40 CFR 98.70 - Definition of source category.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) MANDATORY GREENHOUSE GAS REPORTING Ammonia Manufacturing § 98.70 Definition of source category. The ammonia manufacturing source category comprises the process units listed in paragraphs (a) and (b) of this section. (a) Ammonia manufacturing processes in which ammonia is manufactured from a fossil...

40 CFR 98.70 - Definition of source category.

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) MANDATORY GREENHOUSE GAS REPORTING Ammonia Manufacturing § 98.70 Definition of source category. The ammonia manufacturing source category comprises the process units listed in paragraphs (a) and (b) of this section. (a) Ammonia manufacturing processes in which ammonia is manufactured from a fossil...

40 CFR 98.70 - Definition of source category.

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) MANDATORY GREENHOUSE GAS REPORTING Ammonia Manufacturing § 98.70 Definition of source category. The ammonia manufacturing source category comprises the process units listed in paragraphs (a) and (b) of this section. (a) Ammonia manufacturing processes in which ammonia is manufactured from a fossil...

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.

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.

40 CFR 98.73 - Calculating GHG emissions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) MANDATORY GREENHOUSE GAS REPORTING Ammonia Manufacturing § 98.73 Calculating GHG emissions. You must calculate and report the annual process CO2 emissions from each ammonia manufacturing process unit... ammonia manufacturing unit, the CO2 process emissions from gaseous feedstock according to Equation G-1 of...

40 CFR 98.73 - Calculating GHG emissions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) MANDATORY GREENHOUSE GAS REPORTING Ammonia Manufacturing § 98.73 Calculating GHG emissions. You must calculate and report the annual process CO2 emissions from each ammonia manufacturing process unit... ammonia manufacturing unit, the CO2 process emissions from gaseous feedstock according to Equation G-1 of...

40 CFR 98.73 - Calculating GHG emissions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) MANDATORY GREENHOUSE GAS REPORTING Ammonia Manufacturing § 98.73 Calculating GHG emissions. You must calculate and report the annual process CO2 emissions from each ammonia manufacturing process unit... ammonia manufacturing unit, the CO2 process emissions from gaseous feedstock according to Equation G-1 of...

40 CFR 98.73 - Calculating GHG emissions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) MANDATORY GREENHOUSE GAS REPORTING Ammonia Manufacturing § 98.73 Calculating GHG emissions. You must calculate and report the annual process CO2 emissions from each ammonia manufacturing process unit... ammonia manufacturing unit, the CO2 process emissions from gaseous feedstock according to Equation G-1 of...

40 CFR 98.73 - Calculating GHG emissions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... (CONTINUED) MANDATORY GREENHOUSE GAS REPORTING Ammonia Manufacturing § 98.73 Calculating GHG emissions. You must calculate and report the annual process CO2 emissions from each ammonia manufacturing process unit... ammonia manufacturing unit, the CO2 process emissions from gaseous feedstock according to Equation G-1 of...

40 CFR 461.71 - Effluent limitations representing the degree of effluent reduction attainable by the application...

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Zinc...) There shall be no discharge allowance for process wastewater pollutants from any battery manufacturing operation other than those battery manufacturing operations listed above. [49 FR 9134, Mar. 9, 1984; 49 FR...

40 CFR 461.71 - Effluent limitations representing the degree of effluent reduction attainable by the application...

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Zinc...) There shall be no discharge allowance for process wastewater pollutants from any battery manufacturing operation other than those battery manufacturing operations listed above. [49 FR 9134, Mar. 9, 1984; 49 FR...

Continuous Flow in Labour-Intensive Manufacturing Process

NASA Astrophysics Data System (ADS)

Pacheco Eng., Jhonny; Carbajal MSc., Eduardo; Stoll-Ing., Cesar, Dr.

2017-06-01

A continuous-flow manufacturing represents the peak of standard production, and usually it means high production in a strict line production. Furthermore, low-tech industry demands high labour-intensive, in this context the efficient of the line production is tied at the job shop organization. Labour-intensive manufacturing processes are a common characteristic for developing countries. This research aims to propose a methodology for production planning in order to fulfilment a variable monthly production quota. The main idea is to use a clock as orchestra director in order to synchronize the rate time (takt time) of customer demand with the manufacturing time. In this way, the study is able to propose a stark reduction of stock in process, over-processing, and unnecessary variability.

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

PubMed

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

2017-07-01

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

White paper on continuous bioprocessing. May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Konstantinov, Konstantin B; Cooney, Charles L

2015-03-01

There is a growing interest in realizing the benefits of continuous processing in biologics manufacturing, which is reflected by the significant number of industrial and academic researchers who are actively involved in the development of continuous bioprocessing systems. These efforts are further encouraged by guidance expressed in recent US FDA conference presentations. The advantages of continuous manufacturing include sustained operation with consistent product quality, reduced equipment size, high-volumetric productivity, streamlined process flow, low-process cycle times, and reduced capital and operating cost. This technology, however, poses challenges, which need to be addressed before routine implementation is considered. This paper, which is based on the available literature and input from a large number of reviewers, is intended to provide a consensus of the opportunities, technical needs, and strategic directions for continuous bioprocessing. The discussion is supported by several examples illustrating various architectures of continuous bioprocessing systems. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Study on parameters affecting the mechanical properties of dry fiber bundles during continuous composite manufacturing processes

NASA Astrophysics Data System (ADS)

Maier, A.; Schledjewski, R.

2016-07-01

For continuous manufacturing processes mechanical preloading of the fibers occurs during the delivery of the fibers from the spool creel to the actual manufacturing process step. Moreover preloading of the dry roving bundles might be mandatory, e.g. during winding, to be able to produce high quality components. On the one hand too high tensile loads within dry roving bundles might result in a catastrophic failure and on the other hand the part produced under too low pre-tension might have low quality and mechanical properties. In this work, load conditions influencing mechanical properties of dry glass fiber bundles during continuous composite manufacturing processes were analyzed. Load conditions, i.e. fiber delivery speed, necessary pre-tension and other effects of the delivery system during continuous fiber winding, were chosen in process typical ranges. First, the strain rate dependency under static tensile load conditions was investigated. Furthermore different free gauge lengths up to 1.2 m, interactions between fiber points of contact regarding influence of sizing as well as impregnation were tested and the effect of twisting on the mechanical behavior of dry glass fiber bundles during the fiber delivery was studied.

Crystal and Particle Engineering Strategies for Improving Powder Compression and Flow Properties to Enable Continuous Tablet Manufacturing by Direct Compression.

PubMed

Chattoraj, Sayantan; Sun, Changquan Calvin

2018-04-01

Continuous manufacturing of tablets has many advantages, including batch size flexibility, demand-adaptive scale up or scale down, consistent product quality, small operational foot print, and increased manufacturing efficiency. Simplicity makes direct compression the most suitable process for continuous tablet manufacturing. However, deficiencies in powder flow and compression of active pharmaceutical ingredients (APIs) limit the range of drug loading that can routinely be considered for direct compression. For the widespread adoption of continuous direct compression, effective API engineering strategies to address power flow and compression problems are needed. Appropriate implementation of these strategies would facilitate the design of high-quality robust drug products, as stipulated by the Quality-by-Design framework. Here, several crystal and particle engineering strategies for improving powder flow and compression properties are summarized. The focus is on the underlying materials science, which is the foundation for effective API engineering to enable successful continuous manufacturing by the direct compression process. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2017-06-16

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

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.

27 CFR 40.355 - Return of manufacturer.

Code of Federal Regulations, 2010 CFR

2010-04-01

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

27 CFR 40.355 - Return of manufacturer.

Code of Federal Regulations, 2013 CFR

2013-04-01

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

27 CFR 40.355 - Return of manufacturer.

Code of Federal Regulations, 2014 CFR

2014-04-01

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

27 CFR 40.355 - Return of manufacturer.

Code of Federal Regulations, 2011 CFR

2011-04-01

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

27 CFR 40.355 - Return of manufacturer.

Code of Federal Regulations, 2012 CFR

2012-04-01

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

Reducing shingle waste at a manufacturing facility: 1990 MNTAP summer intern report

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

Menke, D.

1990-12-31

CertainTeed manufactures roofing shingles at it`s Shakopee, MN facility. Two process coating lines, and one assembly line, produce fifteen shingle types in fifteen different colors. The wastes generated by this process were the result of planned and unplanned variations in the continuous production process. Planned variations included changes in color, while felt breaks were common unplanned variations. Five options were identified that could reduce the amount of waste generated: Using a standard procedure for recovering from felt breaks, Creating a process cushion to maintain continuous production in the event of temporary shutdowns, An automated color change process, Manufacture of amore » new product from waste material, Minor process changes to reduce the frequency of breaks.« less

21 CFR 640.102 - Manufacture of Immune Globulin (Human).

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Manufacture of Immune Globulin (Human). 640.102... (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Immune Globulin (Human) § 640.102 Manufacture of Immune Globulin (Human). (a) Processing method. The processing method shall be one...

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

PubMed

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

2013-04-05

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

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

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Applicability of current good manufacturing... AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL § 210.2 Applicability of current good manufacturing...

An interval programming model for continuous improvement in micro-manufacturing

NASA Astrophysics Data System (ADS)

Ouyang, Linhan; Ma, Yizhong; Wang, Jianjun; Tu, Yiliu; Byun, Jai-Hyun

2018-03-01

Continuous quality improvement in micro-manufacturing processes relies on optimization strategies that relate an output performance to a set of machining parameters. However, when determining the optimal machining parameters in a micro-manufacturing process, the economics of continuous quality improvement and decision makers' preference information are typically neglected. This article proposes an economic continuous improvement strategy based on an interval programming model. The proposed strategy differs from previous studies in two ways. First, an interval programming model is proposed to measure the quality level, where decision makers' preference information is considered in order to determine the weight of location and dispersion effects. Second, the proposed strategy is a more flexible approach since it considers the trade-off between the quality level and the associated costs, and leaves engineers a larger decision space through adjusting the quality level. The proposed strategy is compared with its conventional counterparts using an Nd:YLF laser beam micro-drilling process.

Thermographic In-Situ Process Monitoring of the Electron Beam Melting Technology used in Additive Manufacturing

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

Dinwiddie, Ralph Barton; Dehoff, Ryan R; Lloyd, Peter D

2013-01-01

Oak Ridge National Laboratory (ORNL) has been utilizing the ARCAM electron beam melting technology to additively manufacture complex geometric structures directly from powder. Although the technology has demonstrated the ability to decrease costs, decrease manufacturing lead-time and fabricate complex structures that are impossible to fabricate through conventional processing techniques, certification of the component quality can be challenging. Because the process involves the continuous deposition of successive layers of material, each layer can be examined without destructively testing the component. However, in-situ process monitoring is difficult due to metallization on inside surfaces caused by evaporation and condensation of metal from themore » melt pool. This work describes a solution to one of the challenges to continuously imaging inside of the chamber during the EBM process. Here, the utilization of a continuously moving Mylar film canister is described. Results will be presented related to in-situ process monitoring and how this technique results in improved mechanical properties and reliability of the process.« less

40 CFR 461.64 - Pretreatment standards for existing sources (PSES).

Code of Federal Regulations, 2014 CFR

2014-07-01

...) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Magnesium... allowance for process wastewater pollutants from any battery manufacturing operation other than those battery manufacturing operations listed above. ...

40 CFR 461.64 - Pretreatment standards for existing sources (PSES).

Code of Federal Regulations, 2013 CFR

2013-07-01

...) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Magnesium... allowance for process wastewater pollutants from any battery manufacturing operation other than those battery manufacturing operations listed above. ...

Continuous Manufacturing of Recombinant Therapeutic Proteins: Upstream and Downstream Technologies.

PubMed

Patil, Rohan; Walther, Jason

2017-03-07

Continuous biomanufacturing of recombinant therapeutic proteins offers several potential advantages over conventional batch processing, including reduced cost of goods, more flexible and responsive manufacturing facilities, and improved and consistent product quality. Although continuous approaches to various upstream and downstream unit operations have been considered and studied for decades, in recent years interest and application have accelerated. Researchers have achieved increasingly higher levels of process intensification, and have also begun to integrate different continuous unit operations into larger, holistically continuous processes. This review first discusses approaches for continuous cell culture, with a focus on perfusion-enabling cell separation technologies including gravitational, centrifugal, and acoustic settling, as well as filtration-based techniques. We follow with a review of various continuous downstream unit operations, covering categories such as clarification, chromatography, formulation, and viral inactivation and filtration. The review ends by summarizing case studies of integrated and continuous processing as reported in the literature.

21 CFR 210.1 - Status of current good manufacturing practice regulations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Status of current good manufacturing practice... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL § 210.1 Status of current good manufacturing practice regulations...

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

PubMed

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

2016-01-01

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

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

PubMed

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

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

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

PubMed

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

2016-09-01

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

40 CFR 763.175 - Enforcement.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

A Roadmap for the Implementation of Continued Process Verification.

PubMed

Boyer, Marcus; Gampfer, Joerg; Zamamiri, Abdel; Payne, Robin

2016-01-01

In 2014, the members of the BioPhorum Operations Group (BPOG) produced a 100-page continued process verification case study, entitled "Continued Process Verification: An Industry Position Paper with Example Protocol". This case study captures the thought processes involved in creating a continued process verification plan for a new product in response to the U.S. Food and Drug Administration's guidance on the subject introduced in 2011. In so doing, it provided the specific example of a plan developed for a new molecular antibody product based on the "A MAb Case Study" that preceded it in 2009.This document provides a roadmap that draws on the content of the continued process verification case study to provide a step-by-step guide in a more accessible form, with reference to a process map of the product life cycle. It could be used as a basis for continued process verification implementation in a number of different scenarios: For a single product and process;For a single site;To assist in the sharing of data monitoring responsibilities among sites;To assist in establishing data monitoring agreements between a customer company and a contract manufacturing organization. The U.S. Food and Drug Administration issued guidance on the management of manufacturing processes designed to improve quality and control of drug products. This involved increased focus on regular monitoring of manufacturing processes, reporting of the results, and the taking of opportunities to improve. The guidance and practice associated with it is known as continued process verification This paper summarizes good practice in responding to continued process verification guidance, gathered from subject matter experts in the biopharmaceutical industry. © PDA, Inc. 2016.

Microgravity Manufacturing: Extending Rapid Prototyping Past the Horizon

NASA Technical Reports Server (NTRS)

Cooper, Ken

2003-01-01

Over the last decade, rapid prototyping (RP) technologies have continued to advance in all aspects of operation and application. From continuously advanced materials and processes development to more hard-core manufacturing uses, the RP realm has stretched considerably past its original expectations as a prototyping capability. This paper discusses the unique applications for which NASA has chosen these manufacturing techniques to be utilized in outer space.

Twin Screw Extruders as Continuous Mixers for Thermal Processing: a Technical and Historical Perspective.

PubMed

Martin, Charlie

2016-02-01

Developed approximately 100 years ago for natural rubber/plastics applications, processes via twin screw extrusion (TSE) now generate some of the most cutting-edge drug delivery systems available. After 25 or so years of usage in pharmaceutical environments, it has become evident why TSE processing offers significant advantages as compared to other manufacturing techniques. The well-characterized nature of the TSE process lends itself to ease of scale-up and process optimization while also affording the benefits of continuous manufacturing. Interestingly, the evolution of twin screw extrusion for pharmaceutical products has followed a similar path as previously trodden by plastics processing pioneers. Almost every plastic has been processed at some stage in the manufacturing train on a twin screw extruder, which is utilized to mix materials together to impart desired properties into a final part. The evolution of processing via TSEs since the early/mid 1900s is recounted for plastics and also for pharmaceuticals from the late 1980s until today. The similarities are apparent. The basic theory and development of continuous mixing via corotating and counterrotating TSEs for plastics and drug is also described. The similarities between plastics and pharmaceutical applications are striking. The superior mixing characteristics inherent with a TSE have allowed this device to dominate other continuous mixers and spurred intensive development efforts and experimentation that spawned highly engineered formulations for the commodity and high-tech plastic products we use every day. Today, twin screw extrusion is a battle hardened, well-proven, manufacturing process that has been validated in 24-h/day industrial settings. The same thing is happening today with new extrusion technologies being applied to advanced drug delivery systems to facilitate commodity, targeted, and alternative delivery systems. It seems that the "extrusion evolution" will continue for wide-ranging pharmaceutical products.

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

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

PubMed

Scholze, Sebastian; Barata, Jose; Stokic, Dragan

2017-02-24

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

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

PubMed Central

Scholze, Sebastian; Barata, Jose; Stokic, Dragan

2017-01-01

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

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

PubMed

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

2017-01-01

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

40 CFR 429.140 - Applicability; description of the particleboard manufacturing subcategory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... particleboard manufacturing subcategory. 429.140 Section 429.140 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS TIMBER PRODUCTS PROCESSING POINT SOURCE CATEGORY Particleboard Manufacturing Subcategory § 429.140 Applicability; description of the particleboard...

40 CFR 461.11 - Effluent limitations representing the degree of effluent reduction attainable by the application...

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS BATTERY MANUFACTURING POINT SOURCE CATEGORY Cadmium Subcategory... allowance for process wastewater pollutants from any battery manufacturing operation other than those battery manufacturing operations listed above. ...

40 CFR 461.15 - Pretreatment standards for new sources (PSNS).

Code of Federal Regulations, 2012 CFR

2012-07-01

...) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Cadmium....16 (b) There shall be no discharge allowance for process wastewater pollutants from any battery manufacturing operation other than those battery manufacturing operations listed above. ...

40 CFR 461.15 - Pretreatment standards for new sources (PSNS).

Code of Federal Regulations, 2013 CFR

2013-07-01

...) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Cadmium....16 (b) There shall be no discharge allowance for process wastewater pollutants from any battery manufacturing operation other than those battery manufacturing operations listed above. ...

40 CFR 461.15 - Pretreatment standards for new sources (PSNS).

Code of Federal Regulations, 2014 CFR

2014-07-01

...) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Cadmium....16 (b) There shall be no discharge allowance for process wastewater pollutants from any battery manufacturing operation other than those battery manufacturing operations listed above. ...

40 CFR 461.11 - Effluent limitations representing the degree of effluent reduction attainable by the application...

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS BATTERY MANUFACTURING POINT SOURCE CATEGORY Cadmium Subcategory... allowance for process wastewater pollutants from any battery manufacturing operation other than those battery manufacturing operations listed above. ...

21 CFR 820.70 - Production and process controls.

Code of Federal Regulations, 2010 CFR

2010-04-01

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

Engineering aspects of rate-related processes in food manufacturing.

PubMed

Adachi, Shuji

2015-01-01

Many rate-related phenomena occur in food manufacturing processes. This review addresses four of them, all of which are topics that the author has studied in order to design food manufacturing processes that are favorable from the standpoint of food engineering. They include chromatographic separation through continuous separation with a simulated moving adsorber, lipid oxidation kinetics in emulsions and microencapsulated systems, kinetic analysis and extraction in subcritical water, and water migration in pasta.

40 CFR 461.23 - New source performance standards (NSPS).

Code of Federal Regulations, 2012 CFR

2012-07-01

... GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Calcium Subcategory § 461.23... discharge for process wastewater pollutants from any battery manufacturing operations. ...

40 CFR 461.23 - New source performance standards (NSPS).

Code of Federal Regulations, 2013 CFR

2013-07-01

... GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Calcium Subcategory § 461.23... discharge for process wastewater pollutants from any battery manufacturing operations. ...

40 CFR 461.23 - New source performance standards (NSPS).

Code of Federal Regulations, 2014 CFR

2014-07-01

... GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Calcium Subcategory § 461.23... discharge for process wastewater pollutants from any battery manufacturing operations. ...

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

PubMed

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

2018-05-30

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

Production process stability - core assumption of INDUSTRY 4.0 concept

NASA Astrophysics Data System (ADS)

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

2017-06-01

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

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

Code of Federal Regulations, 2011 CFR

2011-04-01

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

Integrated continuous bioprocessing: Economic, operational, and environmental feasibility for clinical and commercial antibody manufacture.

PubMed

Pollock, James; Coffman, Jon; Ho, Sa V; Farid, Suzanne S

2017-07-01

This paper presents a systems approach to evaluating the potential of integrated continuous bioprocessing for monoclonal antibody (mAb) manufacture across a product's lifecycle from preclinical to commercial manufacture. The economic, operational, and environmental feasibility of alternative continuous manufacturing strategies were evaluated holistically using a prototype UCL decisional tool that integrated process economics, discrete-event simulation, environmental impact analysis, operational risk analysis, and multiattribute decision-making. The case study focused on comparing whole bioprocesses that used either batch, continuous or a hybrid combination of batch and continuous technologies for cell culture, capture chromatography, and polishing chromatography steps. The cost of goods per gram (COG/g), E-factor, and operational risk scores of each strategy were established across a matrix of scenarios with differing combinations of clinical development phase and company portfolio size. The tool outputs predict that the optimal strategy for early phase production and small/medium-sized companies is the integrated continuous strategy (alternating tangential flow filtration (ATF) perfusion, continuous capture, continuous polishing). However, the top ranking strategy changes for commercial production and companies with large portfolios to the hybrid strategy with fed-batch culture, continuous capture and batch polishing from a COG/g perspective. The multiattribute decision-making analysis highlighted that if the operational feasibility was considered more important than the economic benefits, the hybrid strategy would be preferred for all company scales. Further considerations outside the scope of this work include the process development costs required to adopt continuous processing. © 2017 The Authors Biotechnology Progress published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers Biotechnol. Prog., 33:854-866, 2017. © 2017 The Authors Biotechnology Progress published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers.

Integrated continuous bioprocessing: Economic, operational, and environmental feasibility for clinical and commercial antibody manufacture

PubMed Central

Pollock, James; Coffman, Jon; Ho, Sa V.

2017-01-01

This paper presents a systems approach to evaluating the potential of integrated continuous bioprocessing for monoclonal antibody (mAb) manufacture across a product's lifecycle from preclinical to commercial manufacture. The economic, operational, and environmental feasibility of alternative continuous manufacturing strategies were evaluated holistically using a prototype UCL decisional tool that integrated process economics, discrete‐event simulation, environmental impact analysis, operational risk analysis, and multiattribute decision‐making. The case study focused on comparing whole bioprocesses that used either batch, continuous or a hybrid combination of batch and continuous technologies for cell culture, capture chromatography, and polishing chromatography steps. The cost of goods per gram (COG/g), E‐factor, and operational risk scores of each strategy were established across a matrix of scenarios with differing combinations of clinical development phase and company portfolio size. The tool outputs predict that the optimal strategy for early phase production and small/medium‐sized companies is the integrated continuous strategy (alternating tangential flow filtration (ATF) perfusion, continuous capture, continuous polishing). However, the top ranking strategy changes for commercial production and companies with large portfolios to the hybrid strategy with fed‐batch culture, continuous capture and batch polishing from a COG/g perspective. The multiattribute decision‐making analysis highlighted that if the operational feasibility was considered more important than the economic benefits, the hybrid strategy would be preferred for all company scales. Further considerations outside the scope of this work include the process development costs required to adopt continuous processing. © 2017 The Authors Biotechnology Progress published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers Biotechnol. Prog., 33:854–866, 2017 PMID:28480535

40 CFR 461.25 - Pretreatment standards for new sources (PSNS).

Code of Federal Regulations, 2013 CFR

2013-07-01

...) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Calcium...) There shall be no discharge for process wastewater pollutants from any battery manufacturing operations. ...

40 CFR 461.25 - Pretreatment standards for new sources (PSNS).

Code of Federal Regulations, 2014 CFR

2014-07-01

...) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Calcium...) There shall be no discharge for process wastewater pollutants from any battery manufacturing operations. ...

40 CFR 461.53 - New source performance standards (NSPS).

Code of Federal Regulations, 2014 CFR

2014-07-01

... GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Lithium Subcategory § 461.53... process wastewater pollutants from any battery manufacturing operation other than those battery...

