21 CFR 111.60 - What are the design requirements for the production and process control system?

Code of Federal Regulations, 2013 CFR

2013-04-01

... to Establish a Production and Process Control System § 111.60 What are the design requirements for... 21 Food and Drugs 2 2013-04-01 2013-04-01 false What are the design requirements for the production and process control system? 111.60 Section 111.60 Food and Drugs FOOD AND DRUG ADMINISTRATION...

21 CFR 111.60 - What are the design requirements for the production and process control system?

Code of Federal Regulations, 2011 CFR

2011-04-01

... to Establish a Production and Process Control System § 111.60 What are the design requirements for... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What are the design requirements for the production and process control system? 111.60 Section 111.60 Food and Drugs FOOD AND DRUG ADMINISTRATION...

21 CFR 111.60 - What are the design requirements for the production and process control system?

Code of Federal Regulations, 2014 CFR

2014-04-01

... to Establish a Production and Process Control System § 111.60 What are the design requirements for... 21 Food and Drugs 2 2014-04-01 2014-04-01 false What are the design requirements for the production and process control system? 111.60 Section 111.60 Food and Drugs FOOD AND DRUG ADMINISTRATION...

21 CFR 111.60 - What are the design requirements for the production and process control system?

Code of Federal Regulations, 2010 CFR

2010-04-01

... to Establish a Production and Process Control System § 111.60 What are the design requirements for... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What are the design requirements for the production and process control system? 111.60 Section 111.60 Food and Drugs FOOD AND DRUG ADMINISTRATION...

[Study on "multi-dimensional structure and process dynamics quality control system" of Danshen infusion solution based on component structure theory].

PubMed

Feng, Liang; Zhang, Ming-Hua; Gu, Jun-Fei; Wang, Gui-You; Zhao, Zi-Yu; Jia, Xiao-Bin

2013-11-01

As traditional Chinese medicine (TCM) preparation products feature complex compounds and multiple preparation processes, the implementation of quality control in line with the characteristics of TCM preparation products provides a firm guarantee for the clinical efficacy and safety of TCM preparation products. Danshen infusion solution is a preparation commonly used in clinic, but its quality control is restricted to indexes of finished products, which can not guarantee its inherent quality. Our study group has proposed "multi-dimensional structure and process dynamics quality control system" on the basis of "component structure theory", for the purpose of controlling the quality of Danshen infusion solution at multiple levels and in multiple links from the efficacy-related material basis, the safety-related material basis, the characteristics of dosage form to the preparation process. This article, we bring forth new ideas and models to the quality control of TCM preparation products.

[Establishment and application of "multi-dimensional structure and process dynamic quality control technology system" in preparation products of traditional Chinese medicine (I)].

PubMed

Gu, Jun-Fei; Feng, Liang; Zhang, Ming-Hua; Wu, Chan; Jia, Xiao-Bin

2013-11-01

Safety is an important component of the quality control of traditional Chinese medicine (TCM) preparation products, as well as an important guarantee for clinical application. Currently, the quality control of TCMs in Chinese Pharmacopoeia mostly focuses on indicative compounds for TCM efficacy. TCM preparations are associated with multiple links, from raw materials to products, and each procedure may have impacts on the safety of preparation. We make a summary and analysis on the factors impacting safety during the preparation of TCM products, and then expound the important role of the "multi-dimensional structure and process dynamic quality control technology system" in the quality safety of TCM preparations. Because the product quality of TCM preparation is closely related to the safety, the control over safety-related material basis is an important component of the product quality control of TCM preparations. The implementation of the quality control over the dynamic process of TCM preparations from raw materials to products, and the improvement of the TCM quality safety control at the microcosmic level help lay a firm foundation for the development of the modernization process of TCM preparations.

Quality control process improvement of flexible printed circuit board by FMEA

NASA Astrophysics Data System (ADS)

Krasaephol, Siwaporn; Chutima, Parames

2018-02-01

This research focuses on the quality control process improvement of Flexible Printed Circuit Board (FPCB), centred around model 7-Flex, by using Failure Mode and Effect Analysis (FMEA) method to decrease proportion of defective finished goods that are found at the final inspection process. Due to a number of defective units that were found at the final inspection process, high scraps may be escaped to customers. The problem comes from poor quality control process which is not efficient enough to filter defective products from in-process because there is no In-Process Quality Control (IPQC) or sampling inspection in the process. Therefore, the quality control process has to be improved by setting inspection gates and IPCQs at critical processes in order to filter the defective products. The critical processes are analysed by the FMEA method. IPQC is used for detecting defective products and reducing chances of defective finished goods escaped to the customers. Reducing proportion of defective finished goods also decreases scrap cost because finished goods incur higher scrap cost than work in-process. Moreover, defective products that are found during process can reflect the abnormal processes; therefore, engineers and operators should timely solve the problems. Improved quality control was implemented for 7-Flex production lines from July 2017 to September 2017. The result shows decreasing of the average proportion of defective finished goods and the average of Customer Manufacturers Lot Reject Rate (%LRR of CMs) equal to 4.5% and 4.1% respectively. Furthermore, cost saving of this quality control process equals to 100K Baht.

Pharmaceutical quality by design: product and process development, understanding, and control.

PubMed

Yu, Lawrence X

2008-04-01

The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and describe how it can be used to ensure pharmaceutical quality. The QbD was described and some of its elements identified. Process parameters and quality attributes were identified for each unit operation during manufacture of solid oral dosage forms. The use of QbD was contrasted with the evaluation of product quality by testing alone. The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include: Defining target product quality profile; Designing product and manufacturing processes; Identifying critical quality attributes, process parameters, and sources of variability; Controlling manufacturing processes to produce consistent quality over time. Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality. Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.

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

PubMed

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

2015-01-01

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

76 FR 13973 - United States Warehouse Act; Processed Agricultural Products Licensing Agreement

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-15

... license for the processed agricultural products that are stored in climate controlled, cooler, and freezer..., and dry beans. Warehouse operators voluntarily agree to be licensed, observe the rules for licensing... program for processed agricultural products that are stored in climate controlled, cooler, and freezer...

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

NASA Astrophysics Data System (ADS)

Hong, Chen

2017-11-01

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

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

PubMed

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

2012-04-01

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

Advanced model-based control strategies for the intensification of upstream and downstream processing in mAb production.

PubMed

Papathanasiou, Maria M; Quiroga-Campano, Ana L; Steinebach, Fabian; Elviro, Montaña; Mantalaris, Athanasios; Pistikopoulos, Efstratios N

2017-07-01

Current industrial trends encourage the development of sustainable, environmentally friendly processes with minimal energy and material consumption. In particular, the increasing market demand in biopharmaceutical industry and the tight regulations in product quality necessitate efficient operating procedures that guarantee products of high purity. In this direction, process intensification via continuous operation paves the way for the development of novel, eco-friendly processes, characterized by higher productivity and lower production costs. This work focuses on the development of advanced control strategies for (i) a cell culture system in a bioreactor and (ii) a semicontinuous purification process. More specifically, we consider a fed-batch culture of GS-NS0 cells and the semicontinuous Multicolumn Countercurrent Solvent Gradient Purification (MCSGP) for the purification process. The controllers are designed following the PAROC framework/software platform and their capabilities are assessed in silico, against the process models. It is demonstrated that the proposed controllers efficiently manage to increase the system productivity, returning strategies that can lead to continuous, stable process operation. © 2017 American Institute of Chemical Engineers Biotechnol. Prog., 33:966-988, 2017. © 2017 American Institute of Chemical Engineers.

21 CFR 123.16 - Process controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Process controls. 123.16 Section 123.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FISH AND FISHERY PRODUCTS Smoked and Smoke-Flavored Fishery Products § 123.16 Process controls. In...

21 CFR 123.16 - Process controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Process controls. 123.16 Section 123.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FISH AND FISHERY PRODUCTS Smoked and Smoke-Flavored Fishery Products § 123.16 Process controls. In...

21 CFR 123.16 - Process controls.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Process controls. 123.16 Section 123.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FISH AND FISHERY PRODUCTS Smoked and Smoke-Flavored Fishery Products § 123.16 Process controls. In...

21 CFR 123.16 - Process controls.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Process controls. 123.16 Section 123.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FISH AND FISHERY PRODUCTS Smoked and Smoke-Flavored Fishery Products § 123.16 Process controls. In...

40 CFR 82.24 - Recordkeeping and reporting requirements for class II controlled substances.

Code of Federal Regulations, 2010 CFR

2010-07-01

... kilograms) of production of each class II controlled substance used in processes resulting in their...) The quantity (in kilograms) of production of each class II controlled substance used in processes... processes resulting in their transformation or eventual destruction; (vi) A list of the quantities and names...

Industrial Technology Modernization Program. Project 32. Factory Vision. Phase 2

DTIC Science & Technology

1988-04-01

instructions for the PWA’s, generating the numerical control (NC) program instructions for factory assembly equipment, controlling the process... generating the numerical control (NC) program instructions for factory assembly equipment, controlling the production process instructions and NC... Assembly Operations the "Create Production Process Program" will automatically generate a sequence of graphics pages (in paper mode), or graphics screens

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

PubMed

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

2016-04-01

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

Quality by control: Towards model predictive control of mammalian cell culture bioprocesses.

PubMed

Sommeregger, Wolfgang; Sissolak, Bernhard; Kandra, Kulwant; von Stosch, Moritz; Mayer, Martin; Striedner, Gerald

2017-07-01

The industrial production of complex biopharmaceuticals using recombinant mammalian cell lines is still mainly built on a quality by testing approach, which is represented by fixed process conditions and extensive testing of the end-product. In 2004 the FDA launched the process analytical technology initiative, aiming to guide the industry towards advanced process monitoring and better understanding of how critical process parameters affect the critical quality attributes. Implementation of process analytical technology into the bio-production process enables moving from the quality by testing to a more flexible quality by design approach. The application of advanced sensor systems in combination with mathematical modelling techniques offers enhanced process understanding, allows on-line prediction of critical quality attributes and subsequently real-time product quality control. In this review opportunities and unsolved issues on the road to a successful quality by design and dynamic control implementation are discussed. A major focus is directed on the preconditions for the application of model predictive control for mammalian cell culture bioprocesses. Design of experiments providing information about the process dynamics upon parameter change, dynamic process models, on-line process state predictions and powerful software environments seem to be a prerequisite for quality by control realization. © 2017 The Authors. Biotechnology Journal published by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

9 CFR 318.24 - Product prepared using advanced meat/bone separation machinery; process control.

Code of Federal Regulations, 2013 CFR

2013-01-01

.../bone separation machinery; process control. 318.24 Section 318.24 Animals and Animal Products FOOD.../bone separation machinery; process control. (a) General. Meat, as defined in § 301.2 of this subchapter, may be derived by mechanically separating skeletal muscle tissue from the bones of livestock, other...

9 CFR 318.24 - Product prepared using advanced meat/bone separation machinery; process control.

Code of Federal Regulations, 2012 CFR

2012-01-01

.../bone separation machinery; process control. 318.24 Section 318.24 Animals and Animal Products FOOD.../bone separation machinery; process control. (a) General. Meat, as defined in § 301.2 of this subchapter, may be derived by mechanically separating skeletal muscle tissue from the bones of livestock, other...

9 CFR 318.24 - Product prepared using advanced meat/bone separation machinery; process control.

Code of Federal Regulations, 2010 CFR

2010-01-01

.../bone separation machinery; process control. 318.24 Section 318.24 Animals and Animal Products FOOD.../bone separation machinery; process control. (a) General. Meat, as defined in § 301.2 of this subchapter, may be derived by mechanically separating skeletal muscle tissue from the bones of livestock, other...

9 CFR 318.24 - Product prepared using advanced meat/bone separation machinery; process control.

Code of Federal Regulations, 2014 CFR

2014-01-01

.../bone separation machinery; process control. 318.24 Section 318.24 Animals and Animal Products FOOD.../bone separation machinery; process control. (a) General. Meat, as defined in § 301.2 of this subchapter, may be derived by mechanically separating skeletal muscle tissue from the bones of livestock, other...

9 CFR 318.24 - Product prepared using advanced meat/bone separation machinery; process control.

Code of Federal Regulations, 2011 CFR

2011-01-01

.../bone separation machinery; process control. 318.24 Section 318.24 Animals and Animal Products FOOD.../bone separation machinery; process control. (a) General. Meat, as defined in § 301.2 of this subchapter, may be derived by mechanically separating skeletal muscle tissue from the bones of livestock, other...

It Systems Supporting the Management of Production Capacity

NASA Astrophysics Data System (ADS)

Milewska, Elżbieta

2017-03-01

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

The effect of material productivity on scrap reduction on aluminum reduction pot process

NASA Astrophysics Data System (ADS)

Huda, L. N.

2018-02-01

Scrap in the production process is defined as part of production that can not be accepted as the final product due to production failure. The amount of scarp occurring in the reduction pot production process of one of the aluminum smelting furnaces exceeds the acceptance standard of 5 to 10%. This affects the amount of production produced. The purpose of this study is to reduce the amount of scrap produced to increase the productivity of the materials used. The solution is carried-out by making improvements using Lean Six Sigma method. In the initial calculation, material productivity ranged from 0.88. Based on the study, the factors that cause the high amount of scrap produced is the use of Na2O which is inserted into the alumina is different in size and the influence of noise that occurs in pots that are difficult to control. The analysis base on Lean Six Sigma obtained process cycle efficiency (PCE) equal to 86,92% for actual condition. Process improvement is carried-out through define, measure, analyze, improve and control procedure on Na2O feeding process and PCE value decrease 6,05%. This indicates that increased process capability will reduce scrap. A decrease in scrap amount of about 6% will be able to increase material productivity by 0.05%. This indicates that continuous process control is needed to decrease the number of scraps and increase productivity.

Generation of control sequences for a pilot-disassembly system

NASA Astrophysics Data System (ADS)

Seliger, Guenther; Kim, Hyung-Ju; Keil, Thomas

2002-02-01

Closing the product and material cycles has emerged as a paradigm for industry in the 21st century. Disassembly plays a key role in a life cycle economy since it enables the recovery of resources. A partly automated disassembly system should adapt to a large variety of products and different degrees of devaluation. Also the amounts of products to be disassembled can vary strongly. To cope with these demands an approach to generate on-line disassembly control sequences will be presented. In order to react on these demands the technological feasibility is considered within a procedure for the generation of disassembly control sequences. Procedures are designed to find available and technologically feasible disassembly processes. The control system is formed by modularised and parameterised control units in the cell level within the entire control architecture. In the first development stage product and process analyses at the sample product washing machine were executed. Furthermore a generalized disassembly process was defined. Afterwards these processes were structured in primary and secondary functions. In the second stage the disassembly control at the technological level was investigated. Factors were the availability of the disassembly tools and the technological feasibility of the disassembly processes within the disassembly system. Technical alternative disassembly processes are determined as a result of availability of the tools and technological feasibility of processes. The fourth phase was the concept for the generation of the disassembly control sequences. The approach will be proved in a prototypical disassembly system.

Enhanced Traceability for Bulk Processing of Sentinel-Derived Information Products

NASA Astrophysics Data System (ADS)

Lankester, Thomas; Hubbard, Steven; Knowelden, Richard

2016-08-01

The advent of widely available, systematically acquired and advanced Earth observations from the Sentinel platforms is spurring development of a wide range of derived information products. Whilst welcome, this rapid rate of development inevitably leads to some processing instability as algorithms and production steps are required to evolve accordingly. To mitigate this instability, the provenance of EO-derived information products needs to be traceable and transparent.Airbus Defence and Space (Airbus DS) has developed the Airbus Processing Cloud (APC) as a virtualised processing farm for bulk production of EO-derived data and information products. The production control system of the APC transforms internal configuration control information into an INSPIRE metadata file containing a stepwise set of processing steps and data source elements that provide the complete and transparent provenance of each product generated.

A real time quality control application for animal production by image processing.

PubMed

Sungur, Cemil; Özkan, Halil

2015-11-01

Standards of hygiene and health are of major importance in food production, and quality control has become obligatory in this field. Thanks to rapidly developing technologies, it is now possible for automatic and safe quality control of food production. For this purpose, image-processing-based quality control systems used in industrial applications are being employed to analyze the quality of food products. In this study, quality control of chicken (Gallus domesticus) eggs was achieved using a real time image-processing technique. In order to execute the quality control processes, a conveying mechanism was used. Eggs passing on a conveyor belt were continuously photographed in real time by cameras located above the belt. The images obtained were processed by various methods and techniques. Using digital instrumentation, the volume of the eggs was measured, broken/cracked eggs were separated and dirty eggs were determined. In accordance with international standards for classifying the quality of eggs, the class of separated eggs was determined through a fuzzy implication model. According to tests carried out on thousands of eggs, a quality control process with an accuracy of 98% was possible. © 2014 Society of Chemical Industry.

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

PubMed

Pianigiani, Elisa; Ierardi, Francesca; Fimiani, Michele

2013-12-01

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

Effective Process Design for the Production of HIC-Resistant Linepipe Steels

NASA Astrophysics Data System (ADS)

Nieto, J.; Elías, T.; López, G.; Campos, G.; López, F.; Garcia, R.; De, Amar K.

2013-09-01

Production of slabs for sour service applications requires stringent control in slab internal quality and secondary processing so as to guarantee resistance against hydrogen-induced cracking (HIC). ArcelorMittal Steelmaking facility at Lazaro Cardenas, Mexico had recently implemented key steelmaking and casting processing technologies for production of sound, centerline free slabs for catering to the growing API Linepipe and off-shore market for sour service applications. State-of-the-art steelmaking with use of residual-free Direct-reduced Iron and continuous casting facilities with dynamic soft reduction were introduced for the production of slabs with ultra clean centerline. Introduction of controlled cooling of slabs for atomic hydrogen control well below 2 ppm has enabled production of slabs suitable for excellent HIC-resistant plate processing. Substantial tonnages of slabs were produced for production of API X52-X65 grade plates and pipes for sour service. Stringent quality control at each stage of steelmaking, casting, and slab inspection ensured slabs with excellent internal quality suitable for HIC resistance to be guaranteed in final product (Plates & Pipes). Details of production steps which resulted in successful HIC-resistant slab production have been described in this article.

[Discussion on research and development of new traditional Chinese medicine preparation process based on idea of QbD].

PubMed

Feng, Yi; Hong, Yan-Long; Xian, Jie-Chen; Du, Ruo-Fei; Zhao, Li-Jie; Shen, Lan

2014-09-01

Traditional processes are mostly adopted in traditional Chinese medicine (TCM) preparation production and the quality of products is mostly controlled by terminal. Potential problems of the production in the process are unpredictable and is relied on experience in most cases. Therefore, it is hard to find the key points affecting the preparation process and quality control. A pattern of research and development of traditional Chinese medicine preparation process based on the idea of Quality by Design (QbD) was proposed after introducing the latest research achievement. Basic theories of micromeritics and rheology were used to characterize the physical property of TCM raw material. TCM preparation process was designed in a more scientific and rational way by studying the correlation among enhancing physical property of raw material, preparation process and product quality of preparation. So factors affecting the quality of TCM production would be found out and problems that might occur in the pilot process could be predicted. It would be a foundation for the R&D and production of TCM preparation as well as support for the "process control" of TCMIs gradually realized in the future.

Chemical Stockpile Disposal Program. Chemical Agent and Munition Disposal. Summary of the U.S. Army’s Experience

DTIC Science & Technology

1987-09-21

a difficult process to control; continuous generation of acidic products results in the possibility of side reactions and in gaseous by- products . Ion...dissolved in hydrochlorlo acid. The acid chlorination forms non-toxic reaction products as per Figure 3-3. (2) To initiate the neutralization process ...et al, "Emission and Control of By- Products From Hazarduus Waste Combustion Processes ", Land Disposal, Remedial Action, Incineration and Treatment

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.

[Monitoring method of extraction process for Schisandrae Chinensis Fructus based on near infrared spectroscopy and multivariate statistical process control].

PubMed

Xu, Min; Zhang, Lei; Yue, Hong-Shui; Pang, Hong-Wei; Ye, Zheng-Liang; Ding, Li

2017-10-01

To establish an on-line monitoring method for extraction process of Schisandrae Chinensis Fructus, the formula medicinal material of Yiqi Fumai lyophilized injection by combining near infrared spectroscopy with multi-variable data analysis technology. The multivariate statistical process control (MSPC) model was established based on 5 normal batches in production and 2 test batches were monitored by PC scores, DModX and Hotelling T2 control charts. The results showed that MSPC model had a good monitoring ability for the extraction process. The application of the MSPC model to actual production process could effectively achieve on-line monitoring for extraction process of Schisandrae Chinensis Fructus, and can reflect the change of material properties in the production process in real time. This established process monitoring method could provide reference for the application of process analysis technology in the process quality control of traditional Chinese medicine injections. Copyright© by the Chinese Pharmaceutical Association.

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

PubMed

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

2017-01-01

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

Adjustment of automatic control systems of production facilities at coal processing plants using multivariant physico- mathematical models

NASA Astrophysics Data System (ADS)

Evtushenko, V. F.; Myshlyaev, L. P.; Makarov, G. V.; Ivushkin, K. A.; Burkova, E. V.

2016-10-01

The structure of multi-variant physical and mathematical models of control system is offered as well as its application for adjustment of automatic control system (ACS) of production facilities on the example of coal processing plant.

Controlling high-throughput manufacturing at the nano-scale

NASA Astrophysics Data System (ADS)

Cooper, Khershed P.

2013-09-01

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

21 CFR 123.16 - Process controls.

Code of Federal Regulations, 2010 CFR

2010-04-01

... CONSUMPTION FISH AND FISHERY PRODUCTS Smoked and Smoke-Flavored Fishery Products § 123.16 Process controls. In order to meet the requirements of subpart A of this part, processors of smoked and smoke-flavored...

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.

A Quality Assurance Initiative for Commercial-Scale Production in High-Throughput Cryopreservation of Blue Catfish Sperm

PubMed Central

Hu, E; Liao, T. W.; Tiersch, T. R.

2013-01-01

Cryopreservation of fish sperm has been studied for decades at a laboratory (research) scale. However, high-throughput cryopreservation of fish sperm has recently been developed to enable industrial-scale production. This study treated blue catfish (Ictalurus furcatus) sperm high-throughput cryopreservation as a manufacturing production line and initiated quality assurance plan development. The main objectives were to identify: 1) the main production quality characteristics; 2) the process features for quality assurance; 3) the internal quality characteristics and their specification designs; 4) the quality control and process capability evaluation methods, and 5) the directions for further improvements and applications. The essential product quality characteristics were identified as fertility-related characteristics. Specification design which established the tolerance levels according to demand and process constraints was performed based on these quality characteristics. Meanwhile, to ensure integrity throughout the process, internal quality characteristics (characteristics at each quality control point within process) that could affect fertility-related quality characteristics were defined with specifications. Due to the process feature of 100% inspection (quality inspection of every fish), a specific calculation method, use of cumulative sum (CUSUM) control charts, was applied to monitor each quality characteristic. An index of overall process evaluation, process capacity, was analyzed based on in-control process and the designed specifications, which further integrates the quality assurance plan. With the established quality assurance plan, the process could operate stably and quality of products would be reliable. PMID:23872356

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

PubMed

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

2012-01-01

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

21 CFR 211.100 - Written procedures; deviations.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

21 CFR 211.100 - Written procedures; deviations.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

21 CFR 211.100 - Written procedures; deviations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

21 CFR 211.100 - Written procedures; deviations.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

21 CFR 211.100 - Written procedures; deviations.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

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.

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...

Development of a Premium Quality Plasma-derived IVIg (IQYMUNE®) Utilizing the Principles of Quality by Design-A Worked-through Case Study.

PubMed

Paolantonacci, Philippe; Appourchaux, Philippe; Claudel, Béatrice; Ollivier, Monique; Dennett, Richard; Siret, Laurent

2018-01-01

Polyvalent human normal immunoglobulins for intravenous use (IVIg), indicated for rare and often severe diseases, are complex plasma-derived protein preparations. A quality by design approach has been used to develop the Laboratoire Français du Fractionnement et des Biotechnologies new-generation IVIg, targeting a high level of purity to generate an enhanced safety profile while maintaining a high level of efficacy. A modular approach of quality by design was implemented consisting of five consecutive steps to cover all the stages from the product design to the final product control strategy.A well-defined target product profile was translated into 27 product quality attributes that formed the basis of the process design. In parallel, a product risk analysis was conducted and identified 19 critical quality attributes among the product quality attributes. Process risk analysis was carried out to establish the links between process parameters and critical quality attributes. Twelve critical steps were identified, and for each of these steps a risk mitigation plan was established.Among the different process risk mitigation exercises, five process robustness studies were conducted at qualified small scale with a design of experiment approach. For each process step, critical process parameters were identified and, for each critical process parameter, proven acceptable ranges were established. The quality risk management and risk mitigation outputs, including verification of proven acceptable ranges, were used to design the process verification exercise at industrial scale.Finally, the control strategy was established using a mix, or hybrid, of the traditional approach plus elements of the quality by design enhanced approach, as illustrated, to more robustly assign material and process controls and in order to securely meet product specifications.The advantages of this quality by design approach were improved process knowledge for industrial design and process validation and a clear justification of the process and product specifications as a basis for control strategy and future comparability exercises. © PDA, Inc. 2018.

Integrated Application of Quality-by-Design Principles to Drug Product Development: A Case Study of Brivanib Alaninate Film-Coated Tablets.

PubMed

Badawy, Sherif I F; Narang, Ajit S; LaMarche, Keirnan R; Subramanian, Ganeshkumar A; Varia, Sailesh A; Lin, Judy; Stevens, Tim; Shah, Pankaj A

2016-01-01

Modern drug product development is expected to follow quality-by-design (QbD) paradigm. At the same time, although there are several issue-specific examples in the literature that demonstrate the application of QbD principles, a holistic demonstration of the application of QbD principles to drug product development and control strategy, is lacking. This article provides an integrated case study on the systematic application of QbD to product development and demonstrates the implementation of QbD concepts in the different aspects of product and process design for brivanib alaninate film-coated tablets. Using a risk-based approach, the strategy for development entailed identification of product critical quality attributes (CQAs), assessment of risks to the CQAs, and performing experiments to understand and mitigate identified risks. Quality risk assessments and design of experiments were performed to understand the quality of the input raw materials required for a robust formulation and the impact of manufacturing process parameters on CQAs. In addition to the material property and process parameter controls, the proposed control strategy includes use of process analytical technology and conventional analytical tests to control in-process material attributes and ensure quality of the final product. Copyright © 2016. Published by Elsevier Inc.

Quality Control through Design and Process: Gambrel Roof Truss Challenge

ERIC Educational Resources Information Center

Ward, Dell; Jones, James

2011-01-01

Customers determine whether a product fulfills their needs or satisfies them. "Quality control", then, is the process of finding out what the customer wants, along with designing, producing, delivering, and servicing the product--and ultimately satisfying the customer's expectations. For many years, people considered a product to be of good…

Quality control troubleshooting tools for the mill floor

Treesearch

John Dramm

2000-01-01

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

Differences in net primary production and biogeochemistry between contrasting floodplain forests

Treesearch

Erik B. Schilling; B. Graeme Lockaby

2000-01-01

A firm understanding of the driving forces controlling variation among wetland forests continues to elude scientists and land managers—specifically the biogeochemical processes controlling vegetation production. Within contrasting wetland forests, insight into the biogeochemical processes driving productivity levels may befound by examining the degree to which nitrogen...

Contribution au developpement d'une methode de controle des procedes dans une usine de bouletage

NASA Astrophysics Data System (ADS)

Gosselin, Claude

This thesis, a collaborative effort between Ecole de technologie superieure and ArcelorMittal Company, presents the development of a methodology for monitoring and quality control of multivariable industrial production processes. This innovation research mandate was developed at ArcelorMittal Exploitation Miniere (AMEM) pellet plant in Port-Cartier (Quebec, Canada). With this undertaking, ArcelorMittal is striving to maintain its world class level of excellence and continues to pursue initiatives that can augment its competitive advantage worldwide. The plant's gravimetric classification process was retained as a prototype and development laboratory due to its effect on the company's competitiveness and its impact on subsequent steps leading to final production of iron oxide pellets. Concretely, the development of this expertise in process control and in situ monitoring will establish a firm basic knowledge in the fields of complex system physical modeling, data reconciliation, statistical observers, multivariate command and quality control using real-time monitoring of the desirability function. The hydraulic classifier is mathematically modeled. Using planned disturbances on the production line, an identification procedure was established to provide empirical estimations of the model's structural parameters. A new sampling campaign and a previously unpublished data collection and consolidation policy were implemented plant-wide. Access to these invaluable data sources has enabled the establishment of new thresholds that govern the production process and its control. Finally, as a substitute for the traditional quality control process, we have implemented a new strategy based on the use of the desirability function. Our innovation is not in using this Finally, as a substitute for the traditional quality control process, we have implemented a new strategy based on the use of the desirability function. Our innovation is not in using this function as an indicator of overall (economic) satisfaction in the production process, but rather in proposing it as an "observer" of the system's state. The first implementation steps have already demonstrated the method's feasibility as well as other numerous industrial impacts on production processes within the company. Namely, the emergence of the economical aspect as a strategic variable that assures better governance of production processes where quality variables present strategic issues.

Application of the suggestion system in the improvement of the production process and product quality control

NASA Astrophysics Data System (ADS)

Gołaś, H.; Mazur, A.; Gruszka, J.; Szafer, P.

2016-08-01

The elaboration is a case study and the research was carried out in the company Alco-Mot Ltd., which employs 120 people. The company specializes in the production of lead poles for industrial and traction batteries using gravity casting. The elements embedded in the cast are manufactured on a machining centre, which provides the stability of the process and of the dimensions of the product as well as a very short production time. As a result of observation and analysis the authors have developed a concept for the implementation of a dynamic suggestion system in ALCO-MOT, including, among others, a standard for actions in the implementation of the suggestion system, as well as clear guidelines for the processing and presentation of the activities undertaken in the time between the establishment of the concept (suggestions) and the benefits analysis after the proposed solutions have been implemented. The authors also present how suggestions proposed by ALCO-MOT staff contributed to the improvement of the processes of production and quality control. Employees offered more than 30 suggestions, of which more than a half are being implemented now and further actions are being prepared for implementation. The authors will present the results of improvements in, for example, tool replacement time, scrap reduction. The authors will present how kaizen can improve the production and quality control processes. They will present how the production and quality control processes looked before and after the implementation of employee suggestions.

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

NASA Astrophysics Data System (ADS)

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

2003-05-01

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

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

PubMed

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

2014-07-01

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

Optimization Control of the Color-Coating Production Process for Model Uncertainty

PubMed Central

He, Dakuo; Wang, Zhengsong; Yang, Le; Mao, Zhizhong

2016-01-01

Optimized control of the color-coating production process (CCPP) aims at reducing production costs and improving economic efficiency while meeting quality requirements. However, because optimization control of the CCPP is hampered by model uncertainty, a strategy that considers model uncertainty is proposed. Previous work has introduced a mechanistic model of CCPP based on process analysis to simulate the actual production process and generate process data. The partial least squares method is then applied to develop predictive models of film thickness and economic efficiency. To manage the model uncertainty, the robust optimization approach is introduced to improve the feasibility of the optimized solution. Iterative learning control is then utilized to further refine the model uncertainty. The constrained film thickness is transformed into one of the tracked targets to overcome the drawback that traditional iterative learning control cannot address constraints. The goal setting of economic efficiency is updated continuously according to the film thickness setting until this reaches its desired value. Finally, fuzzy parameter adjustment is adopted to ensure that the economic efficiency and film thickness converge rapidly to their optimized values under the constraint conditions. The effectiveness of the proposed optimization control strategy is validated by simulation results. PMID:27247563

Optimization Control of the Color-Coating Production Process for Model Uncertainty.

PubMed

He, Dakuo; Wang, Zhengsong; Yang, Le; Mao, Zhizhong

2016-01-01

Optimized control of the color-coating production process (CCPP) aims at reducing production costs and improving economic efficiency while meeting quality requirements. However, because optimization control of the CCPP is hampered by model uncertainty, a strategy that considers model uncertainty is proposed. Previous work has introduced a mechanistic model of CCPP based on process analysis to simulate the actual production process and generate process data. The partial least squares method is then applied to develop predictive models of film thickness and economic efficiency. To manage the model uncertainty, the robust optimization approach is introduced to improve the feasibility of the optimized solution. Iterative learning control is then utilized to further refine the model uncertainty. The constrained film thickness is transformed into one of the tracked targets to overcome the drawback that traditional iterative learning control cannot address constraints. The goal setting of economic efficiency is updated continuously according to the film thickness setting until this reaches its desired value. Finally, fuzzy parameter adjustment is adopted to ensure that the economic efficiency and film thickness converge rapidly to their optimized values under the constraint conditions. The effectiveness of the proposed optimization control strategy is validated by simulation results.

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

NASA Astrophysics Data System (ADS)

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

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

Appetitive drives for ultra-processed food products and the ability of text warnings to counteract consumption predispositions.

PubMed

David, Isabel A; Krutman, Laura; Fernández-Santaella, María Carmen; Andrade, Jéssica R; Andrade, Eduardo B; Oliveira, Leticia; Pereira, Mirtes G; Gomes, Fabio S; Gleiser, Sonia; Oliveira, José M; Araújo, Renata L; Volchan, Eliane; Braga, Filipe

2018-02-01

The present study aimed to (i) assess the appetitive drives evoked by the visual cues of ultra-processed food and drink products and (ii) investigate whether text warnings reduce appetitive drives and consumers' reported intentions to eat or drink ultra-processed products. In Study I, a well-established psychometric tool was applied to estimate the appetitive drives associated with ultra-processed products using sixty-four image representations. Sixteen product types with four exemplars of a given product were included. Pictures from the International Affective Picture System (IAPS) served as controls. The two exemplars of each product type rated as more appetitive were selected for investigation in the second study. Study II assessed the impact of textual warnings on the appetitive drive towards these thirty-two exemplars. Each participant was exposed to two picture exemplars of the same product type preceded by a text warning or a control text. After viewing each displayed picture, the participants reported their emotional reactions and their intention to consume the product. Controlled classroom experiments SUBJECTS: Undergraduate students (Study I: n 215, 135 women; Study II: n 98, 52 women). In Study I, the pictures of ultra-processed products prompted an appetitive motivation associated with the products' nutritional content. In Study II, text warnings were effective in reducing the intention to consume and the appetitive drive evoked by ultra-processed products. This research provides initial evidence favouring the use of text warnings as a public policy tool to curb the powerful influence of highly appetitive ultra-processed food cues.

Development of Chemical Process Design and Control for ...

EPA Pesticide Factsheets

This contribution describes a novel process systems engineering framework that couples advanced control with sustainability evaluation and decision making for the optimization of process operations to minimize environmental impacts associated with products, materials, and energy. The implemented control strategy combines a biologically inspired method with optimal control concepts for finding more sustainable operating trajectories. The sustainability assessment of process operating points is carried out by using the U.S. E.P.A.’s Gauging Reaction Effectiveness for the ENvironmental Sustainability of Chemistries with a multi-Objective Process Evaluator (GREENSCOPE) tool that provides scores for the selected indicators in the economic, material efficiency, environmental and energy areas. The indicator scores describe process performance on a sustainability measurement scale, effectively determining which operating point is more sustainable if there are more than several steady states for one specific product manufacturing. Through comparisons between a representative benchmark and the optimal steady-states obtained through implementation of the proposed controller, a systematic decision can be made in terms of whether the implementation of the controller is moving the process towards a more sustainable operation. The effectiveness of the proposed framework is illustrated through a case study of a continuous fermentation process for fuel production, whose materi

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

DTIC Science & Technology

1993-08-01

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

The influence of processing on the microbial risk associated with Rooibos (Aspalathus linearis) tea.

PubMed

Gouws, Pieter; Hartel, Toni; van Wyk, Rudean

2014-12-01

This review discusses the influence of processing on the microbial risk associated with Salmonella in Rooibos tea, the identification of Salmonella and preventative and control measures to control microbial contamination. Rooibos tea, like other plant products, naturally contains a high microbial load. Downstream processing steps of these products usually help in reducing any contaminants present. Due to the delicate flavour properties and nature of Rooibos, gentle processing techniques are necessary for the production of good quality tea. However, this has a major influence on the microbiological status of the product. The presence of Salmonella in Rooibos is poorly understood. The ubiquitous distribution of Salmonella in the natural environment and its prevalence in the global food chain, the physiological adaptability, virulence of the bacterial pathogen and its serious economic impact on the food industry, emphasises the need for continued awareness and stringent controls at all levels of food production. With the advances of technology and information at hand, the processing of Rooibos needs to be re-evaluated. Since the delicate nature of Rooibos prohibits the use of harsh methods to control Salmonella, alternative methods for the steam pasteurisation of Rooibos show great potential to control Salmonella in a fast, efficient and cost-effective manner. These alternative methods will significantly improve the microbiological quality of Rooibos and provide a product that is safe to consumers. © 2014 Society of Chemical Industry.

Measuring Software Product Quality: The ISO 25000 Series and CMMI

DTIC Science & Technology

2004-06-14

performance objectives” covers objectives and requirements for product quality, service quality , and process performance. Process performance objectives...such that product quality, service quality , and process performance attributes are measurable and controlled throughout the project (internal and

Identification of Sources of Endotoxin Exposure as Input for Effective Exposure Control Strategies.

PubMed

van Duuren-Stuurman, Birgit; Gröllers-Mulderij, Mariska; van de Runstraat, Annemieke; Duisterwinkel, Anton; Terwoert, Jeroen; Spaan, Suzanne

2018-02-13

Aim of the present study is to investigate the levels of endotoxins on product samples from potatoes, onions, and seeds, representing a relevant part of the agro-food industry in the Netherlands, to gather valuable insights in possibilities for exposure control measures early in the process of industrial processing of these products. Endotoxin levels on 330 products samples from companies representing the potato, onion, and seed (processing) industry (four potato-packaging companies, five potato-processing companies, five onion-packaging companies, and four seed-processing companies) were assessed using the Limulus Amboecyte Lysate (LAL) assay. As variation in growth conditions (type of soil, growth type) and product characteristics (surface roughness, dustiness, size, species) are assumed to influence the level of endotoxin on products, different types, and growth conditions were considered when collecting the samples. Additionally, waste material, rotten products, felt material (used for drying), and process water were collected. A large variation in the endotoxin levels was found on samples of potatoes, onions, and seeds (overall geometric standard deviation 17), in the range between 0.7 EU g-1 to 16400000 EU g-1. The highest geometric mean endotoxin levels were found in plant material (319600 EU g-1), followed by soil material (49100 EU g-1) and the outer side of products (9300 EU g-1), indicating that removal of plant and soil material early in the process would be an effective exposure control strategy. The high levels of endotoxins found in the limited number of samples from rotten onions indicate that these rotten onions should also be removed early in the process. Mean endotoxin levels found in waste material (only available for seed processing) is similar to the level found in soil material, although the range is much larger. On uncleaned seeds, higher endotoxin levels were found than on cleaned seeds, indicating that cleaning processes are important control measures and also that the waste material should be handled with care. Although endotoxin levels in batches of to-be-processed potatoes, onions, and seeds vary quite dramatically, it could be concluded that rotten products, plant material, and waste material contain particularly high endotoxin levels. This information was used to propose control measures to reduce exposure to endotoxins of workers during the production process. © The Author(s) 2017. Published by Oxford University Press on behalf of the British Occupational Hygiene Society.

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.

Implementation of hazard analysis and critical control point (HACCP) in dried anchovy production process

NASA Astrophysics Data System (ADS)

Citraresmi, A. D. P.; Wahyuni, E. E.

2018-03-01

The aim of this study was to inspect the implementation of Hazard Analysis and Critical Control Point (HACCP) for identification and prevention of potential hazards in the production process of dried anchovy at PT. Kelola Mina Laut (KML), Lobuk unit, Sumenep. Cold storage process is needed in each anchovy processing step in order to maintain its physical and chemical condition. In addition, the implementation of quality assurance system should be undertaken to maintain product quality. The research was conducted using a survey method, by following the whole process of making anchovy from the receiving raw materials to the packaging of final product. The method of data analysis used was descriptive analysis method. Implementation of HACCP at PT. KML, Lobuk unit, Sumenep was conducted by applying Pre Requisite Programs (PRP) and preparation stage consisting of 5 initial stages and 7 principles of HACCP. The results showed that CCP was found in boiling process flow with significant hazard of Listeria monocytogenesis bacteria and final sorting process with significant hazard of foreign material contamination in the product. Actions taken were controlling boiling temperature of 100 – 105°C for 3 - 5 minutes and training for sorting process employees.

Setting new standards in MEMS

NASA Astrophysics Data System (ADS)

Rimskog, Magnus; O'Loughlin, Brian J.

2007-02-01

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

Process yield improvements with process control terminal for varian serial ion implanters

NASA Astrophysics Data System (ADS)

Higashi, Harry; Soni, Ameeta; Martinez, Larry; Week, Ken

Implant processes in a modern wafer production fab are extremely complex. There can be several types of misprocessing, i.e. wrong dose or species, double implants and missed implants. Process Control Terminals (PCT) for Varian 350Ds installed at Intel fabs were found to substantially reduce the number of misprocessing steps. This paper describes those misprocessing steps and their subsequent reduction with use of PCTs. Reliable and simple process control with serial process ion implanters has been in increasing demand. A well designed process control terminal greatly increases device yield by monitoring all pertinent implanter functions and enabling process engineering personnel to set up process recipes for simple and accurate system operation. By programming user-selectable interlocks, implant errors are reduced and those that occur are logged for further analysis and prevention. A process control terminal should also be compatible with office personal computers for greater flexibility in system use and data analysis. The impact from the capability of a process control terminal is increased productivity, ergo higher device yield.

Statistical Methods in Assembly Quality Management of Multi-Element Products on Automatic Rotor Lines

NASA Astrophysics Data System (ADS)

Pries, V. V.; Proskuriakov, N. E.

2018-04-01

To control the assembly quality of multi-element mass-produced products on automatic rotor lines, control methods with operational feedback are required. However, due to possible failures in the operation of the devices and systems of automatic rotor line, there is always a real probability of getting defective (incomplete) products into the output process stream. Therefore, a continuous sampling control of the products completeness, based on the use of statistical methods, remains an important element in managing the quality of assembly of multi-element mass products on automatic rotor lines. The feature of continuous sampling control of the multi-element products completeness in the assembly process is its breaking sort, which excludes the possibility of returning component parts after sampling control to the process stream and leads to a decrease in the actual productivity of the assembly equipment. Therefore, the use of statistical procedures for continuous sampling control of the multi-element products completeness when assembled on automatic rotor lines requires the use of such sampling plans that ensure a minimum size of control samples. Comparison of the values of the limit of the average output defect level for the continuous sampling plan (CSP) and for the automated continuous sampling plan (ACSP) shows the possibility of providing lower limit values for the average output defects level using the ACSP-1. Also, the average sample size when using the ACSP-1 plan is less than when using the CSP-1 plan. Thus, the application of statistical methods in the assembly quality management of multi-element products on automatic rotor lines, involving the use of proposed plans and methods for continuous selective control, will allow to automating sampling control procedures and the required level of quality of assembled products while minimizing sample size.

Development of Statistical Process Control Methodology for an Environmentally Compliant Surface Cleaning Process in a Bonding Laboratory

NASA Technical Reports Server (NTRS)

Hutchens, Dale E.; Doan, Patrick A.; Boothe, Richard E.

1997-01-01

Bonding labs at both MSFC and the northern Utah production plant prepare bond test specimens which simulate or witness the production of NASA's Reusable Solid Rocket Motor (RSRM). The current process for preparing the bonding surfaces employs 1,1,1-trichloroethane vapor degreasing, which simulates the current RSRM process. Government regulations (e.g., the 1990 Amendments to the Clean Air Act) have mandated a production phase-out of a number of ozone depleting compounds (ODC) including 1,1,1-trichloroethane. In order to comply with these regulations, the RSRM Program is qualifying a spray-in-air (SIA) precision cleaning process using Brulin 1990, an aqueous blend of surfactants. Accordingly, surface preparation prior to bonding process simulation test specimens must reflect the new production cleaning process. The Bonding Lab Statistical Process Control (SPC) program monitors the progress of the lab and its capabilities, as well as certifies the bonding technicians, by periodically preparing D6AC steel tensile adhesion panels with EA-91 3NA epoxy adhesive using a standardized process. SPC methods are then used to ensure the process is statistically in control, thus producing reliable data for bonding studies, and identify any problems which might develop. Since the specimen cleaning process is being changed, new SPC limits must be established. This report summarizes side-by-side testing of D6AC steel tensile adhesion witness panels and tapered double cantilevered beams (TDCBs) using both the current baseline vapor degreasing process and a lab-scale spray-in-air process. A Proceco 26 inches Typhoon dishwasher cleaned both tensile adhesion witness panels and TDCBs in a process which simulates the new production process. The tests were performed six times during 1995, subsequent statistical analysis of the data established new upper control limits (UCL) and lower control limits (LCL). The data also demonstrated that the new process was equivalent to the vapor degreasing process.

Multivariable model predictive control design of reactive distillation column for Dimethyl Ether production

NASA Astrophysics Data System (ADS)

Wahid, A.; Putra, I. G. E. P.

2018-03-01

Dimethyl ether (DME) as an alternative clean energy has attracted a growing attention in the recent years. DME production via reactive distillation has potential for capital cost and energy requirement savings. However, combination of reaction and distillation on a single column makes reactive distillation process a very complex multivariable system with high non-linearity of process and strong interaction between process variables. This study investigates a multivariable model predictive control (MPC) based on two-point temperature control strategy for the DME reactive distillation column to maintain the purities of both product streams. The process model is estimated by a first order plus dead time model. The DME and water purity is maintained by controlling a stage temperature in rectifying and stripping section, respectively. The result shows that the model predictive controller performed faster responses compared to conventional PI controller that are showed by the smaller ISE values. In addition, the MPC controller is able to handle the loop interactions well.

