27 CFR 19.395 - Manufacture of articles.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2014-04-01 2014-04-01 false Manufacture of articles..., DEPARTMENT OF THE TREASURY ALCOHOL DISTILLED SPIRITS PLANTS Denaturing Operations and Manufacture of Articles Rules for Restoration and Redenaturation, Inventories, and Manufacture of Articles; Records Required...

27 CFR 19.395 - Manufacture of articles.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2013-04-01 2013-04-01 false Manufacture of articles..., DEPARTMENT OF THE TREASURY ALCOHOL DISTILLED SPIRITS PLANTS Denaturing Operations and Manufacture of Articles Rules for Restoration and Redenaturation, Inventories, and Manufacture of Articles; Records Required...

27 CFR 53.182 - Supporting evidence required in case of tax-paid articles used for further manufacture.

Code of Federal Regulations, 2010 CFR

2010-04-01

... required in case of tax-paid articles used for further manufacture. 53.182 Section 53.182 Alcohol, Tobacco... articles used for further manufacture. (a) Evidence to be submitted by claimant. No claim for credit or... material in the manufacture or production of, or as a component part of, a second article manufactured or...

Development and Deployment of the Purdue TAP Green Enterprise Development Program

ERIC Educational Resources Information Center

Rogers, Ethan A.

2013-01-01

Purdue University--Mechanical, Engineering, and Technology (MET) faculty and Purdue Technical Assistance Program (TAP) staff partnered with the Society of Manufacturing Engineers (SME) to create a new workforce training program and certificate exam in the field of green manufacturing. This article describes how the body of knowledge for the…

Documentation: Records and Reports.

PubMed

Akers, Michael J

2017-01-01

This article deals with documentation to include the beginning of documentation, the requirements of Good Manufacturing Practice reports and records, and the steps that can be taken to minimize Good Manufacturing Practice documentation problems. It is important to remember that documentation for 503a compounding involves the Formulation Record, Compounding Record, Standard Operating Procedures, Safety Data Sheets, etc. For 503b outsourcing facilities, compliance with Current Good Manufacturing Practices is required, so this article is applicable to them. For 503a pharmacies, one can see the development and modification of Good Manufacturing Practice and even observe changes as they are occurring in 503a documentation requirements and anticipate that changes will probably continue to occur. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Potential of Continuous Manufacturing for Liposomal Drug Products.

PubMed

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

2018-05-21

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

[Risk management for medical devices].

PubMed

Xie, Ying-jie; Xu, Xing-gang

2007-07-01

Based on the practices of the risk management activities by Chinese medical device manufacturers and theoretical study of the latest international standard ISO 14971:2007, this article analyses the risk management in medical device manufacturing industry by introducing the status quo of applications, four requirements at operational stages, and future trends of development. Methods and suggestions are therefore given to medical device manufacturers for risk management.

27 CFR 19.753 - Record of article manufacture.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Record of article... Account § 19.753 Record of article manufacture. Each processor qualified to manufacture articles shall maintain daily records arranged by the name and authorized use code of the article to show the following...

Use of digital technologies for nasal prosthesis manufacturing.

PubMed

Palousek, David; Rosicky, Jiri; Koutny, Daniel

2014-04-01

Digital technology is becoming more accessible for common use in medical applications; however, their expansion in prosthetic and orthotic laboratories is not large because of the persistent image of difficult applicability to real patients. This article aims to offer real example in the area of human facial prostheses. This article describes the utilization of optical digitization, computational modelling, rapid prototyping, mould fabrication and manufacturing of a nasal silicone prosthesis. This technical note defines the key points of the methodology and aspires to contribute to the introduction of a certified manufacturing procedure. The results show that the used technologies reduce the manufacturing time, reflect patient's requirements and allow the manufacture of high-quality prostheses for missing facial asymmetric parts. The methodology provides a good position for further development issues and is usable for clinical practice. Clinical relevance Utilization of digital technologies in facial prosthesis manufacturing process can be a good contribution for higher patient comfort and higher production efficiency but with higher initial investment and demands for experience with software tools.

19 CFR 134.35 - Articles substantially changed by manufacture.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 19 Customs Duties 1 2012-04-01 2012-04-01 false Articles substantially changed by manufacture. 134...; DEPARTMENT OF THE TREASURY COUNTRY OF ORIGIN MARKING Exceptions to Marking Requirements § 134.35 Articles substantially changed by manufacture. (a) Articles other than goods of a NAFTA country. An article used in the...

19 CFR 134.35 - Articles substantially changed by manufacture.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 19 Customs Duties 1 2010-04-01 2010-04-01 false Articles substantially changed by manufacture. 134...; DEPARTMENT OF THE TREASURY COUNTRY OF ORIGIN MARKING Exceptions to Marking Requirements § 134.35 Articles substantially changed by manufacture. (a) Articles other than goods of a NAFTA country. An article used in the...

19 CFR 134.35 - Articles substantially changed by manufacture.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 19 Customs Duties 1 2011-04-01 2011-04-01 false Articles substantially changed by manufacture. 134...; DEPARTMENT OF THE TREASURY COUNTRY OF ORIGIN MARKING Exceptions to Marking Requirements § 134.35 Articles substantially changed by manufacture. (a) Articles other than goods of a NAFTA country. An article used in the...

Integrated control system for electron beam processes

NASA Astrophysics Data System (ADS)

Koleva, L.; Koleva, E.; Batchkova, I.; Mladenov, G.

2018-03-01

The ISO/IEC 62264 standard is widely used for integration of the business systems of a manufacturer with the corresponding manufacturing control systems based on hierarchical equipment models, functional data and manufacturing operations activity models. In order to achieve the integration of control systems, formal object communication models must be developed, together with manufacturing operations activity models, which coordinate the integration between different levels of control. In this article, the development of integrated control system for electron beam welding process is presented as part of a fully integrated control system of an electron beam plant, including also other additional processes: surface modification, electron beam evaporation, selective melting and electron beam diagnostics.

The Determinants of Training in Australian Manufacturing SMEs

ERIC Educational Resources Information Center

Jones, Janice T.

2005-01-01

Purpose: The purpose of this article is to examine the factors influencing the provision of increased training in Australian manufacturing small and medium-sized enterprises (SMEs) that have embarked upon different growth development pathways. Design/Methodology/Approach: The longitudinal panel data employed in this research are drawn from the…

Ethics and Privacy.

ERIC Educational Resources Information Center

Brewer, Erin; Eastmond, Nick; Geertsen, Reed; Johnson, Doug; Lewandowski, Judith; Yeaman, Andrew R. J.

2003-01-01

Contains four articles covering trends and issues on ethics and privacy in instructional technology, including: considerations for assessing ethical issues; what schools must do to develop ethical behaviors in students; a privacy primer for educators; and manufacturing technophopia. Each article contains references. (MES)

19 CFR 10.84 - Automotive vehicles and articles for use as original equipment in the manufacture of automotive...

Code of Federal Regulations, 2010 CFR

2010-04-01

... original equipment in the manufacture of automotive vehicles. 10.84 Section 10.84 Customs Duties U.S... vehicles and articles for use as original equipment in the manufacture of automotive vehicles. (a)(1... his declaration that the articles are being imported for use as original equipment in the manufacture...

Tele-manufactured affordable smartphone anterior segment microscope.

PubMed

Chiong, Hong Sheng; Fang, Joyce Lim Luann; Wilson, Graham

2016-11-01

The recent advances in mobile technology have made the smartphone a powerful and accessible tool. This article describe the development of a novel smartphone-based anterior segment microscope that is compatible with tele-manufacturing. The anterior segment microscope is equipped with both cobalt-blue and red-free filters that can be used for clinical photo-documentation. The digital files of the microscope are transferrable and compatible with additive-manufacturing. Therefore, the entire device can be locally manufactured with rapid prototyping techniques such as 3D printing. © 2016 Optometry Australia.

22 CFR 122.1 - Registration requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... in the business of either manufacturing or exporting defense articles or furnishing defense services... subchapter, engaging in the business of manufacturing or exporting defense articles or furnishing defense services requires only one occasion of manufacturing or exporting a defense article or furnishing a defense...

26 CFR 48.6416(b)(3)-3 - Supporting evidence required in case of tax-paid articles used for further manufacture.

Code of Federal Regulations, 2010 CFR

2010-04-01

... articles used for further manufacture. 48.6416(b)(3)-3 Section 48.6416(b)(3)-3 Internal Revenue INTERNAL... manufacture. (a) Evidence to be submitted by claimant. No claim for credit or refund of an overpayment, within... of payment, (5) Indicating that the article was used by the claimant as material in the manufacture...

Manned remote work station development article. Volume 3: Development test plan. Appendix A: Manufacturing requirements/schedule

NASA Technical Reports Server (NTRS)

1979-01-01

The tests and procedures for the manned remote work station (MRWS) open cherry picker (OCP) development test article (DTA) are described to validate systems requirements and performance specifications. A development test program is outlined to evaluate key design issues and man/machine interfaces when the MRWS OCP is used in a shuttle support role of satellite servicing and in orbit construction of large structures.

Manned remote work station development article

NASA Technical Reports Server (NTRS)

1978-01-01

The two prime objectives of the Manned Remote Work Station (MRWS) Development Article Study are to first, evaluate the MRWS flight article roles and associated design concepts for fundamental requirements and embody key technology developments into a simulation program; and to provide detail manufacturing drawings and schedules for a simulator development test article. An approach is outlined which establishes flight article requirements based on past studies of Solar Power Satellite, orbital construction support equipments, construction bases and near term shuttle operations. Simulation objectives are established for those technology issues that can best be addressed on a simulator. Concepts for full-scale and sub-scale simulators are then studied to establish an overall approach to studying MRWS requirements. Emphasis then shifts to design and specification of a full-scale development test article.

Consumable core for manufacture of composite articles and related method

DOEpatents

Taxacher, Glenn Curtis; de Diego, Peter; Gray, Paul Edward; Monaghan, Philip Harold

2017-09-05

Systems, methods and devices adapted to ease manufacture of composite articles (e.g., ceramic composite articles), particularly composite articles which include a hollow feature are disclosed. In one embodiment, a system includes: a consumable core formed to be disposed within an inner portion of a composite precursor, the consumable core adapted to convert into an infiltrant during a manufacturing process and infiltrate the composite precursor.

Manufacturing Road Map for Tissue Engineering and Regenerative Medicine Technologies

PubMed Central

Hunsberger, Joshua; Harrysson, Ola; Shirwaiker, Rohan; Starly, Binil; Wysk, Richard; Cohen, Paul; Allickson, Julie; Yoo, James

2015-01-01

Summary The Regenerative Medicine Foundation Annual Conference held on May 6 and 7, 2014, had a vision of assisting with translating tissue engineering and regenerative medicine (TERM)-based technologies closer to the clinic. This vision was achieved by assembling leaders in the field to cover critical areas. Some of these critical areas included regulatory pathways for regenerative medicine therapies, strategic partnerships, coordination of resources, developing standards for the field, government support, priorities for industry, biobanking, and new technologies. The final day of this conference featured focused sessions on manufacturing, during which expert speakers were invited from industry, government, and academia. The speakers identified and accessed roadblocks plaguing the field where improvements in advanced manufacturing offered many solutions. The manufacturing sessions included (a) product development toward commercialization in regenerative medicine, (b) process challenges to scale up manufacturing in regenerative medicine, and (c) infrastructure needs for manufacturing in regenerative medicine. Subsequent to this, industry was invited to participate in a survey to further elucidate the challenges to translation and scale-up. This perspective article will cover the lessons learned from these manufacturing sessions and early results from the survey. We also outline a road map for developing the manufacturing infrastructure, resources, standards, capabilities, education, training, and workforce development to realize the promise of TERM. PMID:25575525

27 CFR 20.148 - Manufacture of articles with completely denatured alcohol.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Manufacture of articles with completely denatured alcohol. 20.148 Section 20.148 Alcohol, Tobacco Products and Firearms ALCOHOL... ALCOHOL AND RUM Sale and Use of Completely Denatured Alcohol § 20.148 Manufacture of articles with...

27 CFR 53.132 - Tax-free sale of articles to be used for, or resold for, further manufacture.

Code of Federal Regulations, 2010 CFR

2010-04-01

... to be used for, or resold for, further manufacture. 53.132 Section 53.132 Alcohol, Tobacco Products... articles to be used for, or resold for, further manufacture. (a) Further manufacture—(1) In general. Under... manufacturer, pursuant to section 4221(a)(1) of the Code, for use by the purchaser in further manufacture, or...

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

32 CFR 507.8 - Articles authorized for manufacture and sale.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

Electronic labelling in recycling of manufactured articles.

PubMed

Olejnik, Lech; Krammer, Alfred

2002-12-01

The concept of a recycling system aiming at the recovery of resources from manufactured articles is proposed. The system integrates electronic labels for product identification and internet for global data exchange. A prototype for the recycling of electric motors has been developed, which implements a condition-based recycling decision system to automatically select the environmentally and economically appropriate recycling strategy, thereby opening a potential market for second-hand motors and creating a profitable recycling process itself. The project has been designed to evaluate the feasibility of electronic identification applied on a large number of motors and to validate the system in real field conditions.

Additive Manufacturing Techniques in Prosthodontics: Where Do We Currently Stand? A Critical Review.

PubMed

Alharbi, Nawal; Wismeijer, Daniel; Osman, Reham B

The aim of this article was to critically review the current application of additive manufacturing (AM)/3D-printing techniques in prosthodontics and to highlight the influence of various technical factors involved in different AM technologies. A standard approach of searching MEDLINE, EMBASE, and Google Scholar databases was followed. The following search terms were used: (Prosth* OR Restoration) AND (Prototype OR Additive Manufacture* OR Compute* OR 3D-print* OR CAD/CAM) AND (Dentistry OR Dental). Hand searching the reference lists of the included articles and personal connections revealed additional relevant articles. Selection criteria were any article written in English and reporting on the application of AM in prosthodontics from 1990 to February 2016. From a total of 4,290 articles identified, 33 were seen as relevant. Of these, 3 were narrative reviews, 18 were in vitro studies, and 12 were clinical in vivo studies. Different AM technologies are applied in prosthodontics, directly and indirectly for the fabrication of fixed metal copings, metal frameworks for removable partial dentures, and plastic mock-ups and resin patterns for further conventional metal castings. Technical factors involved in different AM techniques influence the overall quality, the mechanical properties of the printed parts, and the total cost and manufacturing time. AM is promising and offers new possibilities in the field of prosthodontics, though its application is still limited. An understanding of these limitations and of developments in material science is crucial prior to considering AM as an acceptable method for the fabrication of dental prostheses.

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

PubMed

Goswami, Tarun; Audett, Jay

2015-01-01

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

Design of conveyor type machine with numerical control for manufacturing of extrusion thermoplastic thread

NASA Astrophysics Data System (ADS)

Gorbunova, T. N.; Koltunov, I. I.; Tumanova, M. B.

2018-05-01

The article is devoted to the development of a model and control program for a 3D printer working based on extrusion technology. The article contains descriptions of all components of the machine and blocks of the interface of the control program.

9 CFR 318.12 - Manufacture of dog food or similar uninspected article at official establishments.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Manufacture of dog food or similar... ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS General § 318.12 Manufacture of dog food or similar uninspected article at official establishments. (a) When dog food, or similar uninspected article is...

9 CFR 318.12 - Manufacture of dog food or similar uninspected article at official establishments.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Manufacture of dog food or similar... ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS General § 318.12 Manufacture of dog food or similar uninspected article at official establishments. (a) When dog food, or similar uninspected article is...

9 CFR 318.12 - Manufacture of dog food or similar uninspected article at official establishments.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Manufacture of dog food or similar... ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS General § 318.12 Manufacture of dog food or similar uninspected article at official establishments. (a) When dog food, or similar uninspected article is...

9 CFR 318.12 - Manufacture of dog food or similar uninspected article at official establishments.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Manufacture of dog food or similar... ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS General § 318.12 Manufacture of dog food or similar uninspected article at official establishments. (a) When dog food, or similar uninspected article is...

9 CFR 318.12 - Manufacture of dog food or similar uninspected article at official establishments.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Manufacture of dog food or similar... ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS General § 318.12 Manufacture of dog food or similar uninspected article at official establishments. (a) When dog food, or similar uninspected article is...

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.

Development (design and systematization) of HMS Group pump ranges

NASA Astrophysics Data System (ADS)

Tverdokhleb, I.; Yamburenko, V.

2017-08-01

The article reveals the need for pump range charts development for different applications and describes main principles used by HMS Group. Some modern approaches to pump selection are reviewed and highlighted the need for pump compliance with international standards and modern customer requirements. Even though pump design types are similar for different applications they need adjustment to specific requirements, which gets manufacturers develop their particular design for each pump range. Having wide pump ranges for different applications enables to create pump selection software, facilitating manufacturers to prepare high quality quotations in shortest time.

Partnering for Vaccine Emerging Markets—Berlin, June 10–11, 2013

PubMed Central

Onraedt, Annelies

2013-01-01

Phacilitates 1st Partnering event for Vaccine Emerging Markets brought together approximately 100 attendees from developed and developing world vaccine manufacturers, leading non-profit organizations and industry suppliers. The goal was to discuss the vaccine needs in the developing world and how these needs can be met by leveraging collaboration and partnership models, by improving access to existing, new and next generation vaccines, by using novel technologies to drive competitive advantage and economics of vaccine manufacturing and by investing in localized capacity, including capacity for pandemic vaccines. The present article summarizes insights out of 30 oral contributions on how quality and capacity requirements can be balanced with cost by using novel manufacturing technologies and operating models. PMID:23966097

A review of computer-aided design/computer-aided manufacture techniques for removable denture fabrication.

PubMed

Bilgin, Mehmet Selim; Baytaroğlu, Ebru Nur; Erdem, Ali; Dilber, Erhan

2016-01-01

The aim of this review was to investigate usage of computer-aided design/computer-aided manufacture (CAD/CAM) such as milling and rapid prototyping (RP) technologies for removable denture fabrication. An electronic search was conducted in the PubMed/MEDLINE, ScienceDirect, Google Scholar, and Web of Science databases. Databases were searched from 1987 to 2014. The search was performed using a variety of keywords including CAD/CAM, complete/partial dentures, RP, rapid manufacturing, digitally designed, milled, computerized, and machined. The identified developments (in chronological order), techniques, advantages, and disadvantages of CAD/CAM and RP for removable denture fabrication are summarized. Using a variety of keywords and aiming to find the topic, 78 publications were initially searched. For the main topic, the abstract of these 78 articles were scanned, and 52 publications were selected for reading in detail. Full-text of these articles was gained and searched in detail. Totally, 40 articles that discussed the techniques, advantages, and disadvantages of CAD/CAM and RP for removable denture fabrication and the articles were incorporated in this review. Totally, 16 of the papers summarized in the table. Following review of all relevant publications, it can be concluded that current innovations and technological developments of CAD/CAM and RP allow the digitally planning and manufacturing of removable dentures from start to finish. As a result according to the literature review CAD/CAM techniques and supportive maxillomandibular relationship transfer devices are growing fast. In the close future, fabricating removable dentures will become medical informatics instead of needing a technical staff and procedures. However the methods have several limitations for now.

A review of computer-aided design/computer-aided manufacture techniques for removable denture fabrication

PubMed Central

Bilgin, Mehmet Selim; Baytaroğlu, Ebru Nur; Erdem, Ali; Dilber, Erhan

2016-01-01

The aim of this review was to investigate usage of computer-aided design/computer-aided manufacture (CAD/CAM) such as milling and rapid prototyping (RP) technologies for removable denture fabrication. An electronic search was conducted in the PubMed/MEDLINE, ScienceDirect, Google Scholar, and Web of Science databases. Databases were searched from 1987 to 2014. The search was performed using a variety of keywords including CAD/CAM, complete/partial dentures, RP, rapid manufacturing, digitally designed, milled, computerized, and machined. The identified developments (in chronological order), techniques, advantages, and disadvantages of CAD/CAM and RP for removable denture fabrication are summarized. Using a variety of keywords and aiming to find the topic, 78 publications were initially searched. For the main topic, the abstract of these 78 articles were scanned, and 52 publications were selected for reading in detail. Full-text of these articles was gained and searched in detail. Totally, 40 articles that discussed the techniques, advantages, and disadvantages of CAD/CAM and RP for removable denture fabrication and the articles were incorporated in this review. Totally, 16 of the papers summarized in the table. Following review of all relevant publications, it can be concluded that current innovations and technological developments of CAD/CAM and RP allow the digitally planning and manufacturing of removable dentures from start to finish. As a result according to the literature review CAD/CAM techniques and supportive maxillomandibular relationship transfer devices are growing fast. In the close future, fabricating removable dentures will become medical informatics instead of needing a technical staff and procedures. However the methods have several limitations for now. PMID:27095912

Manufacture of conical springs with elastic medium technology improvement

NASA Astrophysics Data System (ADS)

Kurguzov, S. A.; Mikhailova, U. V.; Kalugina, O. B.

2018-01-01

This article considers the manufacturing technology improvement by using an elastic medium in the stamping tool forming space to improve the conical springs performance characteristics and reduce the costs of their production. Estimation technique of disk spring operational properties is developed by mathematical modeling of the compression process during the operation of a spring. A technique for optimizing the design parameters of a conical spring is developed, which ensures a minimum voltage value when operated in the edge of the spring opening.

Physicochemical interactions in solid dosage forms.

PubMed

Narang, Ajit S; Desai, Divyakant; Badawy, Sherif

2012-10-01

Complete characterization and mechanistic understanding of physicochemical interactions in solid dosage forms are not only important for consistent manufacturability, stability, and bioavailability of the drug product, but are also expected under the quality-by-design paradigm of drug development. Lack of this understanding can impact successful and timely development, scale-up, and commercial manufacture of dosage forms. This article highlights the stability and bioavailability implications of physicochemical interactions in dosage forms citing a couple of examples where such interactions necessitated the recall of commercial drug products.

Cryogenic Propellant Storage and Transfer Engineering Development Unit Hydrogen Tank

NASA Technical Reports Server (NTRS)

Werkheiser, Arthur

2015-01-01

The Cryogenic Propellant Storage and Transfer (CPST) project has been a long-running program in the Space Technology Mission Directorate to enhance the knowledge and technology related to handling cryogenic propellants, specifically liquid hydrogen. This particular effort, the CPST engineering development unit (EDU), was a proof of manufacturability effort in support of a flight article. The EDU was built to find and overcome issues related to manufacturability and collect data to anchor the thermal models for use on the flight design.

Harbin 2020 R&D Personnel Demand Forecast Based on Manufacturing Green Innovation System

NASA Astrophysics Data System (ADS)

Jiang, Xin; Duan, Yu Ting; Shen, Jun Yi; Zhang, Dong Ying

2018-06-01

Because of the constraints of energy conservation and the impact on the environment, the manufacturing industry has adopted sustainable development as the goal, and a green manufacturing innovation system based on environmental protection has emerged. In order to provide R&D personnel support to manufacturing enterprises in Harbin, and in order to promote the construction of a green innovation system for manufacturing and the realization of the 13th Five-Year Plan, this article used the grey forecasting model and the univariate linear regression prediction to predict the number of R&D personnel in Harbin in 2020 based on the number of R&D personnel in 2010-2016, and the predicted values were 24,952 and 31,172 respectively. The results show that if Harbin continues to use its original development model, it will not be able to achieve the established development goals by 2020 because of the shortage of R&D personnel. Therefore, it is necessary to increase investment in R&D personnel so as to achieve the 13th Five-Year Plan of Harbin City and protect the ecological green development goals.

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

NASA Astrophysics Data System (ADS)

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

2016-08-01

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

27 CFR 53.114 - Use in further manufacture.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2010-04-01 2010-04-01 false Use in further manufacture... further manufacture. For purposes of section 4218 and § 53.111, an article is used as material in the manufacture or production of, or as a component part of, another article, if it is incorporated in, or is a...

19 CFR Appendix B to Part 191 - Sample Formats for Applications for Specific Manufacturing Drawback Rulings

Code of Federal Regulations, 2010 CFR

2010-04-01

... (see § 191.8(a)).) LOCATION OF FACTORY (Give the address of the factory(s) where the process of... article described under the PROCESS OF MANUFACTURE OR PRODUCTION section below and each article listed... manufacture or production by giving a thorough description of the manufacturing process. This description...

Cables and fire hazards

NASA Technical Reports Server (NTRS)

Zanelli, C.; Philbrick, S.; Beretta, G.

1986-01-01

Besides describing the experiments conducted to develop a nonflammable cable, this article discusses several considerations regarding other hazards which might result from cable fires, particularly the toxicity and opacity of the fumes emitted by the burning cable. In addition, this article examines the effects of using the Oxygen Index as a gauge of quality control during manufacture.

Nanoparticles for heat transfer and thermal energy storage

DOEpatents

Singh, Dileep; Cingarapu, Sreeram; Timofeeva, Elena V.; Moravek, Michael

2015-07-14

An article of manufacture and method of preparation thereof. The article of manufacture and method of making the article includes an eutectic salt solution suspensions and a plurality of nanocrystalline phase change material particles having a coating disposed thereon and the particles capable of undergoing the phase change which provides increase in thermal energy storage. In addition, other articles of manufacture can include a nanofluid additive comprised of nanometer-sized particles consisting of copper decorated graphene particles that provide advanced thermal conductivity to heat transfer fluids.

New Product Development (NPD) Process - An Example of Industrial Sector

NASA Astrophysics Data System (ADS)

Kazimierska, Marianna; Grębosz-Krawczyk, Magdalena

2017-12-01

This aim of this article is to present the process of new product introduction on example of industrial sector in context of new product development (NPD) concept. In the article, the concept of new product development is discussed and the different stages of the process of new electric motor development are analysed taking into account its objectives, implemented procedures, functions and responsibilities division. In the article, information from secondary sources and the results of empirical research - conducted in an international manufacturing company - are used. The research results show the significance of project leader and regular cooperation with final client in the NPD process.

26 CFR 48.4221-2 - Tax-free sale of articles to be used for, or resold for, further manufacture.

Code of Federal Regulations, 2010 CFR

2010-04-01

... resold for, further manufacture. 48.4221-2 Section 48.4221-2 Internal Revenue INTERNAL REVENUE SERVICE... manufacture. (a) Further manufacture—(1) In general. Under prescribed conditions, an article subject to tax...)(1), for use by the purchaser in further manufacture, or for resale by the purchaser to a second...

Diffusion of novel healthcare technologies to resource poor settings.

PubMed

Malkin, Robert; von Oldenburg Beer, Kim

2013-09-01

A new product has completed clinical trials in a distant, resource poor hospital using a few dozen prototypes. The data looks great. The novel medical device solves a widely felt problem. The next goal is to integrate the device into the country's healthcare system and spread the device to other countries. But how? In order to be widely used, the device must be manufactured and distributed. One option is to license the intellectual property (IP) to an interested third party, if one can be found. However, it is possible to manage the manufacturing and distribution without licensing. There are at least two common means for manufacturing a novel medical device targeted to resource poor settings: (a) formal (contract) manufacturing and (b) informal (local) manufacturing. There are three primary routes to diffusion of novel medical devices in the developing world: (1) local distributors (2) direct international sales and (3) international donations. Perhaps surprisingly, the least effective mechanism is direct importation through donation. The most successful mechanism, the method used by nearly all working medical devices in resource-poor settings, is the use of contract manufacturing and a local distributor. This article is written for the biomedical innovator and entrepreneur who wishes to make a novel healthcare technology or product available and accessible to healthcare providers and patients in the developing world. There are very few documented cases and little formal research in this area. To this end, this article describes and explores the manufacturing and distribution options in order to provide insights into when and how each can be applied to scale up a novel technology to make a difference in a resource poor setting.

Additive manufacturing of optical components

NASA Astrophysics Data System (ADS)

Heinrich, Andreas; Rank, Manuel; Maillard, Philippe; Suckow, Anne; Bauckhage, Yannick; Rößler, Patrick; Lang, Johannes; Shariff, Fatin; Pekrul, Sven

2016-08-01

The development of additive manufacturing methods has enlarged rapidly in recent years. Thereby, the work mainly focuses on the realization of mechanical components, but the additive manufacturing technology offers a high potential in the field of optics as well. Owing to new design possibilities, completely new solutions are possible. This article briefly reviews and compares the most important additive manufacturing methods for polymer optics. Additionally, it points out the characteristics of additive manufactured polymer optics. Thereby, surface quality is of crucial importance. In order to improve it, appropriate post-processing steps are necessary (e.g. robot polishing or coating), which will be discussed. An essential part of this paper deals with various additive manufactured optical components and their use, especially in optical systems for shape metrology (e.g. borehole sensor, tilt sensor, freeform surface sensor, fisheye lens). The examples should demonstrate the potentials and limitations of optical components produced by additive manufacturing.

Partnering for Vaccine Emerging Markets--Berlin, June 10-11, 2013: balancing vaccine quality, capacity, and cost-of-goods in emerging markets.

PubMed

Onraedt, Annelies

2013-09-01

Phacilitates 1st Partnering event for Vaccine Emerging Markets brought together approximately 100 attendees from developed and developing world vaccine manufacturers, leading non-profit organizations and industry suppliers. The goal was to discuss the vaccine needs in the developing world and how these needs can be met by leveraging collaboration and partnership models, by improving access to existing, new and next generation vaccines, by using novel technologies to drive competitive advantage and economics of vaccine manufacturing and by investing in localized capacity, including capacity for pandemic vaccines. The present article summarizes insights out of 30 oral contributions on how quality and capacity requirements can be balanced with cost by using novel manufacturing technologies and operating models.

Method of manufacturing ceramic shaped articles

NASA Technical Reports Server (NTRS)

Inoue, K.

1983-01-01

A method of manufacturing ceramic shaped articles, wherein tapes of ceramic powder material in mixture with a binder material and special additives are shaped and then articles are stamped out from said tapes and sintered in a sintering furnace is described.

Design for life-cycle profit with simultaneous consideration of initial manufacturing and end-of-life remanufacturing

NASA Astrophysics Data System (ADS)

Kwak, Minjung; Kim, Harrison

2015-01-01

Remanufacturing is emerging as a promising solution for achieving green, profitable businesses. This article considers a manufacturer that produces new products and also remanufactured versions of the new products that become available at the end of their life cycle. For such a manufacturer, design decisions at the initial design stage determine both the current profit from manufacturing and future profit from remanufacturing. To maximize the total profit, design decisions must carefully consider both ends of product life cycle, i.e. manufacturing and end-of-life stages. This article proposes a decision-support model for the life-cycle design using mixed-integer nonlinear programming. With an aim to maximize the total life-cycle profit, the proposed model searches for an (at least locally) optimal product design (i.e. design specifications and the selling price) for the new and remanufactured products. It optimizes both the initial design and design upgrades at the end-of-life stage and also provides corresponding production strategies, including production quantities and take-back rate. The model is extended to a multi-objective model that maximizes both economic profit and environmental-impact saving. To illustrate, the developed model is demonstrated with an example of a desktop computer.

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.

Intellectual property rights and challenges for development of affordable human papillomavirus, rotavirus and pneumococcal vaccines: Patent landscaping and perspectives of developing country vaccine manufacturers.

PubMed

Chandrasekharan, Subhashini; Amin, Tahir; Kim, Joyce; Furrer, Eliane; Matterson, Anna-Carin; Schwalbe, Nina; Nguyen, Aurélia

2015-11-17

The success of Gavi, the Vaccine Alliance depends on the vaccine markets providing appropriate, affordable vaccines at sufficient and reliable quantities. Gavi's current supplier base for new and underutilized vaccines, such as the human papillomavirus (HPV), rotavirus, and the pneumococcal conjugate vaccine is very small. There is growing concern that following globalization of laws on intellectual property rights (IPRs) through trade agreements, IPRs are impeding new manufacturers from entering the market with competing vaccines. This article examines the extent to which IPRs, specifically patents, can create such obstacles, in particular for developing country vaccine manufacturers (DCVMs). Through building patent landscapes in Brazil, China, and India and interviews with manufacturers and experts in the field, we found intense patenting activity for the HPV and pneumococcal vaccines that could potentially delay the entry of new manufacturers. Increased transparency around patenting of vaccine technologies, stricter patentability criteria suited for local development needs and strengthening of IPRs management capabilities where relevant, may help reduce impediments to market entry for new manufacturers and ensure a competitive supplier base for quality vaccines at sustainably low prices. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Development of an arthroscopically compatible polymer additive layer manufacture technique.

PubMed

Partridge, Simon W; Benning, Matthew J; German, Matthew J; Dalgarno, Kenneth W

2017-06-01

This article describes a proof of concept study designed to evaluate the potential of an in vivo three-dimensional printing route to support minimally invasive repair of the musculoskeletal system. The study uses a photocurable material to additively manufacture in situ a model implant and demonstrates that this can be achieved effectively within a clinically relevant timescale. The approach has the potential to be applied with a wide range of light-curable materials and with development could be applied to create functionally gradient structures in vivo.

19 CFR 10.253 - Articles eligible for preferential treatment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... the production or manufacture of a new or different article which is imported directly into the United... incurred in the growth, production, or manufacture of the material, including general expenses; (2) An... merchandise: (A) All actual labor costs involved in the growth, production, manufacture, or assembly of the...

49 CFR 661.11 - Rolling stock procurements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... article, material, or supply, whether manufactured or unmanufactured, that is directly incorporated into... into a new and functionally different article. (f) Except as provided in paragraph (k) of this section, a subcomponent is any article, material, or supply, whether manufactured or unmanufactured, that is...

49 CFR 661.11 - Rolling stock procurements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... article, material, or supply, whether manufactured or unmanufactured, that is directly incorporated into... into a new and functionally different article. (f) Except as provided in paragraph (k) of this section, a subcomponent is any article, material, or supply, whether manufactured or unmanufactured, that is...

Health economics and outcomes research within drug development: challenges and opportunities for reimbursement and market access within biopharma research.

PubMed

van Nooten, Floortje; Holmstrom, Stefan; Green, Julia; Wiklund, Ingela; Odeyemi, Isaac A O; Wilcox, Teresa K

2012-06-01

Healthcare decision makers who determine funding for new medical technologies depend on manufacturers to provide evidence of the technology's efficacy, safety and cost-effectiveness. Constrained budgets and increasing reliance on formal health technology assessment (HTA) have created an abundance of external hurdles that manufacturers must navigate to ensure successful product commercialization. These demands have pushed pharmaceutical companies to adjust their internal structures to coordinate generation of appropriate evidence. In this article we summarize internal and external opportunities for manufacturers to establish a foundation of evidence for successful market access, starting in Phase I of development and continuing throughout the post-approval product lifecycle. Copyright © 2012 Elsevier Ltd. All rights reserved.

Virtual aluminum castings: An industrial application of ICME

NASA Astrophysics Data System (ADS)

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

2006-11-01

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

Supply chain model with price- and trade credit-sensitive demand under two-level permissible delay in payments

NASA Astrophysics Data System (ADS)

Giri, B. C.; Maiti, T.

2013-05-01

This article develops a single-manufacturer and single-retailer supply chain model under two-level permissible delay in payments when the manufacturer follows a lot-for-lot policy in response to the retailer's demand. The manufacturer offers a trade credit period to the retailer with the contract that the retailer must share a fraction of the profit earned during the trade credit period. On the other hand, the retailer provides his customer a partial trade credit which is less than that of the manufacturer. The demand at the retailer is assumed to be dependent on the selling price and the trade credit period offered to the customers. The average net profit of the supply chain is derived and an algorithm for finding the optimal solution is developed. Numerical examples are given to demonstrate the coordination policy of the supply chain and examine the sensitivity of key model-parameters.

Feasibility Study on 3-D Printing of Metallic Structural Materials with Robotized Laser-Based Metal Additive Manufacturing

NASA Astrophysics Data System (ADS)

Ding, Yaoyu; Kovacevic, Radovan

2016-07-01

Metallic structural materials continue to open new avenues in achieving exotic mechanical properties that are naturally unavailable. They hold great potential in developing novel products in diverse industries such as the automotive, aerospace, biomedical, oil and gas, and defense. Currently, the use of metallic structural materials in industry is still limited because of difficulties in their manufacturing. This article studied the feasibility of printing metallic structural materials with robotized laser-based metal additive manufacturing (RLMAM). In this study, two metallic structural materials characterized by an enlarged positive Poisson's ratio and a negative Poisson's ratio were designed and simulated, respectively. An RLMAM system developed at the Research Center for Advanced Manufacturing of Southern Methodist University was used to print them. The results of the tensile tests indicated that the printed samples successfully achieved the corresponding mechanical properties.

Common clay and shale

USGS Publications Warehouse

Virta, R.L.

2011-01-01

The article discusses the latest developments in the global common clay and shale industry, particularly in the U.S. It claims that common clay and shale is mainly used in the manufacture of heavy clay products like brick, flue tile and sewer pipe. The main producing states in the U.S. include North Carolina, New York and Oklahoma. Among the firms that manufacture clay and shale-based products are Mid America Brick & Structural Clay Products LLC and Boral USA.

29 CFR 570.51 - Occupations in or about plants or establishments manufacturing or storing explosives or articles...

Code of Federal Regulations, 2012 CFR

2012-07-01

... 29 Labor 3 2012-07-01 2012-07-01 false Occupations in or about plants or establishments... § 570.51 Occupations in or about plants or establishments manufacturing or storing explosives or... occupations in or about plants or establishments manufacturing or storing explosives or articles containing...

29 CFR 570.51 - Occupations in or about plants or establishments manufacturing or storing explosives or articles...

Code of Federal Regulations, 2013 CFR

2013-07-01

... 29 Labor 3 2013-07-01 2013-07-01 false Occupations in or about plants or establishments... § 570.51 Occupations in or about plants or establishments manufacturing or storing explosives or... occupations in or about plants or establishments manufacturing or storing explosives or articles containing...

29 CFR 570.51 - Occupations in or about plants or establishments manufacturing or storing explosives or articles...

Code of Federal Regulations, 2014 CFR

2014-07-01

... 29 Labor 3 2014-07-01 2014-07-01 false Occupations in or about plants or establishments... § 570.51 Occupations in or about plants or establishments manufacturing or storing explosives or... occupations in or about plants or establishments manufacturing or storing explosives or articles containing...

29 CFR 570.51 - Occupations in or about plants or establishments manufacturing or storing explosives or articles...

Code of Federal Regulations, 2011 CFR

2011-07-01

... 29 Labor 3 2011-07-01 2011-07-01 false Occupations in or about plants or establishments... § 570.51 Occupations in or about plants or establishments manufacturing or storing explosives or... occupations in or about plants or establishments manufacturing or storing explosives or articles containing...

Developing a World-Class Workforce: Transformation, Not Iteration

ERIC Educational Resources Information Center

Mosier, Jerrilee K.; Richey, Michael C.; McPherson, Kenneth B.; Eckhol, John O.; Cox, Frank Z.

2006-01-01

This article features a "Triad" partnership of a group of Snohomish County organizations representing education, government and industry. Recognizing the need for a training and workforce development effort to address the aerospace manufacturing employers' needs, Triad views themselves as the pivotal cornerstone for deployment of complex…

Philadelphia Printing and Publishing, 1876-1976

ERIC Educational Resources Information Center

Whitehead, Thomas M.

1976-01-01

Two Philadelphia printing histories, both reflecting the relationship of printing to publishing, are examined in this article: the manufacture by the publisher of his own product and the development and commercialization of the photomechanical halftone process. (Author)

Continuous filament composite parts and articles of manufacture thereof

DOEpatents

Weisberg, Andrew H.