40 CFR 461.25 - Pretreatment standards for new sources (PSNS).

Code of Federal Regulations, 2012 CFR

2012-07-01

...) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Calcium...) There shall be no discharge for process wastewater pollutants from any battery manufacturing operations. ...

40 CFR 461.53 - New source performance standards (NSPS).

Code of Federal Regulations, 2013 CFR

2013-07-01

... GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Lithium Subcategory § 461.53... process wastewater pollutants from any battery manufacturing operation other than those battery...

40 CFR 98.97 - Records that must be retained.

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) MANDATORY GREENHOUSE GAS REPORTING Electronics Manufacturing § 98.97 Records that must be... vapor deposition processes and for the aggregate of all other electronics manufacturing production...

40 CFR 98.76 - Data reporting requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

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

40 CFR 98.76 - Data reporting requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

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

40 CFR 98.76 - Data reporting requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

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

40 CFR 98.76 - Data reporting requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

40 CFR 98.76 - Data reporting requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

27 CFR 40.372 - Rate of special tax.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., DEPARTMENT OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Manufacture of Cigarette Papers and Tubes Special (occupational) Taxes § 40.372... on every manufacturer of cigarette papers and tubes. (b) Reduced rate for small proprietors. Title 26...

27 CFR 40.372 - Rate of special tax.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., DEPARTMENT OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Manufacture of Cigarette Papers and Tubes Special (occupational) Taxes § 40.372... on every manufacturer of cigarette papers and tubes. (b) Reduced rate for small proprietors. Title 26...

27 CFR 40.372 - Rate of special tax.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., DEPARTMENT OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Manufacture of Cigarette Papers and Tubes Special (occupational) Taxes § 40.372... on every manufacturer of cigarette papers and tubes. (b) Reduced rate for small proprietors. Title 26...

40 CFR 461.13 - New source performance standards (NSPS).

Code of Federal Regulations, 2013 CFR

2013-07-01

... GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Cadmium Subcategory § 461.13... allowance for process wastewater pollutants from any battery manufacturing operation other than those battery manufacturing operations listed above. [49 FR 9134, Mar. 9, 1984; 49 FR 13879, Apr. 9, 1984] ...

40 CFR 461.13 - New source performance standards (NSPS).

Code of Federal Regulations, 2012 CFR

2012-07-01

... GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Cadmium Subcategory § 461.13... allowance for process wastewater pollutants from any battery manufacturing operation other than those battery manufacturing operations listed above. [49 FR 9134, Mar. 9, 1984; 49 FR 13879, Apr. 9, 1984] ...

40 CFR 461.13 - New source performance standards (NSPS).

Code of Federal Regulations, 2014 CFR

2014-07-01

... GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Cadmium Subcategory § 461.13... allowance for process wastewater pollutants from any battery manufacturing operation other than those battery manufacturing operations listed above. [49 FR 9134, Mar. 9, 1984; 49 FR 13879, Apr. 9, 1984] ...

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

NASA Astrophysics Data System (ADS)

Demeri, Mahmoud Y.

2001-02-01

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

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.

Toward predicting tensile strength of pharmaceutical tablets by ultrasound measurement in continuous manufacturing.

PubMed

Razavi, Sonia M; Callegari, Gerardo; Drazer, German; Cuitiño, Alberto M

2016-06-30

An ultrasound measurement system was employed as a non-destructive method to evaluate its reliability in predicting the tensile strength of tablets and investigate the benefits of incorporating it in a continuous line, manufacturing solid dosage forms. Tablets containing lactose, acetaminophen, and magnesium stearate were manufactured continuously and in batches. The effect of two processing parameters, compaction force and level of shear strain were examined. Young's modulus and tensile strength of tablets were obtained by ultrasound and diametrical mechanical testing, respectively. It was found that as the blend was exposed to increasing levels of shear strain, the speed of sound in the tablets decreased and the tablets became both softer and mechanically weaker. Moreover, the results indicate that two separate tablet material properties (e.g., relative density and Young's modulus) are necessary in order to predict tensile strength. A strategy for hardness prediction is proposed that uses the existing models for Young's modulus and tensile strength of porous materials. Ultrasound testing was found to be very sensitive in differentiating tablets with similar formulation but produced under different processing conditions (e.g., different level of shear strain), thus, providing a fast, and non-destructive method for hardness prediction that could be incorporated to a continuous manufacturing process. Copyright © 2016 Elsevier B.V. All rights reserved.

40 CFR 458.41 - Specialized definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Lamp Process... shall apply to this subpart. (b) The term “product” shall mean carbon black manufactured by the lamp...

40 CFR 458.41 - Specialized definitions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Lamp Process... shall apply to this subpart. (b) The term “product” shall mean carbon black manufactured by the lamp...

40 CFR 458.41 - Specialized definitions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Lamp Process... shall apply to this subpart. (b) The term “product” shall mean carbon black manufactured by the lamp...

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

PubMed

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

2017-05-01

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

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.

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

PubMed

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

2016-01-15

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

40 CFR 63.7182 - What parts of my facility does this subpart cover?

Code of Federal Regulations, 2011 CFR

2011-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Semiconductor... manufactures semiconductors. (b) An affected source subject to this subpart is the collection of all semiconductor manufacturing process units used to manufacture p-type and n-type semiconductors and active solid...

Continuous Processing of High Thermal Conductivity Polyethylene Fibers and Sheets

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

None

2016-12-01

This factsheet describes a project that developed a new, continuous manufacturing process to make high molecular weight, high thermal conductivity polyethylene fibers and sheets to replace metals and ceramics in heat transfer applications.

Lean Thinking in Libraries: A Case Study on Improving Shelving Turnaround

ERIC Educational Resources Information Center

Kress, Nancy J.

2007-01-01

The University of Chicago's Joseph Regenstein Library Bookstacks Department has used process mapping and continuous improvement to successfully improve its overall operations. The most recent efforts focus on Lean manufacturing, an initiative centered on eliminating waste in manufacturing processes. The conversion of the Bookstacks Department from…

40 CFR 461.71 - Effluent limitations representing the degree of effluent reduction attainable by the application...

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS BATTERY MANUFACTURING POINT SOURCE CATEGORY Zinc Subcategory...) There shall be no discharge allowance for process wastewater pollutants from any battery manufacturing operation other than those battery manufacturing operations listed above. [49 FR 9134, Mar. 9, 1984; 49 FR...

27 CFR 40.372 - Rate of special tax.

Code of Federal Regulations, 2012 CFR

2012-04-01

... OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Manufacture of Cigarette Papers and Tubes Special (occupational) Taxes § 40.372 Rate of... manufacturer of cigarette papers and tubes. (b) Reduced rate for small proprietors. Title 26 U.S.C. 5731(b...

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

NASA Astrophysics Data System (ADS)

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

2018-03-01

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

Using PAT to accelerate the transition to continuous API manufacturing.

PubMed

Gouveia, Francisca F; Rahbek, Jesper P; Mortensen, Asmus R; Pedersen, Mette T; Felizardo, Pedro M; Bro, Rasmus; Mealy, Michael J

2017-01-01

Significant improvements can be realized by converting conventional batch processes into continuous ones. The main drivers include reduction of cost and waste, increased safety, and simpler scale-up and tech transfer activities. Re-designing the process layout offers the opportunity to incorporate a set of process analytical technologies (PAT) embraced in the Quality-by-Design (QbD) framework. These tools are used for process state estimation, providing enhanced understanding of the underlying variability in the process impacting quality and yield. This work describes a road map for identifying the best technology to speed-up the development of continuous processes while providing the basis for developing analytical methods for monitoring and controlling the continuous full-scale reaction. The suitability of in-line Raman, FT-infrared (FT-IR), and near-infrared (NIR) spectroscopy for real-time process monitoring was investigated in the production of 1-bromo-2-iodobenzene. The synthesis consists of three consecutive reaction steps including the formation of an unstable diazonium salt intermediate, which is critical to secure high yield and avoid formation of by-products. All spectroscopic methods were able to capture critical information related to the accumulation of the intermediate with very similar accuracy. NIR spectroscopy proved to be satisfactory in terms of performance, ease of installation, full-scale transferability, and stability to very adverse process conditions. As such, in-line NIR was selected to monitor the continuous full-scale production. The quantitative method was developed against theoretical concentration values of the intermediate since representative sampling for off-line reference analysis cannot be achieved. The rapid and reliable analytical system allowed the following: speeding up the design of the continuous process and a better understanding of the manufacturing requirements to ensure optimal yield and avoid unreacted raw materials and by-products in the continuous reactor effluent. Graphical Abstract Using PAT to accelerate the transition to continuous API manufacturing.

Microwave heat treating of manufactured components

DOEpatents

Ripley, Edward B.

2007-01-09

An apparatus for heat treating manufactured components using microwave energy and microwave susceptor material. Heat treating medium such as eutectic salts may be employed. A fluidized bed introduces process gases which may include carburizing or nitriding gases. The process may be operated in a batch mode or continuous process mode. A microwave heating probe may be used to restart a frozen eutectic salt bath.

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

PubMed

Hattori, Yusuke; Otsuka, Makoto

2017-05-30

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

15 CFR 400.32 - Procedure for review of request for approval of manufacturing or processing.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 15 Commerce and Foreign Trade 2 2010-01-01 2010-01-01 false Procedure for review of request for approval of manufacturing or processing. 400.32 Section 400.32 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued) FOREIGN-TRADE ZONES BOARD, DEPARTMENT OF COMMERCE...

40 CFR 411.20 - Applicability; description of the leaching subcategory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS CEMENT MANUFACTURING POINT SOURCE CATEGORY Leaching Subcategory... manufacturing of cement and in which kiln dust is contacted with water as an integral part of the process or...

40 CFR 63.8690 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2011 CFR

2011-07-01

... SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing Continuous Compliance Requirements § 63.8690 How do I monitor...

40 CFR 63.8690 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2012 CFR

2012-07-01

... SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing Continuous Compliance Requirements § 63.8690 How do I monitor...

40 CFR 63.8690 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2014 CFR

2014-07-01

... SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing Continuous Compliance Requirements § 63.8690 How do I monitor...

40 CFR 63.8690 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2013 CFR

2013-07-01

... SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing Continuous Compliance Requirements § 63.8690 How do I monitor...

Nanofiltration-Enabled In Situ Solvent and Reagent Recycle for Sustainable Continuous-Flow Synthesis.

PubMed

Fodi, Tamas; Didaskalou, Christos; Kupai, Jozsef; Balogh, Gyorgy T; Huszthy, Peter; Szekely, Gyorgy

2017-09-11

Solvent usage in the pharmaceutical sector accounts for as much as 90 % of the overall mass during manufacturing processes. Consequently, solvent consumption poses significant costs and environmental burdens. Continuous processing, in particular continuous-flow reactors, have great potential for the sustainable production of pharmaceuticals but subsequent downstream processing remains challenging. Separation processes for concentrating and purifying chemicals can account for as much as 80 % of the total manufacturing costs. In this work, a nanofiltration unit was coupled to a continuous-flow rector for in situ solvent and reagent recycling. The nanofiltration unit is straightforward to implement and simple to control during continuous operation. The hybrid process operated continuously over six weeks, recycling about 90 % of the solvent and reagent. Consequently, the E-factor and the carbon footprint were reduced by 91 % and 19 %, respectively. Moreover, the nanofiltration unit led to a solution of the product eleven times more concentrated than the reaction mixture and increased the purity from 52.4 % to 91.5 %. The boundaries for process conditions were investigated to facilitate implementation of the methodology by the pharmaceutical sector. © 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

Influence of raw material properties upon critical quality attributes of continuously produced granules and tablets.

PubMed

Fonteyne, Margot; Wickström, Henrika; Peeters, Elisabeth; Vercruysse, Jurgen; Ehlers, Henrik; Peters, Björn-Hendrik; Remon, Jean Paul; Vervaet, Chris; Ketolainen, Jarkko; Sandler, Niklas; Rantanen, Jukka; Naelapää, Kaisa; De Beer, Thomas

2014-07-01

Continuous manufacturing gains more and more interest within the pharmaceutical industry. The International Conference of Harmonisation (ICH) states in its Q8 'Pharmaceutical Development' guideline that the manufacturer of pharmaceuticals should have an enhanced knowledge of the product performance over a range of raw material attributes, manufacturing process options and process parameters. This fits further into the Process Analytical Technology (PAT) and Quality by Design (QbD) framework. The present study evaluates the effect of variation in critical raw material properties on the critical quality attributes of granules and tablets, produced by a continuous from-powder-to-tablet wet granulation line. The granulation process parameters were kept constant to examine the differences in the end product quality caused by the variability of the raw materials properties only. Theophylline-Lactose-PVP (30-67.5-2.5%) was used as model formulation. Seven different grades of theophylline were granulated. Afterward, the obtained granules were tableted. Both the characteristics of granules and tablets were determined. The results show that differences in raw material properties both affect their processability and several critical quality attributes of the resulting granules and tablets. Copyright © 2014 Elsevier B.V. All rights reserved.

Total Quality Management in Space Shuttle Main Engine manufacturing

NASA Technical Reports Server (NTRS)

Ding, J.

1992-01-01

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

Advances in solid dosage form manufacturing technology.

PubMed

Andrews, Gavin P

2007-12-15

Currently, the pharmaceutical and healthcare industries are moving through a period of unparalleled change. Major multinational pharmaceutical companies are restructuring, consolidating, merging and more importantly critically assessing their competitiveness to ensure constant growth in an ever-more demanding market where the cost of developing novel products is continuously increasing. The pharmaceutical manufacturing processes currently in existence for the production of solid oral dosage forms are associated with significant disadvantages and in many instances provide many processing problems. Therefore, it is well accepted that there is an increasing need for alternative processes to dramatically improve powder processing, and more importantly to ensure that acceptable, reproducible solid dosage forms can be manufactured. Consequently, pharmaceutical companies are beginning to invest in innovative processes capable of producing solid dosage forms that better meet the needs of the patient while providing efficient manufacturing operations. This article discusses two emerging solid dosage form manufacturing technologies, namely hot-melt extrusion and fluidized hot-melt granulation.

Analysis on critical success factors for agile manufacturing evaluation in original equipment manufacturing industry-an AHP approach

NASA Astrophysics Data System (ADS)

Ajay Guru Dev, C.; Senthil Kumar, V. S.

2016-09-01

Manufacturing industries are facing challenges in the implementation of agile manufacturing in their products and processes. Agility is widely accepted as a new competitive concept in the manufacturing sector in fulfilling varying customer demand. Thus, evaluation of agile manufacturing in industries has become a necessity. The success of an organisation depends on its ability to manage finding the critical success factors and give them special and continued attention in order to bring about high performance. This paper proposes a set of critical success factors (CSFs) for evaluating agile manufacturing considered appropriate for the manufacturing sector. The analytical hierarchy process (AHP) method is applied for prioritizing the success factors, by summarizing the opinions of experts. It is believed that the proposed CSFs enable and assist manufacturing industries to achieve a higher performance in agile manufacturing so as to increase competitiveness.

Apparatus with moderating material for microwave heat treatment of manufactured components

DOEpatents

Ripley, Edward B [Knoxville, TN

2011-05-10

An apparatus for heat treating manufactured components using microwave energy and microwave susceptor material. Heat treating medium such as eutectic salts may be employed. A fluidized bed introduces process gases which may include carburizing or nitriding gases The process may be operated in a batch mode or continuous process mode. A microwave heating probe may be used to restart a frozen eutectic salt bath.

Apparatus for microwave heat treatment of manufactured components

DOEpatents

Babcock & Wilcox Technical Services Y-12, LLC

2008-04-15

An apparatus for heat treating manufactured components using microwave energy and microwave susceptor material. Heat treating medium such as eutectic salts may be employed. A fluidized bed introduces process gases which may include carburizing or nitriding gases. The process may be operated in a batch mode or continuous process mode. A microwave heating probe may be used to restart a frozen eutectic salt bath.

Methods for microwave heat treatment of manufactured components

DOEpatents

Ripley, Edward B.

2010-08-03

An apparatus for heat treating manufactured components using microwave energy and microwave susceptor material. Heat treating medium such as eutectic salts may be employed. A fluidized bed introduces process gases which may include carburizing or nitriding gases. The process may be operated in a batch mode or continuous process mode. A microwave heating probe may be used to restart a frozen eutectic salt bath.

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.

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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

PubMed

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

2015-03-01

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

The relationship between quality management practices and organisational performance: A structural equation modelling approach

NASA Astrophysics Data System (ADS)

Jamaluddin, Z.; Razali, A. M.; Mustafa, Z.

2015-02-01

The purpose of this paper is to examine the relationship between the quality management practices (QMPs) and organisational performance for the manufacturing industry in Malaysia. In this study, a QMPs and organisational performance framework is developed according to a comprehensive literature review which cover aspects of hard and soft quality factors in manufacturing process environment. A total of 11 hypotheses have been put forward to test the relationship amongst the six constructs, which are management commitment, training, process management, quality tools, continuous improvement and organisational performance. The model is analysed using Structural Equation Modeling (SEM) with AMOS software version 18.0 using Maximum Likelihood (ML) estimation. A total of 480 questionnaires were distributed, and 210 questionnaires were valid for analysis. The results of the modeling analysis using ML estimation indicate that the fits statistics of QMPs and organisational performance model for manufacturing industry is admissible. From the results, it found that the management commitment have significant impact on the training and process management. Similarly, the training had significant effect to the quality tools, process management and continuous improvement. Furthermore, the quality tools have significant influence on the process management and continuous improvement. Likewise, the process management also has a significant impact to the continuous improvement. In addition the continuous improvement has significant influence the organisational performance. However, the results of the study also found that there is no significant relationship between management commitment and quality tools, and between the management commitment and continuous improvement. The results of the study can be used by managers to prioritize the implementation of QMPs. For instances, those practices that are found to have positive impact on organisational performance can be recommended to managers so that they can allocate resources to improve these practices to get better performance.

40 CFR 458.40 - Applicability; description of the carbon black lamp process subcategory.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 31 2013-07-01 2013-07-01 false Applicability; description of the carbon black lamp process subcategory. 458.40 Section 458.40 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Lamp Process...

40 CFR 458.40 - Applicability; description of the carbon black lamp process subcategory.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 30 2014-07-01 2014-07-01 false Applicability; description of the carbon black lamp process subcategory. 458.40 Section 458.40 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Lamp Process...

40 CFR 461.45 - Pretreatment standards for new sources (PSNS).

Code of Federal Regulations, 2014 CFR

2014-07-01

...) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Leclanche.... (1) Subpart D—Foliar Battery Miscellaneous Wash—PSNS. Pollutant or pollutant property Maximum for any... shall be no discharge allowance for process wastewater pollutants from any battery manufacturing...

40 CFR 461.45 - Pretreatment standards for new sources (PSNS).

Code of Federal Regulations, 2012 CFR

2012-07-01

...) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Leclanche.... (1) Subpart D—Foliar Battery Miscellaneous Wash—PSNS. Pollutant or pollutant property Maximum for any... shall be no discharge allowance for process wastewater pollutants from any battery manufacturing...

40 CFR 461.45 - Pretreatment standards for new sources (PSNS).

Code of Federal Regulations, 2013 CFR

2013-07-01

...) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Leclanche.... (1) Subpart D—Foliar Battery Miscellaneous Wash—PSNS. Pollutant or pollutant property Maximum for any... shall be no discharge allowance for process wastewater pollutants from any battery manufacturing...

Process analytical technology in continuous manufacturing of a commercial pharmaceutical product.

PubMed

Vargas, Jenny M; Nielsen, Sarah; Cárdenas, Vanessa; Gonzalez, Anthony; Aymat, Efrain Y; Almodovar, Elvin; Classe, Gustavo; Colón, Yleana; Sanchez, Eric; Romañach, Rodolfo J

2018-03-01

The implementation of process analytical technology and continuous manufacturing at an FDA approved commercial manufacturing site is described. In this direct compaction process the blends produced were monitored with a Near Infrared (NIR) spectroscopic calibration model developed with partial least squares (PLS) regression. The authors understand that this is the first study where the continuous manufacturing (CM) equipment was used as a gravimetric reference method for the calibration model. A principal component analysis (PCA) model was also developed to identify the powder blend, and determine whether it was similar to the calibration blends. An air diagnostic test was developed to assure that powder was present within the interface when the NIR spectra were obtained. The air diagnostic test as well the PCA and PLS calibration model were integrated into an industrial software platform that collects the real time NIR spectra and applies the calibration models. The PCA test successfully detected an equipment malfunction. Variographic analysis was also performed to estimate the sampling analytical errors that affect the results from the NIR spectroscopic method during commercial production. The system was used to monitor and control a 28 h continuous manufacturing run, where the average drug concentration determined by the NIR method was 101.17% of label claim with a standard deviation of 2.17%, based on 12,633 spectra collected. The average drug concentration for the tablets produced from these blends was 100.86% of label claim with a standard deviation of 0.4%, for 500 tablets analyzed by Fourier Transform Near Infrared (FT-NIR) transmission spectroscopy. The excellent agreement between the mean drug concentration values in the blends and tablets produced provides further evidence of the suitability of the validation strategy that was followed. Copyright © 2018 Elsevier B.V. All rights reserved.

Identifying Critical Manufacturing Technologies Required for Transforming the Army Industrial Base

DTIC Science & Technology

2014-04-01

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

40 CFR 439.31 - Special definitions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... STANDARDS (CONTINUED) PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY Chemical Synthesis Products § 439.31 Special definitions. For the purpose of this subpart: (a) Chemical synthesis means using one or a series of chemical reactions in the manufacturing process of a specified product. (b) Product means any...

40 CFR 439.31 - Special definitions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... STANDARDS (CONTINUED) PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY Chemical Synthesis Products § 439.31 Special definitions. For the purpose of this subpart: (a) Chemical synthesis means using one or a series of chemical reactions in the manufacturing process of a specified product. (b) Product means any...

40 CFR 439.31 - Special definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... STANDARDS (CONTINUED) PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY Chemical Synthesis Products § 439.31 Special definitions. For the purpose of this subpart: (a) Chemical synthesis means using one or a series of chemical reactions in the manufacturing process of a specified product. (b) Product means any...

40 CFR 461.43 - New source performance standards (NSPS).

Code of Federal Regulations, 2012 CFR

2012-07-01

... GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Leclanche Subcategory § 461... Battery Miscellaneous Wash—NSPS. Pollutant or pollutant property Maximum for any 1 day Maximum for monthly... process wastewater pollutants from any battery manufacturing operation other than those battery...

40 CFR 461.43 - New source performance standards (NSPS).

Code of Federal Regulations, 2013 CFR

2013-07-01

... GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Leclanche Subcategory § 461... Battery Miscellaneous Wash—NSPS. Pollutant or pollutant property Maximum for any 1 day Maximum for monthly... process wastewater pollutants from any battery manufacturing operation other than those battery...

40 CFR 461.43 - New source performance standards (NSPS).

Code of Federal Regulations, 2014 CFR

2014-07-01

... GUIDELINES AND STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY Leclanche Subcategory § 461... Battery Miscellaneous Wash—NSPS. Pollutant or pollutant property Maximum for any 1 day Maximum for monthly... process wastewater pollutants from any battery manufacturing operation other than those battery...

Advanced Polymer Processing Facility

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

Muenchausen, Ross E.

Some conclusions of this presentation are: (1) Radiation-assisted nanotechnology applications will continue to grow; (2) The APPF will provide a unique focus for radiolytic processing of nanomaterials in support of DOE-DP, other DOE and advanced manufacturing initiatives; (3) {gamma}, X-ray, e-beam and ion beam processing will increasingly be applied for 'green' manufacturing of nanomaterials and nanocomposites; and (4) Biomedical science and engineering may ultimately be the biggest application area for radiation-assisted nanotechnology development.

40 CFR 458.42 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

Code of Federal Regulations, 2014 CFR

2014-07-01

... AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Lamp Process Subcategory § 458.42 Effluent limitations guidelines representing the...): There shall be no discharge of process waste water pollutants into navigable waters. [60 FR 33972, June...

