

Omar A. Espinoza; Brian H. Bond; Joseph R. Loferski

2007-01-01

After lumber is kiln-dried it is important to keep its moisture content (MC) as close as possible to its target value during all stages of production to assure final product quality. Knowledge of climate conditions at all stages of the manufacturing process is essential to provide a good control of lumber MC. This study is the first step to provide Bolivian companies...

Physician strives to create lean, clean health care machine. Studies of manufacturing processes may one day help make your practice more efficient.

PubMed

Hill, D

2001-01-01

Elisabeth Hager, MD, MMM, CPE, is teaming up with scientists and industrialists to teach physicians how to apply principles of lean, total-quality manufacturing to their practices. She believes innovation and efficiencies can help doctors resurrect their profession's image and their control over it--and perhaps even reinvent American health care.

Experimentally validated computational modeling of organic binder burnout from green ceramic compacts

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

Ewsuk, K.G.; Cochran, R.J.; Blackwell, B.F.

The properties and performance of a ceramic component is determined by a combination of the materials from which it was fabricated and how it was processed. Most ceramic components are manufactured by dry pressing a powder/binder system in which the organic binder provides formability and green compact strength. A key step in this manufacturing process is the removal of the binder from the powder compact after pressing. The organic binder is typically removed by a thermal decomposition process in which heating rate, temperature, and time are the key process parameters. Empirical approaches are generally used to design the burnout time-temperaturemore » cycle, often resulting in excessive processing times and energy usage, and higher overall manufacturing costs. Ideally, binder burnout should be completed as quickly as possible without damaging the compact, while using a minimum of energy. Process and computational modeling offer one means to achieve this end. The objective of this study is to develop an experimentally validated computer model that can be used to better understand, control, and optimize binder burnout from green ceramic compacts.« less

Traceability of On-Machine Tool Measurement: A Review

PubMed Central

Gomez-Acedo, Eneko; Kortaberria, Gorka; Olarra, Aitor

2017-01-01

Nowadays, errors during the manufacturing process of high value components are not acceptable in driving industries such as energy and transportation. Sectors such as aerospace, automotive, shipbuilding, nuclear power, large science facilities or wind power need complex and accurate components that demand close measurements and fast feedback into their manufacturing processes. New measuring technologies are already available in machine tools, including integrated touch probes and fast interface capabilities. They provide the possibility to measure the workpiece in-machine during or after its manufacture, maintaining the original setup of the workpiece and avoiding the manufacturing process from being interrupted to transport the workpiece to a measuring position. However, the traceability of the measurement process on a machine tool is not ensured yet and measurement data is still not fully reliable enough for process control or product validation. The scientific objective is to determine the uncertainty on a machine tool measurement and, therefore, convert it into a machine integrated traceable measuring process. For that purpose, an error budget should consider error sources such as the machine tools, components under measurement and the interactions between both of them. This paper reviews all those uncertainty sources, being mainly focused on those related to the machine tool, either on the process of geometric error assessment of the machine or on the technology employed to probe the measurand. PMID:28696358

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

PubMed

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

2013-01-01

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

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

1366 Project Automate: Enabling Automation for <$0.10/W High-Efficiency Kerfless Wafers Manufactured in the US

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

Lorenz, Adam

For photovoltaic (PV) manufacturing to thrive in the U.S., there must be an innovative core to the technology. Project Automate builds on 1366’s proprietary Direct Wafer® kerfless wafer technology and aims to unlock the cost and efficiency advantages of thin kerfless wafers. Direct Wafer is an innovative, U.S.-friendly (efficient, low-labor content) manufacturing process that addresses the main cost barrier limiting silicon PV cost-reductions – the 35-year-old grand challenge of manufacturing quality wafers (40% of the cost of modules) without the cost and waste of sawing. This simple, scalable process will allow 1366 to manufacture “drop-in” replacement wafers for the $10more » billion silicon PV wafer market at 50% of the cost, 60% of the capital, and 30% of the electricity of conventional casting and sawing manufacturing processes. This SolarMat project developed the Direct Wafer processes’ unique capability to tailor the shape of wafers to simultaneously make thinner AND stronger wafers (with lower silicon usage) that enable high-efficiency cell architectures. By producing wafers with a unique target geometry including a thick border (which determines handling characteristics) and thin interior regions (which control light capture and electron transport and therefore determine efficiency), 1366 can simultaneously improve quality and lower cost (using less silicon).« less

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

Quality control in the development of coagulation factor concentrates.