2016-06-28

An article of manufacture according to one embodiment includes a plurality of plies in a stacked configuration, where each ply includes a plurality of tape winds having edges. A distance between the edges of adjacent tape winds in the same ply is about constant along a length of the wind. Each tape wind comprises elongated fibers and a matrix, axes of the fibers being oriented about parallel to a longitudinal axis of the tape wind. Additional systems, methods and articles of manufacture are also presented.

Build platform that provides mechanical engagement with additive manufacturing prints

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

Elliott, Amelia M.

A build platform and methods of fabricating an article with such a platform in an extrusion-type additive manufacturing machine are provided. A platform body 202 includes features 204 that extend outward from the body 202. The features 204 define protrusive areas 206 and recessive areas 208 that cooperate to mechanically engage the extruded material that forms the initial layers 220 of an article when the article is being fabricated by a nozzle 12 of the additive manufacturing machine 10.

Design and manufacture of monoclonal antibodies for radioimmunotherapy.

PubMed

Hale, G; Berrie, E; Bird, P

2004-12-01

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

Lot sizing and unequal-sized shipment policy for an integrated production-inventory system

NASA Astrophysics Data System (ADS)

Giri, B. C.; Sharma, S.

2014-05-01

This article develops a single-manufacturer single-retailer production-inventory model in which the manufacturer delivers the retailer's ordered quantity in unequal shipments. The manufacturer's production process is imperfect and it may produce some defective items during a production run. The retailer performs a screening process immediately after receiving the order from the manufacturer. The expected average total cost of the integrated production-inventory system is derived using renewal theory and a solution procedure is suggested to determine the optimal production and shipment policy. An extensive numerical study based on different sets of parameter values is conducted and the optimal results so obtained are analysed to examine the relative performance of the models under equal and unequal shipment policies.

Development of novel IVD assays: a manufacturer's perspective.

PubMed

Metcalfe, Thomas A

2010-01-01

IVD manufacturers are heavily reliant on novel IVD assays to fuel their growth and drive innovation within the industry. They represent a key part of the IVD industry's value proposition to customers and the healthcare industry in general, driving product differentiation, helping to create demand for new systems and generating incremental revenue. However, the discovery of novel biomarkers and their qualification for a specific clinical purpose is a high risk undertaking and the large, risky investments associated with doing this on a large scale are incompatible with IVD manufacturer's business models. This article describes the sources of novel IVD assays, the processes for discovering and qualifying novel assays and the reliance of IVD manufacturers on collaborations and in-licensing to source new IVD assays for their platforms.

75 FR 72827 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-26

... Manufacturing Practice Regulations for Type A Medicated Articles AGENCY: Food and Drug Administration, HHS... on the recordkeeping requirements for manufacturers of type A medicated articles. DATES: Submit... Type A Medicated Articles--21 CFR Part 226 (OMB Control Number 0910-0154)--Extension Under section 501...

Innovations in vaccine development: can regulatory authorities keep up?

PubMed

Cox, Manon M J; Onraedt, Annelies

2012-10-01

Vaccine Production Summit San Francisco, CA, USA, 4-6 June 2012 IBC's 3rd Vaccine Production Summit featured 28 presentations discussing regulatory challenges in vaccine development, including the use of adjuvants, vaccine manufacturing and technology transfer, process development for vaccines and the role of quality by design, how to address vaccine stability, and how vaccine development timelines can be improved. The conference was run in parallel with the single-use applications for Biopharmaceutical Manufacturing conference. Approximately 250 attendees from large pharmaceutical companies, large and small biotech companies, vendors and a more limited number from academia were allowed to access sessions of either conference, including one shared session. This article summarizes the recurring themes across various presentations.

Article and process for producing an article

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

Lacy, Benjamin Paul; Jacala, Ariel Caesar Prepena; Kottilingam, Srikanth Chandrudu

An article and a process of producing an article are provided. The article includes a base material, a cooling feature arrangement positioned on the base material, the cooling feature arrangement including an additive-structured material, and a cover material. The cooling feature arrangement is between the base material and the cover material. The process of producing the article includes manufacturing a cooling feature arrangement by an additive manufacturing technique, and then positioning the cooling feature arrangement between a base material and a cover material.

The making of helicopters: its strategic implications for EMS helicopter operations.

PubMed

Thomas, F

1998-01-01

The purpose of this article is to provide EMS helicopter personnel with an understanding of the civil helicopter manufacturing industry. Specifically, this article examines the current helicopter marketplace and how various manufactures are responding to the recent decline in new helicopter sales. This article further describes how helicopters are designed and manufactured and how global markets, international competition, and strategic considerations are influencing future helicopter design and production. Data for this paper were obtained from a literature search through the ABI-inform Telnet Services offered through the University of Utah Marriott Library. On a search of "helicopter" during the past 5 years, 566 abstracts were identified, all of which were reviewed for information related to the purpose of this article. Forty-seven articles were identified and read in detail for information that may have related to the purpose of this article. In addition, a library search to identify textbooks that describe helicopter production systems was undertaken but did not identify any written resources. Because of the lack of written resources available in writing this article, a direct interview survey of leading helicopter manufactures, associations, and industry writers was conducted. Only information that was considered "public knowledge" was available because of concerns by the various manufactures that publication of confidential information could be detrimental to their competitive advantage. Because helicopter-manufacturing plants were not located within easy travel range, no direct observation of the production facilities could be undertaken. Furthermore, information regarding production and operational management was not easily accessible because the data were not published or were considered confidential. Therefore industry analysis had to take place through direct survey interviewing technique and data obtained through an analysis of the available published data.

Review of research and developments in self healing composite materials

NASA Astrophysics Data System (ADS)

Reddy Madara, Sahith; Sarath Raj, N. S.; Pon Selvan, Chithirai, Dr.

2018-04-01

Self-healing materials are artificial or synthetically created substances that have the built-in ability to automatically repair damage to themselves without any external diagnosis of the problem or human intervention. This article presents the current research and developments in self-healing composite materials. A detailed study is conducted on various types of self-healing composites with their self-healing mechanisms. The applications of self-healing materials in various fields including space sector is also discussed. Economics and Future outlooks for self-healing smart materials is highlighted at the end of the article. This research article will be useful to manufacturers, policy makers and researchers widely.

Make-to-order manufacturing - new approach to management of manufacturing processes

NASA Astrophysics Data System (ADS)

Saniuk, A.; Waszkowski, R.

2016-08-01

Strategic management must now be closely linked to the management at the operational level, because only in such a situation the company can be flexible and can quickly respond to emerging opportunities and pursue ever-changing strategic objectives. In these conditions industrial enterprises seek constantly new methods, tools and solutions which help to achieve competitive advantage. They are beginning to pay more attention to cost management, economic effectiveness and performance of business processes. In the article characteristics of make-to-order systems (MTO) and needs associated with managing such systems is identified based on the literature analysis. The main aim of this article is to present the results of research related to the development of a new solution dedicated to small and medium enterprises manufacture products solely on the basis of production orders (make-to- order systems). A set of indicators to enable continuous monitoring and control of key strategic areas this type of company is proposed. A presented solution includes the main assumptions of the following concepts: the Performance Management (PM), the Balanced Scorecard (BSC) and a combination of strategic management with the implementation of operational management. The main benefits of proposed solution are to increase effectiveness of MTO manufacturing company management.

Modeling Sustainability in Product Development and Commercialization

ERIC Educational Resources Information Center

Carlson, Robert C.; Rafinejad, Dariush

2008-01-01

In this article, the authors present the framework of a model that integrates strategic product development decisions with the product's impact on future conditions of resources and the environment. The impact of a product on stocks of nonrenewable sources and sinks is linked in a feedback loop to the cost of manufacturing and using the product…

Centrifugal dryers keep pace with the market

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

Fiscor, S.

2008-03-15

New plant design and upgrades create a shift in dewatering strategies. The article describes recent developments. Three major manufacturers supply centrifugal dryers - TEMA, Centrifugal & Mechanical Industries (CMI) and Ludowici. CMI introduced a line of vertical centrifugal dryers. TEMA improved the techniques by developing a horizontal vibratory centrifuge (HVC) which simplified maintenance. 3 figs., 1 photo.

Development and manufacture of visor for helmet-mounted display

NASA Astrophysics Data System (ADS)

Krevor, David H.; McNelly, Gregg; Skubon, John; Speirs, Robert

2004-01-01

The manufacturing design and process development for the Visor for the JHMCS (Joint Helmet Mounted Cueing System) are discussed. The JHMCS system is a Helmet Mounted Display (HMD) system currently flying on the F-15, F-16 and F/A-18 aircraft. The Visor manufacturing processes are essential to both system performance and economy. The Visor functions both as the system optical combiner and personal protective equipment for the pilot. The Visor material is optical polycarbonate. For a military HMD system, the mechanical and environmental properties of the Visor are as necessary as the optical properties. The visor must meet stringent dimensional requirements to assure adequate system optical performance. Injection molding can provide dimensional fidelity to the requirements, if done properly. Concurrent design of the visor and the tool (i.e., the injection mold) is essential. The concurrent design necessarily considers manufacturing operations and the use environment of the Visor. Computer modeling of the molding process is a necessary input to the mold design. With proper attention to product design and tool development, it is possible to improve upon published standard dimensional tolerances for molded polycarbonate articles.

Roadmap for Lean implementation in Indian automotive component manufacturing industry: comparative study of UNIDO Model and ISM Model

NASA Astrophysics Data System (ADS)

Jadhav, J. R.; Mantha, S. S.; Rane, S. B.

2015-06-01

The demands for automobiles increased drastically in last two and half decades in India. Many global automobile manufacturers and Tier-1 suppliers have already set up research, development and manufacturing facilities in India. The Indian automotive component industry started implementing Lean practices to fulfill the demand of these customers. United Nations Industrial Development Organization (UNIDO) has taken proactive approach in association with Automotive Component Manufacturers Association of India (ACMA) and the Government of India to assist Indian SMEs in various clusters since 1999 to make them globally competitive. The primary objectives of this research are to study the UNIDO-ACMA Model as well as ISM Model of Lean implementation and validate the ISM Model by comparing with UNIDO-ACMA Model. It also aims at presenting a roadmap for Lean implementation in Indian automotive component industry. This paper is based on secondary data which include the research articles, web articles, doctoral thesis, survey reports and books on automotive industry in the field of Lean, JIT and ISM. ISM Model for Lean practice bundles was developed by authors in consultation with Lean practitioners. The UNIDO-ACMA Model has six stages whereas ISM Model has eight phases for Lean implementation. The ISM-based Lean implementation model is validated through high degree of similarity with UNIDO-ACMA Model. The major contribution of this paper is the proposed ISM Model for sustainable Lean implementation. The ISM-based Lean implementation framework presents greater insight of implementation process at more microlevel as compared to UNIDO-ACMA Model.

A case study on topology optimized design for additive manufacturing

NASA Astrophysics Data System (ADS)

Gebisa, A. W.; Lemu, H. G.

2017-12-01

Topology optimization is an optimization method that employs mathematical tools to optimize material distribution in a part to be designed. Earlier developments of topology optimization considered conventional manufacturing techniques that have limitations in producing complex geometries. This has hindered the topology optimization efforts not to fully be realized. With the emergence of additive manufacturing (AM) technologies, the technology that builds a part layer upon a layer directly from three dimensional (3D) model data of the part, however, producing complex shape geometry is no longer an issue. Realization of topology optimization through AM provides full design freedom for the design engineers. The article focuses on topologically optimized design approach for additive manufacturing with a case study on lightweight design of jet engine bracket. The study result shows that topology optimization is a powerful design technique to reduce the weight of a product while maintaining the design requirements if additive manufacturing is considered.

Advances in solid dosage form manufacturing technology.

PubMed

Andrews, Gavin P

2007-12-15

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

UV-CURED FINISHING WORKS FOR LANE

EPA Science Inventory

The Midwest Research Institute, under a cooperative agreement with the U.S. EPA, conducted a study to identify wood furniture manufacturing facilities that had converted to low-VOC/HAP wood furniture coatings and to develop case studies for those facilities. This article addresse...

Implementing high-temperature short-time media treatment in commercial-scale cell culture manufacturing processes.

PubMed

Pohlscheidt, Michael; Charaniya, Salim; Kulenovic, Fikret; Corrales, Mahalia; Shiratori, Masaru; Bourret, Justin; Meier, Steven; Fallon, Eric; Kiss, Robert

2014-04-01

The production of therapeutic proteins by mammalian cell culture is complex and sets high requirements for process, facility, and equipment design, as well as rigorous regulatory and quality standards. One particular point of concern and significant risk to supply chain is the susceptibility to contamination such as bacteria, fungi, mycoplasma, and viruses. Several technologies have been developed to create barriers for these agents to enter the process, e.g. filtration, UV inactivation, and temperature inactivation. However, if not implemented during development of the manufacturing process, these types of process changes can have significant impact on process performance if not managed appropriately. This article describes the implementation of the high-temperature short-time (HTST) treatment of cell culture media as an additional safety barrier against adventitious agents during the transfer of a large-scale commercial cell culture manufacturing process. The necessary steps and experiments, as well as subsequent results during qualification runs and routine manufacturing, are shown.

Basics of Compounding: 3D Printing--Pharmacy Applications, Part 2.

PubMed

Allen, Loyd V

2017-01-01

3D printing is a standard tool in the automotive, aerospace, and consumer goods in industry and is gaining traction in pharmaceutical manufacturing, which has introduced a new element into dosage-form development. This article, which represents part 2 of a 3-part article on the topic of 3D printing, discusses the different technologies available for 3D printing. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

26 CFR 48.6416(b)(3)-2 - Further manufacture included.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 16 2010-04-01 2010-04-01 true Further manufacture included. 48.6416(b)(3)-2... of Special Application to Retailers and Manufacturers Taxes § 48.6416(b)(3)-2 Further manufacture... overpayment by reason of any use in further manufacture, or sale as part of a second manufactured article...

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

NASA Astrophysics Data System (ADS)

Demeri, Mahmoud Y.

2001-02-01

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

Computed Tomography Inspection and Analysis for Additive Manufacturing Components

NASA Technical Reports Server (NTRS)

Beshears, Ronald D.

2017-01-01

Computed tomography (CT) inspection was performed on test articles additively manufactured from metallic materials. Metallic AM and machined wrought alloy test articles with programmed flaws and geometric features were inspected using a 2-megavolt linear accelerator based CT system. Performance of CT inspection on identically configured wrought and AM components and programmed flaws was assessed to determine the impact of additive manufacturing on inspectability of objects with complex geometries.

The development of small-scale mechanization means positioning algorithm using radio frequency identification technology in industrial plants

NASA Astrophysics Data System (ADS)

Astafiev, A.; Orlov, A.; Privezencev, D.

2018-01-01

The article is devoted to the development of technology and software for the construction of positioning and control systems for small mechanization in industrial plants based on radio frequency identification methods, which will be the basis for creating highly efficient intelligent systems for controlling the product movement in industrial enterprises. The main standards that are applied in the field of product movement control automation and radio frequency identification are considered. The article reviews modern publications and automation systems for the control of product movement developed by domestic and foreign manufacturers. It describes the developed algorithm for positioning of small-scale mechanization means in an industrial enterprise. Experimental studies in laboratory and production conditions have been conducted and described in the article.

27 CFR 53.181 - Further manufacture included.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2010-04-01 2010-04-01 false Further manufacture... Further manufacture included. (a) In general. The payment of tax imposed by chapter 32 of the Code on the... of any use in further manufacture, or sale as part of a second manufactured article, described in...

Pricing and ordering policies for price-dependent demand in a supply chain of a single retailer and a single manufacturer

NASA Astrophysics Data System (ADS)

Kim, Jungkyu; Hong, Yushin; Kim, Taebok

2011-01-01

This article discusses joint pricing and ordering policies for price-dependent demand in a supply chain consisting of a single retailer and a single manufacturer. The retailer places orders for products according to an EOQ policy and the manufacturer produces them on a lot-for-lot basis. Four mechanisms with differing levels of coordination are presented. Mathematical models are formulated and solution procedures are developed to determine the optimal retail prices and order quantities. Through extensive numerical experiments, we analyse and compare the behaviours and characteristics of the proposed mechanisms, and find that enhancing the level of coordination has important benefits for the supply chain.

Computed Tomography Inspection and Analysis for Additive Manufacturing Components

NASA Technical Reports Server (NTRS)

Beshears, Ronald D.

2016-01-01

Computed tomography (CT) inspection was performed on test articles additively manufactured from metallic materials. Metallic AM and machined wrought alloy test articles with programmed flaws were inspected using a 2MeV linear accelerator based CT system. Performance of CT inspection on identically configured wrought and AM components and programmed flaws was assessed using standard image analysis techniques to determine the impact of additive manufacturing on inspectability of objects with complex geometries.

Readability of Patient Education Materials From the Web Sites of Orthopedic Implant Manufacturers.

PubMed

Yi, Meghan M; Yi, Paul H; Hussein, Khalil I; Cross, Michael B; Della Valle, Craig J

2017-12-01

Prior studies indicate that orthopedic patient education materials are written at a level that is too high for the average patient. The purpose of this study was to assess the readability of online patient education materials provided by orthopedic implant manufacturers. All patient education articles available in 2013 from the web sites of the 5 largest orthopedic implant manufacturers were identified. Each article was evaluated with the Flesch-Kincaid (FK) readability test. The number of articles with readability ≤ the eighth-grade level (average reading ability of US adults) and the sixth-grade level (recommended level for patient education materials) was determined. Mean readability levels of each company's articles were compared using analysis of variance (significance set at P < .05). A total of 581 articles were reviewed from the 5 largest implant manufacturers. The mean overall FK grade level was 10.9 (range, 3.8-16.1). Only 58 articles (10%) were written ≤ the eighth-grade level, and only 13 (2.2%) were ≤ the sixth-grade level. The mean FK grade level was significantly different among groups (Smith & Nephew = 12.0, Stryker = 11.6, Biomet = 11.3, DePuy = 10.6, Zimmer = 10.1; P < .0001). The majority of patient education materials from implant manufacturers are written at a level too high to be comprehended by the average patient. Future efforts should be made to improve the readability of orthopedic patient education materials. Copyright © 2017 Elsevier Inc. All rights reserved.

19 CFR 10.84 - Automotive vehicles and articles for use as original equipment in the manufacture of automotive...

Code of Federal Regulations, 2011 CFR

2011-04-01

... 19 Customs Duties 1 2011-04-01 2011-04-01 false Automotive vehicles and articles for use as original equipment in the manufacture of automotive vehicles. 10.84 Section 10.84 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY ARTICLES CONDITIONALLY FREE, SUBJECT TO A REDUCED RATE, ETC....

19 CFR 10.84 - Automotive vehicles and articles for use as original equipment in the manufacture of automotive...

Code of Federal Regulations, 2012 CFR

2012-04-01

... 19 Customs Duties 1 2012-04-01 2012-04-01 false Automotive vehicles and articles for use as original equipment in the manufacture of automotive vehicles. 10.84 Section 10.84 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY ARTICLES CONDITIONALLY FREE, SUBJECT TO A REDUCED RATE, ETC....

19 CFR 10.84 - Automotive vehicles and articles for use as original equipment in the manufacture of automotive...

Code of Federal Regulations, 2013 CFR

2013-04-01

... 19 Customs Duties 1 2013-04-01 2013-04-01 false Automotive vehicles and articles for use as original equipment in the manufacture of automotive vehicles. 10.84 Section 10.84 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY ARTICLES CONDITIONALLY FREE, SUBJECT TO A REDUCED RATE, ETC....

19 CFR 10.84 - Automotive vehicles and articles for use as original equipment in the manufacture of automotive...

Code of Federal Regulations, 2014 CFR

2014-04-01

... 19 Customs Duties 1 2014-04-01 2014-04-01 false Automotive vehicles and articles for use as original equipment in the manufacture of automotive vehicles. 10.84 Section 10.84 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY ARTICLES CONDITIONALLY FREE, SUBJECT TO A REDUCED RATE, ETC....

East Europe Report.

DTIC Science & Technology

1987-02-09

role of the council you chair in supporting and bolstering the development of small manufacturing? [Answer]: I would not exaggerate my assessment of...postwar period of the development of our economy there has been an unsatisfied demand for food articles. This was especially evident in the second half...results. Comprehensive measures, aimed primarily at restoring full confidence in farm policy and establishing long-range goals in the development of

Lock Up Those Lines: Protecting against Phone Fraud.

ERIC Educational Resources Information Center

Schleyer, Peggy E.; Hibner, Dale V.

1996-01-01

School business officials must be aware of potential liabilities associated with Centrex and Private Branch Exchange (PBX). This article describes these systems, presents guidelines for developing a telecommunications management plan, and discusses options to limit toll fraud exposure. PBX owners should implement manufacturers' recommended…

Education Policy Analysis Archives, 1996.

ERIC Educational Resources Information Center

Glass, Gene V., Ed.

1997-01-01

This document consists of the 19 articles published in the Electronic Journal "Education Policy Analysis Archives" for the year 1996: (1) "The Achievement Crisis Is Real: A Review of 'The Manufactured Crisis'" (Lawrence C. Stedman); (2) "Staff Development Policy: Fuzzy Choices in an Imperfect Market" (Robert T.…

Training Innovations for Economic Development

ERIC Educational Resources Information Center

Breeden, Kenneth H.

2002-01-01

This article talks about Certified Manufacturing Specialist (CMS), a Georgia training program that has successfully addressed the needs of both students and partners in business and industry. The program helped business reduce the learning curve for new employees; improved productivity, quality, and safety; reduced material waste; eased the…

Crossword Puzzle Makes It Fun: Introduce Green Manufacturing in Wood Technology Courses

ERIC Educational Resources Information Center

Iley, John L.; Hague, Doug

2012-01-01

Sustainable, or "green," manufacturing and its practices are becoming more and more a part of today's industry, including wood product manufacturing. This article provides introductory information on green manufacturing in wood technology and a crossword puzzle based on green manufacturing terms. The authors use the puzzle at the college level to…

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

NASA Astrophysics Data System (ADS)

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

2016-08-01

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

BN Bonded BN fiber article and method of manufacture

DOEpatents

Hamilton, Robert S.

1981-08-18

A boron nitride bonded boron nitride fiber article and the method for its manufacture which comprises forming a shaped article with a composition comprising a bonding compound selected from boron oxide and boric acid and a structural fiber selected from the group consisting of boron oxide, boron nitride and partially nitrided boron oxide fibers, heating the composition in an anhydrous gas to a temperature above the melting point of the compound and nitriding the resulting article in ammonia gas.

A Roundtable Discussion: Combination Products: Twice the Challenge?

PubMed

Baird, Nolan; Binion, Steven B; Cammack, Jon; Paine, Stephanie Del; Gonzales, Rosemary; Passut, Jena; Weiner, John Barlow Barr

2015-01-01

Combination products are therapeutic or diagnostic medical products that combine drugs, devices, and/or biological products with one another. FDA developed a regulation (final rule) on Current Good Manufacturing Practices (CGMP) for combination products that became effective July 22, 2013 (21 CFR Part 4). AAMI recently developed a technical information report (TIR) that provides information on how to effectively implement FDA's regulation. The overall goal of the TIR is to aid informed, risk-based decisions in establishing CGMP operating systems that support development, manufacture, premarket regulatory evaluation, and ultimately commercialization of combination products. This article, a result of an discussion with industry and FDA representatives, explores the landscape of combination products, highlights important considerations in developing and seeking marketing clearance for these innovative products, and provides insight on trends in the area.

State of the art review on design and manufacture of hybrid biomedical materials: Hip and knee prostheses.

PubMed

Bahraminasab, Marjan; Farahmand, Farzam

2017-09-01

The trend in biomaterials development has now headed for tailoring the properties and making hybrid materials to achieve the optimal performance metrics in a product. Modern manufacturing processes along with advanced computational techniques enable systematical fabrication of new biomaterials by design strategy. Functionally graded materials as a recent group of hybrid materials have found numerous applications in biomedical area, particularly for making orthopedic prostheses. This article, therefore, seeks to address the following research questions: (RQ1) What is the desired structure of orthopedic hybrid materials? (RQ2) What is the contribution of the literature in the development of hybrid materials in the field of orthopedic research? (RQ3) Which type of manufacturing approaches is prevalently used to build these materials for knee and hip implants? (RQ4) Is there any inadequacy in the methods applied?

Scientific, statistical, practical, and regulatory considerations in design space development.

PubMed

Debevec, Veronika; Srčič, Stanko; Horvat, Matej

2018-03-01

The quality by design (QbD) paradigm guides the pharmaceutical industry towards improved understanding of products and processes, and at the same time facilitates a high degree of manufacturing and regulatory flexibility throughout the establishment of the design space. This review article presents scientific, statistical and regulatory considerations in design space development. All key development milestones, starting with planning, selection of factors, experimental execution, data analysis, model development and assessment, verification, and validation, and ending with design space submission, are presented and discussed. The focus is especially on frequently ignored topics, like management of factors and CQAs that will not be included in experimental design, evaluation of risk of failure on design space edges, or modeling scale-up strategy. Moreover, development of a design space that is independent of manufacturing scale is proposed as the preferred approach.

14 CFR 21.621 - Transferability and duration.

Code of Federal Regulations, 2010 CFR

2010-01-01

... FAA design and production approval issued to the manufacturer of an article that has been found to... authorization, or letter of TSO design approval may continue to manufacture articles that meet the original TSO... Transferability and duration. A TSO authorization or letter of TSO design approval issued under this part is not...

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

Code of Federal Regulations, 2010 CFR

2010-10-01

... (Quality Management Systems—Requirements). A documented description of the inspection system shall be made... inspections or tests of materials and components before incorporation into end articles and for inspection of such end articles before shipment. When the manufacturing plant is located outside of the United States...

Work Measurements: Interdisciplinary Overlap in Manufacturing and Algebra I

ERIC Educational Resources Information Center

Rose, Mary Annette

2007-01-01

Manufacturing engineering provides a relevant context from which to envision interdisciplinary learning experiences because engineers integrate their knowledge and skills of manufacturing and algebra processes in order to plan the efficient manufacture of products. In this article, the author describes an interdisciplinary learning activity that…

Training for the Future? A Case Study of Emerging Education, Training and Development Practitioners in the South African Clothing Manufacturing Industry

ERIC Educational Resources Information Center

Jones, Barbara; Cooper, Linda; McMillan, Janice

2006-01-01

This article investigates how training instructors in the South African clothing industry were prepared for their roles as Education, Training and Development Practitioners (ETDPs) by a university adult education programme. The key focus is on how these emerging ETDPs experienced their changing roles, identities and approaches to teaching and the…

Development of an ear cap in chronic suppurative otitis media using additive manufacturing and TRIZ.

PubMed

Mawale, Mahesh B; Kuthe, Abhaykumar; Mawale, Anupama M; Dahake, Sandeep W

2018-06-01

The prevalence rate of chronic suppurative otitis media is high and its treatment continues to be a challenge for the otorhinolaryngologists. Due to middle ear infection, there may be pain, hearing loss and spontaneous rupture of the eardrum which results in perforation. Infections can cause a hole in the eardrum as a side effect of otitis media. The patients suffering from ear perforation or having a hole in eardrum require preventing entry of water in the ear. This article describes the development of ear cap using additive manufacturing and TRIZ (a collaborative tool) to prevent the entry of water in the ear during chronic otitis media.

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

PubMed

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

2016-08-01

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

21 CFR 226.1 - Current good manufacturing practice.

Code of Federal Regulations, 2010 CFR

2010-04-01

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

27 CFR 19.374 - Manufacture of nonbeverage products, intermediate products, or eligible flavors.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Manufacture of nonbeverage... PLANTS Processing Operations Other Than Denaturation and Manufacture of Articles Receipt and Use of Spirits, Wines and Alcoholic Flavoring Materials § 19.374 Manufacture of nonbeverage products...

76 FR 20800 - Bureau of Political-Military Affairs: Directorate of Defense Trade Controls; Notifications to the...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-13

..., certification of a proposed manufacturing license agreement for the manufacture of significant military..., certification of a proposed manufacturing license agreement for the manufacture of significant military... transfer of defense articles, to include technical data, and defense services to support the design...

76 FR 30751 - Bureau of Political-Military Affairs: Directorate of Defense Trade Controls; Notifications to the...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-26

... transmitting, herewith, certification of a proposed manufacturing license agreement for the manufacture of... services to support the design, manufacture and delivery of the Es'Hail Satellite Program. The United... defense articles, including technical data, and defense services to support the design, manufacture...

Simulation Modeling of a Facility Layout in Operations Management Classes

ERIC Educational Resources Information Center

Yazici, Hulya Julie

2006-01-01

Teaching quantitative courses can be challenging. Similarly, layout modeling and lean production concepts can be difficult to grasp in an introductory OM (operations management) class. This article describes a simulation model developed in PROMODEL to facilitate the learning of layout modeling and lean manufacturing. Simulation allows for the…

The Value of Sustainability Education

ERIC Educational Resources Information Center

Bradfield, Steven L.

2009-01-01

This article offers the perspectives of a veteran in the field of sustainability. The author shares the steps in the development, evolution, and management of sustainability and sustainable practices at a leading flooring manufacturer. The author leverages over 20 years of experience in industry to discuss the necessary skills and mindsets to…

Strategic drivers of contract manufacturing: Part I, The theory.

PubMed

Tomlinson, Geoff; Geimer, Harald

2002-12-01

Medical device manufacturers and diagnostics companies have significantly increased their use of contract manufacturers to outsource production of components. This, the first of a two-part article, reviews strategic benefits and best practices in outsourcing.

Aluminum space frame technology

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

Birch, S.

This article examines the increased application of aluminum to the construction of automobile frames. The topics of the article include a joint venture between Audi and Alcoa, forms in which aluminum is used, new alloys and construction methods, meeting rigidity and safety levels, manufacturing techniques, the use of extrusions, die casting, joining techniques, and pollution control during manufacturing.

27 CFR 26.92 - Subject to tax.

Code of Federal Regulations, 2010 CFR

2010-04-01

... OF THE TREASURY LIQUORS LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Taxpayment of Liquors and Articles in Puerto Rico Wine § 26.92 Subject to tax. (a) Wine of Puerto Rican manufacture... on wine of Puerto Rican manufacture shall be deposited in the Treasury of Puerto Rico only if the sum...

26 CFR 48.4218-3 - Events subsequent to taxable use of article.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 16 2010-04-01 2010-04-01 true Events subsequent to taxable use of article. 48.4218-3 Section 48.4218-3 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY... to Manufacturers Taxes Use by Manufacturer Or Importer Considered Sale § 48.4218-3 Events subsequent...

26 CFR 48.4218-3 - Events subsequent to taxable use of article.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 26 Internal Revenue 16 2012-04-01 2012-04-01 false Events subsequent to taxable use of article. 48.4218-3 Section 48.4218-3 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY... to Manufacturers Taxes Use by Manufacturer Or Importer Considered Sale § 48.4218-3 Events subsequent...

26 CFR 48.4218-3 - Events subsequent to taxable use of article.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 26 Internal Revenue 16 2013-04-01 2013-04-01 false Events subsequent to taxable use of article. 48.4218-3 Section 48.4218-3 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY... to Manufacturers Taxes Use by Manufacturer Or Importer Considered Sale § 48.4218-3 Events subsequent...

26 CFR 48.4218-3 - Events subsequent to taxable use of article.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 16 2011-04-01 2011-04-01 false Events subsequent to taxable use of article. 48.4218-3 Section 48.4218-3 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY... to Manufacturers Taxes Use by Manufacturer Or Importer Considered Sale § 48.4218-3 Events subsequent...

Clinical development of a novel inactivated poliomyelitis vaccine based on attenuated Sabin poliovirus strains.

PubMed

Verdijk, Pauline; Rots, Nynke Y; Bakker, Wilfried A M

2011-05-01

Following achievement of polio eradication, the routine use of all live-attenuated oral poliovirus vaccines should be discontinued. However, the costs per vaccine dose for the alternative inactivated poliovirus vaccine (IPV) are significantly higher and the current production capacity is not sufficient for worldwide distribution of the vaccine. In order to achieve cost-prize reduction and improve affordability, IPV production processes and dose-sparing strategies should be developed to facilitate local manufacture at a relatively lower cost. The use of attenuated Sabin instead of wild-type polio strains will provide additional safety during vaccine production and permits production in low-cost settings. Sabin-IPV is under development by several manufacturers. This article gives an overview of results from clinical trials with Sabin-IPV and discusses the requirements and challenges in the clinical development of this novel IPV.

Basics of Compounding: 3D Printing: Pharmacy Applications, Part 3: Compounding, Formulation Considerations, and the Future.

PubMed

Allen, Loyd V

2017-01-01

3D printing is a standard tool in the automotive, aerospace, and consumer goods in industry and is gaining traction in pharmaceutical manufacturing, which has introduced a new element into dosage form development. This article, which represents part 3 of a 3-part article on the topic of 3D printing, discusses the compounding, formulation considerations, and the future of 3D printing. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

26 CFR 301.6511(e)-1 - Special rules applicable to manufactured sugar.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 18 2011-04-01 2011-04-01 false Special rules applicable to manufactured sugar... Assessment and Collection § 301.6511(e)-1 Special rules applicable to manufactured sugar. (a) Use as... the person entitled thereto. Such right accrues as of the date the manufactured sugar, or article...

26 CFR 301.6511(e)-1 - Special rules applicable to manufactured sugar.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 18 2010-04-01 2010-04-01 false Special rules applicable to manufactured sugar... Assessment and Collection § 301.6511(e)-1 Special rules applicable to manufactured sugar. (a) Use as... the person entitled thereto. Such right accrues as of the date the manufactured sugar, or article...

46 CFR 53.10-15 - Manufacturers' data report forms.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 2 2014-10-01 2014-10-01 false Manufacturers' data report forms. 53.10-15 Section 53.10-15 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING HEATING BOILERS Tests, Inspection, Stamping, and Reporting (Article 5) § 53.10-15 Manufacturers' data report forms. The manufacturers' data report forms require...

46 CFR 53.10-15 - Manufacturers' data report forms.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 2 2010-10-01 2010-10-01 false Manufacturers' data report forms. 53.10-15 Section 53.10-15 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING HEATING BOILERS Tests, Inspection, Stamping, and Reporting (Article 5) § 53.10-15 Manufacturers' data report forms. The manufacturers' data report forms require...

46 CFR 53.10-15 - Manufacturers' data report forms.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 2 2012-10-01 2012-10-01 false Manufacturers' data report forms. 53.10-15 Section 53.10-15 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING HEATING BOILERS Tests, Inspection, Stamping, and Reporting (Article 5) § 53.10-15 Manufacturers' data report forms. The manufacturers' data report forms require...

46 CFR 53.10-15 - Manufacturers' data report forms.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 2 2013-10-01 2013-10-01 false Manufacturers' data report forms. 53.10-15 Section 53.10-15 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING HEATING BOILERS Tests, Inspection, Stamping, and Reporting (Article 5) § 53.10-15 Manufacturers' data report forms. The manufacturers' data report forms require...

46 CFR 53.10-15 - Manufacturers' data report forms.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 2 2011-10-01 2011-10-01 false Manufacturers' data report forms. 53.10-15 Section 53.10-15 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING HEATING BOILERS Tests, Inspection, Stamping, and Reporting (Article 5) § 53.10-15 Manufacturers' data report forms. The manufacturers' data report forms require...

26 CFR 301.6511(e)-1 - Special rules applicable to manufactured sugar.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 26 Internal Revenue 18 2012-04-01 2012-04-01 false Special rules applicable to manufactured sugar... Assessment and Collection § 301.6511(e)-1 Special rules applicable to manufactured sugar. (a) Use as... the person entitled thereto. Such right accrues as of the date the manufactured sugar, or article...

26 CFR 301.6511(e)-1 - Special rules applicable to manufactured sugar.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 26 Internal Revenue 18 2014-04-01 2014-04-01 false Special rules applicable to manufactured sugar... Assessment and Collection § 301.6511(e)-1 Special rules applicable to manufactured sugar. (a) Use as... the person entitled thereto. Such right accrues as of the date the manufactured sugar, or article...

26 CFR 301.6511(e)-1 - Special rules applicable to manufactured sugar.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 26 Internal Revenue 18 2013-04-01 2013-04-01 false Special rules applicable to manufactured sugar... Assessment and Collection § 301.6511(e)-1 Special rules applicable to manufactured sugar. (a) Use as... the person entitled thereto. Such right accrues as of the date the manufactured sugar, or article...

21st Century Manufacturing Supervisors and Their Historical Roots

ERIC Educational Resources Information Center

Hotek, Douglas R.

2003-01-01

This article provides a perspective of the past and present roles of the manufacturing supervisor with a specific focus on new skills requirements. Within the structure of manufacturing management, the supervisor plays a key role in implementing today's complex automated manufacturing technologies. The supervisor is at the bottom of the management…

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

PubMed

Sharp, J R

1995-01-01

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

Vaccine supply, demand, and policy: a primer.

PubMed

Muzumdar, Jagannath M; Cline, Richard R

2009-01-01

To provide an overview of supply and demand issues in the vaccine industry and the policy options that have been implemented to resolve these issues. Medline, Policy File, and International Pharmaceutical Abstracts were searched to locate academic journal articles. Other sources reviewed included texts on the topics of vaccine history and policy, government agency reports, and reports from independent think tanks. Keywords included vaccines, immunizations, supply, demand, and policy. Search criteria were limited to English language and human studies. Articles pertaining to vaccine demand, supply, and public policy were selected and reviewed for inclusion. By the authors. Vaccines are biologic medications, therefore making their development and production more difficult and costly compared with "small-molecule" drugs. Research and development costs for vaccines can exceed $800 million, and development may require 10 years or more. Strict manufacturing regulations and facility upgrades add to these costs. Policy options to increase and stabilize the supply of vaccines include those aimed at increasing supply, such as government subsidies for basic vaccine research, liability protection for manufacturers, and fast-track approval for new vaccines. Options to increase vaccine demand include advance purchase commitments, government stockpiles, and government financing for select populations. High development costs and multiple barriers to entry have led to a decline in the number of vaccine manufacturers. Although a number of vaccine policies have met with mixed success in increasing the supply of and demand for vaccines, a variety of concerns remain, including developing vaccines for complex pathogens and increasing immunization rates with available vaccines. New policy innovations such as advance market commitments and Medicare Part D vaccine coverage have been implemented and may aid in resolving some of the problems in the vaccine industry.

Structural Testing at the NWTC Helps Improve Blade Design and Increase System Reliability; NREL (National Renewable Energy Laboratory)

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

None

2015-08-01

Since 1990, the National Renewable Energy Laboratory’s (NREL's) National Wind Technology Center (NWTC) has tested more than 150 wind turbine blades. NWTC researchers can test full-scale and subcomponent articles, conduct data analyses, and provide engineering expertise on best design practices. Structural testing of wind turbine blades enables designers, manufacturers, and owners to validate designs and assess structural performance to specific load conditions. Rigorous structural testing can reveal design and manufacturing problems at an early stage of development that can lead to overall improvements in design and increase system reliability.

19 CFR 19.15 - Withdrawal for exportation of articles manufactured in bond; waste or byproducts for consumption.

Code of Federal Regulations, 2010 CFR

2010-04-01

... direct exportation, unless an authorization of the manufacturer is endorsed on the face of the withdrawal... be required as in the case of other warehouse withdrawals for exportation. (l) When the fact of... 19 Customs Duties 1 2010-04-01 2010-04-01 false Withdrawal for exportation of articles...

50 CFR 14.62 - Exceptions to import declaration requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... manufactured articles that are not intended for commercial use and are used as clothing or contained in... products or manufactured articles that are not intended for commercial use and are a part of a shipment of.... Except: That this exception will not apply to any specimens or parts thereof taken as a result of sport...