40 CFR 458.32 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

Code of Federal Regulations, 2014 CFR

2014-07-01

... AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Channel Process Subcategory § 458.32 Effluent limitations guidelines representing the...): There shall be no discharge of process waste water pollutants into navigable waters. [60 FR 33972, June...

40 CFR 458.22 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

Code of Federal Regulations, 2012 CFR

2012-07-01

... AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Thermal Process Subcategory § 458.22 Effluent limitations guidelines representing the...): There shall be no discharge of process waste water pollutants into navigable waters. [60 FR 33972, June...

40 CFR 458.42 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

Code of Federal Regulations, 2013 CFR

2013-07-01

... AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Lamp Process Subcategory § 458.42 Effluent limitations guidelines representing the...): There shall be no discharge of process waste water pollutants into navigable waters. [60 FR 33972, June...

40 CFR 458.22 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

Code of Federal Regulations, 2014 CFR

2014-07-01

... AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Thermal Process Subcategory § 458.22 Effluent limitations guidelines representing the...): There shall be no discharge of process waste water pollutants into navigable waters. [60 FR 33972, June...

40 CFR 458.22 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

Code of Federal Regulations, 2013 CFR

2013-07-01

... AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Thermal Process Subcategory § 458.22 Effluent limitations guidelines representing the...): There shall be no discharge of process waste water pollutants into navigable waters. [60 FR 33972, June...

40 CFR 458.32 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

Code of Federal Regulations, 2013 CFR

2013-07-01

... AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Channel Process Subcategory § 458.32 Effluent limitations guidelines representing the...): There shall be no discharge of process waste water pollutants into navigable waters. [60 FR 33972, June...

40 CFR 458.32 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

Code of Federal Regulations, 2012 CFR

2012-07-01

... AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Channel Process Subcategory § 458.32 Effluent limitations guidelines representing the...): There shall be no discharge of process waste water pollutants into navigable waters. [60 FR 33972, June...

40 CFR 458.42 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

Code of Federal Regulations, 2012 CFR

2012-07-01

... AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Lamp Process Subcategory § 458.42 Effluent limitations guidelines representing the...): There shall be no discharge of process waste water pollutants into navigable waters. [60 FR 33972, June...

A new large-scale manufacturing platform for complex biopharmaceuticals.

PubMed

Vogel, Jens H; Nguyen, Huong; Giovannini, Roberto; Ignowski, Jolene; Garger, Steve; Salgotra, Anil; Tom, Jennifer

2012-12-01

Complex biopharmaceuticals, such as recombinant blood coagulation factors, are addressing critical medical needs and represent a growing multibillion-dollar market. For commercial manufacturing of such, sometimes inherently unstable, molecules it is important to minimize product residence time in non-ideal milieu in order to obtain acceptable yields and consistently high product quality. Continuous perfusion cell culture allows minimization of residence time in the bioreactor, but also brings unique challenges in product recovery, which requires innovative solutions. In order to maximize yield, process efficiency, facility and equipment utilization, we have developed, scaled-up and successfully implemented a new integrated manufacturing platform in commercial scale. This platform consists of a (semi-)continuous cell separation process based on a disposable flow path and integrated with the upstream perfusion operation, followed by membrane chromatography on large-scale adsorber capsules in rapid cycling mode. Implementation of the platform at commercial scale for a new product candidate led to a yield improvement of 40% compared to the conventional process technology, while product quality has been shown to be more consistently high. Over 1,000,000 L of cell culture harvest have been processed with 100% success rate to date, demonstrating the robustness of the new platform process in GMP manufacturing. While membrane chromatography is well established for polishing in flow-through mode, this is its first commercial-scale application for bind/elute chromatography in the biopharmaceutical industry and demonstrates its potential in particular for manufacturing of potent, low-dose biopharmaceuticals. Copyright © 2012 Wiley Periodicals, Inc.

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

Code of Federal Regulations, 2010 CFR

2010-04-01

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

27 CFR 40.351 - Cigarette papers.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2013-04-01 2013-04-01 false Cigarette papers. 40.351... OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Manufacture of Cigarette Papers and Tubes Taxes § 40.351 Cigarette papers. Cigarette...

27 CFR 40.351 - Cigarette papers.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2012-04-01 2011-04-01 true Cigarette papers. 40.351... OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Manufacture of Cigarette Papers and Tubes Taxes § 40.351 Cigarette papers. Cigarette...

27 CFR 40.351 - Cigarette papers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2010-04-01 2010-04-01 false Cigarette papers. 40.351... OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Manufacture of Cigarette Papers and Tubes Taxes § 40.351 Cigarette papers. Cigarette...

27 CFR 40.351 - Cigarette papers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2011-04-01 2011-04-01 false Cigarette papers. 40.351... OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Manufacture of Cigarette Papers and Tubes Taxes § 40.351 Cigarette papers. Cigarette...

27 CFR 40.351 - Cigarette papers.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2014-04-01 2014-04-01 false Cigarette papers. 40.351... OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Manufacture of Cigarette Papers and Tubes Taxes § 40.351 Cigarette papers. Cigarette...

Process for fabricating continuous lengths of superconductor

DOEpatents

Kroeger, Donald M.; List, III, Frederick A.

1998-01-01

A process for manufacturing a superconductor. The process is accomplished by depositing a superconductor precursor powder on a continuous length of a first substrate ribbon, overlaying a continuous length of a second substrate ribbon on said first substrate ribbon, and applying sufficient pressure to form a bound layered superconductor precursor between said first substrate ribbon and said second substrates ribbon. The layered superconductor precursor is then heat treated to form a super conductor layer.

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

NASA Technical Reports Server (NTRS)

1978-01-01

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

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

DTIC Science & Technology

2011-06-30

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

Future supply chains enabled by continuous processing--opportunities and challenges. May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

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

2015-03-01

This paper examines the opportunities and challenges facing the pharmaceutical industry in moving to a primarily "continuous processing"-based supply chain. The current predominantly "large batch" and centralized manufacturing system designed for the "blockbuster" drug has driven a slow-paced, inventory heavy operating model that is increasingly regarded as inflexible and unsustainable. Indeed, new markets and the rapidly evolving technology landscape will drive more product variety, shorter product life-cycles, and smaller drug volumes, which will exacerbate an already unsustainable economic model. Future supply chains will be required to enhance affordability and availability for patients and healthcare providers alike despite the increased product complexity. In this more challenging supply scenario, we examine the potential for a more pull driven, near real-time demand-based supply chain, utilizing continuous processing where appropriate as a key element of a more "flow-through" operating model. In this discussion paper on future supply chain models underpinned by developments in the continuous manufacture of pharmaceuticals, we have set out; The significant opportunities to moving to a supply chain flow-through operating model, with substantial opportunities in inventory reduction, lead-time to patient, and radically different product assurance/stability regimes. Scenarios for decentralized production models producing a greater variety of products with enhanced volume flexibility. Production, supply, and value chain footprints that are radically different from today's monolithic and centralized batch manufacturing operations. Clinical trial and drug product development cost savings that support more rapid scale-up and market entry models with early involvement of SC designers within New Product Development. The major supply chain and industrial transformational challenges that need to be addressed. The paper recognizes that although current batch operational performance in pharma is far from optimal and not necessarily an appropriate end-state benchmark for batch technology, the adoption of continuous supply chain operating models underpinned by continuous production processing, as full or hybrid solutions in selected product supply chains, can support industry transformations to deliver right-first-time quality at substantially lower inventory profiles. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

Feedstock powder processing research needs for additive manufacturing development

DOE PAGES

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

2018-02-01

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

Feedstock powder processing research needs for additive manufacturing development

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

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

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

27 CFR 40.352 - Cigarette tubes.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2010-04-01 2010-04-01 false Cigarette tubes. 40.352... OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Manufacture of Cigarette Papers and Tubes Taxes § 40.352 Cigarette tubes. Cigarette tubes...

27 CFR 40.352 - Cigarette tubes.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2013-04-01 2013-04-01 false Cigarette tubes. 40.352... OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Manufacture of Cigarette Papers and Tubes Taxes § 40.352 Cigarette tubes. Cigarette tubes...

21 CFR 106.100 - Records.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Records. 106.100 Section 106.100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... degradation from the manufacturing process. (g) The manufacturer shall maintain all records pertaining to...

21 CFR 133.10 - Notice to manufacturers, packers, and distributors of pasteurized blended cheese, pasteurized...

Code of Federal Regulations, 2011 CFR

2011-04-01

... of pasteurized blended cheese, pasteurized process cheese, cheese food, cheese spread, and related... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CHEESES AND RELATED CHEESE PRODUCTS General Provisions § 133.10 Notice to manufacturers, packers, and distributors of pasteurized blended cheese, pasteurized...

21 CFR 133.10 - Notice to manufacturers, packers, and distributors of pasteurized blended cheese, pasteurized...

Code of Federal Regulations, 2010 CFR

2010-04-01

... of pasteurized blended cheese, pasteurized process cheese, cheese food, cheese spread, and related... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CHEESES AND RELATED CHEESE PRODUCTS General Provisions § 133.10 Notice to manufacturers, packers, and distributors of pasteurized blended cheese, pasteurized...

27 CFR 40.352 - Cigarette tubes.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2011-04-01 2011-04-01 false Cigarette tubes. 40.352... OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Manufacture of Cigarette Papers and Tubes Taxes § 40.352 Cigarette tubes. Cigarette tubes...

27 CFR 40.352 - Cigarette tubes.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2012-04-01 2011-04-01 true Cigarette tubes. 40.352... OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Manufacture of Cigarette Papers and Tubes Taxes § 40.352 Cigarette tubes. Cigarette tubes...

27 CFR 40.352 - Cigarette tubes.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2014-04-01 2014-04-01 false Cigarette tubes. 40.352... OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Manufacture of Cigarette Papers and Tubes Taxes § 40.352 Cigarette tubes. Cigarette tubes...

40 CFR 461.2 - General definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY General Provisions § 461.2 General... this part: (a) “Battery” means a modular electric power source where part or all of the fuel is... and a battery. (b) “Battery manufacturing operations” means all of the specific processes used to...

40 CFR 461.2 - General definitions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY General Provisions § 461.2 General... this part: (a) “Battery” means a modular electric power source where part or all of the fuel is... and a battery. (b) “Battery manufacturing operations” means all of the specific processes used to...

40 CFR 461.2 - General definitions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... STANDARDS (CONTINUED) BATTERY MANUFACTURING POINT SOURCE CATEGORY General Provisions § 461.2 General... this part: (a) “Battery” means a modular electric power source where part or all of the fuel is... and a battery. (b) “Battery manufacturing operations” means all of the specific processes used to...

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

PubMed

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

2017-01-01

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

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.

40 CFR 458.20 - Applicability: description of the carbon black thermal process subcategory.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 31 2013-07-01 2013-07-01 false Applicability: description of the carbon black thermal process subcategory. 458.20 Section 458.20 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Thermal...

40 CFR 458.10 - Applicability; description of the carbon black furnace process subcategory.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 30 2014-07-01 2014-07-01 false Applicability; description of the carbon black furnace process subcategory. 458.10 Section 458.10 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Furnace...

40 CFR 458.30 - Applicability; description of the carbon black channel process subcategory.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 30 2014-07-01 2014-07-01 false Applicability; description of the carbon black channel process subcategory. 458.30 Section 458.30 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Channel...

40 CFR 458.10 - Applicability; description of the carbon black furnace process subcategory.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 31 2013-07-01 2013-07-01 false Applicability; description of the carbon black furnace process subcategory. 458.10 Section 458.10 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Furnace...

40 CFR 458.20 - Applicability: description of the carbon black thermal process subcategory.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 30 2014-07-01 2014-07-01 false Applicability: description of the carbon black thermal process subcategory. 458.20 Section 458.20 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Thermal...

40 CFR 458.30 - Applicability; description of the carbon black channel process subcategory.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 31 2013-07-01 2013-07-01 false Applicability; description of the carbon black channel process subcategory. 458.30 Section 458.30 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Channel...

Environmentally sound manufacturing

NASA Technical Reports Server (NTRS)

Caddy, Larry A.; Bowman, Ross; Richards, Rex A.

1994-01-01

The NASA/Thiokol/industry team has developed and started implementation of an environmentally sound manufacturing plan for the continued production of solid rocket motors. They have worked with other industry representatives and the U.S. Environmental Protection Agency to prepare a comprehensive plan to eliminate all ozone depleting chemicals from manufacturing processes and to reduce the use of other hazardous materials used to produce the space shuttle reusable solid rocket motors. The team used a classical approach for problem solving combined with a creative synthesis of new approaches to attack this problem. As our ability to gather data on the state of the Earth's environmental health increases, environmentally sound manufacturing must become an integral part of the business decision making process.

21 CFR 113.5 - Current good manufacturing practice.

Code of Federal Regulations, 2011 CFR

2011-04-01

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

21 CFR 113.5 - Current good manufacturing practice.

Code of Federal Regulations, 2013 CFR

2013-04-01

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

21 CFR 113.5 - Current good manufacturing practice.

Code of Federal Regulations, 2012 CFR

2012-04-01

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

21 CFR 113.5 - Current good manufacturing practice.

Code of Federal Regulations, 2014 CFR

2014-04-01

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

Lean manufacturing: A better way for enhancement in productivity

NASA Astrophysics Data System (ADS)

Kumar Ahir, Pankaj; Kumar Yadav, Lalit; Singh Chandrawat, Saurabh

2012-03-01

Productivity is the impact of peoples working together. Machines are merely an extended way of collective imagination and energy. Lean Manufacturing is the most used method for continues improvement of business. Organization management philosophy focusing on the reduction of wastage to improve overall customer value. "Lean" operating principles began in manufacturing environments and are known by a variety of synonyms; Lean Manufacturing, Lean Production, Toyota Production System, etc. It is commonly believed that Lean started in Japan "The notable activities in keeping the price of Ford products low is the steady restriction of the production cycle. The longer an article is in the process of manufacture and the more it is moved about, the greater is its ultimate cost." "A systematic approach to identifying and eliminating waste through continuous improvement, flowing the product at the pull of the customer in pursuit of perfection."

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.

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.

Readiness Assessment Towards Smart Manufacturing System for Tuna Processing Industry in Indonesia

NASA Astrophysics Data System (ADS)

Anggrahini, D.; Kurniati, N.; Karningsih, P. D.; Parenreng, S. M.; Syahroni, N.

2018-04-01

Marine product processing is one of the top priority clusters in the national development. Tuna, as a kind of deep ocean fishes, has the highest number of production that significantly increased throughout the years. Indonesia government encourages tuna processing industry, which are mostly dominated by small to medium enterprises, to grow continuously. Nowadays, manufacturers are facing substantial challenges in adopting modern system and technology that will lead a significant improvement through the internet of things (IoT). A smart factory transform integrated manufacturing process, in a high speed processing to respond customer needs. It has some positive impacts, such as increasing productivity, reducing set up time, shortening marketing and other support activities, hence the process is being more flexible and efficient. To implement smart manufacturing system, factories should know the readiness at any level of them, technology capability and strategy appropriateness. This exploratory study aims to identify the criterias, and develop an assessment tools to measure the level towards smart factory.

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

PubMed

Major, Ian; McConville, Christopher

2015-01-01

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

Using Lean Process Improvement to Enhance Safety and Value in Orthopaedic Surgery: The Case of Spine Surgery.

PubMed

Sethi, Rajiv; Yanamadala, Vijay; Burton, Douglas C; Bess, Robert Shay

2017-11-01

Lean methodology was developed in the manufacturing industry to increase output and decrease costs. These labor organization methods have become the mainstay of major manufacturing companies worldwide. Lean methods involve continuous process improvement through the systematic elimination of waste, prevention of mistakes, and empowerment of workers to make changes. Because of the profit and productivity gains made in the manufacturing arena using lean methods, several healthcare organizations have adopted lean methodologies for patient care. Lean methods have now been implemented in many areas of health care. In orthopaedic surgery, lean methods have been applied to reduce complication rates and create a culture of continuous improvement. A step-by-step guide based on our experience can help surgeons use lean methods in practice. Surgeons and hospital centers well versed in lean methodology will be poised to reduce complications, improve patient outcomes, and optimize cost/benefit ratios for patient care.

40 CFR Table 1 to Subpart Ffff of... - Emission Limits and Work Practice Standards for Continuous Process Vents

Code of Federal Regulations, 2012 CFR

2012-07-01

... Pollutants: Miscellaneous Organic Chemical Manufacturing Pt. 63, Subpt. FFFF, Table 1 Table 1 to Subpart FFFF... continuous process vent a. Not applicable i. Reduce emissions of total organic HAP by ≥98 percent by weight or to an outlet process concentration ≤20 ppmv as organic HAP or TOC by venting emissions through a...

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

NASA Astrophysics Data System (ADS)

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

2017-03-01

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

40 CFR 424.30 - Applicability; description of the slag processing subcategory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... processing subcategory. 424.30 Section 424.30 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS FERROALLOY MANUFACTURING POINT SOURCE CATEGORY Slag Processing Subcategory § 424.30 Applicability; description of the slag processing subcategory. The provisions of this...

Throughput Optimization of Continuous Biopharmaceutical Manufacturing Facilities.

PubMed

Garcia, Fernando A; Vandiver, Michael W

2017-01-01

In order to operate profitably under different product demand scenarios, biopharmaceutical companies must design their facilities with mass output flexibility in mind. Traditional biologics manufacturing technologies pose operational challenges in this regard due to their high costs and slow equipment turnaround times, restricting the types of products and mass quantities that can be processed. Modern plant design, however, has facilitated the development of lean and efficient bioprocessing facilities through footprint reduction and adoption of disposable and continuous manufacturing technologies. These development efforts have proven to be crucial in seeking to drastically reduce the high costs typically associated with the manufacturing of recombinant proteins. In this work, mathematical modeling is used to optimize annual production schedules for a single-product commercial facility operating with a continuous upstream and discrete batch downstream platform. Utilizing cell culture duration and volumetric productivity as process variables in the model, and annual plant throughput as the optimization objective, 3-D surface plots are created to understand the effect of process and facility design on expected mass output. The model shows that once a plant has been fully debottlenecked it is capable of processing well over a metric ton of product per year. Moreover, the analysis helped to uncover a major limiting constraint on plant performance, the stability of the neutralized viral inactivated pool, which may indicate that this should be a focus of attention during future process development efforts. LAY ABSTRACT: Biopharmaceutical process modeling can be used to design and optimize manufacturing facilities and help companies achieve a predetermined set of goals. One way to perform optimization is by making the most efficient use of process equipment in order to minimize the expenditure of capital, labor and plant resources. To that end, this paper introduces a novel mathematical algorithm used to determine the most optimal equipment scheduling configuration that maximizes the mass output for a facility producing a single product. The paper also illustrates how different scheduling arrangements can have a profound impact on the availability of plant resources, and identifies limiting constraints on the plant design. In addition, simulation data is presented using visualization techniques that aid in the interpretation of the scientific concepts discussed. © PDA, Inc. 2017.

40 CFR 63.8690 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2010 CFR

2010-07-01

... Processing and Asphalt Roofing Manufacturing Continuous Compliance Requirements § 63.8690 How do I monitor... emission or operating levels, nor may such data be used in fulfilling a minimum data availability...

40 CFR 63.1329 - Process contact cooling towers provisions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... existing affected source that manufactures PET using a continuous terephthalic acid high viscosity multiple... viscosity multiple end finisher process, and who is subject or becomes subject to 40 CFR part 60, subpart...

40 CFR 63.1329 - Process contact cooling towers provisions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... existing affected source that manufactures PET using a continuous terephthalic acid high viscosity multiple... viscosity multiple end finisher process, and who is subject or becomes subject to 40 CFR part 60, subpart...

Development of manufacturing systems for nanocrystalline and ultra-fine grain materials employing indexing equal channel angular pressing

NASA Astrophysics Data System (ADS)

Hester, Michael Wayne

Nanotechnology offers significant opportunities in providing solutions to existing engineering problems as well as breakthroughs in new fields of science and technology. In order to fully realize benefits from such initiatives, nanomanufacturing methods must be developed to integrate enabling constructs into commercial mainstream. Even though significant advances have been made, widespread industrialization in many areas remains limited. Manufacturing methods, therefore, must continually be developed to bridge gaps between nanoscience discovery and commercialization. A promising technology for integration of top-down nanomanufacturing yet to receive full industrialization is equal channel angular pressing, a process transforming metallic materials into nanostructured or ultra-fine grained materials with significantly improved performance characteristics. To bridge the gap between process potential and actual manufacturing output, a prototype top-down nanomanufacturing system identified as indexing equal channel angular pressing (IX-ECAP) was developed. The unit was designed to capitalize on opportunities of transforming spent or scrap engineering elements into key engineering commodities. A manufacturing system was constructed to impose severe plastic deformation via simple shear in an equal channel angular pressing die on 1100 and 4043 aluminum welding rods. 1/4 fraction factorial split-plot experiments assessed significance of five predictors on the response, microhardness, for the 4043 alloy. Predictor variables included temperature, number of passes, pressing speed, back pressure, and vibration. Main effects were studied employing a resolution III design. Multiple linear regression was used for model development. Initial studies were performed using continuous processing followed by contingency designs involving discrete variable length work pieces. IX-ECAP offered a viable solution in severe plastic deformation processing. Discrete variable length work piece pressing proved very successful. With three passes through the system, 4043 processed material experienced an 88.88% increase in microhardness, 203.4% increase in converted yield strength, and a 98.5% reduction in theoretical final grain size to 103 nanometers using the Hall-Petch relation. The process factor, number of passes, was statistically significant at the 95% confidence level; whereas, temperature was significant at the 90% confidence level. Limitations of system components precluded completion of studies involving continuous pressing. Proposed system redesigns, however, will ensure mainstream commercialization of continuous length work piece processing.

Advanced Continuous Flow Platform for On-Demand Pharmaceutical Manufacturing.

PubMed

Zhang, Ping; Weeranoppanant, Nopphon; Thomas, Dale A; Tahara, Kohei; Stelzer, Torsten; Russell, Mary Grace; O'Mahony, Marcus; Myerson, Allan S; Lin, Hongkun; Kelly, Liam P; Jensen, Klavs F; Jamison, Timothy F; Dai, Chunhui; Cui, Yuqing; Briggs, Naomi; Beingessner, Rachel L; Adamo, Andrea

2018-02-21

As a demonstration of an alternative to the challenges faced with batch pharmaceutical manufacturing including the large production footprint and lengthy time-scale, we previously reported a refrigerator-sized continuous flow system for the on-demand production of essential medicines. Building on this technology, herein we report a second-generation, reconfigurable and 25 % smaller (by volume) continuous flow pharmaceutical manufacturing platform featuring advances in reaction and purification equipment. Consisting of two compact [0.7 (L)×0.5 (D)×1.3 m (H)] stand-alone units for synthesis and purification/formulation processes, the capabilities of this automated system are demonstrated with the synthesis of nicardipine hydrochloride and the production of concentrated liquid doses of ciprofloxacin hydrochloride, neostigmine methylsulfate and rufinamide that meet US Pharmacopeia standards. © 2018 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

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

Code of Federal Regulations, 2010 CFR

2010-01-01

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

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

PubMed

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

2018-01-01

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

Metabolic engineering: the ultimate paradigm for continuous pharmaceutical manufacturing.

