A Process Management System for Networked Manufacturing

NASA Astrophysics Data System (ADS)

Liu, Tingting; Wang, Huifen; Liu, Linyan

With the development of computer, communication and network, networked manufacturing has become one of the main manufacturing paradigms in the 21st century. Under the networked manufacturing environment, there exist a large number of cooperative tasks susceptible to alterations, conflicts caused by resources and problems of cost and quality. This increases the complexity of administration. Process management is a technology used to design, enact, control, and analyze networked manufacturing processes. It supports efficient execution, effective management, conflict resolution, cost containment and quality control. In this paper we propose an integrated process management system for networked manufacturing. Requirements of process management are analyzed and architecture of the system is presented. And a process model considering process cost and quality is developed. Finally a case study is provided to explain how the system runs efficiently.

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...

78 FR 65667 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-01

... Request; Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing... chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that FDA has determined will... Pharmaceutical Product Quality Initiative and its risk-based approach to CMC review, FDA has evaluated the types...

21 CFR 111.105 - What must quality control personnel do?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What must quality control personnel do? 111.105... for Quality Control § 111.105 What must quality control personnel do? Quality control personnel must... manufacturing record. To do so, quality control personnel must perform operations that include: (a) Approving or...

[The Contribution of GMP-grade Hospital Preparation to Translational Research].

PubMed

Yonezawa, Atsushi; Kajiwara, Moto; Minami, Ikuko; Omura, Tomohiro; Nakagawa, Shunsaku; Matsubara, Kazuo

2015-01-01

Translational research is important for applying the outcomes of basic research studies to practical medical treatments. In exploratory early-phase clinical trials for an innovative therapy, researchers should generally manufacture investigational agents by themselves. To provide investigational agents with safety and high quality in clinical studies, appropriate production management and quality control are essential. In the Department of Pharmacy of Kyoto University Hospital, a manufacturing facility for sterile drugs was established, independent of existing manufacturing facilities. Manuals on production management and quality control were developed according to Good Manufacturing Practices (GMP) for Investigational New Drugs (INDs). Advanced clinical research has been carried out using investigational agents manufactured in our facility. These achievements contribute to both the safety of patients and the reliability of clinical studies. In addition, we are able to do licensing-out of our technique for the manufacture of investigational drugs. In this symposium, we will introduce our GMP grade manufacturing facility for sterile drugs and discuss the role of GMP grade hospital preparation in translational research.

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.

Monitoring the sensory quality of canned white asparagus through cluster analysis.

PubMed

Arana, Inés; Ibañez, Francisco C; Torre, Paloma

2016-05-01

White asparagus is one of the 30 vegetables most consumed in the world. This paper unifies the stages of their sensory quality control. The aims of this work were to describe the sensory properties of canned white asparagus and their quality control and to evaluate the applicability of agglomerative hierarchical clustering (AHC) for classifying and monitoring the sensory quality of manufacturers. Sixteen sensory descriptors and their evaluation technique were defined. The sensory profile of canned white asparagus was high flavor characteristic, little acidity and bitterness, medium firmness and very light fibrosity, among other characteristics. The dendrogram established groups of manufacturers that had similar scores in the same set of descriptors, and each cluster grouped the manufacturers that had a similar quality profile. The sensory profile of canned white asparagus was clearly defined through the intensity evaluation of 16 descriptors, and the sensory quality report provided to the manufacturers is in detail and of easy interpretation. AHC grouped the manufacturers according to the highest quality scores in certain descriptors and is a useful tool because it is very visual. © 2015 Society of Chemical Industry. © 2015 Society of Chemical Industry.

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.

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.

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

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Quality control data requirements; prime... describing assigned responsibilities and delegated authority of the quality control organization, together with a chart indicating the functional relationship of the quality control organization to management...

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.

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.

Kodak Skills Enhancement Program Curriculum: Math for Manufacturing and Quality Control. Report No. AEP-93-01.

ERIC Educational Resources Information Center

Beaudin, Bart P.; And Others

This teacher's guide is intended for use in helping Kodak Corporation employees develop the basic mathematics skills required to perform the manufacturing and quality control tasks expected of them. The following topics are covered in the first five modules: the four basic functions (adding, subtracting, multiplying, and dividing), calculations…

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

Code of Federal Regulations, 2010 CFR

2010-01-01

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

[Pharmaceutical product quality control and good manufacturing practices].

PubMed

Hiyama, Yukio

2010-01-01

This report describes the roles of Good Manufacturing Practices (GMP) in pharmaceutical product quality control. There are three keys to pharmaceutical product quality control. They are specifications, thorough product characterization during development, and adherence to GMP as the ICH Q6A guideline on specifications provides the most important principles in its background section. Impacts of the revised Pharmaceutical Affairs Law (rPAL) which became effective in 2005 on product quality control are discussed. Progress of ICH discussion for Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) are reviewed. In order to reconstruct GMP guidelines and GMP inspection system in the regulatory agencies under the new paradigm by rPAL and the ICH, a series of Health Science studies were conducted. For GMP guidelines, product GMP guideline, technology transfer guideline, laboratory control guideline and change control system guideline were written. For the GMP inspection system, inspection check list, inspection memo and inspection scenario were proposed also by the Health Science study groups. Because pharmaceutical products and their raw materials are manufactured and distributed internationally, collaborations with other national authorities are highly desired. In order to enhance the international collaborations, consistent establishment of GMP inspection quality system throughout Japan will be essential.

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

NASA Astrophysics Data System (ADS)

Hussein, Abdullahi; Cheng, Kai

2016-10-01

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

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.

49 CFR 179.7 - Quality assurance program.

Code of Federal Regulations, 2010 CFR

2010-10-01

... means to detect any nonconformity in the manufacturing, repair, inspection, testing, and qualification... quality control personnel. (3) Procedures to ensure that the latest applicable drawings, design calculations, specifications, and instructions are used in manufacture, inspection, testing, and repair. (4...

46 CFR 164.120-11 - Production quality control requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 6 2014-10-01 2014-10-01 false Production quality control requirements. 164.120-11... Rescue Boats § 164.120-11 Production quality control requirements. The resin manufacturer must institute a quality control procedure to ensure that all Coast Guard-accepted resin is produced to the same...

46 CFR 164.120-11 - Production quality control requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 6 2012-10-01 2012-10-01 false Production quality control requirements. 164.120-11... Rescue Boats § 164.120-11 Production quality control requirements. The resin manufacturer must institute a quality control procedure to ensure that all Coast Guard-accepted resin is produced to the same...

46 CFR 164.120-11 - Production quality control requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 6 2013-10-01 2013-10-01 false Production quality control requirements. 164.120-11... Rescue Boats § 164.120-11 Production quality control requirements. The resin manufacturer must institute a quality control procedure to ensure that all Coast Guard-accepted resin is produced to the same...

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 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.

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...

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...

Current good manufacturing practices, quality control procedures, quality factors, notification requirements, and records and reports, for infant formula. Final rule.

PubMed

2014-06-10

The Food and Drug Administration (FDA or we) is issuing a final rule that adopts, with some modifications, the interim final rule (IFR) entitled "Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula'' (February 10, 2014). This final rule affirms the IFR's changes to FDA's regulations and provides additional modifications and clarifications. The final rule also responds to certain comments submitted in response to the request for comments in the IFR.

Flat conductor cable design, manufacture, and installation

NASA Technical Reports Server (NTRS)

Angele, W.; Hankins, J. D.

1973-01-01

Pertinent information for hardware selection, design, manufacture, and quality control necessary for flat conductor cable interconnecting harness application is presented. Comparisons are made between round wire cable and flat conductor cable. The flat conductor cable interconnecting harness systems show major cost, weight, and space savings, plus increased system performance and reliability. The design application section includes electrical characteristics, harness design and development, and a full treatise on EMC considerations. Manufacturing and quality control sections pertain primarily to the developed conductor-contact connector system and special flat conductor cable to round wire cable transitions.

76 FR 42558 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Control of Nitrogen...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-19

... from Cement Manufacturing), for Portland cement kilns during the ozone season, from May 1 through... C (Emissions of NO X from Cement Manufacturing), for the control of NO X emissions from Portland... 145--Interstate Pollution Transport Reduction Subchapter C--Emissions of NOX From Cement Manufacturing...

21 CFR 864.9650 - Quality control kit for blood banking reagents.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Quality control kit for blood banking reagents... Manufacture Blood and Blood Products § 864.9650 Quality control kit for blood banking reagents. (a) Identification. A quality control kit for blood banking reagents is a device that consists of sera, cells...

21 CFR 864.9650 - Quality control kit for blood banking reagents.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Quality control kit for blood banking reagents... Manufacture Blood and Blood Products § 864.9650 Quality control kit for blood banking reagents. (a) Identification. A quality control kit for blood banking reagents is a device that consists of sera, cells...

21 CFR 864.9650 - Quality control kit for blood banking reagents.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Quality control kit for blood banking reagents... Manufacture Blood and Blood Products § 864.9650 Quality control kit for blood banking reagents. (a) Identification. A quality control kit for blood banking reagents is a device that consists of sera, cells...

21 CFR 864.9650 - Quality control kit for blood banking reagents.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Quality control kit for blood banking reagents... Manufacture Blood and Blood Products § 864.9650 Quality control kit for blood banking reagents. (a) Identification. A quality control kit for blood banking reagents is a device that consists of sera, cells...

32 CFR 507.6 - Authority to manufacture.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 3 2010-07-01 2010-07-01 true Authority to manufacture. 507.6 Section 507.6... PUBLIC RELATIONS MANUFACTURE AND SALE OF DECORATIONS, MEDALS, BADGES, INSIGNIA, COMMERCIAL USE OF HERALDIC DESIGNS AND HERALDIC QUALITY CONTROL PROGRAM Manufacture and Sale of Decorations, Medals, Badges...

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

40 CFR 63.10 - Recordkeeping and reporting requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... alternative reporting arrangements, in advance, with the permitting authority in that State. Procedures... manufacturer(s) and model number(s); (G) The date of the latest CMS certification or audit; (H) The total..., nonmonitoring equipment malfunctions, quality assurance/quality control calibrations, other known causes, and...

48 CFR 9904.403-60 - Illustrations.

Code of Federal Regulations, 2013 CFR

2013-10-01

... personnel, labor hours, payroll, number of hires. 2. Manufacturing policies, (quality control, industrial engineering, production, scheduling, tooling, inspection and testing, etc 2. Manufacturing cost input, manufacturing direct labor. 3. Engineering policies 3. Total engineering costs, engineering direct labor, number...

48 CFR 9904.403-60 - Illustrations.

Code of Federal Regulations, 2014 CFR

2014-10-01

... personnel, labor hours, payroll, number of hires. 2. Manufacturing policies, (quality control, industrial engineering, production, scheduling, tooling, inspection and testing, etc 2. Manufacturing cost input, manufacturing direct labor. 3. Engineering policies 3. Total engineering costs, engineering direct labor, number...

48 CFR 9904.403-60 - Illustrations.

Code of Federal Regulations, 2012 CFR

2012-10-01

... personnel, labor hours, payroll, number of hires. 2. Manufacturing policies, (quality control, industrial engineering, production, scheduling, tooling, inspection and testing, etc 2. Manufacturing cost input, manufacturing direct labor. 3. Engineering policies 3. Total engineering costs, engineering direct labor, number...

An RFID-Based Manufacturing Control Framework for Loosely Coupled Distributed Manufacturing System Supporting Mass Customization

NASA Astrophysics Data System (ADS)

Chen, Ruey-Shun; Tsai, Yung-Shun; Tu, Arthur

In this study we propose a manufacturing control framework based on radio-frequency identification (RFID) technology and a distributed information system to construct a mass-customization production process in a loosely coupled shop-floor control environment. On the basis of this framework, we developed RFID middleware and an integrated information system for tracking and controlling the manufacturing process flow. A bicycle manufacturer was used to demonstrate the prototype system. The findings of this study were that the proposed framework can improve the visibility and traceability of the manufacturing process as well as enhance process quality control and real-time production pedigree access. Using this framework, an enterprise can easily integrate an RFID-based system into its manufacturing environment to facilitate mass customization and a just-in-time production model.

21 CFR 106.30 - Finished product evaluation.

Code of Federal Regulations, 2013 CFR

2013-04-01

... FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for... maintenance of nutrient content throughout the shelf life of the product. (c) The manufacturer shall evaluate... the biological quality of the protein. A protein biological quality analysis is not necessary for a...

21 CFR 106.30 - Finished product evaluation.

Code of Federal Regulations, 2011 CFR

2011-04-01

... FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for... maintenance of nutrient content throughout the shelf life of the product. (c) The manufacturer shall evaluate... the biological quality of the protein. A protein biological quality analysis is not necessary for a...

21 CFR 106.30 - Finished product evaluation.

Code of Federal Regulations, 2012 CFR

2012-04-01

... FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for... maintenance of nutrient content throughout the shelf life of the product. (c) The manufacturer shall evaluate... the biological quality of the protein. A protein biological quality analysis is not necessary for a...

21 CFR 106.30 - Finished product evaluation.

Code of Federal Regulations, 2010 CFR

2010-04-01

... FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for... maintenance of nutrient content throughout the shelf life of the product. (c) The manufacturer shall evaluate... the biological quality of the protein. A protein biological quality analysis is not necessary for a...

QUALITY ASSURANCE AND QUALITY CONTROL FOR WASTE CONTAINMENT FACILITIES. Project Summary

EPA Science Inventory

It is generally agreed that both quality assurance (QA) and quality control (QC) are essential to the proper installation and eventual performance of environmentally safe and secure waste containment systems. Even further, there are both manufacturing and construction aspects to...

The Manufacture, Shipping and Receiving and Quality Control of Rodent Bedding Materials

NASA Technical Reports Server (NTRS)

Kraft, Lisbeth M.

1980-01-01

The criteria for rodent bedding and nesting materials are discussed. The literature is reviewed regarding sources of bedding materials, manufacturing methods, quality control, procedures (microbiological, physical and chemical), storage, methods, shipment, methods of use and disposal, current knowledge concerning bedding effects on animals as related to research and testing and legal aspects. Future needs, especially with respect to the promulgation of standards, also are addressed.

21 CFR 106.90 - Coding.

Code of Federal Regulations, 2010 CFR

2010-04-01

... CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content of Infant Formulas § 106.90 Coding. The manufacturer shall code all infant formulas in conformity...

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.

32 CFR 507.9 - Articles not authorized for manufacture or sale.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 3 2010-07-01 2010-07-01 true Articles not authorized for manufacture or sale... CIVIL AUTHORITIES AND PUBLIC RELATIONS MANUFACTURE AND SALE OF DECORATIONS, MEDALS, BADGES, INSIGNIA, COMMERCIAL USE OF HERALDIC DESIGNS AND HERALDIC QUALITY CONTROL PROGRAM Manufacture and Sale of Decorations...

32 CFR 507.8 - Articles authorized for manufacture and sale.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 3 2010-07-01 2010-07-01 true Articles authorized for manufacture and sale. 507... CIVIL AUTHORITIES AND PUBLIC RELATIONS MANUFACTURE AND SALE OF DECORATIONS, MEDALS, BADGES, INSIGNIA, COMMERCIAL USE OF HERALDIC DESIGNS AND HERALDIC QUALITY CONTROL PROGRAM Manufacture and Sale of Decorations...

Manufacturing Squares: An Integrative Statistical Process Control Exercise

ERIC Educational Resources Information Center

Coy, Steven P.

2016-01-01

In the exercise, students in a junior-level operations management class are asked to manufacture a simple product. Given product specifications, they must design a production process, create roles and design jobs for each team member, and develop a statistical process control plan that efficiently and effectively controls quality during…

21 CFR 106.30 - Finished product evaluation.

Code of Federal Regulations, 2014 CFR

2014-04-01

... FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES (Eff. until 7-10-14) Quality Control... the maintenance of nutrient content throughout the shelf life of the product. (c) The manufacturer... nutrients, and the biological quality of the protein. A protein biological quality analysis is not necessary...

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.

Quality Control Technician Curriculum. An Elusive Butterfly.

ERIC Educational Resources Information Center

Holler, Michael

Defining and developing a quality control technician curriculum for an associate degree program is a difficult and puzzling job. There are as many definitions of quality control and curriculum ideas as there are educators asked. However, one could start by dividing the field into its major areas--heavy manufacturing, maintenance, research, and…

21 CFR 864.9650 - Quality control kit for blood banking reagents.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Quality control kit for blood banking reagents... SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Products Used In Establishments That Manufacture Blood and Blood Products § 864.9650 Quality control kit for blood banking reagents. (a...

Some Inspection Methods for Quality Control and In-service Inspection of GLARE

NASA Astrophysics Data System (ADS)

Sinke, J.

2003-07-01

Quality control of materials and structures is an important issue, also for GLARE. During the manufacturing stage the processes and materials should be monitored and checked frequently in order to obtain a qualified product. During the operation of the aircraft, frequent monitoring and inspections are performed to maintain the quality at a prescribed level. Therefore, in-service inspection methods are applied, and when necessary repair activities are conducted. For the quality control of the GLARE panels and components during manufacturing, the C-scan method proves to be an effective tool. For in-service inspection the Eddy Current Method is one of the suitable options. In this paper a brief overview is presented of both methods and their application on GLARE products.

Influence of manufacturing practices on quality of pharmaceutical products manufactured in Kenya.

PubMed

Orwa, J A; Keter, L K; Ouko, S P A; Kibwage, I O; Rukunga, G M

2004-06-01

To establish the quality of pharmaceutical products manufactured by the respective industries in Kenya and determine the effect of manufacturing practices on the quality of these products. Cross-sectional study. Industries examined are in Nairobi, Kenya. Laboratory analysis was carried out using available facilities at Kenya Medical Research Institute and University of Nairobi, Faculty of Pharmacy. Structured Questionnaires were administered to examine how the code of good manufacturing practices has been used in the production of each pharmaceutical product by respective companies. Questionnaires designed to evaluate the distribution and carry out limited post-market surveillance study were administered to community pharmacy outlets. Drugs were sampled and analyzed for their quality according to the respective monographs. The questionnaires administered to the industry included the source of raw materials, quarantine procedure before and after manufacture, manufacturing procedure, quality audit, quality assurance procedure, equipment, and staff. That administered to the pharmacy outlet included availability, affordability and acceptability of locally manufactured pharmaceutical products. Quality analysis of products involved the establishment of the chemical content, dissolution profile, friability, uniformity of weight and identity. For antibiotic suspensions the stability after reconstitution was also determined. There were 15 respondents and two non-respondents from the industry and six out of nine respondents from the pharmacy outlets. The ratio of qualified staff to product range produced seemed to influence product quality. Industries producing several products with only limited number of pharmaceutical staff had more products failing to comply with pharmacopoeia specifications compared to those producing only few products. Nevertheless, all companies are well equipped with quality control equipment, in accordance with type of product manufactured. Private pharmacies stocked few of the locally manufactured products. The reason, they said, was due to low doctor and/or patient acceptance. Compliance with quality specifications as set out in respective monographs was overall 76%. Although the local pharmaceutical industries have adopted good manufacturing practices leading to many good quality products currently in commerce, these manufacturing practices are not comprehensive and measures need to be taken to continue improving them.

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

PubMed

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

2012-01-01

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

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.

Advances in clinical NK cell studies: Donor selection, manufacturing and quality control

PubMed Central

Koehl, U.; Kalberer, C.; Spanholtz, J.; Lee, D. A.; Miller, J. S.; Cooley, S.; Lowdell, M.; Uharek, L.; Klingemann, H.; Curti, A.; Leung, W.; Alici, E.

2016-01-01

ABSTRACT Natural killer (NK) cells are increasingly used in clinical studies in order to treat patients with various malignancies. The following review summarizes platform lectures and 2013–2015 consortium meetings on manufacturing and clinical use of NK cells in Europe and United States. A broad overview of recent pre-clinical and clinical results in NK cell therapies is provided based on unstimulated, cytokine-activated, as well as genetically engineered NK cells using chimeric antigen receptors (CAR). Differences in donor selection, manufacturing and quality control of NK cells for cancer immunotherapies are described and basic recommendations are outlined for harmonization in future NK cell studies. PMID:27141397

33 CFR 159.14 - Application for certification.

Code of Federal Regulations, 2010 CFR

2010-07-01

... description of the manufacturer's production quality control and inspection methods, record keeping systems pertaining to the manufacture of marine sanitation devices, and testing procedures; (2) The design for the... device; and (4) The name and address of the applicant and the manufacturing facility. (c) The...

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.

Flexible optical metrology strategies for the control and quality assurance of small series production

NASA Astrophysics Data System (ADS)

Schmitt, R.; Pavim, A.

2009-06-01

The demand for achieving smaller and more flexible production series with a considerable diversity of products complicates the control of the manufacturing tasks, leading to big challenges for the quality assurance systems. The quality assurance strategy that is nowadays used for mass production is unable to cope with the inspection flexibility needed among automated small series production, because the measuring strategy is totally dependent on the fixed features of the few manufactured object variants and on process parameters that can be controlled/compensated during production time. The major challenge faced by a quality assurance system applied to small series production facilities is to guarantee the needed quality level already at the first run, and therefore, the quality assurance system has to adapt itself constantly to the new manufacturing conditions. The small series production culture requires a change of paradigms, because its strategies are totally different from mass production. This work discusses the tight inspection requirements of small series production and presents flexible metrology strategies based on optical sensor data fusion techniques, agent-based systems as well as cognitive and self-optimised systems for assuring the needed quality level of flexible small series. Examples of application scenarios are provided among the automated assembly of solid state lasers and the flexible inspection of automotive headlights.

Quality Control of Laser-Beam-Melted Parts by a Correlation Between Their Mechanical Properties and a Three-Dimensional Surface Analysis

NASA Astrophysics Data System (ADS)

Grimm, T.; Wiora, G.; Witt, G.

2017-03-01

Good correlations between three-dimensional surface analyses of laser-beam-melted parts of nickel alloy HX and their mechanical properties were found. The surface analyses were performed with a confocal microscope, which offers a more profound surface data basis than a conventional, two-dimensional tactile profilometry. This new approach results in a wide range of three-dimensional surface parameters, which were each evaluated with respect to their feasibility for quality control in additive manufacturing. As a result of an automated surface analysis process by the confocal microscope and an industrial six-axis robot, the results are an innovative approach for quality control in additive manufacturing.

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.

21 CFR 106.20 - Ingredient control.

Code of Federal Regulations, 2010 CFR

2010-04-01

... CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content of Infant Formulas § 106.20 Ingredient control. (a) Except as provided in § 106.20(b), no analysis... prepared by the infant formula manufacturer shall be sampled and analyzed for each relied-upon nutrient...

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.

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.

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.

78 FR 28854 - Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-16

... formula regulations, including infant formula labeling, quality control procedures, notification....S.C. 350a) requires manufacturers of infant formula to establish and adhere to quality control..., including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility...

Long-term quality assurance of [(18)F]-fluorodeoxyglucose (FDG) manufacturing.

PubMed

Gaspar, Ludovit; Reich, Michal; Kassai, Zoltan; Macasek, Fedor; Rodrigo, Luis; Kruzliak, Peter; Kovac, Peter

2016-01-01

Nine years of experience with 2286 commercial synthesis allowed us to deliver comprehensive information on the quality of (18)F-FDG production. Semi-automated FDG production line using Cyclone 18/9 machine (IBA Belgium), TRACERLab MXFDG synthesiser (GE Health, USA) using alkalic hydrolysis, grade "A" isolator with dispensing robotic unit (Tema Sinergie, Italy), and automatic control system under GAMP5 (minus2, Slovakia) was assessed by TQM tools as highly reliable aseptic production line, fully compliant with Good Manufacturing Practice and just-in-time delivery of FDG radiopharmaceutical. Fluoride-18 is received in steady yield and of very high radioactive purity. Synthesis yields exhibited high variance connected probably with quality of disposable cassettes and chemicals sets. Most performance non-conformities within the manufacturing cycle occur at mechanical nodes of dispensing unit. The long-term monitoring of 2286 commercial synthesis indicated high reliability of automatic synthesizers. Shewhart chart and ANOVA analysis showed that minor non-compliances occurred were mostly caused by the declinations of less experienced staff from standard operation procedures, and also by quality of automatic cassettes. Only 15 syntheses were found unfinished and in 4 cases the product was out-of-specification of European Pharmacopoeia. Most vulnerable step of manufacturing was dispensing and filling in grade "A" isolator. Its cleanliness and sterility was fully controlled under the investigated period by applying hydrogen peroxide vapours (VHP). Our experience with quality assurance in the production of [(18)F]-fluorodeoxyglucose (FDG) at production facility of BIONT based on TRACERlab MXFDG production module can be used for bench-marking of the emerging manufacturing and automated manufacturing systems.