Development of the antimicrobial effectiveness test as USP chapter <51>.

PubMed

Sutton, Scott V W; Porter, David

2002-01-01

The antimicrobial effectiveness test first appeared as a USP General Chapter in the 18th revision, official September 1, 1970. This chapter, at the beginning, was designed to evaluate the performance of antimicrobials added to inhibit the growth of microorganisms that might be introduced during or subsequent to the manufacturing process. As Good Manufacturing Practices (GMPs) became a governing principal in pharmaceutical manufacturing, the purpose of the test was refined to focus on activity of the preservative system as a protection against inadvertent contamination during storage and usage of the product. This article will review the history of the antimicrobial test; its function, technique, and the background discussions that resulted in the changes from the test that appeared in USP XVIII to that of the current USP 25.

What is going on in augmented reality simulation in laparoscopic surgery?

PubMed

Botden, Sanne M B I; Jakimowicz, Jack J

2009-08-01

To prevent unnecessary errors and adverse results of laparoscopic surgery, proper training is of paramount importance. A safe way to train surgeons for laparoscopic skills is simulation. For this purpose traditional box trainers are often used, however they lack objective assessment of performance. Virtual reality laparoscopic simulators assess performance, but lack realistic haptic feedback. Augmented reality (AR) combines a virtual reality (VR) setting with real physical materials, instruments, and feedback. This article presents the current developments in augmented reality laparoscopic simulation. Pubmed searches were performed to identify articles regarding surgical simulation and augmented reality. Identified companies manufacturing an AR laparoscopic simulator received the same questionnaire referring to the features of the simulator. Seven simulators that fitted the definition of augmented reality were identified during the literature search. Five of the approached manufacturers returned a completed questionnaire, of which one simulator appeared to be VR and was therefore not applicable for this review. Several augmented reality simulators have been developed over the past few years and they are improving rapidly. We recommend the development of AR laparoscopic simulators for component tasks of procedural training. AR simulators should be implemented in current laparoscopic training curricula, in particular for laparoscopic suturing training.

Mechatronics design principles for biotechnology product development.

PubMed

Mandenius, Carl-Fredrik; Björkman, Mats

2010-05-01

Traditionally, biotechnology design has focused on the manufacture of chemicals and biologics. Still, a majority of biotechnology products that appear on the market today is the result of mechanical-electric (mechatronic) construction. For these, the biological components play decisive roles in the design solution; the biological entities are either integral parts of the design, or are transformed by the mechatronic system. This article explains how the development and production engineering design principles used for typical mechanical products can be adapted to the demands of biotechnology products, and how electronics, mechanics and biology can be integrated more successfully. We discuss three emerging areas of biotechnology in which mechatronic design principles can apply: stem cell manufacture, artificial organs, and bioreactors. Copyright 2010 Elsevier Ltd. All rights reserved.

Method For Manufacturing Articles For High Temperature Use, And Articles Made Therewith

DOEpatents

Wang, Hongyu; Mitchell, David Joseph; Lau, Yuk-Chiu; Henry, Arnold Thomas

2006-02-28

A method for manufacturing an article for use in a high-temperature environment, and an article for use in such an environment, are presented. The method comprises providing a substrate; selecting a desired vertical crack density for a protective coating to be deposited on the substrate; providing a powder, wherein the powder has a size range selected to provide a coating having the desired vertical crack density; and applying a thermal-sprayed coating to the substrate, the coating having the desired vertical crack density, wherein the powder is used as a raw material for the coating.

Method For Manufacturing Articles For High Temperature Use, And Articles Made Therewith

DOEpatents

Wang, Hongyu; Mitchell, David Joseph; Lau, Yuk-Chiu; Henry, Arnold Thomas

2005-03-15

A method for manufacturing an article for use in a high-temperature environment, and an article for use in such an environment, are presented. The method comprises providing a substrate; selecting a desired vertical crack density for a protective coating to be deposited on the substrate; providing a powder, wherein the powder has a size range selected to provide a coating having the desired vertical crack density; and applying a thermal-sprayed coating to the substrate, the coating having the desired vertical crack density, wherein the powder is used as a raw material for the coating.

Adult Education in a Workplace Context: Recognising Production Workers' Responses and Partnership Challenges

ERIC Educational Resources Information Center

Wärvik, Gun-Britt

2016-01-01

This article is about a larger regional Swedish partnership programme that was established to develop site-based education for production workers. A partnership is seen as composed of different practice architectures. The actors involved represented larger transnational as well as smaller manufacturing companies, employers, the metal workers'…

An integrated and pragmatic approach: Global plant safety management

NASA Astrophysics Data System (ADS)

McNutt, Jack; Gross, Andrew

1989-05-01

The Bhopal disaster in India in 1984 has compelled manufacturing companies to review their operations in order to minimize their risk exposure. Much study has been done on the subject of risk assessment and in refining safety reviews of plant operations. However, little work has been done to address the broader needs of decision makers in the multinational environment. The corporate headquarters of multinational organizations are concerned with identifying vulnerable areas to assure that appropriate risk-minimization measures are in force or will be taken. But the task of screening global business units for safety prowess is complicated and time consuming. This article takes a step towards simplifying this process by presenting the decisional model developed by the authors. Beginning with an overview of key issues affecting global safety management, the focus shifts to the multinational vulnerability model developed by the authors, which reflects an integration of approaches. The article concludes with a discussion of areas for further research. While the global chemical industry and major incidents therein are used for illustration, the procedures and solutions suggested here are applicable to all manufacturing operations.

Additive manufacturing of hybrid circuits

DOE PAGES

Bell, Nelson S.; Sarobol, Pylin; Cook, Adam; ...

2016-03-26

There is a rising interest in developing functional electronics using additively manufactured components. Considerations in materials selection and pathways to forming hybrid circuits and devices must demonstrate useful electronic function; must enable integration; and must complement the complex shape, low cost, high volume, and high functionality of structural but generally electronically passive additively manufactured components. This article reviews several emerging technologies being used in industry and research/development to provide integration advantages of fabricating multilayer hybrid circuits or devices. First, we review a maskless, noncontact, direct write (DW) technology that excels in the deposition of metallic colloid inks for electrical interconnects.more » Second, we review a complementary technology, aerosol deposition (AD), which excels in the deposition of metallic and ceramic powder as consolidated, thick conformal coatings and is additionally patternable through masking. As a result, we show examples of hybrid circuits/devices integrated beyond 2-D planes, using combinations of DW or AD processes and conventional, established processes.« less

Progress Toward an Integration of Process-Structure-Property-Performance Models for "Three-Dimensional (3-D) Printing" of Titanium Alloys

NASA Astrophysics Data System (ADS)

Collins, P. C.; Haden, C. V.; Ghamarian, I.; Hayes, B. J.; Ales, T.; Penso, G.; Dixit, V.; Harlow, G.

2014-07-01

Electron beam direct manufacturing, synonymously known as electron beam additive manufacturing, along with other additive "3-D printing" manufacturing processes, are receiving widespread attention as a means of producing net-shape (or near-net-shape) components, owing to potential manufacturing benefits. Yet, materials scientists know that differences in manufacturing processes often significantly influence the microstructure of even widely accepted materials and, thus, impact the properties and performance of a material in service. It is important to accelerate the understanding of the processing-structure-property relationship of materials being produced via these novel approaches in a framework that considers the performance in a statistically rigorous way. This article describes the development of a process model, the assessment of key microstructural features to be incorporated into a microstructure simulation model, a novel approach to extract a constitutive equation to predict tensile properties in Ti-6Al-4V (Ti-64), and a probabilistic approach to measure the fidelity of the property model against real data. This integrated approach will provide designers a tool to vary process parameters and understand the influence on performance, enabling design and optimization for these highly visible manufacturing approaches.

Integrating MRP (materiel requirements planning) II and JIT to achieve world-class status.

PubMed

Titone, R C

1994-05-01

The concepts and principles of using manufacturing resource planning (MRP II) for planning are not new. Their success has been proven in numerous manufacturing companies in America. The concepts and principles of using just-in-time (JIT) inventory for execution, while more recent, have also been available for some time, and their success in Japan well documented. However, it is the effective integration of these two powerful tools that open the way to achieving world-class manufacturing status. This article will utilize a newly developed world-class manufacturing model, which will review the aspects of planning, beginning with a business plan through the production planning process and culminating with a master schedule that drives a materiel/capacity plan. The importance and interrelationship of these functions are reviewed. The model then illustrates the important aspects of executing these plans beginning with people issues, through total quality control (TQC) and pull systems. We will then utilize this new functional model to demonstrate the relationship between these various functions and the importance of integrating them with a total comprehensive manufacturing strategy that will lead to world-class manufacturing and profits.

Designing and Implementing Collaborative Improvement in the Extended Manufacturing Enterprise: Action Learning and Action Research (ALAR) in CO-IMPROVE

ERIC Educational Resources Information Center

Coghlan, David; Coughlan, Paul

2006-01-01

Purpose: The purpose of this article is to provide a design and implementation framework for ALAR (action learning action research) programme which aims to address collaborative improvement in the extended manufacturing enterprise. Design/methodology/approach: This article demonstrates the design of a programme in which action learning and action…

Commercialization of a novel fermentation concept.

PubMed

Mazumdar-Shaw, Kiran; Suryanarayan, Shrikumar

2003-01-01

Fermentation is the core of biotechnology where current methodologies span across technologies based on the use of either solid or liquid substrates. Traditionally, solid substrate fermentation technologies have been the widely practiced in the Far East to manufacture fermented foods such as soya sauce, sake etc. The Western World briefly used solid substrate fermentation for the manufacture of antibiotics and enzymes but rapidly replaced this technology with submerged fermentation which proved to be a superior technology in terms of automation, containment and large volume fermentation. Biocon India developed its enzyme technology based on solid substrate fermentation as a low-cost, low-energy option for the production of specialty enzymes. However, the limitations of applying solid substrate fermentation to more sophisticated biotechnology products as well as large volume fermentations were recognized by Biocon India as early as 1990 and the company embarked on a 8 year research and development program to develop a novel bioreactor capable of conducting solid substrate fermentation with comparable levels of automation and containment as those practiced by submerged fermentation. In addition, the novel technology enabled fed-batch fermentation, in situ extraction and other enabling features that will be discussed in this article. The novel bioreactor was christened the "PlaFractor" (pronounced play-fractor). The next level of research on this novel technology is now focused on addressing large volume fermentation. This article traces the evolution of Biocon India's original solid substrate fermentation to the PlaFractor technology and provides details of the scale-up and commercialization processes that were involved therein. What is also apparent in the article is Biocon India's commercially focused research programs and the perceived need to be globally competitive through low costs of innovation that address, at all times, processes and technologies that exhibit high degrees of conformance to the international standards of regulatory and good manufacturing practice.

Additive manufacturing.

PubMed

Mumith, A; Thomas, M; Shah, Z; Coathup, M; Blunn, G

2018-04-01

Increasing innovation in rapid prototyping (RP) and additive manufacturing (AM), also known as 3D printing, is bringing about major changes in translational surgical research. This review describes the current position in the use of additive manufacturing in orthopaedic surgery. Cite this article: Bone Joint J 2018;100-B:455-60.

Designing of a Digital Behind-the-Ear Hearing Aid to Meet the World Health Organization Requirements

PubMed Central

Bento, Ricardo Ferreira; Penteado, Silvio Pires

2010-01-01

Hearing loss is a common health issue that affects nearly 10% of the world population as indicated by many international studies. The hearing impaired typically experience more frustration, anxiety, irritability, depression, and disorientation than those with normal hearing levels. The standard rehabilitation tool for hearing impairment is an electronic hearing aid whose main components are transducers (microphone and receiver) and a digital signal processor. These electronic components are manufactured by supply chain rather than by hearing aid manufacturers. Manufacturers can use custom-designed components or generic off-the-shelf components. These electronic components are available as application-specific or off-the-shelf products, with the former designed for a specific manufacturer and the latter for a generic approach. The choice of custom or generic components will affect the product specifications, pricing, manufacturing, life cycle, and marketing strategies of the product. The World Health Organization is interested in making available to developing countries hearing aids that are inexpensive to purchase and maintain. The hearing aid presented in this article was developed with these specifications in mind together with additional contemporary features such as four channels with wide dynamic range compression, an adjustable compression rate for each channel, four comfort programs, an adaptive feedback manager, and full volume control. This digital hearing aid is fitted using a personal computer with minimal hardware requirements in intuitive three-step fitting software. A trimmer-adjusted version can be developed where human and material resources are scarce. PMID:20724354

Designing of a digital behind-the-ear hearing aid to meet the World Health Organization requirements.

PubMed

Bento, Ricardo Ferreira; Penteado, Silvio Pires

2010-06-01

Hearing loss is a common health issue that affects nearly 10% of the world population as indicated by many international studies. The hearing impaired typically experience more frustration, anxiety, irritability, depression, and disorientation than those with normal hearing levels. The standard rehabilitation tool for hearing impairment is an electronic hearing aid whose main components are transducers (microphone and receiver) and a digital signal processor. These electronic components are manufactured by supply chain rather than by hearing aid manufacturers. Manufacturers can use custom-designed components or generic off-the-shelf components. These electronic components are available as application-specific or off-the-shelf products, with the former designed for a specific manufacturer and the latter for a generic approach. The choice of custom or generic components will affect the product specifications, pricing, manufacturing, life cycle, and marketing strategies of the product. The World Health Organization is interested in making available to developing countries hearing aids that are inexpensive to purchase and maintain. The hearing aid presented in this article was developed with these specifications in mind together with additional contemporary features such as four channels with wide dynamic range compression, an adjustable compression rate for each channel, four comfort programs, an adaptive feedback manager, and full volume control. This digital hearing aid is fitted using a personal computer with minimal hardware requirements in intuitive three-step fitting software. A trimmer-adjusted version can be developed where human and material resources are scarce.

Preparing the Next American Manufacturing Workforce

ERIC Educational Resources Information Center

Taraman, Khalil S.

2010-01-01

Manufacturing has a new face--and the future it offers is exciting. But in order to take advantage of what it offers, one needs a plan and he/she has to know how to execute it. In this article, the author discusses how the Society of Manufacturing Engineers (SME) is working to get the message out that the future of advanced manufacturing will…

Methodological recommendations for comparative research on the treatment of chronic wounds.

PubMed

Sonnad, S S; Goldsack, J C; Mohr, P; Tunis, S

2013-09-01

To provide specific recommendations to product developers and clinical researchers on the design of comparative effectiveness studies for the treatment of chronic wounds, specifically those pertaining to arterial and venous-disease related ulcers, diabetic foot ulcers, pressure ulcers and burn wounds. The recommendations were developed based on a process defined by the Center for Medical Technology Policy (CMTP). After selecting the subject area, semi-structured phone interviews were conducted by one of the authors (SSS) with representatives of payers, manufacturers, clinicians, clinician/researchers and patient advocates. Next, a broad range of stakeholders participated in a meeting convened by CMTP to determine their needs. A technical working group comprising key stakeholders then participated in clarifying recommendations developed by CMTP staff and adding important considerations for their implementation. The resulting draft document was finalised based on public and solicited comment from individual manufacturers; a consortium of product developers and manufacturers; and an alliance of physicians, providers, manufacturers and patient organisations. This article is a summary of the full effectiveness guidance document. To address the needs of patients, clinicians, guideline developers, payers and other post-regulatory decision makers, this work makes ten recommendations to guide comparative effectiveness research for chronic wound care. These recommendations fall into four categories: study design, population, comparators and outcomes. This paper suggests that using the recommendations outlined to conduct comparative effectiveness research on treatments for chronic wound therapies would facilitate trials that provide patients, clinicians, and payers with the information they need to make optimal treatment decisions. These recommendations focus on design changes that would have the largest impact in improving the usability of the results by decision makers and provide specific guidance on the design of prospective studies intended to inform decision making by patients, clinicians and payers. There were no external sources of funding for these recommendations. The Value Institute and the Center for Medical Technology Policy (CMTP) are both private, non-profit organisations. The authors have no financial, commercial or social conflicts of interest to declare with respect to the article or its content.

Geneva-Seattle collaboration in support of developing country vaccine manufacturing.

PubMed

Stevenson, Michael A

2018-04-01

Vaccines were once produced almost exclusively by state-supported entities. While they remain essential tools for public health protection, the majority of the world's governments have allowed industry to assume responsibility for this function. This is significant because while the international harmonisation of quality assurance standards have effectively increased vaccine safety, they have also reduced the number of developing country vaccine producers, and Northern multinational pharmaceutical companies have shown little interest in offering the range of low-priced products needed in low and middle-income-country contexts. This article examines how public-private collaboration is relevant to contemporary efforts aimed at strengthening developing country manufacturers' capacity to produce high-quality, low-priced vaccines. Specifically, it casts light on the important and largely complimentary roles of the World Health Organization, The Bill and Melinda Gates Foundation, and the Seattle-based non-profit PATH, in this process. The take away message is that external support remains critical to ensuring that developing country vaccine manufacturers have the tools needed to produce for both domestic and global markets, and the United Nations supply chain, and collaboration at the public-private interface is driving organisational innovation focused on meeting these goals.

Toxic legacy: the environmental impact of the manufactured gas industry in the United States.

PubMed

Tarr, Joel A

2014-01-01

The manufactured gas industry provided cities in the United States with energy for light and power during much of the period from approximately 1850 to 1950. This article explores the history of the effects of this industry on air, land, and water environments; it also examines attempts by the courts and municipal and state governments to regulate gas-waste pollution and the industry's response. The article concludes by exploring the heritage of badly contaminated sites that the manufactured gas industry left to the nation after it was replaced by natural gas after World War II.

19 CFR 10.206 - Value content requirement.

Code of Federal Regulations, 2013 CFR

2013-04-01

... incorporated in an article which are either: (i) Wholly the growth, product, or manufacture of a beneficiary..., insurance, packing, and all other costs incurred in transporting the materials to the manufacturer's plant... incurred in the growth, production, or manufacture of the material, including general expenses; (B) An...

19 CFR 10.206 - Value content requirement.

Code of Federal Regulations, 2012 CFR

2012-04-01

... incorporated in an article which are either: (i) Wholly the growth, product, or manufacture of a beneficiary..., insurance, packing, and all other costs incurred in transporting the materials to the manufacturer's plant... incurred in the growth, production, or manufacture of the material, including general expenses; (B) An...

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

NASA Technical Reports Server (NTRS)

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

2016-01-01

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

Advances in industrial biopharmaceutical batch process monitoring: Machine-learning methods for small data problems.

PubMed

Tulsyan, Aditya; Garvin, Christopher; Ündey, Cenk

2018-04-06

Biopharmaceutical manufacturing comprises of multiple distinct processing steps that require effective and efficient monitoring of many variables simultaneously in real-time. The state-of-the-art real-time multivariate statistical batch process monitoring (BPM) platforms have been in use in recent years to ensure comprehensive monitoring is in place as a complementary tool for continued process verification to detect weak signals. This article addresses a longstanding, industry-wide problem in BPM, referred to as the "Low-N" problem, wherein a product has a limited production history. The current best industrial practice to address the Low-N problem is to switch from a multivariate to a univariate BPM, until sufficient product history is available to build and deploy a multivariate BPM platform. Every batch run without a robust multivariate BPM platform poses risk of not detecting potential weak signals developing in the process that might have an impact on process and product performance. In this article, we propose an approach to solve the Low-N problem by generating an arbitrarily large number of in silico batches through a combination of hardware exploitation and machine-learning methods. To the best of authors' knowledge, this is the first article to provide a solution to the Low-N problem in biopharmaceutical manufacturing using machine-learning methods. Several industrial case studies from bulk drug substance manufacturing are presented to demonstrate the efficacy of the proposed approach for BPM under various Low-N scenarios. © 2018 Wiley Periodicals, Inc.

Earth analysis methods, subsurface feature detection methods, earth analysis devices, and articles of manufacture

DOEpatents

West, Phillip B [Idaho Falls, ID; Novascone, Stephen R [Idaho Falls, ID; Wright, Jerry P [Idaho Falls, ID

2012-05-29

Earth analysis methods, subsurface feature detection methods, earth analysis devices, and articles of manufacture are described. According to one embodiment, an earth analysis method includes engaging a device with the earth, analyzing the earth in a single substantially lineal direction using the device during the engaging, and providing information regarding a subsurface feature of the earth using the analysis.

Earth analysis methods, subsurface feature detection methods, earth analysis devices, and articles of manufacture

DOEpatents

West, Phillip B [Idaho Falls, ID; Novascone, Stephen R [Idaho Falls, ID; Wright, Jerry P [Idaho Falls, ID

2011-09-27

Earth analysis methods, subsurface feature detection methods, earth analysis devices, and articles of manufacture are described. According to one embodiment, an earth analysis method includes engaging a device with the earth, analyzing the earth in a single substantially lineal direction using the device during the engaging, and providing information regarding a subsurface feature of the earth using the analysis.

Middeck Active Control Experiment (MACE), phase A

NASA Technical Reports Server (NTRS)

Crawley, Edward F.; Deluis, Javier; Miller, David W.

1989-01-01

A rationale to determine which structural experiments are sufficient to verify the design of structures employing Controlled Structures Technology was derived. A survey of proposed NASA missions was undertaken to identify candidate test articles for use in the Middeck Active Control Experiment (MACE). The survey revealed that potential test articles could be classified into one of three roles: development, demonstration, and qualification, depending on the maturity of the technology and the mission the structure must fulfill. A set of criteria was derived that allowed determination of which role a potential test article must fulfill. A review of the capabilities and limitations of the STS middeck was conducted. A reference design for the MACE test article was presented. Computing requirements for running typical closed-loop controllers was determined, and various computer configurations were studied. The various components required to manufacture the structure were identified. A management plan was established for the remainder of the program experiment development, flight and ground systems development, and integration to the carrier. Procedures for configuration control, fiscal control, and safety, reliabilty, and quality assurance were developed.

On-site energy consumption at softwood sawmills in Montana

Treesearch

Dan Loeffler; Nathaniel Anderson; Todd A. Morgan; Colin B. Sorenson

2016-01-01

Total on-site energy requirements for wood product manufacturing are generally not well understood or publicly available, particularly at subregional scales, such as the state level. This article uses a mail survey of softwood sawmills in Montana to develop a profile of all on-site energy consumption. Energy use is delineated by fuel type on a production basis...

Kaolin

USGS Publications Warehouse

Virta, R.L.

2011-01-01

The article discusses the latest developments in the global kaolin industry, particularly in the U.S., as of June 2011. It claims that Georgia is the top producing state in the U.S., with a 94% share in total production. The other top producers include South Carolina, North Carolina and Florida. Kaolin is used in the manufacture of such products as electrical porcelain, pottery and sanitaryware.

The Political Economic Necessity of the Art School 1835-52

ERIC Educational Resources Information Center

Quinn, Malcolm

2011-01-01

This article examines the political economic theories that informed the development of the first publicly funded art school in Britain, by the Select Committee on Arts and Manufactures of 1835/6. It begins by assessing these origins in the context of some recent experiments in art school pedagogy. It then responds to the challenge offered by…

The color of safety

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

Carter, R.A.

The industry's workforce is getting grayer as veteran miners approach retirement, and greener as new hires come onboard. Will the changing complexion of the industry affect future safety technology? The article discusses problems of noise, vibration, and communication faced by coal miners and reports some developments by manufacturers of mining equipment to improve health and safety. 1 fig., 4 photos.

A Graduate Laboratory Course on Biodiesel Production Emphasizing Professional, Teamwork, and Research Skills

ERIC Educational Resources Information Center

Leavesley, West

2011-01-01

In this article we report on the use of a graduate "Special Topics" course to provide vital research and practical laboratory experience, within the context of developing a chemical process to manufacture biodiesel from algal sources. This course contained several key components that we believe are necessary skills in graduate research: 1) a…

Education Modules for Teaching Sustainability in a Mass and Energy Balance Course

ERIC Educational Resources Information Center

Zheng, Kai Liang; Bean, Doyle P., Jr.; Lou, Helen H.; Ho, Thomas C.; Huang, Yinlun

2011-01-01

In this article we report on the use of a graduate "Special Topics" course to provide vital research and practical laboratory experience, within the context of developing a chemical process to manufacture biodiesel from algal sources. This course contained several key components that we believe are necessary skills in graduate research: 1) a…

Application of quality by design principles to the development and technology transfer of a major process improvement for the manufacture of a recombinant protein.

PubMed

Looby, Mairead; Ibarra, Neysi; Pierce, James J; Buckley, Kevin; O'Donovan, Eimear; Heenan, Mary; Moran, Enda; Farid, Suzanne S; Baganz, Frank

2011-01-01

This study describes the application of quality by design (QbD) principles to the development and implementation of a major manufacturing process improvement for a commercially distributed therapeutic protein produced in Chinese hamster ovary cell culture. The intent of this article is to focus on QbD concepts, and provide guidance and understanding on how the various components combine together to deliver a robust process in keeping with the principles of QbD. A fed-batch production culture and a virus inactivation step are described as representative examples of upstream and downstream unit operations that were characterized. A systematic approach incorporating QbD principles was applied to both unit operations, involving risk assessment of potential process failure points, small-scale model qualification, design and execution of experiments, definition of operating parameter ranges and process validation acceptance criteria followed by manufacturing-scale implementation and process validation. Statistical experimental designs were applied to the execution of process characterization studies evaluating the impact of operating parameters on product quality attributes and process performance parameters. Data from process characterization experiments were used to define the proven acceptable range and classification of operating parameters for each unit operation. Analysis of variance and Monte Carlo simulation methods were used to assess the appropriateness of process design spaces. Successful implementation and validation of the process in the manufacturing facility and the subsequent manufacture of hundreds of batches of this therapeutic protein verifies the approaches taken as a suitable model for the development, scale-up and operation of any biopharmaceutical manufacturing process. Copyright © 2011 American Institute of Chemical Engineers (AIChE).

Stress Rupture Testing and Analysis of the NASA WSTF-JPL Carbon Overwrapped Pressure Vessels

NASA Technical Reports Server (NTRS)

Greene, Nathanael; Yoder, Tommy; Saulsberry, Regor; Grimes, Lorie; Thesken, John; Phoenix, Leigh

2007-01-01

Carbon composite overwrapped pressure vessels (COPVs) are widely used in applications from spacecraft to life support. COPV technology provides a pressurized media storage advantage over amorphous technology with weight savings on the order of 30 percent. The National Aeronautics and Space Administration (NASA) has been supporting the development of this technology since the early 1970's with an interest in safe application of these components to reduce mass to orbit. NASA White Sands Test Facility (WSTF) has been testing components in support of this objective since the 1980s and has been involved in test development and analysis to address affects of impact, propellant and cryogenic fluids exposure on Kevlar and carbon epoxy. The focus of this paper is to present results of a recent joint WSTF-Jet Propulsion Laboratories (JPL) effort to assess safe life of these components. The WSTF-JPL test articles consisted of an aluminum liner and a carbon fiber overwrap in an industry standard epoxy resin system. The vessels were specifically designed with one plus-minus helical wrap and one hoop wrap over the helical and they measured 4.23 x 11.4 in. long. 120 test articles were manufactured in August of 1998 of one lot fiber and resin and the 110 test articles were delivered to WSTF for test. Ten of the 120 test articles were burst tested at the manufacturer to establish the delivered fiber stress. Figure 1 shows a test article in a pre burst condition and with a hoop fiber failure (no leak of pressurized media) and post burst (failure of liner and loss of pressurized media).

Regional analyses of labor markets and demography: a model based Norwegian example.

PubMed

Stambol, L S; Stolen, N M; Avitsland, T

1998-01-01

The authors discuss the regional REGARD model, developed by Statistics Norway to analyze the regional implications of macroeconomic development of employment, labor force, and unemployment. "In building the model, empirical analyses of regional producer behavior in manufacturing industries have been performed, and the relation between labor market development and regional migration has been investigated. Apart from providing a short description of the REGARD model, this article demonstrates the functioning of the model, and presents some results of an application." excerpt

Brands or generics: the dilemma of pharmaceutical marketing in a developing country.

PubMed

Quraeshi, Z A; Luqmani, M; Malhotra, N

1983-01-01

A significant issue in pharmaceutical marketing in many developing countries is whether drugs should be sold by generic or by brand names. In Pakistan, legislation prohibited the sale of brand name drugs in order to increase price competition, and strengthen the market position of indigenous manufacturers to compete against multinationals. However, the government's objectives were not achieved for reasons discussed in the article. The Pakistan case has implications for multinational firms and for other developing countries in similar situations.

Design and manufacturing of patient-specific orthodontic appliances by computer-aided engineering techniques.

PubMed

Barone, Sandro; Neri, Paolo; Paoli, Alessandro; Razionale, Armando Viviano

2018-01-01

Orthodontic treatments are usually performed using fixed brackets or removable oral appliances, which are traditionally made from alginate impressions and wax registrations. Among removable devices, eruption guidance appliances are used for early orthodontic treatments in order to intercept and prevent malocclusion problems. Commercially available eruption guidance appliances, however, are symmetric devices produced using a few standard sizes. For this reason, they are not able to meet all the specific patient's needs since the actual dental anatomies present various geometries and asymmetric conditions. In this article, a computer-aided design-based methodology for the design and manufacturing of a patient-specific eruption guidance appliances is presented. The proposed approach is based on the digitalization of several steps of the overall process: from the digital reconstruction of patients' anatomies to the manufacturing of customized appliances. A finite element model has been developed to evaluate the temporomandibular joint disks stress level caused by using symmetric eruption guidance appliances with different teeth misalignment conditions. The developed model can then be used to guide the design of a patient-specific appliance with the aim at reducing the patient discomfort. At this purpose, two different customization levels are proposed in order to face both arches and single tooth misalignment issues. A low-cost manufacturing process, based on an additive manufacturing technique, is finally presented and discussed.

Development of a Design Supporting System for Nano-Materials based on a Framework for Integrated Knowledge of Functioning-Manufacturing Process

NASA Astrophysics Data System (ADS)

Tarumi, Shinya; Kozaki, Kouji; Kitamura, Yoshinobu; Mizoguchi, Riichiro

In the recent materials research, much work aims at realization of ``functional materials'' by changing structure and/or manufacturing process with nanotechnology. However, knowledge about the relationship among function, structure and manufacturing process is not well organized. So, material designers have to consider a lot of things at the same time. It would be very helpful for them to support their design process by a computer system. In this article, we discuss a conceptual design supporting system for nano-materials. Firstly, we consider a framework for representing functional structures and manufacturing processes of nano-materials with relationships among them. We expand our former framework for representing functional knowledge based on our investigation through discussion with experts of nano-materials. The extended framework has two features: 1) it represents functional structures and manufacturing processes comprehensively, 2) it expresses parameters of function and ways with their dependencies because they are important for material design. Next, we describe a conceptual design support system we developed based on the framework with its functionalities. Lastly, we evaluate the utility of our system in terms of functionality for design supports. For this purpose, we tried to represent two real examples of material design. And then we did an evaluation experiment on conceptual design of material using our system with the collaboration of domain experts.

Titanium in dentistry: historical development, state of the art and future perspectives.

PubMed

Jorge, Juliana Ribeiro Pala; Barão, Valentim Adelino; Delben, Juliana Aparecida; Faverani, Leonardo Perez; Queiroz, Thallita Pereira; Assunção, Wirley Gonçalves

2013-06-01

Titanium is a metallic element known by several attractive characteristics, such as biocompatibility, excellent corrosion resistance and high mechanical resistance. It is widely used in Dentistry, with high success rates, providing a favorable biological response when in contact with live tissues. Therefore, the objective of this study was to describe the different uses of titanium in Dentistry, reviewing its historical development and discoursing about its state of art and future perspective of its utilization. A search in the MEDLINE/PubMed database was performed using the terms 'titanium', 'dentistry' and 'implants'. The title and abstract of articles were read, and after this first screening 20 articles were selected and their full-texts were downloaded. Additional text books and manual search of reference lists within selected articles were included. Correlated literature showed that titanium is the most used metal in Implantology for manufacturing osseointegrated implants and their systems, with a totally consolidated utilization. Moreover, titanium can be also employed in prosthodontics to obtain frameworks. However, problems related to its machining, casting, welding and ceramic application for dental prosthesis are still limiting its use. In Endodontics, titanium has been used in association to nickel for manufacturing rotatory instruments, providing a higher resistance to deformation. However, although the different possibilities of using titanium in modern Dentistry, its use for prostheses frameworks still needs technological improvements in order to surpass its limitations.

The availability of references and the sponsorship of original research cited in pharmaceutical advertisements

PubMed Central

Cooper, Richelle J.; Schriger, David L.

2005-01-01

Background The primary goal of pharmaceutical advertisements is to convince physicians to prescribe the manufacturer's product. We sought to determine what materials are cited in support of claims in pharmaceutical ads and medical research articles, and whether health care professionals seeking to verify the claims could obtain these references. Methods We reviewed 438 unique ads from the 1999 issues of 10 American medical journals, and a random sample of 400 references in medical research articles selected from the same journals. We classified references as journal article, data on file, meeting abstract or presentation, book or monograph, marketing report, prescribing information, government document or Internet site. We attempted to confirm or obtain each reference through library and Internet searches or by direct request from the manufacturer. The main outcome we sought to determine was the availability of the reference to a clinician. We also ascertained the source of funding for original research cited in the ads and the research articles. Results In the 438 ads with medical claims, 126 contained no references and 312 contained 721 unique references. Of these ad references, 55% (396/721) cited journal articles and 19% (135/721) cited data on file. In contrast, in the sample of research article references, 88% (351/400) cited journal articles and 8% (33/400) cited books. Overall, 84% of the citations from the ads were available: 98% of journal articles, 86% of books, 71% of meeting abstracts or presentations and 20% of data-on-file references. In all, 99% of the sample of research article references were available. We determined that 58% of the original research cited in the pharmaceutical ads was sponsored by or had an author affiliated with the product's manufacturer, as compared with 8% of the articles cited in the research articles. Interpretation Many pharmaceutical ads contain no references for medical claims. Although references to journal articles were usually obtainable, other published sources were not as easily acquired. The majority of unpublished data-on-file references were not available, and the majority of original research cited to substantiate claims in the pharmaceutical ads was funded by or had authors affiliated with the product's manufacturer. PMID:15710940

The availability of references and the sponsorship of original research cited in pharmaceutical advertisements.

PubMed

Cooper, Richelle J; Schriger, David L

2005-02-15

The primary goal of pharmaceutical advertisements is to convince physicians to prescribe the manufacturer's product. We sought to determine what materials are cited in support of claims in pharmaceutical ads and medical research articles, and whether health care professionals seeking to verify the claims could obtain these references. We reviewed 438 unique ads from the 1999 issues of 10 American medical journals, and a random sample of 400 references in medical research articles selected from the same journals. We classified references as journal article, data on file, meeting abstract or presentation, book or monograph, marketing report, prescribing information, government document or Internet site. We attempted to confirm or obtain each reference through library and Internet searches or by direct request from the manufacturer. The main outcome we sought to determine was the availability of the reference to a clinician. We also ascertained the source of funding for original research cited in the ads and the research articles. In the 438 ads with medical claims, 126 contained no references and 312 contained 721 unique references. Of these ad references, 55% (396/721) cited journal articles and 19% (135/721) cited data on file. In contrast, in the sample of research article references, 88% (351/400) cited journal articles and 8% (33/400) cited books. Overall, 84% of the citations from the ads were available: 98% of journal articles, 86% of books, 71% of meeting abstracts or presentations and 20% of data-on-file references. In all, 99% of the sample of research article references were available. We determined that 58% of the original research cited in the pharmaceutical ads was sponsored by or had an author affiliated with the product's manufacturer, as compared with 8% of the articles cited in the research articles. Many pharmaceutical ads contain no references for medical claims. Although references to journal articles were usually obtainable, other published sources were not as easily acquired. The majority of unpublished data-on-file references were not available, and the majority of original research cited to substantiate claims in the pharmaceutical ads was funded by or had authors affiliated with the product's manufacturer.

Using cell structures to develop functional nanomaterials and nanostructures--case studies of actin filaments and microtubules.

PubMed

Wu, Kevin Chia-Wen; Yang, Chung-Yao; Cheng, Chao-Min

2014-04-25

This article is based on the continued development of biologically relevant elements (i.e., actin filaments and microtubules in living cells) as building blocks to create functional nanomaterials and nanostructures that can then be used to manufacture nature-inspired small-scale devices or systems. Here, we summarize current progress in the field and focus specifically on processes characterized by (1) robustness and ease of use, (2) inexpensiveness, and (3) potential expandability to mass production. This article, we believe, will provide scientists and engineers with a more comprehensive understanding of how to mine biological materials and natural design features to construct functional materials and devices.

Hypothesis analysis methods, hypothesis analysis devices, and articles of manufacture

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

Sanfilippo, Antonio P; Cowell, Andrew J; Gregory, Michelle L

Hypothesis analysis methods, hypothesis analysis devices, and articles of manufacture are described according to some aspects. In one aspect, a hypothesis analysis method includes providing a hypothesis, providing an indicator which at least one of supports and refutes the hypothesis, using the indicator, associating evidence with the hypothesis, weighting the association of the evidence with the hypothesis, and using the weighting, providing information regarding the accuracy of the hypothesis.

The rehabilitation engineering research center for the advancement of cognitive technologies.

PubMed

Heyn, Patricia Cristine; Cassidy, Joy Lucille; Bodine, Cathy

2015-02-01

Barring few exceptions, allied health professionals, engineers, manufacturers of assistive technologies (ATs), and consumer product manufacturers have developed few technologies for individuals with cognitive impairments (CIs). In 2004, the National Institute on Disability Rehabilitation Research (NIDRR) recognized the need to support research in this emergent field. They funded the first Rehabilitation Engineering Research Center for the Advancement of Cognitive Technologies (RERC-ACT). The RERC-ACT has since designed and evaluated existing and emerging technologies through rigorous research, improving upon existing AT devices, and creating new technologies for individuals with CIs. The RERC-ACT has contributed to the development and testing of AT products that assist persons with CIs to actively engage in tasks of daily living at home, school, work, and in the community. This article highlights the RERC-ACT's engineering development and research projects and discusses how current research may impact the quality of life for an aging population. © The Author(s) 2014.

19 CFR 10.710 - Value-content requirement.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., character, or use, which is then used in Jordan in the production or manufacture of a new or different... production or manufacture of a new or different article of commerce that is imported into the United States... determined by computing the sum of: (A) All expenses incurred in the growth, production, or manufacture of...

21 CFR 225.35 - Use of work areas, equipment, and storage areas for other manufacturing and storage purpose.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING..., rodenticides, and other pesticides. Manufacturing, storage, or handling of nonfeed and feed products in the... pesticides unless such articles are approved drugs, indexed drugs, or approved food additives intended for...

21 CFR 225.35 - Use of work areas, equipment, and storage areas for other manufacturing and storage purpose.

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING..., rodenticides, and other pesticides. Manufacturing, storage, or handling of nonfeed and feed products in the... pesticides unless such articles are approved drugs, indexed drugs, or approved food additives intended for...

21 CFR 225.35 - Use of work areas, equipment, and storage areas for other manufacturing and storage purpose.

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING..., rodenticides, and other pesticides. Manufacturing, storage, or handling of nonfeed and feed products in the... pesticides unless such articles are approved drugs, indexed drugs, or approved food additives intended for...

21 CFR 225.35 - Use of work areas, equipment, and storage areas for other manufacturing and storage purpose.

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING..., rodenticides, and other pesticides. Manufacturing, storage, or handling of nonfeed and feed products in the... pesticides unless such articles are approved drugs, indexed drugs, or approved food additives intended for...