PubMed

Yadav, Vikramaditya G; Stephanopoulos, Gregory

2014-07-01

Research and development (R&D) expenditures by pharmaceutical companies doubled over the past decade, yet candidate attrition rates and development times rose markedly during this period. Understandably, companies have begun downsizing their pipelines and diverting investments away from R&D in favor of manufacturing. It is estimated that transitioning to continuous manufacturing could enable companies to compete for a share in emerging markets. Accordingly, the model for continuous manufacturing that has emerged commences with the conversion of late-stage intermediates into the active pharmaceutical ingredient (API) in a series of continuous flow reactors, followed by continuous solid processing to form finished tablets. The use of flow reactions for API synthesis will certainly generate purer products at higher yields in shorter times compared to equivalent batch reactions. However, transitioning from batch to flow configuration simply alleviates transport limitations within the reaction milieu. As the catalogue of reactions used in flow syntheses is a subset of batch-based chemistries, molecules such as natural products will continue to evade drug prospectors. Also, it is uncertain whether flow synthesis can deliver improvements in the atom and energy economies of API production at the scales that would achieve the levels of revenue growth targeted by companies. Instead, it is argued that implementing metabolic engineering for the production of oxidized scaffolds as gateway molecules for flow-based addition of electrophiles is a more effective and scalable strategy for accessing natural product chemical space. This new paradigm for manufacturing, with metabolic engineering as its engine, would also permit rapid optimization of production variables and allow facile scale-up from gram to ton scale to meet material requirements for clinical trials, thus recasting manufacturing as a tool for discovery. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Monolithic amorphous silicon modules on continuous polymer substrate

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

Grimmer, D.P.

This report examines manufacturing monolithic amorphous silicon modules on a continuous polymer substrate. Module production costs can be reduced by increasing module performance, expanding production, and improving and modifying production processes. Material costs can be reduced by developing processes that use a 1-mil polyimide substrate and multilayers of low-cost material for the front encapsulant. Research to speed up a-Si and ZnO deposition rates is needed to improve throughputs. To keep throughput rates compatible with depositions, multibeam fiber optic delivery systems for laser scribing can be used. However, mechanical scribing systems promise even higher throughputs. Tandem cells and production experience canmore » increase device efficiency and stability. Two alternative manufacturing processes are described: (1) wet etching and sheet handling and (2) wet etching and roll-to-roll fabrication.« less

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

NASA Astrophysics Data System (ADS)

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

2018-02-01

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

40 CFR 458.44 - [Reserved

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 31 2013-07-01 2013-07-01 false [Reserved] 458.44 Section 458.44 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Lamp Process Subcategory § 458.44...

40 CFR 458.44 - [Reserved

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 31 2012-07-01 2012-07-01 false [Reserved] 458.44 Section 458.44 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Lamp Process Subcategory § 458.44...

40 CFR 458.44 - [Reserved

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 30 2014-07-01 2014-07-01 false [Reserved] 458.44 Section 458.44 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Lamp Process Subcategory § 458.44...

Drug-printing by flexographic printing technology--a new manufacturing process for orodispersible films.

PubMed

Janssen, Eva Maria; Schliephacke, Ralf; Breitenbach, Armin; Breitkreutz, Jörg

2013-01-30

Orodispersible films (ODFs) are intended to disintegrate within seconds when placed onto the tongue. The common way of manufacturing is the solvent casting method. Flexographic printing on drug-free ODFs is introduced as a highly flexible and cost-effective alternative manufacturing method in this study. Rasagiline mesylate and tadalafil were used as model drugs. Printing of rasagiline solutions and tadalafil suspensions was feasible. Up to four printing cycles were performed. The possibility to employ several printing cycles enables a continuous, highly flexible manufacturing process, for example for individualised medicine. The obtained ODFs were characterised regarding their mechanical properties, their disintegration time, API crystallinity and homogeneity. Rasagiline mesylate did not recrystallise after the printing process. Relevant film properties were not affected by printing. Results were comparable to the results of ODFs manufactured with the common solvent casting technique, but the APIs are less stressed through mixing, solvent evaporation and heat. Further, loss of material due to cutting jumbo and daughter rolls can be reduced. Therefore, a versatile new manufacturing technology particularly for processing high-potent low-dose or heat sensitive drugs is introduced in this study. Copyright © 2012 Elsevier B.V. All rights reserved.

Manufacture of thin-walled clad tubes by pressure welding of roll bonded sheets

NASA Astrophysics Data System (ADS)

Schmidt, Hans Christian; Grydin, Olexandr; Stolbchenko, Mykhailo; Homberg, Werner; Schaper, Mirko

2017-10-01

Clad tubes are commonly manufactured by fusion welding of roll bonded metal sheets or, mechanically, by hydroforming. In this work, a new approach towards the manufacture of thin-walled tubes with an outer diameter to wall thickness ratio of about 12 is investigated, involving the pressure welding of hot roll bonded aluminium-steel strips. By preparing non-welded edges during the roll bonding process, the strips can be zip-folded and (cold) pressure welded together. This process routine could be used to manufacture clad tubes in a continuous process. In order to investigate the process, sample tube sections with a wall thickness of 2.1 mm were manufactured by U-and O-bending from hot roll bonded aluminium-stainless steel strips. The forming and welding were carried out in a temperature range between RT and 400°C. It was found that, with the given geometry, a pressure weld is established at temperatures starting above 100°C. The tensile tests yield a maximum bond strength at 340°C. Micrograph images show a consistent weld of the aluminium layer over the whole tube section.

Method and apparatus for manufacturing gas tags

DOEpatents

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

1996-12-17

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

Method and apparatus for manufacturing gas tags

DOEpatents

Gross, Kenny C.; Laug, Matthew T.

1996-01-01

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

40 CFR 63.133 - Process wastewater provisions-wastewater tanks.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 10 2014-07-01 2014-07-01 false Process wastewater provisions-wastewater tanks. 63.133 Section 63.133 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED... Chemical Manufacturing Industry for Process Vents, Storage Vessels, Transfer Operations, and Wastewater...

40 CFR 63.133 - Process wastewater provisions-wastewater tanks.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 10 2012-07-01 2012-07-01 false Process wastewater provisions-wastewater tanks. 63.133 Section 63.133 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED... Chemical Manufacturing Industry for Process Vents, Storage Vessels, Transfer Operations, and Wastewater...

40 CFR 63.133 - Process wastewater provisions-wastewater tanks.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 9 2011-07-01 2011-07-01 false Process wastewater provisions-wastewater tanks. 63.133 Section 63.133 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED... Chemical Manufacturing Industry for Process Vents, Storage Vessels, Transfer Operations, and Wastewater...

40 CFR 63.133 - Process wastewater provisions-wastewater tanks.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 10 2013-07-01 2013-07-01 false Process wastewater provisions-wastewater tanks. 63.133 Section 63.133 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED... Chemical Manufacturing Industry for Process Vents, Storage Vessels, Transfer Operations, and Wastewater...

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.

Development of Maltodextrin-Based Immediate-Release Tablets Using an Integrated Twin-Screw Hot-Melt Extrusion and Injection-Molding Continuous Manufacturing Process.

PubMed

Puri, Vibha; Brancazio, Dave; Desai, Parind M; Jensen, Keith D; Chun, Jung-Hoon; Myerson, Allan S; Trout, Bernhardt L

2017-11-01

The combination of hot-melt extrusion and injection molding (HME-IM) is a promising process technology for continuous manufacturing of tablets. However, there has been limited research on its application to formulate crystalline drug-containing immediate-release tablets. Furthermore, studies that have applied the HME-IM process to molded tablets have used a noncontinuous 2-step approach. The present study develops maltodextrin (MDX)-based extrusion-molded immediate-release tablets for a crystalline drug (griseofulvin) using an integrated twin-screw HME-IM continuous process. At 10% w/w drug loading, MDX was selected as the tablet matrix former based on a preliminary screen. Furthermore, liquid and solid polyols were evaluated for melt processing of MDX and for impact on tablet performance. Smooth-surfaced tablets, comprising crystalline griseofulvin solid suspension in the amorphous MDX-xylitol matrix, were produced by a continuous process on a twin-screw extruder coupled to a horizontally opening IM machine. Real-time HME process profiles were used to develop automated HME-IM cycles. Formulation adjustments overcame process challenges and improved tablet strength. The developed MDX tablets exhibited adequate strength and a fast-dissolving matrix (85% drug release in 20 min), and maintained performance on accelerated stability conditions. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Equipment and Analytical Companies Meeting Continuous Challenges May 20-21 2014 Continuous Manufacturing Symposium.

PubMed

Page, Trevor; Dubina, Henry; Fillipi, Gabriele; Guidat, Roland; Patnaik, Saroj; Poechlauer, Peter; Shering, Phil; Guinn, Martin; Mcdonnell, Peter; Johnston, Craig

2015-03-01

This white paper focuses on equipment, and analytical manufacturers' perspectives, regarding the challenges of continuous pharmaceutical manufacturing across five prompt questions. In addition to valued input from several vendors, commentary was provided from experienced pharmaceutical representatives, who have installed various continuous platforms. Additionally, a small medium enterprise (SME) perspective was obtained through interviews. A range of technical challenges is outlined, including: the presence of particles, equipment scalability, fouling (and cleaning), technology derisking, specific analytical challenges, and the general requirement of improved technical training. Equipment and analytical companies can make a significant contribution to help the introduction of continuous technology. A key point is that many of these challenges exist in batch processing and are not specific to continuous processing. Backward compatibility of software is not a continuous issue per se. In many cases, there is available learning from other industries. Business models and opportunities through outsourced development partners are also highlighted. Agile smaller companies and academic groups have a key role to play in developing skills, working collaboratively in partnerships, and focusing on solving relevant industry challenges. The precompetitive space differs for vendor companies compared with large pharmaceuticals. Currently, there is no strong consensus around a dominant continuous design, partly because of business dynamics and commercial interests. A more structured common approach to process design and hardware and software standardization would be beneficial, with initial practical steps in modeling. Conclusions include a digestible systems approach, accessible and published business cases, and increased user, academic, and supplier collaboration. This mirrors US FDA direction. The concept of silos in pharmaceutical companies is a common theme throughout the white papers. In the equipment domain, this is equally prevalent among a broad range of companies, mainly focusing on discrete areas. As an example, the flow chemistry and secondary drug product communities are almost entirely disconnected. Control and Process Analytical Technologies (PAT) companies are active in both domains. The equipment actors are a very diverse group with a few major Original Equipment Manufacturers (OEM) players and a variety of SME, project providers, integrators, upstream downstream providers, and specialist PAT. In some cases, partnerships or alliances are formed to increase critical mass. This white paper has focused on small molecules; equipment associated with biopharmaceuticals is covered in a separate white paper. More specifics on equipment detail are provided in final dosage form and drug substance white papers. The equipment and analytical development from laboratory to pilot to production is important, with a variety of sensors and complexity reducing with scale. The importance of robust processing rather than overcomplex control strategy mitigation is important. A search of nonacademic literature highlights, with a few notable exceptions, a relative paucity of material. Much focuses on the economics and benefits of continuous, rather than specifics of equipment issues. The disruptive nature of continuous manufacturing represents either an opportunity or a threat for many companies, so the incentive to change equipment varies. Also, for many companies, the pharmaceutical sector is not actually the dominant sector in terms of sales. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Equipment and analytical companies meeting continuous challenges. May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Page, Trevor; Dubina, Henry; Fillipi, Gabriele; Guidat, Roland; Patnaik, Saroj; Poechlauer, Peter; Shering, Phil; Guinn, Martin; Mcdonnell, Peter; Johnston, Craig

2015-03-01

This white paper focuses on equipment, and analytical manufacturers' perspectives, regarding the challenges of continuous pharmaceutical manufacturing across five prompt questions. In addition to valued input from several vendors, commentary was provided from experienced pharmaceutical representatives, who have installed various continuous platforms. Additionally, a small medium enterprise (SME) perspective was obtained through interviews. A range of technical challenges is outlined, including: the presence of particles, equipment scalability, fouling (and cleaning), technology derisking, specific analytical challenges, and the general requirement of improved technical training. Equipment and analytical companies can make a significant contribution to help the introduction of continuous technology. A key point is that many of these challenges exist in batch processing and are not specific to continuous processing. Backward compatibility of software is not a continuous issue per se. In many cases, there is available learning from other industries. Business models and opportunities through outsourced development partners are also highlighted. Agile smaller companies and academic groups have a key role to play in developing skills, working collaboratively in partnerships, and focusing on solving relevant industry challenges. The precompetitive space differs for vendor companies compared with large pharmaceuticals. Currently, there is no strong consensus around a dominant continuous design, partly because of business dynamics and commercial interests. A more structured common approach to process design and hardware and software standardization would be beneficial, with initial practical steps in modeling. Conclusions include a digestible systems approach, accessible and published business cases, and increased user, academic, and supplier collaboration. This mirrors US FDA direction. The concept of silos in pharmaceutical companies is a common theme throughout the white papers. In the equipment domain, this is equally prevalent among a broad range of companies, mainly focusing on discrete areas. As an example, the flow chemistry and secondary drug product communities are almost entirely disconnected. Control and Process Analytical Technologies (PAT) companies are active in both domains. The equipment actors are a very diverse group with a few major Original Equipment Manufacturers (OEM) players and a variety of SME, project providers, integrators, upstream downstream providers, and specialist PAT. In some cases, partnerships or alliances are formed to increase critical mass. This white paper has focused on small molecules; equipment associated with biopharmaceuticals is covered in a separate white paper. More specifics on equipment detail are provided in final dosage form and drug substance white papers. The equipment and analytical development from laboratory to pilot to production is important, with a variety of sensors and complexity reducing with scale. The importance of robust processing rather than overcomplex control strategy mitigation is important. A search of nonacademic literature highlights, with a few notable exceptions, a relative paucity of material. Much focuses on the economics and benefits of continuous, rather than specifics of equipment issues. The disruptive nature of continuous manufacturing represents either an opportunity or a threat for many companies, so the incentive to change equipment varies. Also, for many companies, the pharmaceutical sector is not actually the dominant sector in terms of sales. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Selective laser melting of Inconel super alloy-a review

NASA Astrophysics Data System (ADS)

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

2017-07-01

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

7 CFR 58.52 - Time limit for packaging inspected or graded products with official identification.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) REGULATIONS AND STANDARDS UNDER THE AGRICULTURAL MARKETING ACT OF 1946... Grading Services of Manufactured or Processed Dairy Products Marking, Branding, and Identifying Product...

40 CFR 63.605 - Monitoring requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants From Phosphoric Acid Manufacturing Plants § 63.605... the mass flow of phosphorus-bearing feed material to the process. The monitoring system shall have an...

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

NASA Astrophysics Data System (ADS)

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

2016-10-01

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

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

NASA Astrophysics Data System (ADS)

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

2016-09-01

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

40 CFR 763.160 - Scope.

Code of Federal Regulations, 2013 CFR

2013-07-01

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

40 CFR 763.160 - Scope.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

40 CFR 763.160 - Scope.

Code of Federal Regulations, 2012 CFR

2012-07-01

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

40 CFR 763.160 - Scope.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

Out-of-autoclave manufacturing of a stiffened thermoplastic carbon fibre PEEK panel

NASA Astrophysics Data System (ADS)

Flanagan, M.; Goggins, J.; Doyle, A.; Weafer, B.; Ward, M.; Bizeul, M.; Canavan, R.; O'Bradaigh, C.; Doyle, K.; Harrison, N.

2017-10-01

Out-of-Autoclave manufacturing methods, specifically Automated Tape Placement (ATP) and induction welding, used in the fabrication of a stiffened thermoplastic demonstrator panel, are presented in this study. The demonstrator panel consists of two stiffeners induction welded to a flat skin, to form a typical load bearing aerospace sub-component. The skin of the panel is manufactured from uni-directional Carbon Fibre (CF) Polyetheretherkeytone (PEEK) using laser assisted Automated Tape Placement (ATP) and the stiffeners are press formed from woven CF-PEEK. The stiffeners are fusion bonded to the skin using a continuous induction welding process. A susceptor material is used at the interface to ensure the required heating is concentrated at the weldline. Microscopy was used to examine the manufactured coupons for defects. Destructive testing was carried out to evaluate the strength of the overall assembly. The work shows that assemblies manufactured using continuous induction welding and ATP are suitable for load bearing aerospace applications.

The Future of Pharmaceutical Manufacturing Sciences

PubMed Central

2015-01-01

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

The Future of Pharmaceutical Manufacturing Sciences.

PubMed

Rantanen, Jukka; Khinast, Johannes

2015-11-01

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

Validation of the manufacturing process used to produce long-acting recombinant factor IX Fc fusion protein

PubMed Central

McCue, J; Osborne, D; Dumont, J; Peters, R; Mei, B; Pierce, G F; Kobayashi, K; Euwart, D

2014-01-01

Recombinant factor IX Fc (rFIXFc) fusion protein is the first of a new class of bioengineered long-acting factors approved for the treatment and prevention of bleeding episodes in haemophilia B. The aim of this work was to describe the manufacturing process for rFIXFc, to assess product quality and to evaluate the capacity of the process to remove impurities and viruses. This manufacturing process utilized a transferable and scalable platform approach established for therapeutic antibody manufacturing and adapted for production of the rFIXFc molecule. rFIXFc was produced using a process free of human- and animal-derived raw materials and a host cell line derived from human embryonic kidney (HEK) 293H cells. The process employed multi-step purification and viral clearance processing, including use of a protein A affinity capture chromatography step, which binds to the Fc portion of the rFIXFc molecule with high affinity and specificity, and a 15 nm pore size virus removal nanofilter. Process validation studies were performed to evaluate identity, purity, activity and safety. The manufacturing process produced rFIXFc with consistent product quality and high purity. Impurity clearance validation studies demonstrated robust and reproducible removal of process-related impurities and adventitious viruses. The rFIXFc manufacturing process produces a highly pure product, free of non-human glycan structures. Validation studies demonstrate that this product is produced with consistent quality and purity. In addition, the scalability and transferability of this process are key attributes to ensure consistent and continuous supply of rFIXFc. PMID:24811361

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

PubMed

Hoss, Udo; Budiman, Erwin Satrya

2017-05-01

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

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

PubMed Central

Budiman, Erwin Satrya

2017-01-01

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

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.

Manufacturing Technology Support (MATES II) Task Order 0005: Manufacturing Integration and Technology Evaluation to Enable Technology Transition. Subtask Phase 0 Study Task: Manufacturing Technology (ManTech) and Systems Engineering For Quick Reaction Systems

DTIC Science & Technology

2014-10-01

Porosity from gas entrapment & shrinkage 4 Continuous Fiber Ti Metal Matrix Composites (Aircraft panels and rotor components) [14...process models for casting, forging, and welding , and software capability to integrate various independent models with design, thermal, and structural...Applications, Ph.D. Thesis, Queen’s College, University of Oxford, (2007). 14. S.A. Singerman and J.J. Jackson, Titanium Metal Matrix Composites for

40 CFR 439.11 - Special definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... STANDARDS (CONTINUED) PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY Fermentation Products § 439.11 Special definitions. For the purpose of this subpart: (a) Fermentation means process operations that...) Product means pharmaceutical products derived from fermentation processes. [68 FR 12271, Mar. 13, 2003] ...

40 CFR 439.11 - Special definitions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... STANDARDS (CONTINUED) PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY Fermentation Products § 439.11 Special definitions. For the purpose of this subpart: (a) Fermentation means process operations that...) Product means pharmaceutical products derived from fermentation processes. [68 FR 12271, Mar. 13, 2003] ...

40 CFR 439.11 - Special definitions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... STANDARDS (CONTINUED) PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY Fermentation Products § 439.11 Special definitions. For the purpose of this subpart: (a) Fermentation means process operations that...) Product means pharmaceutical products derived from fermentation processes. [68 FR 12271, Mar. 13, 2003] ...

Evolving trends in mAb production processes

PubMed Central

Wolfe, Leslie S.; Mostafa, Sigma S.; Norman, Carnley

2017-01-01

Abstract Monoclonal antibodies (mAbs) have established themselves as the leading biopharmaceutical therapeutic modality. The establishment of robust manufacturing platforms are key for antibody drug discovery efforts to seamlessly translate into clinical and commercial successes. Several drivers are influencing the design of mAb manufacturing processes. The advent of biosimilars is driving a desire to achieve lower cost of goods and globalize biologics manufacturing. High titers are now routinely achieved for mAbs in mammalian cell culture. These drivers have resulted in significant evolution in process platform approaches. Additionally, several new trends in bioprocessing have arisen in keeping with these needs. These include the consideration of alternative expression systems, continuous biomanufacturing and non‐chromatographic separation formats. This paper discusses these drivers in the context of the kinds of changes they are driving in mAb production processes. PMID:29313024

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

PubMed

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

2014-02-01

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

40 CFR 458.10 - Applicability; description of the carbon black furnace process subcategory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... carbon black furnace process subcategory. 458.10 Section 458.10 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Furnace Process Subcategory § 458.10 Applicability; description of the carbon black...

40 CFR 458.20 - Applicability: description of the carbon black thermal process subcategory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... carbon black thermal process subcategory. 458.20 Section 458.20 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Thermal Process Subcategory § 458.20 Applicability: description of the carbon black...

40 CFR 458.30 - Applicability; description of the carbon black channel process subcategory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... carbon black channel process subcategory. 458.30 Section 458.30 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Channel Process Subcategory § 458.30 Applicability; description of the carbon black...

Process Makes Thermoplastic Prepreg Ribbon

NASA Technical Reports Server (NTRS)

Wilson, Maywood L.; Johnson, Gary S.

1995-01-01

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

40 CFR 418.10 - Applicability; description of the phosphate subcategory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS FERTILIZER MANUFACTURING POINT SOURCE CATEGORY Phosphate...-process phosphoric acid, normal superphosphate, triple superphosphate and ammonium phosphate, except that...

40 CFR 418.10 - Applicability; description of the phosphate subcategory.

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS FERTILIZER MANUFACTURING POINT SOURCE CATEGORY Phosphate...-process phosphoric acid, normal superphosphate, triple superphosphate and ammonium phosphate, except that...

Process simulation for advanced composites production

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

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

1997-04-01

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

Apparatus for fabricating continuous lengths of superconductor

DOEpatents

Kroeger, Donald M.; List, III, Frederick A.

2002-01-01

A process and apparatus for manufacturing a superconductor. The process is accomplished by depositing a superconductor precursor powder on a continuous length of a first substrate ribbon, overlaying a continuous length of a second substrate ribbon on said first substrate ribbon, and applying sufficient pressure to form a bound layered superconductor comprising a layer of said superconducting precursor powder between said first substrate ribbon and said second substrates ribbon. The layered superconductor is then heat treated to establish the superconducting phase of said superconductor precursor powder.

Apparatus for fabricating continuous lengths of superconductor

DOEpatents

Kroeger, Donald M.; List, III, Frederick A.

2001-01-01

A process and apparatus for manufacturing a superconductor. The process is accomplished by depositing a superconductor precursor powder on a continuous length of a first substrate ribbon, overlaying a continuous length of a second substrate ribbon on said first substrate ribbon, and applying sufficient pressure to form a bound layered superconductor comprising a layer of said superconducting precursor powder between said first substrate ribbon and said second substrates ribbon. The layered superconductor is then heat treated to establish the superconducting phase of said superconductor precursor powder.

Manufacturing and Security Challenges in 3D Printing

NASA Astrophysics Data System (ADS)

Zeltmann, Steven Eric; Gupta, Nikhil; Tsoutsos, Nektarios Georgios; Maniatakos, Michail; Rajendran, Jeyavijayan; Karri, Ramesh

2016-07-01

As the manufacturing time, quality, and cost associated with additive manufacturing (AM) continue to improve, more and more businesses and consumers are adopting this technology. Some of the key benefits of AM include customizing products, localizing production and reducing logistics. Due to these and numerous other benefits, AM is enabling a globally distributed manufacturing process and supply chain spanning multiple parties, and hence raises concerns about the reliability of the manufactured product. In this work, we first present a brief overview of the potential risks that exist in the cyber-physical environment of additive manufacturing. We then evaluate the risks posed by two different classes of modifications to the AM process which are representative of the challenges that are unique to AM. The risks posed are examined through mechanical testing of objects with altered printing orientation and fine internal defects. Finite element analysis and ultrasonic inspection are also used to demonstrate the potential for decreased performance and for evading detection. The results highlight several scenarios, intentional or unintentional, that can affect the product quality and pose security challenges for the additive manufacturing supply chain.