Long-term quality assurance of [18F]-fluorodeoxyglucose (FDG) manufacturing

PubMed Central

Gaspar, Ludovit; Reich, Michal; Kassai, Zoltan; Macasek, Fedor; Rodrigo, Luis; Kruzliak, Peter; Kovac, Peter

2016-01-01

Nine years of experience with 2286 commercial synthesis allowed us to deliver comprehensive information on the quality of 18F-FDG production. Semi-automated FDG production line using Cyclone 18/9 machine (IBA Belgium), TRACERLab MXFDG synthesiser (GE Health, USA) using alkalic hydrolysis, grade “A” isolator with dispensing robotic unit (Tema Sinergie, Italy), and automatic control system under GAMP5 (minus2, Slovakia) was assessed by TQM tools as highly reliable aseptic production line, fully compliant with Good Manufacturing Practice and just-in-time delivery of FDG radiopharmaceutical. Fluoride-18 is received in steady yield and of very high radioactive purity. Synthesis yields exhibited high variance connected probably with quality of disposable cassettes and chemicals sets. Most performance non-conformities within the manufacturing cycle occur at mechanical nodes of dispensing unit. The long-term monitoring of 2286 commercial synthesis indicated high reliability of automatic synthesizers. Shewhart chart and ANOVA analysis showed that minor non-compliances occurred were mostly caused by the declinations of less experienced staff from standard operation procedures, and also by quality of automatic cassettes. Only 15 syntheses were found unfinished and in 4 cases the product was out-of-specification of European Pharmacopoeia. Most vulnerable step of manufacturing was dispensing and filling in grade “A” isolator. Its cleanliness and sterility was fully controlled under the investigated period by applying hydrogen peroxide vapours (VHP). Our experience with quality assurance in the production of [18F]-fluorodeoxyglucose (FDG) at production facility of BIONT based on TRACERlab MXFDG production module can be used for bench-marking of the emerging manufacturing and automated manufacturing systems. PMID:27508102

10 CFR 32.25 - Conditions of licenses issued under § 32.22: Quality control, labeling, and reports of transfer.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Conditions of licenses issued under § 32.22: Quality... Concentrations and Items § 32.25 Conditions of licenses issued under § 32.22: Quality control, labeling, and... in the manufacture of the product to assure that each production lot meets the quality control...

10 CFR 32.25 - Conditions of licenses issued under § 32.22: Quality control, labeling, and reports of transfer.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Conditions of licenses issued under § 32.22: Quality... Concentrations and Items § 32.25 Conditions of licenses issued under § 32.22: Quality control, labeling, and... in the manufacture of the product to assure that each production lot meets the quality control...

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

Occupational Preparation--Inspection and Quality Control. Instructor's Guide. The Manufacturing Cluster.

ERIC Educational Resources Information Center

Fairleigh Dickinson Univ., Rutherford, NJ.

Part of a manufacturing cluster series which addresses itself to career awareness, orientation, exploration, and preparation, this guide and its accompanying student manual were written as a direct followup of the instructor's guide and student manual titled "Exploring Manufacturing Occupations." Four major sections are included. The first section…

Quality control in urinalysis.

PubMed

Takubo, T; Tatsumi, N

1999-01-01

Quality control (QC) has been introduced in laboratories, and QC surveys in urinalysis have been performed by College of American Pathologist, by Japanese Association of Medical Technologists, by Osaka Medical Association and by manufacturers. QC survey in urinalysis for synthetic urine by the reagent strip and instrument made in same manufacturer, and by an automated urine cell analyser provided satisfactory results among laboratories. QC survey in urinalysis for synthetic urine by the reagent strips and instruments made by various manufacturers indicated differences in the determination values among manufacturers, and between manual and automated methods because the reagent strips and instruments have different characteristics, respectively. QC photo survey in urinalysis on the microscopic photos of urine sediment constituents indicated differences in the identification of cells among laboratories. From the results, it is necessary to standardize a reagent strip method, manual and automated methods, and synthetic urine.

Advanced manufacturing development of a composite empennage component for L-1011 aircraft

NASA Technical Reports Server (NTRS)

Alva, T.; Henkel, J.; Johnson, R.; Carll, B.; Jackson, A.; Mosesian, B.; Brozovic, R.; Obrien, R.; Eudaily, R.

1982-01-01

This is the final report of technical work conducted during the fourth phase of a multiphase program having the objective of the design, development and flight evaluation of an advanced composite empennage component manufactured in a production environment at a cost competitive with those of its metal counterpart, and at a weight savings of at least 20 percent. The empennage component selected for this program is the vertical fin box of the L-1011 aircraft. The box structure extends from the fuselage production joint to the tip rib and includes front and rear spars. During Phase 4 of the program, production quality tooling was designed and manufactured to produce three sets of covers, ribs, spars, miscellaneous parts, and subassemblies to assemble three complete ACVF units. Recurring and nonrecurring cost data were compiled and documented in the updated producibility/design to cost plan. Nondestruct inspections, quality control tests, and quality acceptance tests were performed in accordance with the quality assurance plan and the structural integrity control plan. Records were maintained to provide traceability of material and parts throughout the manufacturing development phase. It was also determined that additional tooling would not be required to support the current and projected L-1011 production rate.

76 FR 29180 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Control of Nitrogen...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-20

... regulation to control NO X emissions from Portland cement kilns. Portland cement manufacturing is an energy... Pa. Code) Chapter 145, Subchapter C (Emissions of NO X from Cement Manufacturing), for Portland... Portland Cement Kilns AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is...

[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.

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.

Defense Manufacturing Management Guide for Program Managers, Third Edition

DTIC Science & Technology

1989-04-01

Crosby (Quality goals of quality, cost, schedule, mission need, College), Genechi Taguchi (Experimental 5-1 Design), Dr. Kaoru Ishikawa (Cause/Effect...the remaining problems were resolved. 5-7 6. Ishikawa Diagram 7. Control Charts This technique was developed by Dr. In the minds of some quality Kaoru ... Ishikawa , one of the foremost professionals and nonprofesslonals alike, the authorities on quality control in Japan. The control chart is synonymous

40 CFR 1068.101 - What general actions does this regulation prohibit?

Code of Federal Regulations, 2014 CFR

2014-07-01

..., operating an engine without a supply of appropriate quality urea if the emissions control system relies on urea to reduce NOx emissions or the use of incorrect fuel or engine oil that renders the emissions... manufacturers of new engines, manufacturers of equipment containing these engines, and manufacturers of new...

40 CFR 1068.101 - What general actions does this regulation prohibit?

Code of Federal Regulations, 2012 CFR

2012-07-01

..., operating an engine without a supply of appropriate quality urea if the emissions control system relies on urea to reduce NOx emissions or the use of incorrect fuel or engine oil that renders the emissions... manufacturers of new engines, manufacturers of equipment containing these engines, and manufacturers of new...

40 CFR 1068.101 - What general actions does this regulation prohibit?

Code of Federal Regulations, 2013 CFR

2013-07-01

..., operating an engine without a supply of appropriate quality urea if the emissions control system relies on urea to reduce NOx emissions or the use of incorrect fuel or engine oil that renders the emissions... manufacturers of new engines, manufacturers of equipment containing these engines, and manufacturers of new...

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.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2011-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: procedure for adoption of International Chemical Reference Substances; WHO good practices for pharmaceutical microbiology laboratories; good manufacturing practices: main principles for pharmaceutical products; good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization); guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; good manufacturing practices for sterile pharmaceutical products; guidelines on transfer of technology in pharmaceutical manufacturing; good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO); model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization); procedure for prequalification of pharmaceutical products; guide on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities; prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; guidelines for preparing a laboratory information file; guidelines for drafting a site master file; guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format.

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)

Expert database system for quality control

NASA Astrophysics Data System (ADS)

Wang, Anne J.; Li, Zhi-Cheng

1993-09-01

There are more competitors today. Markets are not homogeneous they are fragmented into increasingly focused niches requiring greater flexibility in the product mix shorter manufacturing production runs and above allhigher quality. In this paper the author identified a real-time expert system as a way to improve plantwide quality management. The quality control expert database system (QCEDS) by integrating knowledge of experts in operations quality management and computer systems use all information relevant to quality managementfacts as well as rulesto determine if a product meets quality standards. Keywords: expert system quality control data base

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.

Modeling of liquid flow in surface discontinuities

NASA Astrophysics Data System (ADS)

Lobanova, I. S.; Meshcheryakov, V. A.; Kalinichenko, A. N.

2018-01-01

Polymer composite and metallic materials have found wide application in various industries such as aviation, rocket, car manufacturing, ship manufacturing, etc. Many design elements need permanent quality control. Ensuring high quality and reliability of products is impossible without effective nondestructive testing methods. One of these methods is penetrant testing using penetrating substances based on liquid penetration into defect cavities. In this paper, we propose a model of liquid flow to determine the rates of filling the defect cavities with various materials and, based on this, to choose optimal control modes.

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.

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

Quality-by-design III: application of near-infrared spectroscopy to monitor roller compaction in-process and product quality attributes of immediate release tablets.

PubMed

Kona, Ravikanth; Fahmy, Raafat M; Claycamp, Gregg; Polli, James E; Martinez, Marilyn; Hoag, Stephen W

2015-02-01

The objective of this study is to use near-infrared spectroscopy (NIRS) coupled with multivariate chemometric models to monitor granule and tablet quality attributes in the formulation development and manufacturing of ciprofloxacin hydrochloride (CIP) immediate release tablets. Critical roller compaction process parameters, compression force (CFt), and formulation variables identified from our earlier studies were evaluated in more detail. Multivariate principal component analysis (PCA) and partial least square (PLS) models were developed during the development stage and used as a control tool to predict the quality of granules and tablets. Validated models were used to monitor and control batches manufactured at different sites to assess their robustness to change. The results showed that roll pressure (RP) and CFt played a critical role in the quality of the granules and the finished product within the range tested. Replacing binder source did not statistically influence the quality attributes of the granules and tablets. However, lubricant type has significantly impacted the granule size. Blend uniformity, crushing force, disintegration time during the manufacturing was predicted using validated PLS regression models with acceptable standard error of prediction (SEP) values, whereas the models resulted in higher SEP for batches obtained from different manufacturing site. From this study, we were able to identify critical factors which could impact the quality attributes of the CIP IR tablets. In summary, we demonstrated the ability of near-infrared spectroscopy coupled with chemometrics as a powerful tool to monitor critical quality attributes (CQA) identified during formulation development.

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.

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…

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...

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.

ISO 9002 as Literacy Practice: Coping with Quality-Control Documents in a High-Tech Company

ERIC Educational Resources Information Center

Kleifgen, Jo Anne

2005-01-01

This study describes the process by which a circuit board manufacturing company became certified in an international quality control program known as ISO 9002. Particular attention is paid to how quality documents were made and used in actual practice and to the relationship between these standardized procedures (official literacies) and…

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2014 CFR

2014-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2013 CFR

2013-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2011 CFR

2011-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2012 CFR

2012-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2010 CFR

2010-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

Manufacturing and certification of a diffraction corrector for controlling the surface shape of the six-meter main mirror of the Big Azimuthal Telescope of the Russian Academy of Sciences

NASA Astrophysics Data System (ADS)

Nasyrov, R. K.; Poleshchuk, A. G.

2017-09-01

This paper describes the development and manufacture of diffraction corrector and imitator for the interferometric control of the surface shape of the 6-m main mirror of the Big Azimuthal Telescope of the Russian Academy of Sciences. The effect of errors in manufacture and adjustment on the quality of the measurement wavefront is studied. The corrector is controlled with the use of an off-axis diffraction imitator operating in a reflection mode. The measured error is smaller than 0.0138λ (RMS).

Illinois Manufacturing Technology Curriculum.

ERIC Educational Resources Information Center

Cliffe, Roger; And Others

This manufacturing technology curriculum involves students in learning problem-solving, communication, team building, quality control, safety, math, science, and technical skills. The document begins with a section on implementation, which gives background information on the purposes and development of the curriculum, explains its rationale,…

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.

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.

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.

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.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2005-01-01

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities and pharmaceutical manufacturers, this report discusses the monographs on antiretrovirals proposed for inclusion in The International Pharmacopoeia and specifications for radiopharmaceuticals, quality specifications for antituberculosis drugs and the revision of the monograph on artemisinin derivatives, as well as quality control of reference materials, good manufacturing practices (GMP), inspection, distribution and trade and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including an amendment to good manufacturing practices: main principles regarding the requirement for the sampling of starting materials, guidelines on good manufacturing practices regarding water for pharmaceutical use, guidelines on the sampling of pharmaceutical products and related materials and draft guidelines for registration of fixed-dose combination medicinal products.

[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.

21 CFR 107.50 - Terms and conditions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR... manufacturer shall maintain records of such quality control procedures sufficient to permit a public health... Food Safety and Applied Nutrition will review information submitted by infant formula manufacturers...

46 CFR 160.037-4 - Approval and production tests.

Code of Federal Regulations, 2013 CFR

2013-10-01

... signal plus packaging in a sealed plastic waterproof bag, the 24-hour water immersion conditioning will... discontinued production line. (2) Inspections and tests by the manufacturer. The manufacturer's quality control...: (i) Conditioning of test specimens—water resistance. Immerse specimen horizontally with uppermost...

46 CFR 160.037-4 - Approval and production tests.

Code of Federal Regulations, 2012 CFR

2012-10-01

... signal plus packaging in a sealed plastic waterproof bag, the 24-hour water immersion conditioning will... discontinued production line. (2) Inspections and tests by the manufacturer. The manufacturer's quality control...: (i) Conditioning of test specimens—water resistance. Immerse specimen horizontally with uppermost...

46 CFR 160.037-4 - Approval and production tests.

Code of Federal Regulations, 2014 CFR

2014-10-01

... signal plus packaging in a sealed plastic waterproof bag, the 24-hour water immersion conditioning will... discontinued production line. (2) Inspections and tests by the manufacturer. The manufacturer's quality control...: (i) Conditioning of test specimens—water resistance. Immerse specimen horizontally with uppermost...

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...

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.

21 CFR 211.22 - Responsibilities of quality control unit.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Responsibilities of quality control unit. 211.22 Section 211.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Organization and...

21 CFR 211.22 - Responsibilities of quality control unit.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Responsibilities of quality control unit. 211.22 Section 211.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Organization and...

21 CFR 211.22 - Responsibilities of quality control unit.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Responsibilities of quality control unit. 211.22 Section 211.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Organization and...

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.

21 CFR 225.65 - Equipment cleanout procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.65 Equipment cleanout procedures. (a) Adequate cleanout procedures for all equipment used in the manufacture... sequential production of feeds. (2) If flushing is utilized, the flush material shall be properly identified...

Manufacture and quality control of interconnecting wire harnesses

NASA Technical Reports Server (NTRS)

1973-01-01

Four-volume series of documents has been prepared as standard reference. Each volume may be used separately and covers wire and cable preparation as well as harness fabrication and installation. Series should be useful addition to libraries of manufactures of electrical and electronic equipment.

40 CFR 89.511 - Suspension and revocation of certificates of conformity.

Code of Federal Regulations, 2010 CFR

2010-07-01

... ENGINES Selective Enforcement Auditing § 89.511 Suspension and revocation of certificates of conformity... proposed quality control and/or quality assurance measures to be taken by the manufacturer to prevent...

40 CFR 90.511 - Suspension and revocation of certificates of conformity.

Code of Federal Regulations, 2010 CFR

2010-07-01

... KILOWATTS Selective Enforcement Auditing § 90.511 Suspension and revocation of certificates of conformity... proposed quality control and/or quality assurance measures to be taken by the manufacturer to prevent...

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.

Manufacturing Aids

NASA Astrophysics Data System (ADS)

1983-01-01

Contractor's work for Lewis Research Center on "thermal barrier" coatings designed to improve aircraft engine efficiency resulted in two related but separate spinoffs. The Materials and Manufacturing Technology Center of TRW, Inc. invented a robotic system for applying the coating, and in the course of that research found it necessary to develop a new, extremely accurate type of optical gage that offers multiple improvements in controlling the quality of certain manufactured parts.

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.

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.

Environment-friendly cycle time optimization and quality improvisation using Six Sigma.

PubMed

Deshpande, V S; Mungle, N P

2008-07-01

Healthy environment in any organization can make a difference in improving productivity and quality with low defect, lack of concentration, willingness to work, minimum accidental problems etc. Six Sigma is one of the more recent quality improvement initiatives to gain popularity and acceptance in many industries across the globe. It is an alternative to TQM to obtain minimum manufacturing defect, cycle time reduction, cost reduction, inventory reduction etc. Its use is increasingly widespread in many industries, in both manufacturing and service industries with many proponents of the approach claiming that it has developed beyond a quality control approach into a broader process improvement concept.

Tracing and control of raw materials sourcing for vaccine manufacturers.

PubMed

Faretra Peysson, Laurence

2010-05-01

The control of the raw materials used to manufacture vaccines is mandatory; therefore, a very clear process must be in place to guarantee that raw materials are traced. Those who make products or supplies used in vaccine manufacture (suppliers of culture media, diagnostic tests, etc.) must apply quality systems proving that they adhere to certain standards. ISO certification, Good Manufacturing Practices for production sites and the registration of culture media with a 'Certificate of Suitability' from the European Directorate for the Quality of Medicines and Healthcare are reliable quality systems pertaining to vaccine production. Suppliers must assure that each lot of raw materials used in a product that will be used in vaccine manufacture adheres to the level of safety and traceability required. Incoming materials must be controlled in a single 'Enterprise Resource Planning' system which is used to document important information, such as the assignment of lot number, expiration date, etc. Ingredients for culture media in particular must conform to certain specifications. The specifications that need to be checked vary according to the ingredient, based on the level of risk. The way a raw material is produced is also important, and any aspect relative to cross-contamination, such as the sanitary measures used in producing and storing the raw material must be checked as well. In addition, suppliers can reduce the risk of viral contamination of raw materials by avoiding purchases in countries where a relevant outbreak is currently declared. 2010 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

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...

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.

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

PubMed

Vidor, Emmanuel; Soubeyrand, Benoit

2016-12-01

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

Total quality assurance

NASA Astrophysics Data System (ADS)

Louzon, E.

1989-12-01

Quality, cost, and schedule are three factors affecting the competitiveness of a company; they require balancing so that products of acceptable quality are delivered, on time and at a competitive cost. Quality costs comprise investment in quality maintenance and failure costs which arise from failure to maintain standards. The basic principle for achieving the required quality at minimum cost is that of prevention of failures, etc., through production control, attention to manufacturing practices, and appropriate management and training. Total quality control involves attention to the product throughout its life cycle, including in-service performance evaluation, servicing, and maintenance.

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...

Developing a tool for the preparation of GMP audit of pharmaceutical contract manufacturer.

PubMed

Linna, Anu; Korhonen, Mirka; Mannermaa, Jukka-Pekka; Airaksinen, Marja; Juppo, Anne Mari

2008-06-01

Outsourcing is rapidly growing in the pharmaceutical industry. When the manufacturing activities are outsourced, control of the product's quality has to be maintained. One way to confirm contract manufacturer's GMP (Good Manufacturing Practice) compliance is auditing. Audits can be supported for instance by using GMP questionnaires. The objective of this study was to develop a tool for the audit preparation of pharmaceutical contract manufacturers and to validate its contents by using Delphi method. At this phase of the study the tool was developed for non-sterile finished product contract manufacturers. A modified Delphi method was used with expert panel consisting of 14 experts from pharmaceutical industry, authorities and university. The content validity of the developed tool was assessed by a Delphi questionnaire round. The response rate in Delphi questionnaire round was 86%. The tool consisted of 103 quality items, from which 90 (87%) achieved the pre-defined agreement rate level (75%). Thirteen quality items which did not achieve the pre-defined agreement rate were excluded from the tool. The expert panel suggested only minor changes to the tool. The results show that the content validity of the developed audit preparation tool was good.

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.

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

NASA Astrophysics Data System (ADS)

Katchasuwanmanee, Kanet; Cheng, Kai; Bateman, Richard

2016-09-01

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

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.

Practical applications of nondestructive materials characterization

NASA Astrophysics Data System (ADS)

Green, Robert E., Jr.

1992-10-01

Nondestructive evaluation (NDE) techniques are reviewed for applications to the industrial production of materials including microstructural, physical, and chemical analyses. NDE techniques addressed include: (1) double-pulse holographic interferometry for sealed-package leak testing; (2) process controls for noncontact metals fabrication; (3) ultrasonic detections of oxygen contamination in titanium welds; and (4) scanning acoustic microscopy for the evaluation of solder bonds. The use of embedded sensors and emerging NDE concepts provides the means for controlling the manufacturing and quality of quartz crystal resonators, nickel single-crystal turbine blades, and integrated circuits. Advances in sensor technology and artificial intelligence algorithms and the use of embedded sensors combine to make NDE technology highly effective in controlling industrial materials manufacturing and the quality of the products.

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.

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.

40 CFR 426.123 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS GLASS MANUFACTURING POINT SOURCE CATEGORY Incandescent Lamp... quality of pollutants or pollutant properties, controlled by this section, which may be discharged by a... technology economically achievable: (a) [Reserved] (b) Any manufacturing plant which frosts incandescent lamp...

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.

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.

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.

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

PubMed

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

2015-02-01

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

Casting off vaccine supply charity -- the pace quickens. CVI goal: quality vaccines for all children.

PubMed

1995-10-01

Several proposals are offered for production of high-quality vaccines within developing countries. The World Health Organization's Vaccine Supply and Quality (VSQ) team from the Global Program for Vaccines and Immunization (GPV) visited 10 countries (Bangladesh, Brazil, Egypt, India, Indonesia, Iran, Mexico, Pakistan, Philippines, and South Africa) out of 14 priority countries (China, Russia, Thailand, and Vietnam were not visited) producing vaccines and found only two with a quality control system that was acceptable. Vaccine-producing countries are urged to consider the full costs of production that include necessary infrastructure, an independent national control authority and laboratory, manufacturers with managerial autonomy, and manufacturers with good management, a qualified staff, and adequate technology. UNICEF has urged both private and public sectors to combine forces in bringing down the price of new vaccines for distribution to a very large market. Some imaginative proposals were made by some manufacturers for vaccine production and supply for a range of less traditional vaccines. The Director of the Massachusetts Public Health Biologic Laboratories proposed the formation of a consortium of vaccine manufacturers who would support public health priorities for market-affordable, simple vaccines against the major childhood diseases. The aim would be international validation of high-quality local vaccine production in developing countries, ease of research collaboration, improvement in information exchange between countries, and structured assistance. Lack of political commitment has been blamed for poor quality local production. A small cooperative effort among some Latin American countries, the Pan American Association's Regional Vaccine System for Latin America (SIREVA), is backed by the Children's Vaccine Initiative. SIREVA is a consortium of manufacturers in Brazil, Chile, and Mexico that plans joint development of some vaccines. Donor assistance is suggested for UNICEF's new targeting strategy and global vaccine fund for well-defined and specific needs. UNICEF is the main distributor of vaccines to developing countries and aims for program sustainability and distribution of the new vaccines.

Using quality control to limit bismuth in copper cathodes

NASA Astrophysics Data System (ADS)

Serrano, John R.; Berger, Dennis; Bridges, Bill

1994-10-01

This article describes quality-control work at Phelps Dodge, undertaken as part of ISO 9003 certification, to better identify and prevent the contamination of copper cathodes by bismuth. It also overviews the implementation of a production control system as well as associated training designed to minimize the possibility of bismuth-contaminated copper progressing beyond the cathode stage to other areas of manufacturing or distribution.

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

PubMed

Kroes, Burt H

2014-12-02

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

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.

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.

[Analysis and countermeasure for quality risk in process of traditional Chinese medicine preparations].

PubMed

Yang, Ming; Yang, Yuan-Zhen; Wang, Ya-Qi; Wu, Zhen-Feng; Wang, Xue-Cheng; Luo, Jing

2017-03-01

Product quality relies on not only testing methods,but also the design and development, production control and product manufacturing all aspects of logistics management. Quality comes from the process control level.Therefore, it is very important to accurately identify the factors that may induce quality risk in the production process and quality control measures correspondingly.This article systematically analyzes the source of the quality risk of all aspects of the production process in traditional Chinese medicine preparation. Discussing ways and methods of quality risk identification of traditional Chinese medicine preparation and providing references for perfecting the whole process quality management of traditional Chinese medicine preparation. Copyright© by the Chinese Pharmaceutical Association.

21 CFR 111.127 - What quality control operations are required for packaging and labeling operations?

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 packaging and labeling operations? 111.127 Section 111.127 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING...

Toward Cost-Effective Manufacturing of Silicon Solar Cells: Electrodeposition of High-Quality Si Films in a CaCl2 -based Molten Salt.

PubMed

Yang, Xiao; Ji, Li; Zou, Xingli; Lim, Taeho; Zhao, Ji; Yu, Edward T; Bard, Allen J

2017-11-20

Electrodeposition of Si films from a Si-containing electrolyte is a cost-effective approach for the manufacturing of solar cells. Proposals relying on fluoride-based molten salts have suffered from low product quality due to difficulties in impurity control. Here we demonstrate the successful electrodeposition of high-quality Si films from a CaCl 2 -based molten salt. Soluble Si IV -O anions generated from solid SiO 2 are electrodeposited onto a graphite substrate to form a dense film of crystalline Si. Impurities in the deposited Si film are controlled at low concentrations (both B and P are less than 1 ppm). In the photoelectrochemical measurements, the film shows p-type semiconductor character and large photocurrent. A p-n junction fabricated from the deposited Si film exhibits clear photovoltaic effects. This study represents the first step to the ultimate goal of developing a cost-effective manufacturing process for Si solar cells based on electrodeposition. © 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

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.

21 CFR 820.50 - Purchasing controls.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Purchasing controls. 820.50 Section 820.50 Food... DEVICES QUALITY SYSTEM REGULATION Purchasing Controls § 820.50 Purchasing controls. Each manufacturer... control to be exercised over the product, services, suppliers, contractors, and consultants, based on the...