21 CFR 225.35 - Use of work areas, equipment, and storage areas for other manufacturing and storage purpose.

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING..., rodenticides, and other pesticides. Manufacturing, storage, or handling of nonfeed and feed products in the... pesticides unless such articles are approved drugs, indexed drugs, or approved food additives intended for...

Manufacturing in Space: (It's Getting off the Ground!) Resources in Technology.

ERIC Educational Resources Information Center

Technology Teacher, 1988

1988-01-01

Discusses current issues and work on the planned manufacturing Space Station. Such topics as human resources, energy sources, and types of products to be manufactured in space are covered. The possibility of mining other planets for raw materials is considered. Student activities and a quiz covering the article are included. (CH)

27 CFR 20.192 - Manufacturing record.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ingredients used; and (c) Name, trade name or brand name and alcoholic content of each article or intermediate product manufactured, as applicable. (Approved by the Office of Management and Budget under control number...

Articles comprising ferritic stainless steels

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

Rakowski, James M.

An article of manufacture comprises a ferritic stainless steel that includes a near-surface region depleted of silicon relative to a remainder of the ferritic stainless steel. The article has a reduced tendency to form an electrically resistive silica layer including silicon derived from the steel when the article is subjected to high temperature oxidizing conditions. The ferritic stainless steel is selected from the group comprising AISI Type 430 stainless steel, AISI Type 439 stainless steel, AISI Type 441 stainless steel, AISI Type 444 stainless steel, and E-BRITE.RTM. alloy, also known as UNS 44627 stainless steel. In certain embodiments, the articlemore » of manufacture is a fuel cell interconnect for a solid oxide fuel cell.« less

Nondestructive Evaluation Methods for the Ares I Common Bulkhead

NASA Technical Reports Server (NTRS)

Walker, James

2010-01-01

A large scale bonding demonstration test article was fabricated to prove out manufacturing techniques for the current design of the NASA Ares I Upper Stage common bulkhead. The common bulkhead serves as the single interface between the liquid hydrogen and liquid oxygen portions of the Upper Stage propellant tank. The bulkhead consists of spin-formed aluminum domes friction stir welded to Y-rings and bonded to a perforated phenolic honeycomb core. Nondestructive evaluation methods are being developed for assessing core integrity and the core-to-dome bond line of the common bulkhead. Detection of manufacturing defects such as delaminations between the core and face sheets as well as service life defects such as crushed or sheared core resulting from impact loading are all of interest. The focus of this work will be on the application of thermographic, shearographic, and phased array ultrasonic methods to the bonding demonstration article as well as various smaller test panels featuring design specific defect types and geometric features.

Developing defined substrates for stem cell culture and differentiation.

PubMed

Hagbard, Louise; Cameron, Katherine; August, Paul; Penton, Christopher; Parmar, Malin; Hay, David C; Kallur, Therése

2018-07-05

Over the past few decades, a variety of different reagents for stem cell maintenance and differentiation have been commercialized. These reagents share a common goal in facilitating the manufacture of products suitable for cell therapy while reducing the amount of non-defined components. Lessons from developmental biology have identified signalling molecules that can guide the differentiation process in vitro , but less attention has been paid to the extracellular matrix used. With the introduction of more biologically relevant and defined matrices, that better mimic specific cell niches, researchers now have powerful resources to fine-tune their in vitro differentiation systems, which may allow the manufacture of therapeutically relevant cell types. In this review article, we revisit the basics of the extracellular matrix, and explore the important role of the cell-matrix interaction. We focus on laminin proteins because they help to maintain pluripotency and drive cell fate specification.This article is part of the theme issue 'Designer human tissue: coming to a lab near you'. © 2018 The Authors.

Flame retardant spandex type polyurethanes

NASA Technical Reports Server (NTRS)

Howarth, J. T.; Sheth, S.; Sidman, K. R.; Massucco, A. A. (Inventor)

1978-01-01

Flame retardant elastomeric compositions were developed, comprised of: (1) spandex type polyurethane having incorporated into the polymer chain, halogen containing polyols; (2) conventional spandex type polyurethanes in physical admixture flame retardant additives; and (3) fluoroelastomeric resins in physical admixture with flame retardant additives. Methods of preparing fibers of the flame retardant elastomeric materials are presented and articles of manufacture comprised of the elastomeric materials are mentioned.

Challenging the FDA's authority to regulate autologous adult stem cells for therapeutic use: Celltex therapeutics' partnership with RNL Bio, substantial medical risks, and the implications of United States v. Regenerative Sciences.

PubMed

Drabiak-Syed, Katherine

2013-01-01

This Article examines the convergence of three corporations that have attempted to capitalize on translating emerging research into clinical procedures by manufacturing and facilitating the process for patients to obtain mesenchymal stem cell (MSC) injections. Although the Food and Drug Administration (FDA) has asserted its authority to regulate somatic cell therapy products like MSCs under the Public Health Service Act and the Food, Drug, and Cosmetic Act, some manufacturers have attempted to circumvent FDA regulation through various mechanisms and argue that their products do not fall within the definition of a biological product or drug. However, scientific knowledge of using MSCs for clinical therapy remains in its infancy, and MSCs pose a number of serious risks to patients. This Article focuses on the development of Celltex, a company based in Sugar Land, Texas that manufactures and facilitates the injection of autologous MSCs; RNL Bio, a company that licenses its operations technology to Celltex; and Regenerative Sciences, a company based in Broomfield, Colorado that was recently involved in litigation with the FDA. Corporate circumvention of intended regulatory oversight exposes patients to potentially inefficacious products that could contribute to serious medical injuries such as viruses, myocardial infarction, cancer, or death.

Considerations for U.S. Policy Toward Conventional Arms Manufacturers in Post-Conflict or Failed-State Environments

DTIC Science & Technology

2014-06-13

article, Chivers highlights the “ development of local arms-producing industries in Syrian cities and the countryside,” claiming that given the absence...At the operational and tactical levels, military commanders and their staffs must develop a mindset where protection of critical infrastructure is...presented to the Faculty of the U.S. Army Command and General Staff College in partial fulfillment of the requirements for the degree MASTER OF

Seasonal Solar Thermal Absorption Energy Storage Development.

PubMed

Daguenet-Frick, Xavier; Gantenbein, Paul; Rommel, Mathias; Fumey, Benjamin; Weber, Robert; Gooneseker, Kanishka; Williamson, Tommy

2015-01-01

This article describes a thermochemical seasonal storage with emphasis on the development of a reaction zone for an absorption/desorption unit. The heat and mass exchanges are modelled and the design of a suitable reaction zone is explained. A tube bundle concept is retained for the heat and mass exchangers and the units are manufactured and commissioned. Furthermore, experimental results of both absorption and desorption processes are presented and the exchanged power is compared to the results of the simulations.

A review on powder-based additive manufacturing for tissue engineering: selective laser sintering and inkjet 3D printing

PubMed Central

Shirazi, Seyed Farid Seyed; Gharehkhani, Samira; Mehrali, Mehdi; Yarmand, Hooman; Metselaar, Hendrik Simon Cornelis; Adib Kadri, Nahrizul; Osman, Noor Azuan Abu

2015-01-01

Since most starting materials for tissue engineering are in powder form, using powder-based additive manufacturing methods is attractive and practical. The principal point of employing additive manufacturing (AM) systems is to fabricate parts with arbitrary geometrical complexity with relatively minimal tooling cost and time. Selective laser sintering (SLS) and inkjet 3D printing (3DP) are two powerful and versatile AM techniques which are applicable to powder-based material systems. Hence, the latest state of knowledge available on the use of AM powder-based techniques in tissue engineering and their effect on mechanical and biological properties of fabricated tissues and scaffolds must be updated. Determining the effective setup of parameters, developing improved biocompatible/bioactive materials, and improving the mechanical/biological properties of laser sintered and 3D printed tissues are the three main concerns which have been investigated in this article. PMID:27877783

A review on powder-based additive manufacturing for tissue engineering: selective laser sintering and inkjet 3D printing.

PubMed

Shirazi, Seyed Farid Seyed; Gharehkhani, Samira; Mehrali, Mehdi; Yarmand, Hooman; Metselaar, Hendrik Simon Cornelis; Adib Kadri, Nahrizul; Osman, Noor Azuan Abu

2015-06-01

Since most starting materials for tissue engineering are in powder form, using powder-based additive manufacturing methods is attractive and practical. The principal point of employing additive manufacturing (AM) systems is to fabricate parts with arbitrary geometrical complexity with relatively minimal tooling cost and time. Selective laser sintering (SLS) and inkjet 3D printing (3DP) are two powerful and versatile AM techniques which are applicable to powder-based material systems. Hence, the latest state of knowledge available on the use of AM powder-based techniques in tissue engineering and their effect on mechanical and biological properties of fabricated tissues and scaffolds must be updated. Determining the effective setup of parameters, developing improved biocompatible/bioactive materials, and improving the mechanical/biological properties of laser sintered and 3D printed tissues are the three main concerns which have been investigated in this article.

An esthetics rehabilitation with computer-aided design/ computer-aided manufacturing technology.

PubMed

Mazaro, Josá Vitor Quinelli; de Mello, Caroline Cantieri; Zavanelli, Adriana Cristina; Santiago, Joel Ferreira; Amoroso, Andressa Paschoal; Pellizzer, Eduardo Piza

2014-07-01

This paper describes a case of a rehabilitation involving Computer Aided Design/Computer Aided Manufacturing (CAD-CAM) system in implant supported and dental supported prostheses using zirconia as framework. The CAD-CAM technology has developed considerably over last few years, becoming a reality in dental practice. Among the widely used systems are the systems based on zirconia which demonstrate important physical and mechanical properties of high strength, adequate fracture toughness, biocompatibility and esthetics, and are indicated for unitary prosthetic restorations and posterior and anterior framework. All the modeling was performed by using CAD-CAM system and prostheses were cemented using resin cement best suited for each situation. The rehabilitation of the maxillary arch using zirconia framework demonstrated satisfactory esthetic and functional results after a 12-month control and revealed no biological and technical complications. This article shows the important of use technology CAD/CAM in the manufacture of dental prosthesis and implant-supported.

Text analysis methods, text analysis apparatuses, and articles of manufacture

DOEpatents

Whitney, Paul D; Willse, Alan R; Lopresti, Charles A; White, Amanda M

2014-10-28

Text analysis methods, text analysis apparatuses, and articles of manufacture are described according to some aspects. In one aspect, a text analysis method includes accessing information indicative of data content of a collection of text comprising a plurality of different topics, using a computing device, analyzing the information indicative of the data content, and using results of the analysis, identifying a presence of a new topic in the collection of text.

Surface modification to improve fireside corrosion resistance of Fe-Cr ferritic steels

DOEpatents

Park, Jong-Hee; Natesan, Krishnamurti; Rink, David L.

2010-03-16

An article of manufacture and a method for providing an Fe--Cr ferritic steel article of manufacture having a surface layer modification for corrosion resistance. Fe--Cr ferritic steels can be modified to enhance their corrosion resistance to liquid coal ash and other chemical environments, which have chlorides or sulfates containing active species. The steel is modified to form an aluminide/silicide passivating layer to reduce such corrosion.

Manufactured Homes as Affordable Housing in Rural Areas. Rural Information Center Publication Series, No. 5.

ERIC Educational Resources Information Center

Czerniak, Robert, Comp.

This bibliography includes citations of approximately 60 books and articles pertaining to manufactured housing or "mobile homes," an important segment of the national housing industry. The availability of manufactured homes for low and moderate income groups is significant in light of skyrocketing new-housing costs. The South leads the nation with…

The Effect of the Implementation of Advanced Manufacturing Technologies on Training in the Manufacturing Sector

ERIC Educational Resources Information Center

Castrillon, Isabel Dieguez; Cantorna, Ana I. Sinde

2005-01-01

Purpose: The aim of this article is to gain insight into some of the factors that determine personnel-training efforts in companies introducing advanced manufacturing technologies (AMTs). The study provides empirical evidence from a sector with high rates of technological modernisation. Design/methodology/approach: "Ad hoc" survey of 90…

Changing Public Perception in Wisconsin: Manufacturing a "Good Life"

ERIC Educational Resources Information Center

Jorgensen, Haley

2006-01-01

Careers in manufacturing are high-wage and high-tech. Yet, a future workforce shortage may be on the horizon. It appears a negative public perception--one that brings to mind low wages, assembly-line work and lay-offs--is thwarting young adults from pursuing manufacturing careers across the country. This article describes how the Wisconsin…

Exporting DBCP and other banned pesticides: consideration of ethical issues.

PubMed

Lowry, L K; Frank, A L

1999-01-01

Many developed countries permit the export of pesticides that are banned, restricted, or unregistered within their own borders. This practice, which leads to the exposure of agricultural workers in developing countries to high levels of pesticides that are not permitted in the country of manufacture, raises many ethical issues as well as economic, social, political, and public health issues. Worldwide attempts to control export of such pesticides, through the FAO/UNEP Prior Informed Consent program, moves this issue in the right direction. This article explores the current U.S. and international practices, using the specific example of export of DBCP to banana-producing countries. The actions taken by multinational corporations, manufacturers of the pesticides, and public health officials in both the exporting and importing countries are explored, along with the impacts on workers, local economies, governments, and the environment.

A combinaison of UV curing technology with ATL process

NASA Astrophysics Data System (ADS)

Balbzioui, I.; Hasiaoui, B.; Barbier, G.; L'hostis, G.; Laurent, F.; Ibrahim, A.; Durand, B.

2017-10-01

In order to reduce the time and the cost of manufacturing composite, UV curing technology combined with automated tape placement process (ATL) based on reverse approach by working with a fixed head was studied in this article. First, a brief description of the developed head placement is presented. Mechanical properties are then evaluated by varying process parameters, including compaction force and tape placement speed. Finally, a parametric study is carried out to identify suitable materials and process parameters to manufacture a photo composite material with high mechanical performances. The obtained results show that UV curing is a very good alternative for thermal polymerization because of its fast cure speed due to less dependency on temperature.

The manufacture of blood plasma products in Scotland: a brief history.

PubMed

Foster, Peter R

2016-02-01

A number of essential clinical products are derived from human blood plasma, including immunoglobulin products for the treatment of infections and disorders of immunity; albumin for protein and fluid replacement and coagulation factors for the treatment of haemophilia and other disorders of haemostasis. For many years, these protein pharmaceuticals were manufactured by the Scottish National Blood Transfusion Service (SNBTS) at its Scottish Protein Fractionation Centre (PFC) in Edinburgh, a contribution which ended with the closure of the PFC in 2008. The origins and development of plasma fractionation in Scotland are summarised in this article, as well as issues which contributed to the closure of the PFC. © The Author(s) 2015.

Update on Risk Reduction Activities for a Liquid Advanced Booster for NASA's Space Launch System

NASA Technical Reports Server (NTRS)

Crocker, Andy; Graham, Bart

2016-01-01

Dynetics has designed innovative structure assemblies; manufactured them using Friction Stir Welding (FSW) to leverage NASA investments in tools, facilities, and processes; conducted proof and burst testing, demonstrating viability of design/build processes Dynetics/AR has applied state-of-the-art manufacturing and processing techniques to the heritage F-1, reducing risk for engine development Dynetics/AR has also made progress on technology demonstrations for ORSC cycle engine, which offers affordability and performance for both NASA and other launch vehicles Full-scale integrated oxidizer-rich test article. Testing will evaluate performance and combustion stability characteristics. Contributes to technology maturation for ox-rich staged combustion engines.

Thermal Protection System Application to Composite Cryotank Technology Demonstrator

NASA Technical Reports Server (NTRS)

Protz, Alison; Nettles, Mindy

2015-01-01

The EM41 Thermal Protection System (TPS) team contributed to the success of the Composite Cryotank Technology Demonstrator (CCTD) manufacturing by developing and implementing a low-cost solution to apply cryoinsulation foam on the exterior surface of the tank in the NASA Marshall Space Flight Center (MSFC) TPS Development Facility, Bldg. 4765. The TPS team used techniques developed for the smallscale composite cryotank to apply Stepanfoam S-180 polyurethane foam to the 5.5-meter CCTD using a manual spray process. Manual spray foam technicians utilized lifts and scaffolding to access the barrel and dome sections of the large-scale tank in the horizontal orientation. During manufacturing, the tank was then oriented vertically, allowing access to the final barrel section for manual spray foam application. The CCTD was the largest application of manual spray foam performed to date with the S-180 polyurethane foam and required the TPS team to employ best practices for process controls on the development article.

Assembly of 5.5-Meter Diameter Developmental Barrel Segments for the Ares I Upper Stage

NASA Technical Reports Server (NTRS)

Carter, Robert W.

2011-01-01

Full scale assembly welding of Ares I Upper Stage 5.5-Meter diameter cryogenic tank barrel segments has been performed at the Marshall Space Flight Center (MSFC). One full-scale developmental article produced under the Ares 1 Upper Stage project is the Manufacturing Demonstration Article (MDA) Barrel. This presentation will focus on the welded assembly of this barrel section, and associated lessons learned. Among the MDA articles planned on the Ares 1 Program, the Barrel was the first to be completed, primarily because the process of manufacture from piece parts (barrel panels) utilized the most mature friction stir process planned for use on the Ares US program: Conventional fixed pin Friction Stir Welding (FSW). This process is in use on other space launch systems, including the Shuttle s External Tank, the Delta IV common booster core, the Delta II, and the Atlas V rockets. The goals for the MDA Barrel development were several fold: 1) to prove out Marshall Space Flight Center s new Vertical Weld Tool for use in manufacture of cylindrical barrel sections, 2) to serve as a first run for weld qualification to a new weld specification, and 3) to provide a full size cylindrical section for downstream use in precision cleaning and Spray-on Foam Insulation development. The progression leading into the welding of the full size barrel included sub scale panel welding, subscale cylinder welding, a full length confidence weld, and finally, the 3 seamed MDA barrel processing. Lessons learned on this MDA program have been carried forward into the production tooling for the Ares 1 US Program, and in the use of the MSFC VWT in processing other large scale hardware, including two 8.4 meter diameter Shuttle External Tank barrel sections that are currently being used in structural analysis to validate shell buckling models.

27 CFR 53.186 - Accounting procedures for like articles.

Code of Federal Regulations, 2014 CFR

2014-04-01

... like articles. 53.186 Section 53.186 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND... Accounting procedures for like articles. (a) Identification of manufacturer. In applying section 6416 of the Code and the regulations thereunder, a person who has purchased like articles from various...

27 CFR 53.186 - Accounting procedures for like articles.

Code of Federal Regulations, 2011 CFR

2011-04-01

... like articles. 53.186 Section 53.186 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND... Accounting procedures for like articles. (a) Identification of manufacturer. In applying section 6416 of the Code and the regulations thereunder, a person who has purchased like articles from various...

27 CFR 53.186 - Accounting procedures for like articles.

Code of Federal Regulations, 2013 CFR

2013-04-01

... like articles. 53.186 Section 53.186 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND... Accounting procedures for like articles. (a) Identification of manufacturer. In applying section 6416 of the Code and the regulations thereunder, a person who has purchased like articles from various...

27 CFR 53.186 - Accounting procedures for like articles.

Code of Federal Regulations, 2010 CFR

2010-04-01

... like articles. 53.186 Section 53.186 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND... Accounting procedures for like articles. (a) Identification of manufacturer. In applying section 6416 of the Code and the regulations thereunder, a person who has purchased like articles from various...

Recent development on computer aided tissue engineering--a review.

PubMed

Sun, Wei; Lal, Pallavi

2002-02-01

The utilization of computer-aided technologies in tissue engineering has evolved in the development of a new field of computer-aided tissue engineering (CATE). This article reviews recent development and application of enabling computer technology, imaging technology, computer-aided design and computer-aided manufacturing (CAD and CAM), and rapid prototyping (RP) technology in tissue engineering, particularly, in computer-aided tissue anatomical modeling, three-dimensional (3-D) anatomy visualization and 3-D reconstruction, CAD-based anatomical modeling, computer-aided tissue classification, computer-aided tissue implantation and prototype modeling assisted surgical planning and reconstruction.

Nanotechnology in food science: Functionality, applicability, and safety assessment.

PubMed

He, Xiaojia; Hwang, Huey-Min

2016-10-01

Rapid development of nanotechnology is expected to transform many areas of food science and food industry with increasing investment and market share. In this article, current applications of nanotechnology in food systems are briefly reviewed. Functionality and applicability of food-related nanotechnology are highlighted in order to provide a comprehensive view on the development and safety assessment of nanotechnology in the food industry. While food nanotechnology offers great potential benefits, there are emerging concerns arising from its novel physicochemical properties. Therefore, the safety concerns and regulatory policies on its manufacturing, processing, packaging, and consumption are briefly addressed. At the end of this article, the perspectives of nanotechnology in active and intelligent packaging applications are highlighted. Copyright © 2016. Published by Elsevier B.V.

Static and dynamic models in economics

NASA Astrophysics Data System (ADS)

Safiullin, N. Z.; Safiullin, B. L.

2018-05-01

In this article, the authors consider the impact of information and advertising on consumer behavior and the process of producing differentiation formation. Advertising, television, radio, magazines and direct mail as major constraints of mass media may act as sources of information. Economic modernization is aimed at development of acceleration of the knowledge intensive industries, which contribute to Russia’s position in terms of the world economy; the recovering process of the Russian economic manufacturing base; development of import substitution industries and limited participation in international labor specialization.

The challenges of packaging combination devices.

PubMed

Mankel, George

2008-01-01

This article focuses on the development of a packaging format for drug eluting stents where the package not only has to meet the needs of the stent, but also the needs of the drug incorporated into its polymer coating. The package has to allow the transfer of ethylene oxide gas for sterilisation, but when in storage, must provide a barrier to keep out moisture and oxygen. A pouch and commercial scale manufacturing process were developed to incorporate this dual function into one item.

International Aviation (Selected Articles)

DTIC Science & Technology

1991-09-11

THE ANAYLYSIS OF DYNAMIC FORCES IN AVIATION STRUCTURES Following along with the development of test manufacturing projects for many types of aircraft...type water troughs. All the main equipment embodies automated measurement controls. It is capable of obtaining test data and curves in a real time...results from thousands of calculations, and decisions were made to select the imaginary origin point to act as the turbulence flow origination point

Advanced manufacturing development of a composite empennage component for L-1011 aircraft. Phase 4: Full scale ground test

NASA Technical Reports Server (NTRS)

Jackson, A. C.; Dorwald, F.

1982-01-01

The ground tests conducted on the advanced composite vertical fin (ACVF) program are described. The design and fabrication of the test fixture and the transition structure, static test of Ground Test Article (GTA) No. 1, rework of GTA No. 2, and static, damage tolerance, fail-safe and residual strength tests of GTA No. 2 are described.

49 CFR 173.426 - Excepted packages for articles containing natural uranium or thorium.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 2 2010-10-01 2010-10-01 false Excepted packages for articles containing natural....426 Excepted packages for articles containing natural uranium or thorium. A manufactured article in which the sole Class 7 (radioactive) material content is natural uranium, unirradiated depleted uranium...

49 CFR 173.426 - Excepted packages for articles containing natural uranium or thorium.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 2 2011-10-01 2011-10-01 false Excepted packages for articles containing natural....426 Excepted packages for articles containing natural uranium or thorium. A manufactured article in which the sole Class 7 (radioactive) material content is natural uranium, unirradiated depleted uranium...

International Aviation (Selected Articles)

DTIC Science & Technology

1991-06-05

The Manufacturing Capabilities of the Shanghai Aviation Company Leap to a New Level, by Yang Xinbang Zhang Shiyuan , Zheng Huilin............9 Setting...international cooperation. 8 THE MANUFACTURING CAPABILITIES OF THE SHANGHAI AVIATION COMPANY LEAP TO A NEW LEVEL Yang Xinbang Zhang Shiyuan Zheng

Cellular Therapies Clinical Research Roadmap: Lessons learned on how to move a cellular therapy into a clinical trial

PubMed Central

Ouseph, Stacy; Tappitake, Darah; Armant, Myriam; Wesselschmidt, Robin; Derecho, Ivy; Draxler, Rebecca; Wood, Deborah; Centanni, John M.

2014-01-01

A clinical research roadmap has been developed as a resource for researchers to identify critical areas and potential pitfalls when transitioning a cellular therapy product from the research laboratory, via and Investigational New Drug (IND) application, into early phase clinical trials. The roadmap describes four key areas; basic and preclinical research, resource development, translational research and good manufacturing practice (GMP), and IND assembly and submission. Basic and preclinical research identifies a new therapeutic concept and demonstrates its potential value using a model of the relevant disease. During resource development the appropriate specialists and the required expertise to bring this product into the clinic are identified (e.g., researchers, regulatory specialists, GMP manufacturing staff, clinicians, and clinical trials staff, etc.). Additionally, the funds required to achieve this goal (or a plan to procure them) are identified. In the next phase the plan to translate the research product into a clinical grade therapeutic is developed. Finally regulatory approval to start the trial must be obtained. In the United States this is done by filing an IND application with the Food and Drug Administration. The NHLBI-funded Production Assistance for Cellular Therapies (PACT) program has facilitated the transition of a variety of cellular therapy products from the laboratory into Phase1/2 trials. The five PACT facilities have assisted investigators by performing translational studies and GMP manufacturing to ensure that cellular products met release specifications and were manufactured safely, reproducibly, and at the appropriate scale. The roadmap resulting from this experience is the focus of this article. PMID:25484311

Image portion identification methods, image parsing methods, image parsing systems, and articles of manufacture

DOEpatents

Lassahn, Gordon D.; Lancaster, Gregory D.; Apel, William A.; Thompson, Vicki S.

2013-01-08

Image portion identification methods, image parsing methods, image parsing systems, and articles of manufacture are described. According to one embodiment, an image portion identification method includes accessing data regarding an image depicting a plurality of biological substrates corresponding to at least one biological sample and indicating presence of at least one biological indicator within the biological sample and, using processing circuitry, automatically identifying a portion of the image depicting one of the biological substrates but not others of the biological substrates.

[The criterion prognostic significance of examinations of chemiluminescence of oral fluid under impact of chemical pollutants of manufacture of rubber and rubber technical production].

PubMed

Galiullina, E F; Valiev, A v; Kamilov, R F; Shakirov, D F; Buliakov, P T

2013-12-01

The article presents the results of studies concerning the effect of unfavorable factors of chemical nature on fluid of oral cavity among workers of the Ufa plant of elastomer materials, articles and structures. It is established that in persons contacting with chemical pollutants of manufacture of rubber and rubber technical production the indicators of chemiluminescence of saliva fluid are significantly expressed and depend on professional standing.

Application of a mathematical model for ergonomics in lean manufacturing.

PubMed

Botti, Lucia; Mora, Cristina; Regattieri, Alberto

2017-10-01

The data presented in this article are related to the research article "Integrating ergonomics and lean manufacturing principles in a hybrid assembly line" (Botti et al., 2017) [1]. The results refer to the application of the mathematical model for the design of lean processes in hybrid assembly lines, meeting both the lean principles and the ergonomic requirements for safe assembly work. Data show that the success of a lean strategy is possible when ergonomics of workers is a parameter of the assembly process design.

Discussion on the Development of Green Chemistry and Chemical Engineering

NASA Astrophysics Data System (ADS)

Zhang, Yunshen

2017-11-01

Chemical industry plays a vital role in the development process of national economy. However, in view of the special nature of the chemical industry, a large number of poisonous and harmful substances pose a great threat to the ecological environment and human health in the entire process of raw material acquisition, production, transportation, product manufacturing, and the final practical application. Therefore, it is a general trend to promote the development of chemistry and chemical engineering towards a greener environment. This article will focus on some basic problems occurred in the development process of green chemistry and chemical engineering.

Roughness and compressive strength of FDM 3D printed specimens affected by acetone vapour treatment

NASA Astrophysics Data System (ADS)

Beniak, Juraj; Križan, Peter; Šooš, Ľubomír; Matúš, Miloš

2018-01-01

Rapid Prototyping technologies are the fastest growing technologies in the manufacturing of components and parts. There are many techniques which can be used with different materials and different purposes of produced part. Gradually, Rapid Prototyping systems have grown into Additive Manufacturing, because technology expansion brings faster production, improved manufactured components, and expanded palette of used materials. So now this techniques are also used for regular production of special parts, where is usual change of part design, where is necessary to produce variety of different designs and shapes. The following article deals with Fused Deposition Modelling (FDM) technology, the core of which is the manufacture models and components from thermoplastic polymers by deposition single fibres of semi-molten plastic material layer by layer. The article focuses on the results of research for testing of manufactured specimens by FDM technology. Components are modified by acetone vapour for surface smoothing. The purpose is to point out how the additional specimen treatment influence the strength properties. Presented paper shows realized experiments and measurements of compressive force on specimens and surface roughness which are influenced by acetone vapour treatment.

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

PubMed

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

2010-01-01

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

Opportunities for Nondestructive Evaluation: Quantitative Characterization (Postprint)

DTIC Science & Technology

2017-07-01

between the design and the as- manufactured and, ultimately, the as-maintained state. As this occurs with the article of interest being placed in...TESTING (STINFO COPY) AIR FORCE RESEARCH LABORATORY MATERIALS AND MANUFACTURING DIRECTORATE WRIGHT-PATTERSON AIR FORCE BASE, OH 45433-7750 AIR FORCE...MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10. SPONSORING/MONITORING AGENCY ACRONYM(S) Air Force Research Laboratory Materials and Manufacturing

Compositions Comprising Nickel-Titanium, Methods Manufacture Thereof and Articles Comprising the Same

NASA Technical Reports Server (NTRS)

DellaCorte, Christopher (Inventor); Glennon, Glenn N. (Inventor)

2016-01-01

Disclosing herein is a method for manufacturing nickel-titanium compositions. The method includes disposing a powdered composition in a mold; the powdered composition comprising nickel and titanium; the titanium being present in an amount of about 38 to about 42 wt % and the nickel being present in an amount of about 58 to about 62 wt %; sintering the powdered composition to produce a sintered preform; compacting the preform; machining the preform to form an article; heat treating the article; the annealing being conducted at a temperature of about 1650.degree. F. to about 1900.degree. F. at a pressure of about 3 Torr to about 5 Kg-f/cm.sup.2 for a time period of about 10 minutes to about 5 hours; and quenching the article.

Laser-Assisted Wire Additive Manufacturing System for the Deep Space Gateway

NASA Astrophysics Data System (ADS)

Foster, B. D.; Matthews, B.

2018-02-01

Investigation on the Deep Space Gateway will involve experiments/operations inside pressurized modules. Support for those experiments may necessitate a means to fabricate and repair required articles. This capability can be provided through an additive manufacturing (AM) system.

Preparation of ormetoprim-sulfadimethoxine-medicated discs for disc diffusion assay

USDA-ARS?s Scientific Manuscript database

Romet ( a blend of ormetoprim and sulfadimethoxine) is a type A medicated article for the manufacture of medicated feed in the catfish industry. Recently, the commercial manufacture of ormetoprim-sulfadimethoxine susceptibility discs was discontinued. Ormetoprim-sulfadimethoxine discs were prepare...

Development of the manufacture of billets based on high-strength aluminum alloys

NASA Astrophysics Data System (ADS)

Korostelev, V. F.; Denisov, M. S.; Bol'shakov, A. E.; Van Khieu, Chan

2017-09-01

When pressure is applied upon casting as a factor of external impact on melt, the problems related mainly to filling of molds are solved; however, some casting defects cannot be avoided. The experimental results demonstrate that complete compensation of shrinkage under pressure can be achieved by compressing of casting by 8-10% prior to beginning of solidification and by 2-3% during the transition of a metal from the liquid to the solid state. It is mentioned that the procedure based on compressing a liquid metal can be efficiently applied for manufacture of high-strength aluminum alloy castings. The selection of engineering parameters is substantiated. Examples of castings made of V95 alloy according to the developed procedure are given. In addition, the article discusses the problems related to designing of engineering and special-purpose equipment, software, and control automation.

Optimisation of assembly scheduling in VCIM systems using genetic algorithm

NASA Astrophysics Data System (ADS)

Dao, Son Duy; Abhary, Kazem; Marian, Romeo

2017-09-01

Assembly plays an important role in any production system as it constitutes a significant portion of the lead time and cost of a product. Virtual computer-integrated manufacturing (VCIM) system is a modern production system being conceptually developed to extend the application of traditional computer-integrated manufacturing (CIM) system to global level. Assembly scheduling in VCIM systems is quite different from one in traditional production systems because of the difference in the working principles of the two systems. In this article, the assembly scheduling problem in VCIM systems is modeled and then an integrated approach based on genetic algorithm (GA) is proposed to search for a global optimised solution to the problem. Because of dynamic nature of the scheduling problem, a novel GA with unique chromosome representation and modified genetic operations is developed herein. Robustness of the proposed approach is verified by a numerical example.

Uncooled infrared focal plane array imaging in China

NASA Astrophysics Data System (ADS)

Lei, Shuyu

2015-06-01

This article reviews the development of uncooled infrared focal plane array (UIFPA) imaging in China in the past decade. Sensors based on optical or electrical read-out mechanism were developed but the latter dominates the market. In resistive bolometers, VOx and amorphous silicon are still the two major thermal-sensing materials. The specifications of the IRFPA made by different manufactures were collected and compared. Currently more than five Chinese companies and institutions design and fabricate uncooled infrared focal plane array. Some devices have sensitivity as high as 30 mK; the largest array for commercial products is 640×512 and the smallest pixel size is 17 μm. Emphasis is given on the pixel MEMS design, ROIC design, fabrication, and packaging of the IRFPA manufactured by GWIC, especially on design for high sensitivities, low noise, better uniformity and linearity, better stabilization for whole working temperature range, full-digital design, etc.

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

Bell, Nelson S.; Sarobol, Pylin; Cook, Adam

There is a rising interest in developing functional electronics using additively manufactured components. Considerations in materials selection and pathways to forming hybrid circuits and devices must demonstrate useful electronic function; must enable integration; and must complement the complex shape, low cost, high volume, and high functionality of structural but generally electronically passive additively manufactured components. This article reviews several emerging technologies being used in industry and research/development to provide integration advantages of fabricating multilayer hybrid circuits or devices. First, we review a maskless, noncontact, direct write (DW) technology that excels in the deposition of metallic colloid inks for electrical interconnects.more » Second, we review a complementary technology, aerosol deposition (AD), which excels in the deposition of metallic and ceramic powder as consolidated, thick conformal coatings and is additionally patternable through masking. As a result, we show examples of hybrid circuits/devices integrated beyond 2-D planes, using combinations of DW or AD processes and conventional, established processes.« less

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

NASA Technical Reports Server (NTRS)

Oravec, Heather Ann; Daniels, Christopher C.

2014-01-01

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

27 CFR 20.134 - Labeling.

Code of Federal Regulations, 2010 CFR

2010-04-01

... container identifying (1) the name, trade name or brand name of the article, and (2) the name and address... identifying the name, trade name or brand name of the article. If the volume of the article in the container..., trade name or brand name of the article and the names and addresses (city and State) of the manufacturer...

27 CFR 40.495 - Articles of partnership or association.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2011-04-01 2011-04-01 false Articles of partnership or... Manufacturers of Processed Tobacco § 40.495 Articles of partnership or association. Every partnership or... its application for the permit required by § 40.492 a true copy of the articles of partnership or...

27 CFR 20.95 - Developmental samples of articles.

Code of Federal Regulations, 2011 CFR

2011-04-01

... articles. 20.95 Section 20.95 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE... Statements of Process § 20.95 Developmental samples of articles. (a) A user may use limited quantities of specially denatured spirits in the manufacture of samples of articles for submission in accordance with § 20...

27 CFR 20.95 - Developmental samples of articles.

Code of Federal Regulations, 2012 CFR

2012-04-01

... articles. 20.95 Section 20.95 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE... Statements of Process § 20.95 Developmental samples of articles. (a) A user may use limited quantities of specially denatured spirits in the manufacture of samples of articles for submission in accordance with § 20...

27 CFR 40.495 - Articles of partnership or association.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2014-04-01 2014-04-01 false Articles of partnership or... Manufacturers of Processed Tobacco § 40.495 Articles of partnership or association. Every partnership or... its application for the permit required by § 40.492 a true copy of the articles of partnership or...

27 CFR 40.495 - Articles of partnership or association.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2013-04-01 2013-04-01 false Articles of partnership or... Manufacturers of Processed Tobacco § 40.495 Articles of partnership or association. Every partnership or... its application for the permit required by § 40.492 a true copy of the articles of partnership or...

27 CFR 20.95 - Developmental samples of articles.

Code of Federal Regulations, 2013 CFR

2013-04-01

... articles. 20.95 Section 20.95 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE... Statements of Process § 20.95 Developmental samples of articles. (a) A user may use limited quantities of specially denatured spirits in the manufacture of samples of articles for submission in accordance with § 20...

27 CFR 20.95 - Developmental samples of articles.

Code of Federal Regulations, 2014 CFR

2014-04-01

... articles. 20.95 Section 20.95 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE... Statements of Process § 20.95 Developmental samples of articles. (a) A user may use limited quantities of specially denatured spirits in the manufacture of samples of articles for submission in accordance with § 20...

27 CFR 20.95 - Developmental samples of articles.

Code of Federal Regulations, 2010 CFR

2010-04-01

... articles. 20.95 Section 20.95 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE... Statements of Process § 20.95 Developmental samples of articles. (a) A user may use limited quantities of specially denatured spirits in the manufacture of samples of articles for submission in accordance with § 20...

27 CFR 40.495 - Articles of partnership or association.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2010-04-01 2010-04-01 false Articles of partnership or... Manufacturers of Processed Tobacco § 40.495 Articles of partnership or association. Every partnership or... its application for the permit required by § 40.492 a true copy of the articles of partnership or...

14 CFR 21.331 - Issuance of export airworthiness approvals for aircraft engines, propellers, and articles.

Code of Federal Regulations, 2014 CFR

2014-01-01

... for aircraft engines, propellers, and articles. 21.331 Section 21.331 Aeronautics and Space FEDERAL... engines, propellers, and articles. (a) A person may obtain from the FAA an export airworthiness approval to export a new aircraft engine, propeller, or article that is manufactured under this part if it...

14 CFR 21.331 - Issuance of export airworthiness approvals for aircraft engines, propellers, and articles.

Code of Federal Regulations, 2013 CFR

2013-01-01

... for aircraft engines, propellers, and articles. 21.331 Section 21.331 Aeronautics and Space FEDERAL... engines, propellers, and articles. (a) A person may obtain from the FAA an export airworthiness approval to export a new aircraft engine, propeller, or article that is manufactured under this part if it...

14 CFR 21.331 - Issuance of export airworthiness approvals for aircraft engines, propellers, and articles.

Code of Federal Regulations, 2012 CFR

2012-01-01

... for aircraft engines, propellers, and articles. 21.331 Section 21.331 Aeronautics and Space FEDERAL... engines, propellers, and articles. (a) A person may obtain from the FAA an export airworthiness approval to export a new aircraft engine, propeller, or article that is manufactured under this part if it...

14 CFR 21.331 - Issuance of export airworthiness approvals for aircraft engines, propellers, and articles.

Code of Federal Regulations, 2011 CFR

2011-01-01

... for aircraft engines, propellers, and articles. 21.331 Section 21.331 Aeronautics and Space FEDERAL... engines, propellers, and articles. (a) A person may obtain from the FAA an export airworthiness approval to export a new aircraft engine, propeller, or article that is manufactured under this part if it...

Identifying viable regulatory and innovation pathways for regenerative medicine: a case study of cultured red blood cells.