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

PubMed

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

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

PLC based automatic control of pasteurize mix in ice cream production

NASA Astrophysics Data System (ADS)

Yao, Xudong; Liang, Kai

2013-03-01

This paper describes the automatic control device of pasteurized mix in the ice cream production process.We design a scheme of control system using FBD program language and develop the programmer in the STEP 7-Micro/WIN software, check for any bugs before downloading into PLC .These developed devices will able to provide flexibility and accuracy to control the step of pasteurized mix. The operator just Input the duration and temperature of pasteurized mix through control panel. All the steps will finish automatically without any intervention in a preprogrammed sequence stored in programmable logic controller (PLC). With the help of this equipment we not only can control the quality of ice cream for various conditions, but also can simplify the production process. This control system is inexpensive and can be widely used in ice cream production industry.

Use of edible coatings to preserve quality of lightly (and slightly) processed products.

PubMed

Baldwin, E A; Nisperos-Carriedo, M O; Baker, R A

1995-11-01

Lightly processed agricultural products present a special problem to the food industry and to scientists involved in postharvest and food technology research. Light or minimal processing includes cutting, slicing, coring, peeling, trimming, or sectioning of agricultural produce. These products have an active metabolism that can result in deteriorative changes, such as increased respiration and ethylene production. If not controlled, these changes can lead to rapid senescence and general deterioration of the product. In addition, the surface water activity of cut fruits and vegetables is generally quite high, inviting microbial attack, which further reduces product stability. Methods for control of these changes are numerous and can include the use of edible coatings. Also mentioned in this review are coating of nut products, and dried, dehydrated, and freeze-dried fruits. Technically, these are not considered to be minimally processed, but many of the problems and benefits of coating these products are similar to coating lightly processed products. Generally, the potential benefits of edible coatings for processed or lightly processed produce is to stabilize the product and thereby extend product shelf life. More specifically, coatings have the potential to reduce moisture loss, restrict oxygen entrance, lower respiration, retard ethylene production, seal in flavor volatiles, and carry additives that retard discoloration and microbial growth.

Use of artificial intelligence in the production of high quality minced meat

NASA Astrophysics Data System (ADS)

Kapovsky, B. R.; Pchelkina, V. A.; Plyasheshnik, P. I.; Dydykin, A. S.; Lazarev, A. A.

2017-09-01

A design for an automatic line for minced meat production according to new production technology based on an innovative meat milling method is proposed. This method allows the necessary degree of raw material comminution at the stage of raw material preparation to be obtained, which leads to production intensification due to the traditional meat mass comminution equipment being unnecessary. To ensure consistent quality of the product obtained, the use of on-line automatic control of the technological process for minced meat production is envisaged. This system has been developed using artificial intelligence methods and technologies. The system is trainable during the operation process, adapts to changes in processed raw material characteristics and to external impacts that affect the system operation, and manufactures meat shavings with minimal dispersion of the typical particle size. The control system includes equipment for express analysis of the chemical composition of the minced meat and its temperature after comminution. In this case, the minced meat production process can be controlled strictly as a function of time, which excludes subjective factors for assessing the degree of finished product readiness. This will allow finished meat products with consistent, targeted high quality to be produced.

Modelling aspects regarding the control in 13C isotope separation column

NASA Astrophysics Data System (ADS)

Boca, M. L.

2016-08-01

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

Case Studies in Modelling, Control in Food Processes.

PubMed

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

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

Application of a tablet film coating model to define a process-imposed transition boundary for robust film coating.

PubMed

van den Ban, Sander; Pitt, Kendal G; Whiteman, Marshall

2018-02-01

A scientific understanding of interaction of product, film coat, film coating process, and equipment is important to enable design and operation of industrial scale pharmaceutical film coating processes that are robust and provide the level of control required to consistently deliver quality film coated product. Thermodynamic film coating conditions provided in the tablet film coating process impact film coat formation and subsequent product quality. A thermodynamic film coating model was used to evaluate film coating process performance over a wide range of film coating equipment from pilot to industrial scale (2.5-400 kg). An approximate process-imposed transition boundary, from operating in a dry to a wet environment, was derived, for relative humidity and exhaust temperature, and used to understand the impact of the film coating process on product formulation and process control requirements. This approximate transition boundary may aid in an enhanced understanding of risk to product quality, application of modern Quality by Design (QbD) based product development, technology transfer and scale-up, and support the science-based justification of critical process parameters (CPPs).

Process Performance of Optima XEx Single Wafer High Energy Implanter

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

Kim, J. H.; Yoon, Jongyoon; Kondratenko, S.

2011-01-07

To meet the process requirements for well formation in future CMOS memory production, high energy implanters require more robust angle, dose, and energy control while maintaining high productivity. The Optima XEx high energy implanter meets these requirements by integrating a traditional LINAC beamline with a robust single wafer handling system. To achieve beam angle control, Optima XEx can control both the horizontal and vertical beam angles to within 0.1 degrees using advanced beam angle measurement and correction. Accurate energy calibration and energy trim functions accelerate process matching by eliminating energy calibration errors. The large volume process chamber and UDC (upstreammore » dose control) using faraday cups outside of the process chamber precisely control implant dose regardless of any chamber pressure increase due to PR (photoresist) outgassing. An optimized RF LINAC accelerator improves reliability and enables singly charged phosphorus and boron energies up to 1200 keV and 1500 keV respectively with higher beam currents. A new single wafer endstation combined with increased beam performance leads to overall increased productivity. We report on the advanced performance of Optima XEx observed during tool installation and volume production at an advanced memory fab.« less

40 CFR 1051.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM RECREATIONAL ENGINES AND VEHICLES Testing Production-Line Vehicles and Engines § 1051.345 What production-line testing records must I send to EPA? (a.... We have not changed production processes or quality-control procedures for test engines (or vehicles...

40 CFR 1051.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM RECREATIONAL ENGINES AND VEHICLES Testing Production-Line Vehicles and Engines § 1051.345 What production-line testing records must I send to EPA? (a.... We have not changed production processes or quality-control procedures for test engines (or vehicles...

40 CFR 1051.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM RECREATIONAL ENGINES AND VEHICLES Testing Production-Line Vehicles and Engines § 1051.345 What production-line testing records must I send to EPA? (a.... We have not changed production processes or quality-control procedures for test engines (or vehicles...

40 CFR 1051.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM RECREATIONAL ENGINES AND VEHICLES Testing Production-Line Vehicles and Engines § 1051.345 What production-line testing records must I send to EPA? (a.... We have not changed production processes or quality-control procedures for test engines (or vehicles...

40 CFR 1051.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2012 CFR

2012-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM RECREATIONAL ENGINES AND VEHICLES Testing Production-Line Vehicles and Engines § 1051.345 What production-line testing records must I send to EPA? (a.... We have not changed production processes or quality-control procedures for test engines (or vehicles...

A Controlled Agitation Process for Improving Quality of Canned Green Beans during Agitation Thermal Processing.

PubMed

Singh, Anika; Pratap Singh, Anubhav; Ramaswamy, Hosahalli S

2016-06-01

This work introduces the concept of a controlled agitation thermal process to reduce quality damage in liquid-particulate products during agitation thermal processing. Reciprocating agitation thermal processing (RA-TP) was used as the agitation thermal process. In order to reduce the impact of agitation, a new concept of "stopping agitations after sufficient development of cold-spot temperature" was proposed. Green beans were processed in No. 2 (307×409) cans filled with liquids of various consistency (0% to 2% CMC) at various frequencies (1 to 3 Hz) of RA-TP using a full-factorial design and heat penetration results were collected. Corresponding operator's process time to impart a 10-min process lethality (Fo ) and agitation time (AT) were calculated using heat penetration results. Accordingly, products were processed again by stopping agitations as per 3 agitation regimes, namely; full time agitation, equilibration time agitation, and partial time agitation. Processed products were photographed and tested for visual quality, color, texture, breakage of green beans, turbidity, and percentage of insoluble solids in can liquid. Results showed that stopping agitations after sufficient development of cold-spot temperatures is an effective way of reducing product damages caused by agitation (for example, breakage of beans and its leaching into liquid). Agitations till one-log temperature difference gave best color, texture and visual product quality for low-viscosity liquid-particulate mixture and extended agitations till equilibration time was best for high-viscosity products. Thus, it was shown that a controlled agitation thermal process is more effective in obtaining high product quality as compared to a regular agitation thermal process. © 2016 Institute of Food Technologists®

Real time monitoring of powder blend bulk density for coupled feed-forward/feed-back control of a continuous direct compaction tablet manufacturing process.

PubMed

Singh, Ravendra; Román-Ospino, Andrés D; Romañach, Rodolfo J; Ierapetritou, Marianthi; Ramachandran, Rohit

2015-11-10

The pharmaceutical industry is strictly regulated, where precise and accurate control of the end product quality is necessary to ensure the effectiveness of the drug products. For such control, the process and raw materials variability ideally need to be fed-forward in real time into an automatic control system so that a proactive action can be taken before it can affect the end product quality. Variations in raw material properties (e.g., particle size), feeder hopper level, amount of lubrication, milling and blending action, applied shear in different processing stages can affect the blend density significantly and thereby tablet weight, hardness and dissolution. Therefore, real time monitoring of powder bulk density variability and its incorporation into the automatic control system so that its effect can be mitigated proactively and efficiently is highly desired. However, real time monitoring of powder bulk density is still a challenging task because of different level of complexities. In this work, powder bulk density which has a significant effect on the critical quality attributes (CQA's) has been monitored in real time in a pilot-plant facility, using a NIR sensor. The sensitivity of the powder bulk density on critical process parameters (CPP's) and CQA's has been analyzed and thereby feed-forward controller has been designed. The measured signal can be used for feed-forward control so that the corrective actions on the density variations can be taken before they can influence the product quality. The coupled feed-forward/feed-back control system demonstrates improved control performance and improvements in the final product quality in the presence of process and raw material variations. Copyright © 2015 Elsevier B.V. All rights reserved.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-18

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

Implementation of quality by design toward processing of food products.

PubMed

Rathore, Anurag S; Kapoor, Gautam

2017-05-28

Quality by design (QbD) is a systematic approach that begins with predefined objectives and emphasizes product and process understanding and process control. It is an approach based on principles of sound science and quality risk management. As the food processing industry continues to embrace the idea of in-line, online, and/or at-line sensors and real-time characterization for process monitoring and control, the existing gaps with regard to our ability to monitor multiple parameters/variables associated with the manufacturing process will be alleviated over time. Investments made for development of tools and approaches that facilitate high-throughput analytical and process development, process analytical technology, design of experiments, risk analysis, knowledge management, and enhancement of process/product understanding would pave way for operational and economic benefits later in the commercialization process and across other product pipelines. This article aims to achieve two major objectives. First, to review the progress that has been made in the recent years on the topic of QbD implementation in processing of food products and second, present a case study that illustrates benefits of such QbD implementation.

Employee empowerment through team building and use of process control methods.

PubMed

Willems, S

1998-02-01

The article examines the use of statistical process control and performance improvement techniques in employee empowerment. The focus is how these techniques provide employees with information to improve their productivity and become involved in the decision-making process. Findings suggest that at one Mississippi hospital employee improvement has had a positive effect on employee productivity, morale, and quality of work.

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

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

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

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

PubMed

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

2017-03-01

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

The design of control system of livestock feeding processing

NASA Astrophysics Data System (ADS)

Sihombing, Juna; Napitupulu, Humala L.; Hidayati, Juliza

2018-03-01

PT. XYZ is a company that produces animal feed. One type of animal feed produced is 105 ISA P. In carrying out its production process, PT. XYZ faces the problem of rejected feed amounts during 2014 to June 2015 due to the amount of animal feed that exceeds the standard feed quality of 13% of moisture content and 3% for ash content. Therefore, the researchers analyzed the relationship between factors affecting the quality and extent of damage by using regression and correlation and determine the optimum value of each processing process. Analysis results found that variables affecting product quality are mixing time, steam conditioning temperature and cooling time. The most dominant variable affecting the product moisture content is mixing time with the correlation coefficient of (0.7959) and the most dominant variable affecting the ash content of the product during the processing is mixing time with the correlation coefficient of (0.8541). The design of the proposed product processing control is to run the product processing process with mixing time 235 seconds, steam conditioning temperature 87 0C and cooling time 192 seconds. Product quality 105 ISA P obtained by using this design is with 12.16% moisture content and ash content of 2.59%.

Multicapillary SDS-gel electrophoresis for the analysis of fluorescently labeled mAb preparations: a high throughput quality control process for the production of QuantiPlasma and PlasmaScan mAb libraries.

PubMed

Székely, Andrea; Szekrényes, Akos; Kerékgyártó, Márta; Balogh, Attila; Kádas, János; Lázár, József; Guttman, András; Kurucz, István; Takács, László

2014-08-01

Molecular heterogeneity of mAb preparations is the result of various co- and post-translational modifications and to contaminants related to the production process. Changes in molecular composition results in alterations of functional performance, therefore quality control and validation of therapeutic or diagnostic protein products is essential. A special case is the consistent production of mAb libraries (QuantiPlasma™ and PlasmaScan™) for proteome profiling, quality control of which represents a challenge because of high number of mAbs (>1000). Here, we devise a generally applicable multicapillary SDS-gel electrophoresis process for the analysis of fluorescently labeled mAb preparations for the high throughput quality control of mAbs of the QuantiPlasma™ and PlasmaScan™ libraries. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

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

NASA Astrophysics Data System (ADS)

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

2011-09-01

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

Improving the Document Development Process: Integrating Relational Data and Statistical Process Control.

ERIC Educational Resources Information Center

Miller, John

1994-01-01

Presents an approach to document numbering, document titling, and process measurement which, when used with fundamental techniques of statistical process control, reveals meaningful process-element variation as well as nominal productivity models. (SR)

Terms of Productivity, Including the Relationship Between Productivity, Effectiveness and Efficiency.

DTIC Science & Technology

1989-04-01

for Awareness Juran on Planning for Quality, 1988, J.M. Juran What is Total Quality Control? The Japanese Way, 1985, Kaoru Ishikawa Guide to Quality...Control, 1982, Kaoru Ishikawa Andrews, M. (1985). Statistical Process Control: Mandatory Management Tool. Production April 1985. Bushe, G. (1988

[Development of whole process quality control and management system of traditional Chinese medicine decoction pieces based on traditional Chinese medicine quality tree].

PubMed

Yu, Wen-Kang; Dong, Ling; Pei, Wen-Xuan; Sun, Zhi-Rong; Dai, Jun-Dong; Wang, Yun

2017-12-01

The whole process quality control and management of traditional Chinese medicine (TCM) decoction pieces is a system engineering, involving the base environment, seeds and seedlings, harvesting, processing and other multiple steps, so the accurate identification of factors in TCM production process that may induce the quality risk, as well as reasonable quality control measures are very important. At present, the concept of quality risk is mainly concentrated in the aspects of management and regulations, etc. There is no comprehensive analysis on possible risks in the quality control process of TCM decoction pieces, or analysis summary of effective quality control schemes. A whole process quality control and management system for TCM decoction pieces based on TCM quality tree was proposed in this study. This system effectively combined the process analysis method of TCM quality tree with the quality risk management, and can help managers to make real-time decisions while realizing the whole process quality control of TCM. By providing personalized web interface, this system can realize user-oriented information feedback, and was convenient for users to predict, evaluate and control the quality of TCM. In the application process, the whole process quality control and management system of the TCM decoction pieces can identify the related quality factors such as base environment, cultivation and pieces processing, extend and modify the existing scientific workflow according to their own production conditions, and provide different enterprises with their own quality systems, to achieve the personalized service. As a new quality management model, this paper can provide reference for improving the quality of Chinese medicine production and quality standardization. Copyright© by the Chinese Pharmaceutical Association.

Monitoring and control of the biogas process based on propionate concentration using online VFA measurement.

PubMed

Boe, Kanokwan; Steyer, Jean-Philippe; Angelidaki, Irini

2008-01-01

Simple logic control algorithms were tested for automatic control of a lab-scale CSTR manure digester. Using an online VFA monitoring system, propionate concentration in the reactor was used as parameter for control of the biogas process. The propionate concentration was kept below a threshold of 10 mM by manipulating the feed flow. Other online parameters such as pH, biogas production, total VFA, and other individual VFA were also measured to examine process performance. The experimental results showed that a simple logic control can successfully prevent the reactor from overload, but with fluctuations of the propionate level due to the nature of control approach. The fluctuation of propionate concentration could be reduced, by adding a lower feed flow limit into the control algorithm to prevent undershooting of propionate response. It was found that use of the biogas production as a main control parameter, rather than propionate can give a more stable process, since propionate was very persistent and only responded very slowly to the decrease of the feed flow which lead to high fluctuation of biogas production. Propionate, however, was still an excellent parameter to indicate process stress under gradual overload and thus recommended as an alarm in the control algorithm. Copyright IWA Publishing 2008.

Soil nitrate reducing processes – drivers, mechanisms for spatial variation, and significance for nitrous oxide production

PubMed Central

Giles, Madeline; Morley, Nicholas; Baggs, Elizabeth M.; Daniell, Tim J.

2012-01-01

The microbial processes of denitrification and dissimilatory nitrate reduction to ammonium (DNRA) are two important nitrate reducing mechanisms in soil, which are responsible for the loss of nitrate (NO3−) and production of the potent greenhouse gas, nitrous oxide (N2O). A number of factors are known to control these processes, including O2 concentrations and moisture content, N, C, pH, and the size and community structure of nitrate reducing organisms responsible for the processes. There is an increasing understanding associated with many of these controls on flux through the nitrogen cycle in soil systems. However, there remains uncertainty about how the nitrate reducing communities are linked to environmental variables and the flux of products from these processes. The high spatial variability of environmental controls and microbial communities across small sub centimeter areas of soil may prove to be critical in determining why an understanding of the links between biotic and abiotic controls has proved elusive. This spatial effect is often overlooked as a driver of nitrate reducing processes. An increased knowledge of the effects of spatial heterogeneity in soil on nitrate reduction processes will be fundamental in understanding the drivers, location, and potential for N2O production from soils. PMID:23264770

Soil nitrate reducing processes - drivers, mechanisms for spatial variation, and significance for nitrous oxide production.

PubMed

Giles, Madeline; Morley, Nicholas; Baggs, Elizabeth M; Daniell, Tim J

2012-01-01

The microbial processes of denitrification and dissimilatory nitrate reduction to ammonium (DNRA) are two important nitrate reducing mechanisms in soil, which are responsible for the loss of nitrate ([Formula: see text]) and production of the potent greenhouse gas, nitrous oxide (N(2)O). A number of factors are known to control these processes, including O(2) concentrations and moisture content, N, C, pH, and the size and community structure of nitrate reducing organisms responsible for the processes. There is an increasing understanding associated with many of these controls on flux through the nitrogen cycle in soil systems. However, there remains uncertainty about how the nitrate reducing communities are linked to environmental variables and the flux of products from these processes. The high spatial variability of environmental controls and microbial communities across small sub centimeter areas of soil may prove to be critical in determining why an understanding of the links between biotic and abiotic controls has proved elusive. This spatial effect is often overlooked as a driver of nitrate reducing processes. An increased knowledge of the effects of spatial heterogeneity in soil on nitrate reduction processes will be fundamental in understanding the drivers, location, and potential for N(2)O production from soils.

Off-Line Quality Control In Integrated Circuit Fabrication Using Experimental Design

NASA Astrophysics Data System (ADS)

Phadke, M. S.; Kackar, R. N.; Speeney, D. V.; Grieco, M. J.

1987-04-01

Off-line quality control is a systematic method of optimizing production processes and product designs. It is widely used in Japan to produce high quality products at low cost. The method was introduced to us by Professor Genichi Taguchi who is a Deming-award winner and a former Director of the Japanese Academy of Quality. In this paper we will i) describe the off-line quality control method, and ii) document our efforts to optimize the process for forming contact windows in 3.5 Aim CMOS circuits fabricated in the Murray Hill Integrated Circuit Design Capability Laboratory. In the fabrication of integrated circuits it is critically important to produce contact windows of size very near the target dimension. Windows which are too small or too large lead to loss of yield. The off-line quality control method has improved both the process quality and productivity. The variance of the window size has been reduced by a factor of four. Also, processing time for window photolithography has been substantially reduced. The key steps of off-line quality control are: i) Identify important manipulatable process factors and their potential working levels. ii) Perform fractional factorial experiments on the process using orthogonal array designs. iii) Analyze the resulting data to determine the optimum operating levels of the factors. Both the process mean and the process variance are considered in this analysis. iv) Conduct an additional experiment to verify that the new factor levels indeed give an improvement.

Product/Process (P/P) Models For The Defense Waste Processing Facility (DWPF): Model Ranges And Validation Ranges For Future Processing

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

Jantzen, C.; Edwards, T.

Radioactive high level waste (HLW) at the Savannah River Site (SRS) has successfully been vitrified into borosilicate glass in the Defense Waste Processing Facility (DWPF) since 1996. Vitrification requires stringent product/process (P/P) constraints since the glass cannot be reworked once it is poured into ten foot tall by two foot diameter canisters. A unique “feed forward” statistical process control (SPC) was developed for this control rather than statistical quality control (SQC). In SPC, the feed composition to the DWPF melter is controlled prior to vitrification. In SQC, the glass product would be sampled after it is vitrified. Individual glass property-compositionmore » models form the basis for the “feed forward” SPC. The models transform constraints on the melt and glass properties into constraints on the feed composition going to the melter in order to guarantee, at the 95% confidence level, that the feed will be processable and that the durability of the resulting waste form will be acceptable to a geologic repository.« less

Design of Control System for Flexible Packaging Bags Palletizing Production Line Based on PLC

NASA Astrophysics Data System (ADS)

Zheng, Huiping; Chen, Lin; Zhao, Xiaoming; Liu, Zhanyang

Flexible packaging bags palletizing production line is to put the bags in the required area according to particular order and size, in order to finish handling, storage, loading and unloading, transportation and other logistics work of goods. Flexible packaging bags palletizing line is composed of turning bags mechanism, shaping mechanism, indexing mechanism, marshalling mechanism, pushing bags mechanism, pressing bags mechanism, laminating mechanism, elevator, tray warehouse, tray conveyor and loaded tray conveyor. Whether the whole production line can smoothly run depends on each of the above equipment and precision control among them. In this paper the technological process and the control logic of flexible packaging bags palletizing production line is introduced. Palletizing process of the production line realized automation by means of a control system based on programmable logic controller (PLC). It has the advantages of simple structure, reliable and easy maintenance etc.

Image processing system performance prediction and product quality evaluation

NASA Technical Reports Server (NTRS)

Stein, E. K.; Hammill, H. B. (Principal Investigator)

1976-01-01

The author has identified the following significant results. A new technique for image processing system performance prediction and product quality evaluation was developed. It was entirely objective, quantitative, and general, and should prove useful in system design and quality control. The technique and its application to determination of quality control procedures for the Earth Resources Technology Satellite NASA Data Processing Facility are described.

Holographic digital microscopy in on-line process control

NASA Astrophysics Data System (ADS)

Osanlou, Ardeshir

2011-09-01

This article investigates the feasibility of real-time three-dimensional imaging of microscopic objects within various emulsions while being produced in specialized production vessels. The study is particularly relevant to on-line process monitoring and control in chemical, pharmaceutical, food, cleaning, and personal hygiene industries. Such processes are often dynamic and the materials cannot be measured once removed from the production vessel. The technique reported here is applicable to three-dimensional characterization analyses on stirred fluids in small reaction vessels. Relatively expensive pulsed lasers have been avoided through the careful control of the speed of the moving fluid in relation to the speed of the camera exposure and the wavelength of the continuous wave laser used. The ultimate aim of the project is to introduce a fully robust and compact digital holographic microscope as a process control tool in a full size specialized production vessel.

21 CFR 110.80 - Processes and controls.

Code of Federal Regulations, 2010 CFR

2010-04-01

... HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD Production and Process Controls § 110.80 Processes and controls. All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in...

Intelligent monitoring and control of semiconductor manufacturing equipment

NASA Technical Reports Server (NTRS)

Murdock, Janet L.; Hayes-Roth, Barbara

1991-01-01

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

[The main directions of improving the system of state accounting and control of radioactive substances and radioactive waste products].

PubMed

2012-01-01

This paper describes a modification of the basic directions of state accounting and control of radioactive substances and radioactive waste products, whose implementation will significantly improve the efficiency of its operation at the regional level. Selected areas are designed to improve accounting and control system for the submission of the enterprises established by the reporting forms, the quality of the information contained in them, as well as structures of information and process for collecting, analyzing and data processing concerning radioactive substances and waste products.

Model based adaptive control of a continuous capture process for monoclonal antibodies production.

PubMed

Steinebach, Fabian; Angarita, Monica; Karst, Daniel J; Müller-Späth, Thomas; Morbidelli, Massimo

2016-04-29

A two-column capture process for continuous processing of cell-culture supernatant is presented. Similar to other multicolumn processes, this process uses sequential countercurrent loading of the target compound in order maximize resin utilization and productivity for a given product yield. The process was designed using a novel mechanistic model for affinity capture, which takes both specific adsorption as well as transport through the resin beads into account. Simulations as well as experimental results for the capture of an IgG antibody are discussed. The model was able to predict the process performance in terms of yield, productivity and capacity utilization. Compared to continuous capture with two columns operated batch wise in parallel, a 2.5-fold higher capacity utilization was obtained for the same productivity and yield. This results in an equal improvement in product concentration and reduction of buffer consumption. The developed model was used not only for the process design and optimization but also for its online control. In particular, the unit operating conditions are changed in order to maintain high product yield while optimizing the process performance in terms of capacity utilization and buffer consumption also in the presence of changing upstream conditions and resin aging. Copyright © 2016 Elsevier B.V. All rights reserved.

Economic Statistical Design of Integrated X-bar-S Control Chart with Preventive Maintenance and General Failure Distribution

PubMed Central

Caballero Morales, Santiago Omar

2013-01-01

The application of Preventive Maintenance (PM) and Statistical Process Control (SPC) are important practices to achieve high product quality, small frequency of failures, and cost reduction in a production process. However there are some points that have not been explored in depth about its joint application. First, most SPC is performed with the X-bar control chart which does not fully consider the variability of the production process. Second, many studies of design of control charts consider just the economic aspect while statistical restrictions must be considered to achieve charts with low probabilities of false detection of failures. Third, the effect of PM on processes with different failure probability distributions has not been studied. Hence, this paper covers these points, presenting the Economic Statistical Design (ESD) of joint X-bar-S control charts with a cost model that integrates PM with general failure distribution. Experiments showed statistically significant reductions in costs when PM is performed on processes with high failure rates and reductions in the sampling frequency of units for testing under SPC. PMID:23527082

On the Design of a Fuzzy Logic-Based Control System for Freeze-Drying Processes.

PubMed

Fissore, Davide

2016-12-01

This article is focused on the design of a fuzzy logic-based control system to optimize a drug freeze-drying process. The goal of the system is to keep product temperature as close as possible to the threshold value of the formulation being processed, without trespassing it, in such a way that product quality is not jeopardized and the sublimation flux is maximized. The method involves the measurement of product temperature and a set of rules that have been obtained through process simulation with the goal to obtain a unique set of rules for products with very different characteristics. Input variables are the difference between the temperature of the product and the threshold value, the difference between the temperature of the heating fluid and that of the product, and the rate of change of product temperature. The output variables are the variation of the temperature of the heating fluid and the pressure in the drying chamber. The effect of the starting value of the input variables and of the control interval has been investigated, thus resulting in the optimal configuration of the control system. Experimental investigation carried out in a pilot-scale freeze-dryer has been carried out to validate the proposed system. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

A modified oxic-settling-anaerobic activated sludge process using gravity thickening for excess sludge reduction

NASA Astrophysics Data System (ADS)

Wang, Jun; Li, Shi-Yu; Jiang, Feng; Wu, Ke; Liu, Guang-Li; Lu, Hui; Chen, Guang-Hao

2015-09-01

Oxic-settling-anaerobic process (OSA) was known as a cost-effective way to reduce the excess sludge production with simple upgrade of conventional activated sludge process (CAS). A low oxidation-reduction potential (ORP) level was the key factor to sludge decay and lysis in the sludge holding tank of the OSA process. However, the ORP control with nitrogen purge or chemical dosing in the OSA process would induce extra expense and complicate the operation. Hence, in this study, a sludge holding tank using gravity thickening was applied to OSA process to reduce the excess sludge production without any ORP control. Results showed that the modified OSA process not only reduced the excess sludge production effectively but also improved the sludge settleability without affected the treatment capacity. The reduction of the excess sludge production in the modified OSA process resulted from interactions among lots of factors. The key element of the process was the gravity thickening sludge holding tank.

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

PubMed

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

2013-05-01

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

Fermentanomics: Relating quality attributes of a monoclonal antibody to cell culture process variables and raw materials using multivariate data analysis.

PubMed

Rathore, Anurag S; Kumar Singh, Sumit; Pathak, Mili; Read, Erik K; Brorson, Kurt A; Agarabi, Cyrus D; Khan, Mansoor

2015-01-01

Fermentanomics is an emerging field of research and involves understanding the underlying controlled process variables and their effect on process yield and product quality. Although major advancements have occurred in process analytics over the past two decades, accurate real-time measurement of significant quality attributes for a biotech product during production culture is still not feasible. Researchers have used an amalgam of process models and analytical measurements for monitoring and process control during production. This article focuses on using multivariate data analysis as a tool for monitoring the internal bioreactor dynamics, the metabolic state of the cell, and interactions among them during culture. Quality attributes of the monoclonal antibody product that were monitored include glycosylation profile of the final product along with process attributes, such as viable cell density and level of antibody expression. These were related to process variables, raw materials components of the chemically defined hybridoma media, concentration of metabolites formed during the course of the culture, aeration-related parameters, and supplemented raw materials such as glucose, methionine, threonine, tryptophan, and tyrosine. This article demonstrates the utility of multivariate data analysis for correlating the product quality attributes (especially glycosylation) to process variables and raw materials (especially amino acid supplements in cell culture media). The proposed approach can be applied for process optimization to increase product expression, improve consistency of product quality, and target the desired quality attribute profile. © 2015 American Institute of Chemical Engineers.

[Establishment of industry promotion technology system in Chinese medicine secondary exploitation based on "component structure theory"].

PubMed

Cheng, Xu-Dong; Feng, Liang; Zhang, Ming-Hua; Gu, Jun-Fei; Jia, Xiao-Bin

2014-10-01

The purpose of the secondary exploitation of Chinese medicine is to improve the quality of Chinese medicine products, enhance core competitiveness, for better use in clinical practice, and more effectively solve the patient suffering. Herbs, extraction, separation, refreshing, preparation and quality control are all involved in the industry promotion of Chinese medicine secondary exploitation of industrial production. The Chinese medicine quality improvement and industry promotion could be realized with the whole process of process optimization, quality control, overall processes improvement. Based on the "component structure theory", "multi-dimensional structure & process dynamic quality control system" and systematic and holistic character of Chinese medicine, impacts of whole process were discussed. Technology systems of Chinese medicine industry promotion was built to provide theoretical basis for improving the quality and efficacy of the secondary development of traditional Chinese medicine products.

Process computerization of No. 13 blast furnace at Gary works

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

Sherman, G.J.; Zmierski, M.L.; Hyle, F.W.

1993-10-01

No. 13 blast furnace underwent extensive modifications to the process control system during the second reline. This represents a major shift in control philosophy from hardwired relays and analog controllers to a totally integrated computer control system. The new system created the opportunity for comprehensive diagnostic analysis and increased flexibility for control strategy modifications. The goal of achieving maximum production with minimal delay was accomplished by an integrated test, and comprehensive operator and maintenance training. Normal production was reached within four days of blow-ink and design production capacity of 7800 NTHM/day was met in the third month of operation. Recordmore » furnace productivity of 8931 NTHM/day (8.56 NTHM/100 crwv) was achieved in less than five months of operation and again in April 1992 of 9062 NTHM/day (8.68 NTHM/100 cfwv).« less

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

NASA Astrophysics Data System (ADS)

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

2014-04-01

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

Impact of processing on the bioavailability and vascular effects of blueberry (poly)phenols.

PubMed

Rodriguez-Mateos, Ana; Del Pino-García, Raquel; George, Trevor W; Vidal-Diez, Alberto; Heiss, Christian; Spencer, Jeremy P E

2014-10-01

Blueberries are a rich source of flavonoids and phenolic acids. Currently, little information is available regarding the impact of processing on the bioavailability and the bioactivity of blueberry (poly)phenols. In a randomized, controlled crossover trial, ten healthy volunteers consumed (a) blueberry-containing baked products, (b) an unprocessed blueberry drink containing the same amount of freeze-dried blueberry powder as used in the baked products, and (c) matched control baked products. Endothelial function was measured as flow-mediated dilation (FMD) and plasma samples taken at baseline and at 1, 2, 4, and 6 h postconsumption. Although processing did not significantly change the total (poly)phenolic amount, the processed products contained significantly less anthocyanins (-42%), more chlorogenic acid (23%), no flavanol nonamers or decamers, and significantly more flavanol dimers and trimers (36% and 28%, respectively). FMD increased after 1, 2, and 6 h consumption of the baked products to a similar degree as the unprocessed blueberries, despite significant differences in the levels of individual plasma metabolites. No changes were observed after the consumption of the control product. Careful processing can preserve important biological activities of blueberries despite changing the blueberry (poly)phenol composition and plasma metabolite profile. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

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

DTIC Science & Technology

1996-01-01

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

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.

The numerical modelling and process simulation for the fault diagnosis of rotary kiln incinerator.

PubMed

Roh, S D; Kim, S W; Cho, W S

2001-10-01

The numerical modelling and process simulation for the fault diagnosis of rotary kiln incinerator were accomplished. In the numerical modelling, two models applied to the modelling within the kiln are the combustion chamber model including the mass and energy balance equations for two combustion chambers and 3D thermal model. The combustion chamber model predicts temperature within the kiln, flue gas composition, flux and heat of combustion. Using the combustion chamber model and 3D thermal model, the production-rules for the process simulation can be obtained through interrelation analysis between control and operation variables. The process simulation of the kiln is operated with the production-rules for automatic operation. The process simulation aims to provide fundamental solutions to the problems in incineration process by introducing an online expert control system to provide an integrity in process control and management. Knowledge-based expert control systems use symbolic logic and heuristic rules to find solutions for various types of problems. It was implemented to be a hybrid intelligent expert control system by mutually connecting with the process control systems which has the capability of process diagnosis, analysis and control.

21 CFR 120.24 - Process controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Process controls. 120.24 Section 120.24 Food and... CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS Pathogen Reduction § 120.24 Process controls. (a) In order to meet the requirements of subpart A of this part, processors of juice products...

21 CFR 120.24 - Process controls.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Process controls. 120.24 Section 120.24 Food and... CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS Pathogen Reduction § 120.24 Process controls. (a) In order to meet the requirements of subpart A of this part, processors of juice products...

21 CFR 120.24 - Process controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Process controls. 120.24 Section 120.24 Food and... CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS Pathogen Reduction § 120.24 Process controls. (a) In order to meet the requirements of subpart A of this part, processors of juice products...

21 CFR 120.24 - Process controls.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Process controls. 120.24 Section 120.24 Food and... CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS Pathogen Reduction § 120.24 Process controls. (a) In order to meet the requirements of subpart A of this part, processors of juice products...

Network-based production quality control

NASA Astrophysics Data System (ADS)

Kwon, Yongjin; Tseng, Bill; Chiou, Richard

2007-09-01

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

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

PubMed

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

2015-05-01

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

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

PubMed

Boiret, Mathieu; Chauchard, Fabien

2017-01-01

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

The remote supervisory and controlling experiment system of traditional Chinese medicine production based on Fieldbus

NASA Astrophysics Data System (ADS)

Zhan, Jinliang; Lu, Pei

2006-11-01

Since the quality of traditional Chinese medicine products are affected by raw material, machining and many other factors, it is difficult for traditional Chinese medicine production process especially the extracting process to ensure the steady and homogeneous quality. At the same time, there exist some quality control blind spots due to lacking on-line quality detection means. But if infrared spectrum analysis technology was used in traditional Chinese medicine production process on the basis of off-line analysis to real-time detect the quality of semi-manufactured goods and to be assisted by advanced automatic control technique, the steady and homogeneous quality can be obtained. It can be seen that the on-line detection of extracting process plays an important role in the development of Chinese patent medicines industry. In this paper, the design and implement of a traditional Chinese medicine extracting process monitoring experiment system which is based on PROFIBUS-DP field bus, OPC, and Internet technology is introduced. The system integrates intelligence node which gathering data, superior sub-system which achieving figure configuration and remote supervisory, during the process of traditional Chinese medicine production, monitors the temperature parameter, pressure parameter, quality parameter etc. And it can be controlled by the remote nodes in the VPN (Visual Private Network). Experiment and application do have proved that the system can reach the anticipation effect fully, and with the merits of operational stability, real-time, reliable, convenient and simple manipulation and so on.

Control and Diagnosis in Integrated Product Development - Observations during the Development of an AGV

NASA Astrophysics Data System (ADS)

Stetter, R.; Simundsson, A.

2015-11-01

This paper is concerned with the integration of control and diagnosis functionalities into the development of complete systems which include mechanical, electrical and electronic subsystems. For the development of such systems the strategies, methods and tools of integrated product development have attracted significant attention during the last decades. Today, it is generally observed that product development processes of complex systems can only be successful if the activities in the different domains are well connected and synchronised and if an ongoing communication is present - an ongoing communication spanning the technical domains and also including functions such as production planning, marketing/distribution, quality assurance, service and project planning. Obviously, numerous approaches to tackle this challenge are present in scientific literature and in industrial practice, as well. Today, the functionality and safety of most products is to a large degree dependent on control and diagnosis functionalities. Still, there is comparatively little research concentrating on the integration of the development of these functionalities into the overall product development processes. The main source of insight of the presented research is the product development process of an Automated Guided Vehicle (AGV) which is intended to be used on rough terrain. The paper starts with a background describing Integrated Product Development. The second section deals with the product development of the sample product. The third part summarizes some insights and formulates first hypotheses concerning control and diagnosis in Integrated Product Development.

Performance of ASML YieldStar μDBO overlay targets for advanced lithography nodes C028 and C014 overlay process control

NASA Astrophysics Data System (ADS)

Blancquaert, Yoann; Dezauzier, Christophe; Depre, Jerome; Miqyass, Mohamed; Beltman, Jan

2013-04-01

Continued tightening of overlay control budget in semiconductor lithography drives the need for improved metrology capabilities. Aggressive improvements are needed for overlay metrology speed, accuracy and precision. This paper is dealing with the on product metrology results of a scatterometry based platform showing excellent production results on resolution, precision, and tool matching for overlay. We will demonstrate point to point matching between tool generations as well as between target sizes and types. Nowadays, for the advanced process nodes a lot of information is needed (Higher order process correction, Reticle fingerprint, wafer edge effects) to quantify process overlay. For that purpose various overlay sampling schemes are evaluated: ultra- dense, dense and production type. We will show DBO results from multiple target type and shape for on product overlay control for current and future node down to at least 14 nm node. As overlay requirements drive metrology needs, we will evaluate if the new metrology platform meets the overlay requirements.

Cell-controlled hybrid perfusion fed-batch CHO cell process provides significant productivity improvement over conventional fed-batch cultures.

PubMed

Hiller, Gregory W; Ovalle, Ana Maria; Gagnon, Matthew P; Curran, Meredith L; Wang, Wenge

2017-07-01

A simple method originally designed to control lactate accumulation in fed-batch cultures of Chinese Hamster Ovary (CHO) cells has been modified and extended to allow cells in culture to control their own rate of perfusion to precisely deliver nutritional requirements. The method allows for very fast expansion of cells to high density while using a minimal volume of concentrated perfusion medium. When the short-duration cell-controlled perfusion is performed in the production bioreactor and is immediately followed by a conventional fed-batch culture using highly concentrated feeds, the overall productivity of the culture is approximately doubled when compared with a highly optimized state-of-the-art fed-batch process. The technology was applied with near uniform success to five CHO cell processes producing five different humanized monoclonal antibodies. The increases in productivity were due to the increases in sustained viable cell densities. Biotechnol. Bioeng. 2017;114: 1438-1447. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Safety Analysis of Soybean Processing for Advanced Life Support

NASA Technical Reports Server (NTRS)

Hentges, Dawn L.

1999-01-01

Soybeans (cv. Hoyt) is one of the crops planned for food production within the Advanced Life Support System Integration Testbed (ALSSIT), a proposed habitat simulation for long duration lunar/Mars missions. Soybeans may be processed into a variety of food products, including soymilk, tofu, and tempeh. Due to the closed environmental system and importance of crew health maintenance, food safety is a primary concern on long duration space missions. Identification of the food safety hazards and critical control points associated with the closed ALSSIT system is essential for the development of safe food processing techniques and equipment. A Hazard Analysis Critical Control Point (HACCP) model was developed to reflect proposed production and processing protocols for ALSSIT soybeans. Soybean processing was placed in the type III risk category. During the processing of ALSSIT-grown soybeans, critical control points were identified to control microbiological hazards, particularly mycotoxins, and chemical hazards from antinutrients. Critical limits were suggested at each CCP. Food safety recommendations regarding the hazards and risks associated with growing, harvesting, and processing soybeans; biomass management; and use of multifunctional equipment were made in consideration of the limitations and restraints of the closed ALSSIT.

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

NASA Astrophysics Data System (ADS)

Maneechote, T.; Luangpaiboon, P.

2010-10-01

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

A rugged landscape model for self-organization and emergent leadership in creative problem solving and production groups.

PubMed

Guastello, Stephen J; Craven, Joanna; Zygowicz, Karen M; Bock, Benjamin R

2005-07-01

The process by which an initially leaderless group differentiates into one containing leadership and secondary role structures was examined using the swallowtail catastrophe model and principles of selforganization. The objectives were to identify the control variables in the process of leadership emergence in creative problem solving groups and production groups. In the first of two experiments, groups of university students (total N = 114) played a creative problem solving game. Participants later rated each other on leadership behavior, styles, and variables related to the process of conversation. A performance quality measure was included also. Control parameters in the swallowtail catastrophe model were identified through a combination of factor analysis and nonlinear regression. Leaders displayed a broad spectrum of behaviors in the general categories of Controlling the Conversation and Creativity in their role-play. In the second experiment, groups of university students (total N = 197) engaged in a laboratory work experiment that had a substantial production goal component. The same system of ratings and modeling strategy was used along with a work production measure. Leaders in the production task emerged to the extent that they exhibited control over both the creative and production aspects of the task, they could keep tension low, and the externally imposed production goals were realistic.

Advanced control of dissolved oxygen concentration in fed batch cultures during recombinant protein production.

PubMed

Kuprijanov, A; Gnoth, S; Simutis, R; Lübbert, A

2009-02-01

Design and experimental validation of advanced pO(2) controllers for fermentation processes operated in the fed-batch mode are described. In most situations, the presented controllers are able to keep the pO(2) in fermentations for recombinant protein productions exactly on the desired value. The controllers are based on the gain-scheduling approach to parameter-adaptive proportional-integral controllers. In order to cope with the most often appearing distortions, the basic gain-scheduling feedback controller was complemented with a feedforward control component. This feedforward/feedback controller significantly improved pO(2) control. By means of numerical simulations, the controller behavior was tested and its parameters were determined. Validation runs were performed with three Escherichia coli strains producing different recombinant proteins. It is finally shown that the new controller leads to significant improvements in the signal-to-noise ratio of other key process variables and, thus, to a higher process quality.

40 CFR 1054.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... 1054. We have not changed production processes or quality-control procedures for test engines in a way...) Describe any facility used to test production-line engines and state its location. (2) State the total U.S...

40 CFR 1054.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... 1054. We have not changed production processes or quality-control procedures for test engines in a way...) Describe any facility used to test production-line engines and state its location. (2) State the total U.S...

40 CFR 1054.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... 1054. We have not changed production processes or quality-control procedures for test engines in a way...) Describe any facility used to test production-line engines and state its location. (2) State the total U.S...

40 CFR 1054.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2012 CFR

2012-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... 1054. We have not changed production processes or quality-control procedures for test engines in a way...) Describe any facility used to test production-line engines and state its location. (2) State the total U.S...

40 CFR 1054.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... 1054. We have not changed production processes or quality-control procedures for test engines in a way...) Describe any facility used to test production-line engines and state its location. (2) State the total U.S...