21 CFR 226.58 - Laboratory controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and test...

21 CFR 820.50 - Purchasing controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Purchasing controls. 820.50 Section 820.50 Food... DEVICES QUALITY SYSTEM REGULATION Purchasing Controls § 820.50 Purchasing controls. Each manufacturer... control to be exercised over the product, services, suppliers, contractors, and consultants, based on the...

21 CFR 226.58 - Laboratory controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and test...

21 CFR 820.50 - Purchasing controls.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Purchasing controls. 820.50 Section 820.50 Food... DEVICES QUALITY SYSTEM REGULATION Purchasing Controls § 820.50 Purchasing controls. Each manufacturer... control to be exercised over the product, services, suppliers, contractors, and consultants, based on the...

21 CFR 820.50 - Purchasing controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Purchasing controls. 820.50 Section 820.50 Food... DEVICES QUALITY SYSTEM REGULATION Purchasing Controls § 820.50 Purchasing controls. Each manufacturer... control to be exercised over the product, services, suppliers, contractors, and consultants, based on the...

21 CFR 226.58 - Laboratory controls.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and test...

21 CFR 820.50 - Purchasing controls.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Purchasing controls. 820.50 Section 820.50 Food... DEVICES QUALITY SYSTEM REGULATION Purchasing Controls § 820.50 Purchasing controls. Each manufacturer... control to be exercised over the product, services, suppliers, contractors, and consultants, based on the...

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

Code of Federal Regulations, 2011 CFR

2011-01-01

... byproduct material and designed to protect life or property from fires and airborne hazards, or to initially... submits sufficient information relating to the design, manufacture, prototype testing, quality control... the product and changes in chemical and physical form that may occur during the useful life of the...

21 CFR 111.113 - What quality control operations are required for a material review and disposition decision?

Code of Federal Regulations, 2010 CFR

2010-04-01

... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... that adulterates or may lead to adulteration of the component, dietary supplement, or packaging, or... or batches of a dietary supplement; or (5) A dietary supplement is returned. (b)(1) When there is a...

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.

Technical assessment for quality control of resins

NASA Technical Reports Server (NTRS)

Gosnell, R. B.

1977-01-01

Survey visits to companies involved in the manufacture and use of graphite-epoxy prepregs were conducted to assess the factors which may contribute to variability in the mechanical properties of graphite-epoxy composites. In particular, the purpose was to assess the contributions of the epoxy resins to variability. Companies represented three segments of the composites industry - aircraft manufacturers, prepreg manufacturers, and epoxy resin manufacturers. Several important sources of performance variability were identified from among the complete spectrum of potential sources which ranged from raw materials to composite test data interpretation.

Probiotic use in at-risk populations.

PubMed

Sanders, Mary Ellen; Merenstein, Daniel J; Ouwehand, Arthur C; Reid, Gregor; Salminen, Seppo; Cabana, Michael D; Paraskevakos, George; Leyer, Gregory

To inform health care providers about quality standards for manufacture of probiotic products being recommended for at-risk patient populations. Probiotics are used in a variety of clinical settings, sometimes in at-risk populations for therapeutic endpoints. Although probiotics might not be approved as drugs, they are sometimes used for the prevention or treatment of disease. In the United States, and many regions of the world, probiotic products are marketed as dietary supplements (not drugs) and are therefore subject to different manufacturing and quality control standards than approved drugs are. Health care providers need to be assured that probiotic products used in at-risk populations are safe for this use. Pharmacists should require certificates of analysis, which document quality standards, from manufacturers of products stocked in hospital formularies or other pharmacies dispensing to at-risk people. Although responsible manufacturers use stringent quality standards on their processes and finished products, using a third party to verify compliance with manufacturing and accuracy of product labeling adds assurance to end users that the product is of high quality. It is in patients' best interest to use probiotics in the prevention and treatment of conditions when the evidence is convincing. To protect high-risk patients, probiotic products should meet stringent microbiological standards. Product testing results should be available for review before recommending probiotic products to at-risk individuals. For products used in at-risk populations, manufacturers should provide this information or participate in a third-party verification program that certifies compliance. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

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...

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.

21 CFR 820.40 - Document controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Document controls. 820.40 Section 820.40 Food and... QUALITY SYSTEM REGULATION Document Controls § 820.40 Document controls. Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall...

21 CFR 820.40 - Document controls.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Document controls. 820.40 Section 820.40 Food and... QUALITY SYSTEM REGULATION Document Controls § 820.40 Document controls. Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall...

21 CFR 820.40 - Document controls.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Document controls. 820.40 Section 820.40 Food and... QUALITY SYSTEM REGULATION Document Controls § 820.40 Document controls. Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall...

21 CFR 820.40 - Document controls.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Document controls. 820.40 Section 820.40 Food and... QUALITY SYSTEM REGULATION Document Controls § 820.40 Document controls. Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall...

21 CFR 820.40 - Document controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Document controls. 820.40 Section 820.40 Food and... QUALITY SYSTEM REGULATION Document Controls § 820.40 Document controls. Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall...

Manufacturing of biodrugs: need for harmonization in regulatory standards.

PubMed

Sahoo, Niharika; Choudhury, Koel; Manchikanti, Padmavati

2009-01-01

Biodrugs (biologics) are much more complex than chemically synthesized drugs because of their structural heterogeneity and interactions within a given biologic system. The manufacturing process in the biodrug industry varies with each type of molecule and is far more elaborate and stringent due to the use of living organisms and complex substrates. Product purity and altered structural characteristics leading to potential immunogenicity have often been of concern when establishing quality and safety in the use of biodrugs. Regulatory compliance in manufacturing and commercialization of biodrugs involves quality control, quality assurance, and batch documentation. Many factors such as host cell development, cell bank establishment, cell culture, protein production, purification, analysis, formulation, storage, and handling are critical for ensuring the purity, activity, and safety of the finished product. Good Manufacturing Practice (GMP) for biodrugs has been developed in certain regions such as the EU, US, and Japan. Due to differences in manufacturing methods and systems, product-specific GMP guidelines are evolving. In general, there are variations in GMP guidelines between countries, which lead to difficulty for the manufacturers in conforming to different standards, thus entailing delays in the commercialization of biodrugs. There is a need to develop a unified regulatory guideline for biodrug manufacturing across various countries, which would be helpful in the marketing of products and trade. This review deals with the comparative framework and analysis of GMP regulation of biodrugs.

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

Application of QC_DR software for acceptance testing and routine quality control of direct digital radiography systems: initial experiences using the Italian Association of Physicist in Medicine quality control protocol.

PubMed

Nitrosi, Andrea; Bertolini, Marco; Borasi, Giovanni; Botti, Andrea; Barani, Adriana; Rivetti, Stefano; Pierotti, Luisa

2009-12-01

Ideally, medical x-ray imaging systems should be designed to deliver maximum image quality at an acceptable radiation risk to the patient. Quality assurance procedures are employed to ensure that these standards are maintained. A quality control protocol for direct digital radiography (DDR) systems is described and discussed. Software to automatically process and analyze the required images was developed. In this paper, the initial results obtained on equipment of different DDR manufacturers were reported. The protocol was developed to highlight even small discrepancies in standard operating performance.

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 211.160 - General requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... drafted by the appropriate organizational unit and reviewed and approved by the quality control unit. The...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls § 211.160... procedures, or other laboratory control mechanisms required by this subpart, including any change in such...

Manufacturing Laboratory for Next Generation Engineers

DTIC Science & Technology

2013-12-16

automated CNC machines, rapid prototype systems, robotic assembly systems, metrology , and non-traditional systems such as a waterjet cutter, EDM machine...CNC machines, rapid prototype systems, robotic assembly systems, metrology , and non-traditional systems such as a waterjet cutter, EDM machine, plasma...System Metrology and Quality Control Equipment - This area already had a CMM and other well known quality control instrumentation. It has been enhanced

Analysis and quality control of carbohydrates in therapeutic proteins with fluorescence HPLC

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

Liu, Kun; Huang, Jian; Center for Informational Biology, University of Electronic Science and Technology of China, Chengdu 610054

Conbercept is an Fc fusion protein with very complicated carbohydrate profiles which must be carefully monitored through manufacturing process. Here, we introduce an optimized fluorescence derivatization high-performance liquid chromatographic method for glycan mapping in conbercept. Compared with conventional glycan analysis method, this method has much better resolution and higher reproducibility making it excellent for product quality control.

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

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

A tutorial for developing a topical cream formulation based on the Quality by Design approach.

PubMed

Simões, Ana; Veiga, Francisco; Vitorino, Carla; Figueiras, Ana

2018-06-20

The pharmaceutical industry has entered in a new era, as there is a growing interest in increasing the quality standards of dosage forms, through the implementation of more structured development and manufacturing approaches. For many decades, the manufacturing of drug products was controlled by a regulatory framework to guarantee the quality of the final product through a fixed process and exhaustive testing. Limitations related to the Quality by Test (QbT) system have been widely acknowledged. The emergence of Quality by Design (QbD) as a systematic and risk-based approach introduced a new quality concept based on a good understanding of how raw materials and process parameters influence the final quality profile. Although the QbD system has been recognized as a revolutionary approach to product development and manufacturing, its full implementation in the pharmaceutical field is still limited. This is particularly evident in the case of semisolid complex formulation development. The present review aims at establishing a practical QbD framework to describe all stages comprised in the pharmaceutical development of a conventional cream in a comprehensible manner. Copyright © 2018. Published by Elsevier Inc.

A modern depleted uranium manufacturing facility

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

Zagula, T.A.

1995-07-01

The Specific Manufacturing Capabilities (SMC) Project located at the Idaho National Engineering Laboratory (INEL) and operated by Lockheed Martin Idaho Technologies Co. (LMIT) for the Department of Energy (DOE) manufactures depleted uranium for use in the U.S. Army MIA2 Abrams Heavy Tank Armor Program. Since 1986, SMC has fabricated more than 12 million pounds of depleted uranium (DU) products in a multitude of shapes and sizes with varying metallurgical properties while maintaining security, environmental, health and safety requirements. During initial facility design in the early 1980`s, emphasis on employee safety, radiation control and environmental consciousness was gaining momentum throughout themore » DOE complex. This fact coupled with security and production requirements forced design efforts to focus on incorporating automation, local containment and computerized material accountability at all work stations. The result was a fully automated production facility engineered to manufacture DU armor packages with virtually no human contact while maintaining security, traceability and quality requirements. This hands off approach to handling depleted uranium resulted in minimal radiation exposures and employee injuries. Construction of the manufacturing facility was complete in early 1986 with the first armor package certified in October 1986. Rolling facility construction was completed in 1987 with the first certified plate produced in the fall of 1988. Since 1988 the rolling and manufacturing facilities have delivered more than 2600 armor packages on schedule with 100% final product quality acceptance. During this period there was an annual average of only 2.2 lost time incidents and a single individual maximum radiation exposure of 150 mrem. SMC is an example of designing and operating a facility that meets regulatory requirements with respect to national security, radiation control and personnel safety while achieving production schedules and product quality.« less

Terahertz imaging and tomography as efficient instruments for testing polymer additive manufacturing objects.

PubMed

Perraud, J B; Obaton, A F; Bou-Sleiman, J; Recur, B; Balacey, H; Darracq, F; Guillet, J P; Mounaix, P

2016-05-01

Additive manufacturing (AM) technology is not only used to make 3D objects but also for rapid prototyping. In industry and laboratories, quality controls for these objects are necessary though difficult to implement compared to classical methods of fabrication because the layer-by-layer printing allows for very complex object manufacturing that is unachievable with standard tools. Furthermore, AM can induce unknown or unexpected defects. Consequently, we demonstrate terahertz (THz) imaging as an innovative method for 2D inspection of polymer materials. Moreover, THz tomography may be considered as an alternative to x-ray tomography and cheaper 3D imaging for routine control. This paper proposes an experimental study of 3D polymer objects obtained by additive manufacturing techniques. This approach allows us to characterize defects and to control dimensions by volumetric measurements on 3D data reconstructed by tomography.

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.

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.

[Application of microscopic spectroscopy in quality control of Niuhuang Qingxin pills].

PubMed

Nie, Li-Xing; Zhang, Ye; Zhang, Nan-Ping; Hu, Xiao-Ru; Kang, Shuai; Hou, Jian-Zhong; Dai, Zhong; Ma, Shuang-Cheng

2016-10-01

Application of microscopic spectroscopy in quality control of Niuhuang Qingxin pills was discussed. First, microscopic characteristics specified by the statutory standard of Niuhuang Qingxin pills were summarized. Then new identification method was established for Dioscoreae Rhizoma, Saigae Tataricae Cornu, Cinnamomi Cortex and Saposhnikoviae Radix. Finally, microscopic spectroscopy was used for test of Dioscoreae Rhizoma's adulterant Dioscoreae Fordii Rhizoma.It was the first time for this technology being applied in adulteration test of Chinese patent medicine.The results showed that Saigae Tataricae Cornu was not detected in 2 batches of Niuhuang Qingxin pills from 1 manufacturer while Dioscoreae Fordii Rhizoma was detected in 3 batches of samples from 2 manufacturers. The proposed methods were accurate, simple, rapid, objective and economic, which offered a more comprehensive approach for quality control of Niuhuang Qingxin pills. It was indicated that conventional technology such as microscopic spectroscopy could play an important role in identification of traditional Chinese medicine whose index ingredient was deficient or tiny. Copyright© by the Chinese Pharmaceutical Association.

78 FR 26251 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Revisions to Control of Air...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-06

... ovens used in wet-laid non-woven fiber mat manufacturing operations when nitrogen containing resins or other additives are used. These two actions affect NOx sources operating in the Dallas Fort-Worth (DFW... include low-temperature drying ovens and curing ovens used in wet-laid, non-woven fiber mat manufacturing...

46 CFR 160.047-5 - Inspections and tests. 1

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 6 2010-10-01 2010-10-01 false Inspections and tests. 1 160.047-5 Section 160.047-5... and Child § 160.047-5 Inspections and tests. 1 1 The manufacturer of a personal flotation device must... labeled buoyant vests shall— (1) Maintain quality control of the materials used, the manufacturing methods...

46 CFR 160.047-5 - Inspections and tests. 1

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 6 2011-10-01 2011-10-01 false Inspections and tests. 1 160.047-5 Section 160.047-5... and Child § 160.047-5 Inspections and tests. 1 1 The manufacturer of a personal flotation device must... labeled buoyant vests shall— (1) Maintain quality control of the materials used, the manufacturing methods...

46 CFR 160.060-7 - Inspections and tests-standard and nonstandard vests. 1

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 6 2010-10-01 2010-10-01 false Inspections and tests-standard and nonstandard vests. 1... and nonstandard vests. 1 1 The manufacturer of a personal flotation device must meet 33 CFR 181.701... shall— (1) Maintain quality control of the materials used, the manufacturing methods, and the finished...

46 CFR 160.060-7 - Inspections and tests-standard and nonstandard vests. 1

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 6 2011-10-01 2011-10-01 false Inspections and tests-standard and nonstandard vests. 1... and nonstandard vests. 1 1 The manufacturer of a personal flotation device must meet 33 CFR 181.701... shall— (1) Maintain quality control of the materials used, the manufacturing methods, and the finished...

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

Code of Federal Regulations, 2010 CFR

2010-01-01

... byproduct material and designed to protect life or property from fires and airborne hazards, or to initially... submits sufficient information relating to the design, manufacture, prototype testing, quality control... paragraphs (b) (3) and (12) of this section; (5) Details of construction and design of the product as related...

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

Code of Federal Regulations, 2012 CFR

2012-01-01

... byproduct material and designed to protect life or property from fires and airborne hazards, or to initially... submits sufficient information relating to the design, manufacture, prototype testing, quality control... paragraphs (b) (3) and (12) of this section; (5) Details of construction and design of the product as related...

Creativity: the key to breakthrough changes, how teaming can harness collective knowledge.

PubMed

Helle, P F

1999-08-01

Our nation's industries do not want for concepts, philosophies or ideas to improve effectiveness. Just-in-Time, continuous improvement, re-engineering, world-class manufacturing, time compression, manufacturing excellence, total quality control, and theory of constraints are examples of approaches to improving our businesses. All have merit and are, to some degree, related.

Enhancing cell and gene therapy manufacture through the application of advanced fluorescent optical sensors (Review).

PubMed

Harrison, Richard P; Chauhan, Veeren M

2017-12-15

Cell and gene therapies (CGTs) are examples of future therapeutics that can be used to cure or alleviate the symptoms of disease, by repairing damaged tissue or reprogramming defective genetic information. However, despite the recent advancements in clinical trial outcomes, the path to wide-scale adoption of CGTs remains challenging, such that the emergence of a "blockbuster" therapy has so far proved elusive. Manufacturing solutions for these therapies require the application of scalable and replicable cell manufacturing techniques, which differ markedly from the existing pharmaceutical incumbent. Attempts to adopt this pharmaceutical model for CGT manufacture have largely proved unsuccessful. The most significant challenges facing CGT manufacturing are process analytical testing and quality control. These procedures would greatly benefit from improved sensory technologies that allow direct measurement of critical quality attributes, such as pH, oxygen, lactate and glucose. In turn, this would make manufacturing more robust, replicable and standardized. In this review, the present-day state and prospects of CGT manufacturing are discussed. In particular, the authors highlight the role of fluorescent optical sensors, focusing on their strengths and weaknesses, for CGT manufacture. The review concludes by discussing how the integration of CGT manufacture and fluorescent optical sensors could augment future bioprocessing approaches.

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.

21 CFR 225.58 - Laboratory controls.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Laboratory controls. 225.58 Section 225.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.58 Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure of...

21 CFR 225.58 - Laboratory controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Laboratory controls. 225.58 Section 225.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.58 Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure of...

21 CFR 225.58 - Laboratory controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Laboratory controls. 225.58 Section 225.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.58 Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure of...

The preanalytical optimization of blood cultures: a review and the clinical importance of benchmarking in 5 Belgian hospitals.

PubMed

Willems, Elise; Smismans, Annick; Cartuyvels, Reinoud; Coppens, Guy; Van Vaerenbergh, Kristien; Van den Abeele, Anne-Marie; Frans, Johan

2012-05-01

Bloodstream infections remain a major challenge in medicine. Optimal detection of pathogens is only possible if the quality of preanalytical factors is thoroughly controlled. Since the laboratory is responsible for this preanalytical phase, the quality control of critical factors should be integrated in its quality control program. The numerous recommendations regarding blood culture collection contain controversies. Only an unambiguous guideline permits standardization and interlaboratory quality control. We present an evidence-based concise guideline of critical preanalytical determinants for blood culture collection and summarize key performance indicators with their concomitant target values. In an attempt to benchmark, we compared the true-positive rate, contamination rate, and collected blood volume of blood culture bottles in 5 Belgian hospital laboratories. The true-positive blood culture rate fell within previously defined acceptation criteria by Baron et al. (2005) in all 5 hospitals, whereas the contamination rate exceeded the target value in 4 locations. Most unexpected, in each of the 5 laboratories, more than one third of the blood culture bottles were incorrectly filled, irrespective of the manufacturer of the blood culture vials. As a consequence of this shortcoming, one manufacturer recently developed an automatic blood volume monitoring system. In conclusion, clear recommendations for standardized blood culture collection combined with quality control of critical factors of the preanalytical phase are essential for diagnostic blood culture improvement. Copyright © 2012 Elsevier Inc. All rights reserved.

Manufacture of fiber-epoxy test specimens: Including associated jigs and instrumentation

NASA Technical Reports Server (NTRS)

Mathur, S. B.; Felbeck, D. K.

1980-01-01

Experimental work on the manufacture and strength of graphite-epoxy composites is considered. The correct data and thus a true assessment of the strength properties based on a proper and scientifically modeled test specimen with engineered design, construction, and manufacture has led to claims of a very broad spread in optimized values. Such behavior is in the main due to inadequate control during manufacture of test specimen, improper curing, and uneven scatter in the fiber orientation. The graphite fibers are strong but brittle. Even with various epoxy matrices and volume fraction, the fracture toughness is still relatively low. Graphite-epoxy prepreg tape was investigated as a sandwich construction with intermittent interlaminar bonding between the laminates in order to produce high strength, high fracture toughness composites. The quality and control of manufacture of the multilaminate test specimen blanks was emphasized. The dimensions, orientation and cure must be meticulous in order to produce the desired mix.

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.

24 CFR 982.621 - Manufactured home: Housing quality standards.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 24 Housing and Urban Development 4 2011-04-01 2011-04-01 false Manufactured home: Housing quality... Types Manufactured Home § 982.621 Manufactured home: Housing quality standards. A manufactured home must meet all the HQS performance requirements and acceptability criteria in § 982.401. A manufactured home...

24 CFR 982.621 - Manufactured home: Housing quality standards.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 24 Housing and Urban Development 4 2012-04-01 2012-04-01 false Manufactured home: Housing quality... Types Manufactured Home § 982.621 Manufactured home: Housing quality standards. A manufactured home must meet all the HQS performance requirements and acceptability criteria in § 982.401. A manufactured home...

24 CFR 982.621 - Manufactured home: Housing quality standards.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Manufactured home: Housing quality... Types Manufactured Home § 982.621 Manufactured home: Housing quality standards. A manufactured home must meet all the HQS performance requirements and acceptability criteria in § 982.401. A manufactured home...

24 CFR 982.621 - Manufactured home: Housing quality standards.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 24 Housing and Urban Development 4 2013-04-01 2013-04-01 false Manufactured home: Housing quality... Types Manufactured Home § 982.621 Manufactured home: Housing quality standards. A manufactured home must meet all the HQS performance requirements and acceptability criteria in § 982.401. A manufactured home...

24 CFR 982.621 - Manufactured home: Housing quality standards.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 24 Housing and Urban Development 4 2014-04-01 2014-04-01 false Manufactured home: Housing quality... Types Manufactured Home § 982.621 Manufactured home: Housing quality standards. A manufactured home must meet all the HQS performance requirements and acceptability criteria in § 982.401. A manufactured home...

21 CFR 820.30 - Design controls.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Design controls. 820.30 Section 820.30 Food and... QUALITY SYSTEM REGULATION Design Controls § 820.30 Design controls. (a) General. (1) Each manufacturer of..., shall establish and maintain procedures to control the design of the device in order to ensure that...

21 CFR 820.30 - Design controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Design controls. 820.30 Section 820.30 Food and... QUALITY SYSTEM REGULATION Design Controls § 820.30 Design controls. (a) General. (1) Each manufacturer of..., shall establish and maintain procedures to control the design of the device in order to ensure that...

21 CFR 820.30 - Design controls.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Design controls. 820.30 Section 820.30 Food and... QUALITY SYSTEM REGULATION Design Controls § 820.30 Design controls. (a) General. (1) Each manufacturer of..., shall establish and maintain procedures to control the design of the device in order to ensure that...

21 CFR 820.30 - Design controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Design controls. 820.30 Section 820.30 Food and... QUALITY SYSTEM REGULATION Design Controls § 820.30 Design controls. (a) General. (1) Each manufacturer of..., shall establish and maintain procedures to control the design of the device in order to ensure that...

21 CFR 820.30 - Design controls.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Design controls. 820.30 Section 820.30 Food and... QUALITY SYSTEM REGULATION Design Controls § 820.30 Design controls. (a) General. (1) Each manufacturer of..., shall establish and maintain procedures to control the design of the device in order to ensure that...

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...

The confusion in complying with good manufacturing practice requirements in Malaysia

NASA Astrophysics Data System (ADS)

Jali, Mohd Bakri; Ghani, Maaruf Abdul; Nor, Norazmir Md

2016-11-01

Food manufacturing operations need to fulfil regulatory requirements related to hygiene and good manufacturing practices (GMP) to successfully market their products as safe and quality products. GMP based on its ten elements used as guidelines to ensure control over biological, chemical and physical hazards. This study aims to investigate the confusion for design and facilities elements among food industries. Both qualitative and quantitative techniques are used as systematic tools. Design and facilities elements lay a firm foundation for good manufacturing practice to ensure food hygiene and should be used in conjunction with each specific code of hygiene practice and guidelines.

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

PubMed

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

2013-01-01

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

Using 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.

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.

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.

Quality Control System using Simple Implementation of Seven Tools for Batik Textile Manufacturing

NASA Astrophysics Data System (ADS)

Ragil Suryoputro, Muhammad; Sugarindra, Muchamad; Erfaisalsyah, Hendy

2017-06-01

In order to produce better products and mitigate defect in products, every company must implement a quality control system. Company will find means to implement a quality control system that is capable and reliable. One of the methods is using the simple implementation of the seven tools in quality control defects. The case studied in this research was the level of disability xyz grey fabric on a shuttle loom 2 on the Batik manufacturing company. The seven tools that include: flowchart, check sheet, histogram, scatter diagram combined with control charts, Pareto diagrams and fishbone diagrams (causal diagram). Check sheet results obtained types of defects in the grey fabric was woven xyz is warp, double warp, the warp break, double warp, empty warp, warp tenuous, ugly edges, thick warp, and rust. Based on the analysis of control chart indicates that the process is out of control. This can be seen in the graph control where there is still a lot of outlier data. Based on a scatter diagram shows a positive correlation between the percentage of disability and the number of production. Based on Pareto diagram, repair needs priority is for the dominant type of defect is warp (44%) and based on double warp value histogram is also the highest with a value of 23635.11 m. In addition, based on the analysis of the factors causing defect by fishbone diagram double warp or other types of defects originating from the materials, methods, machines, measurements, man and environment. Thus the company can take to minimize the prevention and repair of defects and improve product quality.