PubMed

Snape, T J

1987-01-01

Limitation of process change is a major factor contributing to assurance of quality in pharmaceutical manufacturing. This is particularly true in the manufacture of coagulation factor concentrates, for which presumptive testing for poorly defined product characteristics is an integral feature of finished product quality control. The development of new or modified preparations requires that this comfortable position be abandoned, and that the effect on finished product characteristics of changes to individual process steps (and components) be assessed. The degree of confidence in the safety and efficacy of the new product will be determined by, amongst other things, the complexity of the process alteration and the extent to which the results of finished product tests can be considered predictive. The introduction of a heat-treatment step for inactivation of potential viral contaminants in coagulation factor concentrates presents a significant challenge in both respects, quite independent of any consideration of assessment of the effectiveness of the viral inactivation step. These interactions are illustrated by some of the problems encountered with terminal dry heat-treatment (72 h. at 80 degrees C) of factor VIII and prothrombin complex concentrates manufactured by the Blood Products Laboratory.

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

PubMed

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

2016-12-01

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

Design of control system for optical fiber drawing machine driven by double motor

NASA Astrophysics Data System (ADS)

Yu, Yue Chen; Bo, Yu Ming; Wang, Jun

2018-01-01

Micro channel Plate (MCP) is a kind of large-area array electron multiplier with high two-dimensional spatial resolution, used as high-performance night vision intensifier. The high precision control of the fiber is the key technology of the micro channel plate manufacturing process, and it was achieved by the control of optical fiber drawing machine driven by dual-motor in this paper. First of all, utilizing STM32 chip, the servo motor drive and control circuit was designed to realize the dual motor synchronization. Secondly, neural network PID control algorithm was designed for controlling the fiber diameter fabricated in high precision; Finally, the hexagonal fiber was manufactured by this system and it shows that multifilament diameter accuracy of the fiber is +/- 1.5μm.

21 CFR 110.80 - Processes and controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... safe and of adequate sanitary quality. (12) Batters, breading, sauces, gravies, dressings, and other...) Cooling to an adequate temperature during manufacturing. (vi) Disposing of batters at appropriate...

Structural Integrity of an Electron Beam Melted Titanium Alloy.

PubMed

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

2016-06-14

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

[Research on optimal modeling strategy for licorice extraction process based on near-infrared spectroscopy technology].

PubMed

Wang, Hai-Xia; Suo, Tong-Chuan; Yu, He-Shui; Li, Zheng

2016-10-01

The manufacture of traditional Chinese medicine (TCM) products is always accompanied by processing complex raw materials and real-time monitoring of the manufacturing process. In this study, we investigated different modeling strategies for the extraction process of licorice. Near-infrared spectra associate with the extraction time was used to detemine the states of the extraction processes. Three modeling approaches, i.e., principal component analysis (PCA), partial least squares regression (PLSR) and parallel factor analysis-PLSR (PARAFAC-PLSR), were adopted for the prediction of the real-time status of the process. The overall results indicated that PCA, PLSR and PARAFAC-PLSR can effectively detect the errors in the extraction procedure and predict the process trajectories, which has important significance for the monitoring and controlling of the extraction processes. Copyright© by the Chinese Pharmaceutical Association.

Optimized method for manufacturing large aspheric surfaces

NASA Astrophysics Data System (ADS)

Zhou, Xusheng; Li, Shengyi; Dai, Yifan; Xie, Xuhui

2007-12-01

Aspheric optics are being used more and more widely in modern optical systems, due to their ability of correcting aberrations, enhancing image quality, enlarging the field of view and extending the range of effect, while reducing the weight and volume of the system. With optical technology development, we have more pressing requirement to large-aperture and high-precision aspheric surfaces. The original computer controlled optical surfacing (CCOS) technique cannot meet the challenge of precision and machining efficiency. This problem has been thought highly of by researchers. Aiming at the problem of original polishing process, an optimized method for manufacturing large aspheric surfaces is put forward. Subsurface damage (SSD), full aperture errors and full band of frequency errors are all in control of this method. Lesser SSD depth can be gained by using little hardness tool and small abrasive grains in grinding process. For full aperture errors control, edge effects can be controlled by using smaller tools and amendment model with material removal function. For full band of frequency errors control, low frequency errors can be corrected with the optimized material removal function, while medium-high frequency errors by using uniform removing principle. With this optimized method, the accuracy of a K9 glass paraboloid mirror can reach rms 0.055 waves (where a wave is 0.6328μm) in a short time. The results show that the optimized method can guide large aspheric surface manufacturing effectively.