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

Code of Federal Regulations, 2010 CFR

2010-04-01

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

Properties of TiNi intermetallic compound industrially produced by combustion synthesis

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

Kaieda, Yoshinari

Most TiNi shape memory intermetallic compounds are conventionally produced by the process including high frequency induction vacuum melting and casting. A gravity segregation occurs in a cast TiNi ingot because of the big difference in the specific gravity between Ti and Ni. It is difficult to control accurately the phase transformation temperature of TiNi shape memory intermetallic compound produced by the conventional process, because the martensitic transformation temperature shifts by 10K due to the change in 0.1 % of Ni content. Homogeneous TiNi intermetallic compound is produced by the industrial process including combustion synthesis method, which is a newly developedmore » manufacturing process. In the new process, phase transformation temperatures of TiNi can be controlled accurately by controlling the ratio of Ti and Ni elemental starting powders. The chemical component, the impurities and the phase transformation temperatures of the TiNi products industrially produced by the process are revealed. These properties are vitally important when combustion synthesis method is applied to an industrial mass production process for producing TiNi shape memory intermetallic compounds. TiNi shape memory products are industrially and commercially produced today the industrial process including combustion synthesis. The total production weight in a year is 30 tins in 1994.« less

Improved process robustness by using closed loop control in deep drawing applications

NASA Astrophysics Data System (ADS)

Barthau, M.; Liewald, M.; Christian, Held

2017-09-01

The production of irregular shaped deep-drawing parts with high quality requirements, which are common in today’s automotive production, permanently challenges production processes. High requirements on lightweight construction of passenger car bodies following European regulations until 2020 have been massively increasing the use of high strength steels substantially for years and are also leading to bigger challenges in sheet metal part production. Of course, the more and more complex shapes of today’s car body shells also intensify the issue due to modern and future design criteria. The metal forming technology tries to meet these challenges by developing a highly sophisticated layout of deep drawing dies that consider part quality requirements, process robustness and controlled material flow during the deep or stretch drawing process phase. A new method for controlling material flow using a closed loop system was developed at the IFU Stuttgart. In contrast to previous approaches, this new method allows a control intervention during the deep-drawing stroke. The blank holder force around the outline of the drawn part is used as control variable. The closed loop is designed as trajectory follow up with feed forward control. The used command variable is the part-wall stress that is measured with a piezo-electric measuring pin. In this paper the used control loop will be described in detail. The experimental tool that was built for testing the new control approach is explained here with its features. A method for gaining the follow up trajectories from simulation will also be presented. Furthermore, experimental results considering the robustness of the deep drawing process and the gain in process performance with developed control loop will be shown. Finally, a new procedure for the industrial application of the new control method of deep drawing will be presented by using a new kind of active element to influence the local blank holder pressure onto part flange.

Low-Cost Detection of Thin Film Stress during Fabrication

NASA Technical Reports Server (NTRS)

Nabors, Sammy A.

2015-01-01

NASA's Marshall Space Flight Center has developed a simple, cost-effective optical method for thin film stress measurements during growth and/or subsequent annealing processes. Stress arising in thin film fabrication presents production challenges for electronic devices, sensors, and optical coatings; it can lead to substrate distortion and deformation, impacting the performance of thin film products. NASA's technique measures in-situ stress using a simple, noncontact fiber optic probe in the thin film vacuum deposition chamber. This enables real-time monitoring of stress during the fabrication process and allows for efficient control of deposition process parameters. By modifying process parameters in real time during fabrication, thin film stress can be optimized or controlled, improving thin film product performance.

9 CFR 318.306 - Processing and production records.

Code of Federal Regulations, 2010 CFR

2010-01-01

... and style; container code; container size and type; and the process schedule, including the minimum... product temperature. (Approved by the Office of Management and Budget under control number 0583-0015) ...

Computational neuroanatomy of speech production.

PubMed

Hickok, Gregory

2012-01-05

Speech production has been studied predominantly from within two traditions, psycholinguistics and motor control. These traditions have rarely interacted, and the resulting chasm between these approaches seems to reflect a level of analysis difference: whereas motor control is concerned with lower-level articulatory control, psycholinguistics focuses on higher-level linguistic processing. However, closer examination of both approaches reveals a substantial convergence of ideas. The goal of this article is to integrate psycholinguistic and motor control approaches to speech production. The result of this synthesis is a neuroanatomically grounded, hierarchical state feedback control model of speech production.

Control of the dehydration process in production of intermediate-moisture meat products: a review.

PubMed

Chang, S F; Huang, T C; Pearson, A M

1996-01-01

IM meat products are produced by lowering the aw to 0.90 to 0.60. Such products are stable at ambient temperature and humidity and are produced in nearly every country in the world, especially in developing areas where refrigeration is limited or unavailable. Traditionally IM meats use low cost sources of energy for drying, such as sun drying, addition of salt, or fermentation. Products produced by different processes are of interest since they do not require refrigeration during distribution and storage. Many different IM meat products can be produced by utilizing modern processing equipment and methods. Production can be achieved in a relatively short period of time and their advantages during marketing and distribution can be utilized. Nevertheless, a better understanding of the principles involved in heat transfer and efficiency of production are still needed to increase efficiency of processing. A basic understanding of the influence of water vapor pressure and sorption phenomena on water activity can materially improve the efficiency of drying of IM meats. Predrying treatments, such as fermentation and humidity control, can also be taken advantage of during the dehydration process. Such information can lead to process optimization and reduction of energy costs during production of IM meats. The development of sound science-based methods to assure the production of high-quality and nutritious IM meats is needed. Finally, such products also must be free of pathogenic microorganisms to assure their success in production and marketing.

Digital mapping of the Mars Pathfinder landing site: Design, acquisition, and derivation of cartographic products for science applications

USGS Publications Warehouse

Gaddis, L.R.; Kirk, R.L.; Johnson, J. R.; Soderblom, L.A.; Ward, A.W.; Barrett, J.; Becker, K.; Decker, T.; Blue, J.; Cook, D.; Eliason, E.; Hare, T.; Howington-Kraus, E.; Isbell, C.; Lee, E.M.; Redding, B.; Sucharski, R.; Sucharski, T.; Smith, P.H.; Britt, D.T.

1999-01-01

The Imager for Mars Pathfinder (IMP) acquired more than 16,000 images and provided panoramic views of the surface of Mars at the Mars Pathfinder landing site in Ares Vallis. This paper describes the stereoscopic, multispectral IMP imaging sequences and focuses on their use for digital mapping of the landing site and for deriving cartographic products to support science applications of these data. Two-dimensional cartographic processing of IMP data, as performed via techniques and specialized software developed for ISIS (the U.S.Geological Survey image processing software package), is emphasized. Cartographic processing of IMP data includes ingestion, radiometric correction, establishment of geometric control, coregistration of multiple bands, reprojection, and mosaicking. Photogrammetric processing, an integral part of this cartographic work which utilizes the three-dimensional character of the IMP data, supplements standard processing with geometric control and topographic information [Kirk et al., this issue]. Both cartographic and photogrammetric processing are required for producing seamless image mosaics and for coregistering the multispectral IMP data. Final, controlled IMP cartographic products include spectral cubes, panoramic (360?? azimuthal coverage) and planimetric (top view) maps, and topographic data, to be archived on four CD-ROM volumes. Uncontrolled and semicontrolled versions of these products were used to support geologic characterization of the landing site during the nominal and extended missions. Controlled products have allowed determination of the topography of the landing site and environs out to ???60 m, and these data have been used to unravel the history of large- and small-scale geologic processes which shaped the observed landing site. We conclude by summarizing several lessons learned from cartographic processing of IMP data. Copyright 1999 by the American Geophysical Union.

Final Technical Report - Advanced Optical Sensors to Minimize Energy Consumption in Polymer Extrusion Processes

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

Susan J. Foulk

Project Objective: The objectives of this study are to develop an accurate and stable on-line sensor system to monitor color and composition on-line in polymer melts, to develop a scheme for using the output to control extruders to eliminate the energy, material and operational costs of off-specification product, and to combine or eliminate some extrusion processes. Background: Polymer extrusion processes are difficult to control because the quality achieved in the final product is complexly affected by the properties of the extruder screw, speed of extrusion, temperature, polymer composition, strength and dispersion properties of additives, and feeder system properties. Extruder systemsmore » are engineered to be highly reproducible so that when the correct settings to produce a particular product are found, that product can be reliably produced time after time. However market conditions often require changes in the final product, different products or grades may be processed in the same equipment, and feed materials vary from lot to lot. All of these changes require empirical adjustment of extruder settings to produce a product meeting specifications. Optical sensor systems that can continuously monitor the composition and color of the extruded polymer could detect process upsets, drift, blending oscillations, and changes in dispersion of additives. Development of an effective control algorithm using the output of the monitor would enable rapid corrections for changes in materials and operating conditions, thereby eliminating most of the scrap and recycle of current processing. This information could be used to identify extruder systems issues, diagnose problem sources, and suggest corrective actions in real-time to help keep extruder system settings within the optimum control region. Using these advanced optical sensor systems would give extruder operators real-time feedback from their process. They could reduce the amount of off-spec product produced and significantly reduce energy consumption. Also, because blending and dispersion of additives and components in the final product could be continuously verified, we believe that, in many cases, intermediate compounding steps could be eliminated (saving even more time and energy).« less

The Hazard Analysis and Critical Control Points (HACCP) generic model for the production of Thai fermented pork sausage (Nham).

PubMed

Paukatong, K V; Kunawasen, S

2001-01-01

Nham is a traditional Thai fermented pork sausage. The major ingredients of Nham are ground pork meat and shredded pork rind. Nham has been reported to be contaminated with Salmonella spp., Staphylococcus aureus, and Listeria monocytogenes. Therefore, it is a potential cause of foodborne diseases for consumers. A Hazard Analysis and Critical Control Points (HACCP) generic model has been developed for the Nham process. Nham processing plants were observed and a generic flow diagram of Nham processes was constructed. Hazard analysis was then conducted. Other than microbial hazards, the pathogens previously found in Nham, sodium nitrite and metal were identified as chemical and physical hazards in this product, respectively. Four steps in the Nham process have been identified as critical control points. These steps are the weighing of the nitrite compound, stuffing, fermentation, and labeling. The chemical hazard of nitrite must be controlled during the weighing step. The critical limit of nitrite levels in the Nham mixture has been set at 100-200 ppm. This level is high enough to control Clostridium botulinum but does not cause chemical hazards to the consumer. The physical hazard from metal clips could be prevented by visual inspection of every Nham product during stuffing. The microbiological hazard in Nham could be reduced in the fermentation process. The critical limit of the pH of Nham was set at lower than 4.6. Since this product is not cooked during processing, finally, educating the consumer, by providing information on the label such as "safe if cooked before consumption", could be an alternative way to prevent the microbiological hazards of this product.

Quick generation of Raman spectroscopy based in-process glucose control to influence biopharmaceutical protein product quality during mammalian cell culture.

PubMed

Berry, Brandon N; Dobrowsky, Terrence M; Timson, Rebecca C; Kshirsagar, Rashmi; Ryll, Thomas; Wiltberger, Kelly

2016-01-01

Mitigating risks to biotherapeutic protein production processes and products has driven the development of targeted process analytical technology (PAT); however implementing PAT during development without significantly increasing program timelines can be difficult. The development of a monoclonal antibody expressed in a Chinese hamster ovary (CHO) cell line via fed-batch processing presented an opportunity to demonstrate capabilities of altering percent glycated protein product. Glycation is caused by pseudo-first order, non-enzymatic reaction of a reducing sugar with an amino group. Glucose is the highest concentration reducing sugar in the chemically defined media (CDM), thus a strategy controlling glucose in the production bioreactor was developed utilizing Raman spectroscopy for feedback control. Raman regions for glucose were determined by spiking studies in water and CDM. Calibration spectra were collected during 8 bench scale batches designed to capture a wide glucose concentration space. Finally, a PLS model capable of translating Raman spectra to glucose concentration was built using the calibration spectra and spiking study regions. Bolus feeding in mammalian cell culture results in wide glucose concentration ranges. Here we describe the development of process automation enabling glucose setpoint control. Glucose-free nutrient feed was fed daily, however glucose stock solution was fed as needed according to online Raman measurements. Two feedback control conditions were executed where glucose was controlled at constant low concentration or decreased stepwise throughout. Glycation was reduced from ∼9% to 4% using a low target concentration but was not reduced in the stepwise condition as compared to the historical bolus glucose feeding regimen. © 2015 American Institute of Chemical Engineers.

Development of Chemical Process Design and Control for Sustainability

EPA Science Inventory

This contribution describes a novel process systems engineering framework that couples advanced control with sustainability evaluation and decision making for the optimization of process operations to minimize environmental impacts associated with products, materials, and energy....

40 CFR 763.167 - Processing prohibitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

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

PLANT - An experimental task for the study of human problem solving in process control. [Production Levels and Network Troubleshooting

NASA Technical Reports Server (NTRS)

Morris, N. M.; Rouse, W. B.; Fath, J. L.

1985-01-01

An experimental tool for the investigation of human problem-solving behavior is introduced. Production Levels and Network Troubleshooting (PLANT) is a computer-based process-control task which may be used to provide opportunities for subjects to control a dynamic system and diagnose, repair, and compensate for system failures. The task is described in detail, and experiments which have been conducted using PLANT are briefly discussed.

Method of controlling a resin curing process. [for fiber reinforced composites

NASA Technical Reports Server (NTRS)

Webster, Charles Neal (Inventor); Scott, Robert O. (Inventor)

1989-01-01

The invention relates to an analytical technique for controlling the curing process of fiber-reinforced composite materials that are formed using thermosetting resins. The technique is the percent gel method and involves development of a time-to-gel equation as a function of temperature. From this equation a rate-of-gel equation is then determined, and a percent gel is calculated which is the product of rate-of-gel times time. Percent gel accounting is used to control the proper pressure application point in an autoclave cure process to achieve desired properties in a production composite part.

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

PubMed

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

2014-01-01

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

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

PubMed

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

2016-07-01

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

Process control and dosimetry in a multipurpose irradiation facility

NASA Astrophysics Data System (ADS)

Cabalfin, E. G.; Lanuza, L. G.; Solomon, H. M.

1999-08-01

Availability of the multipurpose irradiation facility at the Philippine Nuclear Research Institute has encouraged several local industries to use gamma radiation for sterilization or decontamination of various products. Prior to routine processing, dose distribution studies are undertaken for each product and product geometry. During routine irradiation, dosimeters are placed at the minimum and maximum dose positions of a process load.

Liquid phase methanol reactor staging process for the production of methanol

DOEpatents

Bonnell, Leo W.; Perka, Alan T.; Roberts, George W.

1988-01-01

The present invention is a process for the production of methanol from a syngas feed containing carbon monoxide, carbon dioxide and hydrogen. Basically, the process is the combination of two liquid phase methanol reactors into a staging process, such that each reactor is operated to favor a particular reaction mechanism. In the first reactor, the operation is controlled to favor the hydrogenation of carbon monoxide, and in the second reactor, the operation is controlled so as to favor the hydrogenation of carbon dioxide. This staging process results in substantial increases in methanol yield.

Fuzzy control of burnout of multilayer ceramic actuators

NASA Astrophysics Data System (ADS)

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

1996-08-01

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

50 CFR 260.97 - Conditions for providing fishery products inspection service at official establishments.

Code of Federal Regulations, 2010 CFR

2010-10-01

... CERTIFICATION Inspection and Certification of Establishments and Fishery Products for Human Consumption... control systems and cooperation. The inspection effort requirement may be reevaluated when the contracting...; or (2) For production errors, such as processing temperatures, length of process, or misbranding of...

50 CFR 260.97 - Conditions for providing fishery products inspection service at official establishments.

Code of Federal Regulations, 2011 CFR

2011-10-01

... CERTIFICATION Inspection and Certification of Establishments and Fishery Products for Human Consumption... control systems and cooperation. The inspection effort requirement may be reevaluated when the contracting...; or (2) For production errors, such as processing temperatures, length of process, or misbranding of...

Faculty Return to Industry. Final Report.

ERIC Educational Resources Information Center

Hulse, David R.

Lagging productivity and increased competitiveness from abroad are forcing U.S. management companies to adopt new management styles that promote efficiency and quality in production. High on the agenda is the incorporation of Statistical Process Control (SPC). SPC requires definition of process and product specifications to facilitate their…

21 CFR 211.110 - Sampling and testing of in-process materials and drug products.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Sampling and testing of in-process materials and... PHARMACEUTICALS Production and Process Controls § 211.110 Sampling and testing of in-process materials and drug... testing. (b) Valid in-process specifications for such characteristics shall be consistent with drug...

21 CFR 211.110 - Sampling and testing of in-process materials and drug products.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Sampling and testing of in-process materials and... PHARMACEUTICALS Production and Process Controls § 211.110 Sampling and testing of in-process materials and drug... testing. (b) Valid in-process specifications for such characteristics shall be consistent with drug...

21 CFR 211.110 - Sampling and testing of in-process materials and drug products.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Sampling and testing of in-process materials and... PHARMACEUTICALS Production and Process Controls § 211.110 Sampling and testing of in-process materials and drug... testing. (b) Valid in-process specifications for such characteristics shall be consistent with drug...

21 CFR 211.110 - Sampling and testing of in-process materials and drug products.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Sampling and testing of in-process materials and... PHARMACEUTICALS Production and Process Controls § 211.110 Sampling and testing of in-process materials and drug... testing. (b) Valid in-process specifications for such characteristics shall be consistent with drug...

21 CFR 211.110 - Sampling and testing of in-process materials and drug products.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Sampling and testing of in-process materials and... PHARMACEUTICALS Production and Process Controls § 211.110 Sampling and testing of in-process materials and drug... testing. (b) Valid in-process specifications for such characteristics shall be consistent with drug...

Research and Process-Optimization on Mixed Crystal Caused Uneven-Performance of High-strength Structural Car Steel QStE500TM

NASA Astrophysics Data System (ADS)

Jian-wen, Li; Hong-yan, Liu

Handan Iron and Steel production of high-strength structural car steel QStE500TM thin gauge products using Nb + Ti composite strengthening, with a small amount of Cr element to improve its hardenability, the process parameter control is inappropriate with Nb + Ti complex steel, it is easy to produce in the mixed crystal phenomenon, resulting in decreasing the toughness and uneven performance. In this paper, Gleeble 3500 thermal simulation testing machine for high-strength structural steel car QStE500TM product deformation austenite recrystallization behavior research, determined completely recrystallized, partial recrystallization and non-recrystallization region, provide theoretical basis and necessary data for reasonable controlled rolling process for production.

Improving lactate metabolism in an intensified CHO culture process: productivity and product quality considerations.

PubMed

Xu, Sen; Hoshan, Linda; Chen, Hao

2016-11-01

In this study, we discussed the development and optimization of an intensified CHO culture process, highlighting medium and control strategies to improve lactate metabolism. A few strategies, including supplementing glucose with other sugars (fructose, maltose, and galactose), controlling glucose level at <0.2 mM, and supplementing medium with copper sulfate, were found to be effective in reducing lactate accumulation. Among them, copper sulfate supplementation was found to be critical for process optimization when glucose was in excess. When copper sulfate was supplemented in the new process, two-fold increase in cell density (66.5 ± 8.4 × 10(6) cells/mL) and titer (11.9 ± 0.6 g/L) was achieved. Productivity and product quality attributes differences between batch, fed-batch, and concentrated fed-batch cultures were discussed. The importance of process and cell metabolism understanding when adapting the existing process to a new operational mode was demonstrated in the study.

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

PubMed

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

2018-01-01

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

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

PubMed

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

2015-01-01

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

Object positioning in storages of robotized workcells using LabVIEW Vision

NASA Astrophysics Data System (ADS)

Hryniewicz, P.; Banaś, W.; Sękala, A.; Gwiazda, A.; Foit, K.; Kost, G.

2015-11-01

During the manufacturing process, each performed task is previously developed and adapted to the conditions and the possibilities of the manufacturing plant. The production process is supervised by a team of specialists because any downtime causes great loss of time and hence financial loss. Sensors used in industry for tracking and supervision various stages of a production process make it much easier to maintain it continuous. One of groups of sensors used in industrial applications are non-contact sensors. This group includes: light barriers, optical sensors, rangefinders, vision systems, and ultrasonic sensors. Through to the rapid development of electronics the vision systems were widespread as the most flexible type of non-contact sensors. These systems consist of cameras, devices for data acquisition, devices for data analysis and specialized software. Vision systems work well as sensors that control the production process itself as well as the sensors that control the product quality level. The LabVIEW program as well as the LabVIEW Vision and LabVIEW Builder represent the application that enables program the informatics system intended to process and product quality control. The paper presents elaborated application for positioning elements in a robotized workcell. Basing on geometric parameters of manipulated object or on the basis of previously developed graphical pattern it is possible to determine the position of particular manipulated elements. This application could work in an automatic mode and in real time cooperating with the robot control system. It allows making the workcell functioning more autonomous.

Using Paper Helicopters to Teach Statistical Process Control

ERIC Educational Resources Information Center

Johnson, Danny J.

2011-01-01

This hands-on project uses a paper helicopter to teach students how to distinguish between common and special causes of variability when developing and using statistical process control charts. It allows the student to experience a process that is out-of-control due to imprecise or incomplete product design specifications and to discover how the…

Comparison of Grand Median and Cumulative Sum Control Charts on Shuttlecock Weight Variable in CV Marjoko Kompas dan Domas

NASA Astrophysics Data System (ADS)

Musdalifah, N.; Handajani, S. S.; Zukhronah, E.

2017-06-01

Competition between the homoneous companies cause the company have to keep production quality. To cover this problem, the company controls the production with statistical quality control using control chart. Shewhart control chart is used to normal distributed data. The production data is often non-normal distribution and occured small process shift. Grand median control chart is a control chart for non-normal distributed data, while cumulative sum (cusum) control chart is a sensitive control chart to detect small process shift. The purpose of this research is to compare grand median and cusum control charts on shuttlecock weight variable in CV Marjoko Kompas dan Domas by generating data as the actual distribution. The generated data is used to simulate multiplier of standard deviation on grand median and cusum control charts. Simulation is done to get average run lenght (ARL) 370. Grand median control chart detects ten points that out of control, while cusum control chart detects a point out of control. It can be concluded that grand median control chart is better than cusum control chart.

Batch statistical process control of a fluid bed granulation process using in-line spatial filter velocimetry and product temperature measurements.

PubMed

Burggraeve, A; Van den Kerkhof, T; Hellings, M; Remon, J P; Vervaet, C; De Beer, T

2011-04-18

Fluid bed granulation is a batch process, which is characterized by the processing of raw materials for a predefined period of time, consisting of a fixed spraying phase and a subsequent drying period. The present study shows the multivariate statistical modeling and control of a fluid bed granulation process based on in-line particle size distribution (PSD) measurements (using spatial filter velocimetry) combined with continuous product temperature registration using a partial least squares (PLS) approach. Via the continuous in-line monitoring of the PSD and product temperature during granulation of various reference batches, a statistical batch model was developed allowing the real-time evaluation and acceptance or rejection of future batches. Continuously monitored PSD and product temperature process data of 10 reference batches (X-data) were used to develop a reference batch PLS model, regressing the X-data versus the batch process time (Y-data). Two PLS components captured 98.8% of the variation in the X-data block. Score control charts in which the average batch trajectory and upper and lower control limits are displayed were developed. Next, these control charts were used to monitor 4 new test batches in real-time and to immediately detect any deviations from the expected batch trajectory. By real-time evaluation of new batches using the developed control charts and by computation of contribution plots of deviating process behavior at a certain time point, batch losses or reprocessing can be prevented. Immediately after batch completion, all PSD and product temperature information (i.e., a batch progress fingerprint) was used to estimate some granule properties (density and flowability) at an early stage, which can improve batch release time. Individual PLS models relating the computed scores (X) of the reference PLS model (based on the 10 reference batches) and the density, respectively, flowabililty as Y-matrix, were developed. The scores of the 4 test batches were used to examine the predictive ability of the model. Copyright © 2011 Elsevier B.V. All rights reserved.

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

PubMed

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

2017-11-01

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

40 CFR 63.1425 - Process vent control requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Standards for Hazardous Air Pollutant Emissions for Polyether Polyols Production § 63.1425 Process vent... operators of all affected sources using epoxides in the production of polyether polyols are subject to the... (c) of this section only if epoxides are used in the production of polyether polyols and nonepoxide...

Control of polysilicon on-film particulates with on-product measurements

NASA Astrophysics Data System (ADS)

Barker, Judith B.; Chain, Elizabeth E.; Plachecki, Vincent E.

1997-08-01

Historically, a number of in-line particle measurements have been performed on separate test wafers included with product wafers during polysilicon processes. By performing film thickness and particulate measurements directly on product wafers, instead, a number of benefits accrue: (1) reduced test wafer usage, (2) reduced test wafer storage requirements, (3) reduced need for equipment to reclaim test wafers, (4) reduced need for direct labor to reclaim test wafers, and (5) reduced engineering 'false alarms' due to incorrectly processed test wafers. Implementation of on-product measurements for the polysilicon diffusion process required a number of changes in both philosophy and methodology. We show the necessary steps to implementation of on-product particle measurements with concern for overall manufacturing efficiency and the need to maintain appropriate control. Particle results from the Tencor 7600 Surfscan are presented.

An integrated process analytical technology (PAT) approach to monitoring the effect of supercooling on lyophilization product and process parameters of model monoclonal antibody formulations.

PubMed

Awotwe Otoo, David; Agarabi, Cyrus; Khan, Mansoor A

2014-07-01

The aim of the present study was to apply an integrated process analytical technology (PAT) approach to control and monitor the effect of the degree of supercooling on critical process and product parameters of a lyophilization cycle. Two concentrations of a mAb formulation were used as models for lyophilization. ControLyo™ technology was applied to control the onset of ice nucleation, whereas tunable diode laser absorption spectroscopy (TDLAS) was utilized as a noninvasive tool for the inline monitoring of the water vapor concentration and vapor flow velocity in the spool during primary drying. The instantaneous measurements were then used to determine the effect of the degree of supercooling on critical process and product parameters. Controlled nucleation resulted in uniform nucleation at lower degrees of supercooling for both formulations, higher sublimation rates, lower mass transfer resistance, lower product temperatures at the sublimation interface, and shorter primary drying times compared with the conventional shelf-ramped freezing. Controlled nucleation also resulted in lyophilized cakes with more elegant and porous structure with no visible collapse or shrinkage, lower specific surface area, and shorter reconstitution times compared with the uncontrolled nucleation. Uncontrolled nucleation however resulted in lyophilized cakes with relatively lower residual moisture contents compared with controlled nucleation. TDLAS proved to be an efficient tool to determine the endpoint of primary drying. There was good agreement between data obtained from TDLAS-based measurements and SMART™ technology. ControLyo™ technology and TDLAS showed great potential as PAT tools to achieve enhanced process monitoring and control during lyophilization cycles. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Multi-Mission Automated Task Invocation Subsystem

NASA Technical Reports Server (NTRS)

Cheng, Cecilia S.; Patel, Rajesh R.; Sayfi, Elias M.; Lee, Hyun H.

2009-01-01

Multi-Mission Automated Task Invocation Subsystem (MATIS) is software that establishes a distributed data-processing framework for automated generation of instrument data products from a spacecraft mission. Each mission may set up a set of MATIS servers for processing its data products. MATIS embodies lessons learned in experience with prior instrument- data-product-generation software. MATIS is an event-driven workflow manager that interprets project-specific, user-defined rules for managing processes. It executes programs in response to specific events under specific conditions according to the rules. Because requirements of different missions are too diverse to be satisfied by one program, MATIS accommodates plug-in programs. MATIS is flexible in that users can control such processing parameters as how many pipelines to run and on which computing machines to run them. MATIS has a fail-safe capability. At each step, MATIS captures and retains pertinent information needed to complete the step and start the next step. In the event of a restart, this information is retrieved so that processing can be resumed appropriately. At this writing, it is planned to develop a graphical user interface (GUI) for monitoring and controlling a product generation engine in MATIS. The GUI would enable users to schedule multiple processes and manage the data products produced in the processes. Although MATIS was initially designed for instrument data product generation,

Proactive detection of bones in poultry processing

NASA Astrophysics Data System (ADS)

Daley, W. D. R.; Stewart, John

2009-05-01

Bones continue to be a problem of concern for the poultry industry. Most further processed products begin with the requirement for raw material with minimal bones. The current process for generating deboned product requires systems for monitoring and inspecting the output product. The current detection systems are either people palpitating the product or X-ray systems. The current performance of these inspection techniques are below the desired levels of accuracies and are costly. We propose a technique for monitoring bones that conduct the inspection operation in the deboning the process so as to have enough time to take action to reduce the probability that bones will end up in the final product. This is accomplished by developing active cones with built in illumination to backlight the cage (skeleton) on the deboning line. If the bones of interest are still on the cage then the bones are not in the associated meat. This approach also allows for the ability to practice process control on the deboning operation to keep the process under control as opposed to the current system where the detection is done post production and does not easily present the opportunity to adjust the process. The proposed approach shows overall accuracies of about 94% for the detection of the clavicle bones.

Managing computer-controlled operations

NASA Technical Reports Server (NTRS)

Plowden, J. B.

1985-01-01

A detailed discussion of Launch Processing System Ground Software Production is presented to establish the interrelationships of firing room resource utilization, configuration control, system build operations, and Shuttle data bank management. The production of a test configuration identifier is traced from requirement generation to program development. The challenge of the operational era is to implement fully automated utilities to interface with a resident system build requirements document to eliminate all manual intervention in the system build operations. Automatic update/processing of Shuttle data tapes will enhance operations during multi-flow processing.

Chemometrics-based process analytical technology (PAT) tools: applications and adaptation in pharmaceutical and biopharmaceutical industries.

PubMed

Challa, Shruthi; Potumarthi, Ravichandra

2013-01-01

Process analytical technology (PAT) is used to monitor and control critical process parameters in raw materials and in-process products to maintain the critical quality attributes and build quality into the product. Process analytical technology can be successfully implemented in pharmaceutical and biopharmaceutical industries not only to impart quality into the products but also to prevent out-of-specifications and improve the productivity. PAT implementation eliminates the drawbacks of traditional methods which involves excessive sampling and facilitates rapid testing through direct sampling without any destruction of sample. However, to successfully adapt PAT tools into pharmaceutical and biopharmaceutical environment, thorough understanding of the process is needed along with mathematical and statistical tools to analyze large multidimensional spectral data generated by PAT tools. Chemometrics is a chemical discipline which incorporates both statistical and mathematical methods to obtain and analyze relevant information from PAT spectral tools. Applications of commonly used PAT tools in combination with appropriate chemometric method along with their advantages and working principle are discussed. Finally, systematic application of PAT tools in biopharmaceutical environment to control critical process parameters for achieving product quality is diagrammatically represented.

21 CFR 820.70 - Production and process controls.

Code of Federal Regulations, 2014 CFR

2014-04-01

... to ensure that a device conforms to its specifications. Where deviations from device specifications... specifications. Where process controls are needed they shall include: (1) Documented instructions, standard... establish and maintain procedures for changes to a specification, method, process, or procedure. Such...

21 CFR 820.70 - Production and process controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... to ensure that a device conforms to its specifications. Where deviations from device specifications... specifications. Where process controls are needed they shall include: (1) Documented instructions, standard... establish and maintain procedures for changes to a specification, method, process, or procedure. Such...

A new method for the continuous production of single dosed controlled release matrix systems based on hot-melt extruded starch: analysis of relevant process parameters and implementation of an in-process control.

PubMed

Kipping, Thomas; Rein, Hubert

2013-05-01

In the present study, we evaluated a novel processing technique for the continuous production of hot-melt extruded controlled release matrix systems. A cutting technique derived from plastics industry, where it is widely used for cutting of cables and wires was adapted into the production line. Extruded strands were shaped by a rotary fly cutter. Special focus is laid on the development of a process analytical technology by evaluating signals obtained from the servo control of the rotary fly cutter. The intention is to provide a better insight into the production process and to offer the ability to detect small variations in process-variables. A co-rotating twin-screw extruder ZSE 27 HP-PH from Leistritz (Nürnberg, Germany) was used to plasticize the starch; critical extrusion parameters were recorded. Still elastic strands were shaped by a rotary fly-cutter type Dynamat 20 from Metzner (Neu-Ulm, Germany). Properties of the final products were analyzed via digital image analysis to point out critical parameters influencing the quality. Important aspects were uniformity of diameter, height, roundness, weight, and variations in the cutting angle. Stability of the products was measured by friability tests and by determining the crushing strength of the final products. Drug loading studies up to 70% were performed to evaluate the capacity of the matrix and to prove the technological feasibility. Changes in viscosities during API addition were analyzed by a Haake Minilab capillary rheometer. X-ray studies were performed to investigate molecular structures of the matrices. External shapes of the products were highly affected by die-swelling of the melt. Reliable reproducibility concerning uniformity of mass could be achieved even for high production rates (>2500cuts/min). Both mechanical strength and die-swelling of the products could be linked to the ratio of amylose to amylopectin. Formulations containing up to 70% of API could still be processed. Viscosity measurements revealed the plasticizing effect caused by API addition. Dissolution data proved the suitability of extruded starch matrices as a sustained release dosage form. Monitoring of consumed energies during the cutting process could be linked to changes in viscosity. The established PAT system enables the detection of small variations in material properties and can be an important tool to further improve process stability. Copyright © 2013 Elsevier B.V. All rights reserved.

Pitch perception and production in congenital amusia: Evidence from Cantonese speakers.

PubMed

Liu, Fang; Chan, Alice H D; Ciocca, Valter; Roquet, Catherine; Peretz, Isabelle; Wong, Patrick C M

2016-07-01

This study investigated pitch perception and production in speech and music in individuals with congenital amusia (a disorder of musical pitch processing) who are native speakers of Cantonese, a tone language with a highly complex tonal system. Sixteen Cantonese-speaking congenital amusics and 16 controls performed a set of lexical tone perception, production, singing, and psychophysical pitch threshold tasks. Their tone production accuracy and singing proficiency were subsequently judged by independent listeners, and subjected to acoustic analyses. Relative to controls, amusics showed impaired discrimination of lexical tones in both speech and non-speech conditions. They also received lower ratings for singing proficiency, producing larger pitch interval deviations and making more pitch interval errors compared to controls. Demonstrating higher pitch direction identification thresholds than controls for both speech syllables and piano tones, amusics nevertheless produced native lexical tones with comparable pitch trajectories and intelligibility as controls. Significant correlations were found between pitch threshold and lexical tone perception, music perception and production, but not between lexical tone perception and production for amusics. These findings provide further evidence that congenital amusia is a domain-general language-independent pitch-processing deficit that is associated with severely impaired music perception and production, mildly impaired speech perception, and largely intact speech production.

Pitch perception and production in congenital amusia: Evidence from Cantonese speakers

PubMed Central

Liu, Fang; Chan, Alice H. D.; Ciocca, Valter; Roquet, Catherine; Peretz, Isabelle; Wong, Patrick C. M.

2016-01-01

This study investigated pitch perception and production in speech and music in individuals with congenital amusia (a disorder of musical pitch processing) who are native speakers of Cantonese, a tone language with a highly complex tonal system. Sixteen Cantonese-speaking congenital amusics and 16 controls performed a set of lexical tone perception, production, singing, and psychophysical pitch threshold tasks. Their tone production accuracy and singing proficiency were subsequently judged by independent listeners, and subjected to acoustic analyses. Relative to controls, amusics showed impaired discrimination of lexical tones in both speech and non-speech conditions. They also received lower ratings for singing proficiency, producing larger pitch interval deviations and making more pitch interval errors compared to controls. Demonstrating higher pitch direction identification thresholds than controls for both speech syllables and piano tones, amusics nevertheless produced native lexical tones with comparable pitch trajectories and intelligibility as controls. Significant correlations were found between pitch threshold and lexical tone perception, music perception and production, but not between lexical tone perception and production for amusics. These findings provide further evidence that congenital amusia is a domain-general language-independent pitch-processing deficit that is associated with severely impaired music perception and production, mildly impaired speech perception, and largely intact speech production. PMID:27475178

Use of near-infrared spectroscopy (NIRs) in the biopharmaceutical industry for real-time determination of critical process parameters and integration of advanced feedback control strategies using MIDUS control.

PubMed

Vann, Lucas; Sheppard, John

2017-12-01

Control of biopharmaceutical processes is critical to achieve consistent product quality. The most challenging unit operation to control is cell growth in bioreactors due to the exquisitely sensitive and complex nature of the cells that are converting raw materials into new cells and products. Current monitoring capabilities are increasing, however, the main challenge is now becoming the ability to use the data generated in an effective manner. There are a number of contributors to this challenge including integration of different monitoring systems as well as the functionality to perform data analytics in real-time to generate process knowledge and understanding. In addition, there is a lack of ability to easily generate strategies and close the loop to feedback into the process for advanced process control (APC). The current research aims to demonstrate the use of advanced monitoring tools along with data analytics to generate process understanding in an Escherichia coli fermentation process. NIR spectroscopy was used to measure glucose and critical amino acids in real-time to help in determining the root cause of failures associated with different lots of yeast extract. First, scale-down of the process was required to execute a simple design of experiment, followed by scale-up to build NIR models as well as soft sensors for advanced process control. In addition, the research demonstrates the potential for a novel platform technology that enables manufacturers to consistently achieve "goldenbatch" performance through monitoring, integration, data analytics, understanding, strategy design and control (MIDUS control). MIDUS control was employed to increase batch-to-batch consistency in final product titers, decrease the coefficient of variability from 8.49 to 1.16%, predict possible exhaust filter failures and close the loop to prevent their occurrence and avoid lost batches.

Assessing Subjectivity in Sensor Data Post Processing via a Controlled Experiment

NASA Astrophysics Data System (ADS)

Jones, A. S.; Horsburgh, J. S.; Eiriksson, D.

2017-12-01

Environmental data collected by in situ sensors must be reviewed to verify validity, and conducting quality control often requires making edits in post processing to generate approved datasets. This process involves decisions by technicians, data managers, or data users on how to handle problematic data. Options include: removing data from a series, retaining data with annotations, and altering data based on algorithms related to adjacent data points or the patterns of data at other locations or of other variables. Ideally, given the same dataset and the same quality control guidelines, multiple data quality control technicians would make the same decisions in data post processing. However, despite the development and implementation of guidelines aimed to ensure consistent quality control procedures, we have faced ambiguity when performing post processing, and we have noticed inconsistencies in the practices of individuals performing quality control post processing. Technicians with the same level of training and using the same input datasets may produce different results, affecting the overall quality and comparability of finished data products. Different results may also be produced by technicians that do not have the same level of training. In order to assess the effect of subjective decision making by the individual technician on the end data product, we designed an experiment where multiple users performed quality control post processing on the same datasets using a consistent set of guidelines, field notes, and tools. We also assessed the effect of technician experience and training by conducting the same procedures with a group of novices unfamiliar with the data and the quality control process and compared their results to those generated by a group of more experienced technicians. In this presentation, we report our observations of the degree of subjectivity in sensor data post processing, assessing and quantifying the impacts of individual technician as well as technician experience on quality controlled data products.

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.

Using the scanning electron microscope on the production line to assure quality semiconductors

NASA Technical Reports Server (NTRS)

Adolphsen, J. W.; Anstead, R. J.

1972-01-01

The use of the scanning electron microscope to detect metallization defects introduced during batch processing of semiconductor devices is discussed. A method of determining metallization integrity was developed which culminates in a procurement specification using the scanning microscope on the production line as a quality control tool. Batch process control of the metallization operation is monitored early in the manufacturing cycle.

9 CFR 381.306 - Processing and production records.

Code of Federal Regulations, 2010 CFR

2010-01-01

... recorded by the establishment: Date of production; product name and style; container code; container size... product temperature. (Approved by the Office of Management and Budget under control number 0583-0015) ...

Control by quality: proposition of a typology.

PubMed

Pujo, P; Pillet, M

The application of Quality tools and methods in industrial management has always had a fundamental impact on the control of production. It influences the behavior of the actors concerned, while introducing the necessary notions and formalizations, especially for production systems with little or no automation, which constitute a large part of the industrial activity. Several quality approaches are applied in the workshop and are implemented at the level of the control. In this paper, the authors present a typology of the various approaches that have successively influenced control, such as statistical process control, quality assurance, and continuous improvement. First the authors present a parallel between production control and quality organizational structure. They note the duality between control, which is aimed at increasing productivity, and quality, which aims to satisfy the needs of the customer. They also note the hierarchical organizational structure of these two systems of management with, at each level, the notion of a feedback loop. This notion is fundamental to any kind of decision making. The paper is organized around the operational, tactical, and strategic levels, by describing for each level the main methods and tools for control by quality. The overview of these tools and methods starts at the operational level, with the Statistical Process Control, the Taguchi technique, and the "six sigma" approach. On the tactical level, we find a quality system approach, with a documented description of the procedures introduced in the firm. The management system can refer here to Quality Assurance, Total Productive Maintenance, or Management by Total Quality. The formalization through procedures of the rules of decision governing the process control enhances the validity of these rules. This leads to the enhancement of their reliability and to their consolidation. All this counterbalances the human, intrinsically fluctuating, behavior of the control operators. Strategic control by quality is then detailed, and the two main approaches, the continuous improvement approach and the proactive improvement approach, are introduced. Finally, the authors observe that at each of the three levels, the continuous process improvement, which is a component of Total Quality, becomes an essential preoccupation for the control. Ultimately, the recursive utilization of the Deming cycle remains the best practice for the control by quality.

Near infrared spectroscopy based monitoring of extraction processes of raw material with the help of dynamic predictive modeling

NASA Astrophysics Data System (ADS)

Wang, Haixia; Suo, Tongchuan; Wu, Xiaolin; Zhang, Yue; Wang, Chunhua; Yu, Heshui; Li, Zheng

2018-03-01

The control of batch-to-batch quality variations remains a challenging task for pharmaceutical industries, e.g., traditional Chinese medicine (TCM) manufacturing. One difficult problem is to produce pharmaceutical products with consistent quality from raw material of large quality variations. In this paper, an integrated methodology combining the near infrared spectroscopy (NIRS) and dynamic predictive modeling is developed for the monitoring and control of the batch extraction process of licorice. With the spectra data in hand, the initial state of the process is firstly estimated with a state-space model to construct a process monitoring strategy for the early detection of variations induced by the initial process inputs such as raw materials. Secondly, the quality property of the end product is predicted at the mid-course during the extraction process with a partial least squares (PLS) model. The batch-end-time (BET) is then adjusted accordingly to minimize the quality variations. In conclusion, our study shows that with the help of the dynamic predictive modeling, NIRS can offer the past and future information of the process, which enables more accurate monitoring and control of process performance and product quality.

Tumorigenicity assessment of human cell-processed therapeutic products.

PubMed

Yasuda, Satoshi; Sato, Yoji

2015-09-01

Human pluripotent stem cells (hPSCs) are expected to be sources of various cell types used for cell therapy, although hPSCs are intrinsically tumorigenic and form teratomas in immunodeficient animals after transplant. Despite the urgent need, no detailed guideline for the assessment of tumorigenicity of human cell-processed therapeutic products (hCTPs) has been issued. Here we describe our consideration on tumorigenicity and related tests of hCTPs. The purposes of those tests for hPSC-based products are classified into three categories: 1) quality control of raw materials; 2) quality control of intermediate/final products; and 3) safety assessment of final products. Appropriate types of tests need to be selected, taking the purpose(s) into consideration. In contrast, human somatic (and somatic stem) cells are believed to have little tumorigenicity. Therefore, GMP-compliant quality control is essential to avoid contamination of somatic cell-derived products with tumorigenic cells. Compared with in vivo tumorigenicity tests, in vitro cell proliferation assays may be more useful and reasonable for detecting immortalized cells that have a growth advantage in somatic cell-based products. The results obtained from tumorigenicity and related tests for hCTPs should meet the criteria for decisions on product development, manufacturing processes, and clinical applications. Copyright © 2015.

New approaches to digital transformation of petrochemical production

NASA Astrophysics Data System (ADS)

Andieva, E. Y.; Kapelyuhovskaya, A. A.

2017-08-01

The newest concepts of the reference architecture of digital industrial transformation are considered, the problems of their application for the enterprises having in their life cycle oil products processing and marketing are revealed. The concept of the reference architecture, providing a systematic representation of the fundamental changes in the approaches to production management based on the automation of production process control is proposed.

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.

Base Stock Policy in a Join-Type Production Line with Advanced Demand Information

NASA Astrophysics Data System (ADS)

Hiraiwa, Mikihiko; Tsubouchi, Satoshi; Nakade, Koichi

Production control such as the base stock policy, the kanban policy and the constant work-in-process policy in a serial production line has been studied by many researchers. Production lines, however, usually have fork-type, join-type or network-type figures. In addition, in most previous studies on production control, a finished product is required at the same time as arrival of demand at the system. Demand information is, however, informed before due date in practice. In this paper a join-type (assembly) production line under base stock control with advanced demand information in discrete time is analyzed. The recursive equations for the work-in-process are derived. The heuristic algorithm for finding appropriate base stock levels of all machines at short time is proposed and the effect of advanced demand information is examined by simulation with the proposed algorithm. It is shown that the inventory cost can decreases with little backlogs by using the appropriate amount of demand information and setting appropriate base stock levels.

Advances in Process Control.

ERIC Educational Resources Information Center

Morrison, David L.; And Others

1982-01-01

Advances in electronics and computer science have enabled industries (pulp/paper, iron/steel, petroleum/chemical) to attain better control of their processes with resulting increases in quality, productivity, profitability, and compliance with government regulations. (JN)

Fulfillment of GMP standard, halal standard, and applying HACCP for production process of beef floss (Case study: Ksatria enterprise)

NASA Astrophysics Data System (ADS)

A'diat, Arkan Addien Al; Liquiddanu, Eko; Laksono, Pringgo Widyo; Sutopo, Wahyudi; Suletra, I. Wayan

2018-02-01

Along with the increasing number of the modern retail business in Indonesia, give an opportunity to small and medium enterprise (SME) to sell its products through the modern retailer. There are some obstacles faced by the SMEs, one of them is about product standard. Product standard that must be owned by SMEs are GMP standard and halal standard. This research was conducted to know the fulfillment by the beef floss enterprise in jagalan in fulfilling the GMP standard and halal. In addition, Hazard Analysis and Critical Control Points (HACCP) system was applied to analyze the process. HACCP which used in this research was based on the seven principles in SNI (Indonesian National Standard) 01-4852-1998. The seven principles included hazard analysis, critical control point (CCP) determination, critical limit establishment, CCP monitor system establishment, corrective action establishment, verification, and also documentation establishment that must be applied in preparing HACCP plan. Based on this case study, it is concluded that there were 5 CCPs : the boiling process, roasting process, frying process, the beef floss draining process, and the packaging process.