Continuous-flow processes for the catalytic partial hydrogenation reaction of alkynes

PubMed Central

Moreno-Marrodan, Carmen; Liguori, Francesca

2017-01-01

The catalytic partial hydrogenation of substituted alkynes to alkenes is a process of high importance in the manufacture of several market chemicals. The present paper shortly reviews the heterogeneous catalytic systems engineered for this reaction under continuous flow and in the liquid phase. The main contributions appeared in the literature from 1997 up to August 2016 are discussed in terms of reactor design. A comparison with batch and industrial processes is provided whenever possible. PMID:28503209

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

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

Code of Federal Regulations, 2011 CFR

2011-07-01

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

40 CFR 420.111 - Specialized definitions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... AND STANDARDS IRON AND STEEL MANUFACTURING POINT SOURCE CATEGORY Alkaline Cleaning Subcategory § 420.111 Specialized definitions. (a) The term batch means those alkaline cleaning operations which process... continuous means those alkaline cleaning operations which process steel products other than in discrete...

40 CFR 420.111 - Specialized definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... AND STANDARDS IRON AND STEEL MANUFACTURING POINT SOURCE CATEGORY Alkaline Cleaning Subcategory § 420.111 Specialized definitions. (a) The term batch means those alkaline cleaning operations which process... continuous means those alkaline cleaning operations which process steel products other than in discrete...

40 CFR 420.111 - Specialized definitions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... AND STANDARDS IRON AND STEEL MANUFACTURING POINT SOURCE CATEGORY Alkaline Cleaning Subcategory § 420.111 Specialized definitions. (a) The term batch means those alkaline cleaning operations which process... continuous means those alkaline cleaning operations which process steel products other than in discrete...

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%.

27 CFR 40.522 - Reports.

Code of Federal Regulations, 2010 CFR

2010-04-01

... TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED... of this paragraph. (e) Concluding report. A concluding report, covering the period from the first of...

40 CFR 63.11502 - What definitions apply to this subpart?

Code of Federal Regulations, 2010 CFR

2010-07-01

...: process knowledge, an engineering assessment, or test data. Byproduct means a chemical (liquid, gas, or... (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Chemical Manufacturing Area Sources... system(s); (5) A gas stream routed to other processes for reaction or other use in another process (i.e...

Big Data Analysis of Manufacturing Processes

NASA Astrophysics Data System (ADS)

Windmann, Stefan; Maier, Alexander; Niggemann, Oliver; Frey, Christian; Bernardi, Ansgar; Gu, Ying; Pfrommer, Holger; Steckel, Thilo; Krüger, Michael; Kraus, Robert

2015-11-01

The high complexity of manufacturing processes and the continuously growing amount of data lead to excessive demands on the users with respect to process monitoring, data analysis and fault detection. For these reasons, problems and faults are often detected too late, maintenance intervals are chosen too short and optimization potential for higher output and increased energy efficiency is not sufficiently used. A possibility to cope with these challenges is the development of self-learning assistance systems, which identify relevant relationships by observation of complex manufacturing processes so that failures, anomalies and need for optimization are automatically detected. The assistance system developed in the present work accomplishes data acquisition, process monitoring and anomaly detection in industrial and agricultural processes. The assistance system is evaluated in three application cases: Large distillation columns, agricultural harvesting processes and large-scale sorting plants. In this paper, the developed infrastructures for data acquisition in these application cases are described as well as the developed algorithms and initial evaluation results.

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.

Validation of the manufacturing process used to produce long-acting recombinant factor IX Fc fusion protein.

PubMed

McCue, J; Osborne, D; Dumont, J; Peters, R; Mei, B; Pierce, G F; Kobayashi, K; Euwart, D

2014-07-01

Recombinant factor IX Fc (rFIXFc) fusion protein is the first of a new class of bioengineered long-acting factors approved for the treatment and prevention of bleeding episodes in haemophilia B. The aim of this work was to describe the manufacturing process for rFIXFc, to assess product quality and to evaluate the capacity of the process to remove impurities and viruses. This manufacturing process utilized a transferable and scalable platform approach established for therapeutic antibody manufacturing and adapted for production of the rFIXFc molecule. rFIXFc was produced using a process free of human- and animal-derived raw materials and a host cell line derived from human embryonic kidney (HEK) 293H cells. The process employed multi-step purification and viral clearance processing, including use of a protein A affinity capture chromatography step, which binds to the Fc portion of the rFIXFc molecule with high affinity and specificity, and a 15 nm pore size virus removal nanofilter. Process validation studies were performed to evaluate identity, purity, activity and safety. The manufacturing process produced rFIXFc with consistent product quality and high purity. Impurity clearance validation studies demonstrated robust and reproducible removal of process-related impurities and adventitious viruses. The rFIXFc manufacturing process produces a highly pure product, free of non-human glycan structures. Validation studies demonstrate that this product is produced with consistent quality and purity. In addition, the scalability and transferability of this process are key attributes to ensure consistent and continuous supply of rFIXFc. © 2014 The Authors. Haemophilia Published by John Wiley & Sons Ltd.

Continuous Improvement in Schools and Districts: Policy Considerations

ERIC Educational Resources Information Center

Best, Jane; Dunlap, Allison

2014-01-01

Discussions about improving public education often focus on outcomes without considering how schools and districts can accomplish those outcomes. Research shows that using a continuous improvement process has proven successful in healthcare, manufacturing, and technology, and may hold potential for use in education as well. This brief defines and…

21 CFR 211.188 - Batch production and control records.

Code of Federal Regulations, 2010 CFR

2010-04-01

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

21 CFR 211.188 - Batch production and control records.

Code of Federal Regulations, 2011 CFR

2011-04-01

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

Advances in downstream processing of biologics - Spectroscopy: An emerging process analytical technology.

PubMed

Rüdt, Matthias; Briskot, Till; Hubbuch, Jürgen

2017-03-24

Process analytical technologies (PAT) for the manufacturing of biologics have drawn increased interest in the last decade. Besides being encouraged by the Food and Drug Administration's (FDA's) PAT initiative, PAT promises to improve process understanding, reduce overall production costs and help to implement continuous manufacturing. This article focuses on spectroscopic tools for PAT in downstream processing (DSP). Recent advances and future perspectives will be reviewed. In order to exploit the full potential of gathered data, chemometric tools are widely used for the evaluation of complex spectroscopic information. Thus, an introduction into the field will be given. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Unlocking the potential of supported liquid phase catalysts with supercritical fluids: low temperature continuous flow catalysis with integrated product separation

PubMed Central

Franciò, Giancarlo; Hintermair, Ulrich; Leitner, Walter

2015-01-01

Solution-phase catalysis using molecular transition metal complexes is an extremely powerful tool for chemical synthesis and a key technology for sustainable manufacturing. However, as the reaction complexity and thermal sensitivity of the catalytic system increase, engineering challenges associated with product separation and catalyst recovery can override the value of the product. This persistent downstream issue often renders industrial exploitation of homogeneous catalysis uneconomical despite impressive batch performance of the catalyst. In this regard, continuous-flow systems that allow steady-state homogeneous turnover in a stationary liquid phase while at the same time effecting integrated product separation at mild process temperatures represent a particularly attractive scenario. While continuous-flow processing is a standard procedure for large volume manufacturing, capitalizing on its potential in the realm of the molecular complexity of organic synthesis is still an emerging area that requires innovative solutions. Here we highlight some recent developments which have succeeded in realizing such systems by the combination of near- and supercritical fluids with homogeneous catalysts in supported liquid phases. The cases discussed exemplify how all three levels of continuous-flow homogeneous catalysis (catalyst system, separation strategy, process scheme) must be matched to locate viable process conditions. PMID:26574523

Unlocking the potential of supported liquid phase catalysts with supercritical fluids: low temperature continuous flow catalysis with integrated product separation.

PubMed

Franciò, Giancarlo; Hintermair, Ulrich; Leitner, Walter

2015-12-28

Solution-phase catalysis using molecular transition metal complexes is an extremely powerful tool for chemical synthesis and a key technology for sustainable manufacturing. However, as the reaction complexity and thermal sensitivity of the catalytic system increase, engineering challenges associated with product separation and catalyst recovery can override the value of the product. This persistent downstream issue often renders industrial exploitation of homogeneous catalysis uneconomical despite impressive batch performance of the catalyst. In this regard, continuous-flow systems that allow steady-state homogeneous turnover in a stationary liquid phase while at the same time effecting integrated product separation at mild process temperatures represent a particularly attractive scenario. While continuous-flow processing is a standard procedure for large volume manufacturing, capitalizing on its potential in the realm of the molecular complexity of organic synthesis is still an emerging area that requires innovative solutions. Here we highlight some recent developments which have succeeded in realizing such systems by the combination of near- and supercritical fluids with homogeneous catalysts in supported liquid phases. The cases discussed exemplify how all three levels of continuous-flow homogeneous catalysis (catalyst system, separation strategy, process scheme) must be matched to locate viable process conditions. © 2015 The Authors.

40 CFR 63.11562 - What are my initial compliance requirements?

Code of Federal Regulations, 2011 CFR

2011-07-01

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

40 CFR 63.11562 - What are my initial compliance requirements?

Code of Federal Regulations, 2014 CFR

2014-07-01

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

40 CFR 63.11562 - What are my initial compliance requirements?

Code of Federal Regulations, 2012 CFR

2012-07-01

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

40 CFR 63.11562 - What are my initial compliance requirements?

Code of Federal Regulations, 2013 CFR

2013-07-01

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

40 CFR 63.11562 - What are my initial compliance requirements?

Code of Federal Regulations, 2010 CFR

2010-07-01

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

Electronics manufacturing and assembly in Japan

NASA Technical Reports Server (NTRS)

Kukowski, John A.; Boulton, William R.

1995-01-01

In the consumer electronics industry, precision processing technology is the basis for enhancing product functions and for minimizing components and end products. Throughout Japan, manufacturing technology is seen as critical to the production and assembly of advanced products. While its population has increased less than 30 percent over twenty-five years, Japan's gross national product has increase thirtyfold; this growth has resulted in large part from rapid replacement of manual operations with innovative, high-speed, large-scale, continuously running, complex machines that process a growing number of miniaturized components. The JTEC panel found that introduction of next-generation electronics products in Japan goes hand-in-hand with introduction of new and improved production equipment. In the panel's judgment, Japan's advanced process technologies and equipment development and its highly automated factories are crucial elements of its domination of the consumer electronics marketplace - and Japan's expertise in manufacturing consumer electronics products gives it potentially unapproachable process expertise in all electronics markets.

Cellulose nanocrystals the next big nano-thing?

NASA Astrophysics Data System (ADS)

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

2008-08-01

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

40 CFR 60.473 - Monitoring of operations.

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) STANDARDS OF PERFORMANCE FOR NEW STATIONARY SOURCES Standards of Performance for Asphalt Processing and Asphalt Roofing Manufacture § 60.473 Monitoring of operations. (a) The owner or operator...

40 CFR 60.473 - Monitoring of operations.

Code of Federal Regulations, 2012 CFR

2012-07-01

... (CONTINUED) STANDARDS OF PERFORMANCE FOR NEW STATIONARY SOURCES Standards of Performance for Asphalt Processing and Asphalt Roofing Manufacture § 60.473 Monitoring of operations. (a) The owner or operator...

40 CFR 60.473 - Monitoring of operations.

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) STANDARDS OF PERFORMANCE FOR NEW STATIONARY SOURCES Standards of Performance for Asphalt Processing and Asphalt Roofing Manufacture § 60.473 Monitoring of operations. (a) The owner or operator...

40 CFR 429.145 - Pretreatment standards for existing sources (PSES).

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS TIMBER PRODUCTS PROCESSING POINT SOURCE CATEGORY Particleboard Manufacturing Subcategory § 429.145 Pretreatment standards for existing sources (PSES). Any existing source...

19 CFR 191.141 - Drawback allowance.

Code of Federal Regulations, 2010 CFR

2010-04-01

... TREASURY (CONTINUED) DRAWBACK Foreign-Built Jet Aircraft Engines Processed in the United States § 191.141... exportation of jet aircraft engines manufactured or produced abroad that have been overhauled, repaired...

19 CFR 191.141 - Drawback allowance.

Code of Federal Regulations, 2011 CFR

2011-04-01

... TREASURY (CONTINUED) DRAWBACK Foreign-Built Jet Aircraft Engines Processed in the United States § 191.141... exportation of jet aircraft engines manufactured or produced abroad that have been overhauled, repaired...

Continuous downstream processing for high value biological products: A Review.

PubMed

Zydney, Andrew L

2016-03-01

There is growing interest in the possibility of developing truly continuous processes for the large-scale production of high value biological products. Continuous processing has the potential to provide significant reductions in cost and facility size while improving product quality and facilitating the design of flexible multi-product manufacturing facilities. This paper reviews the current state-of-the-art in separations technology suitable for continuous downstream bioprocessing, focusing on unit operations that would be most appropriate for the production of secreted proteins like monoclonal antibodies. This includes cell separation/recycle from the perfusion bioreactor, initial product recovery (capture), product purification (polishing), and formulation. Of particular importance are the available options, and alternatives, for continuous chromatographic separations. Although there are still significant challenges in developing integrated continuous bioprocesses, recent technological advances have provided process developers with a number of attractive options for development of truly continuous bioprocessing operations. © 2015 Wiley Periodicals, Inc.

Exploring Flow Procedures for Diazonium Formation.

PubMed

Hu, Te; Baxendale, Ian R; Baumann, Marcus

2016-07-14

The synthesis of diazonium salts is historically an important transformation extensively utilized in dye manufacture. However the highly reactive nature of the diazonium functionality has additionally led to the development of many new reactions including several carbon-carbon bond forming processes. It is therefore highly desirable to determine optimum conditions for the formation of diazonium compounds utilizing the latest processing tools such as flow chemistry to take advantage of the increased safety and continuous manufacturing capabilities. Herein we report a series of flow-based procedures to prepare diazonium salts for subsequent in-situ consumption.

40 CFR 428.95 - Standards of performance for new sources.

Code of Federal Regulations, 2012 CFR

2012-07-01

...) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) RUBBER MANUFACTURING POINT SOURCE CATEGORY Pan, Dry Digestion..., dry digestion, and mechanical reclaimed rubber processes which are integrated with a wet digestion...

40 CFR 428.95 - Standards of performance for new sources.

Code of Federal Regulations, 2014 CFR

2014-07-01

...) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) RUBBER MANUFACTURING POINT SOURCE CATEGORY Pan, Dry Digestion..., dry digestion, and mechanical reclaimed rubber processes which are integrated with a wet digestion...

40 CFR 428.95 - Standards of performance for new sources.

Code of Federal Regulations, 2013 CFR

2013-07-01

...) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) RUBBER MANUFACTURING POINT SOURCE CATEGORY Pan, Dry Digestion..., dry digestion, and mechanical reclaimed rubber processes which are integrated with a wet digestion...

40 CFR 428.96 - Pretreatment standards for new sources.

Code of Federal Regulations, 2012 CFR

2012-07-01

... GUIDELINES AND STANDARDS (CONTINUED) RUBBER MANUFACTURING POINT SOURCE CATEGORY Pan, Dry Digestion, and... this section and attributable to pan, dry digestion, and mechanical reclaimed rubber processes which are integrated with a wet digestion reclaimed rubber process, which may be discharged to a publicly...

40 CFR 428.96 - Pretreatment standards for new sources.

Code of Federal Regulations, 2014 CFR

2014-07-01

... GUIDELINES AND STANDARDS (CONTINUED) RUBBER MANUFACTURING POINT SOURCE CATEGORY Pan, Dry Digestion, and... this section and attributable to pan, dry digestion, and mechanical reclaimed rubber processes which are integrated with a wet digestion reclaimed rubber process, which may be discharged to a publicly...

40 CFR 428.96 - Pretreatment standards for new sources.

Code of Federal Regulations, 2013 CFR

2013-07-01

... GUIDELINES AND STANDARDS (CONTINUED) RUBBER MANUFACTURING POINT SOURCE CATEGORY Pan, Dry Digestion, and... this section and attributable to pan, dry digestion, and mechanical reclaimed rubber processes which are integrated with a wet digestion reclaimed rubber process, which may be discharged to a publicly...

40 CFR 63.11502 - What definitions apply to this subpart?

Code of Federal Regulations, 2013 CFR

2013-07-01

...: process knowledge, an engineering assessment, or test data. Byproduct means a chemical (liquid, gas, or... limit applicable to the process vent. (4) Design analysis based on accepted chemical engineering... (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Chemical Manufacturing Area Sources...

40 CFR 63.11502 - What definitions apply to this subpart?

Code of Federal Regulations, 2014 CFR

2014-07-01

...: process knowledge, an engineering assessment, or test data. Byproduct means a chemical (liquid, gas, or... limit applicable to the process vent. (4) Design analysis based on accepted chemical engineering... (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Chemical Manufacturing Area Sources...

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.

Electro-optic product design for manufacture: where next?

NASA Astrophysics Data System (ADS)

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

2016-10-01

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

40 CFR 761.378 - Decontamination, reuse, and disposal of solvents, cleaners, and equipment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING, DISTRIBUTION IN COMMERCE, AND USE PROHIBITIONS Double Wash/Rinse Method for Decontaminating Non...

40 CFR Table 35 to Subpart G of... - Control Requirements for Items of Equipment That Meet the Criteria of § 63.149 of Subpart G

Code of Federal Regulations, 2011 CFR

2011-07-01

... Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES National Emission Standards for Organic Hazardous Air Pollutants From the Synthetic Organic Chemical Manufacturing Industry for Process Vents, Storage...

Continuous manufacturing of tablets with PROMIS-line - Introduction and case studies from continuous feeding, blending and tableting.

PubMed

Simonaho, Simo-Pekka; Ketolainen, Jarkko; Ervasti, Tuomas; Toiviainen, Maunu; Korhonen, Ossi

2016-07-30

Drug manufacturing technology is in the midst of modernization and continuous manufacturing of drug products is especially the focus of great interest. The adoption of new manufacturing approaches requires extensive cooperation between industry, regulatory bodies, academics and equipment manufacturers. In this paper we introduce PROMIS-line which is a continuous tableting line built at the University of Eastern Finland, School of Pharmacy, PROMIS-centre. PROMIS-line is modular and tablets can be produced via dry granulation or direct compression. In three case studies, continuous feeding, blending and tablet performance is studied to illustrate some basic features of PROMIS-line. In conclusion, the PROMIS-line is an excellent tool for studying the fundamentals of continuous manufacturing of tablets. Copyright © 2016 Elsevier B.V. All rights reserved.

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

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

Code of Federal Regulations, 2011 CFR

2011-07-01

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

21 CFR 640.68 - Processing.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Processing. 640.68 Section 640.68 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL... manufacturing into injectable or noninjectable products and all interior surfaces of plasma containers used for...

27 CFR 40.182 - Record of processed tobacco.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2011-04-01 2011-04-01 false Record of processed tobacco. 40.182 Section 40.182 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS...

27 CFR 40.182 - Record of processed tobacco.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2010-04-01 2010-04-01 false Record of processed tobacco. 40.182 Section 40.182 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS...

An update on coating/manufacturing techniques of microneedles.

PubMed

Tarbox, Tamara N; Watts, Alan B; Cui, Zhengrong; Williams, Robert O

2017-12-29

Recently, results have been published for the first successful phase I human clinical trial investigating the use of dissolving polymeric microneedles… Even so, further clinical development represents an important hurdle that remains in the translation of microneedle technology to approved products. Specifically, the potential for accumulation of polymer within the skin upon repeated application of dissolving and coated microneedles, combined with a lack of safety data in humans, predicates a need for further clinical investigation. Polymers are an important consideration for microneedle technology-from both manufacturing and drug delivery perspectives. The use of polymers enables a tunable delivery strategy, but the scalability of conventional manufacturing techniques could arguably benefit from further optimization. Micromolding has been suggested in the literature as a commercially viable means to mass production of both dissolving and swellable microneedles. However, the reliance on master molds, which are commonly manufactured using resource intensive microelectronics industry-derived processes, imparts notable material and design limitations. Further, the inherently multi-step filling and handling processes associated with micromolding are typically batch processes, which can be challenging to scale up. Similarly, conventional microneedle coating processes often follow step-wise batch processing. Recent developments in microneedle coating and manufacturing techniques are highlighted, including micromilling, atomized spraying, inkjet printing, drawing lithography, droplet-born air blowing, electro-drawing, continuous liquid interface production, 3D printing, and polyelectrolyte multilayer coating. This review provides an analysis of papers reporting on potentially scalable production techniques for the coating and manufacturing of microneedles.

EUV patterning improvement toward high-volume manufacturing

NASA Astrophysics Data System (ADS)

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

2015-03-01

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

40 CFR 415.160 - Applicability; description of the sodium chloride production subcategory.

Code of Federal Regulations, 2011 CFR

2011-07-01

... PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS INORGANIC CHEMICALS MANUFACTURING POINT... the production of sodium chloride by the solution brine-mining process and by the solar evaporation...

40 CFR 63.11565 - What general provisions sections apply to this subpart?

Code of Federal Regulations, 2010 CFR

2010-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Other Requirements and Information § 63.11565 What general...

40 CFR 63.11565 - What general provisions sections apply to this subpart?

Code of Federal Regulations, 2013 CFR

2013-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Other Requirements and Information § 63.11565 What general...

40 CFR 63.11565 - What general provisions sections apply to this subpart?

Code of Federal Regulations, 2014 CFR

2014-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Other Requirements and Information § 63.11565 What general...

40 CFR 63.11565 - What general provisions sections apply to this subpart?

Code of Federal Regulations, 2012 CFR

2012-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Other Requirements and Information § 63.11565 What general...

40 CFR 63.11565 - What general provisions sections apply to this subpart?

Code of Federal Regulations, 2011 CFR

2011-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Area Sources: Asphalt Processing and Asphalt Roofing Manufacturing Other Requirements and Information § 63.11565 What general...

40 CFR 63.1080 - What is the purpose of this subpart?

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) National Emission Standards for Ethylene Manufacturing Process Units: Heat Exchange Systems and... requirements for controlling emissions of hazardous air pollutants (HAP) from heat exchange systems and waste...

40 CFR 63.1080 - What is the purpose of this subpart?

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) National Emission Standards for Ethylene Manufacturing Process Units: Heat Exchange Systems and... requirements for controlling emissions of hazardous air pollutants (HAP) from heat exchange systems and waste...

40 CFR 63.1080 - What is the purpose of this subpart?

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) National Emission Standards for Ethylene Manufacturing Process Units: Heat Exchange Systems and... requirements for controlling emissions of hazardous air pollutants (HAP) from heat exchange systems and waste...

40 CFR 63.1080 - What is the purpose of this subpart?

Code of Federal Regulations, 2012 CFR

2012-07-01

... (CONTINUED) National Emission Standards for Ethylene Manufacturing Process Units: Heat Exchange Systems and... requirements for controlling emissions of hazardous air pollutants (HAP) from heat exchange systems and waste...

40 CFR 63.1080 - What is the purpose of this subpart?

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) National Emission Standards for Ethylene Manufacturing Process Units: Heat Exchange Systems and... requirements for controlling emissions of hazardous air pollutants (HAP) from heat exchange systems and waste...

40 CFR 421.310 - Applicability: Description of the secondary tungsten and cobalt subcategory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS NONFERROUS METALS MANUFACTURING POINT SOURCE... the production of tungsten or cobalt at secondary tungsten and cobalt facilities processing tungsten...

27 CFR 40.522 - Reports.

Code of Federal Regulations, 2014 CFR

2014-04-01

... TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED... such removals on TTB F 5250.2. Records of such removals must still be kept pursuant to § 40.521. (e...

