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Once approved, a proposed new ASTM standard would provide the U.S. Food and Drug Administration and personal lubricant manufacturers a means to evaluate the effect of a lubricant on the physical integrity of condoms. No standard currently exists for this type of testing. Manufacturers of condoms and rubber gloves as well as personal lubricants are welcome to join in the development of ASTM…
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The growing number and severity of healthcare association infections has increased interest in standardization efforts for antimicrobial gloves. In order to explore this area, ASTM International Committee D11 on Rubber has created a new task group on antimicrobial medical gloves. Glove suppliers, manufacturers and distributors, as well as contract test labs, government agency…
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Responding to requests from the food service industry, ASTM International Committee D11 on Rubber has developed and approved a new standard, D7329 , Specification for Food Preparation and Food Handling (Food Service) Gloves. The new standard, under the jurisdiction of Subcommittee D11.40 on Consumer Rubber Products, will serve as a referee and guide to glove manufacturers, distributors and the…
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As a means of ensuring the safety of electrical wiring systems in airplanes, ASTM International Committee F39 on Normal and Utility Category Airplane Electrical Wiring Systems has recently approved F2639 , Practice for Design, Alteration and Certification of Airplane Electrical Wiring Systems, a standard developed by Subcommittee F39.01 on Design, Alteration and Certification. According to…
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While the continuous quality verification concept is still quite new, it has the potential to become an important approach to assuring product quality in the pharmaceutical industry. With this in mind, ASTM International Committee E55 on Manufacture of Pharmaceutical Products has approved a new standard, E2537 , Guide for Application of Continuous Quality Verification to Pharmaceutical and…
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ASTM International Committee E55 on Manufacture of Pharmaceutical Products has developed a new standard that covers the life cycle of pharmaceutical and biopharmaceutical manufacturing systems. The new standard, E 2500 , Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment, is under the jurisdiction of Subcommittee E55.03 on…
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Testing for potent allergens in rubber is the purpose of a proposed new ASTM standard. WK16334 , Test Method for the Immunological Measurement of Four Principal Allergenic Protein (Hev b 1, 3, 5 and 6.02) in Natural Rubber and Its Products, is being developed by Subcommittee D11.40 on Consumer Rubber Products, part of ASTM International Committee D11 on Rubber. According to Timo Palosuo and…
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The ASTM International committee formerly known as E55 on Pharmaceutical Application of Process Analytical Technology has undergone a change in title and scope that reflects the intent of the committee to be more inclusive of all the tools, instrumentation and sciences that might be used by the industry in the management of pharmaceutical manufacturing processes. The committee is now known as E55…
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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has now approved its first practice. ASTM E 2474 , Practice for Pharmaceutical Process Design Utilizing Processing Analytical Technology, is under the jurisdiction of Subcommittee E55.02 on PAT System Implementation and Practice. Practice E 2474 covers process design, which is integral to process…
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A new ASTM International standard, F 2490 , Guide for Aircraft Electrical Load and Power Source Capacity Analysis, has been accepted by the Federal Aviation Administration (FAA) as a means of compliance with 14 CFR 23.1351(a) (2), Electrical System Capacity for Part 23 (and Predecessor) Aircraft. Guide F 2490 was developed by Subcommittee F39.01 on Design, Alteration, and Certification, which is…