Quality control of commercial bovine lactoferrin.

PubMed

Wakabayashi, Hiroyuki; Yamauchi, Koji; Abe, Fumiaki

2018-06-01

Herein we review commercial bovine lactoferrin quality issues by describing an example of industrial production, the current status of global quality standardization, and quality-activity concerns for further discussion. Morinaga Milk Industry has been industrially producing bovine lactoferrin in Milei GmbH, Germany, since 1989. We delineate its production and quality as an example of safe and high-quality manufacturing. Currently, global standardization in the quality of bovine lactoferrin is progressing through Novel Food and GRAS in the EU and USA, respectively. Novel Food was applied or notified to seven lactoferrin manufacturers and GRAS was notified to three manufacturers, two of which are for infant use and one is for adult use, by the end of 2017. The specifications of these regulations are relatively high, including more than 95% lactoferrin purity in protein, which means that such companies can supply relatively high-grade lactoferrin. There appear to be several concerns regarding lactoferrin quality affecting activities, including contamination of lipopolysaccharide (LPS) and angiogenin, purity, and degradation of lactoferrin sample. Although LPS is immunologically toxic when invading the body, it is distributed normally in foods and the gut. However, an industrial lactoferrin sample may contain LPS at a maximum LPS/lactoferrin molecule ratio = 1/1724, which means 99.9% of the lactoferrin molecule is LPS-free. It is difficult to speculate that LPS contained in a lactoferrin sample affects its activities. Finally in order to achieve good and reproducible results, we make proposals to researchers a use of high-grade lactoferrin, careful storage, and indication the manufacturers' names and specifications in the paper.

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.

WHO Expert Committee on Biological Standardization.

PubMed

2002-01-01

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and quality control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on issues relevant to international guidelines, recommendations and other matters related to the manufacture and quality control of biologicals. This is followed by information on the status and development of reference materials for bovine spongiform encephalopathy, various antigens, blood products, cytokines, growth factors and endocrinological substances. The second part of the report, of particular interest to manufacturers and national control authorities, contains sets of recommendations for the production and control of poliomyelitis vaccine (oral) and poliomyelitis vaccine (inactivated) and guidelines for the production and control of live attenuated Japanese encephalitis vaccine. Also included are lists of recommendations and guidelines for biological substances used in medicine, and other relevant documents.

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

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...

A quality system for PET: An industry perspective

NASA Astrophysics Data System (ADS)

Zigler, Steven S.; Breslow, Kenneth; Nazerias, Michael

2005-12-01

Quality systems have been employed in a variety of industries to develop and supply products that meet customer expectations and regulatory requirements. Most quality systems address organizational structure, design controls, production, complaints, audits, corrective actions and preventive actions. This paper describes PETNET's efforts to develop a quality system for use in the production of PET tracers. Our goal is to ensure quality products and to facilitate compliance with impending PET good manufacturing practice (GMP) regulations.

The Papers Printing Quality Complex Assessment Algorithm Development Taking into Account the Composition and Production Technological Features

NASA Astrophysics Data System (ADS)

Babakhanova, Kh A.; Varepo, L. G.; Nagornova, I. V.; Babluyk, E. B.; Kondratov, A. P.

2018-04-01

Paper is one of the printing system key components causing the high-quality printed products output. Providing the printing companies with the specified printing properties paper, while simultaneously increasing the paper products range and volume by means of the forecasting methods application and evaluation during the production process, is certainly a relevant problem. The paper presents the printing quality control algorithm taking into consideration the paper printing properties quality assessment depending on the manufacture technological features and composition variation. The information system including raw material and paper properties data and making possible pulp and paper enterprises to select paper composition optimal formulation is proposed taking into account the printing process procedure peculiarities of the paper manufacturing with specified printing properties.

21 CFR 226.40 - Production and control procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Production and control procedures. 226.40 Section 226.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control...

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.

48 CFR 552.246-70 - Source Inspection by Quality Approved Manufacturer.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Quality Approved Manufacturer. 552.246-70 Section 552.246-70 Federal Acquisition Regulations System... Provisions and Clauses 552.246-70 Source Inspection by Quality Approved Manufacturer. As prescribed in 546.302-70, insert the following clause: Source Inspection by Quality Approved Manufacturer (JUL 09) (a...

48 CFR 552.246-70 - Source Inspection by Quality Approved Manufacturer.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Quality Approved Manufacturer. 552.246-70 Section 552.246-70 Federal Acquisition Regulations System... Provisions and Clauses 552.246-70 Source Inspection by Quality Approved Manufacturer. As prescribed in 546.302-70, insert the following clause: Source Inspection by Quality Approved Manufacturer (JUL 09) (a...

46 CFR 160.049-5 - Inspections and tests. 1

Code of Federal Regulations, 2014 CFR

2014-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Cushion Plastic Foam § 160.049-5... maintain quality control of the materials used, manufacturing methods and the finished product so as to... samples and components produced to maintain the quality of the finished product. Records of tests...

46 CFR 160.049-5 - Inspections and tests. 1

Code of Federal Regulations, 2012 CFR

2012-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Cushion Plastic Foam § 160.049-5... maintain quality control of the materials used, manufacturing methods and the finished product so as to... samples and components produced to maintain the quality of the finished product. Records of tests...

46 CFR 160.049-5 - Inspections and tests. 1

Code of Federal Regulations, 2013 CFR

2013-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Cushion Plastic Foam § 160.049-5... maintain quality control of the materials used, manufacturing methods and the finished product so as to... samples and components produced to maintain the quality of the finished product. Records of tests...

Accountability Indicators from the Viewpoint of Statistical Method.

ERIC Educational Resources Information Center

Jordan, Larry

Few people seriously regard students as "products" coming off an educational assembly line, but notions about accountability and quality improvement in higher education are pervaded by manufacturing ideas and metaphors. Because numerical indicators of quality are inevitably expressed by trend lines or statistical control chars of some kind, they…

75 FR 59973 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Control of Volatile...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-29

...; Cleaning of high precision optics; Stripping; Janitorial cleaning; cleaning of resin, coating, ink, and... laboratories; Cleaning operations in medical device or pharmaceutical manufacturing; and Cleaning operations related to performance or quality assurance testing of coatings, inks, or adhesives. COMAR 26.11.19.09-1...

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

PubMed

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

2018-01-01

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

[Quality control of Guci tablets using UPLC-ELSD fingerprint analysis coupled with chemometrics].

PubMed

Wang, Ya-Dan; Dai, Zhong; Sun, Cai-Lin; Wu, Xian-Fu; Ma, Shuang-Cheng

2018-03-01

Ultra-performance liquid chromatography-evaporative light scattering detection (UPLC-ELSD) fingerprint analysis method was established for quality control of Guci tablets. Chromatographic separation was performed on Waters Acquity UPLC BEH C₁₈ column (2.1 mm×100 mm, 1.7 μm) at 30 °C of column temperature. Acetonitrile-0.1% formic acid solution was adopted as mobile phase for gradient elution. The flow rate was set at 0.3 mL·min⁻¹, and the injection volume was 3 μL. Detection was carried out on an ELSD with a nitrogen pressure of 0.28 MPa, drift tube temperature of 60 °C, and gain of 400. A total of 39 batches of samples produced by six manufacturers were measured by using the above method and the data were analyzed by ChemPattern software. The peak present in more than 75% of the samples was defined as a common peak, and 30 common peaks were determined. Among them, 19 peaks were identified by rapid resolution liquid chromatography/tandem mass spectrometry (RRLC-MS/MS) method, 16 of which were confirmed by reference substances. The similarity of the tested samples was 0.47-0.98, suggesting that the quality of the samples from different manufacturers varied greatly. Furthermore, principal component analysis (PCA) and hierarchical analysis (HCA) were performed to clarify the main different components in samples. The results indicated that there might be some feeding problems about Paeoniae Radix Alba, Notoginseng Radix et Rhizoma, and Clematidis Radix et Rhizoma in a few manufacturers. This study provided some evidences for the overall quality control of Guci tablets, as well as its quality standard improvements. Copyright© by the Chinese Pharmaceutical Association.

WHO Expert Committee on specifications for pharmaceutical preparations.

PubMed

2010-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: good practices for pharmaceutical quality control laboratories; supplementary guidelines for active pharmaceutical ingredients; good manufacturing practices for pharmaceutical products containing hazardous substances; good manufacturing practices for sterile pharmaceutical products; good distribution practices for pharmaceutical products; guidelines on the requalification of prequalified dossiers: and guidelines for the preparation of a contract research organization master file.

Quality assurance program guidelines for application to and use by manufacturers of rail/guideway vehicles, buses, automatic train control systems, and their major subsystems

NASA Technical Reports Server (NTRS)

Witkin, S. A.

1976-01-01

Guidelines are presented for a quality assurance system to be implemented by the manufacturer in support of designing, developing, fabricating, assembling, inspecting, testing, handling, and delivery of equipment being procured for use in public urban mass transit systems. The guidelines apply to this equipment when being procured for: (1) use in revenue service; (2) demonstration of systems that will be revenue producing or used by the public; (3) use as a prototype for follow-on operational/revenue producing equipment procurements; and (4) qualification tests.

A risk-based auditing process for pharmaceutical manufacturers.

PubMed

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

2014-01-01

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

Surface evaluation of orthopedic hip implants marketed in Brazil

NASA Astrophysics Data System (ADS)

Souza, M. M.; Trommer, R. M.; Maru, M. M.; Roesler, C. R. M.; Barros, W. S.; Dutra, M. S.

2016-07-01

One of the factors that contribute to the quality of total hip prostheses is the degree of accuracy in the manufacturing of the joint surfaces. The dimensional control of joint components is important because of its direct influence on the durability and, consequently, in the patients’ life quality. This work presents studies on the form and roughness of orthopedic hip prostheses marketed in Brazil. The results provide data for quality control of the surfaces of the femoral heads and acetabular components of hip prostheses and indicate the need of improvement in the procedures used to this control.

Quality controls in cellular immunotherapies: rapid assessment of clinical grade dendritic cells by gene expression profiling.

PubMed

Castiello, Luciano; Sabatino, Marianna; Zhao, Yingdong; Tumaini, Barbara; Ren, Jiaqiang; Ping, Jin; Wang, Ena; Wood, Lauren V; Marincola, Francesco M; Puri, Raj K; Stroncek, David F

2013-02-01

Cell-based immunotherapies are among the most promising approaches for developing effective and targeted immune response. However, their clinical usefulness and the evaluation of their efficacy rely heavily on complex quality control assessment. Therefore, rapid systematic methods are urgently needed for the in-depth characterization of relevant factors affecting newly developed cell product consistency and the identification of reliable markers for quality control. Using dendritic cells (DCs) as a model, we present a strategy to comprehensively characterize manufactured cellular products in order to define factors affecting their variability, quality and function. After generating clinical grade human monocyte-derived mature DCs (mDCs), we tested by gene expression profiling the degrees of product consistency related to the manufacturing process and variability due to intra- and interdonor factors, and how each factor affects single gene variation. Then, by calculating for each gene an index of variation we selected candidate markers for identity testing, and defined a set of genes that may be useful comparability and potency markers. Subsequently, we confirmed the observed gene index of variation in a larger clinical data set. In conclusion, using high-throughput technology we developed a method for the characterization of cellular therapies and the discovery of novel candidate quality assurance markers.

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.

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

NASA Astrophysics Data System (ADS)

Rusch, Peter

2014-10-01

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

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.

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.

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.

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.

Motto: We work for people and environment

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

Barcik, M.

1995-12-31

This target has been under Danfoss realization for over 60 years, both in Denmark and all over the world. The operational range of the enterprise: is very wide. Danfoss manufactures a large assortment of products, starting from heat automatic control systems, through heat metering devices, industrial and refrigeration automatic control, compressors, flow meters, frequency converters, control systems, and monitoring. The four mainstays of the business activity are based on: high quality products; advanced manufacturing technology; care of the environment, and engagement of the staff. Since 1992 Danfoss has been manufacturing heat radiator thermostats in Poland. A unique solution - namelymore » the use of a gas thermostatic head secures the highest energy savings and operational reliability. In 1993, Danfoss as the sixth company in Poland and the first in its business field, gained a ISO 9002 certificate.« less

Use of near-infrared spectroscopy and multipoint measurements for quality control of pharmaceutical drug products.

PubMed

Boiret, Mathieu; Chauchard, Fabien

2017-01-01

Near-infrared (NIR) spectroscopy is a non-destructive analytical technique that enables better-understanding and optimization of pharmaceutical processes and final drug products. The use in line is often limited by acquisition speed and sampling area. This work focuses on performing a multipoint measurement at high acquisition speed at the end of the manufacturing process on a conveyor belt system to control both the distribution and the content of active pharmaceutical ingredient within final drug products, i.e., tablets. A specially designed probe with several collection fibers was developed for this study. By measuring spectral and spatial information, it provides physical and chemical knowledge on the final drug product. The NIR probe was installed on a conveyor belt system that enables the analysis of a lot of tablets. The use of these NIR multipoint measurement probes on a conveyor belt system provided an innovative method that has the potential to be used as a new paradigm to ensure the drug product quality at the end of the manufacturing process and as a new analytical method for the real-time release control strategy. Graphical abstract Use of near-infrared spectroscopy and multipoint measurements for quality control of pharmaceutical drug products.

A multiple objective optimization approach to quality control

NASA Technical Reports Server (NTRS)

Seaman, Christopher Michael

1991-01-01

The use of product quality as the performance criteria for manufacturing system control is explored. The goal in manufacturing, for economic reasons, is to optimize product quality. The problem is that since quality is a rather nebulous product characteristic, there is seldom an analytic function that can be used as a measure. Therefore standard control approaches, such as optimal control, cannot readily be applied. A second problem with optimizing product quality is that it is typically measured along many dimensions: there are many apsects of quality which must be optimized simultaneously. Very often these different aspects are incommensurate and competing. The concept of optimality must now include accepting tradeoffs among the different quality characteristics. These problems are addressed using multiple objective optimization. It is shown that the quality control problem can be defined as a multiple objective optimization problem. A controller structure is defined using this as the basis. Then, an algorithm is presented which can be used by an operator to interactively find the best operating point. Essentially, the algorithm uses process data to provide the operator with two pieces of information: (1) if it is possible to simultaneously improve all quality criteria, then determine what changes to the process input or controller parameters should be made to do this; and (2) if it is not possible to improve all criteria, and the current operating point is not a desirable one, select a criteria in which a tradeoff should be made, and make input changes to improve all other criteria. The process is not operating at an optimal point in any sense if no tradeoff has to be made to move to a new operating point. This algorithm ensures that operating points are optimal in some sense and provides the operator with information about tradeoffs when seeking the best operating point. The multiobjective algorithm was implemented in two different injection molding scenarios: tuning of process controllers to meet specified performance objectives and tuning of process inputs to meet specified quality objectives. Five case studies are presented.

Quality controls for gamma cameras and PET cameras: development of a free open-source ImageJ program

NASA Astrophysics Data System (ADS)

Carlier, Thomas; Ferrer, Ludovic; Berruchon, Jean B.; Cuissard, Regis; Martineau, Adeline; Loonis, Pierre; Couturier, Olivier

2005-04-01

Acquisition data and treatments for quality controls of gamma cameras and Positron Emission Tomography (PET) cameras are commonly performed with dedicated program packages, which are running only on manufactured computers and differ from each other, depending on camera company and program versions. The aim of this work was to develop a free open-source program (written in JAVA language) to analyze data for quality control of gamma cameras and PET cameras. The program is based on the free application software ImageJ and can be easily loaded on any computer operating system (OS) and thus on any type of computer in every nuclear medicine department. Based on standard parameters of quality control, this program includes 1) for gamma camera: a rotation center control (extracted from the American Association of Physics in Medicine, AAPM, norms) and two uniformity controls (extracted from the Institute of Physics and Engineering in Medicine, IPEM, and National Electronic Manufacturers Association, NEMA, norms). 2) For PET systems, three quality controls recently defined by the French Medical Physicist Society (SFPM), i.e. spatial resolution and uniformity in a reconstructed slice and scatter fraction, are included. The determination of spatial resolution (thanks to the Point Spread Function, PSF, acquisition) allows to compute the Modulation Transfer Function (MTF) in both modalities of cameras. All the control functions are included in a tool box which is a free ImageJ plugin and could be soon downloaded from Internet. Besides, this program offers the possibility to save on HTML format the uniformity quality control results and a warning can be set to automatically inform users in case of abnormal results. The architecture of the program allows users to easily add any other specific quality control program. Finally, this toolkit is an easy and robust tool to perform quality control on gamma cameras and PET cameras based on standard computation parameters, is free, run on any type of computer and will soon be downloadable from the net (http://rsb.info.nih.gov/ij/plugins or http://nucleartoolkit.free.fr).

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.

Application of the Critical Success Factor Methodology to DoD Organization.

DTIC Science & Technology

1984-09-01

high technology manufacturing, banking, airline, insurance, railway, and automobile . Sullen (6t22-25) lists the current CSFs of the 14 S automobile ...industry as image, quality dealer system, cost control, and meting energy standards. However, in 1981 the automobile CSFs included only styling, quality...bearing on current car purchases as well as future car buys. And finally cost control influenced the auto industry as a CSF, since profit per automobile had

New & Special Grad School Programs.

ERIC Educational Resources Information Center

Ross, Steven S.

1988-01-01

Discusses some special Master of Science in engineering (MS) programs including manufacturing and quality control, safety engineering, transportation engineering, and computer related areas. Gives a table showing MS degrees, institutions, and faculty. (YP)

The use of fatigue tests in the manufacture of automotive steel wheels.

NASA Astrophysics Data System (ADS)

Drozyner, P.; Rychlik, A.

2016-08-01

Production for the automotive industry must be particularly sensitive to the aspect of safety and reliability of manufactured components. One of such element is the rim, where durability is a feature which significantly affects the safety of transport. Customer complaints regarding this element are particularly painful for the manufacturer because it is almost always associated with the event of accident or near-accident. Authors propose original comprehensive method of quality control at selected stages of rims production: supply of materials, production and pre-shipment inspections. Tests by the proposed method are carried out on the originally designed inertial fatigue machine The machine allows bending fatigue tests in the frequency range of 0 to 50 Hz at controlled increments of vibration amplitude. The method has been positively verified in one of rims factory in Poland. Implementation resulted in an almost complete elimination of complaints resulting from manufacturing and material errors.

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.

76 FR 64237 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Adhesives and Sealants Rule

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-18

... chemical production and polytetrafluoroethylene operations; from paint, resin, and adhesive manufacturing... miscellaneous industrial adhesives control techniques guideline (CTG) category in accordance with the... to COMAR 26.11.19.30 ``Control of VOC from Chemical Production and Polytetrafluoroethylene Operations...

An Application of Six Sigma to Reduce Supplier Quality Cost

NASA Astrophysics Data System (ADS)

Gaikwad, Lokpriya Mohanrao; Teli, Shivagond Nagappa; Majali, Vijay Shashikant; Bhushi, Umesh Mahadevappa

2016-01-01

This article presents an application of Six Sigma to reduce supplier quality cost in manufacturing industry. Although there is a wider acceptance of Six Sigma in many organizations today, there is still a lack of in-depth case study of Six Sigma. For the present research the case study methodology was used. The company decided to reduce quality cost and improve selected processes using Six Sigma methodologies. Regarding the fact that there is a lack of case studies dealing with Six Sigma especially in individual manufacturing organization this article could be of great importance also for the practitioners. This paper discusses the quality and productivity improvement in a supplier enterprise through a case study. The paper deals with an application of Six Sigma define-measure-analyze-improve-control methodology in an industry which provides a framework to identify, quantify and eliminate sources of variation in an operational process in question, to optimize the operation variables, improve and sustain performance viz. process yield with well-executed control plans. Six Sigma improves the process performance (process yield) of the critical operational process, leading to better utilization of resources, decreases variations and maintains consistent quality of the process output.

Guidelines for Risk-Based Changeover of Biopharma Multi-Product Facilities.

PubMed

Lynch, Rob; Barabani, David; Bellorado, Kathy; Canisius, Peter; Heathcote, Doug; Johnson, Alan; Wyman, Ned; Parry, Derek Willison

2018-01-01

In multi-product biopharma facilities, the protection from product contamination due to the manufacture of multiple products simultaneously is paramount to assure product quality. To that end, the use of traditional changeover methods (elastomer change-out, full sampling, etc.) have been widely used within the industry and have been accepted by regulatory agencies. However, with the endorsement of Quality Risk Management (1), the use of risk-based approaches may be applied to assess and continuously improve established changeover processes. All processes, including changeover, can be improved with investment (money/resources), parallel activities, equipment design improvements, and standardization. However, processes can also be improved by eliminating waste. For product changeover, waste is any activity not needed for the new process or that does not provide added assurance of the quality of the subsequent product. The application of a risk-based approach to changeover aligns with the principles of Quality Risk Management. Through the use of risk assessments, the appropriate changeover controls can be identified and controlled to assure product quality is maintained. Likewise, the use of risk assessments and risk-based approaches may be used to improve operational efficiency, reduce waste, and permit concurrent manufacturing of products. © PDA, Inc. 2018.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2003-01-01

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities and pharmaceutical manufacturers, the report discusses activities related to the development of The International Pharmacopoeia and basic tests for pharmaceutical substances and dosage forms, as well as quality control of reference materials, good manufacturing practices (GMP), stability studies, inspection, hazard analysis, procurement, storage and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including recommendations on the risk of transmitting animal spongiform encephalopathy agents via medicinal products, guidelines on GMP for pharmaceutical products, a model certificate for GMP and guidance on a GMP inspection report. The final annexes provide guidance on the application of Hazard Analysis and Critical Control Point (HACCP) method to pharmaceuticals, good storage practices and a procedure for assessing acceptability of pharmaceutical products for purchase by United Nations agencies.

Postproduction Handling and Administration of Protein Pharmaceuticals and Potential Instability Issues.

PubMed

Nejadnik, M Reza; Randolph, Theodore W; Volkin, David B; Schöneich, Christian; Carpenter, John F; Crommelin, Daan J A; Jiskoot, Wim

2018-04-14

The safety and efficacy of protein pharmaceuticals depend not only on biological activity but also on purity levels. Impurities may be process related because of limitations in manufacturing or product related because of protein degradation occurring throughout the life history of a product. Although the pharmaceutical biotechnology industry has made great progress in improving bulk and drug product manufacturing as well as company-controlled storage and transportation conditions to minimize the level of degradation, there is less control over the many factors that may subsequently affect product quality after the protein pharmaceuticals are released and shipped by the manufacturer. Routine handling or unintentional mishandling of therapeutic protein products may cause protein degradation that remains unnoticed but can potentially compromise the clinical safety and efficacy of the product. In this commentary, we address some potential risks associated with (mis)handling of protein pharmaceuticals after release by the manufacturer. We summarize the environmental stress factors that have been shown to cause protein degradation and that may be encountered during typical handling procedures of protein pharmaceuticals in a hospital setting or during self-administration by patients. Moreover, we provide recommendations for improvements in product handling to help ensure the quality of protein pharmaceuticals during use. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Good manufacturing practice and viral safety.

PubMed

Kerner, B

1995-07-01

The concept of virus inactivation during the manufacture of blood products raises questions about possible recontamination of the product by the environment. A strict regime of good manufacturing practice (GMP) is mandatory. The guidelines originally issued by the World Health Organization (WHO), and now law in most countries, are an excellent basis for the operation of a production plant. The following elements of GMP require special concern: (i) All functions shall be defined in a clear organization chart. (ii) Personnel shall be appropriately trained for the job and to perfect hygiene. (iii) Buildings and facilities, as well as supply systems, shall exclude the possibility of recontamination of already virus-inactivated materials. (iv) Equipment shall be easy to clean and fully sterilizable. (v) Production shall follow appropriate written procedures. (vi) The Quality Control Organization shall monitor the process by in-process controls and review the records for possible deviations. All GMP issues are coordinated by a Quality Assurance Organization that also reviews the overall performance of the operation. The maintenance of viral safety of the products basically depends upon the full commitment of all bodies involved to proper and non-negotiable GMP.

Virtual environment assessment for laser-based vision surface profiling

NASA Astrophysics Data System (ADS)

ElSoussi, Adnane; Al Alami, Abed ElRahman; Abu-Nabah, Bassam A.

2015-03-01

Oil and gas businesses have been raising the demand from original equipment manufacturers (OEMs) to implement a reliable metrology method in assessing surface profiles of welds before and after grinding. This certainly mandates the deviation from the commonly used surface measurement gauges, which are not only operator dependent, but also limited to discrete measurements along the weld. Due to its potential accuracy and speed, the use of laser-based vision surface profiling systems have been progressively rising as part of manufacturing quality control. This effort presents a virtual environment that lends itself for developing and evaluating existing laser vision sensor (LVS) calibration and measurement techniques. A combination of two known calibration techniques is implemented to deliver a calibrated LVS system. System calibration is implemented virtually and experimentally to scan simulated and 3D printed features of known profiles, respectively. Scanned data is inverted and compared with the input profiles to validate the virtual environment capability for LVS surface profiling and preliminary assess the measurement technique for weld profiling applications. Moreover, this effort brings 3D scanning capability a step closer towards robust quality control applications in a manufacturing environment.