Outgassing of Out-of-Autoclave Composite Primary Structures for Small Satellites

NASA Astrophysics Data System (ADS)

Komus, Alastair

Out-of-autoclave vacuum-bagged-only (VBO) processing is capable of producing lower cost composite primary structures for small satellites than autoclave processing. However, the outgassing performance of VBO structures in a vacuum environment has not been examined. Panels were manufactured from CYCOM 5320-1 and TC275-1 carbon fiber/epoxy prepreg using VBO processing. The humidity level, pre-cure dwell time, and cure cycle parameters were varied during manufacturing. The degree of cure and glass transition temperature were shown to increase with increasing oven temperature. Processing humidity levels and the length of pre-cure dwell times had no discernable effect on the total mass loss (TML) and collected volatile condensable material (CVCM) that were outgassed under vacuum. Instead the TML was controlled by moisture saturation after manufacturing. Fourier transform infrared spectroscopy showed that epoxy oligomers were the primary CVCM. The study showed the VBO laminates had outgassing values that were comparable to the autoclave-cured laminates.

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.

Structural Color for Additive Manufacturing: 3D-Printed Photonic Crystals from Block Copolymers.

PubMed

Boyle, Bret M; French, Tracy A; Pearson, Ryan M; McCarthy, Blaine G; Miyake, Garret M

2017-03-28

The incorporation of structural color into 3D printed parts is reported, presenting an alternative to the need for pigments or dyes for colored parts produced through additive manufacturing. Thermoplastic build materials composed of dendritic block copolymers were designed, synthesized, and used to additively manufacture plastic parts exhibiting structural color. The reflection properties of the photonic crystals arise from the periodic nanostructure formed through block copolymer self-assembly during polymer processing. The wavelength of reflected light could be tuned across the visible spectrum by synthetically controlling the block copolymer molecular weight and manufacture parts that reflected violet, green, or orange light with the capacity to serve as selective optical filters and light guides.

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

The new production theory for health care through clinical reengineering: a study of clinical guidelines--Part II.

PubMed

Sharp, J R

1995-01-01

In Part I of this two-part article, in the December 1994 issue of the journal, the author discussed the manufacturing theories of Peter Drucker in terms of their applicability for the health care field. He concluded that Drucker's four principles and practices of manufacturing--statistical quality control, manufacturing accounting, modular organization, and systems approach--do have application to the health care system. Clinical guidelines, a variation on the Drucker theory, are a specific example of the manufacturing process in health. The performance to date of some guidelines and their implications for the health care reform debate are discussed in Part II of the article.

A flexible architecture for advanced process control solutions

NASA Astrophysics Data System (ADS)

Faron, Kamyar; Iourovitski, Ilia

2005-05-01

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

Characterization of a Saccharomyces cerevisiae fermentation process for production of a therapeutic recombinant protein using a multivariate Bayesian approach.

PubMed

Fu, Zhibiao; Baker, Daniel; Cheng, Aili; Leighton, Julie; Appelbaum, Edward; Aon, Juan

2016-05-01

The principle of quality by design (QbD) has been widely applied to biopharmaceutical manufacturing processes. Process characterization is an essential step to implement the QbD concept to establish the design space and to define the proven acceptable ranges (PAR) for critical process parameters (CPPs). In this study, we present characterization of a Saccharomyces cerevisiae fermentation process using risk assessment analysis, statistical design of experiments (DoE), and the multivariate Bayesian predictive approach. The critical quality attributes (CQAs) and CPPs were identified with a risk assessment. The statistical model for each attribute was established using the results from the DoE study with consideration given to interactions between CPPs. Both the conventional overlapping contour plot and the multivariate Bayesian predictive approaches were used to establish the region of process operating conditions where all attributes met their specifications simultaneously. The quantitative Bayesian predictive approach was chosen to define the PARs for the CPPs, which apply to the manufacturing control strategy. Experience from the 10,000 L manufacturing scale process validation, including 64 continued process verification batches, indicates that the CPPs remain under a state of control and within the established PARs. The end product quality attributes were within their drug substance specifications. The probability generated with the Bayesian approach was also used as a tool to assess CPP deviations. This approach can be extended to develop other production process characterization and quantify a reliable operating region. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:799-812, 2016. © 2016 American Institute of Chemical Engineers.