REDUCING WASTEWATER FROM CUCUMBER PICKLING PROCESS BY CONTROLLED CULTURE FERMENTATION

EPA Science Inventory

On a demonstration scale, the controlled culture fermentation process (CCF) developed by the U.S. Food Fermentation Laboratory was compared with the conventional natural fermentation process (NF) in regard to product quality and yield and volume and concentration of wastewaters. ...

3D Printing Optical Engine for Controlling Material Microstructure

NASA Astrophysics Data System (ADS)

Huang, Wei-Chin; Chang, Kuang-Po; Wu, Ping-Han; Wu, Chih-Hsien; Lin, Ching-Chih; Chuang, Chuan-Sheng; Lin, De-Yau; Liu, Sung-Ho; Horng, Ji-Bin; Tsau, Fang-Hei

Controlling the cooling rate of alloy during melting and resolidification is the most commonly used method for varying the material microstructure and consequently the resuling property. However, the cooling rate of a selective laser melting (SLM) production is restricted by a preset optimal parameter of a good dense product. The head room for locally manipulating material property in a process is marginal. In this study, we invent an Optical Engine for locally controlling material microstructure in a SLM process. It develops an invovative method to control and adjust thermal history of the solidification process to gain desired material microstucture and consequently drastically improving the quality. Process parameters selected locally for specific materials requirement according to designed characteristics by using thermal dynamic principles of solidification process. It utilize a technique of complex laser beam shape of adaptive irradiation profile to permit local control of material characteristics as desired. This technology could be useful for industrial application of medical implant, aerospace and automobile industries.

Neuro-estimator based GMC control of a batch reactive distillation.

PubMed

Prakash, K J Jithin; Patle, Dipesh S; Jana, Amiya K

2011-07-01

In this paper, an artificial neural network (ANN)-based nonlinear control algorithm is proposed for a simulated batch reactive distillation (RD) column. In the homogeneously catalyzed reactive process, an esterification reaction takes place for the production of ethyl acetate. The fundamental model has been derived incorporating the reaction term in the model structure of the nonreactive distillation process. The process operation is simulated at the startup phase under total reflux conditions. The open-loop process dynamics is also addressed running the batch process at the production phase under partial reflux conditions. In this study, a neuro-estimator based generic model controller (GMC), which consists of an ANN-based state predictor and the GMC law, has been synthesized. Finally, this proposed control law has been tested on the representative batch reactive distillation comparing with a gain-scheduled proportional integral (GSPI) controller and with its ideal performance (ideal GMC). Copyright © 2011 ISA. Published by Elsevier Ltd. All rights reserved.

Scheduling algorithms for automatic control systems for technological processes

NASA Astrophysics Data System (ADS)

Chernigovskiy, A. S.; Tsarev, R. Yu; Kapulin, D. V.

2017-01-01

Wide use of automatic process control systems and the usage of high-performance systems containing a number of computers (processors) give opportunities for creation of high-quality and fast production that increases competitiveness of an enterprise. Exact and fast calculations, control computation, and processing of the big data arrays - all of this requires the high level of productivity and, at the same time, minimum time of data handling and result receiving. In order to reach the best time, it is necessary not only to use computing resources optimally, but also to design and develop the software so that time gain will be maximal. For this purpose task (jobs or operations), scheduling techniques for the multi-machine/multiprocessor systems are applied. Some of basic task scheduling methods for the multi-machine process control systems are considered in this paper, their advantages and disadvantages come to light, and also some usage considerations, in case of the software for automatic process control systems developing, are made.

CONTROL OF MICROBIAL CONTAMINANTS AND DISINFECTION BY-PRODUCTS (DBPS): COST AND PERFORMANCE

EPA Science Inventory

The USEPA is in the process of developing a sophisticated regulatory strategy in an attempt to balance the complex trade-offs in risks associated with controlling disinfectants and disinfection by-products (D/DBPs) in drinking water. EPA first attempted to control DBPs in 1974, w...

Economics of electron beam and electrical discharge processing for post-combustion NO(x) control in internal combustion engines

NASA Astrophysics Data System (ADS)

Penetrante, B. M.

1993-08-01

The physics and chemistry of non-thermal plasma processing for post-combustion NO(x) control in internal combustion engines are discussed. A comparison of electron beam and electrical discharge processing is made regarding their power consumption, radical production, NO(x) removal mechanisms, and by-product formation. Pollution control applications present a good opportunity for transferring pulsed power techniques to the commercial sector. However, unless advances are made to drastically reduce the price and power consumption of electron beam sources and pulsed power systems, these plasma techniques will not become commercially competitive with conventional thermal or surface-catalytic methods.

Guidance for Selecting Legitimate Recycling Products and Processes

DTIC Science & Technology

1998-10-23

information you have provided on the GIL glassification process for electric arc furnace ( EAF ) dust or K061 when the EAF dust is a hazardous waste. Based on the...regarding the regulatory status of the GIL process and glass frit product has been whether EAF dust incorporated into GIL glass frit meets the definition...emission control dust from a primary copper smelter could be returned to any part of the process associated with copper production. The material also cannot

Enhancement of methane production from co-digestion of chicken manure with agricultural wastes.

PubMed

Abouelenien, Fatma; Namba, Yuzaburo; Kosseva, Maria R; Nishio, Naomichi; Nakashimada, Yutaka

2014-05-01

The potential for methane production from semi-solid chicken manure (CM) and mixture of agricultural wastes (AWS) in a co-digestion process has been experimentally evaluated at thermophilic and mesophilic temperatures. To the best of author(')s knowledge, it is the first time that CM is co-digested with mixture of AWS consisting of coconut waste, cassava waste, and coffee grounds. Two types of anaerobic digestion processes (AD process) were used, process 1 (P1) using fresh CM (FCM) and process 2 (P2) using treated CM (TCM), ammonia stripped CM, were conducted. Methane production in P1 was increased by 93% and 50% compared to control (no AWS added) with maximum methane production of 502 and 506 mL g(-1)VS obtained at 55°C and 35°C, respectively. Additionally, 42% increase in methane production was observed with maximum volume of 695 mL g(-1)VS comparing P2 test with P2 control under 55°C. Ammonia accumulation was reduced by 39% and 32% in P1 and P2 tests. Copyright © 2014 Elsevier Ltd. All rights reserved.

Valuation of OSA process and folic acid addition as excess sludge minimization alternatives applied in the activated sludge process.

PubMed

Martins, C L; Velho, V F; Ramos, S R A; Pires, A S C D; Duarte, E C N F A; Costa, R H R

2016-01-01

The aim of this study was to investigate the ability of the oxic-settling-anaerobic (OSA)-process and the folic acid addition applied in the activated sludge process to reduce the excess sludge production. The study was monitored during two distinct periods: activated sludge system with OSA-process, and activated sludge system with folic acid addition. The observed sludge yields (Yobs) were 0.30 and 0.08 kgTSS kg(-1) chemical oxygen demand (COD), control phase and OSA-process (period 1); 0.33 and 0.18 kgTSS kg(-1) COD, control phase and folic acid addition (period 2). The Yobs decreased by 73 and 45% in phases with the OSA-process and folic acid addition, respectively, compared with the control phases. The sludge minimization alternatives result in a decrease in excess sludge production, without negatively affecting the performance of the effluent treatment.

A fuzzy-logic-based controller for methane production in anaerobic fixed-film reactors.

PubMed

Robles, A; Latrille, E; Ruano, M V; Steyer, J P

2017-01-01

The main objective of this work was to develop a controller for biogas production in continuous anaerobic fixed-bed reactors, which used effluent total volatile fatty acids (VFA) concentration as control input in order to prevent process acidification at closed loop. To this aim, a fuzzy-logic-based control system was developed, tuned and validated in an anaerobic fixed-bed reactor at pilot scale that treated industrial winery wastewater. The proposed controller varied the flow rate of wastewater entering the system as a function of the gaseous outflow rate of methane and VFA concentration. Simulation results show that the proposed controller is capable to achieve great process stability even when operating at high VFA concentrations. Pilot results showed the potential of this control approach to maintain the process working properly under similar conditions to the ones expected at full-scale plants.

Planning and tracking chemotherapy production for cancer treatment: a performing and integrated solution.

PubMed

Kergosien, Y; Tournamille, J-F; Laurence, B; Billaut, J-C

2011-09-01

Chemotherapy drugs are intended for the treatment of cancer. The production of such drugs and their administration to the patient is a delicate and expensive operation. The study deals with the acquisition and processing of data regarding the production of intravenous chemotherapy, from the production request (the medical prescription), the production itself (pharmaceutical process), to the delivery in the health care unit, for the administration of the chemotherapy. The goal of this study is to develop a system that can schedule, control and track the chemotherapy preparations and satisfy a certification process of quality management ("ISO 9001 version 2000" standard). The solution proposed in this paper was developed within the framework of a common certification process at the Biopharmaceutical Unit of the Oncology Clinic (UBCO) of the Bretonneau hospital in Tours (France). The system consists of two software programs: a software to insure traceability and a decision making software to plan the production. To simplify the data entry process, some mobile entry points with bar code reader have been deployed. These tools enable an accurate tracking of the production, a security and control for the schedule production phases, and a full traceability of each operation leading to the administration of the chemotherapy drug. The first result is a software that creates the production schedule, allows a real time control of the production process and a full traceability of each step. Computational experiments are based on real data sets, with a comparison of a time period before and after the implementation of this solution. The results show the positive impacts of this software, like the reduction of delayed deliveries, real time generation of production indicators, optimization of the production and a saving of staff time. This intuitive system guarantees a traceability in connection with a high quality system certified ISO 9001-v2000 (with a rapid data entry), an assistant to schedule the production of preparations in a better way, a permanent follow-up and analysis of operations. This project proves the benefits of implementing computer solutions for the traceability and assistance in decision making in the hospital systems. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Pulse-Flow Microencapsulation System

NASA Technical Reports Server (NTRS)

Morrison, Dennis R.

2006-01-01

The pulse-flow microencapsulation system (PFMS) is an automated system that continuously produces a stream of liquid-filled microcapsules for delivery of therapeutic agents to target tissues. Prior microencapsulation systems have relied on batch processes that involve transfer of batches between different apparatuses for different stages of production followed by sampling for acquisition of quality-control data, including measurements of size. In contrast, the PFMS is a single, microprocessor-controlled system that performs all processing steps, including acquisition of quality-control data. The quality-control data can be used as real-time feedback to ensure the production of large quantities of uniform microcapsules.

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

NASA Technical Reports Server (NTRS)

Bauer, J. L.

1979-01-01

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

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

NASA Astrophysics Data System (ADS)

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

2017-02-01

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

Use of a small molecule cell cycle inhibitor to control cell growth and improve specific productivity and product quality of recombinant proteins in CHO cell cultures.

PubMed

Du, Zhimei; Treiber, David; McCarter, John D; Fomina-Yadlin, Dina; Saleem, Ramsey A; McCoy, Rebecca E; Zhang, Yuling; Tharmalingam, Tharmala; Leith, Matthew; Follstad, Brian D; Dell, Brad; Grisim, Brent; Zupke, Craig; Heath, Carole; Morris, Arvia E; Reddy, Pranhitha

2015-01-01

The continued need to improve therapeutic recombinant protein productivity has led to ongoing assessment of appropriate strategies in the biopharmaceutical industry to establish robust processes with optimized critical variables, that is, viable cell density (VCD) and specific productivity (product per cell, qP). Even though high VCD is a positive factor for titer, uncontrolled proliferation beyond a certain cell mass is also undesirable. To enable efficient process development to achieve consistent and predictable growth arrest while maintaining VCD, as well as improving qP, without negative impacts on product quality from clone to clone, we identified an approach that directly targets the cell cycle G1-checkpoint by selectively inhibiting the function of cyclin dependent kinases (CDK) 4/6 with a small molecule compound. Results from studies on multiple recombinant Chinese hamster ovary (CHO) cell lines demonstrate that the selective inhibitor can mediate a complete and sustained G0/G1 arrest without impacting G2/M phase. Cell proliferation is consistently and rapidly controlled in all recombinant cell lines at one concentration of this inhibitor throughout the production processes with specific productivities increased up to 110 pg/cell/day. Additionally, the product quality attributes of the mAb, with regard to high molecular weight (HMW) and glycan profile, are not negatively impacted. In fact, high mannose is decreased after treatment, which is in contrast to other established growth control methods such as reducing culture temperature. Microarray analysis showed major differences in expression of regulatory genes of the glycosylation and cell cycle signaling pathways between these different growth control methods. Overall, our observations showed that cell cycle arrest by directly targeting CDK4/6 using selective inhibitor compound can be utilized consistently and rapidly to optimize process parameters, such as cell growth, qP, and glycosylation profile in recombinant antibody production cultures. © 2014 The Authors. Biotechnology and Bioengineering Published by Wiley Periodicals, Inc.

Stochastic state-space temperature regulation of biochar production. Part I: Theoretical development.

PubMed

Cantrell, Keri B; Martin, Jerry H

2012-02-01

The concept of a designer biochar that targets the improvement of a specific soil property imposes the need for production processes to generate biochars with both high consistency and quality. These important production parameters can be affected by variations in process temperature that must be taken into account when controlling the pyrolysis of agricultural residues such as manures and other feedstocks. A novel stochastic state-space temperature regulator was developed to accurately match biochar batch production to a defined temperature input schedule. This was accomplished by describing the system's state-space with five temperature variables--four directly measured and one change in temperature. Relationships were derived between the observed state and the desired, controlled state. When testing the unit at two different temperatures, the actual pyrolytic temperature was within 3 °C of the control with no overshoot. This state-space regulator simultaneously controlled the indirect heat source and sample temperature by employing difficult-to-measure variables such as temperature stability in the description of the pyrolysis system's state-space. These attributes make a state-space controller an optimum control scheme for the production of a predictable, repeatable designer biochar. Published 2011 by John Wiley & Sons, Ltd.

Overview of processing activities aimed at higher efficiencies and economical production

NASA Technical Reports Server (NTRS)

Bickler, D. B.

1985-01-01

An overview of processing activities aimed at higher efficiencies and economical production were presented. Present focus is on low-cost process technology for higher-efficiency cells of up to 18% or higher. Process development concerns center on the use of less than optimum silicon sheet, the control of production yields, and making uniformly efficient large-area cells. High-efficiency cell factors that require process development are bulk material perfection, very shallow junction formation, front-surface passivation, and finely detailed metallization. Better bulk properties of the silicon sheet and the keeping of those qualities throughout large areas during cell processing are required so that minority carrier lifetimes are maintained and cell performance is not degraded by high doping levels. When very shallow junctions are formed, the process must be sensitive to metallizatin punch-through, series resisitance in the cell, and control of dopant leaching during surface passivation. There is a need to determine the sensitivity to processing by mathematical modeling and experimental activities.

Trichinae certification in the United States pork industry.

PubMed

Pyburn, David G; Gamble, H Ray; Wagstrom, Elizabeth A; Anderson, Lowell A; Miller, Lawrence E

2005-09-05

Control of Trichinella infection in U.S. pork has traditionally been accomplished by inspection of individual carcasses at slaughter or by post-slaughter processing to inactivate parasites. We propose that an alternative to individual carcass testing or processing can be used when pigs are raised in production systems where risk of exposure to Trichinella spiralis has been mitigated. Declines in prevalence of this parasite in U.S. domestic swine during the last 30 years, coupled with improvements in pork production systems, now allow Trichinella control to be shifted to the farm through implementation of specific pork production practices. Knowledge of risk factors for exposure of swine to T. spiralis was used to develop an objective audit of risk that can be applied to pork production sites. In a pilot study, 461 production site audits were performed by trained veterinary practitioners. The on-farm audit included aspects of farm management, bio-security, feed and feed storage, rodent control programs and general hygiene. Of the 461 production site audits, 450 audits (97.6%) indicated compliance with the required good production practices. These sites are eligible for certification under the U.S. Trichinae Certification Program and will be audited regularly to maintain that status. The described trichinae certification mechanism will establish a process for ensuring the Trichinella safety of swine, and ultimately food products derived from swine, at the production level.

ISO 9000 and/or Systems Engineering Capability Maturity Model?

NASA Technical Reports Server (NTRS)

Gholston, Sampson E.

2002-01-01

For businesses and organizations to remain competitive today they must have processes and systems in place that will allow them to first identify customer needs and then develop products/processes that will meet or exceed the customers needs and expectations. Customer needs, once identified, are normally stated as requirements. Designers can then develop products/processes that will meet these requirements. Several functions, such as quality management and systems engineering management are used to assist product development teams in the development process. Both functions exist in all organizations and both have a similar objective, which is to ensure that developed processes will meet customer requirements. Are efforts in these organizations being duplicated? Are both functions needed by organizations? What are the similarities and differences between the functions listed above? ISO 9000 is an international standard of goods and services. It sets broad requirements for the assurance of quality and for management's involvement. It requires organizations to document the processes and to follow these documented processes. ISO 9000 gives customers assurance that the suppliers have control of the process for product development. Systems engineering can broadly be defined as a discipline that seeks to ensure that all requirements for a system are satisfied throughout the life of the system by preserving their interrelationship. The key activities of systems engineering include requirements analysis, functional analysis/allocation, design synthesis and verification, and system analysis and control. The systems engineering process, when followed properly, will lead to higher quality products, lower cost products, and shorter development cycles. The System Engineering Capability Maturity Model (SE-CMM) will allow companies to measure their system engineering capability and continuously improve those capabilities. ISO 9000 and SE-CMM seem to have a similar objective, which is to document the organization's processes and certify to potential customers the capability of a supplier to control the processes that determine the quality of the product or services being produced. The remaining sections of this report examine the differences and similarities between ISO 9000 and SE-CMM and make recommendations for implementation.

WaferOptics® mass volume production and reliability

NASA Astrophysics Data System (ADS)

Wolterink, E.; Demeyer, K.

2010-05-01

The Anteryon WaferOptics® Technology platform contains imaging optics designs, materials, metrologies and combined with wafer level based Semicon & MEMS production methods. WaferOptics® first required complete new system engineering. This system closes the loop between application requirement specifications, Anteryon product specification, Monte Carlo Analysis, process windows, process controls and supply reject criteria. Regarding the Anteryon product Integrated Lens Stack (ILS), new design rules, test methods and control systems were assessed, implemented, validated and customer released for mass production. This includes novel reflowable materials, mastering process, replication, bonding, dicing, assembly, metrology, reliability programs and quality assurance systems. Many of Design of Experiments were performed to assess correlations between optical performance parameters and machine settings of all process steps. Lens metrologies such as FFL, BFL, and MTF were adapted for wafer level production and wafer mapping was introduced for yield management. Test methods for screening and validating suitable optical materials were designed. Critical failure modes such as delamination and popcorning were assessed and modeled with FEM. Anteryon successfully managed to integrate the different technologies starting from single prototypes to high yield mass volume production These parallel efforts resulted in a steep yield increase from 30% to over 90% in a 8 months period.

The strange case of the [13N]NH3: validation of the production process for human use.

PubMed

Statuto, Massimo; Galli, Elisa; Bertagna, Francesco; Migliorati, Elena; Zanella, Isabella; Di Lorenzo, Diego; De Agostini, Antonio; Rodella, Carlo; Apostoli, Pietro; Caimi, Luigi; Giubbini, Raffaele; Biasiotto, Giorgio

2016-04-01

PET radiopharmaceuticals are often injected in patients before all quality controls are performed and before sterility results are available. We propose a process validation to produce very safe and pure [N]NH3 for human use. [N]NH3 was produced in the cyclotron target. Online purification was performed by anionic exchange resin. All the production steps were subjected to a sterility test. Some additional controls were added to those required by the monograph. The radiochemical yield of the syntheses was 26.3 and 61.5% corrected for decay, with a radiochemical purity of 100%. In addition to quality controls requested by the European Pharmacopeia monograph, we carefully analyzed the product for the presence of possible contaminants. Some elements, mainly metals, were found in very low amounts at concentrations in the range of ppb. The radionuclidic purity was verified. The achievement of the parameters of osmolality, by addition of saline solution to the preparation, made the analysis of chemical purity difficult and worsened the measurement of radiochemical purity by high performance liquid chromatography. Only pH control is necessary before administration to patients and therefore a safe production process was set up to prevent microbiological contamination. All phases were carefully standardized, starting from in-target production of [N]NH3, to final splitting in the syringes. Sterility tests showed no bacterial growth, indicating the safety of the production process. All our syntheses followed the monograph indications and were optimal to obtain PET imaging of a patient's myocardium.

Welding wire selection critical to jet engine repair work

NASA Astrophysics Data System (ADS)

1992-11-01

A review is provided of issues related to the selection of welding wire for aircraft gas-turbine engines emphasizing the importance of cleanliness in the welding wire product. A three-step metallurgical control process is described for the production of welding wire that is clean and suitable for turbine repair. The process is based on: (1) vacuum induction melting; (2) contamination-free processing of the wire; and (3) environmentally controlled packaging. Weld work on aerospace casting is shown to be useful and suitable for many alloy and superalloy materials with various filler materials.

Mathematical modeling for resource and energy saving control of extruders in multi-assortment productions of polymeric films

NASA Astrophysics Data System (ADS)

Polosin, A. N.; Chistyakova, T. B.

2018-05-01

In this article, the authors describe mathematical modeling of polymer processing in extruders of various types used in extrusion and calender productions of film materials. The method consists of the synthesis of a static model for calculating throughput, energy consumption of the extruder, extrudate quality indices, as well as a dynamic model for evaluating polymer residence time in the extruder, on which the quality indices depend. Models are adjusted according to the extruder type (single-screw, reciprocating, twin-screw), its screw and head configuration, extruder’s work temperature conditions, and the processed polymer type. Models enable creating extruder screw configurations and determining extruder controlling action values that provide the extrudate of required quality while satisfying extruder throughput and energy consumption requirements. Model adequacy has been verified using polyolefins’ and polyvinylchloride processing data in different extruders. The program complex, based on mathematical models, has been developed in order to control extruders of various types in order to ensure resource and energy saving in multi-assortment productions of polymeric films. Using the program complex in the control system for the extrusion stage of the polymeric film productions enables improving film quality, reducing spoilage, lessening the time required for production line change-over to other throughput and film type assignment.

Dissolved oxygen control strategy for improvement of TL1-1 production in submerged fermentation by Daldinia eschscholzii.

PubMed

Wei, Xing-Chen; Tang, Liu; Lu, Yan-Hua

2017-01-01

2,3-Dihydro-5-hydroxy-2-methylchromen-4-one (TL1-1) is a phenolic compound with significant anti-fungal and anti-cancer activities produced by Daldinia eschscholzii ( D. eschscholzii ). However, studies have rarely been reported on the fermentation process of D. eschscholzii due to the urgent demand for its pharmaceutical researches and applications. In this work, the optimal fermentation medium for improved TL1-1 yield was first obtained in a shake flask. As the fermentation process was scaling up, the marked effects of dissolved oxygen (DO) on cell growth and TL1-1 biosynthesis were observed and confirmed. Controlling a suitable DO level by the adjustment of agitation speed and aeration rate remarkably enhanced TL1-1 production in a lab-scale bioreactor. Moreover, the fermentation of D. eschscholzii was successfully applied in 500-L bioreactor, and TL1-1 production has achieved 873.63 mg/L, approximately 15.4-fold than its initial production (53.27 mg/L). Dissolved oxygen control strategy for enhancing TL1-1 production was first proposed. Furthermore, control of the appropriate DO level has successfully performed for improving TL1-1 yield and scale-up of D. eschscholzii fermentation process.

A multi-run chemistry module for the production of [18F]FDG

NASA Astrophysics Data System (ADS)

Sipe, B.; Murphy, M.; Best, B.; Zigler, S.; Lim, J.; Dorman, E.; Mangner, T.; Weichelt, M.

2001-07-01

We have developed a new chemistry module for the production of up to four batches of [18F]FDG. Prior to starting a batch sequence, the module automatically performs a series of self-diagnostic tests, including a reagent detection sequence. The module then executes a user-defined production sequence followed by an automated process to rinse tubing, valves, and the reaction vessel prior to the next production sequence. Process feedback from the module is provided to a graphical user interface by mass flow controllers, radiation detectors, a pressure switch, a pressure transducer, and an IR temperature sensor. This paper will describe the module, the operating system, and the results of multi-site trials, including production data and quality control results.

Biotechnology in Food Production and Processing

NASA Astrophysics Data System (ADS)

Knorr, Dietrich; Sinskey, Anthony J.

1985-09-01

The food processing industry is the oldest and largest industry using biotechnological processes. Further development of food products and processes based on biotechnology depends upon the improvement of existing processes, such as fermentation, immobilized biocatalyst technology, and production of additives and processing aids, as well as the development of new opportunities for food biotechnology. Improvements are needed in the characterization, safety, and quality control of food materials, in processing methods, in waste conversion and utilization processes, and in currently used food microorganism and tissue culture systems. Also needed are fundamental studies of the structure-function relationship of food materials and of the cell physiology and biochemistry of raw materials.

Monitoring autocorrelated process: A geometric Brownian motion process approach

NASA Astrophysics Data System (ADS)

Li, Lee Siaw; Djauhari, Maman A.

2013-09-01

Autocorrelated process control is common in today's modern industrial process control practice. The current practice of autocorrelated process control is to eliminate the autocorrelation by using an appropriate model such as Box-Jenkins models or other models and then to conduct process control operation based on the residuals. In this paper we show that many time series are governed by a geometric Brownian motion (GBM) process. Therefore, in this case, by using the properties of a GBM process, we only need an appropriate transformation and model the transformed data to come up with the condition needs in traditional process control. An industrial example of cocoa powder production process in a Malaysian company will be presented and discussed to illustrate the advantages of the GBM approach.

Laser displacement sensor to monitor the layup process of composite laminate production

NASA Astrophysics Data System (ADS)

Miesen, Nick; Groves, Roger M.; Sinke, Jos; Benedictus, Rinze

2013-04-01

Several types of flaw can occur during the layup process of prepreg composite laminates. Quality control after the production process checks the end product by testing the specimens for flaws which are included during the layup process or curing process, however by then these flaws are already irreversibly embedded in the laminate. This paper demonstrates the use of a laser displacement sensor technique applied during the layup process of prepreg laminates for in-situ flaw detection, for typical flaws that can occur during the composite production process. An incorrect number of layers and fibre wrinkling are dominant flaws during the process of layup. These and other dominant flaws have been modeled to determine the requirements for an in-situ monitoring during the layup process of prepreg laminates.

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

NASA Astrophysics Data System (ADS)

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

1999-10-01

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

EPQ model with learning consideration, imperfect production and partial backlogging in fuzzy random environment

NASA Astrophysics Data System (ADS)

Shankar Kumar, Ravi; Goswami, A.

2015-06-01

The article scrutinises the learning effect of the unit production time on optimal lot size for the uncertain and imprecise imperfect production process, wherein shortages are permissible and partially backlogged. Contextually, we contemplate the fuzzy chance of production process shifting from an 'in-control' state to an 'out-of-control' state and re-work facility of imperfect quality of produced items. The elapsed time until the process shifts is considered as a fuzzy random variable, and consequently, fuzzy random total cost per unit time is derived. Fuzzy expectation and signed distance method are used to transform the fuzzy random cost function into an equivalent crisp function. The results are illustrated with the help of numerical example. Finally, sensitivity analysis of the optimal solution with respect to major parameters is carried out.

Training verb argument structure production in agrammatic aphasia: Behavioral and neural recovery patterns

PubMed Central

Thompson, Cynthia K.; Riley, Ellyn A.; den Ouden, Dirk-Bart; Meltzer-Asscher, Aya; Lukic, Sladjana

2013-01-01

Introduction Neuroimaging and lesion studies indicate a left hemisphere network for verb and verb argument structure processing, involving both frontal and temporoparietal brain regions. Although their verb comprehension is generally unimpaired, it is well known that individuals with agrammatic aphasia often present with verb production deficits, characterized by an argument structure complexity hierarchy, indicating faulty access to argument structure representations for production and integration into syntactic contexts. Recovery of verb processing in agrammatism, however, has received little attention and no studies have examined the neural mechanisms associated with improved verb and argument structure processing. In the present study we trained agrammatic individuals on verbs with complex argument structure in sentence contexts and examined generalization to verbs with less complex argument structure. The neural substrates of improved verb production were examined using functional magnetic resonance imaging (fMRI). Methods Eight individuals with chronic agrammatic aphasia participated in the study (four experimental and four control participants). Production of three-argument verbs in active sentences was trained using a sentence generation task emphasizing the verb’s argument structure and the thematic roles of sentential noun phrases. Before and after training, production of trained and untrained verbs was tested in naming and sentence production and fMRI scans were obtained, using an action naming task. Results Significant pre- to post-training improvement in trained and untrained (one- and two-argument) verbs was found for treated, but not control, participants, with between-group differences found for verb naming, production of verbs in sentences, and production of argument structure. fMRI activation derived from post-treatment compared to pre-treatment scans revealed upregulation in cortical regions implicated for verb and argument structure processing in healthy controls. Conclusions Training verb deficits emphasizing argument structure and thematic role mapping is effective for improving verb and sentence production and results in recruitment of neural networks engaged for verb and argument structure processing in healthy individuals. PMID:23514929

40 CFR 429.51 - Effluent limitations representing the degree of effluent reduction attainable by the application...

Code of Federal Regulations, 2010 CFR

2010-07-01

... application of the best practicable control technology (BPT): There shall be no discharge of process... degree of effluent reduction attainable by the application of the best practicable control technology... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS TIMBER PRODUCTS PROCESSING POINT SOURCE CATEGORY Dry Process...

Applying the Theory of Constraints to a Base Civil Engineering Operations Branch

DTIC Science & Technology

1991-09-01

Figure Page 1. Typical Work Order Processing . .......... 7 2. Typical Job Order Processing . .......... 8 3. Typical Simplified In-Service Work Plan for...Customers’ Customer Request Service Planning Unit Production] Control Center Material Control Scheduling CE Shops Figure 1.. Typical Work Order Processing 7

Using Statistical Process Control to Make Data-Based Clinical Decisions.

ERIC Educational Resources Information Center

Pfadt, Al; Wheeler, Donald J.

1995-01-01

Statistical process control (SPC), which employs simple statistical tools and problem-solving techniques such as histograms, control charts, flow charts, and Pareto charts to implement continual product improvement procedures, can be incorporated into human service organizations. Examples illustrate use of SPC procedures to analyze behavioral data…

Catalytic processes towards the production of biofuels in a palm oil and oil palm biomass-based biorefinery.

PubMed

Chew, Thiam Leng; Bhatia, Subhash

2008-11-01

In Malaysia, there has been interest in the utilization of palm oil and oil palm biomass for the production of environmental friendly biofuels. A biorefinery based on palm oil and oil palm biomass for the production of biofuels has been proposed. The catalytic technology plays major role in the different processing stages in a biorefinery for the production of liquid as well as gaseous biofuels. There are number of challenges to find suitable catalytic technology to be used in a typical biorefinery. These challenges include (1) economic barriers, (2) catalysts that facilitate highly selective conversion of substrate to desired products and (3) the issues related to design, operation and control of catalytic reactor. Therefore, the catalytic technology is one of the critical factors that control the successful operation of biorefinery. There are number of catalytic processes in a biorefinery which convert the renewable feedstocks into the desired biofuels. These include biodiesel production from palm oil, catalytic cracking of palm oil for the production of biofuels, the production of hydrogen as well as syngas from biomass gasification, Fischer-Tropsch synthesis (FTS) for the conversion of syngas into liquid fuels and upgrading of liquid/gas fuels obtained from liquefaction/pyrolysis of biomass. The selection of catalysts for these processes is essential in determining the product distribution (olefins, paraffins and oxygenated products). The integration of catalytic technology with compatible separation processes is a key challenge for biorefinery operation from the economic point of view. This paper focuses on different types of catalysts and their role in the catalytic processes for the production of biofuels in a typical palm oil and oil palm biomass-based biorefinery.

Elements for successful sensor-based process control {Integrated Metrology}

NASA Astrophysics Data System (ADS)

Butler, Stephanie Watts

1998-11-01

Current productivity needs have stimulated development of alternative metrology, control, and equipment maintenance methods. Specifically, sensor applications provide the opportunity to increase productivity, tighten control, reduce scrap, and improve maintenance schedules and procedures. Past experience indicates a complete integrated solution must be provided for sensor-based control to be used successfully in production. In this paper, Integrated Metrology is proposed as the term for an integrated solution that will result in a successful application of sensors for process control. This paper defines and explores the perceived four elements of successful sensor applications: business needs, integration, components, and form. Based upon analysis of existing successful commercially available controllers, the necessary business factors have been determined to be strong, measurable industry-wide business needs whose solution is profitable and feasible. This paper examines why the key aspect of integration is the decision making process. A detailed discussion is provided of the components of most importance to sensor based control: decision-making methods, the 3R's of sensors, and connectivity. A metric for one of the R's (resolution) is proposed to allow focus on this important aspect of measurement. A form for these integrated components which synergistically partitions various aspects of control at the equipment and MES levels to efficiently achieve desired benefits is recommended.

Lysine production from methanol at 50 degrees C using Bacillus methanolicus: Modeling volume control, lysine concentration, and productivity using a three-phase continuous simulation.

PubMed

Lee, G H; Hur, W; Bremmon, C E; Flickinger, M C

1996-03-20

A simulation was developed based on experimental data obtained in a 14-L reactor to predict the growth and L-lysine accumulation kinetics, and change in volume of a large-scale (250-m(3)) Bacillus methanolicus methanol-based process. Homoserine auxotrophs of B. methanolicus MGA3 are unique methylotrophs because of the ability to secrete lysine during aerobic growth and threonine starvation at 50 degrees C. Dissolved methanol (100 mM), pH, dissolved oxygen tension (0.063 atm), and threonine levels were controlled to obtain threonine-limited conditions and high-cell density (25 g dry cell weight/L) in a 14-L reactor. As a fed-batch process, the additions of neat methanol (fed on demand), threonine, and other nutrients cause the volume of the fermentation to increase and the final lysine concentration to decrease. In addition, water produced as a result of methanol metabolism contributes to the increase in the volume of the reactor. A three-phase approach was used to predict the rate of change of culture volume based on carbon dioxide production and methanol consumption. This model was used for the evaluation of volume control strategies to optimize lysine productivity. A constant volume reactor process with variable feeding and continuous removal of broth and cells (VF(cstr)) resulted in higher lysine productivity than a fed-batch process without volume control. This model predicts the variation in productivity of lysine with changes in growth and in specific lysine productivity. Simple modifications of the model allows one to investigate other high-lysine-secreting strains with different growth and lysine productivity characteristics. Strain NOA2#13A5-2 which secretes lysine and other end-products were modeled using both growth and non-growth-associated lysine productivity. A modified version of this model was used to simulate the change in culture volume of another L-lysine producing mutant (NOA2#13A52-8A66) with reduced secretion of end-products. The modified simulation indicated that growth-associated production dominates in strain NOA2#13A52-8A66. (c) 1996 John Wiley & Sons, Inc.

Reproductive adverse outcome pathways for chemical inhibitors of steroid synthesis in fish

EPA Science Inventory

A key physiological process controlling reproductive success of oviparous vertebrates (fish, amphibian, reptiles, birds) involves production of the egg yolk protein precursor vitellogenin (VTG). VTG production is an estrogen receptor (ER)-mediated process that, in females, is con...

Evaluation of erosion control blanket properties and test criteria for specification and design : final report.

DOT National Transportation Integrated Search

2016-07-01

A research project to investigate the product approval, design process, and ongoing product evaluation of erosion control blankets : (ECBs) for the Missouri Department of Transportation (MoDOT) was conducted. An overview of federal and state environm...

Demonstrating PQS Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction.

PubMed

Ramnarine, Emma; O'Donnell, Kevin

2018-04-18

Product knowledge grows and evolves during the life of a product. In order to maintain a state of control and deliver product with consistent quality throughout its commercial life, continuous improvement and product lifecycle management become essential. The practical link between product and process knowledge, risk-based control strategies, and continual improvement and innovation can be made stronger through evidence-based risk reduction. Regulatory relief and flexibility in post approval change management and overall product lifecycle management will only be possible with effective application of science and risk-based concepts and demonstrated effectiveness of the PQS in assuring a state of control. Copyright © 2018, Parenteral Drug Association.

CELSS research and development program

NASA Technical Reports Server (NTRS)

Bubenheim, David

1990-01-01

Research in Controlled Ecological Life Support Systems (CELSS) conducted by NASA indicate that plant based systems are feasible candidates for human support in space. Ames has responsibility for research and development, systems integration and control, and space flight experiment portions of the CELSS program. Important areas for development of new methods and technologies are biomass production, waste processing, water purification, air revitalization, and food processing. For the plant system, the approach was to identify the flexibility and response time for the food, water, and oxygen production, and carbon dioxide consumption processes. Tremendous increases in productivity, compared with terrestrial agriculture, were realized. Waste processing research emphasizes recycle (transformation) of human wastes, trash, and inedible biomass to forms usable as inputs to the plant production system. Efforts to improve efficiency of the plant system, select new CELSS crops for a balanced diet, and initiate closed system research with the Crop Growth Research Chambers continue. The System Control and Integration program goal is to insure orchestrated system operation of the biological, physical, and chemical operation of the biological, physical, and chemical component processors of the CELSS. Space flight studies are planned to verify adequate operation of the system in reduced gravity or microgravity environments.

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.

Assessment Methodology for Process Validation Lifecycle Stage 3A.

PubMed

Sayeed-Desta, Naheed; Pazhayattil, Ajay Babu; Collins, Jordan; Chen, Shu; Ingram, Marzena; Spes, Jana

2017-07-01

The paper introduces evaluation methodologies and associated statistical approaches for process validation lifecycle Stage 3A. The assessment tools proposed can be applied to newly developed and launched small molecule as well as bio-pharma products, where substantial process and product knowledge has been gathered. The following elements may be included in Stage 3A: number of 3A batch determination; evaluation of critical material attributes, critical process parameters, critical quality attributes; in vivo in vitro correlation; estimation of inherent process variability (IPV) and PaCS index; process capability and quality dashboard (PCQd); and enhanced control strategy. US FDA guidance on Process Validation: General Principles and Practices, January 2011 encourages applying previous credible experience with suitably similar products and processes. A complete Stage 3A evaluation is a valuable resource for product development and future risk mitigation of similar products and processes. Elements of 3A assessment were developed to address industry and regulatory guidance requirements. The conclusions made provide sufficient information to make a scientific and risk-based decision on product robustness.

A novel process control method for a TT-300 E-Beam/X-Ray system

NASA Astrophysics Data System (ADS)

Mittendorfer, Josef; Gallnböck-Wagner, Bernhard

2018-02-01

This paper presents some aspects of the process control method for a TT-300 E-Beam/X-Ray system at Mediscan, Austria. The novelty of the approach is the seamless integration of routine monitoring dosimetry with process data. This allows to calculate a parametric dose for each production unit and consequently a fine grain and holistic process performance monitoring. Process performance is documented in process control charts for the analysis of individual runs as well as historic trending of runs of specific process categories over a specified time range.

Sustainable improvement of animal health care by systematic quality risk management according to the HACCP concept.

PubMed

Noordhuizen, J P; Welpelo, H J

1996-12-01

This paper addresses the principles of the Hazard Analysis Critical Control Point (HACCP) concept as applied to animal health management strategy. Characteristics of the concept were analysed and compared with those of current animal health care strategies for disease risk identification and herd health management, insurance, and certification. HACCP is a hybrid strategy of quality control at both production process and product level. Animal health is considered a particular quality feature. We show that process control (expressed in terms of controlling both general and specific disease risk factors) and product control (expressed in terms of testing animals or animal products for specific disease agents) could form the basis for improving animal health. We conclude that HACCP provides ample opportunity for preventive health action and risk management at a relatively low cost in terms of labour, finance and documentation expenditure, at both the farm and sector level. Epidemiological field studies are currently needed to identify critical control points and to design HACCP procedures for livestock producers. In the long run, HACCP based animal health care can be further developed into a quality control systems approach to cover all aspects that are related, either directly or indirectly, to animal health.

The role of pH control on biohydrogen production by single stage hybrid dark- and photo-fermentation.

PubMed

Zagrodnik, R; Laniecki, M

2015-10-01

The role of pH control on biohydrogen production by co-culture of dark-fermentative Clostridium acetobutylicum and photofermentative Rhodobacter sphaeroides was studied. Single stage dark fermentation, photofermentation and hybrid co-culture systems were studied at different values of controlled and uncontrolled pH. Increasing pH during dark fermentation resulted in lower hydrogen production rate (HPR) and longer lag time for both controlled and uncontrolled conditions. However, it only slightly affected cumulative H2 volume. Results have shown that pH control at pH 7.5 increased photofermentative hydrogen production from 0.966 to 2.502 L H2/L(medium) when compared to uncontrolled process. Fixed pH value has proven to be an important control strategy also for the hybrid process and resulted in obtaining balanced co-culture of dark and photofermentative bacteria. Control of pH at 7.0 was found optimum for bacteria cooperation in the co-culture what resulted in obtaining 2.533 L H2/L(medium) and H2 yield of 6.22 mol H2/mol glucose. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

NASA Technical Reports Server (NTRS)

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

1979-01-01

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

Development of optical-electronic system for the separation of cullet

NASA Astrophysics Data System (ADS)

Solovey, Alexey A.; Alekhin, Artem A.

2017-06-01

Broken glass being the waste in many fields of production is usually used as a raw material in the production of construction materials. The purity level of collected and processed glass cullet, as a rule, is quite low. Direct usage of these materials without preliminary processing leads to the emergence of defects in the end product or sometimes even to technological downtime. That's why purity control of cullet should be strictly verified. The study shows the method of construction and requirements for an optical-electronic system designed for cullet separation. Moreover, the author proposes a registration channel scheme and shows a scheme of control exposure area. Also the issues of image processing for the implementation of a typical system are examined.

Fluidized bed selective pyrolysis of coal

DOEpatents

Shang, J.Y.; Cha, C.Y.; Merriam, N.W.

1992-12-15

The present invention discloses a process for the pyrolysis of coal which comprises the effective utilization of two zonal inclined fluidized beds, where said zones can be selectively controlled as to temperature and heating rate. The first zonal inclined fluidized bed serves as a dryer for crushed coal and additionally is controlled to selectively pyrolyze said coal producing substantially carbon dioxide for recycle use. The second zonal inclined fluidized bed further pyrolyses the coal to gaseous, liquid and char products under controlled temperature and heating rate zones designed to economically integrate the product mix. The gas and liquid products are recovered from the gaseous effluent stream while the char which remains can be further treated or utilized in a subsequent process step. 9 figs.

Fluidized bed selective pyrolysis of coal

DOEpatents

Shang, Jer Y.; Cha, Chang Y.; Merriam, Norman W.

1992-01-01

The present invention discloses a process for the pyrolysis of coal which comprises the effective utilization of two zonal inclined fluidized beds, where said zones can be selectively controlled as to temperature and heating rate. The first zonal inclined fluidized bed serves as a dryer for crushed coal and additionally is controlled to selectively pyrolyze said coal producing substantially carbon dioxide for recycle use. The second zonal inclined fluidized bed further pyrolyzes the coal to gaseous, liquid and char products under controlled temperature and heating rate zones designed to economically integrate the product mix. The gas and liquid products are recovered from the gaseous effluent stream while the char which remains can be further treated or utilized in a subsequent process step.

The Changing Hardwood Export Market and Research to Keep the U.S. Competitive

Treesearch

Philip A. Araman

1988-01-01

Primary hardwood processors face many interrelated market, product, processing, and resource problems generated by the increasing export market. In processing, yields and quality must be increased and costs must be reduced to stay competitive. Computer-aided and computer-controlled automated processing is also needed. The industry needs to keep its products competitive...

21 CFR 1005.25 - Service of process on manufacturers.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Subchapter C—Electronic Product Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly the Radiation Control for Health and Safety Act of 1968) (21 U.S.C. 360mm(d)) and this section. The agent may be... Subchapter C—Electronic Product Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly the...

21 CFR 1005.25 - Service of process on manufacturers.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Subchapter C—Electronic Product Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly the Radiation Control for Health and Safety Act of 1968) (21 U.S.C. 360mm(d)) and this section. The agent may be... Subchapter C—Electronic Product Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly the...

Seek and destroy process: Listeria monocytogenes process controls in the ready-to-eat meat and poultry industry.

PubMed

Malley, Thomas J V; Butts, John; Wiedmann, Martin

2015-02-01

The majority of human listeriosis cases appear to be caused by consumption of ready-to-eat (RTE) foods contaminated at the time of consumption with high levels of Listeria monocytogenes. Although strategies to prevent growth of L. monocytogenes in RTE products are critical for reducing the incidence of human listeriosis, control of postprocessing environmental contamination of RTE meat and poultry products is an essential component of a comprehensive L. monocytogenes intervention and control program. Complete elimination of postprocessing L. monocytogenes contamination is challenging because this pathogen is common in various environments outside processing plants and can persist in food processing environments for years. Persistent L. monocytogenes strains in processing plants have been identified as the most common postprocessing contaminants of RTE foods and the cause of multiple listeriosis outbreaks. Identification and elimination of L. monocytogenes strains persisting in processing plants is thus critical for (i) compliance with zero-tolerance regulations for L. monocytogenes in U.S. RTE meat and poultry products and (ii) reduction of the incidence of human listeriosis. The seek-and-destroy process is a systematic approach to finding sites of persistent strains (niches) in food processing plants, with the goal of either eradicating or mitigating effects of these strains. This process has been used effectively to address persistent L. monocytogenes contamination in food processing plants, as supported by peer-reviewed evidence detailed here. Thus, a regulatory environment that encourages aggressive environmental Listeria testing is required to facilitate continued use of this science-based strategy for controlling L. monocytogenes in RTE foods.