Computer applications in scientific balloon quality control

NASA Astrophysics Data System (ADS)

Seely, Loren G.; Smith, Michael S.

Seal defects and seal tensile strength are primary determinants of product quality in scientific balloon manufacturing; they therefore require a unit of quality measure. The availability of inexpensive and powerful data-processing tools can serve as the basis of a quality-trends-discerning analysis of products. The results of one such analysis are presently given in graphic form for use on the production floor. Software descriptions and their sample outputs are presented, together with a summary of overall and long-term effects of these methods on product quality.

Emerging technology: A key enabler for modernizing pharmaceutical manufacturing and advancing product quality.

PubMed

O'Connor, Thomas F; Yu, Lawrence X; Lee, Sau L

2016-07-25

Issues in product quality have produced recalls and caused drug shortages in United States (U.S.) in the past few years. These quality issues were often due to outdated manufacturing technologies and equipment as well as lack of an effective quality management system. To ensure consistent supply of safe, effective and high-quality drug products available to the patients, the U.S. Food and Drug Administration (FDA) supports modernizing pharmaceutical manufacturing for improvements in product quality. Specifically, five new initiatives are proposed here to achieve this goal. They include: (i) advancing regulatory science for pharmaceutical manufacturing; (ii) establishing a public-private institute for pharmaceutical manufacturing innovation; (iii) creating incentives for investment in the technological upgrade of manufacturing processes and facilities; (iv) leveraging external expertise for regulatory quality assessment of emerging technologies; and (v) promoting the international harmonization of approaches for expediting the global adoption of emerging technologies. Published by Elsevier B.V.

The effect of laser focus and process parameters on microstructure and mechanical properties of SLM Inconel 718

NASA Astrophysics Data System (ADS)

Bean, Glenn E.; Witkin, David B.; McLouth, Tait D.; Zaldivar, Rafael J.

2018-02-01

Research on the selective laser melting (SLM) method of laser powder bed fusion additive manufacturing (AM) has shown that surface and internal quality of AM parts is directly related to machine settings such as laser energy density, scanning strategies, and atmosphere. To optimize laser parameters for improved component quality, the energy density is typically controlled via laser power, scanning rate, and scanning strategy, but can also be controlled by changing the spot size via laser focal plane shift. Present work being conducted by The Aerospace Corporation was initiated after observing inconsistent build quality of parts printed using OEM-installed settings. Initial builds of Inconel 718 witness geometries using OEM laser parameters were evaluated for surface roughness, density, and porosity while varying energy density via laser focus shift. Based on these results, hardware and laser parameter adjustments were conducted in order to improve build quality and consistency. Tensile testing was also conducted to investigate the effect of build plate location and laser settings on SLM 718. This work has provided insight into the limitations of OEM parameters compared with optimized parameters towards the goal of manufacturing aerospace-grade parts, and has led to the development of a methodology for laser parameter tuning that can be applied to other alloy systems. Additionally, evidence was found that for 718, which derives its strength from post-manufacturing heat treatment, there is a possibility that tensile testing may not be perceptive to defects which would reduce component performance. Ongoing research is being conducted towards identifying appropriate testing and analysis methods for screening and quality assurance.

Manufacturing Bms/Iso System Review

NASA Technical Reports Server (NTRS)

Gomez, Yazmin

2004-01-01

The Quality Management System (QMS) is one that recognizes the need to continuously change and improve an organization s products and services as determined by system feedback, and corresponding management decisions. The purpose of a Quality Management System is to minimize quality variability of an organization's products and services. The optimal Quality Management System balances the need for an organization to maintain flexibility in the products and services it provides with the need for providing the appropriate level of discipline and control over the processes used to provide them. The goal of a Quality Management System is to ensure the quality of the products and services while consistently (through minimizing quality variability) meeting or exceeding customer expectations. The GRC Business Management System (BMS) is the foundation of the Center's ISO 9001:2000 registered quality system. ISO 9001 is a quality system model developed by the International Organization for Standardization. BMS supports and promote the Glenn Research Center Quality Policy and wants to ensure the customer satisfaction while also meeting quality standards. My assignment during this summer is to examine the manufacturing processes used to develop research hardware, which in most cases are one of a kind hardware, made with non conventional equipment and materials. During this process of observation I will make a determination, based on my observations of the hardware development processes the best way to meet customer requirements and at the same time achieve the GRC quality standards. The purpose of my task is to review the manufacturing processes identifying opportunities in which to optimize the efficiency of the processes and establish a plan for implementation and continuous improvement.

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%.

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.

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.

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.

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)

Colorimetry as Quality Control Tool for Individual Inkjet-Printed Pediatric Formulations.

PubMed

Wickström, Henrika; Nyman, Johan O; Indola, Mathias; Sundelin, Heidi; Kronberg, Leif; Preis, Maren; Rantanen, Jukka; Sandler, Niklas

2017-02-01

Printing technologies were recently introduced to the pharmaceutical field for manufacturing of drug delivery systems. Printing allows on demand manufacturing of flexible pharmaceutical doses in a personalized manner, which is critical for a successful and safe treatment of patient populations with specific needs, such as children and the elderly, and patients facing multimorbidity. Printing of pharmaceuticals as technique generates new demands on the quality control procedures. For example, rapid quality control is needed as the printing can be done on demand and at the point of care. This study evaluated the potential use of a handheld colorimetry device for quality control of printed doses of vitamin Bs on edible rice and sugar substrates. The structural features of the substrates with and without ink were also compared. A multicomponent ink formulation with vitamin B 1 , B 2 , B 3 , and B 6 was developed. Doses (4 cm 2 ) were prepared by applying 1-10 layers of yellow ink onto the white substrates using thermal inkjet technology. The colorimetric method was seen to be viable in detecting doses up to the 5th and 6th printed layers until color saturation of the yellow color parameter (b*) was observed on the substrates. Liquid chromatography mass spectrometry was used as a reference method for the colorimetry measurements plotted against the number of printed layers. It was concluded that colorimetry could be used as a quality control tool for detection of different doses. However, optimization of the color addition needs to be done to avoid color saturation within the planned dose interval.

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.

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.

Statistical Methods for Quality Control of Steel Coils Manufacturing Process using Generalized Linear Models

NASA Astrophysics Data System (ADS)

García-Díaz, J. Carlos

2009-11-01

Fault detection and diagnosis is an important problem in process engineering. Process equipments are subject to malfunctions during operation. Galvanized steel is a value added product, furnishing effective performance by combining the corrosion resistance of zinc with the strength and formability of steel. Fault detection and diagnosis is an important problem in continuous hot dip galvanizing and the increasingly stringent quality requirements in automotive industry has also demanded ongoing efforts in process control to make the process more robust. When faults occur, they change the relationship among these observed variables. This work compares different statistical regression models proposed in the literature for estimating the quality of galvanized steel coils on the basis of short time histories. Data for 26 batches were available. Five variables were selected for monitoring the process: the steel strip velocity, four bath temperatures and bath level. The entire data consisting of 48 galvanized steel coils was divided into sets. The first training data set was 25 conforming coils and the second data set was 23 nonconforming coils. Logistic regression is a modeling tool in which the dependent variable is categorical. In most applications, the dependent variable is binary. The results show that the logistic generalized linear models do provide good estimates of quality coils and can be useful for quality control in manufacturing process.

Improving Quality of Shoe Soles Product using Six Sigma

NASA Astrophysics Data System (ADS)

Jesslyn Wijaya, Athalia; Trusaji, Wildan; Akbar, Muhammad; Ma’ruf, Anas; Irianto, Dradjad

2018-03-01

A manufacture in Bandung produce kind of rubber-based product i.e. trim, rice rollers, shoe soles, etc. After penetrating the shoe soles market, the manufacture has met customer with tight quality control. Based on the past data, defect level of this product was 18.08% that caused the manufacture’s loss of time and money. Quality improvement effort was done using six sigma method that included phases of define, measure, analyse, improve, and control (DMAIC). In the design phase, the object’s problem and definition were defined. Delphi method was also used in this phase to identify critical factors. In the measure phase, the existing process stability and sigma quality level were measured. Fishbone diagram and failure mode and effect analysis (FMEA) were used in the next phase to analyse the root cause and determine the priority issues. Improve phase was done by designing alternative improvement strategy using 5W1H method. Some improvement efforts were identified, i.e. (i) modifying design of the hanging rack, (ii) create pantone colour book and check sheet, (iii) provide pedestrian line at compound department, (iv) buying stop watch, and (v) modifying shoe soles dies. Some control strategies for continuous improvement were proposed such as SOP or reward and punishment 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.

The gallium melting-point standard: its role in manufacture and quality control of electronic thermometers for the clinical laboratory.

PubMed

Sostman, H E

1977-01-01

I discuss the traceability of calibration of electronic thermometers to thermometric constants of nature or to the National Bureau of Standards, form a manufacturer's basic standards through the manufacturing process to the user's laboratory. Useful electrical temperature sensors, their advantages, and means for resolving their disadvantages are described. I summarize our development of a cell for realizing the melting phase equilibrium of pure gallium (at 29.770 degrees C) as a thermometer calibration fixed point, and enumerate its advantages in the routine calibration verification of electrical thermometers in the clinical chemistry laboratory.

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.

40 CFR 86.612-97 - Suspension and revocation of certificates of conformity.

Code of Federal Regulations, 2010 CFR

2010-07-01

... ENGINES (CONTINUED) Selective Enforcement Auditing of New Light-Duty Vehicles, Light-Duty Trucks, and... control and/or quality assurance measures to be taken by the manufacturer to prevent the future occurrence...

48 CFR 225.7007-1 - Restrictions.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., quality control, testing, and welding (both forging and shot blasting process); and (2) The cost of the components manufactured in the United States exceeds 50 percent of the total cost of components. (b) 10 U.S.C...

Keeping waived tests simple.

PubMed

2004-01-01

Laboratories performing waived testing must follow the manufacturer's instructions as well as good laboratory practices to ensure that test results are reliable. Four things to concentrate on to maximize the performance and reliability of waived tests are to: 1. Read and follow the information found in the package inserts. 2. Follow the manufacturer's recommendations for running quality control. 3. Train staff members to perform tests correctly. 4. Follow established policies and procedures for patient testing in the practice.

Fabrication and Improvement of Lmsc's All-silica RSI

NASA Technical Reports Server (NTRS)

Beasley, R. M.; Izu, Y. D.; Nakano, H. N.; Ozolin, A. A.; Peachman, A.

1973-01-01

The LI-1500 and LI-900 all silica RSI materials have made the transition from laboratory to manufacturing operation. Improvements in both quality and reproducibility have been achieved. The LI-1500 material has displayed superior reliability in evaluations conducted at various facilities. The dependable performance of the material is attributed to the adherence to the stringent requirements of the numerous material, process, and product control evaluations and inspection points performed during manufacture.

Antimisting Kerosene: Base Fuel Effects; Blending and Quality Control Techniques.

DTIC Science & Technology

1984-01-01

Jet A in a single short period of mixing followed by a 20-minute development. Judging from the filter -. , ratio, the products are as good or better...assumes no liability Eor the contents or use thereof. The United States Government does not endorse products or manufacturers. Trade or manufacturer’s names...LINE BLENDING: EFFECTS OF ADDING THE SECOND MIXING STAGE -------------------------------------- 36 Table 13. IN-LINE BLENDING: RESISTANCE TO MECHANICAL

First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--Chapter 3: Porcine islet product manufacturing and release testing criteria.

PubMed

Rayat, Gina R; Gazda, Lawrence S; Hawthorne, Wayne J; Hering, Bernhard J; Hosking, Peter; Matsumoto, Shinichi; Rajotte, Ray V

2016-01-01

In the 2009 IXA consensus, the requirements for the quality and control of manufacturing of porcine islet products were based on the U.S. regulatory framework where the porcine islet products fall within the definition of somatic cell therapy under the statutory authority of the U.S. Food and Drug Administration (FDA). In addition, porcine islet products require pre-market approval as a biologic product under the Public Health Services Act and they meet the definition of a drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Thus, they are subject to applicable provisions of the law and as such, control of manufacturing as well as reproducibility and consistency of porcine islet products, safety of porcine islet products, and characterization of porcine islet products must be met before proceeding to clinical trials. In terms of control of manufacturing as well as reproducibility and consistency of porcine islet products, the manufacturing facility must be in compliance with current Good Manufacturing Practices (cGMP) guidelines appropriate for the initiation of Phase 1/2 clinical trials. Sponsors intending to conduct a Phase 1/2 trial of islet xenotransplantation products must be able to demonstrate the safety of the product through the establishment of particular quality assurance and quality control procedures. All materials (including animal source and pancreas) used in the manufacturing process of the porcine islet products must be free of adventitious agents. The final porcine islet product must undergo tests for the presence of these adventitious agents including sterility, mycoplasma (if they are cultured), and endotoxin. Assessments of the final product must include the safety specifications mentioned above even if the results are not available until after release as these data would be useful for patient diagnosis and treatment if necessary. In addition, a plan of action must be in place for patient notification and treatment in case the sterility culture results are positive. In terms of the characterization of porcine islet products and product release criteria, the information on the porcine islet products should be acquired from a sample of the final product to be used for transplantation and must include the morphology of the islets, specific identity, purity, viability, and potency of the product. In addition, information on the quantity of the islet products should also be provided in a standardized fashion and this should be in terms of islet equivalents and/or cell numbers. The current consensus was created to provide guidelines that manufacturing facilities may find helpful in the manufacture of and the release criteria for porcine islet products including encapsulated islets and combined islet products. Our intent with the above recommendations is to provide a framework for individual porcine islet manufacturing facilities to ensure a high level of safety for the initiation of Phase 1/2 clinical trials on porcine islet xenotransplantation. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

[Feedforward control strategy and its application in quality improvement of ethanol precipitation process of danhong injection].

PubMed

Yan, Bin-Jun; Guo, Zheng-Tai; Qu, Hai-Bin; Zhao, Bu-Chang; Zhao, Tao

2013-06-01

In this work, a feedforward control strategy basing on the concept of quality by design was established for the manufacturing process of traditional Chinese medicine to reduce the impact of the quality variation of raw materials on drug. In the research, the ethanol precipitation process of Danhong injection was taken as an application case of the method established. Box-Behnken design of experiments was conducted. Mathematical models relating the attributes of the concentrate, the process parameters and the quality of the supernatants produced were established. Then an optimization model for calculating the best process parameters basing on the attributes of the concentrate was built. The quality of the supernatants produced by ethanol precipitation with optimized and non-optimized process parameters were compared. The results showed that using the feedforward control strategy for process parameters optimization can control the quality of the supernatants effectively. The feedforward control strategy proposed can enhance the batch-to-batch consistency of the supernatants produced by ethanol precipitation.

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.

Production of rotational parts in small-series and computer-aided planning of its production engineering

NASA Astrophysics Data System (ADS)

Dudas, Illes; Berta, Miklos; Cser, Istvan

1998-12-01

Up-to-date manufacturing equipments of production of rotational parts in small series are lathe-centers and CNC grinding machines with high concentration of manufacturing operations. By the use of these machine tools it can be produced parts with requirements of increased accuracy and surface quality. In the lathe centers, which contain the manufacturing procedures of lathes using stationary tools and of drilling-milling machine tools using rotational tools, non-rotational surfaces of rotational parts can also be produced. The high concentration of manufacturing operations makes necessary the planning and programing of the measuring, monitoring and quality control into the technological process during manufacturing operation. In this way, taking into consideration the technological possibilities of lathe canters, the scope of computer aided technological planning duties significantly increases. It is trivial requirement to give only once the descriptions of the prefabricated parts and ready made parts. Starting taking into account these careful considerations we have been developing the planning system of technology of body of revolution on the base of GTIPROG/EC system which useful for programming of lathe centers. Out paper deals with the results of development and the occurring problems.

Process-based quality for thermal spray via feedback control

NASA Astrophysics Data System (ADS)

Dykhuizen, R. C.; Neiser, R. A.

2006-09-01

Quality control of a thermal spray system manufacturing process is difficult due to the many input variables that need to be controlled. Great care must be taken to ensure that the process remains constant to obtain a consistent quality of the parts. Control is greatly complicated by the fact that measurement of particle velocities and temperatures is a noisy stochastic process. This article illustrates the application of quality control concepts to a wire flame spray process. A central feature of the real-time control system is an automatic feedback control scheme that provides fine adjustments to ensure that uncontrolled variations are accommodated. It is shown how the control vectors can be constructed from simple process maps to independently control particle velocity and temperature. This control scheme is shown to perform well in a real production environment. We also demonstrate that slight variations in the feed wire curvature can greatly influence the process. Finally, the geometry of the spray system and sensor must remain constant for the best reproducibility.

Radio Frequency Scanning and Simulation of Oriented Strand Board Material Property

NASA Astrophysics Data System (ADS)

Liu, Xiaojian; Zhang, Jilei; Steele, Philip. H.; Donohoe, J. Patrick

2008-02-01

Oriented strandboard (OSB) is a wood composite product with the largest market share in U.S. residential and commercial construction. Wood specific gravity (SG) and moisture content (MC) play an important role in the OSB manufacturing process. They are the two of the critical variables that manufacturers are required to monitor, locate, and control in order to produce a product with consistent quality. In this study, radio frequency scanning nondestructive evaluation (NDE) technologies evaluated the local area MC and SG of OSB panels following panel production by hot pressing. A finite element software simulation tool was used to optimize the sensor geometry and for investigating the interaction between electromagnetic field and wood dielectric properties. Our results indicate the RF scanning response is closely correlated to the MC and SG variations in OSB panels. Radio frequency NDE appears to have potential as an effective method for insuring OSB panel quality during manufacturing.

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.

Understanding error generation in fused deposition modeling

NASA Astrophysics Data System (ADS)

Bochmann, Lennart; Bayley, Cindy; Helu, Moneer; Transchel, Robert; Wegener, Konrad; Dornfeld, David

2015-03-01

Additive manufacturing offers completely new possibilities for the manufacturing of parts. The advantages of flexibility and convenience of additive manufacturing have had a significant impact on many industries, and optimizing part quality is crucial for expanding its utilization. This research aims to determine the sources of imprecision in fused deposition modeling (FDM). Process errors in terms of surface quality, accuracy and precision are identified and quantified, and an error-budget approach is used to characterize errors of the machine tool. It was determined that accuracy and precision in the y direction (0.08-0.30 mm) are generally greater than in the x direction (0.12-0.62 mm) and the z direction (0.21-0.57 mm). Furthermore, accuracy and precision tend to decrease at increasing axis positions. The results of this work can be used to identify possible process improvements in the design and control of FDM technology.

Effect of IN718 Recycled Powder Reuse on Properties of Parts Manufactured by Means of Selective Laser Melting

NASA Astrophysics Data System (ADS)

Ardila, L. C.; Garciandia, F.; González-Díaz, J. B.; Álvarez, P.; Echeverria, A.; Petite, M. M.; Deffley, R.; Ochoa, J.

Powder quality control is essential to obtain parts with suitable mechanical properties in Selective Laser Melting manufacturing technique. One of the most important advantages of suchtechnique is that it allows an efficient use of the material, due to the possibility to recycle and reuse un-melted powder. Nevertheless, powder material properties may change due to repeated recycling, affecting this way the mechanicalbehavior of parts. In this paper the effect of powder reuse on its quality and on the mechanical properties of the resulting melted parts is studied via self-developed recycling methodology. The material considered for investigation was IN718, a nickel superalloy widely used in industry. After recycling powder up to 14 times, no significant changes were observed in powder and test parts properties. The results obtained in this work will help to validate powder recycling methodology for its use in current industrial Selective Laser Melting manufacturing.

An automated technique for manufacturing thermoplastic stringers in continuous length

NASA Astrophysics Data System (ADS)

Pantelakis, Sp.; Baxevani, E.; Spelz, U.

In the present work an automated Continuous Compression Moulding Technique for the manufacture of stringers in continuous length is presented. The method combines pultrusion and hot-pressing. The technique is utilized for the production of L-shape stringers which are widely applied in aerospace constructions. The investigation was carried out on carbon reinforced PEEK (C/PEEK), as well as, for comparison, on the thermoplastic composites carbon reinforced polyethersulfon (C/PES), glass and carbon reinforced polyphenylene-sulfide (G/PPS, C/PPS) and Kevlar reinforced Polyamide 6 (K/PA 6). For the materials investigated the optimized process parameters for manufacturing the L-shape stringers were derived experimentally. To achieve this goal, the quality of the produced parts was controlled by using non-destructive testing techniques. Parts providing satisfactory quality were also tested destructively to measure their mechanical properties. The investigation results have shown the suitability of the technique to produce continuous length stringers.

Implementation workshop of WHO guidelines on evaluation of malaria vaccines: Current regulatory concepts and issues related to vaccine quality, Pretoria, South Africa 07 Nov 2014.

PubMed

Ho, Mei Mei; Baca-Estrada, Maria; Conrad, Christoph; Karikari-Boateng, Eric; Kang, Hye-Na

2015-08-26

The current World Health Organization (WHO) guidelines on the quality, safety and efficacy of recombinant malaria vaccines targeting the pre-erythrocytic and blood stages of Plasmodium falciparum were adopted by the WHO Expert Committee on Biological Standardization in 2012 to provide guidance on the quality, nonclinical and clinical aspects of recombinant malaria vaccines. A WHO workshop was organised to facilitate implementation into African (national/regional) regulatory practices, of the regulatory evaluation principles outlined in the guidelines regarding quality aspects. The workshop was used also to share knowledge and experience on regulatory topics of chemistry, manufacturing and control with a focus on vaccines through presentations and an interactive discussion using a case study approach. The basic principles and concepts of vaccine quality including consistency of production, quality control and manufacturing process were presented and discussed in the meeting. By reviewing and practicing a case study, better understanding on the relationship between consistency of production and batch release tests of an adjuvanted pre-erythrocytic recombinant malaria vaccine was reached. The case study exercise was considered very useful to understand regulatory evaluation principles of vaccines and a suggestion was made to WHO to provide such practices also through its Global Learning Opportunities for Vaccine Quality programme. Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.

A Machine Vision Quality Control System for Industrial Acrylic Fibre Production

NASA Astrophysics Data System (ADS)

Heleno, Paulo; Davies, Roger; Correia, Bento A. Brázio; Dinis, João

2002-12-01

This paper describes the implementation of INFIBRA, a machine vision system used in the quality control of acrylic fibre production. The system was developed by INETI under a contract with a leading industrial manufacturer of acrylic fibres. It monitors several parameters of the acrylic production process. This paper presents, after a brief overview of the system, a detailed description of the machine vision algorithms developed to perform the inspection tasks unique to this system. Some of the results of online operation are also presented.

The quality of antimalarials available in Yemen

PubMed Central

Abdo-Rabbo, Ahmed; Bassili, Amal; Atta, Hoda

2005-01-01

Background Malaria has always been a major public health problem in Yemen. Several studies in developing countries have demonstrated ineffective and poor quality drugs including antimalarials. Therefore, quality assessment of antimalarial drugs is of crucial importance. This study aimed to assess the quality of antimalarials (chloroquine and sulfadoxine/pyrimethamine) available in Yemen and to determine whether the quality of these products was related to the level of the distribution chain at which the samples were collected or related to the manufacturers. Methods Four samples from each antimalarial product were collected from each of the various levels of the distribution chain. One sample was kept with the research team. Two were tested at Sana'a and Aden Drug Quality Control Laboratories. The fourth was sent to the Centre for Quality Assurance of Medicines in Potchefstroom, South Africa, for analysis. Quality indicators measured were the content of the active ingredient and dissolution rate (for tablets only) in comparison to standard specifications for these products in the relevant pharmacopoeia. Results The results identified several problems of sub-standard products within the drug distribution chain. They included high and low failures in ingredient content for chloroquine tablets and chloroquine syrup. There was some dissolution failure for chloroquine tablets, and high sulfadoxine/pyrimethamine tablets dissolution failures. Failures with the dissolution of the pyrimethamine were found at most of the collection points. No clear relationship neither between the quality products and the level of the distribution chain, nor between locally manufactured and imported products was observed. Conclusion There are sub-standard antimalarial products circulating within the drug distribution chains in the country, which will have serious implications on the reduced therapeutic effectiveness and on the development of drug resistance. This appears to be due to non-compliance with Good Manufacturing Practice guidelines by manufacturers in the production of the antimalarials. PMID:15987508

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.

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

PubMed

Sharp, J R

1994-12-01

Drucker writes that the emerging theory of manufacturing includes four principles and practices: statistical quality control, manufacturing accounting, modular organization, and systems approach. SQC is a rigorous, scientific method of identifying variation in the quality and productivity of a given production process, with an emphasis on improvement. The new manufacturing economics intends to integrate the production strategy with the business strategy in order to account for the biggest portions of costs that the old methods did not assess: time and automation. Production operations that are both standardized and flexible will allow the organization to keep up with changes in design, technology, and the market. The return on innovation in this environment is predicated on a modular arrangement of flexible steps in the process. Finally, the systems approach sees the entire process as being integrated in converting goods or services into economic satisfaction. There is now a major restructuring of the U.S. health care industry, and the incorporation of these four theories into health care reform would appear to be essential. This two-part article will address two problems: Will Drucker's theories relate to health care (Part I)? Will the "new manufacturing" in health care (practice guidelines) demonstrate cost, quality, and access changes that reform demands (Part II)?