PubMed

Mittra, J; Tait, J; Mastroeni, M; Turner, M L; Mountford, J C; Bruce, K

2015-01-25

The creation of red blood cells for the blood transfusion markets represents a highly innovative application of regenerative medicine with a medium term (5-10 year) prospect for first clinical studies. This article describes a case study analysis of a project to derive red blood cells from human embryonic stem cells, including the systemic challenges arising from (i) the selection of appropriate and viable regulatory protocols and (ii) technological constraints related to stem cell manufacture and scale up to clinical Good Manufacturing Practice (GMP) standard. The method used for case study analysis (Analysis of Life Science Innovation Systems (ALSIS)) is also innovative, demonstrating a new approach to social and natural science collaboration to foresight product development pathways. Issues arising along the development pathway include cell manufacture and scale-up challenges, affected by regulatory demands emerging from the innovation ecosystem (preclinical testing and clinical trials). Our discussion reflects on the efforts being made by regulators to adapt the current pharmaceuticals-based regulatory model to an allogeneic regenerative medicine product and the broader lessons from this case study for successful innovation and translation of regenerative medicine therapies, including the role of methodological and regulatory innovation in future development in the field. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

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

PubMed

Kino-oka, Masahiro; Taya, Masahito

2009-10-01

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

Development of Self Fire Retardant Melamine-Animal Glue Formaldehyde (MGF) Resin for the Manufacture of BWR Ply Board

NASA Astrophysics Data System (ADS)

Khatua, Pijus Kanti; Dubey, Rajib Kumar; Roymahapatra, Gourisankar; Mishra, Anjan; Shahoo, Shadhu Charan; Kalawate, Aparna

2017-10-01

Wood is one of the most sustainable, naturally growing materials that consist mainly of combustible organic carbon compounds. Since plywood are widely used nowadays especially in buildings, furniture and cabinets. Too often the fire behavior of ply-board may be viewed as a drawback. Amino-plastic based thermosetting resin adhesives are the important and most widely used in the plywood panel industries. The fire retardant property of wood panel products by adding animal glue as an additive in the form of MGF resin and used as substitute of melamine for manufacture of plywood. Environment concerns and higher cost of petroleum based resins have resulted in the development of technologies to replace melamine partially by biomaterials for the manufacturing of resin adhesive. Natural bio-based materials such as tannin, CNSL (cardanol), lignin, soya etc. are used as partial substitution of melamine. This article presents the development of melamine-animal glue formaldehyde resin as plywood binder. About 30 % melamine was substituted by animal glue and optimized. The different physico-mechanical and fire retardant property properties tested as per IS: 1734-1983 and IS: 5509-2000 respectively are quite satisfactory. The production of adhesive from melamine with compatible natural proteinous material is cost effective, eco-friendly and enhance the fire retardant property.

Rapid prototyping prosthetic hand acting by a low-cost shape-memory-alloy actuator.

PubMed

Soriano-Heras, Enrique; Blaya-Haro, Fernando; Molino, Carlos; de Agustín Del Burgo, José María

2018-06-01

The purpose of this article is to develop a new concept of modular and operative prosthetic hand based on rapid prototyping and a novel shape-memory-alloy (SMA) actuator, thus minimizing the manufacturing costs. An underactuated mechanism was needed for the design of the prosthesis to use only one input source. Taking into account the state of the art, an underactuated mechanism prosthetic hand was chosen so as to implement the modifications required for including the external SMA actuator. A modular design of a new prosthesis was developed which incorporated a novel SMA actuator for the index finger movement. The primary objective of the prosthesis is achieved, obtaining a modular and functional low-cost prosthesis based on additive manufacturing executed by a novel SMA actuator. The external SMA actuator provides a modular system which allows implementing it in different systems. This paper combines rapid prototyping and a novel SMA actuator to develop a new concept of modular and operative low-cost prosthetic hand.

Medicine patent pool--pharma philanthropy or PR?

PubMed

De Luca, Carmela

2015-01-01

Merck recently signed an agreement with The Medicines Patent Pool (MPP) to license intellectual property relating to pediatric formulations of its integrase HIV drug, raltegravir (Ral) (the 'Agreement'). The Agreement is alleged to clear the way for cheaper formulations for use in developing and some middle income countries and allows for the development of novel pediatric formulations of Ral as well as novel combinations. Merck's license is royalty free and under the terms of the Agreement, manufacturers anywhere in the world who meet the quality assurance criteria, can manufacture and sell pediatric versions of the drug in the licensed countries under the agreed conditions without paying a royalty to Merck. The Agreement covers at least 92 countries and MPP reports that 98.1% of children with HIV in the developing world live in the included countries. The Agreement has been criticized as a public relations exercise. The article asks if the criticism is justified and explores several aspects of the Agreement in addressing the question.

DIMP: an interoperable solution for software integration and product data exchange

NASA Astrophysics Data System (ADS)

Wang, Xi Vincent; Xu, Xun William

2012-08-01

Today, globalisation has become one of the main trends of manufacturing business that has led to a world-wide decentralisation of resources amongst not only individual departments within one company but also business partners. However, despite the development and improvement in the last few decades, difficulties in information exchange and sharing still exist in heterogeneous applications environments. This article is divided into two parts. In the first part, related research work and integrating solutions are reviewed and discussed. The second part introduces a collaborative environment called distributed interoperable manufacturing platform, which is based on a module-based, service-oriented architecture (SOA). In the platform, the STEP-NC data model is used to facilitate data-exchange among heterogeneous CAD/CAM/CNC systems.

MEMS Based Micro Aerial Vehicles

NASA Astrophysics Data System (ADS)

Joshi, Niranjan; Köhler, Elof; Enoksson, Peter

2016-10-01

Designing a flapping wing insect robot requires understanding of insect flight mechanisms, wing kinematics and aerodynamic forces. These subsystems are interconnected and their dependence on one another affects the overall performance. Additionally it requires an artificial muscle like actuator and transmission to power the wings. Several kinds of actuators and mechanisms are candidates for this application with their own strengths and weaknesses. This article provides an overview of the insect scaled flight mechanism along with discussion of various methods to achieve the Micro Aerial Vehicle (MAV) flight. Ongoing projects in Chalmers is aimed at developing a low cost and low manufacturing time MAV. The MAV design considerations and design specifications are mentioned. The wings are manufactured using 3D printed carbon fiber and are under experimental study.

A living foundry for Synthetic Biological Materials: A synthetic biology roadmap to new advanced materials.

PubMed

Le Feuvre, Rosalind A; Scrutton, Nigel S

2018-06-01

Society is on the cusp of harnessing recent advances in synthetic biology to discover new bio-based products and routes to their affordable and sustainable manufacture. This is no more evident than in the discovery and manufacture of Synthetic Biological Materials , where synthetic biology has the capacity to usher in a new Materials from Biology era that will revolutionise the discovery and manufacture of innovative synthetic biological materials. These will encompass novel, smart, functionalised and hybrid materials for diverse applications whose discovery and routes to bio-production will be stimulated by the fusion of new technologies positioned across physical, digital and biological spheres. This article, which developed from an international workshop held in Manchester, United Kingdom, in 2017 [1], sets out to identify opportunities in the new materials from biology era. It considers requirements, early understanding and foresight of the challenges faced in delivering a Discovery to Manufacturing Pipeline for synthetic biological materials using synthetic biology approaches. This challenge spans the complete production cycle from intelligent and predictive design, fabrication, evaluation and production of synthetic biological materials to new ways of bringing these products to market. Pathway opportunities are identified that will help foster expertise sharing and infrastructure development to accelerate the delivery of a new generation of synthetic biological materials and the leveraging of existing investments in synthetic biology and advanced materials research to achieve this goal.

Borates

USGS Publications Warehouse

Angulo, M.A.

2011-01-01

The article discusses the latest developments in the borates industry, particularly in the U.S., as of June 2011. It claims that the biggest economically feasible deposits of borates are seen in the U.S.' Mojave Desert, the Alpide belt in southern Asia and the Andean belt of South America. Turkish state-owned mining firm Eti Maden AS reported that borates were mainly used in the manufacture of glass, ceramics, fertilizer and detergent in 2009.

JPRS Report, Near East & South Asia.

DTIC Science & Technology

1988-03-15

pursue economic activity in manufacturing, agriculture, fish and animal resources, contracting, hotels , restaurants, retail, import, export and in...WIRTSCHAFT in German 13 Jan 88 p 2 [Article by W. An., Frankfurt: "Tunisia Develops Sahara Tourism; New Hotel Projects in Planning Stage; Trans- portation...In the comparable period of 1986 the figure was 355.8 million dinars. In 1987 roughly 87,000 tourist beds were used while in 1986 82,207 hotel

21 CFR 226.30 - Equipment.

Code of Federal Regulations, 2010 CFR

2010-04-01

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

24 CFR 3280.803 - Power supply.

Code of Federal Regulations, 2010 CFR

2010-04-01

...-Wiring Devices-Dimensional Specifications). (g) The overall length of a power-supply cord, measured from... supply shall be by means of: (1) One mast weatherhead installation installed in accordance with Article... underside of the manufactured home. The manufacturer shall provide in his written installation instructions...

Preparation of ormetoprim sulfadimethoxine medicated discs for disc diffusion assay

USDA-ARS?s Scientific Manuscript database

Romet (a blend of ormetoprim and sulfadimethoxine) is a typeA medicated article for the manufacture of medicated feed in the catfish industry. Recently, the commercial manufacture of ormetoprim–sulfadimethoxine susceptibility discs was discontinued. Ormetoprim–sulfadimethoxine discs were prepared at...

27 CFR 20.265 - Retention of invoices.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) Purchases of all essential oils, chemicals, and other materials used in manufacturing articles, including..., including the name and address of the vendor and the quantity; and (3) Dispositions of all articles...

26 CFR 48.4219-1 - Sales of taxable articles by a person other than the manufacturer, producer, or importer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... this rule: (1) The surviving spouse, child or children, executors or administrators, or other legal... a damage claim, such transfer is not considered a taxable sale of the article. If the article is...

26 CFR 48.4219-1 - Sales of taxable articles by a person other than the manufacturer, producer, or importer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... this rule: (1) The surviving spouse, child or children, executors or administrators, or other legal... a damage claim, such transfer is not considered a taxable sale of the article. If the article is...

26 CFR 48.4219-1 - Sales of taxable articles by a person other than the manufacturer, producer, or importer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... this rule: (1) The surviving spouse, child or children, executors or administrators, or other legal... a damage claim, such transfer is not considered a taxable sale of the article. If the article is...

The hierarchy of environmental health and safety practices in the U.S. nanotechnology workplace.

PubMed

Engeman, Cassandra D; Baumgartner, Lynn; Carr, Benjamin M; Fish, Allison M; Meyerhofer, John D; Satterfield, Terre A; Holden, Patricia A; Harthorn, Barbara Herr

2013-01-01

Manufacturing of nanoscale materials (nanomaterials) is a major outcome of nanotechnology. However, the potential adverse human health effects of manufactured nanomaterial exposure are not yet fully understood, and exposures in humans are mostly uncharacterized. Appropriate exposure control strategies to protect workers are still being developed and evaluated, and regulatory approaches rely largely on industry self-regulation and self-reporting. In this context of soft regulation, the authors sought to: 1) assess current company-reported environmental health and safety practices in the United States throughout the product life cycle, 2) consider their implications for the manufactured nanomaterial workforce, and 3) identify the needs of manufactured nanomaterial companies in developing nano-protective environmental health and safety practices. Analysis was based on the responses of 45 U.S.-based company participants in a 2009-2010 international survey of private companies that use and/or produce nanomaterials. Companies reported practices that span all aspects of the current government-recommended hierarchical approach to manufactured nanomaterials' exposure controls. However, practices that were tailored to current manufactured nanomaterials' hazard and exposure knowledge, whether within or outside the hierarchical approach, were reported less frequently than general chemical hygiene practices. Product stewardship and waste management practices-the influences of which are substantially downstream-were reported less frequently than most other environmental health and safety practices. Larger companies had more workers handling nanomaterials, but smaller companies had proportionally more employees handling nanomaterials and more frequently identified impediments to implementing nano-protective practices. Company-reported environmental health and safety practices suggest more attention to environmental health and safety is necessary, especially with regard to practices that can cause external effects. Given reported impediments, smaller companies may especially benefit from more attention. However, the manufactured nanomaterial workforce within smaller companies is particularly difficult to identify and hence locate, posing challenges to developing and enforcing appropriate workplace environmental health and safety. [Supplementary materials are available for this article. Go to the publisher's online edition of Journal of Occupational and Environmental Hygiene for the following free supplemental resource: a file containing Survey of Current Health and Safety Practices in the Nanomaterial Industry and a file containing figures.].

The global biopharma industry and the rise of Indian drug multinationals: implications for Australian generics policy.

PubMed

Löfgren, Hans

2007-06-01

This article provides a synopsis of the new dynamics of the global biopharma industry. The emergence of global generics companies with capabilities approximating those of 'big pharma' has accelerated the blurring of boundaries between the innovator and generics sectors. Biotechnology-based products form a large and growing segment of prescription drug markets and regulatory pathways for biogenerics are imminent. Indian biopharma multinationals with large-scale efficient manufacturing plants and growing R&D capabilities are now major suppliers of Active Pharmaceutical Ingredients (APIs) and generic drugs across both developed and developing countries. In response to generic competition, innovator companies employ a range of life cycle management techniques, including the launch of 'authorised generics'. The generics segment in Australia will see high growth rates in coming years but the prospect for local manufacturing is bleak. The availability of cheap generics in international markets has put pressure on Pharmaceutical Benefits Scheme (PBS) pricing arrangements, and a new policy direction was announced in November 2006. Lower generics prices will have a negative impact on some incumbent suppliers but industrial renewal policies for the medicines industry in Australia are better focused on higher value R&D activities and niche manufacturing of sophisticated products.

Cradle-to-Gate Life-Cycle Inventory and Impact Assessment of Wood Fuel Pellet Manufacturing from Hardwood Flooring Residues in the Southeastern United States

Treesearch

Daniel Reed; Richard Bergman; Jae-Woo Kim; Adam Tayler; David Harper; David Jones; Chris Knowles; Maureen E. Puettmann

2012-01-01

In this article, we present cradle-to-gate life-cycle inventory (LCI) data for wood fuel pellets manufactured in the Southeast United States. We surveyed commercial pellet manufacturers in 2010, collecting annual production data for 2009. Weighted-average inputs to, and emissions from, the pelletization process were determined. The pellet making unit process was...

Sensors for Metering Heat Flux Area Density and Metrological Equipment for the Heat Flux Density Measurement

NASA Astrophysics Data System (ADS)

Doronin, D. O.

2018-04-01

The demand in measuring and studies of heat conduction of various media is very urgent now. This article considers the problem of heat conduction monitoring and measurement in various media and materials in any industries and branches of science as well as metrological support of the heat flux measurement equipment. The main study objects are both the sensors manufactured and facilities onto which these sensors will be installed: different cladding structures of the buildings, awnings, rocket fairings, boiler units, internal combustion engines. The Company develops and manufactures different types of heat flux sensors: thermocouple, thin-film, heterogeneous gradient as well as metrological equipment for the gauging calibration of the heat flux density measurement. The calibration shall be performed using both referencing method in the unit and by fixed setting of the heat flux in the unit. To manufacture heterogeneous heat flux gradient sensors (HHFGS) the Company developed and designed a number of units: diffusion welding unit, HHFGS cutting unit. Rather good quality HHFGS prototypes were obtained. At this stage the factory tests on the equipment for the heat flux density measurement equipment are planned. A high-sensitivity heat flux sensor was produced, now it is tested at the Construction Physics Research Institute (Moscow). It became possible to create thin-film heat flux sensors with the sensitivity not worse than that of the sensors manufactured by Captec Company (France). The Company has sufficient premises to supply the market with a wide range of sensors, to master new sensor manufacture technologies which will enable their application range.

Design of forging process variables under uncertainties

NASA Astrophysics Data System (ADS)

Repalle, Jalaja; Grandhi, Ramana V.

2005-02-01

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

Intelligent freeform manufacturing of complex organs.

PubMed

Wang, Xiaohong

2012-11-01

Different from the existing tissue engineering strategies, rapid prototyping (RP) techniques aim to automatically produce complex organs directly from computer-aided design freeform models with high resolution and sophistication. Analogous to building a nuclear power plant, cell biology (especially, renewable stem cells), implantable biomaterials, tissue engineering, and single/double/four nozzle RP techniques currently enable researchers in the field to realize a part of the task of complex organ manufacturing. To achieve this multifaceted undertaking, a multi-nozzle rapid prototyping system which can simultaneously integrate an anti-suture vascular system, multiple cell types, and a cocktail of growth factors in a construct should be developed. This article reviews the pros and cons of the existing cell-laden RP techniques for complex organ manufacturing. It is hoped that with the comprehensive multidisciplinary efforts, the implants can virtually replace the functions of a solid internal organ, such as the liver, heart, and kidney. © 2012, Copyright the Author. Artificial Organs © 2012, International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Mirror, mirror on the wall--evaluating Fair Market Value for manufacturer-physician consulting arrangements.

PubMed

Eaton, Fred; Reid, Jaimee

2010-01-01

Pharmaceutical and medical device manufacturers contract with thousands of physicians each year, and struggle to comply with the Fair Market Value requirements of the Anti-Kickback Statute's "personal services" safe harbor. Consultant arrangements between physicians and manufactures have come under increasing scrutiny by regulators. In 2007, the five leading Hip & Knee manufacturers entered into settlement agreements related to their contract practices with physician consultants. Government sources do not provide guidance for calculating Fair Market Value; however, this article recommends four principles to use when evaluating Fair Market Value methodologies.

10 CFR 850.3 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

.... Beryllium article means a manufactured item that is formed to a specific shape or design during manufacture... particles. Immune response refers to the series of cellular events by which the immune system reacts to... medical removal from beryllium areas following a recommendation by the Site Occupational Medicine Director...

Additive Manufacturing of Fuel Injectors

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

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

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

49 CFR 173.426 - Excepted packages for articles containing natural uranium or thorium.

Code of Federal Regulations, 2013 CFR

2013-10-01

... uranium or thorium. 173.426 Section 173.426 Transportation Other Regulations Relating to Transportation....426 Excepted packages for articles containing natural uranium or thorium. A manufactured article in which the sole Class 7 (radioactive) material content is natural uranium, unirradiated depleted uranium...

49 CFR 173.426 - Excepted packages for articles containing natural uranium or thorium.

Code of Federal Regulations, 2014 CFR

2014-10-01

... uranium or thorium. 173.426 Section 173.426 Transportation Other Regulations Relating to Transportation....426 Excepted packages for articles containing natural uranium or thorium. A manufactured article in which the sole Class 7 (radioactive) material content is natural uranium, unirradiated depleted uranium...

49 CFR 173.426 - Excepted packages for articles containing natural uranium or thorium.

Code of Federal Regulations, 2012 CFR

2012-10-01

... uranium or thorium. 173.426 Section 173.426 Transportation Other Regulations Relating to Transportation....426 Excepted packages for articles containing natural uranium or thorium. A manufactured article in which the sole Class 7 (radioactive) material content is natural uranium, unirradiated depleted uranium...

Dense high temperature ceramic oxide superconductors

DOEpatents

Landingham, Richard L.

1993-01-01

Dense superconducting ceramic oxide articles of manufacture and methods for producing these articles are described. Generally these articles are produced by first processing these superconducting oxides by ceramic processing techniques to optimize materials properties, followed by reestablishing the superconducting state in a desired portion of the ceramic oxide composite.

Dense high temperature ceramic oxide superconductors

DOEpatents

Landingham, R.L.

1993-10-12

Dense superconducting ceramic oxide articles of manufacture and methods for producing these articles are described. Generally these articles are produced by first processing these superconducting oxides by ceramic processing techniques to optimize materials properties, followed by reestablishing the superconducting state in a desired portion of the ceramic oxide composite.

BN Bonded BN fiber article from boric oxide fiber

DOEpatents

Hamilton, Robert S.

1978-12-19

A boron nitride bonded boron nitride fiber article and the method for its manufacture which comprises forming a shaped article with a composition comprising boron oxide fibers and boric acid, heating the composition in an anhydrous gas to a temperature above the melting point of the boric acid and nitriding the resulting article in ammonia gas.

27 CFR 46.207 - Articles held in bond.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2012-04-01 2011-04-01 true Articles held in bond. 46... Tubes Held for Sale on April 1, 2009 Inventories § 46.207 Articles held in bond. If the dealer is a manufacturer or an export warehouse proprietor and holds articles in TTB bond on April 1, 2009, the floor...

27 CFR 46.207 - Articles held in bond.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2011-04-01 2011-04-01 false Articles held in bond. 46... Tubes Held for Sale on April 1, 2009 Inventories § 46.207 Articles held in bond. If the dealer is a manufacturer or an export warehouse proprietor and holds articles in TTB bond on April 1, 2009, the floor...

27 CFR 46.207 - Articles held in bond.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2013-04-01 2013-04-01 false Articles held in bond. 46... Tubes Held for Sale on April 1, 2009 Inventories § 46.207 Articles held in bond. If the dealer is a manufacturer or an export warehouse proprietor and holds articles in TTB bond on April 1, 2009, the floor...

27 CFR 46.207 - Articles held in bond.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2014-04-01 2014-04-01 false Articles held in bond. 46... Tubes Held for Sale on April 1, 2009 Inventories § 46.207 Articles held in bond. If the dealer is a manufacturer or an export warehouse proprietor and holds articles in TTB bond on April 1, 2009, the floor...

27 CFR 46.207 - Articles held in bond.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2010-04-01 2010-04-01 false Articles held in bond. 46... Tubes Held for Sale on April 1, 2009 Inventories § 46.207 Articles held in bond. If the dealer is a manufacturer or an export warehouse proprietor and holds articles in TTB bond on April 1, 2009, the floor...

Methods for tape fabrication of continuous filament composite parts and articles of manufacture thereof

DOEpatents

Weisberg, Andrew H

2013-10-01

A method for forming a composite structure according to one embodiment includes forming a first ply; and forming a second ply above the first ply. Forming each ply comprises: applying a bonding material to a tape, the tape comprising a fiber and a matrix, wherein the bonding material has a curing time of less than about 1 second; and adding the tape to a substrate for forming adjacent tape winds having about a constant distance therebetween. Additional systems, methods and articles of manufacture are also presented.

Interaction of microwaves with carbon nanotubes to facilitate modification

NASA Technical Reports Server (NTRS)

Tour, James M. (Inventor); Dyke, Christopher A. (Inventor); Stephenson, Jason J. (Inventor); Yakobson, Boris I. (Inventor)

2011-01-01

The present invention is directed toward methods of crosslinking carbon nanotubes to each other using microwave radiation, articles of manufacture produced by such methods, compositions produced by such methods, and applications for such compositions and articles of manufacture. The present invention is also directed toward methods of radiatively modifying composites and/or blends comprising carbon nanotubes with microwaves, and to the compositions produced by such methods. In some embodiments, the modification comprises a crosslinking process, wherein the carbon nanotubes serve as a conduit for thermally and photolytically crosslinking the host matrix with microwave radiation.

Supply chain coordination with two production modes and random demand depending on advertising expenditure and selling price

NASA Astrophysics Data System (ADS)

Wang, Sheng-Dong; Zhou, Yong-Wu; Wang, Jun-Ping

2010-10-01

This article discusses production and order as well as advertising coordination issues in a single-manufacturer single-buyer supply chain, where the manufacturer sells a newsvendor-type product through the buyer who faces a random demand depending on advertising expenditure and selling price. The buyer has two ordering opportunities: the one happens before the beginning of the season, and the other takes place at the end of the season. The ordered items are produced by the manufacturer in two production modes for different requirements. The first production mode is relatively cheap but requires a long lead-time, whereas the second is expensive but offers quick response. Under such a setting, the centralised and decentralised decision models are developed, respectively, and the closed form solution to each model is provided as well. Moreover, we point out that the traditional revenue-sharing contract fails to coordinate the supply chain. We thus propose an improved revenue-sharing contract that requests the manufacturer not only shares the buyer's revenue but also bears a portion of the buyer's operating costs. Such a contract can achieve perfect coordination of the supply chain and arbitrarily allocate its profit between two parties.

Cellular Therapies Clinical Research Roadmap: lessons learned on how to move a cellular therapy into a clinical trial.

PubMed

Ouseph, Stacy; Tappitake, Darah; Armant, Myriam; Wesselschmidt, Robin; Derecho, Ivy; Draxler, Rebecca; Wood, Deborah; Centanni, John M

2015-04-01

A clinical research roadmap has been developed as a resource for researchers to identify critical areas and potential pitfalls when transitioning a cellular therapy product from the research laboratory, by means of an Investigational New Drug (IND) application, into early-phase clinical trials. The roadmap describes four key areas: basic and preclinical research, resource development, translational research and Good Manufacturing Practice (GMP) and IND assembly and submission. Basic and preclinical research identifies a new therapeutic concept and demonstrates its potential value with the use of a model of the relevant disease. During resource development, the appropriate specialists and the required expertise to bring this product into the clinic are identified (eg, researchers, regulatory specialists, GMP manufacturing staff, clinicians and clinical trials staff, etc). Additionally, the funds required to achieve this goal (or a plan to procure them) are identified. In the next phase, the plan to translate the research product into a clinical-grade therapeutic is developed. Finally regulatory approval to start the trial must be obtained. In the United States, this is done by filing an IND application with the Food and Drug Administration. The National Heart, Lung and Blood Institute-funded Production Assistance for Cellular Therapies program has facilitated the transition of a variety of cellular therapy products from the laboratory into Phase1/2 trials. The five Production Assistance for Cellular Therapies facilities have assisted investigators by performing translational studies and GMP manufacturing to ensure that cellular products met release specifications and were manufactured safely, reproducibly and at the appropriate scale. The roadmap resulting from this experience is the focus of this article. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Ethical pharmaceutical promotion and communications worldwide: codes and regulations

PubMed Central

2014-01-01

The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice. Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines. PMID:24679064

Ethical pharmaceutical promotion and communications worldwide: codes and regulations.

PubMed

Francer, Jeffrey; Izquierdo, Jose Zamarriego; Music, Tamara; Narsai, Kirti; Nikidis, Chrisoula; Simmonds, Heather; Woods, Paul

2014-03-29

The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice.Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines.

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.

Prescription for fairness: a new approach to tort liability of brand-name and generic drug manufacturers.

PubMed

Rostron, Allen

2011-02-01

Over the past two decades, courts have consistently ruled that the manufacturer of a brand-name prescription drug cannot be liable for injuries suffered by those taking generic imitations of its product. This meant that a patient injured by a generic drug could have no remedy at all because in many instances the generic drug manufacturer would escape liability on the ground that it did not produce any information on which the patient's doctor relied. It was a perplexing dilemma. The generic drug manufacturer made the product that the plaintiff received, the brand-name manufacturer produced all of the information the patient's doctor saw, and neither manufacturer could be held liable even if each acted negligently. The California Court of Appeal recently issued a stunning decision in which it concluded that a brand-name drug manufacturer could be liable to a plaintiff who took a generic version of its product. The reaction to the decision has been overwhelmingly negative. Commentators have condemned the decision as one of the worst rulings made by any court in recent years. Judges around the country have dismissed it as a misguided aberration from the otherwise strong judicial consensus on the issue. Although the decision has been the subject of scathing criticism, this Article argues that the California court's ruling actually represents the first time that a court has properly examined this issue. In addition, the Article points out some weaknesses in the California court's reasoning and proposes a novel general framework for analyzing the liability of brand-name and generic drug manufacturers.

The impact of two pharmaceutical risk-sharing agreements on pricing, promotion, and net health benefits.

PubMed

Zaric, Gregory S; Xie, Bin

2009-01-01

Health insurers are increasingly making use of risk-sharing agreements with drug manufacturers to manage uncertainties regarding the costs and effectiveness of new drugs. Several risk-sharing models exist including those based on sales volume, achievement of clinical thresholds, and achievement of cost-effectiveness thresholds. The objective of this article is to compare two risk-sharing arrangements and to investigate conditions under which each is preferable from the perspective of the payer and the manufacturer. We develop two two-period models to compare two risk-sharing arrangements between a payer and a drug manufacturer in which there is uncertainty about the effectiveness of the new drug. In the first risk-sharing agreement, the drug is listed on a formulary in the first period but delisted in the second period if the net monetary benefit in the first period is negative. In the second risk-sharing agreement, the manufacturer pays a rebate in each period if the net monetary benefit in that period is negative. We show that the relative performance of the two arrangements depends on several factors and that neither arrangement is always preferred. Additionally, we are able to identify situations in which a payer and a manufacturer would prefer the same plan and other situations in which the two parties would disagree on which plan was most desirable. Because neither risk-sharing arrangement is always preferred, payers and manufacturers must carefully consider the characteristics of their individual situation when entering into such contracts.

Raw material variability of an active pharmaceutical ingredient and its relevance for processability in secondary continuous pharmaceutical manufacturing.

PubMed

Stauffer, F; Vanhoorne, V; Pilcer, G; Chavez, P-F; Rome, S; Schubert, M A; Aerts, L; De Beer, T

2018-06-01

Active Pharmaceutical Ingredients (API) raw material variability is not always thoroughly considered during pharmaceutical process development, mainly due to low quantities of drug substance available. However, synthesis, crystallization routes and production sites evolve during product development and product life cycle leading to changes in physical material attributes which can potentially affect their processability. Recent literature highlights the need for a global approach to understand the link between material synthesis, material variability, process and product quality. The study described in this article aims at explaining the raw material variability of an API using extensive material characterization on a restricted number of representative batches using multivariate data analysis. It is part of a larger investigation trying to link the API drug substance manufacturing process, the resulting physical API raw material attributes and the drug product continuous manufacturing process. Eight API batches produced using different synthetic routes, crystallization, drying, delumping processes and processing equipment were characterized, extensively. Seventeen properties from seven characterization techniques were retained for further analysis using Principal Component Analysis (PCA). Three principal components (PCs) were sufficient to explain 92.9% of the API raw material variability. The first PC was related to crystal length, agglomerate size and fraction, flowability and electrostatic charging. The second PC was driven by the span of the particle size distribution and the agglomerates strength. The third PC was related to surface energy. Additionally, the PCA allowed to summarize the API batch-to-batch variability in only three PCs which can be used in future drug product development studies to quantitatively evaluate the impact of the API raw material variability upon the drug product process. The approach described in this article could be applied to any other compound which is prone to batch-to-batch variability. Copyright © 2018 Elsevier B.V. All rights reserved.

40 CFR 372.3 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... means Title III. Article means a manufactured item: (1) Which is formed to a specific shape or design during manufacture; (2) which has end use functions dependent in whole or in part upon its shape or design during end use; and (3) which does not release a toxic chemical under normal conditions of...

26 CFR 48.4218-4 - Use in further manufacture.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 16 2010-04-01 2010-04-01 true Use in further manufacture. 48.4218-4 Section 48.4218-4 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) MISCELLANEOUS... wholly consumed in quality testing a production run of like articles (as, for example, an automotive part...

CNC Preparation Meets Manufacturing Opportunity

ERIC Educational Resources Information Center

Cassola, Joel

2006-01-01

This article features the machining technology program at Cape Fear Community College (CFCC) of Wilmington, North Carolina. North Carolina's Cape Fear Community College is working to meet diverse industry needs through its CNC training. The school's program has gained the attention of the local manufacturing community and students when it shifted…

General Tips Concerning What Has Been Learned About Cotton Processing in Traditional Textile Manufacturing

USDA-ARS?s Scientific Manuscript database

This article, under the following sub-headings, briefly describes a few important practical tips involving processing of cotton in traditional textile manufacturing: (1)Bale Selection and Fiber Mixing, (2) Fiber Opening and Cleaning, (3) Carding, (4) Drawing, (5) Combing (if necessary), (6) Roving, ...

The 1995 Medical Device Technology raw materials survey.

PubMed

Pearson, L S

1995-09-01

Using information supplied by manufacturers, this article reports on the use of raw materials and compounding and conversion practices in the European medical device manufacturing industry. The findings of the survey provide an indication of which materials are being used and how frequently, and the process of selecting suppliers.

26 CFR 48.4161(b)-3 - Use considered sale.

Code of Federal Regulations, 2010 CFR

2010-04-01

....4161(b)-3 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) MISCELLANEOUS EXCISE TAXES MANUFACTURERS AND RETAILERS EXCISE TAXES Sporting Goods § 48.4161(b)-3 Use considered sale. For provisions relating to the tax on use of taxable articles by the manufacturer, producer, or...

26 CFR 48.4161(a)-4 - Use considered sale.

Code of Federal Regulations, 2010 CFR

2010-04-01

....4161(a)-4 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) MISCELLANEOUS EXCISE TAXES MANUFACTURERS AND RETAILERS EXCISE TAXES Sporting Goods § 48.4161(a)-4 Use considered sale. For provisions relating to the tax on use of taxable articles by the manufacturer, producer, or...

Advanced Manufacturing as an Online Case Study for Global Geography Education

ERIC Educational Resources Information Center

Glass, Michael R.; Kalafsky, Ronald V.; Drake, Dawn M.

2013-01-01

Advanced manufacturing continues to be an important sector for emerging and industrialized economies, therefore, remaining an important topic for economic geography education. This article describes a case study created for the Association of American Geographer's Center for Global Geography Education and its implementation. The international…

From Old 2 New

ERIC Educational Resources Information Center

Engstrom, Daniel E.; Boulton, Janice L.; Wurzelbacher, Lisa

2004-01-01

This article describes an integrated activity that can teach students important lessons in recycling, manufacturing, measurement, art, and ecology, while at the same time putting old crayons to good use. The activity involved organizing fourth-grade students into a manufacturing company that would melt old crayons into molds to form a new product…

Evaluating pet foods: how confident are you when you recommend a commercial pet food?

PubMed

Zicker, Steven C

2008-08-01

The safety, adequacy, and efficacy of pet foods are important considerations for veterinarians and consumers. Manufacturers of pet foods in the United States are required to comply with multiple regulations from a variety of governmental and state agencies to market foods in the public sector. However, consumers and veterinarians may not be aware of the multiple systems in place that help ensure the safety and adequacy of foods for their pets. Since the veterinarian occupies a key role to make recommendations to consumers regarding pet foods, it is the purpose of this article to review the processes of pet food manufacturing, as well as the processes that have been developed to help ensure safety and adequacy of pet foods in the United States.

Oil from hydrocracking as a raw material for the production of white oils

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

Potanina, V.A.; Dremova, T.I.; Ponomareva, T.P.

1984-01-01

This article investigates the feasibility of using distillate oil from hydrocracking for white oil production. A process technology has been developed in the USSR for the manufacture of high-quality oils by hydrocracking a heavy distillate feed in high-pressure equipment. The neutral and hydrocracked oil sample and a blend of these stocks were subjected to treatment with oleum, neutralization with 65% ethyl alcohol, and contact finishing to obtain white oils. The physicochemical properties of the white oils are given. It is determined that the hydrocracked oil can be used as the raw material in manufacturing perfume oil meeting the standard GOSTmore » 4225-76, and that the blends can be used to obtain pharmaceutical white oil meeting the standard GOST 3164-78.« less

Friction Stir Additive Manufacturing: Route to High Structural Performance

NASA Astrophysics Data System (ADS)

Palanivel, S.; Sidhar, H.; Mishra, R. S.

2015-03-01

Aerospace and automotive industries provide the next big opportunities for additive manufacturing. Currently, the additive industry is confronted with four major challenges that have been identified in this article. These challenges need to be addressed for the additive technologies to march into new frontiers and create additional markets. Specific potential success in the transportation sectors is dependent on the ability to manufacture complicated structures with high performance. Most of the techniques used for metal-based additive manufacturing are fusion based because of their ability to fulfill the computer-aided design to component vision. Although these techniques aid in fabrication of complex shapes, achieving high structural performance is a key problem due to the liquid-solid phase transformation. In this article, friction stir additive manufacturing (FSAM) is shown as a potential solid-state process for attaining high-performance lightweight alloys for simpler geometrical applications. To illustrate FSAM as a high-performance route, manufactured builds of Mg-4Y-3Nd and AA5083 are shown as examples. In the Mg-based alloy, an average hardness of 120 HV was achieved in the built structure and was significantly higher than that of the base material (97 HV). Similarly for the Al-based alloy, compared with the base hardness of 88 HV, the average built hardness was 104 HV. A potential application of FSAM is illustrated by taking an example of a simple stiffener assembly.

From R&D to the mouth--a viable roadmap for the technology era.

PubMed

Simon, M

1996-09-01

This article serves as an overview of the status of dental technology as the profession approaches a new century. Its purpose is to define various ways in which dental manufacturers and marketers can better understand the thinking of the dental professional, those factors that influence their thought processes and how to use this information to develop more effective and predictive marketing strategies. With the advent of more complex and expensive dental technologies, e.g., video imaging, digitized radiology, electronic data transmission, etc., the dentist is faced with a variety of decisions relating to purchasing, implementation and costs/benefits analysis that go beyond the normal daily concerns of delivering competent dental care. It is no longer enough for a manufacturer to make a good product; successful marketing strategies must also include a means for guiding the dentist in the successful integration of these technologies into their offices. In order for dental marketers to meet the competitive demands of this advanced technology era, there must be a commitment to the development of strategic information through the use of third party, customized marketing research. Too much of the input currently used to develop marketing strategies is anecdotal, inherently biased and often not representative of the target market as a whole. It is hoped that this article will effectively challenge the reader to look at the development of dental products and services from a somewhat different, less traditional perspective and that it will provide the impetus and direction for creating better targeted and more rewarding marketing strategies.

Scientific Challenges in the Risk Assessment of Food Contact Materials.

PubMed

Muncke, Jane; Backhaus, Thomas; Geueke, Birgit; Maffini, Maricel V; Martin, Olwenn Viviane; Myers, John Peterson; Soto, Ana M; Trasande, Leonardo; Trier, Xenia; Scheringer, Martin

2017-09-11

Food contact articles (FCAs) are manufactured from food contact materials (FCMs) that include plastics, paper, metal, glass, and printing inks. Chemicals can migrate from FCAs into food during storage, processing, and transportation. Food contact materials' safety is evaluated using chemical risk assessment (RA). Several challenges to the RA of FCAs exist. We review regulatory requirements for RA of FCMs in the United States and Europe, identify gaps in RA, and highlight opportunities for improving the protection of public health. We intend to initiate a discussion in the wider scientific community to enhance the safety of food contact articles. Based on our evaluation of the evidence, we conclude that current regulations are insufficient for addressing chemical exposures from FCAs. RA currently focuses on monomers and additives used in the manufacture of products, but it does not cover all substances formed in the production processes. Several factors hamper effective RA for many FCMs, including a lack of information on chemical identity, inadequate assessment of hazardous properties, and missing exposure data. Companies make decisions about the safety of some food contact chemicals (FCCs) without review by public authorities. Some chemical migration limits cannot be enforced because analytical standards are unavailable. We think that exposures to hazardous substances migrating from FCAs require more attention. We recommend a ) limiting the number and types of chemicals authorized for manufacture and b ) developing novel approaches for assessing the safety of chemicals in FCAs, including unidentified chemicals that form during or after production. https://doi.org/10.1289/EHP644.