Thermally sprayed prepregs for thixoforging of UD fiber reinforced light metal MMCs

NASA Astrophysics Data System (ADS)

Silber, Martin; Wenzelburger, Martin; Gadow, Rainer

2007-04-01

Low density and good mechanical properties are the basic requirements for lightweight structures in automotive and aerospace applications. With their high specific strength and strain to failure values, aluminum alloys could be used for such applications. Only the insufficient stiffness and thermal and fatigue strength prevented their usage in high-end applications. One possibility to solve this problem is to reinforce the light metal with unidirectional fibers. The UD fiber allows tailoring of the reinforcement to meet the direction of the component's load. In this study, the production of thermally sprayed prepregs for the manufacturing of continuous fiber reinforced MMC by thixoforging is analysed. The main aim is to optimize the winding procedure, which determines the fiber strand position and tension during the coating process. A method to wind and to coat the continuous fibers with an easy-to-use handling technique for the whole manufacturing process is presented. The prepregs were manufactured by producing arc wire sprayed AlSi6 coatings on fibers bundles. First results of bending experiments showed appropriate mechanical properties.

Active pharmaceutical ingredient (API) production involving continuous processes--a process system engineering (PSE)-assisted design framework.

PubMed

Cervera-Padrell, Albert E; Skovby, Tommy; Kiil, Søren; Gani, Rafiqul; Gernaey, Krist V

2012-10-01

A systematic framework is proposed for the design of continuous pharmaceutical manufacturing processes. Specifically, the design framework focuses on organic chemistry based, active pharmaceutical ingredient (API) synthetic processes, but could potentially be extended to biocatalytic and fermentation-based products. The method exploits the synergic combination of continuous flow technologies (e.g., microfluidic techniques) and process systems engineering (PSE) methods and tools for faster process design and increased process understanding throughout the whole drug product and process development cycle. The design framework structures the many different and challenging design problems (e.g., solvent selection, reactor design, and design of separation and purification operations), driving the user from the initial drug discovery steps--where process knowledge is very limited--toward the detailed design and analysis. Examples from the literature of PSE methods and tools applied to pharmaceutical process design and novel pharmaceutical production technologies are provided along the text, assisting in the accumulation and interpretation of process knowledge. Different criteria are suggested for the selection of batch and continuous processes so that the whole design results in low capital and operational costs as well as low environmental footprint. The design framework has been applied to the retrofit of an existing batch-wise process used by H. Lundbeck A/S to produce an API: zuclopenthixol. Some of its batch operations were successfully converted into continuous mode, obtaining higher yields that allowed a significant simplification of the whole process. The material and environmental footprint of the process--evaluated through the process mass intensity index, that is, kg of material used per kg of product--was reduced to half of its initial value, with potential for further reduction. The case-study includes reaction steps typically used by the pharmaceutical industry featuring different characteristic reaction times, as well as L-L separation and distillation-based solvent exchange steps, and thus constitutes a good example of how the design framework can be useful to efficiently design novel or already existing API manufacturing processes taking advantage of continuous processes. Copyright © 2012 Elsevier B.V. All rights reserved.

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.

NREL Patents Method for Continuous Monitoring of Materials During

Science.gov Websites

Manufacturing | News | NREL NREL Patents Method for Continuous Monitoring of Materials During Manufacturing News Release: NREL Patents Method for Continuous Monitoring of Materials During Manufacturing patent for a novel method that rapidly characterizes specialized materials during the manufacturing

40 CFR 63.8696 - What parts of the General Provisions apply to me?

Code of Federal Regulations, 2014 CFR

2014-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing Other Requirements and Information § 63.8696 What parts of the General...

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

40 CFR 63.8696 - What parts of the General Provisions apply to me?

Code of Federal Regulations, 2013 CFR

2013-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing Other Requirements and Information § 63.8696 What parts of the General...

40 CFR 63.8696 - What parts of the General Provisions apply to me?

Code of Federal Regulations, 2010 CFR

2010-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing Other Requirements and Information § 63.8696 What parts of the General...

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

Code of Federal Regulations, 2011 CFR

2011-07-01

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

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

40 CFR 63.8696 - What parts of the General Provisions apply to me?

Code of Federal Regulations, 2011 CFR

2011-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing Other Requirements and Information § 63.8696 What parts of the General...

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

40 CFR 63.8696 - What parts of the General Provisions apply to me?

Code of Federal Regulations, 2012 CFR

2012-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing Other Requirements and Information § 63.8696 What parts of the General...

40 CFR 429.143 - Effluent limitations representing the degree of effluent reduction attainable by the application...

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS TIMBER PRODUCTS PROCESSING POINT SOURCE CATEGORY Particleboard Manufacturing Subcategory § 429.143 Effluent limitations representing the degree of effluent reduction...

40 CFR 429.142 - Effluent limitations representing the degree of effluent reduction attainable by the application...

Code of Federal Regulations, 2010 CFR

2010-07-01

... AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS TIMBER PRODUCTS PROCESSING POINT SOURCE CATEGORY Particleboard Manufacturing Subcategory § 429.142 Effluent limitations representing the degree of effluent...

40 CFR 63.8684 - What emission limitations must I meet?

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing Emission Limitations § 63.8684 What emission limitations must I meet? (a) You must meet each...

40 CFR 429.141 - Effluent limitations representing the degree of effluent reduction attainable by the application...

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS TIMBER PRODUCTS PROCESSING POINT SOURCE CATEGORY Particleboard Manufacturing Subcategory § 429.141 Effluent limitations representing the degree of effluent reduction...

40 CFR 421.230 - Applicability: Description of the primary nickel and cobalt subcategory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS NONFERROUS METALS MANUFACTURING POINT SOURCE... production of nickel or cobalt by primary nickel and cobalt facilities processing ore concentrate raw...

40 CFR 63.1093 - Does this subpart apply to my waste streams?

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) National Emission Standards for Ethylene Manufacturing Process Units: Heat Exchange Systems and... ethylene production facility expressly referenced to this subpart XX from subpart YY of this part. The...

40 CFR 63.1083 - Does this subpart apply to my heat exchange system?

Code of Federal Regulations, 2010 CFR

2010-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Ethylene Manufacturing Process Units: Heat Exchange... or operate an ethylene production unit expressly referenced to this subpart XX from subpart YY of...

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.

Lubricant based determination of design space for continuously manufactured high dose paracetamol tablets.

PubMed

Taipale-Kovalainen, Krista; Karttunen, Anssi-Pekka; Ketolainen, Jarkko; Korhonen, Ossi

2018-03-30

The objective of this study was to devise robust and stable continuous manufacturing process settings, by exploring the design space after an investigation of the lubrication-based parameters influencing the continuous direct compression tableting of high dose paracetamol tablets. Experimental design was used to generate a structured study plan which involved 19 runs. The formulation variables studied were the type of lubricant (magnesium stearate or stearic acid) and its concentration (0.5, 1.0 and 1.5%). Process variables were total production feed rate (5, 10.5 and 16kg/h), mixer speed rpm (500, 850 and 1200rpm), and mixer inlet port for lubricant (A or B). The continuous direct compression tableting line consisted of loss-in-weight feeders, a continuous mixer and a tablet press. The Quality Target Product Profile (QTPP) was defined for the final product, as the flowability of powder blends (2.5s), tablet strength (147N), dissolution in 2.5min (90%) and ejection force (425N). A design space was identified which fulfilled all the requirements of QTPP. The type and concentration of lubricant exerted the greatest influence on the design space. For example, stearic acid increased the tablet strength. Interestingly, the studied process parameters had only a very minor effect on the quality of the final product and the design space. It is concluded that the continuous direct compression tableting process itself is insensitive and can cope with changes in lubrication, whereas formulation parameters exert a major influence on the end product quality. Copyright © 2017 Elsevier B.V. All rights reserved.

40 CFR 458.32 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

Code of Federal Regulations, 2011 CFR

2011-07-01

... AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Channel Process Subcategory § 458.32 Effluent limitations guidelines representing the degree...): There shall be no discharge of process waste water pollutants into navigable waters. [60 FR 33972, June...

40 CFR 458.22 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

Code of Federal Regulations, 2011 CFR

2011-07-01

... AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Thermal Process Subcategory § 458.22 Effluent limitations guidelines representing the degree...): There shall be no discharge of process waste water pollutants into navigable waters. [60 FR 33972, June...

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

NASA Technical Reports Server (NTRS)

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

2018-01-01

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

Fenestration system energy performance research, implementation, and international harmonization

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

McGowan, Raymond F

The research conducted by the NFRC and its contractors adds significantly to the understanding of several areas of investigation. NFRC enables manufacturers to rate fenestration energy performance to comply with building energy codes, participate in ENERGY STAR, and compete fairly. NFRC continuously seeks to improve its ratings and also seeks to simplify the rating process. Several research projects investigated rating improvement potential such as • Complex Product VT Rating Research • Window 6 and Therm 6 Validation Research Project • Complex Product VT Rating Research Conclusions from these research projects led to important changes and increased confidence in the existingmore » NFRC rating process. Conclusions from the Window 6/Therm 6 project will enable window manufacturers to rate an expanded array of products and improve existing ratings. Some research lead to an improved new rating method called the Component Modeling Approach. A primary goal of the CMA was a simplification of the commercial energy rating process to increase participation and make the commercial industry more competitive and code compliant. The project below contributed towards CMA development: • Component Modeling Approach Condensation Resistance Research NFRC continues to implement the Component Modeling Approach program. The program includes the CMA software tool, CMAST, and several procedural documents to govern the certification process. This significant accomplishment was a response the commercial fenestration industry’s need for a simplification of the present NFRC energy rating method (named site built). To date, most commercial fenestration is self-rated by a variety of techniques. The CMA enables commercial fenestration manufacturers to rate according to the NFRC 100/200 as most commercial energy codes require. International Harmonization NFRC achieved significant international harmonization success by continuing its licensing agreements with the Australian Fenestration Rating Council and the Association of Architectural Aluminum Manufacturers of South Africa (AAAMSA) to produce NFRC certified product ratings in their respective nations. NFRC worked in several other nations to introduce the NFRC ratings system: • India • China • Japan • Canada • Thailand • South Africa • Brazil • Korea NFRC attended or hosted several meetings in each of these nations establishing academic, commercial, industrial, and governmental contacts. NFRC presented the NFRC process and then necessary infrastructure steps necessary to achieve harmonization with the NFRC labeling system. NFRC looks forward to continued work toward harmonization in these nations and potentially others.« less

In-situ measurement of processing properties during fabrication in a production tool

NASA Technical Reports Server (NTRS)

Kranbuehl, D. E.; Haverty, P.; Hoff, M.; Loos, A. C.

1988-01-01

Progress is reported on the use of frequency-dependent electromagnetic measurements (FDEMs) as a single, convenient technique for continuous in situ monitoring of polyester cure during fabrication in a laboratory and manufacturing environment. Preliminary FDEM sensor and modeling work using the Loss-Springer model in order to develop an intelligent closed-loop, sensor-controlled cure process is described. FDEMs using impedance bridges in the Hz to MHz region is found to be ideal for automatically monitoring polyester processing properties continuously throughout the cure cycle.

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

PubMed

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

2002-03-01

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

Implementation of Total Employee Involvement as Part of a Continuous Improvement Program at a Fortune 500 Company

ERIC Educational Resources Information Center

Carlson, Kathy Lynn

2012-01-01

Over the last several decades, Continuous Improvement (CI) type initiatives have been implemented in companies across the United States to improve quality, reduce process variation, eliminate waste and ultimately reduce costs. Approximately five years ago, one particular Fortune 500 company implemented CI in its manufacturing facilities. A key…

Microgravity Manufacturing

NASA Technical Reports Server (NTRS)

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

2002-01-01

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

40 CFR 763.173 - Exemptions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT ASBESTOS Prohibition of the Manufacture, Importation, Processing, and Distribution in Commerce of Certain Asbestos... Pennsylvania Ave., NW., Washington, DC 20460, ATTENTION: Asbestos Exemption. For information regarding the...

40 CFR 424.32 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

Code of Federal Regulations, 2010 CFR

2010-07-01

... AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS FERROALLOY MANUFACTURING POINT SOURCE CATEGORY Slag Processing Subcategory § 424.32 Effluent limitations guidelines representing the degree of effluent reduction...

Rigid-Flex Printed Circuit Manufacturing process. A Project of the Manufacturing Technology Program.

DTIC Science & Technology

1979-06-30

utilized epoxy glass laminate stiffeners in order to improve drilling characteristics, prevent thermal damage created by Z-axis expansion, and increase...temperatures. I 41 6. Fortin Laminates 1323 Truman Street San Fernando, CA q1340 7. Howe Industries 13704 Saticoy Street Panorama City, CA 8. Atl antic...to determine thickness, inner layer continuity and uniformity). In addition, tests such as thermal shock and thermal stress (per MIL-P-55640) were

Ergonomic development work: co-education as a support for user participation at a car assembly plant. A case study.

PubMed

Garmer, K; Dahlman, S; Sperling, L

1995-12-01

This study deals with the design, trials and evaluation of a co-education programme at the Volvo Uddevalla plant in Sweden. Involving operators, manufacturing engineers and managers, the programme served as a support for the creation of a participatory ergonomics process, intended for continuous use at the plant. It consisted of a basic ergonomics knowledge package, and a dialogue model defining the roles and relations of actors involved. As a practical part of the programme, trial development projects were also carried out by the participants. The main and long term objective of the project was to start the participants cooperating in a continuous change and development process on the shop-floor. The outcome of the co-education programme was evaluated immediately after the first two regular courses, and, as a longterm follow-up, after seven subsequent courses shortly after the closing of the Uddevalla plant. The co-education programme was shown to be successful. Later on, the expertize of both operators and manufacturing engineers became obvious to everyone at the plant, and the cooperation between operators and manufacturing engineers increased steadily. The main conclusion drawn was that the co-education programme is a good starting point for a process of participation and industrial change work. However, in order to get a permanent impact, the whole organization must nurse and nourish the further development, and implementation of the process.

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

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

Hale, Steve

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

Properties of Rolled AZ31 Magnesium Alloy Sheet Fabricated by Continuous Variable Cross-Section Direct Extrusion

NASA Astrophysics Data System (ADS)

Liu, Yang; Li, Feng; Li, Xue Wen; Shi, Wen Yong

2018-03-01

Rolling is currently a widely used method for manufacturing and processing high-performance magnesium alloy sheets and has received widespread attention in recent years. Here, we combined continuous variable cross-section direct extrusion (CVCDE) and rolling processes. The microstructure and mechanical properties of the resulting sheets rolled at different temperatures from CVCDE extrudate were investigated by optical microscopy, scanning electron microscope, transmission electron microscopy and electron backscatter diffraction. The results showed that a fine-grained microstructure was present with an average grain size of 3.62 μm in sheets rolled from CVCDE extrudate at 623 K. Dynamic recrystallization and a large strain were induced by the multi-pass rolling, which resulted in grain refinement. In the 573-673 K range, the yield strength, tensile strength and elongation initially increased and then declined as the CVCDE temperature increased. The above results provide an important scientific basis of processing, manufacturing and the active control on microstructure and property for high-performance magnesium alloy sheet.

Manufacture of bulk superconducting YBa2Cu3O(7-delta) by a continuous process

NASA Technical Reports Server (NTRS)

Meng, R. L.; Kinalidis, C.; Sun, Y. Y.; Gao, L.; Tao, Y. K.

1990-01-01

The development of a continuous process for fabricating large bulk superconductors with a predetermined grain orientation is reported. A bar of the 123 compound with dimensions 5 x 0.5 x about 0.3 cm with excellent grain alignment has been fabricated continuously. The bulk 123 thus obtained has magnetically determined J(c)s of about 30,000 and 12,000 A/sq cm at 0 and 1 T, respectively, and transport J(c)s of 20,000, 11,000, and 7500 A-sq cm at 0, 0.54, and 0.83 T.

Manufacturing development of pultruded composite panels

NASA Technical Reports Server (NTRS)

Meade, L. E.

1989-01-01

The weight savings potential, of graphite-epoxy composites for secondary and medium primary aircraft structures, was demonstrated. One of the greatest challenges facing the aircraft industry is to reduce the acquisition costs for composite structures to a level below that of metal structures. The pultrusion process, wherein reinforcing fibers, after being passed through a resin bath are drawn through a die to form and cure the desired cross-section, is an automated low cost manufacturing process for composite structures. The Lockheed Aeronautical Systems Company (LASC) Composites Development Center designed, characterizated materials for, fabricated and tested a stiffened cover concept compatible with the continuous pultrusion process. The procedures used and the results obtained are presented.

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

NASA Astrophysics Data System (ADS)

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

2018-03-01

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

The challenges of lean manufacturing implementation in kitting assembly

NASA Astrophysics Data System (ADS)

Fansuri, A. F. H.; Rose, A. N. M.; Nik Mohamed, N. M. Z.; Ahmad, H.

2017-10-01

Literature studies shows that lean manufacturing goes way back with the original founder Eli Whitney in year 1799. The main purpose of lean manufacturing is to identify and eliminate waste in production. The application of lean manufacturing can be carried out in any industrial processes with regards to the understanding of lean principles, theories and practices. Kitting is one of the important aspects in a successful production. The continuous supply of materials from store to production has to be systematic and able to achieve lean standard for it to be successful. The objective of this paper is to review the implementation of lean manufacturing in kitting assembly. Previous papers show that, the implementation of lean manufacturing in kitting assembly may be beneficial to the organization such as reduce in space occupancy, part shortages, lead time and manpower. Based on previous research, some industries may tend to change between kitting and line stocking which are due to lack of understanding when implementing kitting and causes longer lead time and materials overflow in store. With a proper understanding on what to kit, where to kit, how to kit, why to kit and who kits the material with a standardised process flow may ensure the success of kitting.

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

NASA Astrophysics Data System (ADS)

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

2017-02-01

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

40 CFR 63.11459 - What definitions apply to this subpart?

Code of Federal Regulations, 2010 CFR

2010-07-01

... or more furnaces that are identical in design, including manufacturer, dimensions, production... (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Glass Manufacturing Area Sources.... Continuous furnace means a glass manufacturing furnace that operates continuously except during periods of...

Processing of continuous fiber reinforced ceramic composites for ultra high temperature applications using organosilicon polymer precursors

NASA Astrophysics Data System (ADS)

Nicholas, James Robert

The current work is on the development of continuous fiber reinforced ceramic materials (CFCCs) for use in ultra high temperature applications. These applications subject materials to extremely high temperatures(> 2000°C). Monolithic ceramics are currently being used for these applications, but the tendency to fail catastrophically has driven the need for the next generation of material. Reinforcing with continuous fibers significantly improves the toughness of the monolithic materials; however, this is a manufacturing challenge. The development of commercial, low-viscosity preceramic polymers provides new opportunities to fabricate CFCCs. Preceramic polymers behave as polymers at low temperatures and are transformed into ceramics upon heating to high temperatures. The polymer precursors enable the adaptation of well-established polymer processing techniques to produce high quality materials at relatively low cost. In the present work, SMP-10 from Starfire Systems, and PURS from KiON Corp. were used to manufacture ZrB2-SiC/SiC CFCCs using low cost vacuum bagging process in conjunction with the polymer infiltration and pyrolysis process. The microstructure was investigated using scanning electron microscopy and it was determined that the initial greenbody cure produced porosity of both closed and open pores. The open pores were found to be more successfully re-infiltrated using neat resin compared to slurry reinfiltrate; however, the closed pores were found to be impenetrable during subsequent reinfiltrations. The mechanical performance of the manufactured samples was evaluated using flexure tests and found the fiber reinforcement prevented catastrophic failure behavior by increasing fracture toughness. Wedge sample were fabricated and evaluated to demonstrate the ability to produce CFCC of complex geometry.

40 CFR 63.8695 - In what form and how long must I keep my records?

Code of Federal Regulations, 2010 CFR

2010-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing Notifications, Reports, and Records § 63.8695 In what form and how long must...

40 CFR 63.8695 - In what form and how long must I keep my records?

Code of Federal Regulations, 2013 CFR

2013-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing Notifications, Reports, and Records § 63.8695 In what form and how long must...

40 CFR Table 7 to Subpart Lllll of... - Applicability of General Provisions to Subpart LLLLL

Code of Federal Regulations, 2011 CFR

2011-07-01

... SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing Pt. 63, Subpt. LLLLL, Table 7 Table 7 to Subpart LLLLL of Part...

40 CFR 63.8695 - In what form and how long must I keep my records?

Code of Federal Regulations, 2011 CFR

2011-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing Notifications, Reports, and Records § 63.8695 In what form and how long must...

40 CFR 63.8695 - In what form and how long must I keep my records?

Code of Federal Regulations, 2014 CFR

2014-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing Notifications, Reports, and Records § 63.8695 In what form and how long must...

40 CFR Table 7 to Subpart Lllll of... - Applicability of General Provisions to Subpart LLLLL

Code of Federal Regulations, 2014 CFR

2014-07-01

... SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing Pt. 63, Subpt. LLLLL, Table 7 Table 7 to Subpart LLLLL of Part...

40 CFR Table 7 to Subpart Lllll of... - Applicability of General Provisions to Subpart LLLLL

Code of Federal Regulations, 2012 CFR

2012-07-01

... SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing Pt. 63, Subpt. LLLLL, Table 7 Table 7 to Subpart LLLLL of Part...

40 CFR Table 7 to Subpart Lllll of... - Applicability of General Provisions to Subpart LLLLL

Code of Federal Regulations, 2013 CFR

2013-07-01

... SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing Pt. 63, Subpt. LLLLL, Table 7 Table 7 to Subpart LLLLL of Part...

40 CFR 63.8695 - In what form and how long must I keep my records?

Code of Federal Regulations, 2012 CFR

2012-07-01

... CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants: Asphalt Processing and Asphalt Roofing Manufacturing Notifications, Reports, and Records § 63.8695 In what form and how long must...

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

40 CFR 761.316 - Interpreting PCB concentration measurements resulting from this sampling scheme.

Code of Federal Regulations, 2011 CFR

2011-07-01

... ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING, DISTRIBUTION IN COMMERCE, AND USE PROHIBITIONS Sampling Non-Porous Surfaces for... equivalent measurement of micrograms per 100 cm2. ...

40 CFR 761.316 - Interpreting PCB concentration measurements resulting from this sampling scheme.

Code of Federal Regulations, 2012 CFR

2012-07-01

... ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING, DISTRIBUTION IN COMMERCE, AND USE PROHIBITIONS Sampling Non-Porous Surfaces for... equivalent measurement of micrograms per 100 cm2. ...

40 CFR 761.316 - Interpreting PCB concentration measurements resulting from this sampling scheme.

Code of Federal Regulations, 2014 CFR

2014-07-01

... ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING, DISTRIBUTION IN COMMERCE, AND USE PROHIBITIONS Sampling Non-Porous Surfaces for... equivalent measurement of micrograms per 100 cm2. ...

40 CFR 761.316 - Interpreting PCB concentration measurements resulting from this sampling scheme.

Code of Federal Regulations, 2010 CFR

2010-07-01

... ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING, DISTRIBUTION IN COMMERCE, AND USE PROHIBITIONS Sampling Non-Porous Surfaces for... equivalent measurement of micrograms per 100 cm2. ...

Design, Test, Redesign: Simulation in Technology, Engineering, and Design Education Classrooms

ERIC Educational Resources Information Center

Swinson, Ronnie; Clark, Aaron C.; Ernst, Jeremy V.; Sutton, Kevin

2016-01-01

Today's engineers, designers, and technologists are often thrust into the role of problem solver, from the initial design phase of a product or process all the way to final development. Many engineers in manufacturing environments are tasked with solving problems and continuously improving processes to enhance company profitability, efficiency,…

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

Code of Federal Regulations, 2010 CFR

2010-04-01

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

40 CFR 458.42 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

Code of Federal Regulations, 2011 CFR

2011-07-01

... AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Lamp Process Subcategory § 458.42 Effluent limitations guidelines representing the degree of... shall be no discharge of process waste water pollutants into navigable waters. [60 FR 33972, June 29...

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

The complexity and cost of vaccine manufacturing - An overview.