Raw materials in the manufacture of biotechnology products: regulatory considerations.

PubMed

Cordoba-Rodriguez, Ruth

2010-01-01

The Food and Drug Administration's Pharmaceutical cGMPs for the 21st Century initiative emphasizes science and risk-based approaches in the manufacture of drugs. These approaches are reflected in the International Conference on Harmonization (ICH) guidances ICH Q8, Q9, and Q10 and encourage a comprehensive assessment of the manufacture of a biologic, including all aspects of manufacture that have the potential to affect the finished drug product. Appropriate assessment and management of raw materials are an important part of this initiative. Ideally, a raw materials program should strive to assess and minimize the risk to product quality. With this in mind, risk-assessment concepts and control strategies will be discussed and illustrated by examples, with an emphasis on the impact of raw materials on cell substrates. Finally, the life cycle of the raw material will be considered, including its potential to affect the drug product life cycle. In this framework, the supply chain and the vendor-manufacturer relationship will be explored as important parts of an adequate raw materials control strategy.

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.

Assurance of Medical Device Quality with Quality Management System: An Analysis of Good Manufacturing Practice Implementation in Taiwan

PubMed Central

Tu, Pei-Weng; Wu, Shiow-Ing

2015-01-01

The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development. PMID:26075255

Assurance of medical device quality with quality management system: an analysis of good manufacturing practice implementation in Taiwan.

PubMed

Li, Tzu-Wei; Tu, Pei-Weng; Liu, Li-Ling; Wu, Shiow-Ing

2015-01-01

The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development.

Irritable Bowel Syndrome and Complementary Health Practices: What the Science Says

MedlinePlus

... controlled trials on various herbal preparations; however, the methodological quality of most of these studies is poor. ... if improperly manufactured. A 2012 systematic review of case reports and case series concluded that using certain ...

Instrumentation to Aid in Steel Bridge Fabrication : Bridge Virtual Assembly System

DOT National Transportation Integrated Search

2018-05-01

This pool funded project developed a BRIDGE VIRTUAL ASSEMBLY SYSTEM (BRIDGE VAS) that improves manufacturing processes and enhances quality control for steel bridge fabrication. The system replaces conventional match-drilling with virtual assembly me...

Substandard drugs: a potential crisis for public health

PubMed Central

Johnston, Atholl; Holt, David W

2014-01-01

Poor-quality medicines present a serious public health problem, particularly in emerging economies and developing countries, and may have a significant impact on the national clinical and economic burden. Attention has largely focused on the increasing availability of deliberately falsified drugs, but substandard medicines are also reaching patients because of poor manufacturing and quality-control practices in the production of genuine drugs (either branded or generic). Substandard medicines are widespread and represent a threat to health because they can inadvertently lead to healthcare failures, such as antibiotic resistance and the spread of disease within a community, as well as death or additional illness in individuals. This article reviews the different aspects of substandard drug formulation that can occur (for example, pharmacological variability between drug batches or between generic and originator drugs, incorrect drug quantity and presence of impurities). The possible means of addressing substandard manufacturing practices are also discussed. A concerted effort is required on the part of governments, drug manufacturers, charities and healthcare providers to ensure that only drugs of acceptable quality reach the patient. PMID:24286459

Tire Production and Pollution Control. Environmental Education Curriculum. Revised.

ERIC Educational Resources Information Center

Topeka Public Schools, KS.

This unit was developed to introduce secondary students to the many facets of a typical, large manufacturing plant - the Topeka Goodyear Tire and Rubber Company - in an effort to increase awareness of sound environmental practices in industry. Its five major foci include the production of tires and quality control procedures; applications of…

Best Manufacturing Practices Survey Conducted at Motorola, Incorporated Government Electronics Group Scottsdale, Arizona

DTIC Science & Technology

1988-03-01

operators recommendations, certain select individuals are trained and used as SPC technicians. " POKA - YOKE " or mistake proofing from Shiegeo Shingo’s "Zero...Quality Control: Source Inspection and the POKA - YOKE System" has been locally applied to operators processes with great success. This pre-control

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.

Investigating catalyst coated membrane equilibration time for polymer electrolyte membrane fuel cell manufacturing

NASA Astrophysics Data System (ADS)

Cote, Philippe

Mercedes-Benz Canada Inc., Fuel Cell Division, manufactures polymer electrolyte membrane fuel cell stacks for use in vehicles. The manufacturing line is being optimized for efficiency and quality control, in order to uphold the high standards of Mercedes-Benz Inc. vehicles. In an operating polymer electrolyte membrane fuel cell, the catalyst coated membrane facilitates the electrochemical reaction that generates electricity. This research examines the equilibration of catalyst coated membrane rolls to controlled temperature and humidity conditions, before they are used in the manufacturing of polymer electrolyte membrane fuel cells. Equilibration involves allowing the water content in the catalyst coated membrane to stabilize at the controlled conditions, in order to reduce mechanical stress in the material for better manufacturability. Initial equilibration measurements were conducted on discrete catalyst coated membrane samples using novel electronic conductivity measurements of the catalyst layer, and compared to ionic conductivity measurements of the membrane. Electronic conductivity measurements are easier to implement in the manufacturing environment than the more complex ionic conductivity measurements. When testing discrete catalyst coated membrane samples in an environmental chamber, the equilibration trends for the measured ionic and electronic conductivity signals were similar enough to permit us to adapt the electronic conductivity measurements for catalyst coated membrane in roll form. Equilibration measurements of catalyst coated membrane rolls were optimized to achieve a robust and repeatable procedure which could be used in the manufacturing environment at Mercedes-Benz Canada Inc., Fuel Cell Division.

Advanced composite aileron for L-1011 transport aircraft: Aileron manufacture

NASA Technical Reports Server (NTRS)

Dunning, E. G.; Cobbs, W. L.; Legg, R. L.

1981-01-01

The fabrication activities of the Advanced Composite Aileron (ACA) program are discussed. These activities included detail fabrication, manufacturing development, assembly, repair and quality assurance. Five ship sets of ailerons were manufactured. The detail fabrication effort of ribs, spar and covers was accomplished on male tools to a common cure cycle. Graphite epoxy tape and fabric and syntactic epoxy materials were utilized in the fabrication. The ribs and spar were net cured and required no post cure trim. Material inconsistencies resulted in manufacturing development of the front spar during the production effort. The assembly effort was accomplished in subassembly and assembly fixtures. The manual drilling system utilized a dagger type drill in a hydraulic feed control hand drill. Coupon testing for each detail was done.

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

Design and manufacture of monoclonal antibodies for radioimmunotherapy.

PubMed

Hale, G; Berrie, E; Bird, P

2004-12-01

antibodies is fundamental to their use for radioimmunotherapy. Besides the right selection of antibody specificity and affinity, recombinant antibodies can be designed to simplify manufacture and minimise unwanted side effects. Although many innovative new technologies have been developed in recent years, antibodies are still most commonly produced from mammalian cells and purified by column chromatography. Purification methods have to be designed and validated to remove potential contaminants, especially retroviruses, which in principle might be present in mammalian cell lines. Adherence to relevant ''Good Manufacturing Practices'' is mandatory in the production of any medicinal product and there are numerous guidelines regarding the manufacture of antibodies. This article outlines some methods used for fermentation, purification and quality control of antibodies intended for radiolabelling.

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.

Reticle variation influence on manufacturing line and wafer device performance

NASA Astrophysics Data System (ADS)

Nistler, John L.; Spurlock, Kyle

1994-01-01

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

Fabrication of light water reactor tritium targets

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

Pilger, J.P.

1991-11-01

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

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.

Tribology in secondary wood machining

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

Ko, P.L.; Hawthorne, H.M.; Andiappan, J.

Secondary wood manufacturing covers a wide range of products from furniture, cabinets, doors and windows, to musical instruments. Many of these are now mass produced in sophisticated, high speed numerical controlled machines. The performance and the reliability of the tools are key to an efficient and economical manufacturing process as well as to the quality of the finished products. A program concerned with three aspects of tribology of wood machining, namely, tool wear, tool-wood friction characteristics and wood surface quality characterization, was set up in the Integrated Manufacturing Technologies Institute (IMTI) of the National Research Council of Canada. The studiesmore » include friction and wear mechanism identification and modeling, wear performance of surface-engineered tool materials, friction-induced vibration and cutting efficiency, and the influence of wear and friction on finished products. This research program underlines the importance of tribology in secondary wood manufacturing and at the same time adds new challenges to tribology research since wood is a complex, heterogeneous, material and its behavior during machining is highly sensitive to the surrounding environments and to the moisture content in the work piece.« less

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.

Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturer.

PubMed

Anyakora, Chimezie; Ekwunife, Obinna; Alozie, Faith; Esuga, Mopa; Ukwuru, Jonathan; Onya, Steve; Nwokike, Jude

2017-09-18

Pharmaceutical companies in Africa need to invest in both facilities and quality management systems to achieve good manufacturing practice (GMP) compliance. Compliance to international GMP standards is important to the attainment of World Health Organization (WHO) prequalification. However, most of the local pharmaceutical manufacturing companies may be deterred from investing in quality because of many reasons, ranging from financial constraints to technical capacity. This paper primarily evaluates benefits against the cost of investing in GMP, using a Nigerian pharmaceutical company, Chi Pharmaceuticals Limited, as a case study. This paper also discusses how to drive more local manufacturers to invest in quality to attain GMP compliance; and proffers practical recommendations for local manufacturers who would want to invest in quality to meet ethical and regulatory obligations. The cost benefit of improving the quality of Chi Pharmaceuticals Limited's facilities and system to attain WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was calculated by dividing the annual benefits derived from quality improvement interventions by the annual costs of implementing quality improvement interventions, referred to as a benefit-cost ratio (BCR). Cost benefit of obtaining WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was 5.3 (95% confidence interval of 5.0-5.5). Investment in quality improvement intervention is cost-beneficial for local manufacturing companies. Governments and regulators in African countries should support pharmaceutical companies striving to invest in quality. Collaboration of local manufacturing companies with global companies will further improve quality. Local pharmaceutical companies should be encouraged to key into development opportunities available for pharmaceutical companies in Africa.

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.

Job Rotation Designed to Prevent Musculoskeletal Disorders and Control Risk in Manufacturing Industries: A Systematic Review

PubMed Central

Padula, Rosimeire Simprini; Comper, Maria Luiza Caires; Sparer, Emily H.; Dennerlein, Jack T

2017-01-01

To better understand job rotation in the manufacturing industry, we completed a systematic review asking the following questions: 1) How do job-rotation programs impact work-related musculoskeletal disorders (MSDs) and related risk control for these MSDs, as well as psychosocial factors? and 2) How best should the job rotation programs be designed? We searched MEDLINE, EMBASE, Business Source Premier, ISI Web of Knowledge, CINAHL, PsyINFO, Scopus, and SciELO databases for articles published in peer-reviewed journals. Eligible studies were examined by two independent reviewers for relevance (population of manufacturing workers, outcomes of musculoskeletal disease, physical factors, psychosocial factors, and strategies used in job-rotation implantation) and methodological quality rating. From 10,809 potential articles, 71 were read for full text analysis. Of the 14 studies included for data extraction, two were non-randomized control trial studies, one was a case-control study, and 11 were cross-sectional comparisons. Only one, with a case-control design, was scored with good methodological quality. Currently, weak evidence exists supporting job rotation as a strategy for the prevention and control of musculoskeletal disorders. Job rotation did not appear to reduce the exposure of physical risk factors; yet, there are positive correlations between job rotation and higher job satisfaction. Worker training has been described as a crucial component of a successful job-rotation program. The studies reported a range of parameters used to implement and measure job-rotation programs. More rigorous studies are needed to better understand the full impact of job rotation on production and health. PMID:27633235

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.

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

Corner smoothing of 2D milling toolpath using b-spline curve by optimizing the contour error and the feedrate

NASA Astrophysics Data System (ADS)

Özcan, Abdullah; Rivière-Lorphèvre, Edouard; Ducobu, François

2018-05-01

In part manufacturing, efficient process should minimize the cycle time needed to reach the prescribed quality on the part. In order to optimize it, the machining time needs to be as low as possible and the quality needs to meet some requirements. For a 2D milling toolpath defined by sharp corners, the programmed feedrate is different from the reachable feedrate due to kinematic limits of the motor drives. This phenomena leads to a loss of productivity. Smoothing the toolpath allows to reduce significantly the machining time but the dimensional accuracy should not be neglected. Therefore, a way to address the problem of optimizing a toolpath in part manufacturing is to take into account the manufacturing time and the part quality. On one hand, maximizing the feedrate will minimize the manufacturing time and, on the other hand, the maximum of the contour error needs to be set under a threshold to meet the quality requirements. This paper presents a method to optimize sharp corner smoothing using b-spline curves by adjusting the control points defining the curve. The objective function used in the optimization process is based on the contour error and the difference between the programmed feedrate and an estimation of the reachable feedrate. The estimation of the reachable feedrate is based on geometrical information. Some simulation results are presented in the paper and the machining times are compared in each cases.

A Closed-Loop Supply Chain under Retail Price and Quality Dependent Demand with Remanufacturing and Refurbishing

NASA Astrophysics Data System (ADS)

Christy, A. Y.; Fauzi, B. N.; Kurdi, N. A.; Jauhari, W. A.; Saputro, D. R. S.

2017-06-01

The demand of a product is linearly dependent on the retail price and quality of the product. We address a closed-loop supply chain where the manufacturer manufactures products according to the demand and sells them through a retailer in the market. A third party collects the used products from costumers and sends to the manufacturer to increase the quality. If the products can retrieve the original quality, thus the process is called remanufacturing. Not every products can retrieve the original quality, thus manufacturer refurbish this products with lower price. We construct four different scenarios - centralized and decentralized led by manufacturer, retailer, and third party. From the comparison of the result obtained in the numerical example, we conclude that the joint profit obtained under centralized, manufacturer-led, and retailer-led policies is higher than third party-led policy.

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

Cost Effective Prototyping

NASA Technical Reports Server (NTRS)

Wickman, Jerry L.; Kundu, Nikhil K.

1996-01-01

This laboratory exercise seeks to develop a cost effective prototype development. The exercise has the potential of linking part design, CAD, mold development, quality control, metrology, mold flow, materials testing, fixture design, automation, limited parts production and other issues as related to plastics manufacturing.

46 CFR 154.467 - Submission of insulation information.

Code of Federal Regulations, 2011 CFR

2011-10-01

... conductivity. (m) Resistance to vibrations. (n) Resistance to fire and flame spread. (o) The manufacturing and... (5) Quality control. [CGD 74-289, 44 FR 26009, May 3, 1979, as amended by CGD 82-063b, 48 FR 4782...

46 CFR 154.467 - Submission of insulation information.

Code of Federal Regulations, 2013 CFR

2013-10-01

... conductivity. (m) Resistance to vibrations. (n) Resistance to fire and flame spread. (o) The manufacturing and... (5) Quality control. [CGD 74-289, 44 FR 26009, May 3, 1979, as amended by CGD 82-063b, 48 FR 4782...

46 CFR 154.467 - Submission of insulation information.

Code of Federal Regulations, 2014 CFR

2014-10-01

... conductivity. (m) Resistance to vibrations. (n) Resistance to fire and flame spread. (o) The manufacturing and... (5) Quality control. [CGD 74-289, 44 FR 26009, May 3, 1979, as amended by CGD 82-063b, 48 FR 4782...

46 CFR 154.467 - Submission of insulation information.

Code of Federal Regulations, 2012 CFR

2012-10-01

... conductivity. (m) Resistance to vibrations. (n) Resistance to fire and flame spread. (o) The manufacturing and... (5) Quality control. [CGD 74-289, 44 FR 26009, May 3, 1979, as amended by CGD 82-063b, 48 FR 4782...

Statistical quality control through overall vibration analysis

NASA Astrophysics Data System (ADS)

Carnero, M. ^a. Carmen; González-Palma, Rafael; Almorza, David; Mayorga, Pedro; López-Escobar, Carlos

2010-05-01

The present study introduces the concept of statistical quality control in automotive wheel bearings manufacturing processes. Defects on products under analysis can have a direct influence on passengers' safety and comfort. At present, the use of vibration analysis on machine tools for quality control purposes is not very extensive in manufacturing facilities. Noise and vibration are common quality problems in bearings. These failure modes likely occur under certain operating conditions and do not require high vibration amplitudes but relate to certain vibration frequencies. The vibration frequencies are affected by the type of surface problems (chattering) of ball races that are generated through grinding processes. The purpose of this paper is to identify grinding process variables that affect the quality of bearings by using statistical principles in the field of machine tools. In addition, an evaluation of the quality results of the finished parts under different combinations of process variables is assessed. This paper intends to establish the foundations to predict the quality of the products through the analysis of self-induced vibrations during the contact between the grinding wheel and the parts. To achieve this goal, the overall self-induced vibration readings under different combinations of process variables are analysed using statistical tools. The analysis of data and design of experiments follows a classical approach, considering all potential interactions between variables. The analysis of data is conducted through analysis of variance (ANOVA) for data sets that meet normality and homoscedasticity criteria. This paper utilizes different statistical tools to support the conclusions such as chi squared, Shapiro-Wilks, symmetry, Kurtosis, Cochran, Hartlett, and Hartley and Krushal-Wallis. The analysis presented is the starting point to extend the use of predictive techniques (vibration analysis) for quality control. This paper demonstrates the existence of predictive variables (high-frequency vibration displacements) that are sensible to the processes setup and the quality of the products obtained. Based on the result of this overall vibration analysis, a second paper will analyse self-induced vibration spectrums in order to define limit vibration bands, controllable every cycle or connected to permanent vibration-monitoring systems able to adjust sensible process variables identified by ANOVA, once the vibration readings exceed established quality limits.

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.

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

NASA Astrophysics Data System (ADS)

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

2015-05-01

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

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

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.

Characterization and manufacture of braided composites for large commercial aircraft structures

NASA Technical Reports Server (NTRS)

Fedro, Mark J.; Willden, Kurtis

1992-01-01

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

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.

Implementation Document for Other Contamination Sources Interim Response Action shell Section 36 Trenches, RMA. Volume 1. General

DTIC Science & Technology

1990-12-01

rights and obligations of theA Army as L.aaa Aqency-or Shall as Leand Party under any law or the Federai. Fact..ity (g) Unless otherwise provided in a...Exposure occurs principally during manufacture or during bulk handling activities. Since it is generally injected into the soil at depths of 15 to 30 cm...Slurry Mix Design: The design of the IMPERMIX grouting mix, which shall meet all requirements of the Impermix manufacturer . G. Quality Control Testing

Near common-path optical fiber interferometer for potentially fast on-line microscale-nanoscale surface measurement

NASA Astrophysics Data System (ADS)

Jiang, Xiangqian; Wang, Kaiwei; Martin, Haydn

2006-12-01

We introduce a new surface measurement method for potential online application. Compared with our previous research, the new design is a significant improvement. It also features high stability because it uses a near common-path configuration. The method should be of great benefit to advanced manufacturing, especially for quality and process control in ultraprecision manufacturing and on the production line. Proof-of-concept experiments have been successfully conducted by measuring the system repeatability and the displacements of a mirror surface.

Food and Drug Administration regulation and evaluation of vaccines.

PubMed

Marshall, Valerie; Baylor, Norman W

2011-05-01

The vaccine-approval process in the United States is regulated by the Center for Biologics Evaluation and Research of the US Food and Drug Administration. Throughout the life cycle of development, from preclinical studies to after licensure, vaccines are subject to rigorous testing and oversight. Manufacturers must adhere to good manufacturing practices and control procedures to ensure the quality of vaccines. As mandated by Title 21 of the Code of Regulations, licensed vaccines must meet stringent criteria for safety, efficacy, and potency.

Alignment issues, correlation techniques and their assessment for a visible light imaging-based 3D printer quality control system

NASA Astrophysics Data System (ADS)

Straub, Jeremy

2016-05-01

Quality control is critical to manufacturing. Frequently, techniques are used to define object conformity bounds, based on historical quality data. This paper considers techniques for bespoke and small batch jobs that are not statistical model based. These techniques also serve jobs where 100% validation is needed due to the mission or safety critical nature of particular parts. One issue with this type of system is alignment discrepancies between the generated model and the physical part. This paper discusses and evaluates techniques for characterizing and correcting alignment issues between the projected and perceived data sets to prevent errors attributable to misalignment.

Quality By Design: Concept To Applications.

PubMed

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

2018-03-08

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

The Ins and Outs of Modern Doors.

ERIC Educational Resources Information Center

College Planning & Management, 1999

1999-01-01

Discusses the qualities and trends in modern metal doors for educational facilities that include fire protection and sound-control attributes. Important differences in door manufacturing methods and materials are addressed and sound-transmission class values, ratings, and rating descriptions are listed. (GR)

A new roadmap for biopharmaceutical drug product development: Integrating development, validation, and quality by design.

PubMed

Martin-Moe, Sheryl; Lim, Fredric J; Wong, Rita L; Sreedhara, Alavattam; Sundaram, Jagannathan; Sane, Samir U

2011-08-01

Quality by design (QbD) is a science- and risk-based approach to drug product development. Although pharmaceutical companies have historically used many of the same principles during development, this knowledge was not always formally captured or proactively submitted to regulators. In recent years, the US Food and Drug Administration has also recognized the need for more controls in the drug manufacturing processes, especially for biological therapeutics, and it has recently launched an initiative for Pharmaceutical Quality for the 21st Century to modernize pharmaceutical manufacturing and improve product quality. In the biopharmaceutical world, the QbD efforts have been mainly focused on active pharmaceutical ingredient processes with little emphasis on drug product development. We present a systematic approach to biopharmaceutical drug product development using a monoclonal antibody as an example. The approach presented herein leverages scientific understanding of products and processes, risk assessments, and rational experimental design to deliver processes that are consistent with QbD philosophy without excessive incremental effort. Data generated using these approaches will not only strengthen data packages to support specifications and manufacturing ranges but hopefully simplify implementation of postapproval changes. We anticipate that this approach will positively impact cost for companies, regulatory agencies, and patients, alike. Copyright © 2011 Wiley-Liss, Inc.

Design And Implementation Of Integrated Vision-Based Robotic Workcells

NASA Astrophysics Data System (ADS)

Chen, Michael J.

1985-01-01

Reports have been sparse on large-scale, intelligent integration of complete robotic systems for automating the microelectronics industry. This paper describes the application of state-of-the-art computer-vision technology for manufacturing of miniaturized electronic components. The concepts of FMS - Flexible Manufacturing Systems, work cells, and work stations and their control hierarchy are illustrated in this paper. Several computer-controlled work cells used in the production of thin-film magnetic heads are described. These cells use vision for in-process control of head-fixture alignment and real-time inspection of production parameters. The vision sensor and other optoelectronic sensors, coupled with transport mechanisms such as steppers, x-y-z tables, and robots, have created complete sensorimotor systems. These systems greatly increase the manufacturing throughput as well as the quality of the final product. This paper uses these automated work cells as examples to exemplify the underlying design philosophy and principles in the fabrication of vision-based robotic systems.

[Investigation on production process quality control of traditional Chinese medicine--Banlangen granule as an example].

PubMed

Tan, Manrong; Yan, Dan; Qiu, Lingling; Chen, Longhu; Yan, Yan; Jin, Cheng; Li, Hanbing; Xiao, Xiaohe

2012-04-01

For the quality management system of herbal medicines, intermediate and finished products it exists the " short board" effect of methodologies. Based on the concept of process control, new strategies and new methods of the production process quality control had been established with the consideration of the actual production of traditional Chinese medicine an the characteristics of Chinese medicine. Taking Banlangen granule as a practice example, which was effective and widespread application, character identification, determination of index components, chemical fingerprint and biometrics technology were sequentially used respectively to assess the quality of Banlangen herbal medicines, intermediate (water extraction and alcohol precipitation) and finished product. With the transfer rate of chemical information and biological potency as indicators, the effectiveness and transmission of the above different assessments and control methods had been researched. And ultimately, the process quality control methods of Banlangen granule, which were based on chemical composition analysis-biometric analysis, had been set up. It can not only validly solute the current status that there were many manufacturers varying quality of Banlangen granule, but also ensure and enhance its clinical efficacy. Furthermore it provided a foundation for the construction of the quality control of traditional Chinese medicine production process.

Systematic review of the application of quality improvement methodologies from the manufacturing industry to surgical healthcare.

PubMed

Nicolay, C R; Purkayastha, S; Greenhalgh, A; Benn, J; Chaturvedi, S; Phillips, N; Darzi, A

2012-03-01

The demand for the highest-quality patient care coupled with pressure on funding has led to the increasing use of quality improvement (QI) methodologies from the manufacturing industry. The aim of this systematic review was to identify and evaluate the application and effectiveness of these QI methodologies to the field of surgery. MEDLINE, the Cochrane Database, Allied and Complementary Medicine Database, British Nursing Index, Cumulative Index to Nursing and Allied Health Literature, Embase, Health Business(™) Elite, the Health Management Information Consortium and PsycINFO(®) were searched according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Empirical studies were included that implemented a described QI methodology to surgical care and analysed a named outcome statistically. Some 34 of 1595 articles identified met the inclusion criteria after consensus from two independent investigators. Nine studies described continuous quality improvement (CQI), five Six Sigma, five total quality management (TQM), five plan-do-study-act (PDSA) or plan-do-check-act (PDCA) cycles, five statistical process control (SPC) or statistical quality control (SQC), four Lean and one Lean Six Sigma; 20 of the studies were undertaken in the USA. The most common aims were to reduce complications or improve outcomes (11), to reduce infection (7), and to reduce theatre delays (7). There was one randomized controlled trial. QI methodologies from industry can have significant effects on improving surgical care, from reducing infection rates to increasing operating room efficiency. The evidence is generally of suboptimal quality, and rigorous randomized multicentre studies are needed to bring evidence-based management into the same league as evidence-based medicine. Copyright © 2011 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

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.