Cell and Gene Therapies: European View on Challenges in Translation and How to Address Them

PubMed Central

Rousseau, Cécile F.; Mačiulaitis, Romaldas; Śladowski, Dariusz; Narayanan, Gopalan

2018-01-01

Advanced therapy medicinal products (ATMPs), i.e., cell and gene therapy products, is a rapidly evolving field of therapeutic development. A significant proportion of the products are being developed by academia or small/medium-sized enterprises (SMEs). The many challenges in translation posed by this class of products include aspects covering: manufacturing, non-clinical development plan as relevant to clinical trial, marketing authorization, and reimbursement. In this context, the term translation refers to the relevance of non-clinical data in relation to how it impacts on appropriate and efficient clinical development. In order to successfully overcome these challenges, a clear understanding of the requirements and expectations of all the stakeholders is critical. This article aims to cover the potential challenges related to such translation and suggested approaches to find solutions based on experience and learnings from the perspective of European Union. While commercial challenges have a significant impact on the ATMPs in general, it is considered outside the scope of this article. However, by adopting a strong scientific basis for translation as suggested in this article, it is likely such an approach would help rather than harm successful real world clinical use of ATMPs.

Technical manual for manufacturing autologous fibrin tissue adhesive.

PubMed

Park, J J; Cintron, J R; Siedentop, K H; Orsay, C P; Pearl, R K; Nelson, R L; Abcarian, H

1999-10-01

The aim of this article is to provide a concise and simple technical manual for manufacturing autologous fibrin tissue adhesive derived from the precipitation of fibrinogen using a combination of ethanol and freezing for surgery. All materials and equipment needed to manufacture ethanol-based autologous fibrin tissue adhesive are listed. In addition, step-by-step instructions are provided to allow for easy and rapid fibrin adhesive production. Ethanol-based autologous fibrin tissue adhesive can be manufactured in under 60 minutes. Furthermore, at our institution the startup cost for manufacturing ethanol-based autologous fibrin tissue adhesive was under $2,500.00. Ethanol-based autologous fibrin tissue adhesive is a safe, reliable, and easily manufactured autologous fibrin tissue adhesive that can be made by a trained technician in any blood bank, pharmacy, or surgical laboratory.

26 CFR 48.6412-1 - Floor stocks credit or refund.

Code of Federal Regulations, 2010 CFR

2010-04-01

...; and (D) The quantity of articles held by the dealer as floor stocks on the inventory date. (3) Actual... Revenue Code of 1954 with respect to the articles in my inventory on _____. (Name) By (Signature of... refund authorized by section 6412 for manufacturers excise taxes paid in respect of certain articles held...

Design and Manufacture of Structurally Efficient Tapered Struts

NASA Technical Reports Server (NTRS)

Brewster, Jebediah W.

2009-01-01

Composite materials offer the potential of weight savings for numerous spacecraft and aircraft applications. A composite strut is just one integral part of the node-to-node system and the optimization of the shut and node assembly is needed to take full advantage of the benefit of composites materials. Lockheed Martin designed and manufactured a very light weight one piece composite tapered strut that is fully representative of a full scale flight article. In addition, the team designed and built a prototype of the node and end fitting system that will effectively integrate and work with the full scale flight articles.

Communications device identification methods, communications methods, wireless communications readers, wireless communications systems, and articles of manufacture

DOEpatents

Steele, Kerry D [Kennewick, WA; Anderson, Gordon A [Benton City, WA; Gilbert, Ronald W [Morgan Hill, CA

2011-02-01

Communications device identification methods, communications methods, wireless communications readers, wireless communications systems, and articles of manufacture are described. In one aspect, a communications device identification method includes providing identification information regarding a group of wireless identification devices within a wireless communications range of a reader, using the provided identification information, selecting one of a plurality of different search procedures for identifying unidentified ones of the wireless identification devices within the wireless communications range, and identifying at least some of the unidentified ones of the wireless identification devices using the selected one of the search procedures.

Document clustering methods, document cluster label disambiguation methods, document clustering apparatuses, and articles of manufacture

DOEpatents

Sanfilippo, Antonio [Richland, WA; Calapristi, Augustin J [West Richland, WA; Crow, Vernon L [Richland, WA; Hetzler, Elizabeth G [Kennewick, WA; Turner, Alan E [Kennewick, WA

2009-12-22

Document clustering methods, document cluster label disambiguation methods, document clustering apparatuses, and articles of manufacture are described. In one aspect, a document clustering method includes providing a document set comprising a plurality of documents, providing a cluster comprising a subset of the documents of the document set, using a plurality of terms of the documents, providing a cluster label indicative of subject matter content of the documents of the cluster, wherein the cluster label comprises a plurality of word senses, and selecting one of the word senses of the cluster label.

Data on the surface morphology of additively manufactured Ti-6Al-4V implants during processing by plasma electrolytic oxidation.

PubMed

van Hengel, Ingmar A J; Riool, Martijn; Fratila-Apachitei, Lidy E; Witte-Bouma, Janneke; Farrell, Eric; Zadpoor, Amir A; Zaat, Sebastian A J; Apachitei, Iulian

2017-08-01

Additively manufactured Ti-6Al-4V implants were biofunctionalized using plasma electrolytic oxidation. At various time points during this process scanning electron microscopy imaging was performed to analyze the surface morphology (van Hengel et al., 2017) [1]. This data shows the changes in surface morphology during plasma electrolytic oxidation. Data presented in this article are related to the research article "Selective laser melting porous metallic implants with immobilized silver nanoparticles kill and prevent biofilm formation by methicillin-resistant Staphylococcus aureus" (van Hengel et al., 2017) [1].

[Requirements for CE-marking of apps and wearables].

PubMed

Berensmann, Michael; Gratzfeld, Markus

2018-03-01

Depending on the intended use, apps and wearables can be medical devices. In such cases, the manufacturer has to provide evidence that the requirements stated in directive 93/42/EWG are fulfilled. Depending on the classification of the medical device, several so-called conformity assessment procedures are possible. Once the conformity assessment procedure has been finished successfully, the manufacturer attaches the CE-marking to the product. This assures that all requirements of the directive have been fulfilled and the manufacturer is therefore authorized to put the product onto the market in all member states of the European union. In this article, the possible and practical conformity assessment procedures for apps and wearables are described and their implementation is outlined.For medical devices with sufficiently high-risk classification, the manufacturer has to involve a Notified Body. For the conformity assessment procedure according to annex II, the manufacturer implements a full quality management system and compiles technical documentation. These are supervised and evaluated by Notified Body audits. Especially for startups, it is important for the development of apps and wearables to implement a quality management system early and to fulfill the regulatory requirements, for example, related to the software life-cycle model. This also includes considering accompanying processes during development like risk management, usability engineering, and clinical evaluation.Additionally, it should be pointed out, that according to the new medical device regulation almost all apps will fall at least into class IIa. Thus, the involvement of a Notified Body in the related conformity assessment procedures would be required. Apps that have already been put onto the market as class I devices, and are now upgraded to a higher class, need the approval of a notified body starting from 26 May 2020.

Making Breakthroughs in the Turbulent Decade: China's Space Technology During the Cultural Revolution.

PubMed

Li, Chengzhi; Zhang, Dehui; Hu, Danian

2017-09-01

This article discusses why Chinese space programs were able to develop to the extent they did during the turbulent decade of the Cultural Revolution (1966-1976). It first introduces briefly what China had accomplished in rocket and missile technology before the Cultural Revolution, including the establishment of a system for research and manufacturing, breakthroughs in rocket technology, and programs for future development. It then analyzes the harmful impacts of the Cultural Revolution on Chinese space programs by examining activities of contemporary mass factions in the Seventh Ministry of Machinery Industry. In the third section, this article presents the important developments of Chinese space programs during the Cultural Revolution and explores briefly the significance of these developments for the future and overall progress in space technology. Finally, it discusses the reasons for the series of developments of Chinese space technology during the Cultural Revolution. This article concludes that, although the Cultural Revolution generated certain harmful impacts on the development of Chinese space technology, the Chinese essentially accomplished their scheduled objectives in their space program, both because of the great support of top Chinese leaders, including the officially disgraced Lin Biao and the Gang of Four, and due to the implementation of many effective special measures. Copyright © 2017 Elsevier Ltd. All rights reserved.

Regulatory aspects in the pharmaceutical development of nanoparticle drug delivery systems designed to cross the intestinal epithelium and M-cells.

PubMed

Hussain, Nasir

2016-11-30

This article reviews the field of oral uptake of nanoparticles across the gastrointestinal epithelium for the period 2006-2016. Analysis is conducted from the viewpoint of i) M-cell genetics and model development, ii) drug targeting to Peyer's patches and M-cells, and iii) physicochemical interactions of nanoparticles in the intestinal milieu. In light of these recent developments, regulatory considerations in the development of orally-absorbable nanoparticle drug products are discussed and focused on Module 3.2.P sub-sections of the Common Technical Document. Particular attention is paid to novel excipients, ligands and the non-standard method of manufacture. The novelty of this drug delivery system demands not only a multi-disciplinary scientific and regulatory approach but also a risk-adjusted consideration for a system defined by both processes and specifications. Given the current state of scientific development in the field it is suggested (in the author's personal opinion) that the design of nanoparticulate drug delivery systems should be kept as simple as possible (from a regulatory and manufacturing perspective) and to target the entire gastrointestinal epithelium. Crown Copyright © 2016. Published by Elsevier B.V. All rights reserved.

Process for spinning flame retardant elastomeric compositions. [fabricating synthetic fibers for high oxygen environments

NASA Technical Reports Server (NTRS)

Howarth, J. T.; Sheth, S.; Sidman, K. R.; Massucco, A. A. (Inventor)

1978-01-01

Flame retardant elastomeric compositions comprised of either spandex type polyurethane having halogen containing polyols incorporated into the polymer chain, conventional spandex type polyurethanes in physical admixture with flame retardant additives, or fluoroelastomeric resins in physical admixture with flame retardant additives were developed. Methods are described for preparing fibers of the flame retardant elastomeric materials and manufactured articles as well as nonelastic materials such as polybenzimidazoles, fiberglass, and nylons, for high oxygen environments.

Framework for Identifying Cybersecurity Risks in Manufacturing

DOE PAGES

Hutchins, Margot J.; Bhinge, Raunak; Micali, Maxwell K.; ...

2015-10-21

Increasing connectivity, use of digital computation, and off-site data storage provide potential for dramatic improvements in manufacturing productivity, quality, and cost. However, there are also risks associated with the increased volume and pervasiveness of data that are generated and potentially accessible to competitors or adversaries. Enterprises have experienced cyber attacks that exfiltrate confidential and/or proprietary data, alter information to cause an unexpected or unwanted effect, and destroy capital assets. Manufacturers need tools to incorporate these risks into their existing risk management processes. This article establishes a framework that considers the data flows within a manufacturing enterprise and throughout its supplymore » chain. The framework provides several mechanisms for identifying generic and manufacturing-specific vulnerabilities and is illustrated with details pertinent to an automotive manufacturer. Finally, in addition to providing manufacturers with insights into their potential data risks, this framework addresses an outcome identified by the NIST Cybersecurity Framework.« less

Framework for Identifying Cybersecurity Risks in Manufacturing

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

Hutchins, Margot J.; Bhinge, Raunak; Micali, Maxwell K.

Increasing connectivity, use of digital computation, and off-site data storage provide potential for dramatic improvements in manufacturing productivity, quality, and cost. However, there are also risks associated with the increased volume and pervasiveness of data that are generated and potentially accessible to competitors or adversaries. Enterprises have experienced cyber attacks that exfiltrate confidential and/or proprietary data, alter information to cause an unexpected or unwanted effect, and destroy capital assets. Manufacturers need tools to incorporate these risks into their existing risk management processes. This article establishes a framework that considers the data flows within a manufacturing enterprise and throughout its supplymore » chain. The framework provides several mechanisms for identifying generic and manufacturing-specific vulnerabilities and is illustrated with details pertinent to an automotive manufacturer. Finally, in addition to providing manufacturers with insights into their potential data risks, this framework addresses an outcome identified by the NIST Cybersecurity Framework.« less

16 CFR 1616.31 - Labeling, recordkeeping, retail display and guaranties.

Code of Federal Regulations, 2010 CFR

2010-01-01

... process of manufacture of each production unit of articles of children's sleepwear, or fabrics or related... production unit or by style. A style is a garment design or grouping, preselected by the manufacturer. A... garment design or on the garment packages. A style is a garment design or grouping, preselected by the...

Manufacturing of tattoo ink products today and in future: Europe.

PubMed

Michel, Ralf

2015-01-01

The article describes the European market situation and the legal framework in Europe. It shows the state-of-the-art production under ISO 9001:2008 quality management and describes the future of tattoo ink production based on good manufacturing practice guidelines for tattoo inks. © 2015 S. Karger AG, Basel.

27 CFR 53.103 - Lease considered as sale.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2012-04-01 2011-04-01 true Lease considered as sale... Provisions Applicable to Manufacturers Taxes § 53.103 Lease considered as sale. For purposes of chapter 32 of the Code, the lease of an article by a manufacturer, producer, or importer shall be considered a sale...

26 CFR 48.4161(b)-3 - Use considered sale.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 16 2011-04-01 2011-04-01 false Use considered sale. 48.4161(b)-3 Section 48... sale. For provisions relating to the tax on use of taxable articles by the manufacturer, producer, or importer thereof, see section 4218 relating to use by a manufacturer considered a sale, and the regulations...

26 CFR 48.4161(a)-4 - Use considered sale.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 16 2011-04-01 2011-04-01 false Use considered sale. 48.4161(a)-4 Section 48... sale. For provisions relating to the tax on use of taxable articles by the manufacturer, producer, or importer thereof, see section 4218 relating to use by a manufacturer being considered a sale, and the...

General Tips of What Little This Author has Learned of Cotton Processing in Traditional Textile Manufacturing

USDA-ARS?s Scientific Manuscript database

This article, under the following sub-headings, only lists a few very important tips that the author has experienced in his career involving processing of cotton in the traditional textile manufacturing: (1) Fiber Opening and Cleaning (2) Carding (3) Drawing (4) Combing, if necessary (5) Roving (6)...

21 CFR 178.3910 - Surface lubricants used in the manufacture of metallic articles.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Surface lubricants used in the manufacture of... substances Limitations α-Butyl-Ω--hydroxypoly (oxyethylene)-poly (oxypropylene) (CAS Reg. No. 9038-95-3.... 9004-81-3) having a minimum molecular weight of 200 Acetate esters derived from synthetic straight...

Southern Pennsylvania's Industrial Pipeline: "Pathways" Program Helps Local Manufacturers Find Quality Workers

ERIC Educational Resources Information Center

Dixon, John; Girifalco, Tony; Yakabosky, Walt

2008-01-01

This article describes the Applied Engineering Technology (AET) Career and Educational Pathways Program, which helps local manufacturers find quality workers. The program features 32 high schools, three community colleges, and 10 four-year institutions offering an integrated regional system of applied engineering education. The goal is to enroll…

16 CFR 1199.1 - Children's toys and child care articles: Phthalate-containing inaccessible component parts.

Code of Federal Regulations, 2014 CFR

2014-01-01

... product designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3..., however, vinyl (or other plasticized material) covered mattresses/sleep surfaces, that contain phthalates that are designed or intended by the manufacturer to facilitate sleep of children age 3 and younger...

Recent trends in laboratory automation in the pharmaceutical industry.

PubMed

Rutherford, M L; Stinger, T

2001-05-01

The impact of robotics and automation on the pharmaceutical industry over the last two decades has been significant. In the last ten years, the emphasis of laboratory automation has shifted from the support of manufactured products and quality control of laboratory applications, to research and development. This shift has been the direct result of an increased emphasis on the identification, development and eventual marketing of innovative new products. In this article, we will briefly identify and discuss some of the current trends in laboratory automation in the pharmaceutical industry as they apply to research and development, including screening, sample management, combinatorial chemistry, ADME/Tox and pharmacokinetics.

Utilization Elementary Siphons of Petri Net to Solved Deadlocks in Flexible Manufacturing Systems

NASA Astrophysics Data System (ADS)

Abdul-Hussin, Mowafak Hassan

2015-07-01

This article presents an approach to the constructing a class structural analysis of Petri nets, where elementary siphons are mainly used in the development of a deadlock control policy of flexible manufacturing systems (FMSs), that has been exploited successfully for the design of supervisors of some supervisory control problems. Deadlock-free operation of FMSs is significant objectives of siphons in the Petri net. The structure analysis of Petri net models has efficiency in control of FMSs, however different policy can be implemented for the deadlock prevention. Petri nets models based deadlock prevention for FMS's has gained considerable interest in the development of control theory and methods for design, controlling, operation, and performance evaluation depending of the special class of Petri nets called S3PR. Both structural analysis and reachability tree analysis is used for the purposes analysis, simulation and control of Petri nets. In our ex-perimental approach based to siphon is able to resolve the problem of deadlock occurred to Petri nets that are illustrated with an FMS.

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

PubMed

Revilla-León, Marta; Özcan, Mutlu

2018-04-22

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

Configuration of management accounting information system for multi-stage manufacturing

NASA Astrophysics Data System (ADS)

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

2018-05-01

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

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.

When your contract manufacturer becomes your competitor.

PubMed

Arruñda, Benito; Vázquez, Xosé H

2006-09-01

PC maker Lenovo started out as a distributor of equipment made by IBM and other companies; now it has formed a joint venture with IBM and will eventually affix its own logo to its computers. Shanghai Automotive Industry Corporation (SAIC) started out manufacturing vehicles for Volkswagen and GM; now it's preparing to sell its own cars in China, Europe, and North America. Lenovo and SAIC represent a host of formerly anonymous makers of brand-name products that are breaking out of their defined roles and pushing the brands themselves aside. In this article, the authors explore the double-edged relationships original equipment manufacturers (OEMs) forge with their contract manufacturers (CMs). On the one hand, an OEM can reduce its labor costs, free up capital, and improve worker productivity by outsourcing all the manufacturing of a product. The company can then concentrate on value-adding activities--research and development, product design, and marketing, for instance. On the other hand, an OEM that retains a contract manufacturer may find itself immersed in a melodrama replete with promiscuity (the ambitious CM pursues liaisons with other OEMs), infidelity (the OEM's retailers and distributors shift their business to the upstart CM), and betrayal (the brazen CM transmits the OEM's intellectual property to the OEM's rivals or keeps it for itself when the contract is up). OEMs cannot simply terminate their outsourcing arrangements--they need contract manufacturers in order to keep specializing, adding value, and staying competitive. But OEMs can manage these relationships so that they don't become weak or the CMs too strong. Doing so requires modesty about revealing trade secrets; caution about whom one consorts with; and a judicious degree of intimacy, loyalty, and generosity toward partners and customers.

The global biopharma industry and the rise of Indian drug multinationals: implications for Australian generics policy

PubMed Central

Löfgren, Hans

2007-01-01

This article provides a synopsis of the new dynamics of the global biopharma industry. The emergence of global generics companies with capabilities approximating those of 'big pharma' has accelerated the blurring of boundaries between the innovator and generics sectors. Biotechnology-based products form a large and growing segment of prescription drug markets and regulatory pathways for biogenerics are imminent. Indian biopharma multinationals with large-scale efficient manufacturing plants and growing R&D capabilities are now major suppliers of Active Pharmaceutical Ingredients (APIs) and generic drugs across both developed and developing countries. In response to generic competition, innovator companies employ a range of life cycle management techniques, including the launch of 'authorised generics'. The generics segment in Australia will see high growth rates in coming years but the prospect for local manufacturing is bleak. The availability of cheap generics in international markets has put pressure on Pharmaceutical Benefits Scheme (PBS) pricing arrangements, and a new policy direction was announced in November 2006. Lower generics prices will have a negative impact on some incumbent suppliers but industrial renewal policies for the medicines industry in Australia are better focused on higher value R&D activities and niche manufacturing of sophisticated products. PMID:17543115

Manufacturing of Human Extracellular Vesicle-Based Therapeutics for Clinical Use

PubMed Central

Gimona, Mario; Pachler, Karin; Laner-Plamberger, Sandra; Schallmoser, Katharina; Rohde, Eva

2017-01-01

Extracellular vesicles (EVs) derived from stem and progenitor cells may have therapeutic effects comparable to their parental cells and are considered promising agents for the treatment of a variety of diseases. To this end, strategies must be designed to successfully translate EV research and to develop safe and efficacious therapies, whilst taking into account the applicable regulations. Here, we discuss the requirements for manufacturing, safety, and efficacy testing of EVs along their path from the laboratory to the patient. Development of EV-therapeutics is influenced by the source cell types and the target diseases. In this article, we express our view based on our experience in manufacturing biological therapeutics for routine use or clinical testing, and focus on strategies for advancing mesenchymal stromal cell (MSC)-derived EV-based therapies. We also discuss the rationale for testing MSC-EVs in selected diseases with an unmet clinical need such as critical size bone defects, epidermolysis bullosa and spinal cord injury. While the scientific community, pharmaceutical companies and clinicians are at the point of entering into clinical trials for testing the therapeutic potential of various EV-based products, the identification of the mode of action underlying the suggested potency in each therapeutic approach remains a major challenge to the translational path. PMID:28587212

Manufacturing of Human Extracellular Vesicle-Based Therapeutics for Clinical Use.

PubMed

Gimona, Mario; Pachler, Karin; Laner-Plamberger, Sandra; Schallmoser, Katharina; Rohde, Eva

2017-06-03

Extracellular vesicles (EVs) derived from stem and progenitor cells may have therapeutic effects comparable to their parental cells and are considered promising agents for the treatment of a variety of diseases. To this end, strategies must be designed to successfully translate EV research and to develop safe and efficacious therapies, whilst taking into account the applicable regulations. Here, we discuss the requirements for manufacturing, safety, and efficacy testing of EVs along their path from the laboratory to the patient. Development of EV-therapeutics is influenced by the source cell types and the target diseases. In this article, we express our view based on our experience in manufacturing biological therapeutics for routine use or clinical testing, and focus on strategies for advancing mesenchymal stromal cell (MSC)-derived EV-based therapies. We also discuss the rationale for testing MSC-EVs in selected diseases with an unmet clinical need such as critical size bone defects, epidermolysis bullosa and spinal cord injury. While the scientific community, pharmaceutical companies and clinicians are at the point of entering into clinical trials for testing the therapeutic potential of various EV-based products, the identification of the mode of action underlying the suggested potency in each therapeutic approach remains a major challenge to the translational path.

Taking behavioralism seriously: some evidence of market manipulation.

PubMed

Hanson, J D; Kysar, D A

1999-05-01

Over the last ten to fifteen years, economists and legal scholars have become increasingly interested in and sensitive to behavioralist insights. In a companion article, Jon Hanson and Douglas Kysar argued that those scholars have nevertheless given short shrift to what is, at least for policymaking purposes, perhaps the most important lesson of the behavioralist research: individuals' perceptions and preferences are highly manipulable. According to Hanson and Kysar, one theoretical implication of that insight for products liability law is that manufacturers and marketers will manipulate the risk perceptions of consumers. Indeed, to survive in a competitive market, manufacturers and marketers must do so. In this Article, Hanson and Kysar present empirical evidence of market manipulation--a previously unrecognized source of market failure. The Article begins by surveying the extensive qualitative and quantitative marketing research and consumer behavioral studies that discern and influence consumer perceptions. It then provides evidence of market manipulation by reviewing common practices in everyday market settings, such as gas stations and supermarkets, and by examining familiar marketing approaches, such as environmentally oriented and fear-based advertising. Although consumers may be well-aware of those practices and approaches, they appear to be generally unaware of the extent to which those tactics are manipulative. The Article then focuses on the industry that has most depended upon market manipulation: the cigarette industry. Through decades of sophisticated marketing and public relations efforts, cigarette manufacturers have heightened consumer demand and lowered consumer risk perceptions. Because consumers are aware that smoking may pose significant health risks, the tobacco industry's success in manipulating risk perceptions constitutes especially strong evidence of the power of market manipulation. The Article concludes by arguing that the evidence of market manipulation may justify moving to a regime of enterprise liability. Indeed, according to Hanson and Kysar, the evidence of market manipulation confirms the intuitions of the first generation of product liability scholars, who worried about manufacturers' power to manipulate and called for just such a regime.

Retailer branding of consumer sales promotions. A major development in food marketing?

PubMed

Hamlin, Robert P; Lindsay, Sophie; Insch, Andrea

2012-02-01

This article examines retailer branding of consumer price promotions. It discusses the mechanics of price promotions, consumers' reactions to them and the benefits that accrue to those that use them. It describes how large food retailers can now deploy branded price promotion systems that are fundamentally different to 'traditional' price promotions in both their mechanics and their effects on consumer decision processes. The article describes a field experiment that compared the performance of a food retailer's branded price promotion system with that of a generic (manufacturer) price promotion. The research involved three experiments that covered two food categories (sliced bread and margarine) and two levels of discount (10% and 20%). The results indicate that food retailers are able to attach powerful brands to their price promotion systems, and these brand heuristics can significantly increase consumer purchase intent relative to an equivalent generic/manufacturer promotion. This incremental heuristic effect was stable in both categories and for both levels of price discount studied. These results are consistent with the predictions of alternative, non-cognitive and heuristic based models of food consumer choice that have been published recently in 'Appetite'. Copyright © 2011 Elsevier Ltd. All rights reserved.

An economic assessment of patent settlements in the pharmaceutical industry.

PubMed

Dickey, Bret; Orszag, Jonathan; Tyson, Laura

2010-01-01

This article demonstrates that in recent years, patent settlements between branded and generic manufacturers involving "reverse payments" from branded manufacturers to generic manufacturers have received close antitrust scrutiny, driven by concerns that such settlements harm consumers by delaying the entry of lower-priced generic drugs. The authors note that such settlements will be a focus of the Obama Administration's antitrust enforcement policy, yet there is a growing consensus among the courts that such settlements are anticompetitive only under narrow sets of circumstances. In this article, the authors present an analytical framework for evaluating the competitive effects of patent settlements, including those involving reverse payments, and demonstrate that these settlements can benefit consumers. Thus, the authors conclude that while continued scrutiny of such settlements is important, broad brush treatments are inappropriate and only a more individualized evaluation can correctly determine the competitive effects of a particular settlement agreement.

27 CFR 53.172 - Credit or refund of manufacturers tax under chapter 32.

Code of Federal Regulations, 2010 CFR

2010-04-01

... total inventory, by model number and quantity, of all such articles purchased tax-paid and held for sale... that the article is not subject to tax under chapter 32 of the Code. (C) Inventory requirement. The inventory shall not include any such article, title to which, or possession of which, has previously been...

40 CFR 761.35 - Storage for reuse.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Manufacturing, Processing, Distribution in Commerce, and Use of PCBs and PCB Items § 761.35 Storage for reuse. (a) The owner or operator of a PCB Article may store it for reuse in an area which is not designed... applicable to the PCB Article. (2) Maintains records starting at the time the PCB Article is removed from use...

26 CFR 48.4161(a)-1 - Imposition and rate of tax; fishing equipment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... specified articles of fishing equipment that are designed or constructed for use in the sport of fishing...) imposes a tax on the sale of the following articles of fishing equipment (including in each case parts or accessories of such articles sold on or in connection therewith or with the sale thereof) by the manufacturer...

26 CFR 48.4161(a)-1 - Imposition and rate of tax; fishing equipment.

Code of Federal Regulations, 2011 CFR

2011-04-01

... specified articles of fishing equipment that are designed or constructed for use in the sport of fishing...) imposes a tax on the sale of the following articles of fishing equipment (including in each case parts or accessories of such articles sold on or in connection therewith or with the sale thereof) by the manufacturer...

FDA recognition of consensus standards in the premarket notification program.

PubMed

Marlowe, D E; Phillips, P J

1998-01-01

"The FDA has long advocated the use of standards as a significant contributor to safety and effectiveness of medical devices," Center for Devices and Radiological Health's (CDRH) Donald E. Marlowe and Philip J. Phillips note in the following article, highlighting the latest U.S. Food and Drug Administration (FDA) plans for use of standards. They note that the important role standards can play has been reinforced as part of FDA reengineering efforts undertaken in anticipation of an increased regulatory work-load and declining agency resources. As part of its restructuring effort, the FDA announced last spring that it would recognize some consensus standards for use in the device approval process. Under the new 510(k) paradigm--the FDA's proposal to streamline premarket review, which includes incorporating the use of standards in the review of 510(k) submissions--the FDA will accept proof of compliance with standards as evidence of device safety and effectiveness. Manufacturers may submit declarations of conformity to standards instead of following the traditional review process. The International Electrotechnical Commission (IEC) 60601 series of consensus standards, which deals with many safety issues common to electrical medical devices, was the first to be chosen for regulatory review. Other standards developed by nationally or internationally recognized standards development organizations, such as AAMI, may be eligible for use to ensure review requirements. In the following article, Marlowe and Phillips describe the FDA's plans to use standards in the device review process. The article focuses on the use of standards for medical device review, the development of the standards recognition process for reviewing devices, and the anticipated benefits of using standards to review devices. One important development has been the recent implementation of the FDA Modernization Act of 1997 (FDAMA), which advocates the use of standards in the device review process. In implementing the legislation, the FDA published in the Federal Register a list of standards to which manufacturers may declare conformity. Visit AAMI's Web site at www.aami.org/news/fda.standards for a copy of the list and for information on nominating other standards for official recognition by the agency. The FDA expects that use of standards will benefit the agency and manufacturers alike: "We estimate that in time, reliance on declarations of conformity to recognized standards could save the agency considerable resources while reducing the regulatory obstacles to entry to domestic and international markets," state the authors.

Regulatory requirements in the good manufacturing practice production of an epithelial cell graft for ocular surface reconstruction.

PubMed

Sheth-Shah, Radhika; Vernon, Amanda J; Seetharaman, Shankar; Neale, Michael H; Daniels, Julie T

2016-04-01

In the past decade, stem cell therapy has been increasingly employed for the treatment of various diseases. Subsequently, there has been a great interest in the manufacture of stem cells under good manufacturing practice, which is required by law for their use in humans. The cells for sight Stem Cell Therapy Research Unit, based at UCL Institute of Ophthalmology, delivers somatic cell-based and tissue-engineered therapies to patients suffering from blinding eye diseases at Moorfields Eye Hospital (London, UK). The following article is based on our experience in the conception, design, construction, validation and manufacturing within a good manufacturing practice manufacturing facility based in the UK. As such the regulations can be extrapolated to the 28 members stated within the EU. However, the principles may have a broad relevance outside the EU.

Cholesterol Point-of-Care Testing for Community Pharmacies: A Review of the Current Literature.

PubMed

Haggerty, Lauren; Tran, Deanna

2017-08-01

To summarize the literature on cholesterol point-of-care tests (POCTs). This article would serve as a resource to assist community pharmacists in developing cholesterol point-of-care (POC) pharmacy services. A literature search was performed in MEDLINE Ovid, PubMed, EMBASE, and Cochrane database using the following medical subject headings (MeSH) terms: point-of-care test, cholesterol, blood chemical analysis, rapid testing, collaborative practice, community pharmacy, and ambulatory care. Additional resources including device manufacturer web sites were summarized to supplement the current literature. All human research articles, review articles, meta-analyses, and abstracts published in English through September 1, 2014, were considered. A total of 36 articles were applicable for review. Information was divided into the following categories to be summarized: devices, pharmacists' impact, and operational cost for the pharmacy. The current literature suggests that POCTs in community pharmacies assist with patient outcomes by providing screenings and referring patients with dyslipidemia for further evaluation. The majority of studies on cholesterol POC devices focused on accuracy, revealing the need for further studies to develop best practices and practice models with successful reimbursement. Accuracy, device specifications, required supplies, and patient preference should be considered when selecting a POC device for purchase.

Inventory model with two rates of production for deteriorating items with permissible delay in payments

NASA Astrophysics Data System (ADS)

Roy, Ajanta; Samanta, G. P.

2011-08-01

Goyal (1985) ['Economic Order Quantity Under Conditions of Permissible Delay in Payments', Journal of Operational research Society, 36, 35-38] assumed that unit selling price and unit purchasing price are equal. But in real-life the scenario is different. The purpose of this article is to reflect the real life problem by allowing unit selling price and purchasing price to be unequal. Our model is a continuous production control inventory model for deteriorating items in which two different rates of production are available. The results are illustrated with the help of a numerical example. We discuss the sensitivity of the solution together with the changes of the values of the parameters associated with the model. Our model may be applicable in many manufacturing planning situations where management practices for deterioration are stringent; e.g. the two-production rate will be more profitable than the one-production rate in the manufacture of cold, asthma and allergy medicine. Our proposed model might be applicable to develop a prototype advance planning system for those manufacturers to integrate the management science techniques into commercial planning.

Substandard drugs: a potential crisis for public health

PubMed Central

Johnston, Atholl; Holt, David W

2014-01-01

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

Vaccine production, distribution, access and uptake

PubMed Central

Smith, Jon; Lipsitch, Marc; Almond, Jeffrey W.

2011-01-01

Making human vaccines available on a global scale requires the use of complex production methods, meticulous quality control and reliable distribution channels that ensure the products are potent and effective at their point of use. The technologies involved in manufacturing different types of vaccines may strongly influence vaccine cost, ease of industrial scale-up, stability and ultimately world-wide availability. Manufacturing complexity is compounded by the need for different formulations for different countries and age groups. Reliable vaccine production in appropriate quantities and at affordable prices is the cornerstone of developing global vaccination policies. However, ensuring optimal access and uptake also requires strong partnerships between private manufacturers, regulatory authorities and national and international public health services. For vaccines whose supplies are limited, either due to rapidly emerging diseases or longer-term mismatch of supply and demand, prioritizing target groups can increase vaccine impact. Focusing on influenza vaccines as an example that well illustrates many of the relevant points, this article considers current production, distribution, access and other factors that ultimately impact on vaccine uptake and population-level effectiveness. PMID:21664680

Manufacturing of dental pulp cell-based products from human third molars: current strategies and future investigations

PubMed Central

Ducret, Maxime; Fabre, Hugo; Degoul, Olivier; Atzeni, Gianluigi; McGuckin, Colin; Forraz, Nico; Alliot-Licht, Brigitte; Mallein-Gerin, Frédéric; Perrier-Groult, Emeline; Farges, Jean-Christophe

2015-01-01

In recent years, mesenchymal cell-based products have been developed to improve surgical therapies aimed at repairing human tissues. In this context, the tooth has recently emerged as a valuable source of stem/progenitor cells for regenerating orofacial tissues, with easy access to pulp tissue and high differentiation potential of dental pulp mesenchymal cells. International guidelines now recommend the use of standardized procedures for cell isolation, storage and expansion in culture to ensure optimal reproducibility, efficacy and safety when cells are used for clinical application. However, most dental pulp cell-based medicinal products manufacturing procedures may not be fully satisfactory since they could alter the cells biological properties and the quality of derived products. Cell isolation, enrichment and cryopreservation procedures combined to long-term expansion in culture media containing xeno- and allogeneic components are known to affect cell phenotype, viability, proliferation and differentiation capacities. This article focuses on current manufacturing strategies of dental pulp cell-based medicinal products and proposes a new protocol to improve efficiency, reproducibility and safety of these strategies. PMID:26300779

Human Embryonic Kidney 293 Cells: A Vehicle for Biopharmaceutical Manufacturing, Structural Biology, and Electrophysiology.

PubMed

Hu, Jianwen; Han, Jizhong; Li, Haoran; Zhang, Xian; Liu, Lan Lan; Chen, Fei; Zeng, Bin

2018-01-01

Mammalian cells, e.g., CHO, BHK, HEK293, HT-1080, and NS0 cells, represent important manufacturing platforms in bioengineering. They are widely used for the production of recombinant therapeutic proteins, vaccines, anticancer agents, and other clinically relevant drugs. HEK293 (human embryonic kidney 293) cells and their derived cell lines provide an attractive heterologous system for the development of recombinant proteins or adenovirus productions, not least due to their human-like posttranslational modification of protein molecules to provide the desired biological activity. Secondly, they also exhibit high transfection efficiency yielding high-quality recombinant proteins. They are easy to maintain and express with high fidelity membrane proteins, such as ion channels and transporters, and thus are attractive for structural biology and electrophysiology studies. In this article, we review the literature on HEK293 cells regarding their origins but also stress their advancements into the different cell lines engineered and discuss some significant aspects which make them versatile systems for biopharmaceutical manufacturing, drug screening, structural biology research, and electrophysiology applications. © 2018 S. Karger AG, Basel.

A kinetic modeling of chondrocyte culture for manufacture of tissue-engineered cartilage.

PubMed

Kino-Oka, Masahiro; Maeda, Yoshikatsu; Yamamoto, Takeyuki; Sugawara, Katsura; Taya, Masahito

2005-03-01

For repairing articular cartilage defects, innovative techniques based on tissue engineering have been developed and are now entering into the practical stage of clinical application by means of grafting in vitro cultured products. A variety of natural and artificial materials available for scaffolds, which permit chondrocyte cells to aggregate, have been designed for their ability to promote cell growth and differentiation. From the viewpoint of the manufacturing process for tissue-engineered cartilage, the diverse nature of raw materials (seeding cells) and end products (cultured cartilage) oblige us to design a tailor-made process with less reproducibility, which is an obstacle to establishing a production doctrine based on bioengineering knowledge concerning growth kinetics and modeling as well as designs of bioreactors and culture operations for certification of high product quality. In this article, we review the recent advances in the manufacturing of tissue-engineered cartilage. After outlining the manufacturing processes for tissue-engineered cartilage in the first section, the second and third sections, respectively, describe the three-dimensional culture of chondrocytes with Aterocollagen gel and kinetic model consideration as a tool for evaluating this culture process. In the final section, culture strategy is discussed in terms of the combined processes of monolayer growth (ex vivo chondrocyte cell expansion) and three-dimensional growth (construction of cultured cartilage in the gel).

Assembling surface mounted components on ink-jet printed double sided paper circuit board.

PubMed

Andersson, Henrik A; Manuilskiy, Anatoliy; Haller, Stefan; Hummelgård, Magnus; Sidén, Johan; Hummelgård, Christine; Olin, Håkan; Nilsson, Hans-Erik

2014-03-07

Printed electronics is a rapidly developing field where many components can already be manufactured on flexible substrates by printing or by other high speed manufacturing methods. However, the functionality of even the most inexpensive microcontroller or other integrated circuit is, at the present time and for the foreseeable future, out of reach by means of fully printed components. Therefore, it is of interest to investigate hybrid printed electronics, where regular electrical components are mounted on flexible substrates to achieve high functionality at a low cost. Moreover, the use of paper as a substrate for printed electronics is of growing interest because it is an environmentally friendly and renewable material and is, additionally, the main material used for many packages in which electronics functionalities could be integrated. One of the challenges for such hybrid printed electronics is the mounting of the components and the interconnection between layers on flexible substrates with printed conductive tracks that should provide as low a resistance as possible while still being able to be used in a high speed manufacturing process. In this article, several conductive adhesives are evaluated as well as soldering for mounting surface mounted components on a paper circuit board with ink-jet printed tracks and, in addition, a double sided Arduino compatible circuit board is manufactured and programmed.

Application of Fused Deposition Modelling (FDM) Method of 3D Printing in Drug Delivery.

PubMed

Long, Jingjunjiao; Gholizadeh, Hamideh; Lu, Jun; Bunt, Craig; Seyfoddin, Ali

2017-01-01

Three-dimensional (3D) printing is an emerging manufacturing technology for biomedical and pharmaceutical applications. Fused deposition modelling (FDM) is a low cost extrusion-based 3D printing technique that can deposit materials layer-by-layer to create solid geometries. This review article aims to provide an overview of FDM based 3D printing application in developing new drug delivery systems. The principle methodology, suitable polymers and important parameters in FDM technology and its applications in fabrication of personalised tablets and drug delivery devices are discussed in this review. FDM based 3D printing is a novel and versatile manufacturing technique for creating customised drug delivery devices that contain accurate dose of medicine( s) and provide controlled drug released profiles. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

27 CFR 26.51 - Formulas for articles, eligible articles and products manufactured with denatured spirits.

Code of Federal Regulations, 2010 CFR

2010-04-01

... in the United States. (1) Products may be made with completely denatured alcohol for sale under brand... such a formula is not required to submit a new formula. (Approved by the Office of Management and...