Thin EFG octagons

NASA Astrophysics Data System (ADS)

Kalejs, J. P.

1994-03-01

This report describes work to advance the manufacturing line capabilities in crystal growth and laser cutting of Mobil Solar's unique edge-defined film-fed growth (EFG) octagon technology and to reduce the manufacturing costs of 10 cm x 10 cm polycrystalline silicon EFG wafers. The report summarizes the significant technical improvements in EFG technology achieved in the first 6 months of the PVMaT Phase 2 and the success in meeting program milestones. Technical results are reported for each of the three main pregrain areas: Task 5 -- Thin octagon growth (crystal growth) to reduce the thickness of the octagon to 200 microns; Task 6 -- Laser cutting-to improve the laser cutting process so as to produce wafers with decreased laser cutting damage at increased wafer throughput rates; and Task 7 -- Process control and product specification to implement advanced strategies in crystal growth process control and productivity designed to increase wafer yields.

21 CFR 1005.25 - Service of process on manufacturers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Subchapter C—Electronic Product Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly the Radiation Control for Health and Safety Act of 1968) (21 U.S.C. 360mm(d)) and this section. The agent may be... Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly the Radiation Control for Health and...

21 CFR 1005.25 - Service of process on manufacturers.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Subchapter C—Electronic Product Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly the Radiation Control for Health and Safety Act of 1968) (21 U.S.C. 360mm(d)) and this section. The agent may be... Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly the Radiation Control for Health and...

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

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

Ebert, Jon Llyod

This Small Business Innovative Research (SBIR) Phase I project will demonstrate the feasibility of an innovative temperature control technology for Metal-Organic Chemical Vapor Deposition (MOCVD) process used in the fabrication of Multi-Quantum Well (MQW) LEDs. The proposed control technology has the strong potential to improve both throughput and performance quality of the manufactured LED. The color of the light emitted by an LED is a strong function of the substrate temperature during the deposition process. Hence, accurate temperature control of the MOCVD process is essential for ensuring that the LED performance matches the design specification. The Gallium Nitride (GaN) epitaxymore » process involves depositing multiple layers at different temperatures. Much of the recipe time is spent ramping from one process temperature to another, adding significant overhead to the production time. To increase throughput, the process temperature must transition over a range of several hundred degrees Centigrade many times with as little overshoot and undershoot as possible, in the face of several sources of process disturbance such as changing emissivities. Any throughput increase achieved by faster ramping must also satisfy the constraint of strict temperature uniformity across the carrier so that yield is not affected. SC Solutions is a leading supplier of embedded real-time temperature control technology for MOCVD systems used in LED manufacturing. SC’s Multiple Input Multiple Output (MIMO) temperature controllers use physics-based models to achieve the performance demanded by our customers. However, to meet DOE’s ambitious goals of cost reduction of LED products, a new generation of temperature controllers has to be developed. SC believes that the proposed control technology will be made feasible by the confluence of mathematical formulation as a convex optimization problem, new efficient and scalable algorithms, and the increase in computational power available for real-time control.« less

77 FR 2957 - Application for Manufacturing Authority, Liberty Pumps, Inc. (Submersible and Water Pumps...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-20

..., mechanical seals, electric motors, transformers, capacitors, switches, electronic components, integrated circuits, process controllers, printed circuit assemblies, electrical components, and measuring instruments...

In-Process Thermal Imaging of the Electron Beam Freeform Fabrication Process

NASA Technical Reports Server (NTRS)

Taminger, Karen M.; Domack, Christopher S.; Zalameda, Joseph N.; Taminger, Brian L.; Hafley, Robert A.; Burke, Eric R.