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.

Finite element simulation and experimental verification of ultrasonic non-destructive inspection of defects in additively manufactured materials

NASA Astrophysics Data System (ADS)

Taheri, H.; Koester, L.; Bigelow, T.; Bond, L. J.

2018-04-01

Industrial applications of additively manufactured components are increasing quickly. Adequate quality control of the parts is necessary in ensuring safety when using these materials. Base material properties, surface conditions, as well as location and size of defects are some of the main targets for nondestructive evaluation of additively manufactured parts, and the problem of adequate characterization is compounded given the challenges of complex part geometry. Numerical modeling can allow the interplay of the various factors to be studied, which can lead to improved measurement design. This paper presents a finite element simulation verified by experimental results of ultrasonic waves scattering from flat bottom holes (FBH) in additive manufacturing materials. A focused beam immersion ultrasound transducer was used for both the modeling and simulations in the additive manufactured samples. The samples were SS17 4 PH steel samples made by laser sintering in a powder bed.

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.

The assessment of human skin biomatrixes using raman spectroscopy method

NASA Astrophysics Data System (ADS)

Timchenko, E. V.; Timchenko, P. E.; Volova, L. T.; Dolgushkin, D. A.; Shalkovskaya, P. Y.; Pershutkina, S. V.; Nefedova, I. F.

2017-01-01

There are presented the results of the analysis of the implants made of human skin by Raman scattering method. The main spectral distinctions of bioimplants by using various methods for their manufacture are shown at wavenumbers 1062 cm-1, 1645 cm-1, 1260 cm-1, 850 cm-1, 863 cm-1, corresponding to components that are important for the quality of implant: glycosaminoglycans, amide type I, amide type III, asymmetrical association C-O-S of vibration of glycosaminoglycans GAGs, tyrosine and a C-C stretching of proline ring, ribose. Has been carried out two-dimensional analysis of optical coefficients providing an opportunity to control the quality of cutaneous implants in the process of manufacturing it, and detailed analysis of Raman scattering spectroscopy.

Hardwood pallet cant quality and pallet part yields

Treesearch

Hal L. Mitchell; Marshall White; Philip Araman; Peter Hamner

2005-01-01

Raw materials are the largest cost component in pallet manufacturing. The primary raw material used to produce pallet parts are pallet cants. Therefore, pallet cant quality directly impacts pallet part processing and material costs. By knowing the quality of the cants being processed, pallet manufacturers can predict these costs and improve manufacturing efficiency....

The Method of Manufacturing Nonmetallic Test-Blocks on Different Sensitivity Classes

NASA Astrophysics Data System (ADS)

Kalinichenko, N. P.; Kalinichenko, A. N.; Lobanova, I. S.; Zaitseva, A. A.; Loboda, E. L.

2016-01-01

Nowadays in our modern world there is a vital question of quality control of details made from nonmetallic materials due to their wide spreading. Nondestructive penetrant testing is effective, and in some cases it is the only possible method of accidents prevention at high- risk sites. A brief review of check sample necessary for quality evaluation of penetrant materials is considered. There was offered a way of making agents for quality of penetrant materials testing according to different liquid penetrant testing sensibility classes.

Low-temperature magnetotransport in Si/SiGe heterostructures on 300 mm Si wafers

NASA Astrophysics Data System (ADS)

Scappucci, Giordano; Yeoh, L.; Sabbagh, D.; Sammak, A.; Boter, J.; Droulers, G.; Kalhor, N.; Brousse, D.; Veldhorst, M.; Vandersypen, L. M. K.; Thomas, N.; Roberts, J.; Pillarisetty, R.; Amin, P.; George, H. C.; Singh, K. J.; Clarke, J. S.

Undoped Si/SiGe heterostructures are a promising material stack for the development of spin qubits in silicon. To deploy a qubit into high volume manufacturing in a quantum computer requires stringent control over substrate uniformity and quality. Electron mobility and valley splitting are two key electrical metrics of substrate quality relevant for qubits. Here we present low-temperature magnetotransport measurements of strained Si quantum wells with mobilities in excess of 100000 cm2/Vs fabricated on 300 mm wafers within the framework of advanced semiconductor manufacturing. These results are benchmarked against the results obtained in Si quantum wells deposited on 100 mm Si wafers in an academic research environment. To ensure rapid progress in quantum wells quality we have implemented fast feedback loops from materials growth, to heterostructure FET fabrication, and low temperature characterisation. On this topic we will present recent progress in developing a cryogenic platform for high-throughput magnetotransport measurements.

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

78 FR 26300 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Revisions to Control of Air...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-06

... curing ovens used in wet-laid non-woven fiber mat manufacturing operations when nitrogen containing resins or other additives are used. These two actions affect NO X sources operating in the Dallas Fort...

21 CFR 106.100 - Records.

Code of Federal Regulations, 2011 CFR

2011-04-01

... CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Records and Reports § 106.100 Records. (a) Every..., including tests conducted when nutrients exceed their expiration date or shelf life (retest date). (2) All... when nutrient premixes exceed their expiration date or shelf life (retest date). (e) The manufacturer...

Manufacturing and quality control of interconnecting wire harnesses, Volume 2

NASA Technical Reports Server (NTRS)

1972-01-01

Interconnecting wire harnesses defined in the design standard are considered, including type 4, open bundle (not enclosed). Knowledge gained through experience on the Saturn 5 program coupled with recent advances in techniques, materials, and processes was incorporated into the document.

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.

Importance of good manufacturing practices in microbiological monitoring in processing human tissues for transplant.

PubMed

Pianigiani, Elisa; Ierardi, Francesca; Fimiani, Michele

2013-12-01

Skin allografts represent an important therapeutic resource in the treatment of severe skin loss. The risk associated with application of processed tissues in humans is very low, however, human material always carries the risk of disease transmission. To minimise the risk of contamination of grafts, processing is carried out in clean rooms where air quality is monitored. Procedures and quality control tests are performed to standardise the production process and to guarantee the final product for human use. Since we only validate and distribute aseptic tissues, we conducted a study to determine what type of quality controls for skin processing are the most suitable for detecting processing errors and intercurrent contamination, and for faithfully mapping the process without unduly increasing production costs. Two different methods for quality control were statistically compared using the Fisher exact test. On the basis of the current study we selected our quality control procedure based on pre- and post-processing tissue controls, operator and environmental controls. Evaluation of the predictability of our control methods showed that tissue control was the most reliable method of revealing microbial contamination of grafts. We obtained 100 % sensitivity by doubling tissue controls, while maintaining high specificity (77 %).

Regulatory Considerations in the Design and Manufacturing of Implantable 3D‐Printed Medical Devices

PubMed Central

Morrison, Robert J.; Kashlan, Khaled N.; Flanangan, Colleen L.; Wright, Jeanne K.; Green, Glenn E.; Hollister, Scott J.

2015-01-01

Abstract Three‐dimensional (3D) printing, or additive manufacturing, technology has rapidly penetrated the medical device industry over the past several years, and innovative groups have harnessed it to create devices with unique composition, structure, and customizability. These distinctive capabilities afforded by 3D printing have introduced new regulatory challenges. The customizability of 3D‐printed devices introduces new complexities when drafting a design control model for FDA consideration of market approval. The customizability and unique build processes of 3D‐printed medical devices pose unique challenges in meeting regulatory standards related to the manufacturing quality assurance. Consistent material powder properties and optimal printing parameters such as build orientation and laser power must be addressed and communicated to the FDA to ensure a quality build. Postprinting considerations unique to 3D‐printed devices, such as cleaning, finishing and sterilization are also discussed. In this manuscript we illustrate how such regulatory hurdles can be navigated by discussing our experience with our group's 3D‐printed bioresorbable implantable device. PMID:26243449

Job rotation designed to prevent musculoskeletal disorders and control risk in manufacturing industries: A systematic review.

PubMed

Padula, Rosimeire Simprini; Comper, Maria Luiza Caires; Sparer, Emily H; Dennerlein, Jack T

2017-01-01

To better understand job rotation in the manufacturing industry, we completed a systematic review asking the following questions: 1) How do job-rotation programs impact work-related musculoskeletal disorders (MSDs) and related risk control for these MSDs, as well as psychosocial factors? and 2) How best should the job rotation programs be designed? We searched MEDLINE, EMBASE, Business Source Premier, ISI Web of Knowledge, CINAHL, PsyINFO, Scopus, and SciELO databases for articles published in peer-reviewed journals. Eligible studies were examined by two independent reviewers for relevance (population of manufacturing workers, outcomes of musculoskeletal disorders, physical factors, psychosocial factors, and strategies used in job-rotation implantation) and methodological quality rating. From 10,809 potential articles, 71 were read for full text analysis. Of the 14 studies included for data extraction, two were non-randomized control trial studies, one was a case-control study, and 11 were cross-sectional comparisons. Only one, with a case-control design, was scored with good methodological quality. Currently, weak evidence exists supporting job rotation as a strategy for the prevention and control of musculoskeletal disorders. Job rotation did not appear to reduce the exposure of physical risk factors; yet, there are positive correlations between job rotation and higher job satisfaction. Worker training has been described as a crucial component of a successful job-rotation program. The studies reported a range of parameters used to implement and measure job-rotation programs. More rigorous studies are needed to better understand the full impact of job rotation on production and health. CRD42014013319. Copyright © 2016 Elsevier Ltd. All rights reserved.

Weighing the evidence: trends in managed care formulary decision making.

PubMed

de Lissovoy, Gregory

2003-01-01

Health plans, pharmacy benefit managers, and other organizations use drug formularies to promote quality care while controlling costs. However, restrictive formularies are often viewed as constraints on physician practice and potential barriers to optimal patient care. Reluctance to add new drugs to an established formulary is rational economic behavior. Innovative compounds may have unknown properties with uncertain outcomes and therefore may impose costs in the form of risk. Products that seemingly duplicate drugs already on formulary may increase transaction costs without additional benefit. In evaluating new products, formulary managers face the task of identifying, assembling, and synthesizing a wide range of complex information. Manufacturers, who may be in the best position to supply that information, have been severely restricted by U.S. Food and Drug Administration (FDA) regulations that limited marketing communications to findings from well-controlled clinical trials. The FDA Modernization Act of 1997 eased these restrictions somewhat by acknowledging that sophisticated purchasers such as organized health plans were capable of weighing the quality and impartiality of manufacturer-supplied evidence. The Academy of Managed Care Pharmacy (AMCP) created a standardized template that formularies can use to request comprehensive information about specific drugs from manufacturers. Widespread adoption of the AMCP format by health plans and manufacturers will greatly increase access to information about new drugs, speeding the process of formulary committee deliberation, and instilling greater confidence in the outcome of those decisions. Wider access to new drugs may result.

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%.

Technology for the Sound of Music

NASA Technical Reports Server (NTRS)

1994-01-01

In the early 1960s during an industry recession, Kaman Aircraft lost several defense contracts. Forced to diversify, the helicopter manufacturer began to manufacture acoustic guitars. Kaman's engineers used special vibration analysis equipment based on aerospace technology. While a helicopter's rotor system is highly susceptible to vibration, which must be reduced or "dampened," vibration enhances a guitar's sound. After two years of vibration analysis Kaman produced an instrument, which is very successful. The Ovation guitar is made of fiberglass. It is stronger than the traditional rosewood and manufactured with adapted aircraft techniques such as jigs and fixtures, reducing labor and assuring quality and cost control. Kaman Music Corporation now has annual sales of $100 million.

Is self-sufficiency financially viable and ethically justifiable?--a commercial viewpoint.

PubMed

Christie, R B

1994-12-01

Manufacturers of blood products have to maintain the highest possible standards for plasma screening and good manufacturing practices to ensure maximum purity and viral safety. The private sector companies have much experience in implementing and complying with national and international regulations. These requirements involve considerable cost in the areas of (1) plasma collection facilities, (2) research and clinical research, (3) manufacture, and (4) quality control. Total self-sufficiency would mean the loss of many existing resources. An alternative would be a collaboration between the public and private sectors to meet the needs of all patients who require plasma derived products. The current definition of self-sufficiency suggests that it is not financially viable.

Nickel-cadmium cells

NASA Technical Reports Server (NTRS)

Rubin, E. J.; Turchan, M. J.

1974-01-01

A high energy density nickel cadmium cell of aerospace quality was designed. The approach used was to utilize manufacturing techniques which produce highly uniform and controlled starting materials in addition to improvements in the overall design. Parameters controlling the production of plaque and both positive and negative plate were studied. Quantities of these materials were produced and prototype cells were assembled to test the proposed design.

Pharmaceutical quality of "party pills" raises additional safety concerns in the use of illicit recreational drugs.

PubMed

Young, Simon A; Thrimawithana, Thilini R; Antia, Ushtana; Fredatovich, John D; Na, Yonky; Neale, Peter T; Roberts, Amy F; Zhou, Huanyi; Russell, Bruce

2013-06-14

To determine the content and release kinetics of 1-benzylpiperazine (BZP) and 1-(3-trifluoromethyl-phenyl)piperazine (TFMPP) from "party pill" formulations. From these data, the possible impact of pharmaceutical quality upon the safety of such illicit formulations may be inferred. The amount of BZP and TFMPP in party pill formulations was determined using a validated HPLC method. The in-vitro release kinetics of selected party pill brands were determined using a USP dissolution apparatus (75 rpm, 37.5 degrees Celsius). The release data were then fitted to a first order release model using PLOT software and the time taken to achieve 90% release reported. Many of the tested party pill brands contained amounts of BZP and TFMPP that varied considerably from that stated on the packaging; including considerable TFMPP content in some brands not labelled to contain this drug. Dissolution studies revealed that there was considerable variability in the release kinetics between brands; in one case 90% release required >30 minutes. Lack of quality control in party pill manufacture may have led to the toxic effects reported by users unaware of the true content and release of drug from pills. More stringent regulation in the manufacture and quality control of "new generation party pills" is essential to the harm reduction campaign.

Quality control in urodynamics and the role of software support in the QC procedure.

PubMed

Hogan, S; Jarvis, P; Gammie, A; Abrams, P

2011-11-01

This article aims to identify quality control (QC) best practice, to review published QC audits in order to identify how closely good practice is followed, and to carry out a market survey of the software features that support QC offered by urodynamics machines available in the UK. All UK distributors of urodynamic systems were contacted and asked to provide information on the software features relating to data quality of the products they supply. The results of the market survey show that the features offered by manufacturers differ greatly. Automated features, which can be turned off in most cases, include: cough recognition, detrusor contraction detection, and high pressure alerts. There are currently no systems that assess data quality based on published guidelines. A literature review of current QC guidelines for urodynamics was carried out; QC audits were included in the literature review to see how closely guidelines were being followed. This review highlights the fact that basic QC is not being carried out effectively by urodynamicists. Based on the software features currently available and the results of the literature review there is both the need and capacity for a greater degree of automation in relation to urodynamic data quality and accuracy assessment. Some progress has been made in this area and certain manufacturers have already developed automated cough detection. Copyright © 2011 Wiley Periodicals, Inc.

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

NASA Astrophysics Data System (ADS)

Koga, Tsuyoshi; Aoyama, Kazuhiro

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

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.

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.

Influence of preconsolidation on consolidation quality after stamp forming of C/PEEK composites

NASA Astrophysics Data System (ADS)

Slange, T. K.; Warnet, L.; Grouve, W. J. B.; Akkerman, R.

2016-10-01

Stamp forming is a rapid manufacturing technology used to shape flat blanks of thermoplastic composite material into three-dimensional components. Currently, expensive autoclave and press consolidation are used to preconsolidate blanks. This study investigates the influence of preconsolidation on final consolidation quality after stamp forming and explores the potential of alternative blank manufacturing methods that could reduce part costs. Blanks were manufactured using various blank manufacturing methods and subsequently were stamp formed. The consolidation quality both before and after stamp forming was compared, where the focus was on void content as the main measure for consolidation quality. The void content was characterized through thickness and density measurements, as well as by microscopy analysis. Results indicate that preconsolidation quality does have an influence on the final consolidation quality. This is due to the severe deconsolidation and limited reconsolidation during stamp forming. Nevertheless, the potential of automated fiber placement and ultrasonic spot welding as alternative blank manufacturing methods was demonstrated.

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…

46 CFR 160.001-5 - Production oversight.

Code of Federal Regulations, 2011 CFR

2011-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, General § 160.001-5 Production oversight. (a... additional production tests and inspections necessary to maintain quality control and to monitor compliance..., each manufacturer of a life preserver and each laboratory inspector shall comply with the following, as...

46 CFR 160.001-5 - Production oversight.

Code of Federal Regulations, 2012 CFR

2012-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, General § 160.001-5 Production oversight. (a... additional production tests and inspections necessary to maintain quality control and to monitor compliance..., each manufacturer of a life preserver and each laboratory inspector shall comply with the following, as...

46 CFR 160.001-5 - Production oversight.

Code of Federal Regulations, 2013 CFR

2013-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, General § 160.001-5 Production oversight. (a... additional production tests and inspections necessary to maintain quality control and to monitor compliance..., each manufacturer of a life preserver and each laboratory inspector shall comply with the following, as...

46 CFR 160.001-5 - Production oversight.

Code of Federal Regulations, 2014 CFR

2014-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, General § 160.001-5 Production oversight. (a... additional production tests and inspections necessary to maintain quality control and to monitor compliance..., each manufacturer of a life preserver and each laboratory inspector shall comply with the following, as...

46 CFR 160.001-5 - Production oversight.

Code of Federal Regulations, 2010 CFR

2010-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, General § 160.001-5 Production oversight. (a... additional production tests and inspections necessary to maintain quality control and to monitor compliance..., each manufacturer of a life preserver and each laboratory inspector shall comply with the following, as...

21 CFR 886.1870 - Stereoscope.

Code of Federal Regulations, 2012 CFR

2012-04-01

...-dimensional appearance of solidity and relief. It is intended to measure the angle of strabismus (eye muscle... exercises of eye muscles. (b) Classification. Class I (general controls). The AC-powered device and the... current good manufacturing practice requirements of the quality system regulation in part 820 of this...

21 CFR 886.1870 - Stereoscope.

Code of Federal Regulations, 2014 CFR

2014-04-01

...-dimensional appearance of solidity and relief. It is intended to measure the angle of strabismus (eye muscle... exercises of eye muscles. (b) Classification. Class I (general controls). The AC-powered device and the... current good manufacturing practice requirements of the quality system regulation in part 820 of this...

21 CFR 886.1870 - Stereoscope.

Code of Federal Regulations, 2013 CFR

2013-04-01

...-dimensional appearance of solidity and relief. It is intended to measure the angle of strabismus (eye muscle... exercises of eye muscles. (b) Classification. Class I (general controls). The AC-powered device and the... current good manufacturing practice requirements of the quality system regulation in part 820 of this...

Automatic film processors' quality control test in Greek military hospitals.

PubMed

Lymberis, C; Efstathopoulos, E P; Manetou, A; Poudridis, G

1993-04-01

The two major military radiology installations (Athens, Greece) using a total of 15 automatic film processors were assessed using the 21-step-wedge method. The results of quality control in all these processors are presented. The parameters measured under actual working conditions were base and fog, contrast and speed. Base and fog as well as speed displayed large variations with average values generally higher than acceptable, whilst contrast displayed greater stability. Developer temperature was measured daily during the test and was found to be outside the film manufacturers' recommended limits in nine of the 15 processors. In only one processor did film passing time vary on an every day basis and this was due to maloperation. Developer pH test was not part of the daily monitoring service being performed every 5 days for each film processor and found to be in the range 9-12; 10 of the 15 processors presented pH values outside the limits specified by the film manufacturers.

The good laboratory practice and good clinical practice requirements for the production of radiopharmaceuticals in clinical research.

PubMed

De Vos, Filip J; De Decker, Mario; Dierckx, Rudi A

2005-07-01

Radiopharmaceuticals account for more than 95% of the group of sterile pharmaceutical products and should therefore be handled and produced with care. Since the introduction of the European directive, all pharmaceuticals used in clinical studies must be prepared under good manufacturing practice (GMP) conditions. This review aims to give an overview of the basic principles and guidelines for the preparation of radiopharmaceuticals. Special attention is given to the production area environment and personnel, the two basic requirements for GMP productions. Especially for the production area, two philosophies have to be combined: the cascade system of over-pressure for the production of pharmaceuticals and the under pressure system for the manufacturing of radioisotopes. Personnel should be selected based on education and regularly given special training for the handling of radioactive material. Compared to pharmaceuticals, radiopharmaceuticals have their own labels, taking into account their specific nature. Besides the standard quality control, other items for quality control of radiopharmaceuticals are also discussed in this article.

Multiscale analysis of replication technique efficiency for 3D roughness characterization of manufactured surfaces

NASA Astrophysics Data System (ADS)

Jolivet, S.; Mezghani, S.; El Mansori, M.

2016-09-01

The replication of topography has been generally restricted to optimizing material processing technologies in terms of statistical and single-scale features such as roughness. By contrast, manufactured surface topography is highly complex, irregular, and multiscale. In this work, we have demonstrated the use of multiscale analysis on replicates of surface finish to assess the precise control of the finished replica. Five commercial resins used for surface replication were compared. The topography of five standard surfaces representative of common finishing processes were acquired both directly and by a replication technique. Then, they were characterized using the ISO 25178 standard and multiscale decomposition based on a continuous wavelet transform, to compare the roughness transfer quality at different scales. Additionally, atomic force microscope force modulation mode was used in order to compare the resins’ stiffness properties. The results showed that less stiff resins are able to replicate the surface finish along a larger wavelength band. The method was then tested for non-destructive quality control of automotive gear tooth surfaces.

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.

Summary of the effects of engine throttle response on airplane formation-flying qualities

NASA Technical Reports Server (NTRS)

Walsh, Kevin R.

1993-01-01

A flight evaluation was conducted to determine the effect of engine throttle response characteristics on precision formation-flying qualities. A variable electronic throttle control system was developed and flight-tested on a TF-104G airplane with a J79-11B engine at the NASA Dryden Flight Research Facility. This airplane was chosen because of its known, very favorable thrust response characteristics. Ten research flights were flown to evaluate the effects of throttle gain, time delay, and fuel control rate limiting on engine handling qualities during a demanding precision wing formation task. Handling quality effects of lag filters and lead compensation time delays were also evaluated. The Cooper and Harper Pilot Rating Scale was used to assign levels of handling quality. Data from pilot ratings and comments indicate that throttle control system time delays and rate limits cause significant degradations in handling qualities. Threshold values for satisfactory (level 1) and adequate (level 2) handling qualities of these key variables are presented. These results may provide engine manufacturers with guidelines to assure satisfactory handling qualities in future engine designs.

21 CFR 820.5 - Quality system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Quality system. 820.5 Section 820.5 Food and Drugs... QUALITY SYSTEM REGULATION General Provisions § 820.5 Quality system. Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured...

21 CFR 820.5 - Quality system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Quality system. 820.5 Section 820.5 Food and Drugs... QUALITY SYSTEM REGULATION General Provisions § 820.5 Quality system. Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured...

21 CFR 820.5 - Quality system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Quality system. 820.5 Section 820.5 Food and Drugs... QUALITY SYSTEM REGULATION General Provisions § 820.5 Quality system. Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured...

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

Bridging the gap between PAT concepts and implementation: An integrated software platform for fermentation.

PubMed

Chopda, Viki R; Gomes, James; Rathore, Anurag S

2016-01-01

Bioreactor control significantly impacts both the amount and quality of the product being manufactured. The complexity of the control strategy that is implemented increases with reactor size, which may vary from thousands to tens of thousands of litres in commercial manufacturing. The Process Analytical Technology (PAT) initiative has highlighted the need for having robust monitoring tools and effective control schemes that are capable of taking real time information about the critical quality attributes (CQA) and the critical process parameters (CPP) and executing immediate response as soon as a deviation occurs. However, the limited flexibility that present commercial software packages offer creates a hurdle. Visual programming environments have gradually emerged as potential alternatives to the available text based languages. This paper showcases development of an integrated programme using a visual programming environment for a Sartorius BIOSTAT® B Plus 5L bioreactor through which various peripheral devices are interfaced. The proposed programme facilitates real-time access to data and allows for execution of control actions to follow the desired trajectory. Major benefits of such integrated software system include: (i) improved real time monitoring and control; (ii) reduced variability; (iii) improved performance; (iv) reduced operator-training time; (v) enhanced knowledge management; and (vi) easier PAT implementation. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Drug quality in South Africa: perceptions of key players involved in medicines distribution.