27 CFR 53.121 - Sales of taxable articles by a person other than the manufacturer, producer, or importer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... examples illustrate this rule: (1) The surviving spouse, child or children, executors or administrators, or... in adjustment of a damage claim, such transfer is not considered a taxable sale of the article. If...

27 CFR 53.121 - Sales of taxable articles by a person other than the manufacturer, producer, or importer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... examples illustrate this rule: (1) The surviving spouse, child or children, executors or administrators, or... in adjustment of a damage claim, such transfer is not considered a taxable sale of the article. If...

27 CFR 53.121 - Sales of taxable articles by a person other than the manufacturer, producer, or importer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... examples illustrate this rule: (1) The surviving spouse, child or children, executors or administrators, or... in adjustment of a damage claim, such transfer is not considered a taxable sale of the article. If...

27 CFR 53.121 - Sales of taxable articles by a person other than the manufacturer, producer, or importer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... examples illustrate this rule: (1) The surviving spouse, child or children, executors or administrators, or... in adjustment of a damage claim, such transfer is not considered a taxable sale of the article. If...

27 CFR 53.121 - Sales of taxable articles by a person other than the manufacturer, producer, or importer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... examples illustrate this rule: (1) The surviving spouse, child or children, executors or administrators, or... in adjustment of a damage claim, such transfer is not considered a taxable sale of the article. If...

Methamphetamine Abuse and Manufacture: The Child Welfare Response

ERIC Educational Resources Information Center

Hohman, Melinda; Oliver, Rhonda; Wright, Wendy

2004-01-01

Methamphetamine abuse is on the rise, particularly by women of child-bearing age. This article describes the history and effects of methamphetamine use. The authors examine the ways exposure to the manufacture of this drug affects clients and social workers in the course of their work. Because children are frequently found at the scene of a…

President Gerald Ford holds crystal manufactured in space during Skylab 4

NASA Technical Reports Server (NTRS)

1974-01-01

President Gerald R. Ford, center, holds encased crystal manufactured in space during Skylab 4. Dr. James C. Fletcher, left, NASA Administrator, explains the article to the Chief Executive as Dr. Harold Johnson of M.I.T. looks on. The indium-antimonide crystal was formed in Earth orbit on January 6, 1974, by the Skylab 4 astronauts.

Don't Lose Your Marbles!: Game Project Teaches Introductory Manufacturing Skills

ERIC Educational Resources Information Center

Kapur, Arjun; Carter, Horlin; Dillon, Dave

2006-01-01

This article describes a lab activity conducted in an introductory manufacturing class. In this good, simple, mass-production project, the students designed and produced a small game composed of a piece of plywood and 14 glass marbles. In appearance, the game is something like Chinese checkers, but it involves jumping over marbles, then removing…

An Appreciation and Analysis of "Edward Burtynsky--Manufactured Landscapes": A Film by Jennifer Baichwal

ERIC Educational Resources Information Center

Donar, Ann

2010-01-01

This article begins with a synopsis of the film "Edward Burtynsky: Manufactured Landscapes", directed by Jennifer Baichwal. While the author can relate to the statements made in this synopsis, her experience and understanding of this 90-minute journey is much more intense and complex. In this essay, she attempts to dissect and examine…

Reusing Old Manufacturing Buildings

ERIC Educational Resources Information Center

Roman, Harry T.

2014-01-01

This article presents an interesting design challenge for students, one that will certainly let them integrate subject matter and get a sense of pride for doing something useful in their own community. The author would be willing to bet that the average town or city has some old red brick manufacturing building(s) that have seen much better days.…

27 CFR 53.91 - Charges to be included in sale price.

Code of Federal Regulations, 2010 CFR

2010-04-01

... the Code and § 53.100. In the case of sales on credit, a carrying, finance, or service charge is... connection with collection). (b) Tools and dies. Separate charges for tools and dies used in the manufacture... manufacture taxable articles, the tools and dies used in production pass to the purchaser, only the amount of...

21 CFR 178.3910 - Surface lubricants used in the manufacture of metallic articles.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Surface lubricants used in the manufacture of...--hydroxypoly (oxyethylene)-poly (oxypropylene) (CAS Reg. No. 9038-95-3) produced by random condensation of a 1... molecular weight of 1000 α-Lauroyl-Ω-hydroxpoly(oxyethylene) (CAS Reg. No. 9004-81-3) having a minimum...

21 CFR 178.3910 - Surface lubricants used in the manufacture of metallic articles.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Surface lubricants used in the manufacture of...--hydroxypoly (oxyethylene)-poly (oxypropylene) (CAS Reg. No. 9038-95-3) produced by random condensation of a 1... molecular weight of 1000 α-Lauroyl-Ω-hydroxpoly(oxyethylene) (CAS Reg. No. 9004-81-3) having a minimum...

21 CFR 178.3910 - Surface lubricants used in the manufacture of metallic articles.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Surface lubricants used in the manufacture of...--hydroxypoly (oxyethylene)-poly (oxypropylene) (CAS Reg. No. 9038-95-3) produced by random condensation of a 1... molecular weight of 1000 α-Lauroyl-Ω-hydroxpoly(oxyethylene) (CAS Reg. No. 9004-81-3) having a minimum...

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

ERIC Educational Resources Information Center

Keithley, Michael G.

2009-01-01

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

26 CFR 48.4216(b)-3 - Constructive sale price; special rule for arm's-length sales.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 16 2011-04-01 2011-04-01 false Constructive sale price; special rule for arm's... Provisions Applicable to Manufacturers Taxes § 48.4216(b)-3 Constructive sale price; special rule for arm's... such articles to one or more wholesale distributors in arm's-length transactions, and the manufacturer...

26 CFR 48.4216(b)-3 - Constructive sale price; special rule for arm's-length sales.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 26 Internal Revenue 16 2013-04-01 2013-04-01 false Constructive sale price; special rule for arm's... Provisions Applicable to Manufacturers Taxes § 48.4216(b)-3 Constructive sale price; special rule for arm's... such articles to one or more wholesale distributors in arm's-length transactions, and the manufacturer...

26 CFR 48.4216(b)-3 - Constructive sale price; special rule for arm's-length sales.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 26 Internal Revenue 16 2012-04-01 2012-04-01 false Constructive sale price; special rule for arm's... Provisions Applicable to Manufacturers Taxes § 48.4216(b)-3 Constructive sale price; special rule for arm's... such articles to one or more wholesale distributors in arm's-length transactions, and the manufacturer...

78 FR 37694 - Federal Acquisition Regulation; Deletion of Report to Congress on Foreign-Manufactured Products

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-21

...-AM54 Federal Acquisition Regulation; Deletion of Report to Congress on Foreign-Manufactured Products... heads of each Federal agency to submit a report to Congress on acquisitions of articles, materials, or... report to Congress is no longer required but the collection of the data in the Federal Procurement Data...

19 CFR 191.26 - Recordkeeping for manufacturing drawback.

Code of Federal Regulations, 2012 CFR

2012-04-01

... producer under 19 U.S.C. 1313(a) shall keep records to allow the verifying Customs official to trace all... or producer of articles manufactured or produced in accordance with 19 U.S.C. 1313(b) shall establish... drawback claim under 19 U.S.C. 1313(b). The amount of titanium dioxide in the synthetic rutile is...

19 CFR 191.26 - Recordkeeping for manufacturing drawback.

Code of Federal Regulations, 2011 CFR

2011-04-01

... producer under 19 U.S.C. 1313(a) shall keep records to allow the verifying Customs official to trace all... or producer of articles manufactured or produced in accordance with 19 U.S.C. 1313(b) shall establish... drawback claim under 19 U.S.C. 1313(b). The amount of titanium dioxide in the synthetic rutile is...

19 CFR 191.26 - Recordkeeping for manufacturing drawback.

Code of Federal Regulations, 2013 CFR

2013-04-01

... producer under 19 U.S.C. 1313(a) shall keep records to allow the verifying Customs official to trace all... or producer of articles manufactured or produced in accordance with 19 U.S.C. 1313(b) shall establish... drawback claim under 19 U.S.C. 1313(b). The amount of titanium dioxide in the synthetic rutile is...

3D printing in orthognathic surgery - A literature review.

PubMed

Lin, Hsiu-Hsia; Lonic, Daniel; Lo, Lun-Jou

2018-07-01

With the recent advances in three-dimensional (3D) imaging, computer-assisted surgical planning and simulation are now regularly used for analysis of craniofacial structures and improved prediction of surgical outcomes in orthognathic surgery. A variety of patient-specific surgical guides and devices have been designed and manufactured using 3D printing technology, which rapidly gained widespread popularity to improve the outcomes. The article presents an overview of 3D printing technology for state-of-the-art application in orthognathic surgery and discusses the impacts on treatment feasibility and patient outcome. The current available literature regarding the use of 3D printing methods in orthognathic surgery including 3D computer-aided design/computer-aided manufacturing, rapid prototyping, additive manufacturing, 3D printing, 3D printed models, surgical occlusal splints, custom-made guides, templates and fixation plates is reviewed. A Medline, PubMed, ProQuest and ScienceDirect search was performed to find relevant articles over the past 10 years. A total of 318 articles were found, out of which 69 were publications addressing the topic of this study. An additional 9 hand-searched articles were added. From the review, we can conclude that the use of 3D printing methods in orthognathic surgery provide the benefit of optimal functional and aesthetic results, patient satisfaction, and precise translation of the treatment plan. Copyright © 2018. Published by Elsevier B.V.

Management: A bibliography for NASA managers (supplement 21)

NASA Technical Reports Server (NTRS)

1987-01-01

This bibliography lists 664 reports, articles and other documents introduced into the NASA scientific and technical information system in 1986. Items are selected and grouped according to their usefulness to the manager as manager. Citations are grouped into ten subject categories: human factors and personnel issues; management theory and techniques; industrial management and manufacturing; robotics and expert systems; computers and information management; research and development; economics, costs, and markets; logistics and operations management; reliability and quality control; and legality, legislation, and policy.

Management: A bibliography for NASA Managers

NASA Technical Reports Server (NTRS)

1986-01-01

This bibliography lists 707 reports, articles and other documents introduced into the NASA scientific and technology information system in 1985. Items are selected and grouped according to their usefulness to the manager as manager. Citations are grouped into ten subject categories: human factors and personnel issues; management theory and techniques; industrial management and manufacturing; robotics and expert systems; computers and information management; research and development; economics, costs, and markets; logistics and operations management; reliability and quality control; and legality, legislation, and policy.

Management: A bibliography for NASA managers

NASA Technical Reports Server (NTRS)

1991-01-01

This bibliography lists 731 reports, articles and other documents introduced into the NASA Scientific and Technical Information System in 1990. Items are selected and grouped according to their usefulness to the manager as manager. Citations are grouped into ten subject categories: human factors and personnel issues; management theory and techniques; industrial management and manufacturing; robotics and expert systems; computers and information management; research and development; economics, costs and markets; logistics and operations management; reliability and quality control; and legality, legislation, and policy.

Management: A bibliography for NASA managers

NASA Technical Reports Server (NTRS)

1990-01-01

This bibliography lists 755 reports, articles and other documents introduced into the NASA Scientific and Technical Information System in 1989. Items are selected and grouped according to their usefulness to the manager as manager. Citations are grouped into ten subject categories: human factors and personnel issues; management theory and techniques; industrial management and manufacturing; robotics and expert systems; computers and information management; research and development; economics, costs and markets; logistics and operations management; reliability and quality control; and legality, legislation, and policy.

Digital Noise Reduction: An Overview

PubMed Central

Bentler, Ruth; Chiou, Li-Kuei

2006-01-01

Digital noise reduction schemes are being used in most hearing aids currently marketed. Unlike the earlier analog schemes, these manufacturer-specific algorithms are developed to acoustically analyze the incoming signal and alter the gain/output characteristics according to their predetermined rules. Although most are modulation-based schemes (ie, differentiating speech from noise based on temporal characteristics), spectral subtraction techniques are being applied as well. The purpose of this article is to overview these schemes in terms of their differences and similarities. PMID:16959731

Program finds centrifugal compressor operating point

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

Campos, M.C.M.M.; Rodrigues, P.S.B.

1990-09-01

This article presents the Scop program, a computational procedure developed using Fortran 77 language to find the operating point of centrifugal compressors starting from performance curves. Characteristics or performance curves traditionally are employed by manufacturers to inform users about turbocompressor behavior. Usually, these curves have polytropic head, H, and corresponding polytropic efficiency, {eta} plus rotation speed, N, and inlet volumetric flowrate, Q, as parameters. Two families of curves can be identified in this figure. One provides head-flow relationships for several speeds and the other refers to isoefficiency curves.

Management: A bibliography for NASA managers

NASA Technical Reports Server (NTRS)

1989-01-01

This bibliography lists 822 reports, articles and other documents introduced into the NASA Scientific and Technical Information System in 1988. Items are selected and grouped according to their usefulness to the manager as manager. Citations are grouped into ten subject categories: human factors and personnel issues; management theory and techniques; industrial management and manufacturing; robotics and expert systems; computers and information management; research and development; economics, costs and markets; logistics and operations management; reliability and quality control; and legality, legislation, and policy.

Management: A bibliography for NASA managers

NASA Technical Reports Server (NTRS)

1985-01-01

This bibliography lists 706 reports, articles, and other documents introduced into the NASA scientific and technical information system in 1984. Entries, which include abstracts, are arranged in the following categories: human factors and personnel issues; management theory and techniques; industrial management and manufacturing; robotics and expert systems; computers and information management; research and development; economics, costs, and markets; logistics and operations management; reliability and quality control; and legality, legislation, and policy. Subject, personal author, corporate source, contract number, report number, and accession number indexes are included.

Management: A bibliography for NASA managers

NASA Technical Reports Server (NTRS)

1992-01-01

This bibliography lists 630 reports, articles and other documents introduced into the NASA Scientific and Technical Information System in 1991. Items are selected and grouped according to their usefulness to the manager as manager. Citations are grouped into ten subject categories: human factors and personnel issues; management theory and techniques; industrial management and manufacturing; robotics and expert systems; computers and information management; research and development; economics, costs and markets; logistics and operations management; reliability and quality control; and legality, legislation, and policy.

Management: A bibliography for NASA managers

NASA Technical Reports Server (NTRS)

1988-01-01

This bibliography lists 653 reports, articles and other documents introduced into the NASA scientific and technical information system in 1987. Items are selected and grouped according to their usefulness to the manager as manager. Citiations are grouped into ten subject categories; human factors and personnel issues; management theory and techniques; industrial management and manufacturing; robotics and expert systems; computers and information management; research and development; economics, costs and markets; logistics and operations management, reliability and quality control; and legality, legislation, and policy.

White Paper of the Society of Computed Body Tomography and Magnetic Resonance on Dual-Energy CT, Part 1: Technology and Terminology.

PubMed

Siegel, Marilyn J; Kaza, Ravi K; Bolus, David N; Boll, Daniel T; Rofsky, Neil M; De Cecco, Carlo N; Foley, W Dennis; Morgan, Desiree E; Schoepf, U Joseph; Sahani, Dushyant V; Shuman, William P; Vrtiska, Terri J; Yeh, Benjamin M; Berland, Lincoln L

This is the first of a series of 4 white papers that represent Expert Consensus Documents developed by the Society of Computed Body Tomography and Magnetic Resonance through its task force on dual-energy computed tomography (DECT). This article, part 1, describes the fundamentals of the physical basis for DECT and the technology of DECT and proposes uniform nomenclature to account for differences in proprietary terms among manufacturers.

Laser materials processing of complex components: from reverse engineering via automated beam path generation to short process development cycles

NASA Astrophysics Data System (ADS)

Görgl, Richard; Brandstätter, Elmar

2017-01-01

The article presents an overview of what is possible nowadays in the field of laser materials processing. The state of the art in the complete process chain is shown, starting with the generation of a specific components CAD data and continuing with the automated motion path generation for the laser head carried by a CNC or robot system. Application examples from laser cladding and laser-based additive manufacturing are given.

Role of Chirality in Drugs… An Overview

PubMed

Alkadi, Hourieh; Jbeily, Rajwa

2017-03-29

Stereochemistry has been occupied a great role in manufacture and development of pharmaceuti-cals. Chiral properties play an important role in the determination of pharmacological actions of the drug. In recent years, there is a considerable interest in chiral separation to isolate and examine both enantiomers. This article provides an overview about the stereochemistry and its role in drugs, and also, offers approved isolation methods for enantiomeric pairs. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

CFB: technology of the future?

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

Blankship, S.

2008-02-15

Fuel flexibility and a smaller carbon footprint are behind renewed interest in circulating fluidized bed (CFB) technology. The article explains the technology of CFB and discusses development of CFB units since the late 1990s. China is seeing an explosion in the number of utility-size CFBs. Alstom, Foster Wheeler, Babcock and Wilson and Alex Kvaener are today's major CFB boiler manufacturers. Alstom is testing and developing oxy-firing and post-combustion carbon capture strategies on CFB boilers. One CFB asset is its ability to burn a variety of fuels including waste coal, high sulfur coal and even discarded tires. The article mentions successfulmore » CFB projects at the Seward Station using waste coal and at the Gilbert 3 plant in the USA. Lamar is converting its Light and Power Plant from natural gas to burn coal in a 38.5 MW CFB boiler. 1 tab., 3 photos.« less

Nanotechnology: the revolution of the big future with tiny medicine.

PubMed

Meetoo, Danny

The historically unprecedented developments of nanoscience and nanotechnology (NT) promise to revolutionize the diagnosis, treatment and prevention of disease and traumatic injury, to relieve pain, and to preserve and improve human health, using molecular tools and molecular knowledge of the body. This article focuses on what is known as nanomedicine, referring to a definition of NT, its historical overview and developments as well as its application to medicine. In revolutionizing the manufacturing process to a nanoscale, NT promises to resolve the problems currently faced by the human race. However, in embracing this panacea, its implications, particularly within health care, cannot be ignored. This article, therefore, provides a thought-provoking consideration of how NT is likely to impact on nursing, together with the issues likely to be encountered during the care delivery process. Finally, some of the ethical questions nurses need to debate has been raised.

Wireless device monitoring methods, wireless device monitoring systems, and articles of manufacture

DOEpatents

McCown, Steven H [Rigby, ID; Derr, Kurt W [Idaho Falls, ID; Rohde, Kenneth W [Idaho Falls, ID

2012-05-08

Wireless device monitoring methods, wireless device monitoring systems, and articles of manufacture are described. According to one embodiment, a wireless device monitoring method includes accessing device configuration information of a wireless device present at a secure area, wherein the device configuration information comprises information regarding a configuration of the wireless device, accessing stored information corresponding to the wireless device, wherein the stored information comprises information regarding the configuration of the wireless device, comparing the device configuration information with the stored information, and indicating the wireless device as one of authorized and unauthorized for presence at the secure area using the comparing.

Kickbacks, courtesies or cost-effectiveness?: Application of the Medicare antikickback Law to the marketing and promotional practices of drug and medical device manufacturers.

PubMed

Bulleit, T N; Krause, J H

1999-01-01

This article summarizes the purposes and history of the antikickback law and describes its evolution into a potent weapon against the corruption of medical decision making in the procurement of prescription drugs and medical devices. The article also details a variety of strategies for reducing risks under the law in several key areas of importance to manufacturers. While the purposes of the law are laudable, its current broad interpretation may impede not only corruption, but also benign forms of customer relations and innovative approaches to cost-effective medical care.

The impact of Wyeth v. Levine on FDA regulation of prescription drugs.

PubMed

Ausness, Richard C

2010-01-01

In Wyeth v. Levine, decided in March, 2009, the United States Supreme Court concluded that the plaintiff's failure to warn claim against the makers of the drug Phenergan was not impliedly preempted by the Food, Drug and Cosmetic Act. In doing so, the Court rejected the argument of the U.S. Food and Drug Administration (FDA) that tort claims of this nature stand as an obstacle to federal regulatory objectives. This Article evaluates the Court's opinion in Wyeth and examines that decision's impact on subsequent litigation in the area of prescription drug labeling. The Article first discusses the preemption doctrine and its application to state law tort claims against product manufacturers. It then reviews the history of implied preemption of tort claims against manufacturers of FDA-approved prescription drugs prior to Wyeth and then discusses the Wyeth decisions in the Vermont Supreme Court and the United States Supreme Court. Finally, the Article evaluates some of the prescription drug preemption cases that have been decided in the lower federal courts since Wyeth and suggests that these courts are now reluctant to preempt failure to warn claims unless a manufacturer affirmatively seeks permission from FDA to change a drug's labeling.

[Early achievements of the Danish pharmaceutical industry--8. Lundbeck].

PubMed

Grevsen, Jørgen V; Kirkegaard, Hanne; Kruse, Edith; Kruse, Poul R

2016-01-01

The article series provides a written and pictorial account of the Danish pharmaceutical industry's products from their introduction until about 1950. Part 8 deals with products from Lundbeck. Lundbeck which today is known as a considerable international pharmaceutical company could in 2015 celebrate its 100 years' jubilee. Among the early Danish medicinal companies H. Lundbeck & Co. is in many ways an exception as the company was not originally established as a pharmaceutical company. Not until several years after the foundation the company began to import foreign ready-made medicinal products and later-on to manufacture these medicinal products in own factory and even later to do research and development of own innovative products. When Lundbeck was established in 1915 several Danish medicinal companies, not only the well-known such as Alfred Benzon and Løvens kemiske Fabrik (LEO Pharma), but also Skelskør Frugtplantage, Ferrin and Ferraton, had emerged due to the respective enterprising pharmacy owners who had expanded their traditional pharmacy business and even with commercial success. Other medicinal companies, such as C.R. Evers & Co., Leerbeck & Holms kemiske Fabriker, Chr. F. Petri, Erslevs kemiske Laboratorium, Edward Jacobsen, Th. Fallesen-Schmidt, and yet other companies which were named after the founder had all been established by pharmacists with the primary intention to manufacture and sell medicinal products. Also for the limited companies Medicinalco, Ferrosan, Pharmacia, and GEA the primary task was to manufacture and sell medicinal products, and also in these companies pharmacists were involved in the foundation. Not until 1924, fully 9 years after the foundation, Lundbeck started to be interested in medicinal products and initiated import and sale of foreign medicinal products manufactured by a.o. German and French companies which had not established their own sales companies in Denmark. Almost all contemporary Danish manufacturers of medicinal products could exclusively determine own proprietary names of the articles and could themselves make their own homogeneous and easily recognisable design, a.o. by frequent use of prefixes as Afa, Asa, Gea, Ido, Leo, and Meco which associated to for instance the company name. However, it goes without saying that Lundbeck had to market the articles in commission according to the different contracts with their partners. Consequently their range of products appeared heterogeneously. The international financial crisis and the consequent unemployment in the 1920s and 1930s had in Denmark a.o. resulted in national regulation in order to complicate import of ready-made goods and thus support the domestic manufacture of such articles. This was one of the reasons why Lundbeck decided to initiate its own manufacture of medicinal products in Denmark instead of continuing only with the import business which had been obstructed by the authorities. This article does not mention all Lundbeck's medicinal products which were marketed in Denmark until 1955 where a new Pharmacy Act came into force though undoubtedly a lot of interest can be written about all of them. The products mentioned in this article have been carefully selected, not only because they are representative for Lundbeck's development during the first decades, but also because the Danish Collection of the History of Pharmacy has acquired consumer packages of many of the articles. Several of these packages include patient information leaflets with an instruction for use and/or other information, and especially these leaflets represent a source material which has not previously been given much attention. It does not appear from the available source material whether these earliest medicinal products from Lundbeck were assembled in Danish packages on the production sites, or whether they were repacked in Copenhagen. It is not unlikely that the assembling originally was finalized abroad, and that instructions for the production of packaging material with Danish text were supplied by Lundbeck to the respective manufacturers. However, it is not unlikely either that the currency restrictions which were made after 1932 encouraged Lundbeck, where possible, first of all to import raw materials and bulk products and then manufacture the finished products in Valby. This was the case with Anusol, which Lundbeck certainly emphazised in the advertisement. It has to be pointed out that at that time there were no legal requirements regarding dating, neither of the user instructions nor of advertisements. Thus it is not due to mistakes or omissions made by Lundbeck that these materials are undated. The user instructions which Lundbeck had inserted in the packages were made and distributed at a time where no legal restrictions were in force neither regarding form nor content of such. The user instructions for products marketed after 1932 had probably been presented to the Pharmacopoeia Commission as this was statutory. It is, however, uncertain whether the Commission has dealt with the contents and the look of the user instructions. The most important task of the Commission was besides of the work with maintaining the Pharmacopoeia to look after the economic interests of the pharmacies so that only new drug substances could be marketed by the pharmaceutical industry, cf. below. In order to find out whether, and if so to which extent, the Pharmacopoeia Commission has been occupied in evaluating the informative and promoting printed matters of the industry, would require studies of the unprinted files of the Commission, and that is outside the scope of this article. At that time it was not against the law to inform in a user instruction that in case of a longer period of treatment, it would be more economical for the patient to buy a larger package. If you look at these patient information leaflets with today's eyes in the light of the present detailed, comprehensive and rigid regulations which the EU Commission has stated regarding patient information leaflets, you will find that Lundbeck's patient information leaflets were both simple and easy to read. On a free sample of Gelonida meant for the prescribing physician Lundbeck stated, besides of indication, dosage and warnings, also that the article was "Manufactured in Denmark". At that time it was not required to print information of production sites on packaging materials, however, it was not unusual to use this sales promoting claim in times of unemployment. In 1949 the original packaging material for Beatin was modified because certain text elements, the therapeutic indications were removed as it appeared that they since 1933 had violated the Pharmacy Act against advertisements for medicinal products aimed at the public. The packaging material for Beatin is a model example of the possibilities to combine practical information about the use of a medicinal product with sales claims in a reliable way. The above text modification and thus the legalisation of the packaging material took place upon request from the company as the violation of the advertising rules of the Pharmacy Act apparently had not resulted in any legal problems. Studies of unpublished files from the National Board of Health may possibly explain the background of this sequence of events, however, that is outside the scope of this article. The paragraph of the Pharmacy Act of 1932, stating that a medicinal product containing a common commodity as the active ingredient could not be marketed as a proprietary medicinal product, was meant to protect the pharmacies against the increasing competition from the industry. At first the paragraph did put a strain on the industry which from then on either had to manufacture own originator products or to copy other originator products without breaking patents. In the long run it has probably caused that not only Lundbeck, but also other Danish pharmaceutical companies became research-oriented and thus have been able to develop a relatively large number of originator products. In this context a product like Lucamid can hardly be regarded as an example of such a compulsory development of an originator product, an acetylsalicylic acid analogue. There were already such products on the market, but the wish to develop a better active ingredient has probably been bigger. From the three first editions of The Tariff of Medicines from 1935, 1937 and 1939 respectively it appears how Lundbeck's business within the area of medicines developed during the last half of the 1930s. In 1935 Lundbeck had placed 36 different medicinal products on the market, and all of them were in-licensing products. 4 years later, in 1939 Lundbeck had placed 40 different medicinal products on the market, and the number of in-licensing products had been reduced to 18 and 22 products were Lundbeck products. However, the increased focus on the development of own new medicinal products as Epicutan and Klianyl did not stop the in-licensing activities. Varex which Lundbeck brought on the market in 1942 came from a German pharmaceutical company with which Lundbeck had not previously collaborated. In Denmark Lundbeck had the intention to market 4 of Goedecke's 6 different medicinal products which all had Gelonida as part of the proprietary name. However, only one of these products got a longer life and with a simplified name, namely Gelonida. The fixed combination with three compounds of acetylsalicylic acid, phenacetin and codeine was without doubt effective, however, already at the end of the 1950s concern was raised about the safety of phenacetin. The Card Index of Medicines is a primary source of knowledge of how Lundbeck marketed the earliest medicinal products to the prescribing physicians. (ABSTRACT TRUNCATED)

Open questions in surface topography measurement: a roadmap

NASA Astrophysics Data System (ADS)

Leach, Richard; Evans, Christopher; He, Liangyu; Davies, Angela; Duparré, Angela; Henning, Andrew; Jones, Christopher W.; O'Connor, Daniel

2015-03-01

Control of surface topography has always been of vital importance for manufacturing and many other engineering and scientific disciplines. However, despite over one hundred years of quantitative surface topography measurement, there are still many open questions. At the top of the list of questions is ‘Are we getting the right answer?’ This begs the obvious question ‘How would we know?’ There are many other questions relating to applications, the appropriateness of a technique for a given scenario, or the relationship between a particular analysis and the function of the surface. In this first ‘open questions’ article we have gathered together some experts in surface topography measurement and asked them to address timely, unresolved questions about the subject. We hope that their responses will go some way to answer these questions, address areas where further research is required, and look at the future of the subject. The first section ‘Spatial content characterization for precision surfaces’ addresses the need to characterise the spatial content of precision surfaces. Whilst we have been manufacturing optics for centuries, there still isn’t a consensus on how to specify the surface for manufacture. The most common three methods for spatial characterisation are reviewed and compared, and the need for further work on quantifying measurement uncertainties is highlighted. The article is focussed on optical surfaces, but the ideas are more pervasive. Different communities refer to ‘figure, mid-spatial frequencies, and finish’ and ‘form, waviness, and roughness’, but the mathematics are identical. The second section ‘Light scattering methods’ is focussed on light scattering techniques; an important topic with in-line metrology becoming essential in many manufacturing scenarios. The potential of scattering methods has long been recognized; in the ‘smooth surface limit’ functionally significant relationships can be derived from first principles for statistically stationary, random surfaces. For rougher surfaces, correlations can be found experimentally for specific manufacturing processes. Improvements in computational methods encourage us to revisit light scattering as a powerful and versatile tool to investigate surface and thin film topographies, potentially providing information on both topography and defects over large areas at high speed. Future scattering techniques will be applied for complex film systems and for sub-surface damage measurement, but more research is required to quantify and standardise such measurements. A fundamental limitation of all topography measurement systems is their finite spatial bandwidth, which limits the slopes that they can detect. The third section ‘Optical measurements of surfaces containing high slope angles’ discusses this limitation and potential methods to overcome it. In some cases, a rough surface can allow measurement of slopes outside the classical optics limit, but more research is needed to fully understand this process. The last section ‘What are the challenges for high dynamic range surface measurement?’ presents the challenge facing metrologists by the use of surfaces that need measurement systems with very high spatial and temporal bandwidths, for example, those found in roll-to-roll manufacturing. High resolution, large areas and fast measurement times are needed, and these needs are unlikely to be fulfilled by developing a single all-purpose instrument. A toolbox of techniques needs to be developed which can be applied for any specific manufacturing scenario. The functional significance of surface topography has been known for centuries. Mirrors are smooth. Sliding behaviour depends on roughness. We have been measuring surfaces for centuries, but we still face many challenges. New manufacturing paradigms suggest that we need to make rapid measurements online that relate to the functional performance of the surface. This first ‘open questions’ collection addresses a subset of the challenges facing the surface metrology community. There are many more challenges which we would like to address in future ‘open questions’ articles. We welcome your feedback and your suggestions.

Implications of international law for the treatment of cancer: the Single Convention on Narcotic Drugs and the TRIPS Agreement.

PubMed

Liberman, J

2011-12-01

The development, manufacture, trade and distribution of medicines all take place within a web of international legal obligations that states have accepted under a range of multilateral, plurilateral and bilateral agreements. International law can operate either to facilitate or hinder access, depending on how it is developed and implemented. This article examines two areas of international law that are relevant to cancer treatment: the international drug control system, which regulates opioid analgesics; and the World Trade Organization's Trade-Related Aspects of Intellectual Property Agreement. This article outlines recent developments in relation to both, including in the activities of the Vienna-based agencies that collectively oversee the implementation of the Single Convention on Narcotic Drugs, and in the negotiation of the recent United Nations General Assembly Political Declaration on Non-communicable Diseases. While underlining the importance of law, this article notes that battles over law should not distract from the importance of other essential efforts to enhance access to medicines within the context of the strengthening of health systems. Copyright © 2011 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

78 FR 77426 - Meeting of the Manufacturing Council

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-23

... development and public perception of manufacturing; manufacturing energy policy; tax policy and export growth; and innovation, research and development. The Council will discuss current workforce development... manufacturing, and specific ideas for innovation improvements in manufacturing. The Council will also discuss...

A relic of the Wellcome Tropical Research Laboratories in Khartoum (1903-34).

PubMed

Adeel, Ahmed Awad

2016-01-01

This article explores the origins of an old brass monocular microscope in the Central Laboratory in Khartoum, which used to be the Wellcome Tropical Research Laboratory in Khartoum (1903-1934). Examination of the microscope and review of published literature gave clues to the historical background of this microscope. Identical microscopes were first manufactured by R and J Beck in 1898, and continued to be advertised in 1899. The microscope was probably among the instruments provided by Wellcome for the initial establishment of the laboratories in 1902-1903. The article includes a brief review of the development of light microscopy. The need for preservation and proper restoration of old relics of the Wellcome laboratories in Khartoum is emphasized.

A relic of the Wellcome Tropical Research Laboratories in Khartoum (1903–34)

PubMed Central

2016-01-01

This article explores the origins of an old brass monocular microscope in the Central Laboratory in Khartoum, which used to be the Wellcome Tropical Research Laboratory in Khartoum (1903–1934). Examination of the microscope and review of published literature gave clues to the historical background of this microscope. Identical microscopes were first manufactured by R and J Beck in 1898, and continued to be advertised in 1899. The microscope was probably among the instruments provided by Wellcome for the initial establishment of the laboratories in 1902–1903. The article includes a brief review of the development of light microscopy. The need for preservation and proper restoration of old relics of the Wellcome laboratories in Khartoum is emphasized. PMID:27651557

The dark side of the immunohistochemical moon: industry.

PubMed

Kalyuzhny, Alexander E

2009-12-01

Modern biological research is dependent on tools developed and provided by commercial suppliers, and antibodies for immunohistochemistry are among the most frequently used of these tools. Not all commercial antibodies perform as expected, however; this problem leads researchers to waste time and money when using antibodies that perform inadequately. Different commercial suppliers offer antibodies of varying degrees of quality and, in some cases, are unable to provide expert technical support for the immunohistochemical use of their antibodies. This article briefly describes the production of commercial antibodies from the manufacturer's perspective and presents some guidelines for choosing appropriate commercial antibodies for immunohistochemistry. Additionally, the article suggests steps to establish mutually beneficial relationships between commercial antibody suppliers and researchers who use them.

26 CFR 48.6416(a)-3 - Credit or refund of manufacturers tax under chapter 32.

Code of Federal Regulations, 2010 CFR

2010-04-01

... total inventory, by model number and quantity, of all such articles purchased tax-paid and held for sale... article is not subject to tax under chapter 32. (C) Inventory requirement. The inventory shall not include... the price of the article with respect to which it was imposed nor collected the amount of the tax from...

25th anniversary article: a decade of organic/polymeric photovoltaic research.

PubMed

Dou, Letian; You, Jingbi; Hong, Ziruo; Xu, Zheng; Li, Gang; Street, Robert A; Yang, Yang

2013-12-10

Organic photovoltaic (OPV) technology has been developed and improved from a fancy concept with less than 1% power conversion efficiency (PCE) to over 10% PCE, particularly through the efforts in the last decade. The significant progress is the result of multidisciplinary research ranging from chemistry, material science, physics, and engineering. These efforts include the design and synthesis of novel compounds, understanding and controlling the film morphology, elucidating the device mechanisms, developing new device architectures, and improving large-scale manufacture. All of these achievements catalyzed the rapid growth of the OPV technology. This review article takes a retrospective look at the research and development of OPV, and focuses on recent advances of solution-processed materials and devices during the last decade, particular the polymer version of the materials and devices. The work in this field is exciting and OPV technology is a promising candidate for future thin film solar cells. © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Low Cost Manufacturing of Composite Cryotanks

NASA Technical Reports Server (NTRS)

Meredith, Brent; Palm, Tod; Deo, Ravi; Munafo, Paul M. (Technical Monitor)

2002-01-01

This viewgraph presentation reviews research and development of cryotank manufacturing conducted by Northrup Grumman. The objectives of the research and development included the development and validation of manufacturing processes and technology for fabrication of large scale cryogenic tanks, the establishment of a scale-up and facilitization plan for full scale cryotanks, the development of non-autoclave composite manufacturing processes, the fabrication of subscale tank joints for element tests, the performance of manufacturing risk reduction trials for the subscale tank, and the development of full-scale tank manufacturing concepts.

Laboratory considerations of United States Pharmacopeia Chapter <71> sterility tests and its application to pharmaceutical compounding.

PubMed

Hyde, Tiffany D

2014-01-01

The purpose of this article is to describe United States Pharmacopeia Chapter <71> Sterility Tests from the perspective of Current Good Manufacturing Practices in order to aid compounding pharmacists in understanding the details and complexities that are required. Compounding pharmacists face a unique challenge in the industry today, with their compounding practice and the U.S. Food and Drug Administration trying to impose Current Good Manufacturing Practices guidelines. Naturally, this becomes a challenge to contract testing laboratories as well, as they are caught between the testing for non-Current Good Manufacturing Practices compounding standards and Current Good Manufacturing Practices manufacturing. It is important that the compounding pharmacist and their partner testing laboratory work closely together to ensure appropriate requirements are being met.

A methodology toward manufacturing grid-based virtual enterprise operation platform

NASA Astrophysics Data System (ADS)

Tan, Wenan; Xu, Yicheng; Xu, Wei; Xu, Lida; Zhao, Xianhua; Wang, Li; Fu, Liuliu

2010-08-01

Virtual enterprises (VEs) have become one of main types of organisations in the manufacturing sector through which the consortium companies organise their manufacturing activities. To be competitive, a VE relies on the complementary core competences among members through resource sharing and agile manufacturing capacity. Manufacturing grid (M-Grid) is a platform in which the production resources can be shared. In this article, an M-Grid-based VE operation platform (MGVEOP) is presented as it enables the sharing of production resources among geographically distributed enterprises. The performance management system of the MGVEOP is based on the balanced scorecard and has the capacity of self-learning. The study shows that a MGVEOP can make a semi-automated process possible for a VE, and the proposed MGVEOP is efficient and agile.

Laser re-manufacturing of failure 18Cr2Ni4WA gear in low-speed heavy-load mining machine transmission

NASA Astrophysics Data System (ADS)

Chi, X. F.

2017-10-01

This article investigated laser re-manufacturing technology application in mining industry. The research focused on green re-manufacturing of failure spur. Leave the main gear body stay intact after the dirty, rust, fatigue and injured part were removed completely before the green re-manufacturing procedure begin. The optimized laser operating parameters paved the road for excellent mechanical properties and comparatively neat shape which often means less post processing. The laser re-manufactured gear surface was systematically examined, including microstructure observation, and dry wear test at room temperature. The test results were compared with new gear surface and used but not broken gear surface. Finally, it proved that the green re-manufactured gear surface displayed best comprehensive mechanical properties, followed the new gear surface. The resistance of dry wear properties of used but not broken gear surface was the worst.

BMI Sandwich Wing Box Analysis and Test

NASA Technical Reports Server (NTRS)

Palm, Tod; Mahler, Mary; Shah, Chandu; Rouse, Marshall; Bush, Harold; Wu, Chauncey; Small, William J.