PubMed

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

2017-07-24

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

The journey

NASA Astrophysics Data System (ADS)

Cohen, Lori A.

1995-12-01

Kodak Optical Products has embarked on a journey that will ultimately lead to manufacturing excellence and total customer satisfaction. With quality as our compass we have already obtained ISO 9001 and Manufacturing Resource Planning (MRP) II certifications. Seeking and attaining these certifications enabled us to understand and enhance fundamentals relative to the operation of our business. This has provided a solid foundation from which we can launch continuous improvement activities. Now we continue our journey to such destinations as 10X reduction in both defects and cycle time, measuring and reducing our cost of poor quality, and upgrading our quality information system. Our presentation will emphasize our 10X improvement process and how it applies to high-volume production of precision plastic optics.

Facility for orbital material processing

NASA Astrophysics Data System (ADS)

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

2018-05-01

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

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

NASA Astrophysics Data System (ADS)

Doering, Robert

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

Integrated Process Modeling-A Process Validation Life Cycle Companion.

PubMed

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

2017-10-17

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

Process performance and product quality in an integrated continuous antibody production process.

PubMed

Karst, Daniel J; Steinebach, Fabian; Soos, Miroslav; Morbidelli, Massimo

2017-02-01

Continuous manufacturing is currently being seriously considered in the biopharmaceutical industry as the possible new paradigm for producing therapeutic proteins, due to production cost and product quality related benefits. In this study, a monoclonal antibody producing CHO cell line was cultured in perfusion mode and connected to a continuous affinity capture step. The reliable and stable integration of the two systems was enabled by suitable control loops, regulating the continuous volumetric flow and adapting the operating conditions of the capture process. For the latter, an at-line HPLC measurement of the harvest concentration subsequent to the bioreactor was combined with a mechanistic model of the capture chromatographic unit. Thereby, optimal buffer consumption and productivity throughout the process was realized while always maintaining a yield above the target value of 99%. Stable operation was achieved at three consecutive viable cell density set points (20, 60, and 40 × 10 6 cells/mL), together with consistent product quality in terms of aggregates, fragments, charge isoforms, and N-linked glycosylation. In addition, different values for these product quality attributes such as N-linked glycosylation, charge variants, and aggregate content were measured at the different steady states. As expected, the amount of released DNA and HCP was significantly reduced by the capture step for all considered upstream operating conditions. This study is exemplary for the potential of enhancing product quality control and modulation by integrated continuous manufacturing. Biotechnol. Bioeng. 2017;114: 298-307. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

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.

Roll-to-Roll Continuous Manufacturing Multifunctional Nanocomposites by Electric-Field-Assisted "Z" Direction Alignment of Graphite Flakes in Poly(dimethylsiloxane).

PubMed

Guo, Yuanhao; Chen, Yuwei; Wang, Enmin; Cakmak, Miko

2017-01-11

A roll-to-roll continuous process was developed to manufacture large-scale multifunctional poly(dimethylsiloxane) (PDMS) films embedded with thickness direction ("Z" direction) aligned graphite nanoparticles by application of electric field. The kinetics of particle "Z" alignment and chain formation was studied by tracking the real-time change of optical light transmission through film thickness direction. Benefiting from the anisotropic structure of aligned particle chains, the electrical and thermal properties of the nanocomposites were dramatically enhanced through the thickness direction as compared to those of the nanocomposites containing the same particle loading without electrical field alignment. With 5 vol % graphite loading, 250 times higher electrical conductivity, 43 times higher dielectric permittivity, and 1.5 times higher thermal conductivity was achieved in the film thickness direction after the particles were aligned under electrical field. Moreover, the aligned nanocomposites with merely 2 vol % graphite particles exhibit even higher electric conductivity and dielectric permittivity than those of the nonaligned nanocomposites at random percolation threshold (10 vol % particles), as the "electric-field-directed" percolation threshold concentration is substantially decreased using this process. As the graphite loading increases to 20 vol %, the aligned nanocomposites exhibit thermal conductivity as high as 6.05 W/m·K, which is 35 times the thermal conductivity of pure matrix. This roll-to-roll electric field continuous process provides a simple, low-cost, and commercially viable method to manufacture multifunctional nanocomposites for applications as embedded capacitor, electromagnetic (EM) shielding, and thermal interface materials.

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

NASA Technical Reports Server (NTRS)

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

2016-01-01

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

Virtual aluminum castings: An industrial application of ICME

NASA Astrophysics Data System (ADS)

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

2006-11-01

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

Computers in manufacturing

NASA Astrophysics Data System (ADS)

Hudson, C. A.

1982-02-01

CAD/CAM advances and applications for enhancing productivity in industry are explored. Wide-spread use of CAD/CAM devices are projected to occur by the time period 1992-1997, resulting in a higher percentage of technicians in the manufacturing process, while the cost of computers and software will continue to fall and become more widely available. Computer aided design is becoming a commercially viable system for design and geometric modeling, engineering analysis, kinematics, and drafting, and efforts to bridge the gap between CAD and CAM are indicated, with particular attention given to layering, wherein individual monitoring of different parts of the manufacturing process can be effected without crossover of unnecessary information. The potentials and barriers to the use of robotics are described, with the added optimism that displaced workers to date have moved up to jobs of higher skill and interest.

Coal Liquids: Manufacture and Properties. A Review.

DTIC Science & Technology

1982-09-01

a conventional furnace with flue gas desulfurization ; however, its use as a boiler fuel is not economical at present. Research continues on...J.B., "The Shell Flue Gas Desulfurization Process," Universal Oil Products Process Division, Universal Oil Products, Inc., Des Plaines, IL, presented...in 1980, H-Coal and EDS process, gasification obstacles. 187. Salmeczi, J.G., " Flue Gas Desulfurization by the ThiosorbicC Process," Dravo Time Company

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

NASA Astrophysics Data System (ADS)

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

2013-01-01

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

40 CFR 761.363 - Applicability.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Applicability. 761.363 Section 761.363 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING, DISTRIBUTION IN COMMERCE, AND USE PROHIBITIONS Double...

40 CFR 761.360 - Background.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Background. 761.360 Section 761.360 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING, DISTRIBUTION IN COMMERCE, AND USE PROHIBITIONS Double...

40 CFR 761.320 - Applicability.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Applicability. 761.320 Section 761.320 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING, DISTRIBUTION IN COMMERCE, AND USE PROHIBITIONS Self...

40 CFR 424.34 - [Reserved

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 28 2010-07-01 2010-07-01 true [Reserved] 424.34 Section 424.34 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS FERROALLOY MANUFACTURING POINT SOURCE CATEGORY Slag Processing Subcategory § 424.34 [Reserved] ...

40 CFR 721.6090 - Phosphoramide.

Code of Federal Regulations, 2010 CFR

2010-07-01

....6090 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT...) Hazard communication program. A significant new use of this substance is any manner or method of manufacture, import, or processing associated with any use of this substance without providing risk...

40 CFR 79.20 - Application for registration by additive manufacturer.

Code of Federal Regulations, 2011 CFR

2011-07-01

... additive manufacturer. 79.20 Section 79.20 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.20 Application for registration by additive manufacturer. Any manufacturer of a designated...

40 CFR 79.20 - Application for registration by additive manufacturer.

Code of Federal Regulations, 2010 CFR

2010-07-01

... additive manufacturer. 79.20 Section 79.20 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.20 Application for registration by additive manufacturer. Any manufacturer of a designated...

40 CFR 79.20 - Application for registration by additive manufacturer.

Code of Federal Regulations, 2014 CFR

2014-07-01

... additive manufacturer. 79.20 Section 79.20 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.20 Application for registration by additive manufacturer. Any manufacturer of a designated...

40 CFR 79.20 - Application for registration by additive manufacturer.

Code of Federal Regulations, 2012 CFR

2012-07-01

... additive manufacturer. 79.20 Section 79.20 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.20 Application for registration by additive manufacturer. Any manufacturer of a designated...

40 CFR 79.20 - Application for registration by additive manufacturer.

Code of Federal Regulations, 2013 CFR

2013-07-01

... additive manufacturer. 79.20 Section 79.20 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.20 Application for registration by additive manufacturer. Any manufacturer of a designated...

Additive Manufacturing of Catalytically Active Living Materials.

PubMed

Saha, Abhijit; Johnston, Trevor G; Shafranek, Ryan T; Goodman, Cassandra J; Zalatan, Jesse G; Storti, Duane W; Ganter, Mark A; Nelson, Alshakim

2018-04-25

Living materials, which are composites of living cells residing in a polymeric matrix, are designed to utilize the innate functionalities of the cells to address a broad range of applications such as fermentation and biosensing. Herein, we demonstrate the additive manufacturing of catalytically active living materials (AMCALM) for continuous fermentation. A multi-stimuli-responsive yeast-laden hydrogel ink, based on F127-dimethacrylate, was developed and printed using a direct-write 3D printer. The reversible stimuli-responsive behaviors of the polymer hydrogel inks to temperature and pressure are critical, as they enabled the facile incorporation of yeast cells and subsequent fabrication of 3D lattice constructs. Subsequent photo-cross-linking of the printed polymer hydrogel afforded a robust elastic material. These yeast-laden living materials were metabolically active in the fermentation of glucose into ethanol for 2 weeks in a continuous batch process without significant reduction in efficiency (∼90% yield of ethanol). This cell immobilization platform may potentially be applicable toward other genetically modified yeast strains to produce other high-value chemicals in a continuous biofermentation process.

Present State of the Art of Composite Fabric Forming: Geometrical and Mechanical Approaches

PubMed Central

Cherouat, Abel; Borouchaki, Houman

2009-01-01

Continuous fibre reinforced composites are now firmly established engineering materials for the manufacture of components in the automotive and aerospace industries. In this respect, composite fabrics provide flexibility in the design manufacture. The ability to define the ply shapes and material orientation has allowed engineers to optimize the composite properties of the parts. The formulation of new numerical models for the simulation of the composite forming processes must allow for reduction in the delay in manufacturing and an optimization of costs in an integrated design approach. We propose two approaches to simulate the deformation of woven fabrics: geometrical and mechanical approaches.

Assessment of the State-of-the-Art in the Design and Manufacturing of Large Composite Structure

NASA Technical Reports Server (NTRS)

Harris, C. E.

2001-01-01

This viewgraph presentation gives an assessment of the state-of-the-art in the design and manufacturing of large component structures, including details on the use of continuous fiber reinforced polymer matrix composites (CFRP) in commercial and military aircraft and in space launch vehicles. Project risk mitigation plans must include a building-block test approach to structural design development, manufacturing process scale-up development tests, and pre-flight ground tests to verify structural integrity. The potential benefits of composite structures justifies NASA's investment in developing the technology. Advanced composite structures technology is enabling to virtually every Aero-Space Technology Enterprise Goal.

Application of surface-enhanced Raman spectroscopy (SERS) for cleaning verification in pharmaceutical manufacture.

PubMed

Corrigan, Damion K; Cauchi, Michael; Piletsky, Sergey; Mccrossen, Sean

2009-01-01

Cleaning verification is the process by which pharmaceutical manufacturing equipment is determined as sufficiently clean to allow manufacture to continue. Surface-enhanced Raman spectroscopy (SERS) is a very sensitive spectroscopic technique capable of detection at levels appropriate for cleaning verification. In this paper, commercially available Klarite SERS substrates were employed in order to obtain the necessary enhancement of signal for the identification of chemical species at concentrations of 1 to 10 ng/cm2, which are relevant to cleaning verification. The SERS approach was combined with principal component analysis in the identification of drug compounds recovered from a contaminated steel surface.

The Effect of Tow Shearing on Reinforcement Positional Fidelity in the Manufacture of a Continuous Fiber Reinforced Thermoplastic Matrix Composite via Pultrusion-Like Processing of Commingled Feedstock

NASA Astrophysics Data System (ADS)

Warlick, Kent M.

While the addition of short fiber to 3D printed articles has increased structural performance, ultimate gains will only be realized through the introduction of continuous reinforcement placed along pre-planned load paths. Most additive manufacturing research focusing on the addition of continuous reinforcement has revolved around utilization of a prefrabricated composite filament or a fiber and matrix mixed within a hot end prior to deposition on a printing surface such that conventional extrusion based FDM can be applied. Although stronger 3D printed parts can be made in this manner, high quality homogenous composites are not possible due to fiber dominated regions, matrix dominated regions, and voids present between adjacent filaments. Conventional composite manufacturing processes are much better at creating homogeneous composites; however, the layer by layer approach in which they are made is inhibiting the alignment of reinforcement with loads. Automated Fiber Placement techniques utilize in plane bending deformation of the tow to facilitate tow steering. Due to buckling fibers on the inner radius of curves, manufacturers recommend a minimum curvature for path placement with this technique. A method called continuous tow shearing has shown promise to enable the placement of tows in complex patterns without tow buckling, spreading, and separation inherent in conventional forms of automated reinforcement positioning. The current work employs fused deposition modeling hardware and the continuous tow shearing technique to manufacture high quality fiber reinforced composites with high positional fidelity, varying continuous reinforcement orientations within a layer, and plastic elements incorporated enabling the ultimate gains in structural performance possible. A mechanical system combining concepts of additive manufacturing with fiber placement via filament winding was developed. Paths with and without tension inherent in filament winding were analyzed through microscopy in order to examine best and worst case scenarios. High quality fiber reinforced composite materials, in terms of low void content, high fiber volume fractions and homogeneity in microstructure, were manufactured in both of these scenarios. In order to improve fidelity and quality in fiber path transition regions, a forced air cooling manifold was designed, printed, and implemented into the current system. To better understand the composite performance that results from varying pertinent manufacturing parameters, the effect of feed rate, hot end temperature, forced air cooling, and deposition surface (polypropylene and previously deposited glass polypropylene commingled tow) on interply performance, microstructure, and positional fidelity were analyzed. Interply performance, in terms of average maximum load and average peel strength, was quantified through a t-peel test of the bonding quality between two surfaces. With use of forced air cooling, minor decreases in average peel strength were present due to a reduction in tow deposition temperature which was found to be the variable most indicative of performance. Average maximum load was comparable between the forced air cooled and non-air cooled samples. Microstructure was evaluated through characterization of composite area, void content, and flash percentage. Low void contents mostly between five to seven percent were attained. Further reduction of this void content to two percent is possible through higher processing temperatures; however, reduced composite area, low average peel strength performance, and the presence of smoke during manufacturing implied thermal degradation of the polypropylene matrix occurred in these samples with higher processing temperatures. Positional fidelity was measured through calculations of shear angle, shift width, and error of a predefined path. While positional fidelity variation was low with a polypropylene deposition surface, forced air cooling is necessary to achieve fidelity on top of an already deposited tow surface as evident by the fifty-six percent reduction in error tolerance profile achieved. Lastly, proof of concept articles with unique fiber paths and neat plastic elements incorporated were produced to demonstrate fiber placement along pre-planned load paths and the ability to achieve greater structural efficiency through the use of less material. The results show that high positional fidelity and high quality composites can be produced through the use of the tow shearing technique implemented in the developed mechanical system. The implementation of forced air cooling was critical in achieving fidelity and quality in transition regions. Alignment of continuous reinforcement with pre-planned load paths was demonstrated in the proof of concept article with varying fiber orientations within a layer. Combining fused deposition modeling of plastic with the placement of continuous reinforcement enabled a honeycomb composite to be produced with higher specific properties than traditional composites. Thus, the current system demonstrated a greater capability of achieving ultimate gains in structural performance than previously possible.

Continued investigation of solid propulsion economics. Task 1B: Large solid rocket motor case fabrication methods - Supplement process complexity factor cost technique

NASA Technical Reports Server (NTRS)

Baird, J.

1967-01-01

This supplement to Task lB-Large Solid Rocket Motor Case Fabrication Methods supplies additional supporting cost data and discusses in detail the methodology that was applied to the task. For the case elements studied, the cost was found to be directly proportional to the Process Complexity Factor (PCF). The PCF was obtained for each element by identifying unit processes that are common to the elements and their alternative manufacturing routes, by assigning a weight to each unit process, and by summing the weighted counts. In three instances of actual manufacture, the actual cost per pound equaled the cost estimate based on PCF per pound, but this supplement, recognizes that the methodology is of limited, rather than general, application.

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

PubMed

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

2015-03-01

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

Future Supply Chains Enabled by Continuous Processing—Opportunities and Challenges. May 20–21, 2014 Continuous Manufacturing Symposium

PubMed Central

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

2015-01-01

This paper examines the opportunities and challenges facing the pharmaceutical industry in moving to a primarily “continuous processing”-based supply chain. The current predominantly “large batch” and centralized manufacturing system designed for the “blockbuster” drug has driven a slow-paced, inventory heavy operating model that is increasingly regarded as inflexible and unsustainable. Indeed, new markets and the rapidly evolving technology landscape will drive more product variety, shorter product life-cycles, and smaller drug volumes, which will exacerbate an already unsustainable economic model. Future supply chains will be required to enhance affordability and availability for patients and healthcare providers alike despite the increased product complexity. In this more challenging supply scenario, we examine the potential for a more pull driven, near real-time demand-based supply chain, utilizing continuous processing where appropriate as a key element of a more “flow-through” operating model. In this discussion paper on future supply chain models underpinned by developments in the continuous manufacture of pharmaceuticals, we have set out; The significant opportunities to moving to a supply chain flow-through operating model, with substantial opportunities in inventory reduction, lead-time to patient, and radically different product assurance/stability regimes. Scenarios for decentralized production models producing a greater variety of products with enhanced volume flexibility. Production, supply, and value chain footprints that are radically different from today's monolithic and centralized batch manufacturing operations. Clinical trial and drug product development cost savings that support more rapid scale-up and market entry models with early involvement of SC designers within New Product Development. The major supply chain and industrial transformational challenges that need to be addressed. The paper recognizes that although current batch operational performance in pharma is far from optimal and not necessarily an appropriate end-state benchmark for batch technology, the adoption of continuous supply chain operating models underpinned by continuous production processing, as full or hybrid solutions in selected product supply chains, can support industry transformations to deliver right-first-time quality at substantially lower inventory profiles. © 2015 The Authors. Journal of Pharmaceutical Sciences published by Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:840–849, 2015 PMID:25631279

Identifying and locating surface defects in wood: Part of an automated lumber processing system

Treesearch

Richard W. Conners; Charles W. McMillin; Kingyao Lin; Ramon E. Vasquez-Espinosa

1983-01-01

Continued increases in the cost of materials and labor make it imperative for furniture manufacturers to control costs by improved yield and increased productivity. This paper describes an Automated Lumber Processing System (ALPS) that employs computer tomography, optical scanning technology, the calculation of an optimum cutting strategy, and 1 computer-driven laser...

Feasibility of commercial space manufacturing, production of pharmaceuticals. Volume 1: Executive summary

NASA Technical Reports Server (NTRS)

1978-01-01

The feasibility of the commercial manufacturing of pharmaceuticals in space is examined. The method of obtaining pharmaceutical company involvement, laboratory results of the separation of serum proteins by the continuous flow electrophoresis process, the selection and study of candidate products, and their production requirements is presented. Antihemophilic factor, beta cells, erythropoietin, epidermal growth factor, alpha-1-antitrypsin and interferon were studied. Production mass balances for antihemophilic factor, beta cells, and erythropoietin were compared for space verus ground operation.

Efficient and stable production of Modified Vaccinia Ankara virus in two-stage semi-continuous and in continuous stirred tank cultivation systems.

PubMed

Tapia, Felipe; Jordan, Ingo; Genzel, Yvonne; Reichl, Udo

2017-01-01

One important aim in cell culture-based viral vaccine and vector production is the implementation of continuous processes. Such a development has the potential to reduce costs of vaccine manufacturing as volumetric productivity is increased and the manufacturing footprint is reduced. In this work, continuous production of Modified Vaccinia Ankara (MVA) virus was investigated. First, a semi-continuous two-stage cultivation system consisting of two shaker flasks in series was established as a small-scale approach. Cultures of the avian AGE1.CR.pIX cell line were expanded in the first shaker, and MVA virus was propagated and harvested in the second shaker over a period of 8-15 days. A total of nine small-scale cultivations were performed to investigate the impact of process parameters on virus yields. Harvest volumes of 0.7-1 L with maximum TCID50 titers of up to 1.0×109 virions/mL were obtained. Genetic analysis of control experiments using a recombinant MVA virus containing green-fluorescent-protein suggested that the virus was stable over at least 16 d of cultivation. In addition, a decrease or fluctuation of infectious units that may indicate an excessive accumulation of defective interfering particles was not observed. The process was automated in a two-stage continuous system comprising two connected 1 L stirred tank bioreactors. Stable MVA virus titers, and a total production volume of 7.1 L with an average TCID50 titer of 9×107 virions/mL was achieved. Because titers were at the lower range of the shake flask cultivations potential for further process optimization at large scale will be discussed. Overall, MVA virus was efficiently produced in continuous and semi-continuous cultivations making two-stage stirred tank bioreactor systems a promising platform for industrial production of MVA-derived recombinant vaccines and viral vectors.

40 CFR 763.176 - Inspections.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Inspections. 763.176 Section 763.176 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT ASBESTOS Prohibition of the Manufacture, Importation, Processing, and Distribution in Commerce of Certain Asbestos...

40 CFR 763.178 - Recordkeeping.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Recordkeeping. 763.178 Section 763.178 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT ASBESTOS Prohibition of the Manufacture, Importation, Processing, and Distribution in Commerce of Certain Asbestos...

40 CFR 761.372 - Specific requirements for relatively clean surfaces.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

40 CFR 424.31 - Specialized definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 28 2010-07-01 2010-07-01 true Specialized definitions. 424.31 Section 424.31 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS FERROALLOY MANUFACTURING POINT SOURCE CATEGORY Slag Processing Subcategory § 424.31 Specialized...

40 CFR 761.93 - Import for disposal.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Import for disposal. 761.93 Section 761.93 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING, DISTRIBUTION IN COMMERCE, AND USE...

40 CFR 761.366 - Cleanup equipment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Cleanup equipment. 761.366 Section 761.366 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING, DISTRIBUTION IN COMMERCE, AND USE PROHIBITIONS Double...

40 CFR 458.44 - [Reserved

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 30 2011-07-01 2011-07-01 false [Reserved] 458.44 Section 458.44 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Lamp Process Subcategory § 458.44 [Reserved] ...

40 CFR 458.44 - [Reserved

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 29 2010-07-01 2010-07-01 false [Reserved] 458.44 Section 458.44 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Lamp Process Subcategory § 458.44 [Reserved] ...

40 CFR 721.9540 - Polysulfide mixture.

Code of Federal Regulations, 2010 CFR

2010-07-01

... new information, and any information on methods for protecting against such risk, into the applicable... 721.9540 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES... substance is any manner or method of manufacture, import, or processing associated with any use of this...

40 CFR 458.14 - [Reserved

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 29 2010-07-01 2010-07-01 false [Reserved] 458.14 Section 458.14 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS CARBON BLACK MANUFACTURING POINT SOURCE CATEGORY Carbon Black Furnace Process Subcategory § 458.14...

7 CFR 58.3 - Authority.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Authority. 58.3 Section 58.3 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections... Inspection and Grading Services of Manufactured or Processed Dairy Products Administration § 58.3 Authority...

Integrated hot-melt extrusion - injection molding continuous tablet manufacturing platform: Effects of critical process parameters and formulation attributes on product robustness and dimensional stability.