2016-01-01

Researchers at NASA Langley Research Center have been developing the Electron Beam Freeform Fabrication (EBF3) metal additive manufacturing process for the past 15 years. In this process, an electron beam is used as a heat source to create a small molten pool on a substrate into which wire is fed. The electron beam and wire feed assembly are translated with respect to the substrate to follow a predetermined tool path. This process is repeated in a layer-wise fashion to fabricate metal structural components. In-process imaging has been integrated into the EBF3 system using a near-infrared (NIR) camera. The images are processed to provide thermal and spatial measurements that have been incorporated into a closed-loop control system to maintain consistent thermal conditions throughout the build. Other information in the thermal images is being used to assess quality in real time by detecting flaws in prior layers of the deposit. NIR camera incorporation into the system has improved the consistency of the deposited material and provides the potential for real-time flaw detection which, ultimately, could lead to the manufacture of better, more reliable components using this additive manufacturing process.

Materials Safety - Not just Flammability and Toxic Offgassing

NASA Technical Reports Server (NTRS)

Pedley, Michael D.

2007-01-01

For many years, the safety community has focused on a limited subset of materials and processes requirements as key to safety: Materials flammability, Toxic offgassing, Propellant compatibility, Oxygen compatibility, and Stress-corrosion cracking. All these items are important, but the exclusive focus on these items neglects many other items that are equally important to materials safety. Examples include (but are not limited to): 1. Materials process control -- proper qualification and execution of manufacturing processes such as structural adhesive bonding, welding, and forging are crucial to materials safety. Limitation of discussions on materials process control to an arbitrary subset of processes, known as "critical processes" is a mistake, because any process where the quality of the product cannot be verified by inspection can potentially result in unsafe hardware 2 Materials structural design allowables -- development of valid design allowables when none exist in the literature requires extensive testing of multiple lots of materials and is extremely expensive. But, without valid allowables, structural analysis cannot verify structural safety 3. Corrosion control -- All forms of corrosion, not just stress corrosion, can affect structural integrity of hardware 4. Contamination control during ground processing -- contamination control is critical to manufacturing processes such as adhesive bonding and also to elimination foreign objects and debris (FOD) that are hazardous to the crew of manned spacecraft in microgravity environments. 5. Fasteners -- Fastener design, the use of verifiable secondary locking features, and proper verification of fastener torque are essential for proper structural performance This presentation discusses some of these key factors and the importance of considering them in ensuring the safety of space hardware.

Study on contaminants on flight and other critical surfaces

NASA Technical Reports Server (NTRS)

Workman, Gary L.; Hughes, Charles; Arendale, William F.

1994-01-01

The control of surface contamination in the manufacture of space hardware can become a critical step in the production process. Bonded surfaces have been shown to be affected markedly by contamination. It is important to insure surface cleanliness by preventing contamination prior to bonding. In this vein techniques are needed in which the contamination which may affect bonding are easily found and removed. Likewise, if materials which are detrimental to bonding are not easily removed, then they should not be used in the manufacturing process. This study will address the development of techniques to locate and quantify contamination levels of particular contaminants. With other data becoming available from MSFC and its contractors, this study will also quantify how certain contaminants affect bondlines and how easily they are removed in manufacturing.

The research on visual industrial robot which adopts fuzzy PID control algorithm

NASA Astrophysics Data System (ADS)

Feng, Yifei; Lu, Guoping; Yue, Lulin; Jiang, Weifeng; Zhang, Ye

2017-03-01

The control system of six degrees of freedom visual industrial robot based on the control mode of multi-axis motion control cards and PC was researched. For the variable, non-linear characteristics of industrial robot`s servo system, adaptive fuzzy PID controller was adopted. It achieved better control effort. In the vision system, a CCD camera was used to acquire signals and send them to video processing card. After processing, PC controls the six joints` motion by motion control cards. By experiment, manipulator can operate with machine tool and vision system to realize the function of grasp, process and verify. It has influence on the manufacturing of the industrial robot.

Changes in microbial composition and the prevalence of foodborne pathogens in crab marinated in soy sauce produced by six manufacturing plants.