Quality control education in the community college

NASA Technical Reports Server (NTRS)

Greene, J. Griffen; Wilson, Steve

1966-01-01

This paper describes the Quality Control Program at Daytona Beach Junior College, including course descriptions. The program in quality control required communication between the college and the American Society for Quality Control (ASQC). The college has machinery established for certification of the learning process, and the society has the source of teachers who are competent in the technical field and who are the employers of the educational products. The associate degree for quality control does not have a fixed program, which can serve all needs, any more than all engineering degrees have identical programs. The main ideas which would be common to all quality control programs are the concept of economic control of a repetitive process and the concept of developing individual potentialities into individuals who are needed and productive.

Understanding Emissions from Control-Related Equipment used in Oil and Gas Production Operations to Support EPA’s Air Quality Modeling of Ozone Non-attainment Areas

EPA Science Inventory

Oil and gas production has increased significantly in the United States over the past ten years. Improperly maintained and controlled oil and gas extraction and production (E&P) processes have the potential to emit significant amounts of pollutants that can impact human health an...

High Productivity DRIE solutions for 3D-SiP and MEMS Volume Manufacturing

NASA Astrophysics Data System (ADS)

Puech, M.; Thevenoud, JM; Launay, N.; Arnal, N.; Godinat, P.; Andrieu, B.; Gruffat, JM

2006-04-01

Emerging 3D-SiP technologies and high volume MEMS applications require high productivity mass production DRIE systems. The Alcatel DRIE product range has recently been optimised to reach the highest process and hardware production performances. A study based on sub-micron high aspect ratio structures encountered in the most stringent 3D-SiP has been carried out. The optimization of the Bosch process parameters has resulted in ultra high silicon etch rates, with unrivalled uniformity and repeatability leading to excellent process. In parallel, most recent hardware and proprietary design optimization including vacuum pumping lines, process chamber, wafer chucks, pressure control system, gas delivery are discussed. These improvements have been monitored in a mass production environment for a mobile phone application. Field data analysis shows a significant reduction of cost of ownership thanks to increased throughput and much lower running costs. These benefits are now available for all 3D-SiP and high volume MEMS applications. The typical etched patterns include tapered trenches for CMOS imagers, through silicon via holes for die stacking, well controlled profile angle for 3D high precision inertial sensors, and large exposed area features for inkjet printer heads and Silicon microphones.

Parametric identification of the process of preparing ceramic mixture as an object of control

NASA Astrophysics Data System (ADS)

Galitskov, Stanislav; Nazarov, Maxim; Galitskov, Konstantin

2017-10-01

Manufacture of ceramic materials and products largely depends on the preparation of clay raw materials. The main process here is the process of mixing, which in industrial production is mostly done in cross-compound clay mixers of continuous operation with steam humidification. The authors identified features of dynamics of this technological stage, which in itself is a non-linear control object with distributed parameters. When solving practical tasks for automation of a certain class of ceramic materials production it is important to make parametric identification of moving clay. In this paper the task is solved with the use of computational models, approximated to a particular section of a clay mixer along its length. The research introduces a methodology of computational experiments as applied to the designed computational model. Parametric identification of dynamic links was carried out according to transient characteristics. The experiments showed that the control object in question is to a great extent a non-stationary one. The obtained results are problematically oriented on synthesizing a multidimensional automatic control system for preparation of ceramic mixture with specified values of humidity and temperature exposed to the technological process of major disturbances.

Implementation of "Quality by Design (QbD)" Approach for the Development of 5-Fluorouracil Loaded Thermosensitive Hydrogel.

PubMed

Dalwadi, Chintan; Patel, Gayatri

2016-01-01

The purpose of this study was to investigate Quality by Design (QbD) principle for the preparation of hydrogel products to prove both practicability and utility of executing QbD concept to hydrogel based controlled release systems. Product and process understanding will help in decreasing the variability of critical material and process parameters, which give quality product output and reduce the risk. This study includes the identification of the Quality Target Product Profiles (QTPPs) and Critical Quality Attributes (CQAs) from literature or preliminary studies. To identify and control the variability in process and material attributes, two tools of QbD was utilized, Quality Risk Management (QRM) and Experimental Design. Further, it helps to identify the effect of these attributes on CQAs. Potential risk factors were identified from fishbone diagram and screened by risk assessment and optimized by 3-level 2- factor experimental design with center points in triplicate, to analyze the precision of the target process. This optimized formulation was further characterized by gelling time, gelling temperature, rheological parameters, in-vitro biodegradation and in-vitro drug release. Design space was created using experimental design tool that gives the control space and working within this controlled space reduces all the failure modes below the risk level. In conclusion, QbD approach with QRM tool provides potent and effectual pyramid to enhance the quality into the hydrogel.

APC implementation in Chandra Asri - ethylene plant

NASA Astrophysics Data System (ADS)

Sidiq, Mochamad; Mustofa, Ali

2017-05-01

Nowadays, the modern process plants are continuously improved for maximizing production, Optimization of the energy and raw material and reducing the risk. Due to many disturbances appearance between the process units, hence, the failure of one unit might have a bad effect on the overall productivity. Ethylene Plant have significant opportunities for using Advanced Process Control (APC) technologies to improve operation stability, push closer to quality or equipment limit, and improve the capability of process units to handle disturbances. APC implementation had considered a best answer for solving multivariable control problem. PT. Chandra Asri Petrochemical, Tbk (CAP) operates a large naphtha cracker complex at Cilegon, Indonesia. To optimize the plant operation and to enhance the benefit, Chandra Asri has been decided to implement Advance Process Control (APC) for ethylene plant. The APC implementation technology scopes at CAP are as follows: 1. Hot Section : Furnaces, Quench Tower 2. Cold Section : Demethanizer, Deethanizer, Acetylene Converter, Ethylene Fractionator, Depropanizer, Propylene Fractionator, Debutanizer

Bioreactor process parameter screening utilizing a Plackett-Burman design for a model monoclonal antibody.

PubMed

Agarabi, Cyrus D; Schiel, John E; Lute, Scott C; Chavez, Brittany K; Boyne, Michael T; Brorson, Kurt A; Khan, Mansoora; Read, Erik K

2015-06-01

Consistent high-quality antibody yield is a key goal for cell culture bioprocessing. This endpoint is typically achieved in commercial settings through product and process engineering of bioreactor parameters during development. When the process is complex and not optimized, small changes in composition and control may yield a finished product of less desirable quality. Therefore, changes proposed to currently validated processes usually require justification and are reported to the US FDA for approval. Recently, design-of-experiments-based approaches have been explored to rapidly and efficiently achieve this goal of optimized yield with a better understanding of product and process variables that affect a product's critical quality attributes. Here, we present a laboratory-scale model culture where we apply a Plackett-Burman screening design to parallel cultures to study the main effects of 11 process variables. This exercise allowed us to determine the relative importance of these variables and identify the most important factors to be further optimized in order to control both desirable and undesirable glycan profiles. We found engineering changes relating to culture temperature and nonessential amino acid supplementation significantly impacted glycan profiles associated with fucosylation, β-galactosylation, and sialylation. All of these are important for monoclonal antibody product quality. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

The Maillard reaction and its control during food processing. The potential of emerging technologies.

PubMed

Jaeger, H; Janositz, A; Knorr, D

2010-06-01

The Maillard reaction between reducing sugars and amino acids is a common reaction in foods which undergo thermal processing. Desired consequences like the formation of flavor and brown color of some cooked foods but also the destruction of essential amino acids and the production of anti-nutritive compounds require the consideration of the Maillard reaction and relevant mechanisms for its control. This paper aims to exemplify the recent advances in food processing with regard to the controllability of heat-induced changes in the food quality. Firstly, improved thermal technologies, such as ohmic heating, which allows direct heating of the product and overcoming the heat transfer limitations of conventional thermal processing are presented in terms of their applicability to reduce the thermal exposure during food preservation. Secondly, non-thermal technologies such as high hydrostatic pressure and pulsed electric fields and their ability to extend the shelf life of food products without the application of heat, thus also preserving the quality attributes of the food, will be discussed. Finally, an innovative method for the removal of Maillard reaction substrates in food raw materials by the application of pulsed electric field cell disintegration and extraction as well as enzymatic conversion is presented in order to demonstrate the potential of the combination of processes to control the occurrence of the Maillard reaction in food processing. (c) 2009 Elsevier Masson SAS. All rights reserved.

Enhancement of biogas production by co-digestion of potato pulp with cow manure in a CSTR system.

PubMed

Sanaei-Moghadam, Akbar; Abbaspour-Fard, Mohammad Hossein; Aghel, Hasan; Aghkhani, Mohammad Hossein; Abedini-Torghabeh, Javad

2014-08-01

Anaerobic digestion (AD) process is a well-established method to generate energy from the organic wastes both from the environmental and economical perspectives. The purpose of present study is to evaluate energy production from potato wastes by incorporating cow manure into the process. Firstly, a laboratory pilot of one-stage biogas production was designed and built according to continuously stirred tank reactor (CSTR) system. The setup was able to automatically control the environmental conditions of the process including temperature, duration, and rate of stirring. AD experiment was exclusively performed on co-digestion of potato peel (PP) and cow manure (CM) in three levels of mixing ratio including 20:80, 50:50, 80:20 (PP:CM), and 0:100 as control treatment based on the volatile solid (VS) weight without adding initial inoculums. After hydraulic retention time (HRT) of 50 days on average 193, 256, 348, and 149 norm liter (LN) (kg VS)(-1), methane was produced for different mixing ratios, respectively. Statistical analysis shows that these gas productions are significantly different. The average energy was determined based on the produced methane which was about 2.8 kWh (kg VS)(-1), implying a significant energy production potential. The average chemical oxygen demand (COD) removal of treatments was about 61%, showing that it can be leached significantly with high organic matter by the employed pilot. The energy efficiency of 92% of the process also showed the optimum control of the process by the pilot.

Fermentation process using specific oxygen uptake rates as a process control

DOEpatents

Van Hoek, Pim; Aristidou, Aristos; Rush, Brian J.

2016-08-30

Specific oxygen uptake (OUR) is used as a process control parameter in fermentation processes. OUR is determined during at least the production phase of a fermentation process, and process parameters are adjusted to maintain the OUR within desired ranges. The invention is particularly applicable when the fermentation is conducted using a microorganism having a natural PDC pathway that has been disrupted so that it no longer functions. Microorganisms of this sort often produce poorly under strictly anaerobic conditions. Microaeration controlled by monitoring OUR allows the performance of the microorganism to be optimized.

Fermentation process using specific oxygen uptake rates as a process control

DOEpatents

Van Hoek, Pim [Minnetonka, MN; Aristidou, Aristos [Maple Grove, MN; Rush, Brian [Minneapolis, MN

2011-05-10

Specific oxygen uptake (OUR) is used as a process control parameter in fermentation processes. OUR is determined during at least the production phase of a fermentation process, and process parameters are adjusted to maintain the OUR within desired ranges. The invention is particularly applicable when the fermentation is conducted using a microorganism having a natural PDC pathway that has been disrupted so that it no longer functions. Microorganisms of this sort often produce poorly under strictly anaerobic conditions. Microaeration controlled by monitoring OUR allows the performance of the microorganism to be optimized.

Fermentation process using specific oxygen uptake rates as a process control

DOEpatents

Hoek, Van; Pim, Aristidou [Minnetonka, MN; Aristos, Rush [Maple Grove, MN; Brian, [Minneapolis, MN

2007-06-19

Specific oxygen uptake (OUR) is used as a process control parameter in fermentation processes. OUR is determined during at least the production phase of a fermentation process, and process parameters are adjusted to maintain the OUR within desired ranges. The invention is particularly applicable when the fermentation is conducted using a microorganism having a natural PDC pathway that has been disrupted so that it no longer functions. Microorganisms of this sort often produce poorly under strictly anaerobic conditions. Microaeration controlled by monitoring OUR allows the performance of the microorganism to be optimized.

Fermentation process using specific oxygen uptake rates as a process control

DOEpatents

Van Hoek, Pim; Aristidou, Aristos; Rush, Brian

2014-09-09

Specific oxygen uptake (OUR) is used as a process control parameter in fermentation processes. OUR is determined during at least the production phase of a fermentation process, and process parameters are adjusted to maintain the OUR within desired ranges. The invention is particularly applicable when the fermentation is conducted using a microorganism having a natural PDC pathway that has been disrupted so that it no longer functions. Microorganisms of this sort often produce poorly under strictly anaerobic conditions. Microaeration controlled by monitoring OUR allows the performance of the microorganism to be optimized.

40 CFR 63.1426 - Process vent requirements for determining organic HAP concentration, control efficiency, and...

Code of Federal Regulations, 2014 CFR

2014-07-01

... Production § 63.1426 Process vent requirements for determining organic HAP concentration, control efficiency..., total organic HAP, or as TOC minus methane and ethane according to the procedures specified. When... methane and ethane) concentrations in all process vent streams and primary and secondary fuels introduced...

Optimal control of nutrition restricted dynamics model of Microalgae biomass growth model

NASA Astrophysics Data System (ADS)

Ratianingsih, R.; Azim; Nacong, N.; Resnawati; Mardlijah; Widodo, B.

2017-12-01

The biomass of the microalgae is very potential to be proposed as an alternative renewable energy resources because it could be extracted into lipid. Afterward, the lipid could be processed to get the biodiesel or bioethanol. The extraction of the biomass on lipid synthesis process is very important to be studied because the process just gives some amount of lipid. A mathematical model of restricted microalgae biomass growth just gives 1/3 proportion of lipid with respect to the biomass in the synthesis process. An optimal control is designed to raise the ratio between the number of lipid formation and the microalgae biomass to be used in synthesis process. The minimum/ Pontryagin maximum principle is used to get the optimal lipid production. The simulation shows that the optimal lipid formation could be reach by simultaneously controlling the carbon dioxide, in the respiration and photosynthesis the process, and intake nutrition rates of liquid waste and urea substrate. The production of controlled microalgae lipid could be increase 6.5 times comparing to the uncontrolled one.

The application of hazard analysis and critical control points and risk management in the preparation of anti-cancer drugs.

PubMed

Bonan, Brigitte; Martelli, Nicolas; Berhoune, Malik; Maestroni, Marie-Laure; Havard, Laurent; Prognon, Patrice

2009-02-01

To apply the Hazard analysis and Critical Control Points method to the preparation of anti-cancer drugs. To identify critical control points in our cancer chemotherapy process and to propose control measures and corrective actions to manage these processes. The Hazard Analysis and Critical Control Points application began in January 2004 in our centralized chemotherapy compounding unit. From October 2004 to August 2005, monitoring of the process nonconformities was performed to assess the method. According to the Hazard Analysis and Critical Control Points method, a multidisciplinary team was formed to describe and assess the cancer chemotherapy process. This team listed all of the critical points and calculated their risk indexes according to their frequency of occurrence, their severity and their detectability. The team defined monitoring, control measures and corrective actions for each identified risk. Finally, over a 10-month period, pharmacists reported each non-conformity of the process in a follow-up document. Our team described 11 steps in the cancer chemotherapy process. The team identified 39 critical control points, including 11 of higher importance with a high-risk index. Over 10 months, 16,647 preparations were performed; 1225 nonconformities were reported during this same period. The Hazard Analysis and Critical Control Points method is relevant when it is used to target a specific process such as the preparation of anti-cancer drugs. This method helped us to focus on the production steps, which can have a critical influence on product quality, and led us to improve our process.

The research of laser marking control technology

NASA Astrophysics Data System (ADS)

Zhang, Qiue; Zhang, Rong

2009-08-01

In the area of Laser marking, the general control method is insert control card to computer's mother board, it can not support hot swap, it is difficult to assemble or it. Moreover, the one marking system must to equip one computer. In the system marking, the computer can not to do the other things except to transmit marking digital information. Otherwise it can affect marking precision. Based on traditional control methods existed some problems, introduced marking graphic editing and digital processing by the computer finish, high-speed digital signal processor (DSP) control marking the whole process. The laser marking controller is mainly contain DSP2812, digital memorizer, DAC (digital analog converting) transform unit circuit, USB interface control circuit, man-machine interface circuit, and other logic control circuit. Download the marking information which is processed by computer to U disk, DSP read the information by USB interface on time, then processing it, adopt the DSP inter timer control the marking time sequence, output the scanner control signal by D/A parts. Apply the technology can realize marking offline, thereby reduce the product cost, increase the product efficiency. The system have good effect in actual unit markings, the marking speed is more quickly than PCI control card to 20 percent. It has application value in practicality.

Strategies for enhancing fermentative production of acetoin: a review.

PubMed

Xiao, Zijun; Lu, Jian R

2014-01-01

Acetoin is a volatile compound widely used in foods, cigarettes, cosmetics, detergents, chemical synthesis, plant growth promoters and biological pest controls. It works largely as flavour and fragrance. Since some bacteria were found to be capable of vigorous acetoin biosynthesis from versatile renewable biomass, acetoin, like its reduced form 2,3-butanediol, was also classified as a promising bio-based platform chemical. In spite of several reviews on the biological production of 2,3-butanediol, little has concentrated on acetoin. The two analogous compounds are present in the same acetoin (or 2,3-butanediol) pathway, but their production processes including optimal strains, substrates, derivatives, process controls and product recovery methods are quite different. In this review, the usages of acetoin are reviewed firstly to demonstrate its importance. The biosynthesis pathway and molecular regulation mechanisms are then outlined to depict the principal network of functioning in typical species. A phylogenetic tree is constructed and the relationship between taxonomy and acetoin producing ability is revealed for the first time, which will serve as a useful guide for the screening of competitive acetoin producers. Genetic engineering, medium optimization, and process control are effective strategies to improve productivity as well. Currently, downstream processing is one of the main barriers in efficient and economical industrial acetoin fermentation. The future prospects of microbial acetoin production are discussed in light of the current progress, challenges, and trends in this field. Copyright © 2014 Elsevier Inc. All rights reserved.

Remote control of the industry processes. POWERLINK protocol application

NASA Astrophysics Data System (ADS)

Wóbel, A.; Paruzel, D.; Paszkiewicz, B.

2017-08-01

The present technological development enables the use of solutions characterized by a lower failure rate, and work with greater precision. This allows you to obtain the most efficient production, high speed production and reliability of individual components. The main scope of this article was POWERLINK protocol application for communication with the controller B & R through communication Ethernet for recording process parameters. This enables control of run production cycle using an internal network connected to the PC industry. Knowledge of the most important parameters of the production in real time allows detecting of a failure immediately after occurrence. For this purpose, the position of diagnostic use driver X20CP1301 B&R to record measurement data such as pressure, temperature valve between the parties and the torque required to change the valve setting was made. The use of POWERLINK protocol allows for the transmission of information on the status of every 200 μs.

New Vistas in Chemical Product and Process Design.

PubMed

Zhang, Lei; Babi, Deenesh K; Gani, Rafiqul

2016-06-07

Design of chemicals-based products is broadly classified into those that are process centered and those that are product centered. In this article, the designs of both classes of products are reviewed from a process systems point of view; developments related to the design of the chemical product, its corresponding process, and its integration are highlighted. Although significant advances have been made in the development of systematic model-based techniques for process design (also for optimization, operation, and control), much work is needed to reach the same level for product design. Timeline diagrams illustrating key contributions in product design, process design, and integrated product-process design are presented. The search for novel, innovative, and sustainable solutions must be matched by consideration of issues related to the multidisciplinary nature of problems, the lack of data needed for model development, solution strategies that incorporate multiscale options, and reliability versus predictive power. The need for an integrated model-experiment-based design approach is discussed together with benefits of employing a systematic computer-aided framework with built-in design templates.

77 FR 1996 - National Organic Program (NOP); Sunset Review (2012)

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-12

... production at Sec. 205.601(g)(1) as follows: Sulfur dioxide--underground rodent control only (smoke bombs). The Environmental Protection Agency (EPA) registers smoke bomb products for underground rodent control...). Smoke bombs are placed into rodent burrows and detonated. The detonation process produces sulfur dioxide...

9 CFR 417.1 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION ACT AND THE POULTRY PRODUCTS INSPECTION ACT HAZARD ANALYSIS AND... control point. A point, step, or procedure in a food process at which control can be applied and, as a...

9 CFR 417.1 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION ACT AND THE POULTRY PRODUCTS INSPECTION ACT HAZARD ANALYSIS AND... control point. A point, step, or procedure in a food process at which control can be applied and, as a...

9 CFR 417.1 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION ACT AND THE POULTRY PRODUCTS INSPECTION ACT HAZARD ANALYSIS AND... control point. A point, step, or procedure in a food process at which control can be applied and, as a...

9 CFR 417.1 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION ACT AND THE POULTRY PRODUCTS INSPECTION ACT HAZARD ANALYSIS AND... control point. A point, step, or procedure in a food process at which control can be applied and, as a...

9 CFR 417.1 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION ACT AND THE POULTRY PRODUCTS INSPECTION ACT HAZARD ANALYSIS AND... control point. A point, step, or procedure in a food process at which control can be applied and, as a...

Bacillus thuringiensis: fermentation process and risk assessment. A short review.

PubMed

Capalbo, D M

1995-01-01

Several factors make the local production of Bacillus thuringiensis (Bt) highly appropriate for pest control in developing nations. Bt can be cheaply produced on a wide variety of low cost, organic substrates. Local production results in considerable savings in hard currency which otherwise would be spent on importation of chemical and biological insecticides. The use of Bt in Brazil has been limited in comparison with chemical insecticides. Although Bt is imported, some Brazilian researchers have been working on its development and production. Fermentation processes (submerged and semi-solid) were applied, using by-products from agro-industries. As the semi-solid fermentation process demonstrated to be interesting for Bt endotoxins production, it could be adopted for small scale local production. Although promising results had been achieved, national products have not been registered due to the absence of a specific legislation for biological products. Effective actions are being developed in order to solve this gap. Regardless of the biocontrol agents being considered atoxic and harmless to the environment, information related to direct and indirect effects of microbials are still insufficient in many cases. The risk analysis of the use of microbial control agents is of upmost importance nowadays, and is also discussed.

Economic process to co-produce poly(ε-l-lysine) and poly(l-diaminopropionic acid) by a pH and dissolved oxygen control strategy.

PubMed

Xu, Zhaoxian; Feng, Xiaohai; Sun, Zhuzhen; Cao, Changhong; Li, Sha; Xu, Zheng; Xu, Zongqi; Bo, Fangfang; Xu, Hong

2015-01-01

This study tended to apply biorefinery of indigenous microbes to the fermentation of target-product generation through a novel control strategy. A novel strategy for co-producing two valuable homopoly(amino acid)s, poly(ε-l-lysine) (ε-PL) and poly(l-diaminopropionic acid) (PDAP), was developed by controlling pH and dissolved oxygen concentrations in Streptomyces albulus PD-1 fermentation. The production of ε-PL and PDAP got 29.4 and 9.6gL(-1), respectively, via fed-batch cultivation in a 5L bioreactor. What is more, the highest production yield (21.8%) of similar production systems was achieved by using this novel strategy. To consider the economic-feasibility, large-scale production in a 1t fermentor was also implemented, which would increase the gross profit of 54,243.5USD from one fed-batch bioprocess. This type of fermentation, which produces multiple commercial products from a unified process is attractive, because it will improve the utilization rate of raw materials, enhance production value and enrich product variety. Copyright © 2015 Elsevier Ltd. All rights reserved.

Simulation of generation of new ideas for new product development and IT services

NASA Astrophysics Data System (ADS)

Nasiopoulos, Dimitrios K.; Sakas, Damianos P.; Vlachos, D. S.; Mavrogianni, Amanda

2015-02-01

This paper describes a dynamic model of the New Product Development (NPD) process. The model has been occurring from best practice noticed in our research conducted at a range of situations. The model contributes to determine and put an IT company's NPD activities into the frame of the overall NPD process[1]. It has been found to be a useful tool for organizing data on IT company's NPD activities without enforcement an excessively restrictive research methodology refers to the model of NPD. The framework, which strengthens the model, will help to promote a research of the methods undertaken within an IT company's NPD process, thus promoting understanding and improvement of the simulation process[2]. IT companies tested many techniques with several different practices designed to improve the validity and efficacy of their NPD process[3]. Supported by the model, this research examines how widely accepted stated tactics are and what impact these best tactics have on NPD performance. The main assumption of this study is that simulation of generation of new ideas[4] will lead to greater NPD effectiveness and more successful products in IT companies. With the model implementation, practices concern the implementation strategies of NPD (product selection, objectives, leadership, marketing strategy and customer satisfaction) are all more widely accepted than best practices related with controlling the application of NPD (process control, measurements, results). In linking simulation with impact, our results states product success depends on developing strong products and ensuring organizational emphasis, through proper project selection. Project activities strengthens both product and project success. IT products and services success also depends on monitoring the NPD procedure through project management and ensuring team consistency with group rewards. Sharing experiences between projects can positively influence the NPD process.

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

NASA Technical Reports Server (NTRS)

Sampson, Paul G.; Sny, Linda C.

1992-01-01

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

Contingency learning is reduced for high conflict stimuli.

PubMed

Whitehead, Peter S; Brewer, Gene A; Patwary, Nowed; Blais, Chris

2016-09-16

Recent theories have proposed that contingency learning occurs independent of control processes. These parallel processing accounts propose that behavioral effects originally thought to be products of control processes are in fact products solely of contingency learning. This view runs contrary to conflict-mediated Hebbian-learning models that posit control and contingency learning are parts of an interactive system. In this study we replicate the contingency learning effect and modify it to further test the veracity of the parallel processing accounts in comparison to conflict-mediated Hebbian-learning models. This is accomplished by manipulating conflict to test for an interaction, or lack thereof, between conflict and contingency learning. The results are consistent with conflict-mediated Hebbian-learning in that the addition of conflict reduces the magnitude of the contingency learning effect. Copyright © 2016 Elsevier B.V. All rights reserved.

A Conceptual Model of the Air Force Logistics Pipeline

DTIC Science & Technology

1989-09-01

Contracting Process . ....... 138 Industrial Capacity .. ......... 140 The Disposal Pipeline Subsystem ....... 142 Collective Pipeline Models...Explosion of " Industry ," Acquisition and Production Process .... ............ 202 60. First Level Explosion of "Attrition," the Disposal Process...Terminology and Phrases, a publication of The American Production and Inventory Control Society ( APICS ). This dictionary defines 5 "pipeline stock" as the

Quality data collection and management technology of aerospace complex product assembly process

NASA Astrophysics Data System (ADS)

Weng, Gang; Liu, Jianhua; He, Yongxi; Zhuang, Cunbo

2017-04-01

Aiming at solving problems of difficult management and poor traceability for discrete assembly process quality data, a data collection and management method is proposed which take the assembly process and BOM as the core. Data collection method base on workflow technology, data model base on BOM and quality traceability of assembly process is included in the method. Finally, assembly process quality data management system is developed and effective control and management of quality information for complex product assembly process is realized.

Design requirements for SRB production control system. Volume 3: Package evaluation, modification and hardware

NASA Technical Reports Server (NTRS)

1981-01-01

The software package evaluation was designed to analyze commercially available, field-proven, production control or manufacturing resource planning management technology and software package. The analysis was conducted by comparing SRB production control software requirements and conceptual system design to software package capabilities. The methodology of evaluation and the findings at each stage of evaluation are described. Topics covered include: vendor listing; request for information (RFI) document; RFI response rate and quality; RFI evaluation process; and capabilities versus requirements.

Bioreactor performance: a more scientific approach for practice.

PubMed

Lübbert, A; Bay Jørgensen, S

2001-02-13

In practice, the performance of a biochemical conversion process, i.e. the bioreactor performance, is essentially determined by the benefit/cost ratio. The benefit is generally defined in terms of the amount of the desired product produced and its market price. Cost reduction is the major objective in biochemical engineering. There are two essential engineering approaches to minimizing the cost of creating a particular product in an existing plant. One is to find a control path or operational procedure that optimally uses the dynamics of the process and copes with the many constraints restricting production. The other is to remove or lower the constraints by constructive improvements of the equipment and/or the microorganisms. This paper focuses on the first approach, dealing with optimization of the operational procedure and the measures by which one can ensure that the process adheres to the predetermined path. In practice, feedforward control is the predominant control mode applied. However, as it is frequently inadequate for optimal performance, feedback control may also be employed. Relevant aspects of such performance optimization are discussed.

Increased Reliability of Gas Turbine Components by Robust Coatings Manufacturing

NASA Astrophysics Data System (ADS)

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

2017-08-01

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

RACE pulls for shared control

NASA Astrophysics Data System (ADS)

Leahy, M. B., Jr.; Cassiday, B. K.

1993-02-01

Maintaining and supporting an aircraft fleet, in a climate of reduced manpower and financial resources, dictates effective utilization of robotics and automation technologies. To help develop a winning robotics and automation program the Air Force Logistics Command created the Robotics and Automation Center of Excellence (RACE). RACE is a command wide focal point. Race is an organic source of expertise to assist the Air Logistic Center (ALC) product directorates in improving process productivity through the judicious insertion of robotics and automation technologies. RACE is a champion for pulling emerging technologies into the aircraft logistic centers. One of those technology pulls is shared control. Small batch sizes, feature uncertainty, and varying work load conspire to make classic industrial robotic solutions impractical. One can view ALC process problems in the context of space robotics without the time delay. The ALC's will benefit greatly from the implementation of a common architecture that supports a range of control actions from fully autonomous to teleoperated. Working with national laboratories and private industry, we hope to transition shared control technology to the depot floor. This paper provides an overview of the RACE internal initiatives and customer support, with particular emphasis on production processes that will benefit from shared control technology.

RACE pulls for shared control

NASA Astrophysics Data System (ADS)

Leahy, Michael B., Jr.; Cassiday, Brian K.

1992-11-01

Maintaining and supporting an aircraft fleet, in a climate of reduced manpower and financial resources, dictates effective utilization of robotics and automation technologies. To help develop a winning robotics and automation program the Air Force Logistics Command created the Robotics and Automation Center of Excellence (RACE). RACE is a command wide focal point. An organic source of expertise to assist the Air Logistic Center (ALC) product directorates in improving process productivity through the judicious insertion of robotics and automation technologies. RACE is a champion for pulling emerging technologies into the aircraft logistic centers. One of those technology pulls is shared control. The small batch sizes, feature uncertainty, and varying work load conspire to make classic industrial robotic solutions impractical. One can view ALC process problems in the context of space robotics without the time delay. The ALCs will benefit greatly from the implementation of a common architecture that supports a range of control actions from fully autonomous to teleoperated. Working with national laboratories and private industry we hope to transition shared control technology to the depot floor. This paper provides an overview of the RACE internal initiatives and customer support, with particular emphasis on production processes that will benefit from shared control technology.

RACE pulls for shared control

NASA Technical Reports Server (NTRS)

Leahy, M. B., Jr.; Cassiday, B. K.

1993-01-01

Maintaining and supporting an aircraft fleet, in a climate of reduced manpower and financial resources, dictates effective utilization of robotics and automation technologies. To help develop a winning robotics and automation program the Air Force Logistics Command created the Robotics and Automation Center of Excellence (RACE). RACE is a command wide focal point. Race is an organic source of expertise to assist the Air Logistic Center (ALC) product directorates in improving process productivity through the judicious insertion of robotics and automation technologies. RACE is a champion for pulling emerging technologies into the aircraft logistic centers. One of those technology pulls is shared control. Small batch sizes, feature uncertainty, and varying work load conspire to make classic industrial robotic solutions impractical. One can view ALC process problems in the context of space robotics without the time delay. The ALC's will benefit greatly from the implementation of a common architecture that supports a range of control actions from fully autonomous to teleoperated. Working with national laboratories and private industry, we hope to transition shared control technology to the depot floor. This paper provides an overview of the RACE internal initiatives and customer support, with particular emphasis on production processes that will benefit from shared control technology.

Organic acid formulation and dip to control listeria monocytogenes in hot dogs.

USDA-ARS?s Scientific Manuscript database

Processed meat products such as frankfurters, smoked sausage, and deli meat have gained popularity because consumers have less time for food preparation and demand more convenient meat items. Because these products are handled post processing and may not be reheated before consumption, the presence...

Regulatory Role of PBAN in Sex Pheromone Biosynthesis of Heliothine Moths

PubMed Central

Jurenka, Russell; Rafaeli, Ada

2011-01-01

Both males and females of heliothine moths utilize sex-pheromones during the mating process. Females produce and release a sex pheromone for the long–range attraction of males for mating. Production of sex pheromone in females is controlled by the peptide hormone (pheromone biosynthesis activating neuropeptide, PBAN). This review will highlight what is known about the role PBAN plays in controlling pheromone production in female moths. Male moths produce compounds associated with a hairpencil structure associated with the aedaegus that are used as short-range aphrodisiacs during the mating process. We will discuss the role that PBAN plays in regulating male production of hairpencil pheromones. PMID:22654810

Examining the freezing process of an intermediate bulk containing an industrially relevant protein

PubMed Central

Reinsch, Holger; Spadiut, Oliver; Heidingsfelder, Johannes; Herwig, Christoph

2015-01-01

Numerous biopharmaceuticals are produced in recombinant microorganisms in the controlled environment of a bioreactor, a process known as Upstream Process. To minimize product loss due to physico-chemical and enzymatic degradation, the Upstream Process should be directly followed by product purification, known as Downstream Process. However, the Downstream Process can be technologically complex and time-consuming which is why Upstream and Downstream Process usually have to be decoupled temporally and spatially. Consequently, the product obtained after the Upstream Process, known as intermediate bulk, has to be stored. In those circumstances, a freezing procedure is often performed to prevent product loss. However, the freezing process itself is inseparably linked to physico-chemical changes of the intermediate bulk which may in turn damage the product. The present study analysed the behaviour of a Tris-buffered intermediate bulk containing a biopharmaceutically relevant protein during a bottle freezing process. Major damaging mechanisms, like the spatiotemporal redistribution of ion concentrations and pH, and their influence on product stability were investigated. Summarizing, we show the complex events which happen in an intermediate bulk during freezing and explain the different causes for product loss. PMID:25765305

A fuzzy classifier system for process control

NASA Technical Reports Server (NTRS)

Karr, C. L.; Phillips, J. C.

1994-01-01

A fuzzy classifier system that discovers rules for controlling a mathematical model of a pH titration system was developed by researchers at the U.S. Bureau of Mines (USBM). Fuzzy classifier systems successfully combine the strengths of learning classifier systems and fuzzy logic controllers. Learning classifier systems resemble familiar production rule-based systems, but they represent their IF-THEN rules by strings of characters rather than in the traditional linguistic terms. Fuzzy logic is a tool that allows for the incorporation of abstract concepts into rule based-systems, thereby allowing the rules to resemble the familiar 'rules-of-thumb' commonly used by humans when solving difficult process control and reasoning problems. Like learning classifier systems, fuzzy classifier systems employ a genetic algorithm to explore and sample new rules for manipulating the problem environment. Like fuzzy logic controllers, fuzzy classifier systems encapsulate knowledge in the form of production rules. The results presented in this paper demonstrate the ability of fuzzy classifier systems to generate a fuzzy logic-based process control system.

Seeking key microorganisms for enhancing methane production in anaerobic digestion of waste sewage sludge.

PubMed

Mustapha, Nurul Asyifah; Hu, Anyi; Yu, Chang-Ping; Sharuddin, Siti Suhailah; Ramli, Norhayati; Shirai, Yoshihito; Maeda, Toshinari

2018-06-01

Efficient approaches for the utilization of waste sewage sludge have been widely studied. One of them is to use it for the bioenergy production, specifically methane gas which is well-known to be driven by complex bacterial interactions during the anaerobic digestion process. Therefore, it is important to understand not only microorganisms for producing methane but also those for controlling or regulating the process. In this study, azithromycin analogs belonging to macrolide, ketolide, and lincosamide groups were applied to investigate the mechanisms and dynamics of bacterial community in waste sewage sludge for methane production. The stages of anaerobic digestion process were evaluated by measuring the production of intermediate substrates, such as protease activity, organic acids, the quantification of bacteria and archaea, and its community dynamics. All azithromycin analogs used in this study achieved a high methane production compared to the control sample without any antibiotic due to the efficient hydrolysis process and the presence of important fermentative bacteria and archaea responsible in the methanogenesis stage. The key microorganisms contributing to the methane production may be Clostridia, Cladilinea, Planctomycetes, and Alphaproteobacteria as an accelerator whereas Nitrosomonadaceae and Nitrospiraceae may be suppressors for methane production. In conclusion, the utilization of antibiotic analogs of macrolide, ketolide, and lincosamide groups has a promising ability in finding the essential microorganisms and improving the methane production using waste sewage sludge.

High-autonomy control of space resource processing plants

NASA Technical Reports Server (NTRS)

Schooley, Larry C.; Zeigler, Bernard P.; Cellier, Francois E.; Wang, Fei-Yue

1993-01-01

A highly autonomous intelligent command/control architecture has been developed for planetary surface base industrial process plants and Space Station Freedom experimental facilities. The architecture makes use of a high-level task-oriented mode with supervisory control from one or several remote sites, and integrates advanced network communications concepts and state-of-the-art man/machine interfaces with the most advanced autonomous intelligent control. Attention is given to the full-dynamics model of a Martian oxygen-production plant, event-based/fuzzy-logic process control, and fault management practices.

Major advances in concentrated and dry milk products, cheese, and milk fat-based spreads.

PubMed

Henning, D R; Baer, R J; Hassan, A N; Dave, R

2006-04-01

Advances in dairy foods and dairy foods processing since 1981 have influenced consumers and processors of dairy products. Consumer benefits include dairy products with enhanced nutrition and product functionality for specific applications. Processors convert raw milk to finished product with improved efficiencies and have developed processing technologies to improve traditional products and to introduce new products for expanding the dairy foods market. Membrane processing evolved from a laboratory technique to a major industrial process for milk and whey processing. Ultra-filtration and reverse osmosis have been used extensively in fractionation of milk and whey components. Advances in cheese manufacturing methods have included mechanization of the making process. Membrane processing has allowed uniform composition of the cheese milk and starter cultures have become more predictable. Cheese vats have become larger and enclosed as well as computer controlled. Researchers have learned to control many of the functional properties of cheese by understanding the role of fat and calcium distribution, as bound or unbound, in the cheese matrix. Processed cheese (cheese, foods, spreads, and products) maintain their importance in the industry as many product types can be produced to meet market needs and provide stable products for an extended shelf life. Cheese delivers concentrated nutrients of milk and bio-active peptides to consumers. The technologies for the production of concentrated and dried milk and whey products have not changed greatly in the last 25 yr. The size and efficiencies of the equipment have increased. Use of reverse osmosis in place of vacuum condensing has been proposed. Modifying the fatty acid composition of milkfat to alter the nutritional and functional properties of dairy spread has been a focus of research in the last 2 decades. Conjugated linoleic acid, which can be increased in milkfat by alteration of the cow's diet, has been reported to have anticancer, anti-atherogenic, antidiabetic, and antiobesity effects for human health. Separating milk fat into fractions has been accomplished to provide specific fractions to improve butter spreadability, modulate chocolate meltability, and provide texture for low-fat cheeses.

Advanced development: Fuels

NASA Astrophysics Data System (ADS)

Ramohalli, K.

1981-05-01

The solar thermal fuels and chemicals program at Jet Propulsion Laboratory are described. High technology is developed and applied to displace fossil fuel (oil) use in the production/processing of valuable fuels and chemicals. The technical and economic feasibility is demonstrated to extent that enables the industry to participate and commercialize the product. A representative process, namely Furfural production with a bottoming of acetone, butanol and ethanol, is described. Experimental data from all solar production of furfural is discussed. Estimates are given to show the attractiveness of this process, considering its flexibility to be adaptable to dishes, troughs or central receivers. Peat, lignite and low rank coal processing, heavy oil stripping and innovative technologies for process diagnostics and control are mentioned as examples of current projects under intensive development.

Advanced development: Fuels

NASA Technical Reports Server (NTRS)

Ramohalli, K.

1981-01-01

The solar thermal fuels and chemicals program at Jet Propulsion Laboratory are described. High technology is developed and applied to displace fossil fuel (oil) use in the production/processing of valuable fuels and chemicals. The technical and economic feasibility is demonstrated to extent that enables the industry to participate and commercialize the product. A representative process, namely Furfural production with a bottoming of acetone, butanol and ethanol, is described. Experimental data from all solar production of furfural is discussed. Estimates are given to show the attractiveness of this process, considering its flexibility to be adaptable to dishes, troughs or central receivers. Peat, lignite and low rank coal processing, heavy oil stripping and innovative technologies for process diagnostics and control are mentioned as examples of current projects under intensive development.

Diffraction based overlay re-assessed

NASA Astrophysics Data System (ADS)

Leray, Philippe; Laidler, David; D'havé, Koen; Cheng, Shaunee

2011-03-01

In recent years, numerous authors have reported the advantages of Diffraction Based Overlay (DBO) over Image Based Overlay (IBO), mainly by comparison of metrology figures of merit such as TIS and TMU. Some have even gone as far as to say that DBO is the only viable overlay metrology technique for advanced technology nodes; 22nm and beyond. Typically the only reported drawback of DBO is the size of the required targets. This severely limits its effective use, when all critical layers of a product, including double patterned layers need to be measured, and in-die overlay measurements are required. In this paper we ask whether target size is the only limitation to the adoption of DBO for overlay characterization and control, or are there other metrics, which need to be considered. For example, overlay accuracy with respect to scanner baseline or on-product process overlay control? In this work, we critically re-assess the strengths and weaknesses of DBO for the applications of scanner baseline and on-product process layer overlay control. A comprehensive comparison is made to IBO. For on product process layer control we compare the performance on critical process layers; Gate, Contact and Metal. In particularly we focus on the response of the scanner to the corrections determined by each metrology technique for each process layer, as a measure of the accuracy. Our results show that to characterize an overlay metrology technique that is suitable for use in advanced technology nodes requires much more than just evaluating the conventional metrology metrics of TIS and TMU.

Memory and cognitive control in an integrated theory of language processing.

PubMed

Slevc, L Robert; Novick, Jared M

2013-08-01

Pickering & Garrod's (P&G's) integrated model of production and comprehension includes no explicit role for nonlinguistic cognitive processes. Yet, how domain-general cognitive functions contribute to language processing has become clearer with well-specified theories and supporting data. We therefore believe that their account can benefit by incorporating functions like working memory and cognitive control into a unified model of language processing.

Optimising UAV topographic surveys processed with structure-from-motion: Ground control quality, quantity and bundle adjustment

NASA Astrophysics Data System (ADS)

James, Mike R.; Robson, Stuart; d'Oleire-Oltmanns, Sebastian; Niethammer, Uwe

2016-04-01

Structure-from-motion (SfM) algorithms are greatly facilitating the production of detailed topographic models based on images collected by unmanned aerial vehicles (UAVs). However, SfM-based software does not generally provide the rigorous photogrammetric analysis required to fully understand survey quality. Consequently, error related to problems in control point data or the distribution of control points can remain undiscovered. Even if these errors are not large in magnitude, they can be systematic, and thus have strong implications for the use of products such as digital elevation models (DEMs) and orthophotos. Here, we develop a Monte Carlo approach to (1) improve the accuracy of products when SfM-based processing is used and (2) reduce the associated field effort by identifying suitable lower density deployments of ground control points. The method highlights over-parameterisation during camera self-calibration and provides enhanced insight into control point performance when rigorous error metrics are not available. Processing was implemented using commonly-used SfM-based software (Agisoft PhotoScan), which we augment with semi-automated and automated GCPs image measurement. We apply the Monte Carlo method to two contrasting case studies - an erosion gully survey (Taurodont, Morocco) carried out with an fixed-wing UAV, and an active landslide survey (Super-Sauze, France), acquired using a manually controlled quadcopter. The results highlight the differences in the control requirements for the two sites, and we explore the implications for future surveys. We illustrate DEM sensitivity to critical processing parameters and show how the use of appropriate parameter values increases DEM repeatability and reduces the spatial variability of error due to processing artefacts.

A system framework of inter-enterprise machining quality control based on fractal theory

NASA Astrophysics Data System (ADS)

Zhao, Liping; Qin, Yongtao; Yao, Yiyong; Yan, Peng

2014-03-01

In order to meet the quality control requirement of dynamic and complicated product machining processes among enterprises, a system framework of inter-enterprise machining quality control based on fractal was proposed. In this system framework, the fractal-specific characteristic of inter-enterprise machining quality control function was analysed, and the model of inter-enterprise machining quality control was constructed by the nature of fractal structures. Furthermore, the goal-driven strategy of inter-enterprise quality control and the dynamic organisation strategy of inter-enterprise quality improvement were constructed by the characteristic analysis on this model. In addition, the architecture of inter-enterprise machining quality control based on fractal was established by means of Web service. Finally, a case study for application was presented. The result showed that the proposed method was available, and could provide guidance for quality control and support for product reliability in inter-enterprise machining processes.

Occurrence of Alicyclobacillus in the fruit processing environment--a review.

PubMed

Steyn, Catharina E; Cameron, Michelle; Witthuhn, R Corli

2011-05-14

Concentrated fruit products have a significant place in modern consumption markets and are valuable semi-prepared food components to the bakery, dairy, confectionary, canning, baby food, frozen food, distilling and beverage industries. There is continuous pressure on the beverage industry to improve the quality of concentrated fruit products in order for reconstituted fruit beverages to compete with beverages that are made from fresh fruits. In recent years, Alicyclobacillus spp. have become a major concern to the beverage industry worldwide as many high-acid, concentrated fruit products have been found to be contaminated with these spoilage microbes. The thermo-acidophilic nature of alicyclobacilli and highly resistant endospores allows for their survival during the production of concentrated fruit products. Under favourable conditions, endospores can germinate and multiply to numbers high enough to cause spoilage and product deterioration through the production of chemical taint compounds. It is imperative to understand the nature of Alicyclobacillus within the fruit concentrate processing environment so as to develop effective control strategies and to prevent spoilage in juice and beverage products that are reconstituted from fruit concentrates. This paper reviews the occurrence of alicyclobacilli in the fruit processing environment, control measures, as well as detection, identification and standardised test methods that are currently used for Alicyclobacillus in concentrated fruit products. Copyright © 2011 Elsevier B.V. All rights reserved.