PubMed

Desai, Parind M; Hogan, Rachael C; Brancazio, David; Puri, Vibha; Jensen, Keith D; Chun, Jung-Hoon; Myerson, Allan S; Trout, Bernhardt L

2017-10-05

This study provides a framework for robust tablet development using an integrated hot-melt extrusion-injection molding (IM) continuous manufacturing platform. Griseofulvin, maltodextrin, xylitol and lactose were employed as drug, carrier, plasticizer and reinforcing agent respectively. A pre-blended drug-excipient mixture was fed from a loss-in-weight feeder to a twin-screw extruder. The extrudate was subsequently injected directly into the integrated IM unit and molded into tablets. Tablets were stored in different storage conditions up to 20 weeks to monitor physical stability and were evaluated by polarized light microscopy, DSC, SEM, XRD and dissolution analysis. Optimized injection pressure provided robust tablet formulations. Tablets manufactured at low and high injection pressures exhibited the flaws of sink marks and flashing respectively. Higher solidification temperature during IM process reduced the thermal induced residual stress and prevented chipping and cracking issues. Polarized light microscopy revealed a homogeneous dispersion of crystalline griseofulvin in an amorphous matrix. DSC underpinned the effect of high tablet residual moisture on maltodextrin-xylitol phase separation that resulted in dimensional instability. Tablets with low residual moisture demonstrated long term dimensional stability. This study serves as a model for IM tablet formulations for mechanistic understanding of critical process parameters and formulation attributes required for optimal product performance. Copyright © 2017 Elsevier B.V. All rights reserved.

A continuous process for the development of Kodak Aerochrome Infrared Film 2443 as a negative

NASA Astrophysics Data System (ADS)

Klimes, D.; Ross, D. I.

1993-02-01

A process for the continuous dry-to-dry development of Kodak Aerochrome Infrared Film 2443 as a negative (CIR-neg) is described. The process is well suited for production processing of long film lengths. Chemicals from three commercial film processes are used with modifications. Sensitometric procedures are recommended for the monitoring of processing quality control. Sensitometric data and operational aerial exposures indicate that films developed in this process have approximately the same effective aerial film speed as films processed in the reversal process recommended by the manufacturer (Kodak EA-5). The CIR-neg process is useful when aerial photography is acquired for resources management applications which require print reproductions. Originals can be readily reproduced using conventional production equipment (electronic dodging) in black and white or color (color compensation).

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.

Process Modeling and Validation for Metal Big Area Additive Manufacturing

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

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

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

40 CFR 429.144 - New source performance standards (NSPS).

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 29 2010-07-01 2010-07-01 false New source performance standards (NSPS). 429.144 Section 429.144 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS TIMBER PRODUCTS PROCESSING POINT SOURCE CATEGORY Particleboard Manufacturing...

40 CFR 761.369 - Pre-cleaning the surface.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Pre-cleaning the surface. 761.369 Section 761.369 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING, DISTRIBUTION IN COMMERCE, AND USE...

40 CFR 420.111 - Specialized definitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... steel products such as coiled wire, rods, and tubes in discrete batches or bundles. (b) The term continuous means those alkaline cleaning operations which process steel products other than in discrete... AND STANDARDS IRON AND STEEL MANUFACTURING POINT SOURCE CATEGORY Alkaline Cleaning Subcategory § 420...

40 CFR 421.240 - Applicability: Description of the secondary nickel subcategory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS NONFERROUS METALS MANUFACTURING POINT SOURCE... subcategory. The provisions of this subpart are applicable to discharges resulting from the production of nickel by secondary nickel facilities processing slag, spent acids, or scrap metal raw materials. ...

40 CFR 421.190 - Applicability: Description of the secondary indium subcategory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS NONFERROUS METALS MANUFACTURING POINT SOURCE... subcategory. The provisions of this subpart are applicable to discharges resulting from the production of indium at secondary indium facilities processing spent electrolyte solutions and scrap indium metal raw...

Continuous manufacturing and analytical characterization of fixed-dose, multilayer orodispersible films.

PubMed

Thabet, Yasmin; Lunter, Dominique; Breitkreutz, Joerg

2018-05-30

Various drug therapies require more than one active pharmaceutical ingredient (API) for an effective treatment. There are many advantages, e.g. to improve the compliance or pharmacodynamic response in comparison to a monotherapy or to increase the therapy safety. Until now, there are only a few products available for the paediatric population due to the lack of age appropriate dosage forms or studies proving the efficacy and safety of these products. This study aims to develop orodispersible films (ODFs) in a continuous solvent casting process as child appropriate dosage form containing both enalapril maleate (EM) and hydrochlorothiazide (HCT) separated in different film layers. Furthermore, they should be characterised and the API migration analysed by confocal Raman microscopy (CRM). ODFs were successfully produced in a continuous manufacturing process in form of double- and triple-layer formulations based on hydroxypropylcellulose (HPC) or a combination of HPC and polyvinyl alcohol (PVA). CRM revealed that both APIs migrate within the film layers shortly after manufacturing. PVA inhibits the migration inside the double-layer film, but is not able to prevent the API migration as an interlayer inside a triple-layer ODF. With increasing film layers, the content of residual solvents and the disintegration time increases (mono-layer films: <10 s, triple-layer films: 37 s). In conclusion, it was feasible to produce fixed-dose combinations in therapeutic doses up to 9 mg HCT and 3.5 mg EM for the double-layer film with adequate mechanical properties, which enable coiling up onto jumbo rolls directly after production. The best separation of the two APIs was achieved by casting a double-layer ODF consisting of different film forming polymers, which can be beneficial when processing two incompatible APIs. Copyright © 2018 Elsevier B.V. All rights reserved.

From chaos to control: winning the war.

PubMed

Wojciak, P J

1994-08-01

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

A Comparative Case Study Analysis of Administrators Perceptions on the Adaptation of Quality and Continuous Improvement Tools to Community Colleges in the State of Michigan

ERIC Educational Resources Information Center

Mattis, Ted B.

2011-01-01

The purpose of this study was to determine whether community college administrators in the state of Michigan believe that commonly known quality and continuous improvement tools, prevalent in a manufacturing environment, can be adapted to a community college model. The tools, specifically Six Sigma, benchmarking and process mapping have played a…

Continuous direct compression as manufacturing platform for sustained release tablets.

PubMed

Van Snick, B; Holman, J; Cunningham, C; Kumar, A; Vercruysse, J; De Beer, T; Remon, J P; Vervaet, C

2017-03-15

This study presents a framework for process and product development on a continuous direct compression manufacturing platform. A challenging sustained release formulation with high content of a poorly flowing low density drug was selected. Two HPMC grades were evaluated as matrix former: standard Methocel CR and directly compressible Methocel DC2. The feeding behavior of each formulation component was investigated by deriving feed factor profiles. The maximum feed factor was used to estimate the drive command and depended strongly upon the density of the material. Furthermore, the shape of the feed factor profile allowed definition of a customized refill regime for each material. Inline NIRs was used to estimate the residence time distribution (RTD) in the mixer and monitor blend uniformity. Tablet content and weight variability were determined as additional measures of mixing performance. For Methocel CR, the best axial mixing (i.e. feeder fluctuation dampening) was achieved when an impeller with high number of radial mixing blades operated at low speed. However, the variability in tablet weight and content uniformity deteriorated under this condition. One can therefore conclude that balancing axial mixing with tablet quality is critical for Methocel CR. However, reformulating with the direct compressible Methocel DC2 as matrix former improved tablet quality vastly. Furthermore, both process and product were significantly more robust to changes in process and design variables. This observation underpins the importance of flowability during continuous blending and die-filling. At the compaction stage, blends with Methocel CR showed better tabletability driven by a higher compressibility as the smaller CR particles have a higher bonding area. However, tablets of similar strength were achieved using Methocel DC2 by targeting equal porosity. Compaction pressure impacted tablet properties and dissolution. Hence controlling thickness during continuous manufacturing of sustained release tablets was crucial to ensure reproducible dissolution. Copyright © 2017 Elsevier B.V. All rights reserved.

Processing activities for STS-91 continue in OPF Bay 2

NASA Technical Reports Server (NTRS)

1998-01-01

Processing activities for STS-91 continue in KSC's Orbiter Processing Facility Bay 2. Two Get Away Special (GAS) canisters are shown after their installation into Discovery's payload bay. At left is G-648, an Canadian Space Agency-sponsored study of manufactured organic thin film by the physical vapor transport method, and the can on the right contains commemorative flags to be flown during the mission. STS-91 is scheduled to launch aboard the Space Shuttle Discovery for the ninth and final docking with the Russian Space Station Mir from KSC's Launch Pad 39A on June 2 with a launch window opening around 6:04 p.m. EDT.

Real-time assessment of critical quality attributes of a continuous granulation process.

PubMed

Fonteyne, Margot; Vercruysse, Jurgen; Díaz, Damián Córdoba; Gildemyn, Delphine; Vervaet, Chris; Remon, Jean Paul; De Beer, Thomas

2013-02-01

There exists the intention to shift pharmaceutical manufacturing of solid dosage forms from traditional batch production towards continuous production. The currently applied conventional quality control systems, based on sampling and time-consuming off-line analyses in analytical laboratories, would annul the advantages of continuous processing. It is clear that real-time quality assessment and control is indispensable for continuous production. This manuscript evaluates strengths and weaknesses of several complementary Process Analytical Technology (PAT) tools implemented in a continuous wet granulation process, which is part of a fully continuous from powder-to-tablet production line. The use of Raman and NIR-spectroscopy and a particle size distribution analyzer is evaluated for the real-time monitoring of critical parameters during the continuous wet agglomeration of an anhydrous theophylline- lactose blend. The solid state characteristics and particle size of the granules were analyzed in real-time and the critical process parameters influencing these granule characteristics were identified. The temperature of the granulator barrel, the amount of granulation liquid added and, to a lesser extent, the powder feed rate were the parameters influencing the solid state of the active pharmaceutical ingredient (API). A higher barrel temperature and a higher powder feed rate, resulted in larger granules.

Manufacturing information system

NASA Astrophysics Data System (ADS)

Allen, D. K.; Smith, P. R.; Smart, M. J.

1983-12-01

The size and cost of manufacturing equipment has made it extremely difficult to perform realistic modeling and simulation of the manufacturing process in university research laboratories. Likewise the size and cost factors, coupled with many uncontrolled variables of the production situation has even made it difficult to perform adequate manufacturing research in the industrial setting. Only the largest companies can afford manufacturing research laboratories; research results are often held proprietary and seldom find their way into the university classroom to aid in education and training of new manufacturing engineers. It is the purpose for this research to continue the development of miniature prototype equipment suitable for use in an integrated CAD/CAM Laboratory. The equipment being developed is capable of actually performing production operations (e.g. drilling, milling, turning, punching, etc.) on metallic and non-metallic workpieces. The integrated CAD/CAM Mini-Lab is integrating high resolution, computer graphics, parametric design, parametric N/C parts programmings, CNC machine control, automated storage and retrieval, with robotics materials handling. The availability of miniature CAD/CAM laboratory equipment will provide the basis for intensive laboratory research on manufacturing information systems.

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

NASA Technical Reports Server (NTRS)

1978-01-01

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

Cleaning of parts for new manufacturing and parts rebuilding

NASA Astrophysics Data System (ADS)

Doherty, Jeff

1994-06-01

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

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

Simpson, L.

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

21 CFR 211.115 - Reprocessing.

Code of Federal Regulations, 2013 CFR

2013-04-01

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

21 CFR 211.115 - Reprocessing.

Code of Federal Regulations, 2011 CFR

2011-04-01

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

21 CFR 211.105 - Equipment identification.

Code of Federal Regulations, 2014 CFR

2014-04-01

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

21 CFR 211.115 - Reprocessing.

Code of Federal Regulations, 2010 CFR

2010-04-01

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

21 CFR 211.105 - Equipment identification.

Code of Federal Regulations, 2012 CFR

2012-04-01

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

21 CFR 211.115 - Reprocessing.

Code of Federal Regulations, 2012 CFR

2012-04-01

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

21 CFR 211.115 - Reprocessing.

Code of Federal Regulations, 2014 CFR

2014-04-01

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

21 CFR 211.105 - Equipment identification.

Code of Federal Regulations, 2013 CFR

2013-04-01

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

40 CFR 63.5485 - Am I subject to this subpart?

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES National Emission Standards for Hazardous Air Pollutants for Cellulose Products Manufacturing What This Subpart Covers § 63... operations that use the viscose process. These operations include the cellulose food casing, rayon...

GREEN CHEMISTRY FOR SELECTIRVE OXIDATION PROCESSES

EPA Science Inventory

The costs of handling, treating and disposing of wastes generated annually in the United States has reached to 2.2% of gross domestic product, and continued to rise. The chemical manufacturing industry generates more than 1.5 billion tons of hazardous waste and 9 billion tons of ...

27 CFR 40.24 - Classification of cigarettes.

Code of Federal Regulations, 2013 CFR

2013-04-01

... cigarettes. 40.24 Section 40.24 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Taxes § 40.24 Classification of cigarettes. For tax purposes, small...

27 CFR 40.24 - Classification of cigarettes.

Code of Federal Regulations, 2012 CFR

2012-04-01

... cigarettes. 40.24 Section 40.24 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Taxes § 40.24 Classification of cigarettes. For tax purposes, small...

27 CFR 40.24 - Classification of cigarettes.

Code of Federal Regulations, 2011 CFR

2011-04-01

... cigarettes. 40.24 Section 40.24 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Taxes § 40.24 Classification of cigarettes. For tax purposes, small...

21 CFR 211.25 - Personnel qualifications.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Personnel qualifications. 211.25 Section 211.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS....25 Personnel qualifications. (a) Each person engaged in the manufacture, processing, packing, or...

21 CFR 211.34 - Consultants.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Consultants. 211.34 Section 211.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL... Consultants. Consultants advising on the manufacture, processing, packing, or holding of drug products shall...

21 CFR 211.25 - Personnel qualifications.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Personnel qualifications. 211.25 Section 211.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS....25 Personnel qualifications. (a) Each person engaged in the manufacture, processing, packing, or...

21 CFR 211.34 - Consultants.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Consultants. 211.34 Section 211.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL... Consultants. Consultants advising on the manufacture, processing, packing, or holding of drug products shall...

21 CFR 211.25 - Personnel qualifications.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Personnel qualifications. 211.25 Section 211.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS....25 Personnel qualifications. (a) Each person engaged in the manufacture, processing, packing, or...

21 CFR 211.34 - Consultants.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Consultants. 211.34 Section 211.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL... Consultants. Consultants advising on the manufacture, processing, packing, or holding of drug products shall...

21 CFR 211.34 - Consultants.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Consultants. 211.34 Section 211.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL... Consultants. Consultants advising on the manufacture, processing, packing, or holding of drug products shall...

21 CFR 211.34 - Consultants.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Consultants. 211.34 Section 211.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL... Consultants. Consultants advising on the manufacture, processing, packing, or holding of drug products shall...

21 CFR 175.250 - Paraffin (synthetic).

Code of Federal Regulations, 2011 CFR

2011-04-01

..., manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food in accordance... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Paraffin (synthetic). 175.250 Section 175.250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR...

21 CFR 175.250 - Paraffin (synthetic).

Code of Federal Regulations, 2010 CFR

2010-04-01

..., manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food in accordance... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Paraffin (synthetic). 175.250 Section 175.250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR...

40 CFR 424.36 - Pretreatment standards for new sources.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 28 2010-07-01 2010-07-01 true Pretreatment standards for new sources. 424.36 Section 424.36 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS FERROALLOY MANUFACTURING POINT SOURCE CATEGORY Slag Processing Subcategory § 424.36...

40 CFR 721.3085 - Brominated phthalate ester.

Code of Federal Regulations, 2010 CFR

2010-07-01

... information, and any information on methods for protecting against such risk, into a MSDS as described in... Section 721.3085 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES... substance is any manner or method of manufacture, import, or processing associated with any use of these...

40 CFR 721.3880 - Polyalkylene glycol substituted acetate.

Code of Federal Regulations, 2010 CFR

2010-07-01

... acetate. 721.3880 Section 721.3880 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED... communication program. A significant new use of this substance is any manner or method of manufacture, import, or processing associated with any use of this substance without providing risk notification as...

40 CFR 721.3629 - Triethanolamine salts of fatty acids.

Code of Federal Regulations, 2010 CFR

2010-07-01

.... 721.3629 Section 721.3629 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC...) Hazard communication program. A significant new use of these substances is any manner or method of manufacture, import, or processing associated with any use of these substances without providing risk...

40 CFR 721.3815 - Furan, 2-(ethoxymethyl)- tetrahydro-.

Code of Federal Regulations, 2010 CFR

2010-07-01

... new information, and any information on methods for protecting against such risk, into a Material...-. 721.3815 Section 721.3815 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC... substance is any manner or method of manufacture, import, or processing associated with any use of this...

40 CFR 721.4620 - Dialkylamino alkanoate metal salt.

Code of Federal Regulations, 2010 CFR

2010-07-01

... this new information, and any information on methods for protecting against such risk, into a Material....4620 Section 721.4620 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC... significant new use of this substance is any manner or method of manufacture, import, or processing associated...

40 CFR 721.4600 - Recovered metal hydroxide.

Code of Federal Regulations, 2010 CFR

2010-07-01

... this new information, and any information on methods for protecting against such risk, into an MSDS as... Section 721.4600 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES... new use of this substance is any manner or method of manufacture, import, or processing associated...

40 CFR 721.6060 - Alkylaryl substituted phosphite.

Code of Federal Regulations, 2010 CFR

2010-07-01

... this new information, and any information on methods for protecting against such risk, into an MSDS as....6060 Section 721.6060 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC... significant new use of this substance is any manner or method of manufacture, import, or processing associated...

40 CFR 63.11502 - What definitions apply to this subpart?

Code of Federal Regulations, 2012 CFR

2012-07-01

...: process knowledge, an engineering assessment, or test data. Byproduct means a chemical (liquid, gas, or... (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Chemical Manufacturing Area Sources...., for chemical value as a product, isolated intermediate, byproduct, or coproduct, or for heat value...

21 CFR 175.250 - Paraffin (synthetic).

Code of Federal Regulations, 2012 CFR

2012-04-01

..., manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food in accordance... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Paraffin (synthetic). 175.250 Section 175.250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR...

21 CFR 175.250 - Paraffin (synthetic).

Code of Federal Regulations, 2013 CFR

2013-04-01

..., manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food in accordance... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Paraffin (synthetic). 175.250 Section 175.250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR...

27 CFR 40.24 - Classification of cigarettes.

Code of Federal Regulations, 2014 CFR

2014-04-01

... cigarettes. 40.24 Section 40.24 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Taxes § 40.24 Classification of cigarettes. For tax purposes, small...

27 CFR 40.24 - Classification of cigarettes.

Code of Federal Regulations, 2010 CFR

2010-04-01

... cigarettes. 40.24 Section 40.24 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY (CONTINUED) TOBACCO MANUFACTURE OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Taxes § 40.24 Classification of cigarettes. For tax purposes, small...

27 CFR 44.142 - Records.

Code of Federal Regulations, 2012 CFR

2012-04-01

... cigarettes); (d) Name of manufacturer and brand; and, (e) Quantity of tobacco products, cigarette papers and... sentence of paragraph (e) by adding the words “, and any processed tobacco” after the words “cigarette... TREASURY (CONTINUED) TOBACCO EXPORTATION OF TOBACCO PRODUCTS AND CIGARETTE PAPERS AND TUBES, WITHOUT...

27 CFR 44.142 - Records.

Code of Federal Regulations, 2011 CFR

2011-04-01

... cigarettes); (d) Name of manufacturer and brand; and, (e) Quantity of tobacco products, cigarette papers and... sentence of paragraph (e) by adding the words “, and any processed tobacco” after the words “cigarette... TREASURY (CONTINUED) TOBACCO EXPORTATION OF TOBACCO PRODUCTS AND CIGARETTE PAPERS AND TUBES, WITHOUT...

Continuous Digital Light Processing (cDLP): Highly Accurate Additive Manufacturing of Tissue Engineered Bone Scaffolds.

PubMed

Dean, David; Jonathan, Wallace; Siblani, Ali; Wang, Martha O; Kim, Kyobum; Mikos, Antonios G; Fisher, John P

2012-03-01

Highly accurate rendering of the external and internal geometry of bone tissue engineering scaffolds effects fit at the defect site, loading of internal pore spaces with cells, bioreactor-delivered nutrient and growth factor circulation, and scaffold resorption. It may be necessary to render resorbable polymer scaffolds with 50 μm or less accuracy to achieve these goals. This level of accuracy is available using Continuous Digital Light processing (cDLP) which utilizes a DLP(®) (Texas Instruments, Dallas, TX) chip. One such additive manufacturing device is the envisionTEC (Ferndale, MI) Perfactory(®). To use cDLP we integrate a photo-crosslinkable polymer, a photo-initiator, and a biocompatible dye. The dye attenuates light, thereby limiting the depth of polymerization. In this study we fabricated scaffolds using the well-studied resorbable polymer, poly(propylene fumarate) (PPF), titanium dioxide (TiO(2)) as a dye, Irgacure(®) 819 (BASF [Ciba], Florham Park, NJ) as an initiator, and diethyl fumarate as a solvent to control viscosity.

New concepts and materials for the manufacturing of MR-compatible guide wires.

PubMed

Brecher, Christian; Emonts, Michael; Brack, Alexander; Wasiak, Christian; Schütte, Adrian; Krämer, Nils; Bruhn, Robin

2014-04-01

This paper shows the development of a new magnetic resonance imaging (MRI)-compatible guide wire made from fiber-reinforced plastics. The basic material of the developed guide wire is manufactured using a specially developed micro-pullwinding technology, which allows the adjustment of tensile, bending, and torsional stiffness independent from each other. Additionally, the micro-pullwinding technology provides the possibility to vary the stiffness along the length of the guide wire in a continuous process. With the possibilities of this technology, the mechanical properties of the guide wire were precisely adjusted for the intended usage in MRI-guided interventions. The performance of the guide wire regarding the mechanical properties was investigated. It could be shown, that the mechanical properties could be changed independently from each other by varying the process parameters. Especially, the torsional stiffness could be significantly improved with only a minor influence on bending and tensile properties. The precise influence of the variation of the winding angle on the mechanical and geometrical properties has to be further investigated. The usability of the guide wire as well as its visibility in MRI was investigated by radiologists. With the micro-pullwinding technology, a continuous manufacturing technique for highly stressable, MRI-safe profiles is available and can be the trigger for a new class of medical devices.

A simulation study on garment manufacturing process

NASA Astrophysics Data System (ADS)

Liong, Choong-Yeun; Rahim, Nur Azreen Abdul

2015-02-01

Garment industry is an important industry and continues to evolve in order to meet the consumers' high demands. Therefore, elements of innovation and improvement are important. In this work, research studies were conducted at a local company in order to model the sewing process of clothes manufacturing by using simulation modeling. Clothes manufacturing at the company involves 14 main processes, which are connecting the pattern, center sewing and side neating, pockets sewing, backside-sewing, attaching the front and back, sleeves preparation, attaching the sleeves and over lock, collar preparation, collar sewing, bottomedge sewing, buttonholing sewing, removing excess thread, marking button, and button cross sewing. Those fourteen processes are operated by six tailors only. The last four sets of processes are done by a single tailor. Data collection was conducted by on site observation and the probability distribution of processing time for each of the processes is determined by using @Risk's Bestfit. Then a simulation model is developed using Arena Software based on the data collected. Animated simulation model is developed in order to facilitate understanding and verifying that the model represents the actual system. With such model, what if analysis and different scenarios of operations can be experimented with virtually. The animation and improvement models will be presented in further work.

Phase plate technology for laser marking of magnetic discs

DOEpatents

Neuman, Bill; Honig, John; Hackel, Lloyd; Dane, C. Brent; Dixit, Shamasundar

1998-01-01

An advanced design for a phase plate enables the distribution of spots in arbitrarily shaped patterns with very high uniformity and with a continuously or near-continuously varying phase pattern. A continuous phase pattern eliminates large phase jumps typically expected in a grating that provides arbitrary shapes. Large phase jumps increase scattered light outside of the desired pattern, reduce efficiency and can make the grating difficult to manufacture. When manufacturing capabilities preclude producing a fully continuous grating, the present design can be easily adapted to minimize manufacturing errors and maintain high efficiencies. This continuous grating is significantly more efficient than previously described Dammann gratings, offers much more flexibility in generating spot patterns and is easier to manufacture and replicate than a multi-level phase grating.