PubMed

Kim, Sun Ae; Choi, Eun Sook; Kim, Nam Hee; Kim, Hye Won; Lee, Na Young; Cho, Tae Jin; Jo, Jun Il; Kim, Soon Han; Lee, Soon Ho; Ha, Sang Do; Rhee, Min Suk

2017-04-01

The present study examined the changes in microbiological composition during the production process of crab marinated in soy sauce, potential microbial hazards, potential contamination routes and effective critical control points. Crab and soy sauce samples were obtained from six different manufacturing plants at different stages, and their microbiological content was comprehensively assessed by quantitative and qualitative analyses. The results revealed the following: (1) the final products contained 4.0 log colony-forming units (CFU) g -1 aerobic plate counts (APCs) and 1.1 log CFU g -1 coliforms, which may have been introduced from the raw materials (the level of APCs in raw crab and soy sauce mixed with other ingredients was 3.8 log CFU g -1 and 4.0 log CFU mL -1 respectively); (2) marination of crab in soy sauce may allow cross-contamination by coliforms; (3) only Bacillus cereus and Staphylococcus aureus were qualitatively detected in samples at different stages of manufacture (detection rate of 28 and 5.6% respectively), and these bacteria may impact the microbiological quality and safety of crab marinated in soy sauce; and (4) bacterial counts were either maintained or increased during the manufacturing process (suggesting that no particular step can be targeted to reduce bacterial counts). Proper management of raw materials and the marination process are effective critical control points, and alternative interventions may be needed to control bacterial quantity. The results provide important basic information about the production of crab marinated in soy sauce and may facilitate effective implementation of sanitary management practices in related industries and research fields. © 2016 Society of Chemical Industry. © 2016 Society of Chemical Industry.

Simultaneously enhanced strength and ductility for 3D-printed stainless steel 316L by selective laser melting

NASA Astrophysics Data System (ADS)

Sun, Zhongji; Tan, Xipeng; Tor, Shu Beng; Chua, Chee Kai

2018-04-01

Laser-based powder-bed fusion additive manufacturing or three-dimensional printing technology has gained tremendous attention due to its controllable, digital, and automated manufacturing process, which can afford a refined microstructure and superior strength. However, it is a major challenge to additively manufacture metal parts with satisfactory ductility and toughness. Here we report a novel selective laser melting process to simultaneously enhance the strength and ductility of stainless steel 316L by in-process engineering its microstructure into a <011> crystallographic texture. We find that the tensile strength and ductility of SLM-built stainless steel 316L samples could be enhanced by 16% and 40% respectively, with the engineered <011> textured microstructure compared to the common <001> textured microstructure. This is because the favorable nano-twinning mechanism was significantly more activated in the <011> textured stainless steel 316L samples during plastic deformation. In addition, kinetic simulations were performed to unveil the relationship between the melt pool geometry and crystallographic texture. The new additive manufacturing strategy of engineering the crystallographic texture can be applied to other metals and alloys with twinning-induced plasticity. This work paves the way to additively manufacture metal parts with high strength and high ductility.

Blowing Polymer Bubbles in an Acoustic Levitator

NASA Technical Reports Server (NTRS)

Lee, M. C.

1985-01-01

In new manufacturing process, small gas-filled polymer shells made by injecting gas directly into acoustically levitated prepolymer drops. New process allows sufficient time for precise control of shell geometry. Applications foreseen in fabrication of deuterium/tritium-filled fusion targets and in pharmaceutical coatings. New process also useful in glass blowing and blow molding.

Polyblends of LDPE with EVA

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

Deanin, R.D.; Hou, T.J.A.

1993-12-31

Melt processability of LDPE was improved by blending with EVA copolymers containing 10-28% VA. Softening of modules was controlled primarily by overall VA content of the blends. Tensile necking was converted to smooth rubbery elongation by adding larger amounts of VA. Transparency was produced by adding EVA containing 10% VA and then stretching the polyblend film. These parameters give the film manufacturer wide control over processability and properties.

Using the scanning electron microscope on the production line to assure quality semiconductors

NASA Technical Reports Server (NTRS)

Adolphsen, J. W.; Anstead, R. J.

1972-01-01

The use of the scanning electron microscope to detect metallization defects introduced during batch processing of semiconductor devices is discussed. A method of determining metallization integrity was developed which culminates in a procurement specification using the scanning microscope on the production line as a quality control tool. Batch process control of the metallization operation is monitored early in the manufacturing cycle.

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

Interactive Video: Meeting the Ford Challenge.

ERIC Educational Resources Information Center

Copeland, Peter

Many companies using Statistical Process Control (SPC) in their manufacturing processes have found that, despite the training difficulties presented by the technique, the rewards of successful SPC include increased productivity, quality, and market leadership. The Ford Motor Company has developed its SPC training with interactive video, which…