Semantic Typicality Effects in Acquired Dyslexia: Evidence for Semantic Impairment in Deep Dyslexia.

PubMed

Riley, Ellyn A; Thompson, Cynthia K

2010-06-01

BACKGROUND: Acquired deep dyslexia is characterized by impairment in grapheme-phoneme conversion and production of semantic errors in oral reading. Several theories have attempted to explain the production of semantic errors in deep dyslexia, some proposing that they arise from impairments in both grapheme-phoneme and lexical-semantic processing, and others proposing that such errors stem from a deficit in phonological production. Whereas both views have gained some acceptance, the limited evidence available does not clearly eliminate the possibility that semantic errors arise from a lexical-semantic input processing deficit. AIMS: To investigate semantic processing in deep dyslexia, this study examined the typicality effect in deep dyslexic individuals, phonological dyslexic individuals, and controls using an online category verification paradigm. This task requires explicit semantic access without speech production, focusing observation on semantic processing from written or spoken input. METHODS #ENTITYSTARTX00026; PROCEDURES: To examine the locus of semantic impairment, the task was administered in visual and auditory modalities with reaction time as the primary dependent measure. Nine controls, six phonological dyslexic participants, and five deep dyslexic participants completed the study. OUTCOMES #ENTITYSTARTX00026; RESULTS: Controls and phonological dyslexic participants demonstrated a typicality effect in both modalities, while deep dyslexic participants did not demonstrate a typicality effect in either modality. CONCLUSIONS: These findings suggest that deep dyslexia is associated with a semantic processing deficit. Although this does not rule out the possibility of concomitant deficits in other modules of lexical-semantic processing, this finding suggests a direction for treatment of deep dyslexia focused on semantic processing.

Salmonella and eggs: from production to plate.

PubMed

Whiley, Harriet; Ross, Kirstin

2015-02-26

Salmonella contamination of eggs and egg shells has been identified as a public health concern worldwide. A recent shift in consumer preferences has impacted on the egg industry, with a push for cage-free egg production methods. There has also been an increased desire from consumers for raw and unprocessed foods, potentially increasing the risk of salmonellosis. In response to these changes, this review explores the current literature regarding Salmonella contamination of eggs during the production processing through to food handling protocols. The contamination of eggs with Salmonella during the production process is a complex issue, influenced by many variables including flock size, flock age, stress, feed, vaccination, and cleaning routines. Currently there is no consensus regarding the impact of caged, barn and free range egg production has on Salmonella contamination of eggs. The literature regarding the management and control strategies post-collection, during storage, transport and food handling is also reviewed. Pasteurisation and irradiation were identified as the only certain methods for controlling Salmonella and are essential for the protection of high risk groups, whereas control of temperature and pH were identified as potential control methods to minimise the risk for foods containing raw eggs; however, further research is required to provide more detailed control protocols and education programs to reduce the risk of salmonellosis from egg consumption.

Salmonella and Eggs: From Production to Plate

PubMed Central

Whiley, Harriet; Ross, Kirstin

2015-01-01

Salmonella contamination of eggs and egg shells has been identified as a public health concern worldwide. A recent shift in consumer preferences has impacted on the egg industry, with a push for cage-free egg production methods. There has also been an increased desire from consumers for raw and unprocessed foods, potentially increasing the risk of salmonellosis. In response to these changes, this review explores the current literature regarding Salmonella contamination of eggs during the production processing through to food handling protocols. The contamination of eggs with Salmonella during the production process is a complex issue, influenced by many variables including flock size, flock age, stress, feed, vaccination, and cleaning routines. Currently there is no consensus regarding the impact of caged, barn and free range egg production has on Salmonella contamination of eggs. The literature regarding the management and control strategies post-collection, during storage, transport and food handling is also reviewed. Pasteurisation and irradiation were identified as the only certain methods for controlling Salmonella and are essential for the protection of high risk groups, whereas control of temperature and pH were identified as potential control methods to minimise the risk for foods containing raw eggs; however, further research is required to provide more detailed control protocols and education programs to reduce the risk of salmonellosis from egg consumption. PMID:25730295

Opportunities to improve the conversion of food waste to lactate: Fine-tuning secondary factors.

PubMed

RedCorn, Raymond; Engelberth, Abigail S

2017-11-01

Extensive research has demonstrated the potential for bioconversion of food waste to lactate, with major emphasis on adjusting temperature, pH, and loading rate of the fermentation. Each of these factors has a significant effect on lactate production; however, additional secondary factors have received little attention. Here we investigate three additional factors where opportunities exist for process improvement: freezing of samples during storage, discontinuous pH control, and holdover of fermentation broth between fermentations. Freezing samples prior to fermentation was shown to reduce the production rate of lactate by 8%, indicating freeze-thaw should be avoided in experiments. Prior work indicated a trade-off in pH control strategies, where discontinuous pH control correlated with higher lactate accumulation while continuous pH control correlated with higher production rate. Here we demonstrate that continuous pH control can achieve both higher lactate accumulation and higher production rate. Finally, holding over fermentation broth was shown to be a simple method to improve production rate (by 18%) at high food waste loading rates (>140 g volatile solids L -1 ) but resulted in lower lactate accumulation (by 17%). The results inform continued process improvements within the waste treatment of food waste through fermentation to lactic acid.

Design of neural network model-based controller in a fed-batch microbial electrolysis cell reactor for bio-hydrogen gas production

NASA Astrophysics Data System (ADS)

Azwar; Hussain, M. A.; Abdul-Wahab, A. K.; Zanil, M. F.; Mukhlishien

2018-03-01

One of major challenge in bio-hydrogen production process by using MEC process is nonlinear and highly complex system. This is mainly due to the presence of microbial interactions and highly complex phenomena in the system. Its complexity makes MEC system difficult to operate and control under optimal conditions. Thus, precise control is required for the MEC reactor, so that the amount of current required to produce hydrogen gas can be controlled according to the composition of the substrate in the reactor. In this work, two schemes for controlling the current and voltage of MEC were evaluated. The controllers evaluated are PID and Inverse neural network (NN) controller. The comparative study has been carried out under optimal condition for the production of bio-hydrogen gas wherein the controller output is based on the correlation of optimal current and voltage to the MEC. Various simulation tests involving multiple set-point changes and disturbances rejection have been evaluated and the performances of both controllers are discussed. The neural network-based controller results in fast response time and less overshoots while the offset effects are minimal. In conclusion, the Inverse neural network (NN)-based controllers provide better control performance for the MEC system compared to the PID controller.

Product Definition Data Interface (PDDI) Product Specification

DTIC Science & Technology

1991-07-01

syntax of the language gives a precise specification of the data without interpretation of it. M - Constituent Read Block. CSECT - Control Section, the...to conform to the PDDI Access Software’s internal data representation so that it may be further processed. JCL - Job Control Language - IBM language...software development and life cycle * phases. OUALITY CONTROL - The planned and systematic application of all actions (management/technical) necessary to

Controlling calcium precipitation in an integrated anaerobic-aerobic treatment system of a "zero-discharge" paper mill.

PubMed

van Lier, J B; Boncz, M A

2002-01-01

The pulp and paper industry uses significant amounts of water and energy for the paper production process. Closing the water cycles in this industry, therefore, promises large benefits for the environment and has the potential of huge cost savings for the industry. Closing the water cycle on the other hand also introduces problems with process water quality, quality of the end-product and scaling, owing to increased water contamination. An inline treatment system is discussed in which anaerobic-aerobic bioreactors perform a central role for removing both organic and inorganic pollutants from the process water cycle. In the proposed set-up, the organic compounds are converted to methane gas and reused for energy supply, while sulphur compounds are stripped from the process cycle and calcium carbonate is removed by precipitation. Improved control of the treatment system will direct the inorganic precipitates to a location where it does not adversely affect paper production and process water treatment. A simulation program for triggering and controlling CaCO3 precipitation was developed that takes both biological conversions and all relevant chemical equilibria in the system into account. Simulation results are in good agreement with data gathered in a full-scale "zero-emission" paper plant and indicate that control of CaCO3 precipitation can be improved, e.g. in the aerobic post-treatment. Alternatively, a separate precipitation unit could be considered.

Process for conversion of lignin to reformulated hydrocarbon gasoline

DOEpatents

Shabtai, Joseph S.; Zmierczak, Wlodzimierz W.; Chornet, Esteban

1999-09-28

A process for converting lignin into high-quality reformulated hydrocarbon gasoline compositions in high yields is disclosed. The process is a two-stage, catalytic reaction process that produces a reformulated hydrocarbon gasoline product with a controlled amount of aromatics. In the first stage, a lignin material is subjected to a base-catalyzed depolymerization reaction in the presence of a supercritical alcohol as a reaction medium, to thereby produce a depolymerized lignin product. In the second stage, the depolymerized lignin product is subjected to a sequential two-step hydroprocessing reaction to produce a reformulated hydrocarbon gasoline product. In the first hydroprocessing step, the depolymerized lignin is contacted with a hydrodeoxygenation catalyst to produce a hydrodeoxygenated intermediate product. In the second hydroprocessing step, the hydrodeoxygenated intermediate product is contacted with a hydrocracking/ring hydrogenation catalyst to produce the reformulated hydrocarbon gasoline product which includes various desirable naphthenic and paraffinic compounds.

Flat-plate solar array project: Experimental process system development unit for producing semiconductor-grade silicon using the silane-to-silicon process

NASA Technical Reports Server (NTRS)

1983-01-01

The process technology for the manufacture of semiconductor-grade silicon in a large commercial plant by 1986, at a price less than $14 per kilogram of silicon based on 1975 dollars is discussed. The engineering design, installation, checkout, and operation of an Experimental Process System Development unit was discussed. Quality control of scaling-up the process and an economic analysis of product and production costs are discussed.

Mismatch and lexical retrieval gestures are associated with visual information processing, verbal production, and symptomatology in youth at high risk for psychosis.

PubMed

Millman, Zachary B; Goss, James; Schiffman, Jason; Mejias, Johana; Gupta, Tina; Mittal, Vijay A

2014-09-01

Gesture is integrally linked with language and cognitive systems, and recent years have seen a growing attention to these movements in patients with schizophrenia. To date, however, there have been no investigations of gesture in youth at ultra high risk (UHR) for psychosis. Examining gesture in UHR individuals may help to elucidate other widely recognized communicative and cognitive deficits in this population and yield new clues for treatment development. In this study, mismatch (indicating semantic incongruency between the content of speech and a given gesture) and retrieval (used during pauses in speech while a person appears to be searching for a word or idea) gestures were evaluated in 42 UHR individuals and 36 matched healthy controls. Cognitive functions relevant to gesture production (i.e., speed of visual information processing and verbal production) as well as positive and negative symptomatologies were assessed. Although the overall frequency of cases exhibiting these behaviors was low, UHR individuals produced substantially more mismatch and retrieval gestures than controls. The UHR group also exhibited significantly poorer verbal production performance when compared with controls. In the patient group, mismatch gestures were associated with poorer visual processing speed and elevated negative symptoms, while retrieval gestures were associated with higher speed of visual information-processing and verbal production, but not symptoms. Taken together these findings indicate that gesture abnormalities are present in individuals at high risk for psychosis. While mismatch gestures may be closely related to disease processes, retrieval gestures may be employed as a compensatory mechanism. Copyright © 2014 Elsevier B.V. All rights reserved.

EOS MLS Science Data Processing System: A Description of Architecture and Capabilities

NASA Technical Reports Server (NTRS)

Cuddy, David T.; Echeverri, Mark D.; Wagner, Paul A.; Hanzel, Audrey T.; Fuller, Ryan A.

2006-01-01

This paper describes the architecture and capabilities of the Science Data Processing System (SDPS) for the EOS MLS. The SDPS consists of two major components--the Science Computing Facility and the Science Investigator-led Processing System. The Science Computing Facility provides the facilities for the EOS MLS Science Team to perform the functions of scientific algorithm development, processing software development, quality control of data products, and scientific analyses. The Science Investigator-led Processing System processes and reprocesses the science data for the entire mission and delivers the data products to the Science Computing Facility and to the Goddard Space Flight Center Earth Science Distributed Active Archive Center, which archives and distributes the standard science products.

Guidelines To Validate Control of Cross-Contamination during Washing of Fresh-Cut Leafy Vegetables.

PubMed

Gombas, D; Luo, Y; Brennan, J; Shergill, G; Petran, R; Walsh, R; Hau, H; Khurana, K; Zomorodi, B; Rosen, J; Varley, R; Deng, K

2017-02-01

The U.S. Food and Drug Administration requires food processors to implement and validate processes that will result in significantly minimizing or preventing the occurrence of hazards that are reasonably foreseeable in food production. During production of fresh-cut leafy vegetables, microbial contamination that may be present on the product can spread throughout the production batch when the product is washed, thus increasing the risk of illnesses. The use of antimicrobials in the wash water is a critical step in preventing such water-mediated cross-contamination; however, many factors can affect antimicrobial efficacy in the production of fresh-cut leafy vegetables, and the procedures for validating this key preventive control have not been articulated. Producers may consider three options for validating antimicrobial washing as a preventive control for cross-contamination. Option 1 involves the use of a surrogate for the microbial hazard and the demonstration that cross-contamination is prevented by the antimicrobial wash. Option 2 involves the use of antimicrobial sensors and the demonstration that a critical antimicrobial level is maintained during worst-case operating conditions. Option 3 validates the placement of the sensors in the processing equipment with the demonstration that a critical antimicrobial level is maintained at all locations, regardless of operating conditions. These validation options developed for fresh-cut leafy vegetables may serve as examples for validating processes that prevent cross-contamination during washing of other fresh produce commodities.

[Quality process control system of Chinese medicine preparation based on "holistic view"].

PubMed

Wang, Ya-Qi; Jiao, Jiao-Jiao; Wu, Zhen-Feng; Zheng, Qin; Yang, Ming

2018-01-01

"High quality, safety and effectiveness" are the primary principles for the pharmaceutical research and development process in China. The quality of products relies not only on the inspection method, but also on the design and development, process control and standardized management. The quality depends on the process control level. In this paper, the history and current development of quality control of traditional Chinese medicine (TCM) preparations are reviewed systematically. Based on the development model of international drug quality control and the misunderstanding of quality control of TCM preparations, the reasons for impacting the homogeneity of TCM preparations are analyzed and summarized. According to TCM characteristics, efforts were made to control the diversity of TCM, make "unstable" TCM into "stable" Chinese patent medicines, put forward the concepts of "holistic view" and "QbD (quality by design)", so as to create the "holistic, modular, data, standardized" model as the core of TCM preparation quality process control model. Scientific studies shall conform to the actual production of TCM preparations, and be conducive to supporting advanced equipment and technology upgrade, thoroughly applying the scientific research achievements in Chinese patent medicines, and promoting the cluster application and transformation application of TCM pharmaceutical technology, so as to improve the quality and effectiveness of the TCM industry and realize the green development. Copyright© by the Chinese Pharmaceutical Association.

High-productivity DRIE solutions for 3D-SiP and MEMS volume manufacturing

NASA Astrophysics Data System (ADS)

Puech, M.; Thevenoud, J. M.; Launay, N.; Arnal, N.; Godinat, P.; Andrieu, B.; Gruffat, J. M.

2006-12-01

Emerging 3D-SiP technologies and high volume MEMS applications require high productivity mass production DRIE systems. The Alcatel DRIE product range has recently been optimized to reach the highest process and hardware production performances. A study based on sub-micron high aspect ratio structures encountered in the most stringent 3D-SiP has been carried out. The optimization of the Bosch process parameters have shown ultra high silicon etch rate, with unrivaled uniformity and repeatability leading to excellent process yields. In parallel, most recent hardware and proprietary design optimization including vacuum pumping lines, process chamber, wafer chucks, pressure control system, gas delivery are discussed. A key factor for achieving the highest performances was the recognized expertise of Alcatel vacuum and plasma science technologies. These improvements have been monitored in a mass production environment for a mobile phone application. Field data analysis shows a significant reduction of cost of ownership thanks to increased throughput and much lower running costs. These benefits are now available for all 3D-SiP and high volume MEMS applications. The typical etched patterns include tapered trenches for CMOS imagers, through silicon via holes for die stacking, well controlled profile angle for 3D high precision inertial sensors, and large exposed area features for inkjet printer head and Silicon microphones.

A multiple objective optimization approach to quality control

NASA Technical Reports Server (NTRS)

Seaman, Christopher Michael

1991-01-01

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

Interorganizational relationships within state tobacco control networks: a social network analysis.

PubMed

Krauss, Melissa; Mueller, Nancy; Luke, Douglas

2004-10-01

State tobacco control programs are implemented by networks of public and private agencies with a common goal to reduce tobacco use. The degree of a program's comprehensiveness depends on the scope of its activities and the variety of agencies involved in the network. Structural aspects of these networks could help describe the process of implementing a state's tobacco control program, but have not yet been examined. Social network analysis was used to examine the structure of five state tobacco control networks. Semi-structured interviews with key agencies collected quantitative and qualitative data on frequency of contact among network partners, money flow, relationship productivity, level of network effectiveness, and methods for improvement. Most states had hierarchical communication structures in which partner agencies had frequent contact with one or two central agencies. Lead agencies had the highest control over network communication. Networks with denser communication structures had denser productivity structures. Lead agencies had the highest financial influence within the networks, while statewide coalitions were financially influenced by others. Lead agencies had highly productive relationships with others, while agencies with narrow roles had fewer productive relationships. Statewide coalitions that received Robert Wood Johnson Foundation funding had more highly productive relationships than coalitions that did not receive the funding. Results suggest that frequent communication among network partners is related to more highly productive relationships. Results also highlight the importance of lead agencies and statewide coalitions in implementing a comprehensive state tobacco control program. Network analysis could be useful in developing process indicators for state tobacco control programs.

Process-based quality for thermal spray via feedback control

NASA Astrophysics Data System (ADS)

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

2006-09-01

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

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.

Automation of testing modules of controller ELSY-ТМК

NASA Astrophysics Data System (ADS)

Dolotov, A. E.; Dolotova, R. G.; Petuhov, D. V.; Potapova, A. P.

2017-01-01

In modern life, there are means for automation of various processes which allow one to provide high quality standards of released products and to raise labour efficiency. In the given paper, the data on the automation of the test process of the ELSY-TMK controller [1] is presented. The ELSY-TMK programmed logic controller is an effective modular platform for construction of automation systems for small and average branches of industrial production. The modern and functional standard of communication and open environment of the logic controller give a powerful tool of wide spectrum applications for industrial automation. The algorithm allows one to test controller modules by operating the switching system and external devices faster and at a higher level of quality than a human without such means does.

Application of high-throughput mini-bioreactor system for systematic scale-down modeling, process characterization, and control strategy development.

PubMed

Janakiraman, Vijay; Kwiatkowski, Chris; Kshirsagar, Rashmi; Ryll, Thomas; Huang, Yao-Ming

2015-01-01

High-throughput systems and processes have typically been targeted for process development and optimization in the bioprocessing industry. For process characterization, bench scale bioreactors have been the system of choice. Due to the need for performing different process conditions for multiple process parameters, the process characterization studies typically span several months and are considered time and resource intensive. In this study, we have shown the application of a high-throughput mini-bioreactor system viz. the Advanced Microscale Bioreactor (ambr15(TM) ), to perform process characterization in less than a month and develop an input control strategy. As a pre-requisite to process characterization, a scale-down model was first developed in the ambr system (15 mL) using statistical multivariate analysis techniques that showed comparability with both manufacturing scale (15,000 L) and bench scale (5 L). Volumetric sparge rates were matched between ambr and manufacturing scale, and the ambr process matched the pCO2 profiles as well as several other process and product quality parameters. The scale-down model was used to perform the process characterization DoE study and product quality results were generated. Upon comparison with DoE data from the bench scale bioreactors, similar effects of process parameters on process yield and product quality were identified between the two systems. We used the ambr data for setting action limits for the critical controlled parameters (CCPs), which were comparable to those from bench scale bioreactor data. In other words, the current work shows that the ambr15(TM) system is capable of replacing the bench scale bioreactor system for routine process development and process characterization. © 2015 American Institute of Chemical Engineers.

Use of Atmospheric Pressure Cold Plasma for Meat Industry.

PubMed

Lee, Juri; Lee, Cheol Woo; Yong, Hae In; Lee, Hyun Jung; Jo, Cheorun; Jung, Samooel

2017-01-01

Novel, effective methods to control and prevent spoilage and contamination by pathogenic microorganisms in meat and meat products are in constant demand. Non-thermal pasteurization is an ideal method for the preservation of meat and meat products because it does not use heat during the pasteurization process. Atmospheric pressure cold plasma (APCP) is a new technology for the non-thermal pasteurization of meat and meat products. Several recent studies have shown that APCP treatment reduces the number of pathogenic microorganisms in meat and meat products. Furthermore, APCP treatment can be used to generate nitrite, which is an essential component of the curing process. Here, we introduce the effectiveness of APCP treatment as a pasteurization method and/or curing process for use in the meat and meat product processing industry.

Use of Atmospheric Pressure Cold Plasma for Meat Industry

PubMed Central

Lee, Juri; Lee, Cheol Woo; Yong, Hae In; Lee, Hyun Jung; Jo, Cheorun; Jung, Samooel

2017-01-01

Novel, effective methods to control and prevent spoilage and contamination by pathogenic microorganisms in meat and meat products are in constant demand. Non-thermal pasteurization is an ideal method for the preservation of meat and meat products because it does not use heat during the pasteurization process. Atmospheric pressure cold plasma (APCP) is a new technology for the non-thermal pasteurization of meat and meat products. Several recent studies have shown that APCP treatment reduces the number of pathogenic microorganisms in meat and meat products. Furthermore, APCP treatment can be used to generate nitrite, which is an essential component of the curing process. Here, we introduce the effectiveness of APCP treatment as a pasteurization method and/or curing process for use in the meat and meat product processing industry. PMID:28943759

27 CFR 18.51 - Processing material.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Processing material. 18.51 Section 18.51 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT... and Budget under control number 1512-0098) [T.D. ATF-104, 47 FR 23921, June 2, 1982, as amended by T.D...

9 CFR 430.4 - Control of Listeria monocytogenes in post-lethality exposed ready-to-eat products.

Code of Federal Regulations, 2011 CFR

2011-01-01

... products must control through its HACCP plan or prevent in the processing environment through a Sanitation...: (i) The post-lethality treatment must be included in the establishment's HACCP plan. The... the establishment's HACCP plan or its Sanitation SOP or other prerequisite program. (ii) The...

9 CFR 430.4 - Control of Listeria monocytogenes in post-lethality exposed ready-to-eat products.

Code of Federal Regulations, 2010 CFR

2010-01-01

... products must control through its HACCP plan or prevent in the processing environment through a Sanitation...: (i) The post-lethality treatment must be included in the establishment's HACCP plan. The... the establishment's HACCP plan or its Sanitation SOP or other prerequisite program. (ii) The...

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

PubMed

Laske, Stephan; Paudel, Amrit; Scheibelhofer, Otto

2017-03-01

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

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

NASA Astrophysics Data System (ADS)

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

2017-08-01

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

Development of a sterilizing in-place application for a production machine using Vaporized Hydrogen Peroxide.

PubMed

Mau, T; Hartmann, V; Burmeister, J; Langguth, P; Häusler, H

2004-01-01

The use of steam in sterilization processes is limited by the implementation of heat-sensitive components inside the machines to be sterilized. Alternative low-temperature sterilization methods need to be found and their suitability evaluated. Vaporized Hydrogen Peroxide (VHP) technology was adapted for a production machine consisting of highly sensitive pressure sensors and thermo-labile air tube systems. This new kind of "cold" surface sterilization, known from the Barrier Isolator Technology, is based on the controlled release of hydrogen peroxide vapour into sealed enclosures. A mobile VHP generator was used to generate the hydrogen peroxide vapour. The unit was combined with the air conduction system of the production machine. Terminal vacuum pumps were installed to distribute the gas within the production machine and for its elimination. In order to control the sterilization process, different physical process monitors were incorporated. The validation of the process was based on biological indicators (Geobacillus stearothermophilus). The Limited Spearman Karber Method (LSKM) was used to statistically evaluate the sterilization process. The results show that it is possible to sterilize surfaces in a complex tube system with the use of gaseous hydrogen peroxide. A total microbial reduction of 6 log units was reached.

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.

Adaptive management for ecosystem services (j/a) | Science ...

EPA Pesticide Factsheets

Management of natural resources for the production of ecosystem services, which are vital for human well-being, is necessary even when there is uncertainty regarding system response to management action. This uncertainty is the result of incomplete controllability, complex internal feedbacks, and non-linearity that often interferes with desired management outcomes, and insufficient understanding of nature and people. Adaptive management was developed to reduce such uncertainty. We present a framework for the application of adaptive management for ecosystem services that explicitly accounts for cross-scale tradeoffs in the production of ecosystem services. Our framework focuses on identifying key spatiotemporal scales (plot, patch, ecosystem, landscape, and region) that encompass dominant structures and processes in the system, and includes within- and cross-scale dynamics, ecosystem service tradeoffs, and management controllability within and across scales. Resilience theory recognizes that a limited set of ecological processes in a given system regulate ecosystem services, yet our understanding of these processes is poorly understood. If management actions erode or remove these processes, the system may shift into an alternative state unlikely to support the production of desired services. Adaptive management provides a process to assess the underlying within and cross-scale tradeoffs associated with production of ecosystem services while proceeding with manage

A research factory for polymer microdevices: muFac

NASA Astrophysics Data System (ADS)

Anthony, Brian W.; Hardt, David E.; Hale, Melinda; Zarrouati, Nadege

2010-02-01

As part of our research on the manufacturing science of micron scale polymer-based devices, an automated production cell has been developed to explore its use in a volume manufacturing environment. This "micro-factory" allows the testing of models and hardware that have resulted from research on material characterization and simulation, tooling and equipment design and control, and process control and metrology. More importantly it has allowed us to identify the problems that exist between and within unit-processes. This paper details our efforts to produce basic micro-fluidic products in high volume at acceptable production rates and quality levels. The device chosen for our first product is a simple binary micromixer with 40×50 micron channel cross section manufactured by embossing of PMMA. The processes in the cell include laser cutting and drilling, hot embossing, thermal bonding and high-speed inspection of the components. Our goal is to create a "lights-out" factory that can make long production runs (e.g. an 8 hour shift) at high rates (Takt time of less than 3 minutes) with consistent quality. This contrasts with device foundries where prototypes in limited quantities but with high variety are the goal. Accordingly, rate and yield are dominant factors in this work, along with the need for precise material handling strategies. Production data will be presented to include process run charts, sampled functional testing of the products and measures of the overall system throughput.

Production and dose determination of the Infection and Treatment Method (ITM) Muguga cocktail vaccine used to control East Coast fever in cattle.

PubMed

Patel, Ekta; Mwaura, Stephen; Kiara, Henry; Morzaria, Subhash; Peters, Andrew; Toye, Philip

2016-03-01

The Infection and Treatment Method (ITM) of vaccination against the apicomplexan parasite Theileria parva has been used since the early 1970s and is still the only commercially available vaccine to combat the fatal bovine disease, East Coast fever (ECF). The disease is tick-transmitted and results in annual economic losses of at least $300 million per year. While this vaccine technology has been available for over 40 years, few attempts have been made to standardize the production process and characterize the vaccine. The latest batch was produced in early 2008 at the International Livestock Research Institute (ILRI). The vaccine production involves the use of cattle free from parasites routinely monitored throughout the production process, and a pathogen-free tick colony. This paper describes the protocol used in the recent production, and the process improvements, including improved quality control tools, that had not been employed in previous ITM productions. The paper also describes the processes involved in determining the appropriate field dose, which involved a three-step in vivo study with various dilutions of the vaccine stabilate. The vaccine was shown to be safe and viable after production, and a suitable field dose was identified as 1 ml of a 1:100 dilution. Copyright © 2015 Elsevier GmbH. All rights reserved.

Modeling and parameter identification of the simultaneous saccharification-fermentation process for ethanol production.

PubMed

Ochoa, Silvia; Yoo, Ahrim; Repke, Jens-Uwe; Wozny, Günter; Yang, Dae Ryook

2007-01-01

Despite many environmental advantages of using alcohol as a fuel, there are still serious questions about its economical feasibility when compared with oil-based fuels. The bioethanol industry needs to be more competitive, and therefore, all stages of its production process must be simple, inexpensive, efficient, and "easy" to control. In recent years, there have been significant improvements in process design, such as in the purification technologies for ethanol dehydration (molecular sieves, pressure swing adsorption, pervaporation, etc.) and in genetic modifications of microbial strains. However, a lot of research effort is still required in optimization and control, where the first step is the development of suitable models of the process, which can be used as a simulated plant, as a soft sensor or as part of the control algorithm. Thus, toward developing good, reliable, and simple but highly predictive models that can be used in the future for optimization and process control applications, in this paper an unstructured and a cybernetic model are proposed and compared for the simultaneous saccharification-fermentation process (SSF) for the production of ethanol from starch by a recombinant Saccharomyces cerevisiae strain. The cybernetic model proposed is a new one that considers the degradation of starch not only into glucose but also into dextrins (reducing sugars) and takes into account the intracellular reactions occurring inside the cells, giving a more detailed description of the process. Furthermore, an identification procedure based on the Metropolis Monte Carlo optimization method coupled with a sensitivity analysis is proposed for the identification of the model's parameters, employing experimental data reported in the literature.

Economic-Oriented Stochastic Optimization in Advanced Process Control of Chemical Processes

PubMed Central

Dobos, László; Király, András; Abonyi, János

2012-01-01

Finding the optimal operating region of chemical processes is an inevitable step toward improving economic performance. Usually the optimal operating region is situated close to process constraints related to product quality or process safety requirements. Higher profit can be realized only by assuring a relatively low frequency of violation of these constraints. A multilevel stochastic optimization framework is proposed to determine the optimal setpoint values of control loops with respect to predetermined risk levels, uncertainties, and costs of violation of process constraints. The proposed framework is realized as direct search-type optimization of Monte-Carlo simulation of the controlled process. The concept is illustrated throughout by a well-known benchmark problem related to the control of a linear dynamical system and the model predictive control of a more complex nonlinear polymerization process. PMID:23213298

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

PubMed

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

2018-01-01

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

The interprocess NIR sampling as an alternative approach to multivariate statistical process control for identifying sources of product-quality variability.

PubMed

Marković, Snežana; Kerč, Janez; Horvat, Matej

2017-03-01

We are presenting a new approach of identifying sources of variability within a manufacturing process by NIR measurements of samples of intermediate material after each consecutive unit operation (interprocess NIR sampling technique). In addition, we summarize the development of a multivariate statistical process control (MSPC) model for the production of enteric-coated pellet product of the proton-pump inhibitor class. By developing provisional NIR calibration models, the identification of critical process points yields comparable results to the established MSPC modeling procedure. Both approaches are shown to lead to the same conclusion, identifying parameters of extrusion/spheronization and characteristics of lactose that have the greatest influence on the end-product's enteric coating performance. The proposed approach enables quicker and easier identification of variability sources during manufacturing process, especially in cases when historical process data is not straightforwardly available. In the presented case the changes of lactose characteristics are influencing the performance of the extrusion/spheronization process step. The pellet cores produced by using one (considered as less suitable) lactose source were on average larger and more fragile, leading to consequent breakage of the cores during subsequent fluid bed operations. These results were confirmed by additional experimental analyses illuminating the underlying mechanism of fracture of oblong pellets during the pellet coating process leading to compromised film coating.

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

NASA Astrophysics Data System (ADS)

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

2017-12-01

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

Method for controlling boiling point distribution of coal liquefaction oil product

DOEpatents

Anderson, R.P.; Schmalzer, D.K.; Wright, C.H.

1982-12-21

The relative ratio of heavy distillate to light distillate produced in a coal liquefaction process is continuously controlled by automatically and continuously controlling the ratio of heavy distillate to light distillate in a liquid solvent used to form the feed slurry to the coal liquefaction zone, and varying the weight ratio of heavy distillate to light distillate in the liquid solvent inversely with respect to the desired weight ratio of heavy distillate to light distillate in the distillate fuel oil product. The concentration of light distillate and heavy distillate in the liquid solvent is controlled by recycling predetermined amounts of light distillate and heavy distillate for admixture with feed coal to the process in accordance with the foregoing relationships. 3 figs.

Method for controlling boiling point distribution of coal liquefaction oil product

DOEpatents

Anderson, Raymond P.; Schmalzer, David K.; Wright, Charles H.

1982-12-21

The relative ratio of heavy distillate to light distillate produced in a coal liquefaction process is continuously controlled by automatically and continuously controlling the ratio of heavy distillate to light distillate in a liquid solvent used to form the feed slurry to the coal liquefaction zone, and varying the weight ratio of heavy distillate to light distillate in the liquid solvent inversely with respect to the desired weight ratio of heavy distillate to light distillate in the distillate fuel oil product. The concentration of light distillate and heavy distillate in the liquid solvent is controlled by recycling predetermined amounts of light distillate and heavy distillate for admixture with feed coal to the process in accordance with the foregoing relationships.

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.

Application of Six Sigma/CAP methodology: controlling blood-product utilization and costs.

PubMed

Neri, Robert A; Mason, Cindy E; Demko, Lisa A

2008-01-01

Blood-product components are a limited commodity whose cost is rising. Many patients benefit from their use, but patients who receive transfusions face an unnecessary increased risk for developing infections; fatal, febrile, or allergic reactions; and circulatory overload. To improve patient care, safety, and resource stewardship, transfusion practices must be evaluated for appropriateness (Wilson et al. 2002). A multihospital health system undertook a rigorous study of blood-product utilization patterns and management processes to address cost-control problems in the organization. The system leveraged two process improvement tools widely implemented outside of the healthcare industry: (1) Six Sigma methodology to identify blood-utilization drivers and to standardize transfusion practice, and (2) change acceleration process model to drive effective change. The initiative resulted in a decreased rate of inappropriate transfusions of packed red blood cell from 16 percent to less than 5 percent, improved clinician use of a blood-component order form, establishment of internal benchmarks, enhanced laboratory-to-clinician communication, and better blood-product expense control. The project further demonstrated how out-of-industry tools and methodologies can be adopted, adapted, and systematically applied to generate positive change (Black and Revere 2006).

LANDSAT-D data format control book. Volume 6: (Products)

NASA Technical Reports Server (NTRS)

Kabat, F.

1981-01-01

Four basic product types are generated from the raw thematic mapper (TM) and multispectral scanner (MSS) payload data by the NASA GSFC LANDSAT 4 data management system: (1) unprocessed data (raw sensor data); (2) partially processed data, which consists of radiometrically corrected sensor data with geometric correction information appended; (3) fully processed data, which consists of radiometrically and geometrically corrected sensor data; and (4) inventory data which consists of summary information about product types 2 and 3. High density digital recorder formatting and the radiometric correction process are described. Geometric correction information is included.

A comprehensive review of the implementation of hazard analysis critical control point (HACCP) to the production of flour and flour-based products.

PubMed

Arvanitoyannis, Ioannis S; Traikou, Athina

2005-01-01

The production of flour and semolina and their ensuing products, such as bread, cake, spaghetti, noodles, and corn flakes, is of major importance, because these products constitute some of the main ingredients of the human diet. The Hazard Analysis Critical Control Point (HACCP) system aims at ensuring the safety of these products. HACCP has been implemented within the frame of this study on various products of both Asian and European origin; the hazards, critical control limits (CCLs), observation practices, and corrective actions have been summarized in comprehensive tables. Furthermore, the various production steps, packaging included, were thoroughly analyzed, and reference was made to both the traditional and new methodologies in an attempt to pinpoint the occurring differences (advantages and disadvantages) per process.

The Utility of the Supine-to-Stand Test as a Measure of Functional Motor Competence in Children Aged 5–9 Years

PubMed Central

Duncan, Michael J.; Lawson, Chelsey; Walker, Leanne Jaye; Stodden, David; Eyre, Emma L. J.

2017-01-01

This study examined how supine-to-stand (STS) performance is related to process and product assessment of motor competence (MC) in children. Ninety-one children aged 5–9 years were assessed for process and product MC (10 m running speed and standing long jump) as well as process and product measures of STS. Tertiles were created for STS process and STS product scores to create 3 groups reflecting low, medium, and high STS competency. ANCOVA analysis, controlling for age, for process STS, indicated that process MC was significantly higher in children, classified as medium STS (p = 0.048) and high STS (p = 0.011) competence, and that 10 m run speed was slower for low STS compared to medium (p = 0.019) and high STS (p = 0.004). For product STS tertiles, process MC was significantly higher for children in the lowest (fastest) STS tertile compared to those in the medium highest (slowest) tertile (p = 0.01). PMID:29910427

Case history of Yakin field: its development and sand control

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

Sawolo, N.; Krueger, R.F.; Maly, G.P.

1983-01-01

This paper deals with the development of the Yakin field in East Kalimantan, Indonesia, with emphasis on the sand control methods used. Implementation of an effective sand control program ensured the successful development of this field. Gravel-packed wells had substantially lower production decline rates than the initial completions without gravel packs. Control of sand production also has been demonstrated by the lack of sand problems during the 4 1/2 years since the sand control program was initiated. During this time there have been no submersible pump failures associated with sand production. The successful sand control program was achieved by amore » well-coordinated and cooperative effort of drilling, reservoir engineering, production research, and service company personnel. Establishment of communication among all people involved, starting early in the planning process and continuing through the rig operations to the final production phase, coupled with intensive training at all levels of responsibility, on-site supervision, and quality control were important factors in the success of the development program.« less

Environmental Control Of A Genetic Process

NASA Technical Reports Server (NTRS)

Khosla, Chaitan; Bailey, James E.

1991-01-01

E. coli bacteria altered to contain DNA sequence encoding production of hemoglobin made to produce hemoglobin at rates decreasing with increases in concentration of oxygen in culture media. Represents amplification of part of method described in "Cloned Hemoglobin Genes Enhance Growth Of Cells" (NPO-17517). Manipulation of promoter/regulator DNA sequences opens promising new subfield of recombinant-DNA technology for environmental control of expression of selected DNA sequences. New recombinant-DNA fusion gene products, expression vectors, and nucleotide-base sequences will emerge. Likely applications include such aerobic processes as manufacture of cloned proteins and synthesis of metabolites, production of chemicals by fermentation, enzymatic degradation, treatment of wastes, brewing, and variety of oxidative chemical reactions.

Statistical Process Control in the Practice of Program Evaluation.

ERIC Educational Resources Information Center

Posavac, Emil J.

1995-01-01

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

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

NASA Astrophysics Data System (ADS)

Weyand, J.

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

The effect of sudden server breakdown on the performance of a disassembly line

NASA Astrophysics Data System (ADS)

Udomsawat, Gun; Gupta, Surendra M.

2005-11-01

Product and material recovery relies on the disassembly process to separate target components or materials from the end-of-life (EOL) products. Disassembly line is especially effective when products in large quantity are disassembled. Unlike an assembly line, a disassembly line is more complex and is subjected to numerous uncertainties including stochastic and multi-level arrivals of component demands, stochastic arrival times for EOL products, and process interruption due to equipment failure. These factors seriously impair the control mechanism in the disassembly line. A common production control mechanism is the traditional push system (TPS). TPS responds to the aforementioned complications by carrying substantial amounts of inventories. An alternative control mechanism is a newly developed multi-kanban pull system (MKS) that relies on dynamic routing of kanbans, which tends to minimize the system's inventories while maintaining demand serviceability. In this paper we explore the impact of sudden breakdown of server on the performance of a disassembly line. We compare the overall performances of the TPS and MKS by considering two scenarios. We present the solution procedure and results for these cases.

21 CFR 211.103 - Calculation of yield.

Code of Federal Regulations, 2011 CFR

2011-04-01

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

21 CFR 211.103 - Calculation of yield.

Code of Federal Regulations, 2010 CFR

2010-04-01

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

Statistical Process Control Techniques for the Telecommunications Systems Manager

DTIC Science & Technology

1992-03-01

products that are out of 59 tolerance and bad designs. The third type of defect, mistakes, are remedied by Poka - Yoke methods that are 1 introduced later...based on total production costs plus quality costs. Once production is underway, interventions are determined by their impact on the QLF. F. POKA - YOKE ...Mistakes require process improvements called Poka Yoke or mistake proofing. Shiego Shingo developed Poka Yoke methods to incorporate 100% inspection at

Trends in microbial control techniques for poultry products.

PubMed

Silva, Filomena; Domingues, Fernanda C; Nerín, Cristina

2018-03-04

Fresh poultry meat and poultry products are highly perishable foods and high potential sources of human infection due to the presence of several foodborne pathogens. Focusing on the microbial control of poultry products, the food industry generally implements numerous preventive measures based on the Hazard Analysis and Critical Control Points (HACCP) food safety management system certification together with technological steps, such as refrigeration coupled to modified atmosphere packaging that are able to control identified potential microbial hazards during food processing. However, in recent years, to meet the demand of consumers for minimally processed, high-quality, and additive-free foods, technologies are emerging associated with nonthermal microbial inactivation, such as high hydrostatic pressure, irradiation, and natural alternatives, such as biopreservation or the incorporation of natural preservatives in packaging materials. These technologies are discussed throughout this article, emphasizing their pros and cons regarding the control of poultry microbiota and their effects on poultry sensory properties. The discussion for each of the preservation techniques mentioned will be provided with as much detail as the data and studies provided in the literature for poultry meat and products allow. These new approaches, on their own, have proved to be effective against a wide range of microorganisms in poultry meat. However, since some of these emergent technologies still do not have full consumer's acceptability and, taking into consideration the hurdle technology concept for poultry processing, it is suggested that they will be used as combined treatments or, more frequently, in combination with modified atmosphere packaging.

Process Metallurgy an Enabler of Resource Efficiency: Linking Product Design to Metallurgy in Product Centric Recycling

NASA Astrophysics Data System (ADS)

Reuter, Markus; van Schaik, Antoinette

In this paper the link between process metallurgy, classical minerals processing, product centric recycling and urban/landfill mining is discussed. The depth that has to be achieved in urban mining and recycling must glean from the wealth of theoretical knowledge and insight that have been developed in the past in minerals and metallurgical processing. This background learns that recycling demands a product centric approach, which considers simultaneously the multi-material interactions in man-made complex `minerals'. Fast innovation in recycling and urban mining can be achieved by further evolving from this well developed basis, evolving the techniques and tools that have been developed over the years. This basis has already been used for many years to design, operate and control industrial plants for metal production. This has been the basis for Design for Recycling rules for End-of-Life products. Using, among others, the UNEP Metal Recycling report as a basis (authors are respectively Lead and Main authors of report), it is demonstrated that a common theoretical basis as developed in metallurgy and minerals processing can help much to level the playing field between primary processing, secondary processing, recycling, and urban/landfill mining and product design hence enhancing resource efficiency. Thus various scales of detail link product design with metallurgical process design and its fundamentals.

21 CFR 113.81 - Product preparation.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Production and Process Controls § 113.81 Product preparation. (a) Before using raw materials and ingredients susceptible to microbiological contamination, the processor shall ensure that those materials and ingredients... by receiving the raw materials and ingredients under a supplier's guarantee that they are suitable...

21 CFR 111.105 - What must quality control personnel do?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What must quality control personnel do? 111.105..., LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for Quality Control § 111.105 What must quality control personnel do? Quality control personnel must...

Design and application of process control charting methodologies to gamma irradiation practices

NASA Astrophysics Data System (ADS)

Saylor, M. C.; Connaghan, J. P.; Yeadon, S. C.; Herring, C. M.; Jordan, T. M.

2002-12-01

The relationship between the contract irradiation facility and the customer has historically been based upon a "PASS/FAIL" approach with little or no quality metrics used to gage the control of the irradiation process. Application of process control charts, designed in coordination with mathematical simulation of routine radiation processing, can provide a basis for understanding irradiation events. By using tools that simulate the physical rules associated with the irradiation process, end-users can explore process-related boundaries and the effects of process changes. Consequently, the relationship between contractor and customer can evolve based on the derived knowledge. The resulting level of mutual understanding of the irradiation process and its resultant control benefits both the customer and contract operation, and provides necessary assurances to regulators. In this article we examine the complementary nature of theoretical (point kernel) and experimental (dosimetric) process evaluation, and the resulting by-product of improved understanding, communication and control generated through the implementation of effective process control charting strategies.

Quality control in the development of coagulation factor concentrates.

PubMed

Snape, T J

1987-01-01

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

Optical Method For Monitoring Tool Control For Green Burnishing With Using Of Algorithms With Adaptive Settings

NASA Astrophysics Data System (ADS)

Lukyanov, A. A.; Grigoriev, S. N.; Bobrovskij, I. N.; Melnikov, P. A.; Bobrovskij, N. M.

2017-05-01

With regard to the complexity of the new technology and increase its reliability requirements laboriousness of control operations in industrial quality control systems increases significantly. The importance of quality management control due to the fact that its promotes the correct use of production conditions, the relevant requirements are required. Digital image processing allows to reach a new technological level of production (new technological way). The most complicated automated interpretation of information is the basis for decision-making in the management of production processes. In the case of surface analysis of tools used for processing with the using of metalworking fluids (MWF) it is more complicated. The authors suggest new algorithm for optical inspection of the wear of the cylinder tool for burnishing, which used in surface plastic deformation without using of MWF. The main advantage of proposed algorithm is the possibility of automatic recognition of images of burnisher tool with the subsequent allocation of its boundaries, finding a working surface and automatically allocating the defects and wear area. Software that implements the algorithm was developed by the authors in Matlab programming environment, but can be implemented using other programming languages.