PubMed

Patel, Aarti; Norris, Pauline; Gauld, Robin; Rades, Thomas

2009-01-01

Substandard medicines contribute to poor public health and affect development, especially in the developing world. However knowledge of how manufacturers, distributors and providers understand the concept of drug quality and what strategies they adopt to ensure drug quality is limited, particularly in the developing world. The purpose of this paper is to explore pharmaceutical manufacturers', distributors' and providers' perceptions of drug quality in South Africa and how they ensure the quality of drugs during the distribution process. The approach taken was qualitative data collection through key informant interviews using a semi-structured interview guide. Transcripts were analysed thematically in Johannesburg, Pretoria and Durban, South Africa. Participants were recruited purposefully from a South African pharmaceutical manufacturer, SA subsidiaries of international manufacturers, national distribution companies, national wholesaler, public and private sector pharmacists, and a dispensing doctor. In total, ten interviews were conducted. Participants described drug quality in terms of the product and the processes involved in manufacturing and handling the product. Participants identified purchasing registered medicines from licensed suppliers, use of standard operating procedures, and audits between manufacturer and distributor and/or provider as key strategies employed to protect medicine quality. Effective communication amongst all stakeholders, especially in terms of providing feedback regarding complaints about medicine quality, appears as a potential area of concern, which would benefit from further research. The paper hightlights that ensuring medicine quality should be a shared responsibility amongst all involved in the distribution process to prevent medicines moving from one distribution system (public) into another (private).

In-situ quality monitoring during laser brazing

NASA Astrophysics Data System (ADS)

Ungers, Michael; Fecker, Daniel; Frank, Sascha; Donst, Dmitri; Märgner, Volker; Abels, Peter; Kaierle, Stefan

Laser brazing of zinc coated steel is a widely established manufacturing process in the automotive sector, where high quality requirements must be fulfilled. The strength, impermeablitiy and surface appearance of the joint are particularly important for judging its quality. The development of an on-line quality control system is highly desired by the industry. This paper presents recent works on the development of such a system, which consists of two cameras operating in different spectral ranges. For the evaluation of the system, seam imperfections are created artificially during experiments. Finally image processing algorithms for monitoring process parameters based the captured images are presented.

High-performance thin layer chromatography to assess pharmaceutical product quality.

PubMed

Kaale, Eliangiringa; Manyanga, Vicky; Makori, Narsis; Jenkins, David; Michael Hope, Samuel; Layloff, Thomas

2014-06-01

To assess the sustainability, robustness and economic advantages of high-performance thin layer chromatography (HPTLC) for quality control of pharmaceutical products. We compared three laboratories where three lots of cotrimoxazole tablets were assessed using different techniques for quantifying the active ingredient. The average assay relative standard deviation for the three lots was 1.2 with a range of 0.65-2.0. High-performance thin layer chromatography assessments are yielding valid results suitable for assessing product quality. The local pharmaceutical manufacturer had evolved the capacity to produce very high quality products. © 2014 John Wiley & Sons Ltd.

GMP in blood collection and processing.

PubMed

Wagstaff, W

1998-01-01

The principles of Good Manufacturing Practice have, in the main, been universally developed for the guidance of the pharmaceutical industry rather than for transfusion services. However, these rules and guides are increasingly being adapted for use in blood centres, in the production of labile blood components and of plasma for fractionation. The guide for pharmaceutical industries produced by the commission of the European Communities is used as a model here, the nine basic requirements being those applicable to Quality Management, personnel, premises and equipment, document, production, Quality Control, contract manufacture and analysis, complaints and product recall, and self-inspection. Though having more direct application to the production laboratory preparing blood components, the majority of these requirements and principles are also directly applicable to all of the activities involved in blood collection.

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

Determination of Tasks Required by Graduates of Manufacturing Engineering Technology Programs.

ERIC Educational Resources Information Center

Zirbel, Jay H.

1993-01-01

A Delphi panel of 14 experts identified 37 tasks performed by/qualities needed by manufacturing engineering technologists. Most important were work ethic, performance quality, communication skills, teamwork, computer applications, manufacturing basics, materials knowledge, troubleshooting, supervision, and global issues. (SK)

Order Up

ERIC Educational Resources Information Center

Gibeault, Michael

2005-01-01

Change orders. The words can turn the stomachs of administrators. Horror stories about change orders create fear and distrust among school officials, designers and builders. Can change orders be avoided? If car manufacturers can produce millions of intricately designed vehicles, why can't the same quality control be achieved on a construction…

46 CFR 164.013-6 - Production tests, inspections, and marking.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL MATERIALS Foam, Unicellular Polyethylene (Buoyant... shall provide in-plant quality control of polyethylene foam in accordance with the requirements of § 164.019-13 and any requirements of the recognized laboratory. The manufacturer of the foam has primary...

46 CFR 164.013-6 - Production tests, inspections, and marking.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL MATERIALS Foam, Unicellular Polyethylene (Buoyant... shall provide in-plant quality control of polyethylene foam in accordance with the requirements of § 164.019-13 and any requirements of the recognized laboratory. The manufacturer of the foam has primary...

46 CFR 160.064-6 - Examinations, tests and inspections.

Code of Federal Regulations, 2010 CFR

2010-10-01

... labeled water safety buoyant devices shall maintain quality control of the materials used, manufacturing... available to the recognized laboratory inspector or to the Coast Guard marine inspector, or both, for review upon request. (b) Laboratory inspections and tests. Such examinations, inspections and tests as are...

10 CFR 32.110 - Acceptance sampling procedures under certain specific licenses.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Acceptance sampling procedures under certain specific licenses. 32.110 Section 32.110 Energy NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL Quality Control Sampling Procedures § 32...

10 CFR 32.110 - Acceptance sampling procedures under certain specific licenses.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Acceptance sampling procedures under certain specific licenses. 32.110 Section 32.110 Energy NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL Quality Control Sampling Procedures § 32...

21 CFR 820.130 - Device packaging.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Device packaging. 820.130 Section 820.130 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES QUALITY SYSTEM REGULATION Labeling and Packaging Control § 820.130 Device packaging. Each manufacturer...

21 CFR 820.120 - Device labeling.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Device labeling. 820.120 Section 820.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES QUALITY SYSTEM REGULATION Labeling and Packaging Control § 820.120 Device labeling. Each manufacturer...

76 FR 12934 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-09

..., Manufacturing, and Mining Sectors and Selected Wholesale Industries. OMB Control Number: 0607-0925. Form Number... Business Register data, which provides the Economic Census and current business surveys with their establishment lists. Critical to the quality of data in the Business Register is that establishments are...

77 FR 8884 - Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to a...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-15

... information (e.g., characterization, adventitious agent safety, process controls, and specifications) for the... Manufacturing Process Assessment of Physiochemical Properties Functional Activities Receptor Binding and... 351(k) application. FDA will also seek OMB approval for this information collection. In addition, this...

The Application of Statistical Process Control in Non-Manufacturing Activities

DTIC Science & Technology

1988-01-01

food and lodging, legal, medical, fin- ancial, communication, engineering, architecture, and consultation. Also included would be education...sequence of pro- duction events and an output that is a product or the completion of a 9 service. A good example of this is a fast food restaurant. A...of quality improvement, and how they relate to each other. In discussing the definition of quality, the character- istics of both good and bad

East Europe Report, Economic and Industrial Affairs

DTIC Science & Technology

1984-09-05

As. long as equipment to entrap sulfur dioxide from flue gases is not manufactured in this country, and fuels not desulfurized , or the fluidized...must coordinate, control and direct through the functional units the activities of commercial firms, directorates and offices in accordance with the...and other materials used in the production of goods with substandard indicators. 11 Particular attention has been paid to quality control personnel

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.

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.

24 CFR 3282.203 - DAPIA services.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Requirements § 3282.203 DAPIA services. (a) Each manufacturer shall have each manufactured home design and each... is free to choose which DAPIA will evaluate and approve its designs and quality assurance materials manufacturer may obtain design and quality assurance manual approval from a single DAPIA regardless of the...

24 CFR 3282.203 - DAPIA services.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Requirements § 3282.203 DAPIA services. (a) Each manufacturer shall have each manufactured home design and each... is free to choose which DAPIA will evaluate and approve its designs and quality assurance materials manufacturer may obtain design and quality assurance manual approval from a single DAPIA regardless of the...

24 CFR 3282.203 - DAPIA services.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Requirements § 3282.203 DAPIA services. (a) Each manufacturer shall have each manufactured home design and each... is free to choose which DAPIA will evaluate and approve its designs and quality assurance materials manufacturer may obtain design and quality assurance manual approval from a single DAPIA regardless of the...

24 CFR 3282.203 - DAPIA services.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Requirements § 3282.203 DAPIA services. (a) Each manufacturer shall have each manufactured home design and each... is free to choose which DAPIA will evaluate and approve its designs and quality assurance materials manufacturer may obtain design and quality assurance manual approval from a single DAPIA regardless of the...

24 CFR 3282.203 - DAPIA services.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Requirements § 3282.203 DAPIA services. (a) Each manufacturer shall have each manufactured home design and each... is free to choose which DAPIA will evaluate and approve its designs and quality assurance materials manufacturer may obtain design and quality assurance manual approval from a single DAPIA regardless of the...

21 CFR 111.510 - What requirements apply when a returned dietary supplement is received?

Code of Federal Regulations, 2011 CFR

2011-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.510 What requirements apply when a returned dietary supplement is received? You must identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a...

21 CFR 111.510 - What requirements apply when a returned dietary supplement is received?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.510 What requirements apply when a returned dietary supplement is received? You must identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a...

21 CFR 111.510 - What requirements apply when a returned dietary supplement is received?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.510 What requirements apply when a returned dietary supplement is received? You must identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a...

21 CFR 111.510 - What requirements apply when a returned dietary supplement is received?

Code of Federal Regulations, 2013 CFR

2013-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.510 What requirements apply when a returned dietary supplement is received? You must identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a...

21 CFR 111.510 - What requirements apply when a returned dietary supplement is received?

Code of Federal Regulations, 2010 CFR

2010-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.510 What requirements apply when a returned dietary supplement is received? You must identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a...

32 CFR 507.10 - Incorporation of designs or likenesses of approved designs in commercial articles.

Code of Federal Regulations, 2010 CFR

2010-07-01

... DECORATIONS, MEDALS, BADGES, INSIGNIA, COMMERCIAL USE OF HERALDIC DESIGNS AND HERALDIC QUALITY CONTROL PROGRAM... organizational insignia may be incorporated in articles manufactured for sale provided that permission has been... the coat of arms, crest, seal and organizational emblems. Such permission will be in writing...

[2011 after-service customer satisfaction survey of monitoring devices in Shanghai area].

PubMed

Wang, Lijun; Li, Bin; Qian, Jianguo; Cao, Shaoping; He, Dehua; Zheng, Yunxin

2013-01-01

In 2011, Shanghai Medical Equipment Management Quality Control Center launched the fifth after-sale service satisfaction survey for medical devices in Shanghai area. There are 8 classes medical devices involving in the survey. This paper demonstrates the investigation results of monitoring devices which are from different manufacturers.

Manufacture and quality control of interconnecting wire harnesses, Volume 3

NASA Technical Reports Server (NTRS)

1972-01-01

The document covers interconnecting wire harnesses defined in the design standard, including type 6, enclosed in TFE heat shrink tubing; and type 7, flexible armored. Knowledge gained through experience on the Saturn 5 program coupled with recent advances in techniques, materials, and processes was incorporated into this document.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-31

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

76 FR 27610 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Adoption of Control...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-12

..., freezers, water heaters, dishwashers, trash compactors, air conditioners, ovens, microwave ovens, and other... appliance product. A large appliance product is also defined as any organic surface-coated metal range, oven, microwave, refrigerator, freezer, washer, dryer, dishwasher, water heater, or trash compactor manufactured...

21 CFR 106.100 - Records.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Records. 106.100 Section 106.100 Food and Drugs... CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES (Eff. until 7-10-14) Records and Reports § 106.100 Records. (a) Every manufacturer of infant formula shall maintain the records specified in this regulation...

21 CFR 106.100 - Records.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Records. 106.100 Section 106.100 Food and Drugs... CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Records and Reports § 106.100 Records. (a) Every manufacturer of infant formula shall maintain the records specified in this regulation in order to permit the...

21 CFR 820.150 - Storage.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Storage. 820.150 Section 820.150 Food and Drugs... QUALITY SYSTEM REGULATION Handling, Storage, Distribution, and Installation § 820.150 Storage. (a) Each manufacturer shall establish and maintain procedures for the control of storage areas and stock rooms for...

21 CFR 820.150 - Storage.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Storage. 820.150 Section 820.150 Food and Drugs... QUALITY SYSTEM REGULATION Handling, Storage, Distribution, and Installation § 820.150 Storage. (a) Each manufacturer shall establish and maintain procedures for the control of storage areas and stock rooms for...

21 CFR 820.150 - Storage.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Storage. 820.150 Section 820.150 Food and Drugs... QUALITY SYSTEM REGULATION Handling, Storage, Distribution, and Installation § 820.150 Storage. (a) Each manufacturer shall establish and maintain procedures for the control of storage areas and stock rooms for...

21 CFR 820.150 - Storage.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Storage. 820.150 Section 820.150 Food and Drugs... QUALITY SYSTEM REGULATION Handling, Storage, Distribution, and Installation § 820.150 Storage. (a) Each manufacturer shall establish and maintain procedures for the control of storage areas and stock rooms for...

46 CFR 160.047-5 - Inspections and tests. 1

Code of Federal Regulations, 2013 CFR

2013-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Vest, Kapok or Fibrous Glass, Adult... labeled buoyant vests shall— (1) Maintain quality control of the materials used, the manufacturing methods.... (b) Lot size and sampling. (1) A lot consists of 500 buoyant vests or fewer. (2) A new lot begins...

46 CFR 160.047-5 - Inspections and tests. 1

Code of Federal Regulations, 2014 CFR

2014-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Vest, Kapok or Fibrous Glass, Adult... labeled buoyant vests shall— (1) Maintain quality control of the materials used, the manufacturing methods.... (b) Lot size and sampling. (1) A lot consists of 500 buoyant vests or fewer. (2) A new lot begins...

46 CFR 160.047-5 - Inspections and tests. 1

Code of Federal Regulations, 2012 CFR

2012-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Vest, Kapok or Fibrous Glass, Adult... labeled buoyant vests shall— (1) Maintain quality control of the materials used, the manufacturing methods.... (b) Lot size and sampling. (1) A lot consists of 500 buoyant vests or fewer. (2) A new lot begins...

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

Code of Federal Regulations, 2010 CFR

2010-04-01

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

21 CFR 820.130 - Device packaging.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Device packaging. 820.130 Section 820.130 Food and... QUALITY SYSTEM REGULATION Labeling and Packaging Control § 820.130 Device packaging. Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the...

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.

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.

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.

Viral Vectors for In Vivo Gene Transfer in Parkinson’s disease: Properties and Clinical Grade Production

PubMed Central

Burger, Corinna; Snyder, Richard O.

2009-01-01

Because Parkinson’s disease is a progressive degenerative disorder that is mainly confined to the basal ganglia, gene transfer to deliver therapeutic molecules is an attractive treatment avenue. The present review focuses on direct in vivo gene transfer vectors that have been developed to a degree that they have been successfully used in animal model of Parkinson’s disease. Accordingly, the properties of recombinant adenovirus, recombinant adeno-associated virus, herpes simplex virus, and lentivirus are described and contrasted. In order for viral vectors to be developed into clinical grade reagents, they must be manufactured and tested to precise regulatory standards. Indeed, clinical lots of viral vectors can be produced in compliance with current Good Manufacturing Practices (cGMPs) regulations using industry accepted manufacturing methodologies, manufacturing controls, and quality systems. The viral vector properties themselves combined with physiological product formulations facilitate long-term storage and direct in vivo administration. PMID:17916354

78 FR 31943 - Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-28

... documenting the responsibilities of all parties involved in drug manufacturing, testing, or other support... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0558] Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements...

An evaluation of HACCP implementation status in UK small and medium enterprises in food manufacturing.

PubMed

Fielding, L M; Ellis, L; Beveridge, C; Peters, A C

2005-04-01

To reduce foodborne illnesses, hazard and risk-based quality management systems are essential. Small and medium sized companies (SMEs) tend to have a poor understanding of such systems and limited adoption of the Hazard Analysis Critical Control Point system (HACCP). The requirement for full HACCP implementation by 2006 will place an even greater burden on these businesses. The aim of this project is to assess the current levels of understanding of hazards and risks in SMEs in the manufacturing sector. A questionnaire survey was made of 850 SMEs, including microbusinesses. This determined the industry sector and processes carried out, whether the company operated hazard-based quality management and the knowledge of the technical manager regarding the associated hazards and risks. Follow-up visits to the manufacturing plant observed the processes and the operatives to determine their level of understanding. A benchmarking audit was carried out and each company was rated. The results show that the majority of respondents stated that they operated hazard analysis-based quality management. The ability of the respondents to correctly define a hazard or risk or identify different types of hazard was, however, poor. There was no correlation between business type and audit score. The microbusinesses did, however, perform significantly less well than the larger SMEs.

Cells as advanced therapeutics: State-of-the-art, challenges, and opportunities in large scale biomanufacturing of high-quality cells for adoptive immunotherapies.

PubMed

Dwarshuis, Nate J; Parratt, Kirsten; Santiago-Miranda, Adriana; Roy, Krishnendu

2017-05-15

Therapeutic cells hold tremendous promise in treating currently incurable, chronic diseases since they perform multiple, integrated, complex functions in vivo compared to traditional small-molecule drugs or biologics. However, they also pose significant challenges as therapeutic products because (a) their complex mechanisms of actions are difficult to understand and (b) low-cost bioprocesses for large-scale, reproducible manufacturing of cells have yet to be developed. Immunotherapies using T cells and dendritic cells (DCs) have already shown great promise in treating several types of cancers, and human mesenchymal stromal cells (hMSCs) are now extensively being evaluated in clinical trials as immune-modulatory cells. Despite these exciting developments, the full potential of cell-based therapeutics cannot be realized unless new engineering technologies enable cost-effective, consistent manufacturing of high-quality therapeutic cells at large-scale. Here we review cell-based immunotherapy concepts focused on the state-of-the-art in manufacturing processes including cell sourcing, isolation, expansion, modification, quality control (QC), and culture media requirements. We also offer insights into how current technologies could be significantly improved and augmented by new technologies, and how disciplines must converge to meet the long-term needs for large-scale production of cell-based immunotherapies. Copyright © 2017 Elsevier B.V. All rights reserved.

Quality Improvement, Inventory Management, Lead Time Reduction and Production Scheduling in High-Mix Manufacturing Environments

DTIC Science & Technology

2017-01-13

Quality Improvement, Inventory Management, Lead Time Reduction and Production Scheduling in High-mix Manufacturing Environments by Sean Daigle B.S...for the degree of Master of Engineering in Advanced Manufacturing and Design at the MASSACHUSETTS INSTITUTE OF TECHNOLOGY February 2017 c... Production Scheduling in High-mix Manufacturing Environments by Sean Daigle Submitted to the Department of Mechanical Engineering on January 13, 2017, in

[Application progress on near infrared spectroscopy in quality control and process monitoring of traditional Chinese medicine].

PubMed

Li, Wenlong; Qu, Haibin

2017-01-25

The industry of traditional Chinese medicine (TCM) encounters problems like quality fluctuation of raw materials and unstandardized production process. Near infrared (NIR) spectroscopy technology is widely used in quality control of TCM because of its abundant information, fast and nondestructive characters. The main applications include quantitative analysis of Chinese medicinal materials, intermediates and Chinese patent medicines; the authenticity of TCM, species, origins and manufacturers; monitoring and control of the extraction, alcohol precipitation, column chromatography and blending process. This article reviews the progress on the application of NIR spectroscopy technology in TCM field. In view of the problems existing in the application, the article proposes that the standardization of NIR analysis method should be developed according to specific characteristics of TCM, which will promote the application of NIR technology in the TCM industry.

Drug procurement and management.

PubMed

Salhotra, V S

2003-03-01

A strong drug procurement and management system under the RNTCP is critical to programme success. Significant improvements in manufacturing, inspection, supply, storage and quality control practices and procedures have been achieved due to an intensive RNTCP network. Drugs used in RNTCP are rifampicin, isoniazid, ethambutol, pyrazinamide and streptomycin. Patients of TB are categorised into I, II and III and each category has a different standarised treatment. Procurement, distribution system and quality assurance of drugs are narrated in brief in this article.

Bridging the Gap Between Validation and Implementation of Non-Animal Veterinary Vaccine Potency Testing Methods

PubMed Central

Dozier, Samantha; Brown, Jeffrey; Currie, Alistair

2011-01-01

Simple Summary Many vaccines are tested for quality in experiments that require the use of large numbers of animals in procedures that often cause significant pain and distress. Newer technologies have fostered the development of vaccine quality control tests that reduce or eliminate the use of animals, but the availability of these newer methods has not guaranteed their acceptance by regulators or use by manufacturers. We discuss a strategic approach that has been used to assess and ultimately increase the use of non-animal vaccine quality tests in the U.S. and U.K. Abstract In recent years, technologically advanced high-throughput techniques have been developed that replace, reduce or refine animal use in vaccine quality control tests. Following validation, these tests are slowly being accepted for use by international regulatory authorities. Because regulatory acceptance itself has not guaranteed that approved humane methods are adopted by manufacturers, various organizations have sought to foster the preferential use of validated non-animal methods by interfacing with industry and regulatory authorities. After noticing this gap between regulation and uptake by industry, we began developing a paradigm that seeks to narrow the gap and quicken implementation of new replacement, refinement or reduction guidance. A systematic analysis of our experience in promoting the transparent implementation of validated non-animal vaccine potency assays has led to the refinement of our paradigmatic process, presented here, by which interested parties can assess the local regulatory acceptance of methods that reduce animal use and integrate them into quality control testing protocols, or ensure the elimination of peripheral barriers to their use, particularly for potency and other tests carried out on production batches. PMID:26486625

Advanced qualification of pharmaceutical excipient suppliers by multiple analytics and multivariate analysis combined.

PubMed

Hertrampf, A; Müller, H; Menezes, J C; Herdling, T

2015-11-10

Pharmaceutical excipients have different functions within a drug formulation, consequently they can influence the manufacturability and/or performance of medicinal products. Therefore, critical to quality attributes should be kept constant. Sometimes it may be necessary to qualify a second supplier, but its product will not be completely equal to the first supplier product. To minimize risks of not detecting small non-similarities between suppliers and to detect lot-to-lot variability for each supplier, multivariate data analysis (MVA) can be used as a more powerful alternative to classical quality control that uses one-parameter-at-a-time monitoring. Such approach is capable of supporting the requirements of a new guideline by the European Parliament and Council (2015/C-95/02) demanding appropriate quality control strategies for excipients based on their criticality and supplier risks in ensuring quality, safety and function. This study compares calcium hydrogen phosphate from two suppliers. It can be assumed that both suppliers use different manufacturing processes. Therefore, possible chemical and physical differences were investigated by using Raman spectroscopy, laser diffraction and X-ray powder diffraction. Afterwards MVA was used to extract relevant information from each analytical technique. Both CaHPO4 could be discriminated by their supplier. The gained knowledge allowed to specify an enhanced strategy for second supplier qualification. Copyright © 2015 Elsevier B.V. All rights reserved.

Lessons from industry: one school's transformation toward "lean" curricular governance.

PubMed

Stratton, Terry D; Rudy, David W; Sauer, Marlene J; Perman, Jay A; Jennings, C Darrell

2007-04-01

As medical education grapples with organizational calls for centralized curricular oversight, programs may be compelled to respond by establishing highly vertical, stacked governance structures. Although these models offer discrete advantages over the horizontal, compartmentalized structures they are designed to replace, they pose new challenges to ensuring curricular quality and the educational innovations that drive the curricula. The authors describe a hybrid quality-assurance (QA) governance structure introduced in 2003 at the University of Kentucky College of Medicine (UKCOM) that ensures centralized curricular oversight of the educational product while allowing individualized creative control over the educational process. Based on a Lean production model, this approach draws on industry experiences that strategically separate institutional accountability (management) for a quality curriculum from the decision-making processes required to ensure it (production). In so doing, the authors acknowledge general similarities and key differences between overseeing the manufacture of a complex product versus the education of a physician-emphasizing the structured, sequential, and measurable nature of each process. Further, the authors briefly trace the emergence of quality approaches in manufacturing and discuss the philosophical changes that accompany transition to an institutional governance system that relies on vigorous, robust performance measures to offer continuous feedback on curricular quality.

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

Volatility-dependent 2D IR correlation analysis of traditional Chinese medicine ‘Red Flower Oil’ preparation from different manufacturers

NASA Astrophysics Data System (ADS)

Wu, Yan-Wen; Sun, Su-Qin; Zhou, Qun; Tao, Jia-Xun; Noda, Isao

2008-06-01

As a traditional Chinese medicine (TCM), 'Red Flower Oil' preparation is widely used as a household remedy in China and Southeast Asia. Usually, the preparation is a mixture of several plant essential oils with different volatile features, such as wintergreen oil, turpentine oil and clove oil. The proportions of these plant essential oils in 'Red Flower Oil' vary from different manufacturers. Thus, it is important to develop a simple and rapid evaluation method for quality assurance of the preparations. Fourier transform infrared (FT-IR) was applied and two-dimensional correlation infrared spectroscopy (2D IR) based on the volatile characteristic of samples was used to enhance the resolution of FT-IR spectra. 2D IR technique could, not only easily provide the composition and their volatile sequences in 'Red flower Oil' preparations, but also rapidly discriminate the subtle differences in products from different manufacturers. Therefore, FT-IR combined with volatility-dependent 2D IR correlation analysis provides a very fast and effective method for the quality control of essential oil mixtures in TCM.