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A proposed new ASTM International standard will provide an important process step to be used in the manufacture of protein-based drugs, such as antibodies and fusion proteins, made to inactivate retroviruses. The proposed standard, ASTM WK36552 , Practice for Inactivation of Retrovirus by pH, is being developed by Subcommittee E55.04 on General Biopharmaceutical Standards , part of ASTM…
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A proposed new standard being developed by ASTM International Committee F30 on Emergency Medical Services will be useful to medical equipment manufacturers, certification agencies and care providers, with patients being the ultimate beneficiaries. The proposed new standard, ASTM WK27973 , Specification for Environmental Performance of Medical Equipment for Use on Fixed and Rotary-Wing Aircraft,…, Technical Contact:, Pete Chambers, Marketing Assessment Inc., Phone: 703-673-9003; pete@marketingassessment.com, ASTM Staff Contact:, Scott Orthey, Phone: 610-832-9730; sorthey@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8671/Sept2010
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ASTM International Committee F08 on Sports Equipment and Facilities is focusing on elliptical equipment in its two latest approved standards. Both F2810, Specification for Elliptical Trainers, and ASTM F2811 , Test Methods for Evaluating Design and Performance Characteristics of Elliptical Trainers, are under the jurisdiction of Subcommittee F08.30 on Fitness Products. Harvey Voris, vice…, ASTM Committee F08 Next Meeting:, Nov. 16-19, November Committee Week, San Antonio, Texas, Technical Contact:, Harvey Voris, Paramount Fitness Corp., Los Angeles, Calif., Phone: 323-721-2121; hvoris@paramountfitness.com, ASTM Staff Contact:, Christine Basile, Phone: 610-832-9728; cbasile@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8672/Sept2010
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Mass casualty events, including both natural disasters and man-made events, subject caregivers, patients and medical equipment to environmental extremes. A new standard being developed by ASTM International Committee F30 on Emergency Medical Services provides guidance for how medical equipment is expected to perform under the severe conditions of a mass casualty event. The proposed standard, ASTM…
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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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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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Dried blood represents the greatest challenge to cleaning surgical instruments. To meet this challenge, ASTM International Committee D12 on Soaps and Other Detergents has developed a new standard, D 7225 , Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors. The new guide is under the jurisdiction of Subcommittee D12.16 on Hard Surface Cleaning. Water-soluble components of…