Combined mesophilic anaerobic and thermophilic aerobic digestion process for high-strength food wastewater to increase removal efficiency and reduce sludge discharge.

PubMed

Jang, H M; Park, S K; Ha, J H; Park, J M

2014-01-01

In this study, a process that combines the mesophilic anaerobic digestion (MAD) process with thermophilic aerobic digestion (TAD) for high-strength food wastewater (FWW) treatment was developed to examine the removal of organic matter and methane production. All effluent discharged from the MAD process was separated into solid and liquid portions. The liquid part was discarded and the sludge part was passed to the TAD process for further degradation. Then, the digested sludge from the TAD process was recycled back to the MAD unit to achieve low sludge discharge from the combined process. The reactor combination was operated in two phases: during Phase I, 40 d of total hydraulic retention time (HRT) was applied; during Phase II, 20 d was applied. HRT of the TAD process was fixed at 5 d. For a comparison, a control process (single-stage MAD) was operated with the same HRTs of the combined process. Our results indicated that the combined process showed over 90% total solids, volatile solids and chemical oxygen demand removal efficiencies. In addition, the combined process showed a significantly higher methane production rate than that of the control process. Consequently, the experimental data demonstrated that the combined MAD-TAD process was successfully employed for high-strength FWW treatment with highly efficient organic matter reduction and methane production.

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

PubMed Central

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

2013-01-01

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

77 FR 27586 - Irradiation in the Production, Processing and Handling of Food

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-11

.... FDA-1999-F-0021; formerly 1999F-2673] Irradiation in the Production, Processing and Handling of Food... petition (FAP 9M4673) submitted by Caudill Seed Co., Inc., to amend the regulations in part 179 Irradiation... irradiation of seeds for sprouting to control microbial pathogens in alfalfa and other sprouting seeds at an...

77 FR 43842 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-26

...; Irradiation in the Production, Processing, and Handling of Food AGENCY: Food and Drug Administration, HHS.... Irradiation in the Production, Processing, and Handling of Food--21 CFR Part 179 (OMB Control Number 0910-0186.... 321(s) and 348), food irradiation is subject to regulation under the food additive premarket approval...

The pharmaceutical vial capping process: Container closure systems, capping equipment, regulatory framework, and seal quality tests.

PubMed

Mathaes, Roman; Mahler, Hanns-Christian; Buettiker, Jean-Pierre; Roehl, Holger; Lam, Philippe; Brown, Helen; Luemkemann, Joerg; Adler, Michael; Huwyler, Joerg; Streubel, Alexander; Mohl, Silke

2016-02-01

Parenteral drug products are protected by appropriate primary packaging to protect against environmental factors, including potential microbial contamination during shelf life duration. The most commonly used CCS configuration for parenteral drug products is the glass vial, sealed with a rubber stopper and an aluminum crimp cap. In combination with an adequately designed and controlled aseptic fill/finish processes, a well-designed and characterized capping process is indispensable to ensure product quality and integrity and to minimize rejections during the manufacturing process. In this review, the health authority requirements and expectations related to container closure system quality and container closure integrity are summarized. The pharmaceutical vial, the rubber stopper, and the crimp cap are described. Different capping techniques are critically compared: The most common capping equipment with a rotating capping plate produces the lowest amount of particle. The strength and challenges of methods to control the capping process are discussed. The residual seal force method can characterize the capping process independent of the used capping equipment or CCS. We analyze the root causes of several cosmetic defects associated with the vial capping process. Copyright © 2015 Elsevier B.V. All rights reserved.

Aging changes in hormone production

MedlinePlus

... this page: //medlineplus.gov/ency/article/004000.htm Aging changes in hormone production To use the sharing ... that produce hormones are controlled by other hormones. Aging also changes this process. For example, an endocrine ...

Lyophilization Cycle Design for Dual Chamber Cartridges and a Method for Online Process Control: The "DCC LyoMate" Procedure.

PubMed

Korpus, Christoph; Friess, Wolfgang

2017-08-01

Freeze-drying process design is a challenging task that necessitates a profound understanding of the complex interrelation among critical process parameters (e.g., shelf temperature and chamber pressure), heat transfer characteristics of the involved materials (e.g., product containers and holder devices), and critical quality attributes of the product (e.g., collapse temperatures). The Dual Chamber Cartridge "(DCC) LyoMate" (from lyophilization and automated) is a manometric temperature measurement-based process control strategy that was developed within this study to streamline this complicated task. It was successfully applied using 5% sucrose formulations with 0.5 and 1 mL fill volumes. The system was further challenged using 2, 20, and 100 mg/mL monoclonal antibody formulations. The DCC LyoMate method did not only produce pharmaceutically acceptable cakes but was also able to maintain the desired product temperature irrespective of formulation and protein content. It enabled successful process design even at high protein concentrations and aided the design and online control of the lyophilization process for drying in DCCs within a single development run. Thus, it helps to reduce development cost and the DCC LyoMate can also be easily installed on every freeze-dryer capable of performing a manometric temperature measurement, without the need for hardware modification. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Simultaneous control of microorganisms and disinfection by-products by sequential chlorination.

PubMed

Chen, Chao; Zhang, Xiao-Jian; He, Wen-Jie; Han, Hong-Da

2007-04-01

To introduce a new sequential chlorination disinfection process in which short-term free chlorine and chloramine are sequentially added. Pilot tests of this sequential chlorination were carried out in a drinking water plant. The sequential chlorination disinfection process had the same or better efficiency on microbe (including virus) inactivation compared with the free chlorine disinfection process. There seemed to be some synergetic disinfection effect between free chlorine and monochloramine because they attacked different targets. The sequential chlorination disinfection process resulted in 35.7%-77.0% TTHM formation and 36.6%-54.8% THAA5 formation less than the free chlorination process. The poorer the water quality was, the more advantage the sequential chlorination disinfection had over the free chlorination. This process takes advantages of free chlorine's quick inactivation of microorganisms and chloramine's low disinfection by-product (DBP) yield and long-term residual effect, allowing simultaneous control of microbes and DBPs in an effective and economic way.

Combined Log Inventory and Process Simulation Models for the Planning and Control of Sawmill Operations

Treesearch

Guillermo A. Mendoza; Roger J. Meimban; Philip A. Araman; William G. Luppold

1991-01-01

A log inventory model and a real-time hardwood process simulation model were developed and combined into an integrated production planning and control system for hardwood sawmills. The log inventory model was designed to monitor and periodically update the status of the logs in the log yard. The process simulation model was designed to estimate various sawmill...

Welding and joining techniques.

PubMed

Chipperfield, F A; Dunkerton, S B

2001-05-01

There is a welding solution for most applications. As products must meet more stringent requirements or require more flexible processes to aid design or reduce cost, further improvements or totally new processes are likely to be developed. Quality control aspects are also becoming more important to meet regulation, and monitoring and control of welding processes and the standardised testing of joints will meet some if not all of these requirements.

An NCME Instructional Module on Quality Control Procedures in the Scoring, Equating, and Reporting of Test Scores

ERIC Educational Resources Information Center

Allalouf, Avi

2007-01-01

There is significant potential for error in long production processes that consist of sequential stages, each of which is heavily dependent on the previous stage, such as the SER (Scoring, Equating, and Reporting) process. Quality control procedures are required in order to monitor this process and to reduce the number of mistakes to a minimum. In…

Austenite Grain Size Control in Upstream Processing of Niobium Microalloyed Steels by Nano-Scale Precipitate Engineering of TiN-NbC Composite

NASA Astrophysics Data System (ADS)

Subramanian, S. V.; Ma, Xiaoping; Rehman, Kashif

There is a growing demand for thicker gage pipes particularly for off-shore projects. Austenite grain size control in upstream processing before pancaking is essential to obtain excellent DBTT and DWTT properties in thicker gage product. This paper examines the basic science aspects of austenite grain size control by nano-scale precipitate engineering.

FDA's misplaced priorities: premarket review under the Family Smoking Prevention and Tobacco Control Act.

PubMed

Jenson, Desmond; Lester, Joelle; Berman, Micah L

2016-05-01

Among other key objectives, the 2009 Family Smoking Prevention and Tobacco Control Act was designed to end an era of constant product manipulation by the tobacco industry that had led to more addictive and attractive products. The law requires new tobacco products to undergo premarket review by the US Food and Drug Administration (FDA) before they can be sold. To assess FDA's implementation of its premarket review authorities, we reviewed FDA actions on new product applications, publicly available data on industry applications to market new products, and related FDA guidance documents and public statements. We conclude that FDA has not implemented the premarket review process in a manner that prioritises the protection of public health. In particular, FDA has (1) prioritised the review of premarket applications that allow for the introduction of new tobacco products over the review of potentially non-compliant products that are already on the market; (2) misallocated resources by accommodating the industry's repeated submissions of deficient premarket applications and (3) weakened the premarket review process by allowing the tobacco industry to market new and modified products that have not completed the required review process. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Hydroponic potato production on nutrients derived from anaerobically-processed potato plant residues

NASA Astrophysics Data System (ADS)

Mackowiak, C. L.; Stutte, G. W.; Garland, J. L.; Finger, B. W.; Ruffe, L. M.

1997-01-01

Bioregenerative methods are being developed for recycling plant minerals from harvested inedible biomass as part of NASA's Advanced Life Support (ALS) research. Anaerobic processing produces secondary metabolites, a food source for yeast production, while providing a source of water soluble nutrients for plant growth. Since NH_4-N is the nitrogen product, processing the effluent through a nitrification reactor was used to convert this to NO_3-N, a more acceptable form for plants. Potato (Solanum tuberosum L.) cv. Norland plants were used to test the effects of anaerobically-produced effluent after processing through a yeast reactor or nitrification reactor. These treatments were compared to a mixed-N treatment (75:25, NO_3:NH_4) or a NO_3-N control, both containing only reagent-grade salts. Plant growth and tuber yields were greatest in the NO_3-N control and yeast reactor effluent treatments, which is noteworthy, considering the yeast reactor treatment had high organic loading in the nutrient solution and concomitant microbial activity.

Overlapping Networks Engaged during Spoken Language Production and Its Cognitive Control

PubMed Central

Wise, Richard J.S.; Mehta, Amrish; Leech, Robert

2014-01-01

Spoken language production is a complex brain function that relies on large-scale networks. These include domain-specific networks that mediate language-specific processes, as well as domain-general networks mediating top-down and bottom-up attentional control. Language control is thought to involve a left-lateralized fronto-temporal-parietal (FTP) system. However, these regions do not always activate for language tasks and similar regions have been implicated in nonlinguistic cognitive processes. These inconsistent findings suggest that either the left FTP is involved in multidomain cognitive control or that there are multiple spatially overlapping FTP systems. We present evidence from an fMRI study using multivariate analysis to identify spatiotemporal networks involved in spoken language production in humans. We compared spoken language production (Speech) with multiple baselines, counting (Count), nonverbal decision (Decision), and “rest,” to pull apart the multiple partially overlapping networks that are involved in speech production. A left-lateralized FTP network was activated during Speech and deactivated during Count and nonverbal Decision trials, implicating it in cognitive control specific to sentential spoken language production. A mirror right-lateralized FTP network was activated in the Count and Decision trials, but not Speech. Importantly, a second overlapping left FTP network showed relative deactivation in Speech. These three networks, with distinct time courses, overlapped in the left parietal lobe. Contrary to the standard model of the left FTP as being dominant for speech, we revealed a more complex pattern within the left FTP, including at least two left FTP networks with competing functional roles, only one of which was activated in speech production. PMID:24966373

Overlapping networks engaged during spoken language production and its cognitive control.

PubMed

Geranmayeh, Fatemeh; Wise, Richard J S; Mehta, Amrish; Leech, Robert

2014-06-25

Spoken language production is a complex brain function that relies on large-scale networks. These include domain-specific networks that mediate language-specific processes, as well as domain-general networks mediating top-down and bottom-up attentional control. Language control is thought to involve a left-lateralized fronto-temporal-parietal (FTP) system. However, these regions do not always activate for language tasks and similar regions have been implicated in nonlinguistic cognitive processes. These inconsistent findings suggest that either the left FTP is involved in multidomain cognitive control or that there are multiple spatially overlapping FTP systems. We present evidence from an fMRI study using multivariate analysis to identify spatiotemporal networks involved in spoken language production in humans. We compared spoken language production (Speech) with multiple baselines, counting (Count), nonverbal decision (Decision), and "rest," to pull apart the multiple partially overlapping networks that are involved in speech production. A left-lateralized FTP network was activated during Speech and deactivated during Count and nonverbal Decision trials, implicating it in cognitive control specific to sentential spoken language production. A mirror right-lateralized FTP network was activated in the Count and Decision trials, but not Speech. Importantly, a second overlapping left FTP network showed relative deactivation in Speech. These three networks, with distinct time courses, overlapped in the left parietal lobe. Contrary to the standard model of the left FTP as being dominant for speech, we revealed a more complex pattern within the left FTP, including at least two left FTP networks with competing functional roles, only one of which was activated in speech production. Copyright © 2014 Geranmayeh et al.

21 CFR 211.105 - Equipment identification.

Code of Federal Regulations, 2010 CFR

2010-04-01

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

21 CFR 211.105 - Equipment identification.

Code of Federal Regulations, 2011 CFR

2011-04-01

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

21 CFR 211.188 - Batch production and control records.

Code of Federal Regulations, 2010 CFR

2010-04-01

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

21 CFR 211.188 - Batch production and control records.

Code of Federal Regulations, 2011 CFR

2011-04-01

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

Automated Job Controller for Clouds and the Earth's Radiant Energy System (CERES) Production Processing

NASA Astrophysics Data System (ADS)

Gleason, J. L.; Hillyer, T. N.

2011-12-01

Clouds and the Earth's Radiant Energy System (CERES) is one of NASA's highest priority Earth Observing System (EOS) scientific instruments. The CERES science team will integrate data from the CERES Flight Model 5 (FM5) on the NPOESS Preparatory Project (NPP) in addition to the four CERES scanning instrument on Terra and Aqua. The CERES production system consists of over 75 Product Generation Executives (PGEs) maintained by twelve subsystem groups. The processing chain fuses CERES instrument observations with data from 19 other unique sources. The addition of FM5 to over 22 instrument years of data to be reprocessed from flight models 1-4 creates a need for an optimized production processing approach. This poster discusses a new approach, using JBoss and Perl to manage job scheduling and interdependencies between PGEs and external data sources. The new optimized approach uses JBoss to serve handler servlets which regulate PGE-level job interdependencies and job completion notifications. Additional servlets are used to regulate all job submissions from the handlers and to interact with the operator. Perl submission scripts are used to build Process Control Files and to interact directly with the operating system and cluster scheduler. The result is a reduced burden on the operator by algorithmically enforcing a set of rules that determine the optimal time to produce data products with the highest integrity. These rules are designed on a per PGE basis and periodically change. This design provides the means to dynamically update PGE rules at run time and increases the processing throughput by using an event driven controller. The immediate notification of a PGE's completion (an event) allows successor PGEs to launch at the proper time with minimal start up latency, thereby increasing computer system utilization.

Smart material screening machines using smart materials and controls

NASA Astrophysics Data System (ADS)

Allaei, Daryoush; Corradi, Gary; Waigand, Al

2002-07-01

The objective of this product is to address the specific need for improvements in the efficiency and effectiveness in physical separation technologies in the screening areas. Currently, the mining industry uses approximately 33 billion kW-hr per year, costing 1.65 billion dollars at 0.05 cents per kW-hr, of electrical energy for physical separations. Even though screening and size separations are not the single most energy intensive process in the mining industry, they are often the major bottleneck in the whole process. Improvements to this area offer tremendous potential in both energy savings and production improvements. Additionally, the vibrating screens used in the mining processing plants are the most costly areas from maintenance and worker health and safety point of views. The goal of this product is to reduce energy use in the screening and total processing areas. This goal is accomplished by developing an innovative screening machine based on smart materials and smart actuators, namely smart screen that uses advanced sensory system to continuously monitor the screening process and make appropriate adjustments to improve production. The theory behind the development of Smart Screen technology is based on two key technologies, namely smart actuators and smart Energy Flow ControlT (EFCT) strategies, developed initially for military applications. Smart Screen technology controls the flow of vibration energy and confines it to the screen rather than shaking much of the mass that makes up the conventional vibratory screening machine. Consequently, Smart Screens eliminates and downsizes many of the structural components associated with conventional vibratory screening machines. As a result, the surface area of the screen increases for a given envelope. This increase in usable screening surface area extends the life of the screens, reduces required maintenance by reducing the frequency of screen change-outs and improves throughput or productivity.

Comparative analyses of different variants of standard ground for automatic control systems of technical processes of oil and gas production

NASA Astrophysics Data System (ADS)

Gromakov, E. I.; Gazizov, A. T.; Lukin, V. P.; Chimrov, A. V.

2017-01-01

The paper analyses efficiency (interference resistance) of standard TT, TN, IT networks in control links of automatic control systems (ACS) of technical processes (TP) of oil and gas production. Electromagnetic compatibility (EMC) is a standard term used to describe the interference in grounding circuits. Improved EMC of ACS TP can significantly reduce risks and costs of malfunction of equipment that could have serious consequences. It has been proved that an IT network is the best type of grounds for protection of ACS TP in real life conditions. It allows reducing the interference down to the level that is stated in standards of oil and gas companies.

In-process and post-process measurements of drill wear for control of the drilling process

NASA Astrophysics Data System (ADS)

Liu, Tien-I.; Liu, George; Gao, Zhiyu

2011-12-01

Optical inspection was used in this research for the post-process measurements of drill wear. A precision toolmakers" microscope was used. Indirect index, cutting force, is used for in-process drill wear measurements. Using in-process measurements to estimate the drill wear for control purpose can decrease the operation cost and enhance the product quality and safety. The challenge is to correlate the in-process cutting force measurements with the post-process optical inspection of drill wear. To find the most important feature, the energy principle was used in this research. It is necessary to select only the cutting force feature which shows the highest sensitivity to drill wear. The best feature selected is the peak of torque in the drilling process. Neuro-fuzzy systems were used for correlation purposes. The Adaptive-Network-Based Fuzzy Inference System (ANFIS) can construct fuzzy rules with membership functions to generate an input-output pair. A 1x6 ANFIS architecture with product of sigmoid membership functions can in-process measure the drill wear with an error as low as 0.15%. This is extremely important for control of the drilling process. Furthermore, the measurement of drill wear was performed under different drilling conditions. This shows that ANFIS has the capability of generalization.

NASADEM Initial Production Processing Results: Shuttle Radar Topography Mission (SRTM) Reprocessing with Improvements

NASA Astrophysics Data System (ADS)

Buckley, S.; Agram, P. S.; Belz, J. E.; Crippen, R. E.; Gurrola, E. M.; Hensley, S.; Kobrick, M.; Lavalle, M.; Martin, J. M.; Neumann, M.; Nguyen, Q.; Rosen, P. A.; Shimada, J.; Simard, M.; Tung, W.

2016-12-01

NASADEM is a significant modernization of SRTM digital elevation model (DEM) data supported by the NASA MEaSUREs program. We are reprocessing the raw radar signal data using improved algorithms and incorporating ICESat and DEM data unavailable during the original processing. The NASADEM products will be freely-available through the Land Processes Distributed Active Archive Center (LPDAAC) at one-arcsecond spacing and delivered by continent: North America, South America, Australia, Eurasia, Africa, and Island Groups. We are in the production phase of the project. This involves radar interferometry (InSAR) processing on thousands of radar datatakes. New phase unwrapping and height ripple error correction (HREC) procedures are applied to the data. The resulting strip DEMs and ancillary information are passed to a back-end processor to create DEM mosaics and new geocoded single-swath products. Manual data quality assessment (QA) and fixes are performed at several steps in the processing chain. Post-production DEM void-filling is described in a companion AGU Fall Meeting presentation. The team completed the InSAR processing for all continents and the manual QA of the strip DEMs for more than half the world. North America strip DEM void areas are reduced by more than 50%. The ICESat data is used for height ripple error correction and as control for continent-scale adjustment of the strip DEMs. These ripples are due to uncompensated mast motion most pronounced after Shuttle roll angle adjustment maneuvers. After an initial assessment of the NASADEM production processing for the Americas, we further refined the selection of ICESat data for control by excluded data over glaciers, snow cover, forest clear cuts, and sloped areas. The HREC algorithm reduces the North America ICESat-SRTM bias from 80 cm to 3 cm and the RMS from 5m to 4m.

[Quality control in herbal supplements].

PubMed

Oelker, Luisa

2005-01-01

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

Offline modeling for product quality prediction of mineral processing using modeling error PDF shaping and entropy minimization.

PubMed

Ding, Jinliang; Chai, Tianyou; Wang, Hong

2011-03-01

This paper presents a novel offline modeling for product quality prediction of mineral processing which consists of a number of unit processes in series. The prediction of the product quality of the whole mineral process (i.e., the mixed concentrate grade) plays an important role and the establishment of its predictive model is a key issue for the plantwide optimization. For this purpose, a hybrid modeling approach of the mixed concentrate grade prediction is proposed, which consists of a linear model and a nonlinear model. The least-squares support vector machine is adopted to establish the nonlinear model. The inputs of the predictive model are the performance indices of each unit process, while the output is the mixed concentrate grade. In this paper, the model parameter selection is transformed into the shape control of the probability density function (PDF) of the modeling error. In this context, both the PDF-control-based and minimum-entropy-based model parameter selection approaches are proposed. Indeed, this is the first time that the PDF shape control idea is used to deal with system modeling, where the key idea is to turn model parameters so that either the modeling error PDF is controlled to follow a target PDF or the modeling error entropy is minimized. The experimental results using the real plant data and the comparison of the two approaches are discussed. The results show the effectiveness of the proposed approaches.

IMPACTS OF ANTIFOAM ADDITIONS AND ARGON BUBBLING ON DEFENSE WASTE PROCESSING FACILITY REDUCTION/OXIDATION

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

Jantzen, C.; Johnson, F.

2012-06-05

During melting of HLW glass, the REDOX of the melt pool cannot be measured. Therefore, the Fe{sup +2}/{Sigma}Fe ratio in the glass poured from the melter must be related to melter feed organic and oxidant concentrations to ensure production of a high quality glass without impacting production rate (e.g., foaming) or melter life (e.g., metal formation and accumulation). A production facility such as the Defense Waste Processing Facility (DWPF) cannot wait until the melt or waste glass has been made to assess its acceptability, since by then no further changes to the glass composition and acceptability are possible. therefore, themore » acceptability decision is made on the upstream process, rather than on the downstream melt or glass product. That is, it is based on 'feed foward' statistical process control (SPC) rather than statistical quality control (SQC). In SPC, the feed composition to the melter is controlled prior to vitrification. Use of the DWPF REDOX model has controlled the balanjce of feed reductants and oxidants in the Sludge Receipt and Adjustment Tank (SRAT). Once the alkali/alkaline earth salts (both reduced and oxidized) are formed during reflux in the SRAT, the REDOX can only change if (1) additional reductants or oxidants are added to the SRAT, the Slurry Mix Evaporator (SME), or the Melter Feed Tank (MFT) or (2) if the melt pool is bubble dwith an oxidizing gas or sparging gas that imposes a different REDOX target than the chemical balance set during reflux in the SRAT.« less

Evaluation of particulate matter emissions from manganese alloy production using life-cycle assessment.

PubMed

Davourie, Julia; Westfall, Luke; Ali, Mohammed; McGough, Doreen

2017-01-01

Life-cycle assessments (LCAs) provide a wealth of industry data to assist in evaluating the environmental impacts of industrial processes and product supply chains. In this investigation, data from a recent LCA covering global manganese alloy production was used to evaluate sources of particulate matter (PM) emissions associated with the manganese alloy supply chain. The analysis is aimed at providing an empirical, industry-averaged breakdown of the contribution that processes and emissions controls have on total emissions, manganese releases and occupational exposure. The assessment shows that 66% of PM emissions associated with manganese production occur beyond manganese facilities. Direct or on-site emissions represent 34% of total PM and occur predominantly as disperse sources during mineral extraction and hauling, and as primary furnace emissions. The largest contribution of manganese-bearing PM at ground-level is associated with fugitive emissions from metal and slag tapping, casting, crushing and screening. The evaluation provides a high-level ranking of emissions by process area, to assist in identifying priority areas for industry-wide initiatives to reduce emissions and occupational exposure of manganese. The range of PM emission levels in industry indicate that further enhancements in PM emissions can be achieved by sharing of best practices in emissions controls, limiting furnace conditions which lead to by-passing of emissions controls and application of secondary emission controls to capture fugitive emissions during tapping and casting. The LCA approach to evaluating PM emissions underscores the important role that process optimization and resource efficiency have on reducing PM emissions throughout the manganese supply chain. Copyright © 2016. Published by Elsevier B.V.

Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development.

PubMed

Li, Min; Sander, Sanna; Duan, John; Rosencrance, Susan; Miksinski, Sarah Pope; Yu, Lawrence; Seo, Paul; Rege, Bhagwant

2016-11-01

This review presents scientific and regulatory considerations for the development of solid oral modified release (MR) drug products. It includes a rationale for patient-focused development based on Quality-by-Design (QbD) principles. Product and process understanding of MR products includes identification and risk-based evaluation of critical material attributes (CMAs), critical process parameters (CPPs), and their impact on critical quality attributes (CQAs) that affect the clinical performance. The use of various biopharmaceutics tools that link the CQAs to a predictable and reproducible clinical performance for patient benefit is emphasized. Product and process understanding lead to a more comprehensive control strategy that can maintain product quality through the shelf life and the lifecycle of the drug product. The overall goal is to develop MR products that consistently meet the clinical objectives while mitigating the risks to patients by reducing the probability and increasing the detectability of CQA failures.

Is My Small School Really Just a Business.

ERIC Educational Resources Information Center

Ross, Lee A.; Chance, W. G.

1984-01-01

Discusses steps necessary to running small schools on a more business-like basis, including quality control, product (student) evaluation, production process monitoring, establishment of standards, improved recruitment, market research, and sales promotion. (MH)

Ultra-processed food products and obesity in Brazilian households (2008-2009).

PubMed

Canella, Daniela Silva; Levy, Renata Bertazzi; Martins, Ana Paula Bortoletto; Claro, Rafael Moreira; Moubarac, Jean-Claude; Baraldi, Larissa Galastri; Cannon, Geoffrey; Monteiro, Carlos Augusto

2014-01-01

Production and consumption of industrially processed food and drink products have risen in parallel with the global increase in overweight and obesity and related chronic non-communicable diseases. The objective of this study was to analyze the relationship between household availability of processed and ultra-processed products and the prevalence of excess weight (overweight plus obesity) and obesity in Brazil. The study was based on data from the 2008-2009 Household Budget Survey involving a probabilistic sample of 55,970 Brazilian households. The units of study were household aggregates (strata), geographically and socioeconomically homogeneous. Multiple linear regression models were used to assess the relationship between the availability of processed and ultra-processed products and the average of Body Mass Index (BMI) and the percentage of individuals with excess weight and obesity in the strata, controlling for potential confounders (socio-demographic characteristics, percentage of expenditure on eating out of home, and dietary energy other than that provided by processed and ultra-processed products). Predictive values for prevalence of excess weight and obesity were estimated according to quartiles of the household availability of dietary energy from processed and ultra-processed products. The mean contribution of processed and ultra-processed products to total dietary energy availability ranged from 15.4% (lower quartile) to 39.4% (upper quartile). Adjusted linear regression coefficients indicated that household availability of ultra-processed products was positively associated with both the average BMI and the prevalence of excess weight and obesity, whereas processed products were not associated with these outcomes. In addition, people in the upper quartile of household consumption of ultra-processed products, compared with those in the lower quartile, were 37% more likely to be obese. Greater household availability of ultra-processed food products in Brazil is positively and independently associated with higher prevalence of excess weight and obesity in all age groups in this cross-sectional study.

Ultra-Processed Food Products and Obesity in Brazilian Households (2008–2009)

PubMed Central

Canella, Daniela Silva; Levy, Renata Bertazzi; Martins, Ana Paula Bortoletto; Claro, Rafael Moreira; Moubarac, Jean-Claude; Baraldi, Larissa Galastri; Cannon, Geoffrey; Monteiro, Carlos Augusto

2014-01-01

Background Production and consumption of industrially processed food and drink products have risen in parallel with the global increase in overweight and obesity and related chronic non-communicable diseases. The objective of this study was to analyze the relationship between household availability of processed and ultra-processed products and the prevalence of excess weight (overweight plus obesity) and obesity in Brazil. Methods The study was based on data from the 2008–2009 Household Budget Survey involving a probabilistic sample of 55,970 Brazilian households. The units of study were household aggregates (strata), geographically and socioeconomically homogeneous. Multiple linear regression models were used to assess the relationship between the availability of processed and ultra-processed products and the average of Body Mass Index (BMI) and the percentage of individuals with excess weight and obesity in the strata, controlling for potential confounders (socio-demographic characteristics, percentage of expenditure on eating out of home, and dietary energy other than that provided by processed and ultra-processed products). Predictive values for prevalence of excess weight and obesity were estimated according to quartiles of the household availability of dietary energy from processed and ultra-processed products. Results The mean contribution of processed and ultra-processed products to total dietary energy availability ranged from 15.4% (lower quartile) to 39.4% (upper quartile). Adjusted linear regression coefficients indicated that household availability of ultra-processed products was positively associated with both the average BMI and the prevalence of excess weight and obesity, whereas processed products were not associated with these outcomes. In addition, people in the upper quartile of household consumption of ultra-processed products, compared with those in the lower quartile, were 37% more likely to be obese. Conclusion Greater household availability of ultra-processed food products in Brazil is positively and independently associated with higher prevalence of excess weight and obesity in all age groups in this cross-sectional study. PMID:24667658

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

PubMed

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

2015-01-01

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

Defining process design space for monoclonal antibody cell culture.

PubMed

Abu-Absi, Susan Fugett; Yang, LiYing; Thompson, Patrick; Jiang, Canping; Kandula, Sunitha; Schilling, Bernhard; Shukla, Abhinav A

2010-08-15

The concept of design space has been taking root as a foundation of in-process control strategies for biopharmaceutical manufacturing processes. During mapping of the process design space, the multidimensional combination of operational variables is studied to quantify the impact on process performance in terms of productivity and product quality. An efficient methodology to map the design space for a monoclonal antibody cell culture process is described. A failure modes and effects analysis (FMEA) was used as the basis for the process characterization exercise. This was followed by an integrated study of the inoculum stage of the process which includes progressive shake flask and seed bioreactor steps. The operating conditions for the seed bioreactor were studied in an integrated fashion with the production bioreactor using a two stage design of experiments (DOE) methodology to enable optimization of operating conditions. A two level Resolution IV design was followed by a central composite design (CCD). These experiments enabled identification of the edge of failure and classification of the operational parameters as non-key, key or critical. In addition, the models generated from the data provide further insight into balancing productivity of the cell culture process with product quality considerations. Finally, process and product-related impurity clearance was evaluated by studies linking the upstream process with downstream purification. Production bioreactor parameters that directly influence antibody charge variants and glycosylation in CHO systems were identified.

Inverter-based GTA welding machines improve fabrication

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

Sammons, M.

2000-05-01

While known as precision process, many fabricators using the gas tungsten arc welding (GTAW) process fight several common problems that hinder quality, slow production, frustrate the operator and otherwise prevent the process from achieving its full potential. These include a limited ability to tailor the weld bead profile, poor control of the arc direction and arc wandering, poor arc starting, unstable or inconsistent arcs in the AC mode, high-frequency interference with electronics and tungsten contamination. Fortunately, new GTA welding technology--made possible by advances with inverter-based power sources and micro-processor controls--can eliminate common productivity gremlins. Further, new AC/DC inverter-based GTA powermore » sources provide advanced arc shaping capabilities. As a result, many fabricators adopting this new technology have experienced phenomenal production increases, taken on new types of projects and reduced costs. Most importantly, the operators enjoy welding more.« less

Using fuzzy rule-based knowledge model for optimum plating conditions search

NASA Astrophysics Data System (ADS)

Solovjev, D. S.; Solovjeva, I. A.; Litovka, Yu V.; Arzamastsev, A. A.; Glazkov, V. P.; L’vov, A. A.

2018-03-01

The paper discusses existing approaches to plating process modeling in order to decrease the distribution thickness of plating surface cover. However, these approaches do not take into account the experience, knowledge, and intuition of the decision-makers when searching the optimal conditions of electroplating technological process. The original approach to optimal conditions search for applying the electroplating coatings, which uses the rule-based model of knowledge and allows one to reduce the uneven product thickness distribution, is proposed. The block diagrams of a conventional control system of a galvanic process as well as the system based on the production model of knowledge are considered. It is shown that the fuzzy production model of knowledge in the control system makes it possible to obtain galvanic coatings of a given thickness unevenness with a high degree of adequacy to the experimental data. The described experimental results confirm the theoretical conclusions.

Statistical analysis of the Nb3Sn strand production for the ITER toroidal field coils

NASA Astrophysics Data System (ADS)

Vostner, A.; Jewell, M.; Pong, I.; Sullivan, N.; Devred, A.; Bessette, D.; Bevillard, G.; Mitchell, N.; Romano, G.; Zhou, C.

2017-04-01

The ITER toroidal field (TF) strand procurement initiated the largest Nb3Sn superconducting strand production hitherto. The industrial-scale production started in Japan in 2008 and finished in summer 2015. Six ITER partners (so-called Domestic Agencies, or DAs) are in charge of the procurement and involved eight different strand suppliers all over the world, of which four are using the bronze route (BR) process and four the internal-tin (IT) process. In total more than 500 tons have been produced including excess material covering losses during the conductor manufacturing process, in particular the cabling. The procurement is based on a functional specification where the main strand requirements like critical current, hysteresis losses, Cu ratio and residual resistance ratio are specified but not the strand production process or layout. This paper presents the analysis on the data acquired during the quality control (QC) process that was carried out to ensure the same conductor performance requirements are met by the different strand suppliers regardless of strand design. The strand QC is based on 100% billet testing and on applying statistical process control (SPC) limits. Throughout the production, samples adjacent to the strand pieces tested by the suppliers are cross-checked (‘verified’) by their respective DAs reference labs. The level of verification was lowered from 100% at the beginning of the procurement progressively to approximately 25% during the final phase of production. Based on the complete dataset of the TF strand production, an analysis of the SPC limits of the critical strand parameters is made and the related process capability indices are calculated. In view of the large-scale production and costs, key manufacturing parameters such as billet yield, number of breakages and piece-length distribution are also discussed. The results are compared among all the strand suppliers, focusing on the difference between BR and IT processes. Following the completion of the largest Nb3Sn strand production, our experience gained from monitoring the execution of the QC activities and from auditing the results from the measurements is summarised for future superconducting strand material procurement activities.

Microfluidics: a transformational tool for nanomedicine development and production.

PubMed

Garg, Shyam; Heuck, Gesine; Ip, Shell; Ramsay, Euan

2016-11-01

Microfluidic devices are mircoscale fluidic circuits used to manipulate liquids at the nanoliter scale. The ability to control the mixing of fluids and the continuous nature of the process make it apt for solvent/antisolvent precipitation of drug-delivery nanoparticles. This review describes the use of numerous microfluidic designs for the formulation and production of lipid nanoparticles, liposomes and polymer nanoparticles to encapsulate and deliver small molecule or genetic payloads. The advantages of microfluidics are illustrated through examples from literature comparing conventional processes such as beaker and T-tube mixing to microfluidic approaches. Particular emphasis is placed on examples of microfluidic nanoparticle formulations that have been tested in vitro and in vivo. Fine control of process parameters afforded by microfluidics, allows unprecedented optimization of nanoparticle quality and encapsulation efficiency. Automation improves the reproducibility and optimization of formulations. Furthermore, the continuous nature of the microfluidic process is inherently scalable, allowing optimization at low volumes, which is advantageous with scarce or costly materials, as well as scale-up through process parallelization. Given these advantages, microfluidics is poised to become the new paradigm for nanomedicine formulation and production.

In-line height profiling metrology sensor for zero defect production control

NASA Astrophysics Data System (ADS)

Snel, Rob; Winters, Jasper; Liebig, Thomas; Jonker, Wouter

2017-06-01

Contemporary production systems of mechanical precision parts show challenges as increased complexity, tolerances shrinking to sub-microns and yield losses that must be mastered to the extreme. More advanced automation and process control is required to accomplish this task. Often a solution based on feedforward/feedback control is chosen requiring innovative and more advanced in line metrology. This article concentrates first on the context of in line metrology for process control and then on the development of a specific in line height profiling sensor. The novel sensor technology is based on full field time domain white light interferometry which is well know from the quality lab. The novel metrology system is to be mounted close to the production equipment, as required to minimize time delay in the control loop, and is thereby fully exposed to vibrations. This sensor is innovated to perform in line with an orders of magnitude faster throughput than laboratory instruments; it's robust to withstand the rigors of workshops and has a height resolution that is in the nanometer range.

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.

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

Ebert, Jon Llyod

This Small Business Innovative Research (SBIR) Phase I project will demonstrate the feasibility of an innovative temperature control technology for Metal-Organic Chemical Vapor Deposition (MOCVD) process used in the fabrication of Multi-Quantum Well (MQW) LEDs. The proposed control technology has the strong potential to improve both throughput and performance quality of the manufactured LED. The color of the light emitted by an LED is a strong function of the substrate temperature during the deposition process. Hence, accurate temperature control of the MOCVD process is essential for ensuring that the LED performance matches the design specification. The Gallium Nitride (GaN) epitaxymore » process involves depositing multiple layers at different temperatures. Much of the recipe time is spent ramping from one process temperature to another, adding significant overhead to the production time. To increase throughput, the process temperature must transition over a range of several hundred degrees Centigrade many times with as little overshoot and undershoot as possible, in the face of several sources of process disturbance such as changing emissivities. Any throughput increase achieved by faster ramping must also satisfy the constraint of strict temperature uniformity across the carrier so that yield is not affected. SC Solutions is a leading supplier of embedded real-time temperature control technology for MOCVD systems used in LED manufacturing. SC’s Multiple Input Multiple Output (MIMO) temperature controllers use physics-based models to achieve the performance demanded by our customers. However, to meet DOE’s ambitious goals of cost reduction of LED products, a new generation of temperature controllers has to be developed. SC believes that the proposed control technology will be made feasible by the confluence of mathematical formulation as a convex optimization problem, new efficient and scalable algorithms, and the increase in computational power available for real-time control.« less

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

Elliott, G.R.B.; Vanderborgh, N.E.

Experimental and theoretical analyses show that uncontrolled water invasion during underground coal conversion (UCC) is harmful at all stages of UCC. By contrast, if water invasion is prevented, coal porosity can be created for further processing, pyrolysis can yield uniform hydrocarbon products, gasification can produce a uniform product, coal is fully consumed (not bypassed) during combustion, and environmental problems are minimized. In all cases the experimental results are supportive of the theory of underground coal processing presented. We see no insurmountable technical problems existing for a staged underground coal conversion process, but we emphasize that all concepts in underground coalmore » processing depend critically upon control of water influx. It is important that techniques for measuring and controlling water flow be developed if this technology is to make a contribution to the Nation's energy supply.« less

Application of fluorescence spectroscopy for on-line bioprocess monitoring and control

NASA Astrophysics Data System (ADS)

Boehl, Daniela; Solle, D.; Toussaint, Hans J.; Menge, M.; Renemann, G.; Lindemann, Carsten; Hitzmann, Bernd; Scheper, Thomas-Helmut

2001-02-01

12 Modern bioprocess control requires fast data acquisition and in-time evaluation of bioprocess variables. On-line fluorescence spectroscopy for data acquisition and the use of chemometric methods accomplish these requirements. The presented investigations were performed with fluorescence spectrometers with wide ranges of excitation and emission wavelength. By detection of several biogenic fluorophors (amino acids, coenzymes and vitamins) a large amount of information about the state of the bioprocess are obtained. For the evaluation of the process variables partial least squares regression is used. This technique was applied to several bioprocesses: the production of ergotamine by Claviceps purpurea, the production of t-PA (tissue plasminogen activator) by animal cells and brewing processes. The main point of monitoring the brewing processes was to determine the process variables cell count and extract concentration.

Design and implementation of a control structure for quality products in a crude oil atmospheric distillation column.

PubMed

Sotelo, David; Favela-Contreras, Antonio; Sotelo, Carlos; Jiménez, Guillermo; Gallegos-Canales, Luis

2017-11-01

In recent years, interest for petrochemical processes has been increasing, especially in refinement area. However, the high variability in the dynamic characteristics present in the atmospheric distillation column poses a challenge to obtain quality products. To improve distillates quality in spite of the changes in the input crude oil composition, this paper details a new design of a control strategy in a conventional crude oil distillation plant defined using formal interaction analysis tools. The process dynamic and its control are simulated on Aspen HYSYS ® dynamic environment under real operating conditions. The simulation results are compared against a typical control strategy commonly used in crude oil atmospheric distillation columns. Copyright © 2017 ISA. Published by Elsevier Ltd. All rights reserved.

A comparison of a novel robust decentralised control strategy and MPC for industrial high purity, high recovery, multicomponent distillation.

PubMed

Udugama, Isuru A; Wolfenstetter, Florian; Kirkpatrick, Robert; Yu, Wei; Young, Brent R

2017-07-01

In this work we have developed a novel, robust practical control structure to regulate an industrial methanol distillation column. This proposed control scheme is based on a override control framework and can manage a non-key trace ethanol product impurity specification while maintaining high product recovery. For comparison purposes, a MPC with a discrete process model (based on step tests) was also developed and tested. The results from process disturbance testing shows that, both the MPC and the proposed controller were capable of maintaining both the trace level ethanol specification in the distillate (X D ) and high product recovery (β). Closer analysis revealed that the MPC controller has a tighter X D control, while the proposed controller was tighter in β control. The tight X D control allowed the MPC to operate at a higher X D set point (closer to the 10ppm AA grade methanol standard), allowing for savings in energy usage. Despite the energy savings of the MPC, the proposed control scheme has lower installation and running costs. An economic analysis revealed a multitude of other external economic and plant design factors, that should be considered when making a decision between the two controllers. In general, we found relatively high energy costs favour MPC. Copyright © 2017 ISA. Published by Elsevier Ltd. All rights reserved.

Regulatory challenges in manufacturing of pancreatic islets.

PubMed

Linetsky, E; Ricordi, C

2008-03-01

At the present time, transplantation of pancreatic islet cells is considered an experimental therapy for a selected cohort of patients with type 1 diabetes, and is conducted under an Investigational New Drug (IND) application. Encouraging results of the Edmonton Protocol published in the year 2000 sparked a renewed interest in clinical transplantation of allogeneic islets, triggering a large number of IND applications for phase I clinical trials. Promising results reported by a number of centers since then prompted the Food and Drug Administration (FDA) to consider the possibility of licensing allogeneic islets as a therapeutic treatment for patients with type 1 diabetes. However, prior to licensure, issues such as safety, purity, efficacy, and potency of the islet product must be addressed. This is complicated by the intricate nature of pancreatic islets and limited characterization prior to transplantation. In this context, control of the manufacturing process plays a critical role in the definition of the final product. Despite significant progress made in standardization of the donor organ preservation methods, reagents used, and characterization assays performed to qualify an islet cell product, control of the isolation process remains a challenge. Within the scope of the FDA regulations, islet cells meet the definition of a biologic product, somatic cell therapy, and a drug. In addition, AABB standards that address cellular therapy products apply to manufacturing facilities accredited by this organization. Control of the source material, isolation process, and final product are critical issues that must be addressed in the context of FDA and other relevant regulations applicable to islet cell products.

Improving overly manufacturing metrics through application of feedforward mask-bias

NASA Astrophysics Data System (ADS)

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

2003-06-01

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

Biogasification of papaya processing wastes

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

Yang, P.Y.; Weitzenhoff, M.H.; Moy, J.H.

1984-01-01

Biogasification of papaya processing wastes for pollution control and energy utilization is feasible. The biogasification process with sludge recycling permits smaller reactor volume without any deterioration of CH4 production rate and CH4 content. Appropriate design and operational criteria for biogasification processing of papaya wastes were developed.

29 CFR 1910.95 - Occupational noise exposure.

Code of Federal Regulations, 2012 CFR

2012-07-01

... OCCUPATIONAL SAFETY AND HEALTH STANDARDS Occupational Health and Environmental Control § 1910.95 Occupational... engineering controls shall be utilized. If such controls fail to reduce sound levels within the levels of...) Monitoring shall be repeated whenever a change in production, process, equipment or controls increases noise...

29 CFR 1910.95 - Occupational noise exposure.

Code of Federal Regulations, 2014 CFR

2014-07-01

... OCCUPATIONAL SAFETY AND HEALTH STANDARDS Occupational Health and Environmental Control § 1910.95 Occupational... engineering controls shall be utilized. If such controls fail to reduce sound levels within the levels of...) Monitoring shall be repeated whenever a change in production, process, equipment or controls increases noise...

29 CFR 1910.95 - Occupational noise exposure.

Code of Federal Regulations, 2011 CFR

2011-07-01

... OCCUPATIONAL SAFETY AND HEALTH STANDARDS Occupational Health and Environmental Control § 1910.95 Occupational... engineering controls shall be utilized. If such controls fail to reduce sound levels within the levels of...) Monitoring shall be repeated whenever a change in production, process, equipment or controls increases noise...