2000-01-01

A composite sandwich single bay wing box test article was developed by Northrop Grumman and tested recently at NASA Langley Research Center. The objectives for the wing box development effort were to provide a demonstration article for manufacturing scale up of structural concepts related to a high speed transport wing, and to validate the structural performance of the design. The box concept consisted of highly loaded composite sandwich wing skins, with moderately loaded composite sandwich spars. The dimensions of the box were chosen to represent a single bay of the main wing box, with a spar spacing of 30 inches, height of 20 inches constant depth, and length of 64 inches. The bismaleimide facesheet laminates and titanium honeycomb core chosen for this task are high temperature materials able to sustain a 300F service temperature. The completed test article is shown in Figure 1. The tests at NASA Langley demonstrated the structures ability to sustain axial tension and compression loads in excess of 20,000 lb/in, and to maintain integrity in the thermal environment. Test procedures, analysis failure predictions, and test results are presented.

Networks of innovation or networks of opportunity? The making of the Spanish antibiotics industry.

PubMed

Puig, Nuria

2004-07-01

The pharmaceutical industry is a typically research-intensive, first world-industry. This article seeks to explain why it has been so difficult for late industrialised nations to reproduce the networks of innovation on which the design and manufacturing of new drugs has historically based, and why alternative concepts are needed in order to understand the dynamics of science-based industries in emerging countries. The article analyses the development of the Spanish antibiotics industry, build after the World War II under the strong influence of the new international order and Spain's political framework, academic traditions and business groups. Focusing on the long-term relationships established between two Spanish companies (Antibióticos SA and Compañía Española de Penicilina y Antibióticos, CEPA), their American technological partners (Schenley and Merck), and their social and scientific environment, the article identifies networks of opportunity as the key institutional arrangement of this new industry in Spain. Opportunity (as opposed to innovation) networks are thus proposed to conceptualise the development of technologically complex industries in the European periphery.

Metal- and Polymer-Matrix Composites: Functional Lightweight Materials for High-Performance Structures

NASA Astrophysics Data System (ADS)

Gupta, Nikhil; Paramsothy, Muralidharan

2014-06-01

The special topic "Metal- and Polymer-Matrix Composites" is intended to capture the state of the art in the research and practice of functional composites. The current set of articles related to metal-matrix composites includes reviews on functionalities such as self-healing, self-lubricating, and self-cleaning capabilities; research results on a variety of aluminum-matrix composites; and investigations on advanced composites manufacturing methods. In addition, the processing and properties of carbon nanotube-reinforced polymer-matrix composites and adhesive bonding of laminated composites are discussed. The literature on functional metal-matrix composites is relatively scarce compared to functional polymer-matrix composites. The demand for lightweight composites in the transportation sector is fueling the rapid development in this field, which is captured in the current set of articles. The possibility of simultaneously tailoring several desired properties is attractive but very challenging, and it requires significant advancements in the science and technology of composite materials. The progress captured in the current set of articles shows promise for developing materials that seem capable of moving this field from laboratory-scale prototypes to actual industrial applications.

Exotic Optical Fibers and Glasses: Innovative Material Processing Opportunities in Earth's Orbit.

PubMed

Cozmuta, Ioana; Rasky, Daniel J

2017-09-01

Exotic optical fibers and glasses are the platform material for photonics applications, primarily due to their superior signal transmission (speed, low attenuation), with extending bandwidth deep into the infrared, exceeding that of silica fibers. Gravitational effects (convection sedimentation) have a direct impact on the phase diagram of these materials and influence melting properties, crystallization temperatures, and viscosity of the elemental mix during the manufacturing process. Such factors constitute limits to the yield, transmission quality, and strength and value of these fibers; they also constrain the range of applications. Manufacturing in a gravity-free environment such as the Earth's Orbit also helps with other aspects of the fabrication process (i.e., improved form factor of the manufacturing unit, sustainability). In this article, revolutionary developments in the field of photonics over the past decade merge with the paradigm shift in the privatization of government-owned capabilities supporting a more diverse infrastructure (parabolic, suborbital, orbital), reduced price, and increased frequency to access space and the microgravity environment. With the increased dependence on data (demand, bandwidth, efficiency), space and the microgravity environment provide opportunities for optimized performance of these exotic optical fibers and glasses underlying the development of enabling technologies to meet future data demand. Existing terrestrial markets (Internet, telecommunications, market transactions) and emerging space markets (on-orbit satellite servicing, space manufacturing, space resources, space communications, etc.) seem to converge, and this innovative material processing opportunity of exotic optical fibers and glasses might just be that "killer app": technologically competitive, economically viable, and with the ability to close the business case.

Exotic Optical Fibers and Glasses: Innovative Material Processing Opportunities in Earth's Orbit

PubMed Central

Rasky, Daniel J.

2017-01-01

Abstract Exotic optical fibers and glasses are the platform material for photonics applications, primarily due to their superior signal transmission (speed, low attenuation), with extending bandwidth deep into the infrared, exceeding that of silica fibers. Gravitational effects (convection sedimentation) have a direct impact on the phase diagram of these materials and influence melting properties, crystallization temperatures, and viscosity of the elemental mix during the manufacturing process. Such factors constitute limits to the yield, transmission quality, and strength and value of these fibers; they also constrain the range of applications. Manufacturing in a gravity-free environment such as the Earth's Orbit also helps with other aspects of the fabrication process (i.e., improved form factor of the manufacturing unit, sustainability). In this article, revolutionary developments in the field of photonics over the past decade merge with the paradigm shift in the privatization of government-owned capabilities supporting a more diverse infrastructure (parabolic, suborbital, orbital), reduced price, and increased frequency to access space and the microgravity environment. With the increased dependence on data (demand, bandwidth, efficiency), space and the microgravity environment provide opportunities for optimized performance of these exotic optical fibers and glasses underlying the development of enabling technologies to meet future data demand. Existing terrestrial markets (Internet, telecommunications, market transactions) and emerging space markets (on-orbit satellite servicing, space manufacturing, space resources, space communications, etc.) seem to converge, and this innovative material processing opportunity of exotic optical fibers and glasses might just be that “killer app”: technologically competitive, economically viable, and with the ability to close the business case. PMID:29375939

Scientific Challenges in the Risk Assessment of Food Contact Materials

PubMed Central

Backhaus, Thomas; Geueke, Birgit; Maffini, Maricel V.; Martin, Olwenn Viviane; Myers, John Peterson; Soto, Ana M.; Trasande, Leonardo; Trier, Xenia; Scheringer, Martin

2017-01-01

Background: Food contact articles (FCAs) are manufactured from food contact materials (FCMs) that include plastics, paper, metal, glass, and printing inks. Chemicals can migrate from FCAs into food during storage, processing, and transportation. Food contact materials’ safety is evaluated using chemical risk assessment (RA). Several challenges to the RA of FCAs exist. Objectives: We review regulatory requirements for RA of FCMs in the United States and Europe, identify gaps in RA, and highlight opportunities for improving the protection of public health. We intend to initiate a discussion in the wider scientific community to enhance the safety of food contact articles. Discussion: Based on our evaluation of the evidence, we conclude that current regulations are insufficient for addressing chemical exposures from FCAs. RA currently focuses on monomers and additives used in the manufacture of products, but it does not cover all substances formed in the production processes. Several factors hamper effective RA for many FCMs, including a lack of information on chemical identity, inadequate assessment of hazardous properties, and missing exposure data. Companies make decisions about the safety of some food contact chemicals (FCCs) without review by public authorities. Some chemical migration limits cannot be enforced because analytical standards are unavailable. Conclusion: We think that exposures to hazardous substances migrating from FCAs require more attention. We recommend a) limiting the number and types of chemicals authorized for manufacture and b) developing novel approaches for assessing the safety of chemicals in FCAs, including unidentified chemicals that form during or after production. https://doi.org/10.1289/EHP644 PMID:28893723

A practical approach for exploration and modeling of the design space of a bacterial vaccine cultivation process.

PubMed

Streefland, M; Van Herpen, P F G; Van de Waterbeemd, B; Van der Pol, L A; Beuvery, E C; Tramper, J; Martens, D E; Toft, M

2009-10-15

A licensed pharmaceutical process is required to be executed within the validated ranges throughout the lifetime of product manufacturing. Changes to the process, especially for processes involving biological products, usually require the manufacturer to demonstrate that the safety and efficacy of the product remains unchanged by new or additional clinical testing. Recent changes in the regulations for pharmaceutical processing allow broader ranges of process settings to be submitted for regulatory approval, the so-called process design space, which means that a manufacturer can optimize his process within the submitted ranges after the product has entered the market, which allows flexible processes. In this article, the applicability of this concept of the process design space is investigated for the cultivation process step for a vaccine against whooping cough disease. An experimental design (DoE) is applied to investigate the ranges of critical process parameters that still result in a product that meets specifications. The on-line process data, including near infrared spectroscopy, are used to build a descriptive model of the processes used in the experimental design. Finally, the data of all processes are integrated in a multivariate batch monitoring model that represents the investigated process design space. This article demonstrates how the general principles of PAT and process design space can be applied for an undefined biological product such as a whole cell vaccine. The approach chosen for model development described here, allows on line monitoring and control of cultivation batches in order to assure in real time that a process is running within the process design space.

Efficient Windows Collaborative

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

Nils Petermann

2010-02-28

The project goals covered both the residential and commercial windows markets and involved a range of audiences such as window manufacturers, builders, homeowners, design professionals, utilities, and public agencies. Essential goals included: (1) Creation of 'Master Toolkits' of information that integrate diverse tools, rating systems, and incentive programs, customized for key audiences such as window manufacturers, design professionals, and utility programs. (2) Delivery of education and outreach programs to multiple audiences through conference presentations, publication of articles for builders and other industry professionals, and targeted dissemination of efficient window curricula to professionals and students. (3) Design and implementation of mechanismsmore » to encourage and track sales of more efficient products through the existing Window Products Database as an incentive for manufacturers to improve products and participate in programs such as NFRC and ENERGY STAR. (4) Development of utility incentive programs to promote more efficient residential and commercial windows. Partnership with regional and local entities on the development of programs and customized information to move the market toward the highest performing products. An overarching project goal was to ensure that different audiences adopt and use the developed information, design and promotion tools and thus increase the market penetration of energy efficient fenestration products. In particular, a crucial success criterion was to move gas and electric utilities to increase the promotion of energy efficient windows through demand side management programs as an important step toward increasing the market share of energy efficient windows.« less

Launch Vehicles

NASA Image and Video Library

2007-08-09

Under the goals of the Vision for Space Exploration, Ares I is a chief component of the cost-effective space transportation infrastructure being developed by NASA's Constellation Program. This transportation system will safely and reliably carry human explorers back to the moon, and then onward to Mars and other destinations in the solar system. The Ares I effort includes multiple project element teams at NASA centers and contract organizations around the nation, and is managed by the Exploration Launch Projects Office at NASA's Marshall Space Flight Center (MFSC). ATK Launch Systems near Brigham City, Utah, is the prime contractor for the first stage booster. ATK's subcontractor, United Space Alliance of Houston, is designing, developing and testing the parachutes at its facilities at NASA's Kennedy Space Center in Florida. NASA's Johnson Space Center in Houston hosts the Constellation Program and Orion Crew Capsule Project Office and provides test instrumentation and support personnel. Together, these teams are developing vehicle hardware, evolving proven technologies, and testing components and systems. Their work builds on powerful, reliable space shuttle propulsion elements and nearly a half-century of NASA space flight experience and technological advances. Ares I is an inline, two-stage rocket configuration topped by the Crew Exploration Vehicle, its service module, and a launch abort system. This HD video image depicts the manufacturing of aluminum panels that will be used to form the Ares I barrel. The panels are manufacturing process demonstration articles that will undergo testing until perfected. The panels are built by AMRO Manufacturing located in El Monte, California. (Highest resolution available)

n/a

NASA Image and Video Library

2007-08-09

Under the goals of the Vision for Space Exploration, Ares I is a chief component of the cost-effective space transportation infrastructure being developed by NASA's Constellation Program. This transportation system will safely and reliably carry human explorers back to the moon, and then onward to Mars and other destinations in the solar system. The Ares I effort includes multiple project element teams at NASA centers and contract organizations around the nation, and is managed by the Exploration Launch Projects Office at NASA's Marshall Space Flight Center (MFSC). ATK Launch Systems near Brigham City, Utah, is the prime contractor for the first stage booster. ATK's subcontractor, United Space Alliance of Houston, is designing, developing and testing the parachutes at its facilities at NASA's Kennedy Space Center in Florida. NASA's Johnson Space Center in Houston hosts the Constellation Program and Orion Crew Capsule Project Office and provides test instrumentation and support personnel. Together, these teams are developing vehicle hardware, evolving proven technologies, and testing components and systems. Their work builds on powerful, reliable space shuttle propulsion elements and nearly a half-century of NASA space flight experience and technological advances. Ares I is an inline, two-stage rocket configuration topped by the Crew Exploration Vehicle, its service module, and a launch abort system. This HD video image depicts a manufactured panel that will be used for the Ares I upper stage barrel fabrication. The aluminum panels are manufacturing process demonstration articles that will undergo testing until perfected. The panels are built by AMRO Manufacturing located in El Monte, California. (Highest resolution available)

Development and implementation of a quality assurance program for a hormonal contraceptive implant.

PubMed

Owen, Derek H; Jenkins, David; Cancel, Aida; Carter, Eli; Dorflinger, Laneta; Spieler, Jeff; Steiner, Markus J

2013-04-01

The importance of the distribution of safe, effective and cost-effective pharmaceutical products in resource-constrained countries is the subject of increasing attention. FHI 360 has developed a program aimed at evaluating the quality of a contraceptive implant manufactured in China, while the product is being registered in an increasing number of countries and distributed by international procurement agencies. The program consists of (1) independent product testing; (2) ongoing evaluation of the manufacturing facility through audits and inspections; and (3) post-marketing surveillance. This article focuses on the laboratory testing of the product. The various test methods were chosen from the following test method compendia, the United States Pharmacopeia (USP), British Pharmacopeia (BP), International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), or lot release tests mandated by Chinese regulatory requirements. Each manufactured lot is independently tested prior to its distribution to countries supported by this program. In addition, a more detailed annual testing program includes evaluation of the active ingredient (levonorgestrel), the final product and the packaging material. Over the first 4 years of this 5-year project, all tested lots met the established quality criteria. The quality assurance program developed for this contraceptive implant has helped ensure that a safe product was being introduced into developing country family planning programs. This program provides a template for establishing quality assurance programs for other cost-effective pharmaceutical products that have not yet received stringent regulatory approval and are being distributed in resource-poor settings. Copyright © 2013 Elsevier Inc. All rights reserved.

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

Code of Federal Regulations, 2012 CFR

2012-07-01

... shape or design during manufacture, (ii) which has end use function(s) dependent in whole or in part upon its shape or design during end use, and (iii) which has either no change of chemical composition... particles are not considered articles regardless of shape or design. (3) The terms byproduct, EPA...

Recession effects on the forests and forest products industries of the South.

Treesearch

Douglas Hodges; Andrew Hartsell; Consuelo Brandeis; Thomas Brandeis; James Bentley

2012-01-01

The economic recession affected southern forests and related industries substantially, particularly those sectors most closely related to home construction. Between 2005 and 2009, for example, the three primary forestry sectors – wood manufacturing, paper manufacturing, and forestry and logging – lost more than 110,000 jobs in the southern United States. This article...

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

Code of Federal Regulations, 2011 CFR

2011-07-01

... shape or design during manufacture, (ii) which has end use function(s) dependent in whole or in part upon its shape or design during end use, and (iii) which has either no change of chemical composition... particles are not considered articles regardless of shape or design. (3) The terms byproduct, EPA...

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

Code of Federal Regulations, 2013 CFR

2013-07-01

... shape or design during manufacture, (ii) which has end use function(s) dependent in whole or in part upon its shape or design during end use, and (iii) which has either no change of chemical composition... particles are not considered articles regardless of shape or design. (3) The terms byproduct, EPA...

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

Code of Federal Regulations, 2014 CFR

2014-07-01

... shape or design during manufacture, (ii) which has end use function(s) dependent in whole or in part upon its shape or design during end use, and (iii) which has either no change of chemical composition... particles are not considered articles regardless of shape or design. (3) The terms byproduct, EPA...

Codifying Implementation Guidelines for a Collaborative Improvement Initiative

ERIC Educational Resources Information Center

Coughlan, Paul; Coghlan, David

2008-01-01

The application of action learning in inter-organizational settings is largely undeveloped. This article presents a description of and reflection on an action learning approach to enabling collaborative improvement in the extended manufacturing enterprise. The article focuses in particular on implementing the action learning approach. However, the…

75 FR 70961 - 30-Day Notice of Proposed Information Collection: Voluntary Disclosures

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-19

... message. Fax: 202-395-5806. Attention: Desk Officer for Department of State. FOR FURTHER INFORMATION... collection: The export, temporary import, temporary export and brokering of defense articles, defense... of the Arms Export Control Act (AECA). Those who manufacture or export defense articles, defense...

Transformative research issues and opportunities in energy efficiency

USDA-ARS?s Scientific Manuscript database

This article presents a summary of research opportunities in energy efficiency identified in a workshop by a panel of experts assembled for the Civil, Mechanical and Manufacturing Innovation Division of the U.S. National Science Foundation. The workshop and article are restricted to two areas – red...

Identification of the actual state and entity availability forecasting in power engineering using neural-network technologies

NASA Astrophysics Data System (ADS)

Protalinsky, O. M.; Shcherbatov, I. A.; Stepanov, P. V.

2017-11-01

A growing number of severe accidents in RF call for the need to develop a system that could prevent emergency situations. In a number of cases accident rate is stipulated by careless inspections and neglects in developing repair programs. Across the country rates of accidents are growing because of a so-called “human factor”. In this regard, there has become urgent the problem of identification of the actual state of technological facilities in power engineering using data on engineering processes running and applying artificial intelligence methods. The present work comprises four model states of manufacturing equipment of engineering companies: defect, failure, preliminary situation, accident. Defect evaluation is carried out using both data from SCADA and ASEPCR and qualitative information (verbal assessments of experts in subject matter, photo- and video materials of surveys processed using pattern recognition methods in order to satisfy the requirements). Early identification of defects makes possible to predict the failure of manufacturing equipment using mathematical techniques of artificial neural network. In its turn, this helps to calculate predicted characteristics of reliability of engineering facilities using methods of reliability theory. Calculation of the given parameters provides the real-time estimation of remaining service life of manufacturing equipment for the whole operation period. The neural networks model allows evaluating possibility of failure of a piece of equipment consistent with types of actual defects and their previous reasons. The article presents the grounds for a choice of training and testing samples for the developed neural network, evaluates the adequacy of the neural networks model, and shows how the model can be used to forecast equipment failure. There have been carried out simulating experiments using a computer and retrospective samples of actual values for power engineering companies. The efficiency of the developed model for different types of manufacturing equipment has been proved. There have been offered other research areas in terms of the presented subject matter.

A quality-based cost model for new electronic systems and products

NASA Astrophysics Data System (ADS)

Shina, Sammy G.; Saigal, Anil

1998-04-01

This article outlines a method for developing a quality-based cost model for the design of new electronic systems and products. The model incorporates a methodology for determining a cost-effective design margin allocation for electronic products and systems and its impact on manufacturing quality and cost. A spreadsheet-based cost estimating tool was developed to help implement this methodology in order for the system design engineers to quickly estimate the effect of design decisions and tradeoffs on the quality and cost of new products. The tool was developed with automatic spreadsheet connectivity to current process capability and with provisions to consider the impact of capital equipment and tooling purchases to reduce the product cost.

Changes and Trends in the Pallet Industry: Alternative Materials and Industry Structure

Treesearch

Robert J. Bush; Philip A. Araman

1998-01-01

In the first article of this three-part series we described trends in the use of new wood materials for pallets and containers. The second article described changes in pallet recovery and recycling. In this third article, we describe alternative (i.e., other than solid wood) materials used to manufacture pallets as well as changes in the structure of the industry....

Effects of resistant maltodextrin on bowel movements: a systematic review and meta-analysis

PubMed Central

Watanabe, Norikazu; Suzuki, Masataka; Yamaguchi, Yoshitake; Egashira, Yukari

2018-01-01

It is well known that dietary fiber helps to relieve and prevent constipation, and there are a number of scientific papers, including systematic reviews and meta-analyses on the effects of naturally derived dietary fiber on bowel movements. In recent years, there has been an increase in the manufacture of dietary fiber ingredients obtained from food raw materials, and these are now commonly available in the market. Resistant maltodextrin (RMD), a soluble dietary fiber, is manufactured from starch, and industrially produced soluble dietary fiber is used worldwide. While there are many reports on the effects of RMD on bowel movements, no systematic review or meta-analysis has been reported. We conducted a systematic review and meta-analysis to clarify the effect of RMD on bowel movements based on stool frequency and stool volume. We also investigated the subjective evaluation of RMD effects on bowel movements. Of a total of 314 potentially relevant articles, 28 articles met the eligibility criteria, and 29 randomized controlled trials were identified. As a result of integration analyses, we found that the intake of RMD significantly increased stool volume and stool frequency compared with placebo intake. Furthermore, RMD intake tended to improve sensation of complete/incomplete evacuation. In conclusion, the evidence suggests that RMD has a positive effect on bowel movements, contributing to normal bowel function. This finding will help in the development of new criteria for choice of dietary fiber in the process of developing food products. PMID:29535547

High melt strength, tear resistant blown film based on poly(lactic acid)

NASA Astrophysics Data System (ADS)

Edmonds, Neil R.; Plimmer, Peter N.; Tanner, Chris

2015-05-01

A major problem associated with the commercial manufacture of thin films from PLA is inferior processing characteristics on blown film lines compared to low density polyethylene. PLA has poor melt strength (leading to bubble instability) and develops a permanent crease in the flattened film as it exits the tower of the film line. In addition, the thin film product has poor tear strength and an unacceptable `noise' level when converted into flexible packaging. Furthermore, fabricated articles based on PLA are known to show an unattractive tendency toward dimensional instability. This behaviour is associated with `cold crystallization', a phenomenon which also causes exudation of any plasticizer added for improving flexibility. Blow moulded articles based on PLA also exhibit dimensional sensitivity above 60°C. All of these issues have been overcome by the technology described in this paper. This has been accomplished without loss of the valuable compostability characteristic of PLA; this was confirmed by evaluation of film in a commercial composting operation. These results have been achieved through novel reactive compounding technology which: (a) Creates a PLA-rich structure containing long chain crosslinks, (b) generates a low glass transition temperature phase covalently bonded to the PLA structure, and (c) provides a material which performs like LDPE in a blown film manufacturing operation. The technology developed is covered by NZ Patent 580231 (3). The patent is held by UniServices Ltd, The University of Auckland, New Zealand.

Practical implementation of the concept of converted electric vehicle with advanced traction and dynamic performance and environmental safety indicators

NASA Astrophysics Data System (ADS)

Sidorov, K. M.; Yutt, V. E.; Grishchenko, A. G.; Golubchik, T. V.

2018-02-01

The objective of the work presented in this paper is to describe the implementation of the technical solutions have been developed, with regard to structure, composition, and characteristics, for an experimental prototype of an electric vehicle which has been converted from a conventional vehicle. The methodology of the study results is based on the practical implementation of the developed concept of the conversion of conventional vehicles into electric vehicles. The main components of electric propulsion system of the experimental prototype of electric vehicle are developed and manufactured on the basis of computational researches, taking into account the criteria and principles of conversion within the framework of presented work. The article describes a schematic and a design of power conversion and commutation electrical equipment, traction battery, electromechanical transmission. These results can serve as guidance material in the design and implementation of electric propulsion system (EPS) components of electric vehicles, facilitate the development of optimal technical solutions in the development and manufacture of vehicles, including those aimed at autonomy of operation and the use of perspective driver assistance systems. As part of this work, was suggested a rational structure for an electric vehicle experimental prototype, including technical performance characteristics of the components of EPS.

Injection Molding and its application to drug delivery.

PubMed

Zema, Lucia; Loreti, Giulia; Melocchi, Alice; Maroni, Alessandra; Gazzaniga, Andrea

2012-05-10

Injection Molding (IM) consists in the injection, under high pressure conditions, of heat-induced softened materials into a mold cavity where they are shaped. The advantages the technique may offer in the development of drug products concern both production costs (no need for water or other solvents, continuous manufacturing, scalability, patentability) and technological/biopharmaceutical characteristics of the molded items (versatility of the design and composition, possibility of obtaining solid molecular dispersions/solutions of the active ingredient). In this article, process steps and formulation aspects relevant to IM are discussed, with emphasis on the issues and advantages connected with the transfer of this technique from the plastics industry to the production of conventional and controlled-release dosage forms. Moreover, its pharmaceutical applications thus far proposed in the primary literature, intended as either alternative manufacturing strategies for existing products or innovative systems with improved design and performance characteristics, are critically reviewed. Copyright © 2012 Elsevier B.V. All rights reserved.

Application of superplastically formed and diffusion bonded aluminum to a laminar flow control leading edge

NASA Technical Reports Server (NTRS)

Goodyear, M. D.

1987-01-01

NASA sponsored the Aircraft Energy Efficiency (ACEE) program in 1976 to develop technologies to improve fuel efficiency. Laminar flow control was one such technology. Two approaches for achieving laminar flow were designed and manufactured under NASA sponsored programs: the perforated skin concept used at McDonnell Douglas and the slotted design used at Lockheed-Georgia. Both achieved laminar flow, with the slotted design to a lesser degree (JetStar flight test program). The latter design had several fabrication problems concerning springback and adhesive flow clogging the air flow passages. The Lockheed-Georgia Company accomplishments is documented in designing and fabricating a small section of a leading edge article addressing a simpler fabrication method to overcome the previous program's manufacturing problems, i.e., design and fabrication using advanced technologies such as diffusion bonding of aluminum, which has not been used on aerospace structures to date, and the superplastic forming of aluminum.

Cell-based therapy technology classifications and translational challenges

PubMed Central

Mount, Natalie M.; Ward, Stephen J.; Kefalas, Panos; Hyllner, Johan

2015-01-01

Cell therapies offer the promise of treating and altering the course of diseases which cannot be addressed adequately by existing pharmaceuticals. Cell therapies are a diverse group across cell types and therapeutic indications and have been an active area of research for many years but are now strongly emerging through translation and towards successful commercial development and patient access. In this article, we present a description of a classification of cell therapies on the basis of their underlying technologies rather than the more commonly used classification by cell type because the regulatory path and manufacturing solutions are often similar within a technology area due to the nature of the methods used. We analyse the progress of new cell therapies towards clinical translation, examine how they are addressing the clinical, regulatory, manufacturing and reimbursement requirements, describe some of the remaining challenges and provide perspectives on how the field may progress for the future. PMID:26416686

Customer demand prediction of service-oriented manufacturing using the least square support vector machine optimized by particle swarm optimization algorithm

NASA Astrophysics Data System (ADS)

Cao, Jin; Jiang, Zhibin; Wang, Kangzhou

2017-07-01

Many nonlinear customer satisfaction-related factors significantly influence the future customer demand for service-oriented manufacturing (SOM). To address this issue and enhance the prediction accuracy, this article develops a novel customer demand prediction approach for SOM. The approach combines the phase space reconstruction (PSR) technique with the optimized least square support vector machine (LSSVM). First, the prediction sample space is reconstructed by the PSR to enrich the time-series dynamics of the limited data sample. Then, the generalization and learning ability of the LSSVM are improved by the hybrid polynomial and radial basis function kernel. Finally, the key parameters of the LSSVM are optimized by the particle swarm optimization algorithm. In a real case study, the customer demand prediction of an air conditioner compressor is implemented. Furthermore, the effectiveness and validity of the proposed approach are demonstrated by comparison with other classical predication approaches.

Modular Chemical Process Intensification: A Review.

PubMed

Kim, Yong-Ha; Park, Lydia K; Yiacoumi, Sotira; Tsouris, Costas

2017-06-07

Modular chemical process intensification can dramatically improve energy and process efficiencies of chemical processes through enhanced mass and heat transfer, application of external force fields, enhanced driving forces, and combinations of different unit operations, such as reaction and separation, in single-process equipment. These dramatic improvements lead to several benefits such as compactness or small footprint, energy and cost savings, enhanced safety, less waste production, and higher product quality. Because of these benefits, process intensification can play a major role in industrial and manufacturing sectors, including chemical, pulp and paper, energy, critical materials, and water treatment, among others. This article provides an overview of process intensification, including definitions, principles, tools, and possible applications, with the objective to contribute to the future development and potential applications of modular chemical process intensification in industrial and manufacturing sectors. Drivers and barriers contributing to the advancement of process intensification technologies are discussed.

Method for fabrication of high temperature superconductors

DOEpatents

Balachandran, Uthamalingam; Ma, Beihai; Miller, Dean

2006-03-14

A layered article of manufacture and a method of manufacturing same is disclosed. A substrate has a biaxially textured MgO crystalline layer having the c-axes thereof inclined with respect to the plane of the substrate deposited thereon. A layer of one or more of YSZ or Y₂O₃ and then a layer of CeO₂ is deposited on the MgO. A crystalline superconductor layer with the c-axes thereof normal to the plane of the substrate is deposited on the CeO₂ layer. Deposition of the MgO layer on the substrate is by the inclined substrate deposition method developed at Argonne National Laboratory. Preferably, the MgO has the c-axes thereof inclined with respect to the normal to the substrate in the range of from about 10.degree. to about 40.degree. and YBCO superconductors are used.

Method for fabrication of high temperature superconductors

DOEpatents

Balachandran, Uthamalingam [Hinsdale, IL; Ma, Beihai [Naperville, IL; Miller, Dean [Darien, IL

2009-07-14

A layered article of manufacture and a method of manufacturing same is disclosed. A substrate has a biaxially textured MgO crystalline layer having the c-axes thereof inclined with respect to the plane of the substrate deposited thereon. A layer of one or more of YSZ or Y.sub.2O.sub.3 and then a layer of CeO.sub.2 is deposited on the MgO. A crystalline superconductor layer with the c-axes thereof normal to the plane of the substrate is deposited on the CeO.sub.2 layer. Deposition of the MgO layer on the substrate is by the inclined substrate deposition method developed at Argonne National Laboratory. Preferably, the MgO has the c-axes thereof inclined with respect to the normal to the substrate in the range of from about 10.degree. to about 40.degree. and YBCO superconductors are used.

Organic photovoltaic cells: from performance improvement to manufacturing processes.

PubMed

Youn, Hongseok; Park, Hui Joon; Guo, L Jay

2015-05-20

Organic photovoltaics (OPVs) have been pursued as a next generation power source due to their light weight, thin, flexible, and simple fabrication advantages. Improvements in OPV efficiency have attracted great attention in the past decade. Because the functional layers in OPVs can be dissolved in common solvents, they can be manufactured by eco-friendly and scalable printing or coating technologies. In this review article, the focus is on recent efforts to control nanomorphologies of photoactive layer and discussion of various solution-processed charge transport and extraction materials, to maximize the performance of OPV cells. Next, recent works on printing and coating technologies for OPVs to realize solution processing are reviewed. The review concludes with a discussion of recent advances in the development of non-traditional lamination and transfer method towards highly efficient and fully solution-processed OPV. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Modular Chemical Process Intensification: A Review

DOE PAGES

Kim, Yong-ha; Park, Lydia K.; Yiacoumi, Sotira; ...

2016-06-24

Modular chemical process intensification can dramatically improve energy and process efficiencies of chemical processes through enhanced mass and heat transfer, application of external force fields, enhanced driving forces, and combinations of different unit operations, such as reaction and separation, in single-process equipment. Dramatic improvements such as these lead to several benefits such as compactness or small footprint, energy and cost savings, enhanced safety, less waste production, and higher product quality. Because of these benefits, process intensification can play a major role in industrial and manufacturing sectors, including chemical, pulp and paper, energy, critical materials, and water treatment, among others. Thismore » article provides an overview of process intensification, including definitions, principles, tools, and possible applications, with the objective to contribute to the future development and potential applications of modular chemical process intensification in industrial and manufacturing sectors. Drivers and barriers contributing to the advancement of process intensification technologies are discussed.« less

Between the Bazaar and the Bench: Making of the Drugs Trade in Colonial India, ca. 1900-1930.

PubMed

Bhattacharya, Nandini

2016-01-01

This article analyzes why adulteration became a key trope of the Indian drug market. Adulteration had a pervasive presence, being present in medical discourses, public opinion and debate, and the nationalist claim for government intervention. The article first situates the roots of adulteration in the composite nature of this market, which involved the availability of drugs of different potencies as well as the presence of multiple layers of manufacturers, agents, and distributors. It then shows that such a market witnessed the availability of drugs of diverse potency and strengths, which were understood as elements of adulteration in contemporary medical and official discourse. Although contemporary critics argued that the lack of government legislation and control allowed adulteration to sustain itself, this article establishes that the culture of the dispensation of drugs in India necessarily involved a multitude of manufacturer-retailers, bazaar traders, and medical professionals practicing a range of therapies.

21 CFR 178.3280 - Castor oil, hydrogenated.

Code of Federal Regulations, 2014 CFR

2014-04-01

... polymers used in the manufacture of articles or components of articles authorized for food-contact use For... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Castor oil, hydrogenated. 178.3280 Section 178.3280 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

78 FR 77547 - 30-Day Notice of Proposed Information Collection: Voluntary Disclosures

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-23

... your message. Fax: 202-395-5806. Attention: Desk Officer for Department of State. FOR FURTHER... export, temporary import, and brokering of defense articles, defense services, and related technical data...). Those who manufacture or export defense articles, defense services, and related technical data, or the...

27 CFR 26.87 - Evidence of taxpayment.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., DEPARTMENT OF THE TREASURY LIQUORS LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Taxpayment of Liquors and Articles in Puerto Rico Packages of Distilled Spirits § 26.87 Evidence of taxpayment. Where... distilled spirits of Puerto Rican manufacture to the United States in containers having a capacity of more...

Bilateral Benefits: Student Experiences of Work-Based Learning during Work Placement

ERIC Educational Resources Information Center

O'Donovan, Dermot

2018-01-01

This article explores the varied learning experiences among third-year students undertaking a structured work placement module in the furniture and wood manufacturing industries. Using situated learning theory, the article considers the outcomes of in-depth interviews with 10 students and offers an insight into the multifaceted interactions…

Lexicon generation methods, lexicon generation devices, and lexicon generation articles of manufacture

DOEpatents

Carter, Richard J [Richland, WA; McCall, Jonathon D [West Richland, WA; Whitney, Paul D [Richland, WA; Gregory, Michelle L [Richland, WA; Turner, Alan E [Kennewick, WA; Hetzler, Elizabeth G [Kennewick, WA; White, Amanda M [Kennewick, WA; Posse, Christian [Seattle, WA; Nakamura, Grant C [Kennewick, WA

2010-10-26

Lexicon generation methods, computer implemented lexicon editing methods, lexicon generation devices, lexicon editors, and articles of manufacture are described according to some aspects. In one aspect, a lexicon generation method includes providing a seed vector indicative of occurrences of a plurality of seed terms within a plurality of text items, providing a plurality of content vectors indicative of occurrences of respective ones of a plurality of content terms within the text items, comparing individual ones of the content vectors with respect to the seed vector, and responsive to the comparing, selecting at least one of the content terms as a term of a lexicon usable in sentiment analysis of text.

The principles of quality-associated costing: derivation from clinical transfusion practice.

PubMed

Trenchard, P M; Dixon, R

1997-01-01

As clinical transfusion practice works towards achieving cost-effectiveness, prescribers of blood and its derivatives must be certain that the prices of such products are based on real manufacturing costs and not market forces. Using clinical cost-benefit analysis as the context for the costing and pricing of blood products, this article identifies the following two principles: (1) the product price must equal the product cost (the "price = cost" rule) and (2) the product cost must equal the real cost of product manufacture. In addition, the article describes a new method of blood product costing, quality-associated costing (QAC), that will enable valid cost-benefit analysis of blood products.

Image change detection systems, methods, and articles of manufacture

DOEpatents

Jones, James L.; Lassahn, Gordon D.; Lancaster, Gregory D.

2010-01-05

Aspects of the invention relate to image change detection systems, methods, and articles of manufacture. According to one aspect, a method of identifying differences between a plurality of images is described. The method includes loading a source image and a target image into memory of a computer, constructing source and target edge images from the source and target images to enable processing of multiband images, displaying the source and target images on a display device of the computer, aligning the source and target edge images, switching displaying of the source image and the target image on the display device, to enable identification of differences between the source image and the target image.

The economics of biosimilars.

PubMed

Blackstone, Erwin A; Joseph, P Fuhr

2013-09-01

The high cost of pharmaceuticals, especially biologics, has become an important issue in the battle to control healthcare costs. The Hatch-Waxman Act encourages generic competition but still provides incentives for pioneers to develop new drugs. The Biologics Price Competition and Innovation Act is intended to do the same for biologics and biosimilars. To examine information related to biosimilars to determine their potential impact on competition in the biologic market. Using information concerning the European Union (EU) and the pharmaceutical industry, this article reviews and analyzes the experience of biosimilars in the EU, as well as the obstacles and opportunities that biosimilars face in the United States. Much of the analysis is based on examining current trends in biologic drugs and the potential implications on the future of biosimilars. This article reviews the mixed success of biosimilars in the EU and the implications for the United States. Because biologics are produced from living organisms, manufacturing issues are more important than in the chemical drug market. The barriers to biosimilar entry into the marketplace are much more difficult to overcome than challenges generic manufacturers typically face and are similar to obstacles specialty injectable producers encounter. The competitive responses by pioneers are also likely to be more important. The capital costs and risk issues with biosimilars make alliances and partnering arrangements very likely. Biosimilars often enter emerging markets, where the barriers to entry are easier to overcome. Nevertheless, the United States represents the greatest opportunity for biosimilar producers, in part because it is the largest biologics market and has high prices for biologics. As the United States enters the biosimilar market, the pharmaceutical industry is likely to grow at an accelerated pace. Automatic substitution is likely to be slow to develop, because of safety and quality concerns. The beneficial impact of biosimilars is likely to take a long time to be realized and to be fraught with more difficulties than was the case for small-molecule generics. Various factors, such as safety, pricing, manufacturing, entry barriers, physician acceptance, and marketing, will make the biosimilar market develop different from the generic market. The high cost to enter the market and the size of the biologic drug market make entry attractive but risky.

Companion diagnostics: a regulatory perspective from the last 5 years of molecular companion diagnostic approvals.

PubMed

Roscoe, Donna M; Hu, Yun-Fu; Philip, Reena

2015-01-01

Companion diagnostics are essential for the safe and effective use of the corresponding therapeutic products. The US FDA has approved a number of companion diagnostics used to select cancer patients for treatment with contemporaneously approved novel therapeutics. The processes of co-development and co-approval of a therapeutic product and its companion diagnostic have been a learning experience that continues to evolve. Using several companion diagnostics as examples, this article describes the challenges associated with the scientific, clinical and regulatory hurdles faced by FDA and industry alike. Taken together, this discussion is intended to assist manufacturers toward a successful companion diagnostics development plan.

Vaccination policies and programs: the federal government's role in making the system work.

PubMed

Schwartz, B; Orenstein, W A

2001-12-01

Government agencies play a key role, from preclinical development to postlicensure monitoring, in making vaccinations one of the leading public health interventions. Important steps in this process include development and testing of vaccine antigens, evaluation of clinical and manufacturing data leading to licensure, formulation of recommendations, vaccine purchase, defining strategies to improve coverage, compensation of those injured by vaccine adverse reactions, and monitoring vaccine impact and safety. Using examples of newly recommended vaccines, this article describes the infrastructure that underlies a safe and effective program and highlights some of the opportunities and threats likely to impact the system in coming years.