Quality management of manufacturing process based on manufacturing execution system

NASA Astrophysics Data System (ADS)

Zhang, Jian; Jiang, Yang; Jiang, Weizhuo

2017-04-01

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

Energy efficiency technologies in cement and steel industry

NASA Astrophysics Data System (ADS)

Zanoli, Silvia Maria; Cocchioni, Francesco; Pepe, Crescenzo

2018-02-01

In this paper, Advanced Process Control strategies aimed at energy efficiency achievement and improvement in cement and steel industry are proposed. A flexible and smart control structure constituted by several functional modules and blocks has been developed. The designed control strategy is based on Model Predictive Control techniques, formulated on linear models. Two industrial control solutions have been developed, oriented to energy efficiency and process control improvement in cement industry clinker rotary kilns (clinker production phase) and in steel industry billets reheating furnaces. Tailored customization procedures for the design of ad hoc control systems have been executed, based on the specific needs and specifications of the analysed processes. The installation of the developed controllers on cement and steel plants produced significant benefits in terms of process control which resulted in working closer to the imposed operating limits. With respect to the previous control systems, based on local controllers and/or operators manual conduction, more profitable configurations of the crucial process variables have been provided.

Design of disturbances control model at automotive company

NASA Astrophysics Data System (ADS)

Marie, I. A.; Sari, D. K.; Astuti, P.; Teorema, M.

2017-12-01

The discussion was conducted at PT. XYZ which produces automotive components and motorcycle products. The company produced X123 type cylinder head which is a motor vehicle forming component. The disturbances in the production system has affected the company performance in achieving the target of Key Performance Indicator (KPI). Currently, the determination of the percentage of safety stock of cylinder head products is not in accordance to the control limits set by the company (60% - 80%), and tends to exceed the control limits that cause increasing the inventory wastage in the company. This study aims to identify the production system disturbances that occurs in the production process of manufacturing components of X123 type cylinder head products and design the control model of disturbance to obtain control action and determine the safety stock policy in accordance with the needs of the company. The design stage has been done based on the Disturbance Control Model which already existing and customized with the company need in controlling the production system disturbances at the company. The design of the disturbances control model consists of sub-model of the risk level of the disturbance, sub-model of action status, sub-model action control of the disturbance, and sub-model of determining the safety stock. The model can assist the automotive company in taking the decision to perform the disturbances control action in production system cylinder head while controlling the percentage of the safety stock.

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

NASA Astrophysics Data System (ADS)

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

2016-10-01

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

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

USDA-ARS?s Scientific Manuscript database

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

In-line manufacture of carbon nanotubes

DOEpatents

Brambilla, Nicol Michele; Signorelli, Riccardo; Martini, Fabrizio; Corripio Luna, Oscar Enrique

2015-04-28

Mass production of carbon nanotubes (CNT) are facilitated by methods and apparatus disclosed herein. Advantageously, the methods and apparatus make use of a single production unit, and therefore provide for uninterrupted progress in a fabrication process. Embodiments of control systems for a variety of CNT production apparatus are included.

Genetic, Physiological, and Environmental Factors Affecting Acrylamide Concentration in Fried Potato Products

USDA-ARS?s Scientific Manuscript database

The discovery of acrylamide in processed potato products has brought increased interest in the controlling Maillard reaction precursors (reducing sugars and amino acids) in potato tubers. Because of their effects on nonenzymatic browning of fried potato products, reducing sugars and amino acids have...

[Construction of NIRS-based process analytical system for production of salvianolic acid for injection and relative discussion].

PubMed

Zhang, Lei; Yue, Hong-Shui; Ju, Ai-Chun; Ye, Zheng-Liang

2016-10-01

Currently, near infrared spectroscopy (NIRS) has been considered as an efficient tool for achieving process analytical technology(PAT) in the manufacture of traditional Chinese medicine (TCM) products. In this article, the NIRS based process analytical system for the production of salvianolic acid for injection was introduced. The design of the process analytical system was described in detail, including the selection of monitored processes and testing mode, and potential risks that should be avoided. Moreover, the development of relative technologies was also presented, which contained the establishment of the monitoring methods for the elution of polyamide resin and macroporous resin chromatography processes, as well as the rapid analysis method for finished products. Based on author's experience of research and work, several issues in the application of NIRS to the process monitoring and control in TCM production were then raised, and some potential solutions were also discussed. The issues include building the technical team for process analytical system, the design of the process analytical system in the manufacture of TCM products, standardization of the NIRS-based analytical methods, and improving the management of process analytical system. Finally, the prospect for the application of NIRS in the TCM industry was put forward. Copyright© by the Chinese Pharmaceutical Association.

Abiotic controls on N2O emissions from soils and wetlands

NASA Astrophysics Data System (ADS)

Horwath, W. R.

2016-12-01

The increase in atmospheric nitrous oxide (N2O) is a critical climate change issue contributing to global warming. Most studies on N2O production attribute microbial processes and their associated enzymatic reactions to be the main driver affecting emissions. The role of redox capable iron, manganese and organic compounds that can react with intermediates in the nitrogen cycle has also been shown to produce N2O abiotically. The importance of the abiotic pathways, however, is highly debated. The abiotic production of N2O is related to biophysiochemical controls and unique isotopic signatures of nitrogen cycle intermediates (hydroxylamine, nitric oxide, and nitrite), redox-active metals (iron and manganese) and organic matter (humic and fulvic acids). In a range of soils, we find that the iron directly associated with organic compounds is the strongest variable relating to N2O emissions. In addition to these factors, management is also assumed to affect abiotic N2O production through its impact on nitrogen cycle intermediates, but the environmental and physiochemical conditions that are changed by management are rarely considered in the abiotic production of N2O. We find that the amount and quality of organic compounds in soils directly determines the fate of soil N2O production (i.e. be emitted or consumed). Water depth in rice paddies and wetlands also plays a significant role in partitioning production and consumption of N2O. What is evident from studies on N2O emission is that abiotic reactions are coupled to biotic processes and they cannot be easily separated. The biotic/abiotic interactions have important ecological outcomes that influence abiotic production mechanisms and should be recognized as important controllers of N2O production and consumption processes in soils and sediments.

Industrial hygiene walk-through survey report of E. I. Dupont de Nemours and Company, Inc. , Chocolate Bayou Plant, Alvin, Texas

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

Fajen, J.M.

1985-05-01

A walkthrough survey of EI duPont deNemours and Company, Incorporated, Alvin, Texas was conducted in November, 1984. The purpose of the survey was to obtain information on the 1,3-butadiene monomer manufacturing process and the potential for exposure. The facility manufactured a crude product stream containing 1,3-butadiene as a coproduct of its ethylene process. The crude was refined to a 99.5% 1,3-butadiene product. The refining process occurred in a closed system, tightly maintained for economic, fire, and health-hazard reasons. The product was transferred by way of a pipeline to storage spheres for later transport off site. The facility used an open-loopmore » cylinder (bomb) technique for quality control sampling. All pumps were equipped with single mechanical seals, which were in the process of being replaced by tandem seals. Since 1962, the facility had experienced process changes and three changes of ownership. Because of these changes, records from previous owners of industrial hygiene monitoring were not available. Job titles identified as having potential exposure were processors, wage employee supervisors, production engineers, and laboratory technicians. The author concludes that a closed-loop manual quality-control sampling system should be installed to reduce exposure from this source.« less

Adaptive management for ecosystem services.

PubMed

Birgé, Hannah E; Allen, Craig R; Garmestani, Ahjond S; Pope, Kevin L

2016-12-01

Management of natural resources for the production of ecosystem services, which are vital for human well-being, is necessary even when there is uncertainty regarding system response to management action. This uncertainty is the result of incomplete controllability, complex internal feedbacks, and non-linearity that often interferes with desired management outcomes, and insufficient understanding of nature and people. Adaptive management was developed to reduce such uncertainty. We present a framework for the application of adaptive management for ecosystem services that explicitly accounts for cross-scale tradeoffs in the production of ecosystem services. Our framework focuses on identifying key spatiotemporal scales (plot, patch, ecosystem, landscape, and region) that encompass dominant structures and processes in the system, and includes within- and cross-scale dynamics, ecosystem service tradeoffs, and management controllability within and across scales. Resilience theory recognizes that a limited set of ecological processes in a given system regulate ecosystem services, yet our understanding of these processes is poorly understood. If management actions erode or remove these processes, the system may shift into an alternative state unlikely to support the production of desired services. Adaptive management provides a process to assess the underlying within and cross-scale tradeoffs associated with production of ecosystem services while proceeding with management designed to meet the demands of a growing human population. Copyright © 2016 Elsevier Ltd. All rights reserved.

Integrating metabolic modeling and population heterogeneity analysis into optimizing recombinant protein production by Komagataella (Pichia) pastoris.

PubMed

Theron, Chrispian W; Berrios, Julio; Delvigne, Frank; Fickers, Patrick

2018-01-01

The methylotrophic yeast Komagataella (Pichia) pastoris has become one of the most utilized cell factories for the production of recombinant proteins over the last three decades. This success story is linked to its specific physiological traits, i.e., the ability to grow at high cell density in inexpensive culture medium and to secrete proteins at high yield. Exploiting methanol metabolism is at the core of most P. pastoris-based processes but comes with its own challenges. Co-feeding cultures with glycerol/sorbitol and methanol is a promising approach, which can benefit from improved understanding and prediction of metabolic response. The development of profitable processes relies on the construction and selection of efficient producing strains from less efficient ones but also depends on the ability to master the bioreactor process itself. More specifically, how a bioreactor processes could be monitored and controlled to obtain high yield of production. In this review, new perspectives are detailed regarding a multi-faceted approach to recombinant protein production processes by P. pastoris; including gaining improved understanding of the metabolic pathways involved, accounting for variations in transcriptional and translational efficiency at the single cell level and efficient monitoring and control of methanol levels at the bioreactor level.

Soil erosion and sediment production on watershed landscapes: Processes and control

Treesearch

Peter F. Ffolliott; Kenneth N. Brooks; Daniel G. Neary; Roberto Pizarro Tapia; Pablo Garcia-Chevesich

2013-01-01

Losses of the soil resources from otherwise productive and well functioning watersheds is often a recurring problem confronting hydrologists and watershed managers. These losses of soil have both on-site and off-site effects on the watershed impacted. In addition to the loss of inherent soil resources through erosion processes, on-site effects can include the breakdown...

Optimization of the integrated citric acid-methane fermentation process by air stripping and glucoamylase addition.

PubMed

Xu, Jian; Chen, Yang-Qiu; Zhang, Hong-Jian; Wang, Ke; Tang, Lei; Zhang, Jian-Hua; Chen, Xu-Sheng; Mao, Zhong-Gui

2015-03-01

To solve the problem of extraction wastewater in citric acid industry, an integrated citric acid-methane fermentation process was proposed. In the integrated process, extraction wastewater was treated by mesophilic anaerobic digestion and then reused to make mash for the next batch of citric acid fermentation. In this study, an Aspergillus niger mutant strain exhibiting resistance to high metal ions concentration was used to eliminate the inhibition of 200 mg/L Na(+) and 300 mg/L K(+) in anaerobic digestion effluent (ADE) and citric acid production increased by 25.0 %. Air stripping was used to remove ammonium, alkalinity, and part of metal ions in ADE before making mash. In consequence, citric acid production was significantly improved but still lower by 6.1 % than the control. Results indicated that metal ions in ADE synergistically inhibited the activity of glucoamylase, thus reducing citric acid production. When 130 U/g glucoamylase was added before fermentation, citric acid production was 141.5 g/L, which was even higher than the control (140.4 g/L). This process could completely eliminate extraction wastewater discharge and reduce water resource consumption.

Application of the user-centred design process according ISO 9241-210 in air traffic control.

PubMed

König, Christina; Hofmann, Thomas; Bruder, Ralph

2012-01-01

Designing a usable human machine interface for air traffic control is challenging and should follow approved methods. The ISO 9241-210 standard promises high usability of products by integrating future users and following an iterative process. This contribution describes the proceeding and first results of the analysis and application of ISO 9241-210 to develop a planning tool for air traffic controllers.

Mass production and size control of lipid-polymer hybrid nanoparticles through controlled microvortices

PubMed Central

Kim, YongTae; Chung, Bomy Lee; Ma, Mingming; Mulder, Willem J. M.; Fayad, Zahi A.; Farokhzad, Omid C.; Langer, Robert

2012-01-01

Lipid-polymer hybrid (LPH) nanoparticles can deliver a wide range of therapeutic compounds in a controlled manner. LPH nanoparticle syntheses using microfluidics improve the mixing process, but are restricted by a low throughput. In this study we present a pattern-tunable microvortex platform that allows mass production and size control of LPH nanoparticles with superior reproducibility and homogeneity. We demonstrate that by varying flow rates (i.e. Reynolds number (30∼150)) we can control the nanoparticle size (30∼170nm) with high productivity (∼3g/hour) and low polydispersity (∼0.1). Our approach may contribute to efficient development and optimization of a wide range of multicomponent nanoparticles for medical imaging and drug delivery. PMID:22716029

Defense waste processing facility (DWPF) liquids model: revisions for processing higher TIO 2 containing glasses

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

Jantzen, C. M.; Edwards, T. B.; Trivelpiece, C. L.

Radioactive high level waste (HLW) at the Savannah River Site (SRS) has successfully been vitrified into borosilicate glass in the Defense Waste Processing Facility (DWPF) since 1996. Vitrification requires stringent product/process (P/P) constraints since the glass cannot be reworked once it is poured into ten foot tall by two foot diameter canisters. A unique “feed forward” statistical process control (SPC) was developed for this control rather than statistical quality control (SQC). In SPC, the feed composition to the DWPF melter is controlled prior to vitrification. In SQC, the glass product would be sampled after it is vitrified. Individual glass property-compositionmore » models form the basis for the “feed forward” SPC. The models transform constraints on the melt and glass properties into constraints on the feed composition going to the melter in order to guarantee, at the 95% confidence level, that the feed will be processable and that the durability of the resulting waste form will be acceptable to a geologic repository. This report documents the development of revised TiO 2, Na 2O, Li 2O and Fe 2O 3 coefficients in the SWPF liquidus model and revised coefficients (a, b, c, and d).« less

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.

Multiplex-PCR As a Rapid and Sensitive Method for Identification of Meat Species in Halal-Meat Products.

PubMed

Alikord, Mahsa; Keramat, Javad; Kadivar, Mahdi; Momtaz, Hassan; Eshtiaghi, Mohammad N; Homayouni-Rad, Aziz

2017-01-01

Species identification and authentication in meat products are important subjects for ensuring the health of consumers. The multiplex-PCR amplification and species- specific primer set were used for the identification of horse, donkey, pig and other ruminants in raw and processed meat products. Oligonucleotid primers were designed and patented for amplification of species-specific mitochondrial DNA sequences of each species and samples were prepared from binary meat mixtures. The results showed that meat species were accurately determined in all combinations by multiplex-PCR, and the sensitivity of this method was 0.001 ng, rendering this technique open to and suitable for use in industrial meat products. It is concluded that more fraud is seen in lower percentage industrial meat products than in higher percentage ones. There was also more fraud found in processed products than in raw ones. This rapid and useful test is recommended for quality control firms for applying more rigorous controls over industrial meat products, for the benefit of target consumers. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

29 CFR 1910.1047 - Ethylene oxide.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., rupture of containers, or failure of control equipment that is likely to or does result in an unexpected... there has been a change in the production, process, control equipment, personnel or work practices that... controls and work practices. (i) The employer shall institute engineering controls and work practices to...

On-line IR analyzer system to monitor cephamycin C loading on ion-exchange resin

NASA Astrophysics Data System (ADS)

Shank, Sheldon; Russ, Warren; Gravatt, Douglas; Lee, Wesley; Donahue, Steven M.

1992-08-01

An on-line infrared analyzer is being developed for monitoring cephamycin C loading on ion exchange resin. Accurate measurement of product loading offers productivity improvements with direct savings from product loss avoidance, minimized raw material cost, and reduced off-line laboratory testing. Ultrafiltered fermentation broth is fed onto ion exchange columns under conditions which adsorb the product, cephamycin C, to the resin while allowing impurities to pass unretained. Product loading is stopped when the on-line analyzer determines that resin capacity for adsorbing product is nearly exhausted. Infrared spectroscopy has been shown capable of quantifying cephamycin C in the process matrix at concentrations that support process control decisions. Process-to-analyzer interface challenges have been resolved, including sample conditioning requirements. Analyzer requirements have been defined. The sample conditioning station is under design.

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.

Laser Hot Wire Process: A Novel Process for Near-Net Shape Fabrication for High-Throughput Applications

NASA Astrophysics Data System (ADS)

Kottman, Michael; Zhang, Shenjia; McGuffin-Cawley, James; Denney, Paul; Narayanan, Badri K.

2015-03-01

The laser hot wire process has gained considerable interest for additive manufacturing applications, leveraging its high deposition rate, low dilution, thermal stability, and general metallurgical control including the ability to introduce and preserve desired meta-stable phases. Recent advancements in closed-loop process control and laser technology have increased productivity, process stability, and control of deposit metallurgy. The laser hot wire process has shown success in several applications: repairing and rejuvenating casting dies, depositing a variety of alloys including abrasion wear-resistant overlays with solid and tubular wires, and producing low-dilution (<5%) nickel alloy overlays for corrosion applications. The feasibility of fabricating titanium buildups is being assessed for aerospace applications.

Development of integrated programs for Aerospace-vehicle Design (IPAD): Product program management systems

NASA Technical Reports Server (NTRS)

Isenberg, J. M.; Southall, J. W.

1979-01-01

The Integrated Programs for Aerospace Vehicle Design (IPAD) is a computing system to support company-wide design information processing. This document presents a brief description of the management system used to direct and control a product-oriented program. This document, together with the reference design process (CR 2981) and the manufacture interactions with the design process (CR 2982), comprises the reference information that forms the basis for specifying IPAD system requirements.

Encapsulates for Food Bioconversions and Metabolite Production

NASA Astrophysics Data System (ADS)

Breguet, Véronique; Vojinovic, Vojislav; Marison, Ian W.

The control of production costs in the food industry must be very strict as a result of the relatively low added value of food products. Since a wide variety of enzymes and/or cells are employed in the food industry for starch processing, cheese making, food preservation, lipid hydrolysis and other applications, immobilization of the cells and/or enzymes has been recognized as an attractive approach to improving food processes while minimizing costs. This is due to the fact that biocatalyst immobilization allows for easier separation/purification of the product and reutilization of the biocatalyst. The advantages of the use of immobilized systems are many, and they have a special relevance in the area of food technology, especially because industrial processes using immobilized biosystems are usually characterized by lower capital/energy costs and better logistics. The main applications of immobilization, related to the major processes of food bioconversions and metabolite production, will be described and discussed in this chapter.

Liquid Fuel Production from Biomass via High Temperature Steam Electrolysis

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

Grant L. Hawkes; Michael G. McKellar

2009-11-01

A process model of syngas production using high temperature electrolysis and biomass gasification is presented. Process heat from the biomass gasifier is used to heat steam for the hydrogen production via the high temperature steam electrolysis process. Hydrogen from electrolysis allows a high utilization of the biomass carbon for syngas production. Oxygen produced form the electrolysis process is used to control the oxidation rate in the oxygen-fed biomass gasifier. Based on the gasifier temperature, 94% to 95% of the carbon in the biomass becomes carbon monoxide in the syngas (carbon monoxide and hydrogen). Assuming the thermal efficiency of the powermore » cycle for electricity generation is 50%, (as expected from GEN IV nuclear reactors), the syngas production efficiency ranges from 70% to 73% as the gasifier temperature decreases from 1900 K to 1500 K. Parametric studies of system pressure, biomass moisture content and low temperature alkaline electrolysis are also presented.« less

Science--A Process Approach, Product Development Report No. 8.

ERIC Educational Resources Information Center

Sanderson, Barbara A.; Kratochvil, Daniel W.

Science - A Process Approach, a science program for grades kindergarten through sixth, mainly focuses on scientific processes: observing, classifying, using numbers, measuring, space/time relationships, communicating, predicting, inferring, defining operationally, formulating hypotheses, interpreting data, controlling variables, and experimenting.…

Automated information system for analysis and prediction of production situations in blast furnace plant

NASA Astrophysics Data System (ADS)

Lavrov, V. V.; Spirin, N. A.

2016-09-01

Advances in modern science and technology are inherently connected with the development, implementation, and widespread use of computer systems based on mathematical modeling. Algorithms and computer systems are gaining practical significance solving a range of process tasks in metallurgy of MES-level (Manufacturing Execution Systems - systems controlling industrial process) of modern automated information systems at the largest iron and steel enterprises in Russia. This fact determines the necessity to develop information-modeling systems based on mathematical models that will take into account the physics of the process, the basics of heat and mass exchange, the laws of energy conservation, and also the peculiarities of the impact of technological and standard characteristics of raw materials on the manufacturing process data. Special attention in this set of operations for metallurgic production is devoted to blast-furnace production, as it consumes the greatest amount of energy, up to 50% of the fuel used in ferrous metallurgy. The paper deals with the requirements, structure and architecture of BF Process Engineer's Automated Workstation (AWS), a computer decision support system of MES Level implemented in the ICS of the Blast Furnace Plant at Magnitogorsk Iron and Steel Works. It presents a brief description of main model subsystems as well as assumptions made in the process of mathematical modelling. Application of the developed system allows the engineering and process staff to analyze online production situations in the blast furnace plant, to solve a number of process tasks related to control of heat, gas dynamics and slag conditions of blast-furnace smelting as well as to calculate the optimal composition of blast-furnace slag, which eventually results in increasing technical and economic performance of blast-furnace production.

Attention for speaking: domain-general control from the anterior cingulate cortex in spoken word production

PubMed Central

Piai, Vitória; Roelofs, Ardi; Acheson, Daniel J.; Takashima, Atsuko

2013-01-01

Accumulating evidence suggests that some degree of attentional control is required to regulate and monitor processes underlying speaking. Although progress has been made in delineating the neural substrates of the core language processes involved in speaking, substrates associated with regulatory and monitoring processes have remained relatively underspecified. We report the results of an fMRI study examining the neural substrates related to performance in three attention-demanding tasks varying in the amount of linguistic processing: vocal picture naming while ignoring distractors (picture-word interference, PWI); vocal color naming while ignoring distractors (Stroop); and manual object discrimination while ignoring spatial position (Simon task). All three tasks had congruent and incongruent stimuli, while PWI and Stroop also had neutral stimuli. Analyses focusing on common activation across tasks identified a portion of the dorsal anterior cingulate cortex (ACC) that was active in incongruent trials for all three tasks, suggesting that this region subserves a domain-general attentional control function. In the language tasks, this area showed increased activity for incongruent relative to congruent stimuli, consistent with the involvement of domain-general mechanisms of attentional control in word production. The two language tasks also showed activity in anterior-superior temporal gyrus (STG). Activity increased for neutral PWI stimuli (picture and word did not share the same semantic category) relative to incongruent (categorically related) and congruent stimuli. This finding is consistent with the involvement of language-specific areas in word production, possibly related to retrieval of lexical-semantic information from memory. The current results thus suggest that in addition to engaging language-specific areas for core linguistic processes, speaking also engages the ACC, a region that is likely implementing domain-general attentional control. PMID:24368899

A Machine Vision Quality Control System for Industrial Acrylic Fibre Production

NASA Astrophysics Data System (ADS)

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

2002-12-01

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

Microparticle based morphology engineering of filamentous microorganisms for industrial bio-production.

PubMed

Walisko, Robert; Krull, Rainer; Schrader, Jens; Wittmann, Christoph

2012-11-01

Filamentous microorganisms are important work horses in industrial biotechnology and supply enzymes, antibiotics, pharmaceuticals, bulk and fine chemicals. Here we highlight recent findings on the use of microparticles in the cultivation of filamentous bacteria and fungi, with the aim of enabling a more precise control of their morphology towards better production performance. First examples reveal a broad application range of microparticle based processes, since multiple filamentous organisms are controllable in their growth characteristics and respond by enhanced product formation.

Noncontact conductivity and dielectric measurement for high throughput roll-to-roll nanomanufacturing

NASA Astrophysics Data System (ADS)

Orloff, Nathan D.; Long, Christian J.; Obrzut, Jan; Maillaud, Laurent; Mirri, Francesca; Kole, Thomas P.; McMichael, Robert D.; Pasquali, Matteo; Stranick, Stephan J.; Alexander Liddle, J.

2015-11-01

Advances in roll-to-roll processing of graphene and carbon nanotubes have at last led to the continuous production of high-quality coatings and filaments, ushering in a wave of applications for flexible and wearable electronics, woven fabrics, and wires. These applications often require specific electrical properties, and hence precise control over material micro- and nanostructure. While such control can be achieved, in principle, by closed-loop processing methods, there are relatively few noncontact and nondestructive options for quantifying the electrical properties of materials on a moving web at the speed required in modern nanomanufacturing. Here, we demonstrate a noncontact microwave method for measuring the dielectric constant and conductivity (or geometry for samples of known dielectric properties) of materials in a millisecond. Such measurement times are compatible with current and future industrial needs, enabling real-time materials characterization and in-line control of processing variables without disrupting production.

Noncontact conductivity and dielectric measurement for high throughput roll-to-roll nanomanufacturing

PubMed Central

Orloff, Nathan D.; Long, Christian J.; Obrzut, Jan; Maillaud, Laurent; Mirri, Francesca; Kole, Thomas P.; McMichael, Robert D.; Pasquali, Matteo; Stranick, Stephan J.; Alexander Liddle, J.

2015-01-01

Advances in roll-to-roll processing of graphene and carbon nanotubes have at last led to the continuous production of high-quality coatings and filaments, ushering in a wave of applications for flexible and wearable electronics, woven fabrics, and wires. These applications often require specific electrical properties, and hence precise control over material micro- and nanostructure. While such control can be achieved, in principle, by closed-loop processing methods, there are relatively few noncontact and nondestructive options for quantifying the electrical properties of materials on a moving web at the speed required in modern nanomanufacturing. Here, we demonstrate a noncontact microwave method for measuring the dielectric constant and conductivity (or geometry for samples of known dielectric properties) of materials in a millisecond. Such measurement times are compatible with current and future industrial needs, enabling real-time materials characterization and in-line control of processing variables without disrupting production. PMID:26592441

Characterization of polymer composites during autoclave manufacturing by Fourier transform Raman spectroscopy

NASA Astrophysics Data System (ADS)

Farquharson, Stuart; Smith, Wayne W.; Rigas, Elias J.; Granville, Dana

2001-02-01

12 The superior engineering properties of fiber reinforced polymer matrix composites, primarily the high strength-to- weight ratio, make them suitable to applications ranging from sporting goods to aircraft components (e.g. helicopter blades). Unfortunately, consistent fabrication of components with desired mechanical properties has proven difficult, and has led to high production costs. This is largely due to the inability to monitor and control polymer cure, loosely defined as the process of polymer chain extension and cross- linking. Even with stringent process control, slight variations in the pre-polymer formulations (e.g. prepreg) can influence reaction rates, reaction mechanisms, and ultimately, product properties. In an effort to optimize the performance of thermoset composite, we have integrated fiber optic probes between the plies of laminates and monitored cure by Raman spectroscopy, with the eventual goal of process control. Here we present real-time measurements of two high performance aerospace companies cured within an industrial autoclave.

[Purifying process of gynostemma pentaphyllum saponins based on "adjoint marker" online control technology and identification of their compositions by UPLC-QTOF-MS].

PubMed

Fan, Dong-Dong; Kuang, Yan-Hui; Dong, Li-Hua; Ye, Xiao; Chen, Liang-Mian; Zhang, Dong; Ma, Zhen-Shan; Wang, Jin-Yu; Zhu, Jing-Jing; Wang, Zhi-Min; Wang, De-Qin; Li, Chu-Yuan

2017-04-01

To optimize the purification process of gynostemma pentaphyllum saponins (GPS) based on "adjoint marker" online control technology with GPS as the testing index. UPLC-QTOF-MS technology was used for qualitative analysis. "Adjoint marker" online control results showed that the end point of load sample was that the UV absorbance of effluent liquid was equal to half of that of load sample solution, and the absorbance was basically stable when the end point was stable. In UPLC-QTOF-MS qualitative analysis, 16 saponins were identified from GPS, including 13 known gynostemma saponins and 3 new saponins. This optimized method was proved to be simple, scientific, reasonable, easy for online determination, real-time record, and can be better applied to the mass production and automation of production. The results of qualitative analysis indicated that the "adjoint marker" online control technology can well retain main efficacy components of medicinal materials, and provide analysis tools for the process control and quality traceability. Copyright© by the Chinese Pharmaceutical Association.

Insitu measurement and control of processing properties of composite resins in a production tool

NASA Technical Reports Server (NTRS)

Kranbuehl, D.; Hoff, M.; Haverty, P.; Loos, A.; Freeman, T.

1988-01-01

An in situ measuring technique for use in automated composite processing and quality control is discussed. Frequency dependent electromagnetic sensors are used to measure processing parameters at four ply positions inside a thick section 192-ply graphite-epoxy composite during cure in an 8 x 4 in. autoclave. Viscosity measurements obtained using the sensors are compared with the viscosities calculated using the Loos-Springer cure process model. Good overall agreement is obtained. In a subsequent autoclave run, the output from the four sensors was used to control the autoclave temperature. Using the 'closed loop' sensor controlled autoclave temperature resulted in a more uniform and more rapid cure cycle.

Process optimization at small and medium-sized enterprises: production of small and medium-sized batches

NASA Astrophysics Data System (ADS)

Stettmer, J.

2017-06-01

The organization of a company needs to refer to the production process and especially to the number of employees. Many enterprises which are growing, are primarily focused on the development of the technology and not on the development of the organization. This ends up in an increase of the turnover but in a reduced margin. For the development of the organization in growing companies there are two things necessary. The development of the staff to work systematically and coordinated in teams as well as the flow of the information and material between the teams. ERP - systems are required to install the material and information flow especially in the work floor. Unfortunately many enterprises don't use the ERP-systems to plan and control the material and information flow very detailed. In companies where the control of the material and information flow was installed, it could be demonstrated that the margin increased analog to it. The requirements to the development of the organization based on the increasing number of the employees are basically the same for most of the production processes like the production of metal sheet housings or the production of mirrors and lenses.

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

Scalable graphene production: perspectives and challenges of plasma applications

NASA Astrophysics Data System (ADS)

Levchenko, Igor; Ostrikov, Kostya (Ken); Zheng, Jie; Li, Xingguo; Keidar, Michael; B. K. Teo, Kenneth

2016-05-01

Graphene, a newly discovered and extensively investigated material, has many unique and extraordinary properties which promise major technological advances in fields ranging from electronics to mechanical engineering and food production. Unfortunately, complex techniques and high production costs hinder commonplace applications. Scaling of existing graphene production techniques to the industrial level without compromising its properties is a current challenge. This article focuses on the perspectives and challenges of scalability, equipment, and technological perspectives of the plasma-based techniques which offer many unique possibilities for the synthesis of graphene and graphene-containing products. The plasma-based processes are amenable for scaling and could also be useful to enhance the controllability of the conventional chemical vapour deposition method and some other techniques, and to ensure a good quality of the produced graphene. We examine the unique features of the plasma-enhanced graphene production approaches, including the techniques based on inductively-coupled and arc discharges, in the context of their potential scaling to mass production following the generic scaling approaches applicable to the existing processes and systems. This work analyses a large amount of the recent literature on graphene production by various techniques and summarizes the results in a tabular form to provide a simple and convenient comparison of several available techniques. Our analysis reveals a significant potential of scalability for plasma-based technologies, based on the scaling-related process characteristics. Among other processes, a greater yield of 1 g × h-1 m-2 was reached for the arc discharge technology, whereas the other plasma-based techniques show process yields comparable to the neutral-gas based methods. Selected plasma-based techniques show lower energy consumption than in thermal CVD processes, and the ability to produce graphene flakes of various sizes reaching hundreds of square millimetres, and the thickness varying from a monolayer to 10-20 layers. Additional factors such as electrical voltage and current, not available in thermal CVD processes could potentially lead to better scalability, flexibility and control of the plasma-based processes. Advantages and disadvantages of various systems are also considered.

Scalable graphene production: perspectives and challenges of plasma applications.

PubMed

Levchenko, Igor; Ostrikov, Kostya Ken; Zheng, Jie; Li, Xingguo; Keidar, Michael; B K Teo, Kenneth

2016-05-19

Graphene, a newly discovered and extensively investigated material, has many unique and extraordinary properties which promise major technological advances in fields ranging from electronics to mechanical engineering and food production. Unfortunately, complex techniques and high production costs hinder commonplace applications. Scaling of existing graphene production techniques to the industrial level without compromising its properties is a current challenge. This article focuses on the perspectives and challenges of scalability, equipment, and technological perspectives of the plasma-based techniques which offer many unique possibilities for the synthesis of graphene and graphene-containing products. The plasma-based processes are amenable for scaling and could also be useful to enhance the controllability of the conventional chemical vapour deposition method and some other techniques, and to ensure a good quality of the produced graphene. We examine the unique features of the plasma-enhanced graphene production approaches, including the techniques based on inductively-coupled and arc discharges, in the context of their potential scaling to mass production following the generic scaling approaches applicable to the existing processes and systems. This work analyses a large amount of the recent literature on graphene production by various techniques and summarizes the results in a tabular form to provide a simple and convenient comparison of several available techniques. Our analysis reveals a significant potential of scalability for plasma-based technologies, based on the scaling-related process characteristics. Among other processes, a greater yield of 1 g × h(-1) m(-2) was reached for the arc discharge technology, whereas the other plasma-based techniques show process yields comparable to the neutral-gas based methods. Selected plasma-based techniques show lower energy consumption than in thermal CVD processes, and the ability to produce graphene flakes of various sizes reaching hundreds of square millimetres, and the thickness varying from a monolayer to 10-20 layers. Additional factors such as electrical voltage and current, not available in thermal CVD processes could potentially lead to better scalability, flexibility and control of the plasma-based processes. Advantages and disadvantages of various systems are also considered.

Towards an optimal adaptation of exposure to NOAA assessment methodology in Multi-Source Industrial Scenarios (MSIS): the challenges and the decision-making process

NASA Astrophysics Data System (ADS)

López de Ipiña, JM; Vaquero, C.; Gutierrez-Cañas, C.

2017-06-01

It is expected a progressive increase of the industrial processes that manufacture of intermediate (iNEPs) and end products incorporating ENMs (eNEPs) to bring about improved properties. Therefore, the assessment of occupational exposure to airborne NOAA will migrate, from the simple and well-controlled exposure scenarios in research laboratories and ENMs production plants using innovative production technologies, to much more complex exposure scenarios located around processes of manufacture of eNEPs that, in many cases, will be modified conventional production processes. Here will be discussed some of the typical challenging situations in the process of risk assessment of inhalation exposure to NOAA in Multi-Source Industrial Scenarios (MSIS), from the basis of the lessons learned when confronted to those scenarios in the frame of some European and Spanish research projects.

Application of Advanced Process Control techniques to a pusher type reheating furnace

NASA Astrophysics Data System (ADS)

Zanoli, S. M.; Pepe, C.; Barboni, L.

2015-11-01

In this paper an Advanced Process Control system aimed at controlling and optimizing a pusher type reheating furnace located in an Italian steel plant is proposed. The designed controller replaced the previous control system, based on PID controllers manually conducted by process operators. A two-layer Model Predictive Control architecture has been adopted that, exploiting a chemical, physical and economic modelling of the process, overcomes the limitations of plant operators’ mental model and knowledge. In addition, an ad hoc decoupling strategy has been implemented, allowing the selection of the manipulated variables to be used for the control of each single process variable. Finally, in order to improve the system flexibility and resilience, the controller has been equipped with a supervision module. A profitable trade-off between conflicting specifications, e.g. safety, quality and production constraints, energy saving and pollution impact, has been guaranteed. Simulation tests and real plant results demonstrated the soundness and the reliability of the proposed system.

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

PubMed

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

2015-09-01

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

PROCEDURES FOR ACCURATE PRODUCTION OF COLOR IMAGES FROM SATELLITE OR AIRCRAFT MULTISPECTRAL DIGITAL DATA.

USGS Publications Warehouse

Duval, Joseph S.

1985-01-01

Because the display and interpretation of satellite and aircraft remote-sensing data make extensive use of color film products, accurate reproduction of the color images is important. To achieve accurate color reproduction, the exposure and chemical processing of the film must be monitored and controlled. By using a combination of sensitometry, densitometry, and transfer functions that control film response curves, all of the different steps in the making of film images can be monitored and controlled. Because a sensitometer produces a calibrated exposure, the resulting step wedge can be used to monitor the chemical processing of the film. Step wedges put on film by image recording machines provide a means of monitoring the film exposure and color balance of the machines.

Modelling of the production of gaseous by-products in anaerobic digestion.

PubMed

Strik, D P; Domnanovich, A M; Pfeiffer, B; Karlovitz, M; Zani, L; Braun, R; Holubar, P

2003-01-01

Goal of the EU-Project AMONCO (Advanced Prediction, Monitoring and Controlling of Anaerobic Digestion Processes Behaviour towards Biogas Usage in Fuel Cells) is demonstration of the practical use of biogas in fuel cells. The right precondition is a biogas quality which fits into the fuel cells tolerances. Therefore the mission of the workgroup Environmental biotechnology is to control anaerobic digestion in a way that production of potential harmful by-products for fuel cells is reduced. A good understanding of the production of these by products is essential for an applicable decision support tool. This poster presents the modelling of hydrogen sulfide by means of hierarchical neural networks and a classical mathematical method.

Advanced Manufacturing Systems in Food Processing and Packaging Industry

NASA Astrophysics Data System (ADS)

Shafie Sani, Mohd; Aziz, Faieza Abdul

2013-06-01

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

Rapid Prototyping of Slot Die Devices for Roll to Roll Production of EL Fibers

PubMed Central

Bellingham, Alyssa; Bromhead, Nicholas; Fontecchio, Adam

2017-01-01

There is a growing interest in fibers supporting optoelectrical properties for textile and wearable display applications. Solution-processed electroluminescent (EL) material systems can be continuously deposited onto fiber or yarn substrates in a roll-to-roll process, making it easy to scale manufacturing. It is important to have precise control over layer deposition to achieve uniform and reliable light emission from these EL fibers. Slot-die coating offers this control and increases the rate of EL fiber production. Here, we report a highly adaptable, cost-effective 3D printing model for developing slot dies used in automatic coating systems. The resulting slot-die coating system enables rapid, reliable production of alternating current powder-based EL (ACPEL) fibers and can be adapted for many material systems. The benefits of this system over dip-coating for roll-to-roll production of EL fibers are demonstrated in this work. PMID:28772954

Rapid Prototyping of Slot Die Devices for Roll to Roll Production of EL Fibers.

PubMed

Bellingham, Alyssa; Bromhead, Nicholas; Fontecchio, Adam

2017-05-29

There is a growing interest in fibers supporting optoelectrical properties for textile and wearable display applications. Solution-processed electroluminescent (EL) material systems can be continuously deposited onto fiber or yarn substrates in a roll-to-roll process, making it easy to scale manufacturing. It is important to have precise control over layer deposition to achieve uniform and reliable light emission from these EL fibers. Slot-die coating offers this control and increases the rate of EL fiber production. Here, we report a highly adaptable, cost-effective 3D printing model for developing slot dies used in automatic coating systems. The resulting slot-die coating system enables rapid, reliable production of alternating current powder-based EL (ACPEL) fibers and can be adapted for many material systems. The benefits of this system over dip-coating for roll-to-roll production of EL fibers are demonstrated in this work.

Thick resist for MEMS processing

NASA Astrophysics Data System (ADS)

Brown, Joe; Hamel, Clifford

2001-11-01

The need for technical innovation is always present in today's economy. Microfabrication methods have evolved in support of the demand for smaller and faster integrated circuits with price performance improvements always in the scope of the manufacturing design engineer. The dispersion of processing technology spans well beyond IC fabrication today with batch fabrication and wafer scale processing lending advantages to MEMES applications from biotechnology to consumer electronics from oil exploration to aerospace. Today the demand for innovative processing techniques that enable technology is apparent where only a few years ago appeared too costly or not reliable. In high volume applications where yield and cost improvements are measured in fractions of a percent it is imperative to have process technologies that produce consistent results. Only a few years ago thick resist coatings were limited to thickness less than 20 microns. Factors such as uniformity, edge bead and multiple coatings made high volume production impossible. New developments in photoresist formulation combined with advanced coating equipment techniques that closely controls process parameters have enable thick photoresist coatings of 70 microns with acceptable uniformity and edge bead in one pass. Packaging of microelectronic and micromechanical devices is often a significant cost factor and a reliability issue for high volume low cost production. Technologies such as flip- chip assembly provide a solution for cost and reliability improvements over wire bond techniques. The processing for such technology demands dimensional control and presents a significant cost savings if it were compatible with mainstream technologies. Thick photoresist layers, with good sidewall control would allow wafer-bumping technologies to penetrate the barriers to yield and production where costs for technology are the overriding issue. Single pass processing is paramount to the manufacturability of packaging technology. Uniformity and edge bead control defined the success of process implementation. Today advanced packaging solutions are created with thick photoresist coatings. The techniques and results will be presented.

In-situ sensing using mass spectrometry and its use for run-to-run control on a W-CVD cluster tool

NASA Astrophysics Data System (ADS)

Gougousi, T.; Sreenivasan, R.; Xu, Y.; Henn-Lecordier, L.; Rubloff, G. W.; Kidder, , J. N.; Zafiriou, E.

2001-01-01

A 300 amu closed-ion-source RGA (Leybold-Inficon Transpector 2) sampling gases directly from the reactor of an ULVAC ERA-1000 cluster tool has been used for real time process monitoring of a W CVD process. The process involves H2 reduction of WF6 at a total pressure of 67 Pa (0.5 torr) to produce W films on Si wafers heated at temperatures around 350 °C. The normalized RGA signals for the H2 reagent depletion and the HF product generation were correlated with the W film weight as measured post-process with an electronic microbalance for the establishment of thin-film weight (thickness) metrology. The metrology uncertainty (about 7% for the HF product) was limited primarily by the very low conversion efficiency of the W CVD process (around 2-3%). The HF metrology was then used to drive a robust run-to-run control algorithm, with the deposition time selected as the manipulated (or controlled) variable. For that purpose, during a 10 wafer run, a systematic process drift was introduced as a -5 °C processing temperature change for each successive wafer, in an otherwise unchanged process recipe. Without adjustment of the deposition time the W film weight (thickness) would have declined by about 50% by the 10th wafer. With the aid of the process control algorithm, an adjusted deposition time was computed so as to maintain constant HF sensing signal, resulting in weight (thickness) control comparable to the accuracy of the thickness metrology. These results suggest that in-situ chemical sensing, and particularly mass spectrometry, provide the basis for wafer state metrology as needed to achieve run-to-run control. Furthermore, since the control accuracy was consistent with the metrology accuracy, we anticipate significant improvements for processes as used in manufacturing, where conversion rates are much higher (40-50%) and corresponding signals for metrology will be much larger.

Applications of the bacteriocin, nisin.

PubMed

Delves-Broughton, J; Blackburn, P; Evans, R J; Hugenholtz, J

1996-02-01

Nisin was first introduced commercially as a food preservative in the UK approximately 30 years ago. First established use was as a preservative in processed cheese products and since then numerous other applications in foods and beverages have been identified. It is currently recognised as a safe food preservative in approximately 50 countries. The established uses of nisin as a preservative in processed cheese, various pasteurised dairy products, and canned vegetables will be briefly reviewed. More recent applications of nisin include its use as a preservative in high moisture, hot baked flour products (crumpets) and pasteurised liquid egg. Renewed interest is evident in the use of nisin in natural cheese production. Considerable research has been carried out on the antilisterial properties of nisin in foods and a number of applications have been proposed. Uses of nisin to control spoilage lactic acid bacteria have been identified in beer, wine, alcohol production and low pH foods such as salad dressings. Further developments of nisin are likely to include synergistic action of nisin with chelators and other bacteriocins, and its use as an adjunct in novel food processing technology such as higher pressure sterilisation and electroporation. Production of highly purified nisin preparations and enhancement by chelators has led to interest in the use of nisin for human ulcer therapy, and mastitis control in cattle.

[Design of a HACCP plan for the industrial process of frozen sardines].

PubMed

Rosas, Patricia; Reyes, Genara

2009-09-01

The Hazard Analysis and Critical Control Point (HACCP) is a system to identify, assess and control the hazards related with production, processing, distribution and consumption in order to get safe food. The aim of this study was to design a HACCP plan for implementing in processing line of frozen whole sardine (Sardinella aurita). The methodology was based in the evaluation of the accomplishment of the pre-requisite programs (GMP/SSOP in a previous study), the application of the principles of the HACCP and the sequence of stages settles down by the COVENIN Venezuelan standard No 3802. Time-temperature was recorded in each processing step. Histamine was determined by VERATOX NEOGEN. Results showed that some sardine batches arrived to the plant with high time-temperature records, finding up to 5 ppm of histamine due to the abuse of temperature during transportation. A HACCP plan is proposed with the scope, the selection of the team, the description of the product and the intended use, the flow diagram of the process, hazard analysis and identification of CCP, monitoring system, corrective actions and records. The potential hazards were identified as pathogen growth, presence of histamine and physical objects in the sardines. The control measures of PCC are referred as control of time-temperature during transportation and processing, monitoring of ice supplies and sanitary conditions in the process.

21 CFR 820.75 - Process validation.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Process validation. 820.75 Section 820.75 Food and... QUALITY SYSTEM REGULATION Production and Process Controls § 820.75 Process validation. (a) Where the... validated with a high degree of assurance and approved according to established procedures. The validation...