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ASTM International, in support of efforts stemming from the Part 23 Reorganization Aviation Rulemaking Committee (ARC), will host an organizational meeting for the establishment of a new ASTM standards activity on general aviation (GA) airworthiness design standards. The meeting will be held Sept. 17, from 1:00 p.m. to 4:00 p.m. EST, at the Aircraft Electronics Association headquarters in Lee’s…, Next Meeting:, Sept. 17 at AEA headquarters and Oct. 26 in Atlanta, Ga., ASTM Staff Contact:, Christine DeJong, Phone: 610-832-9736; cdejong@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9277
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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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No industry standard currently exists that addresses the vacuum sealing requirements of knife-edged flanges for high vacuum applications. Existing international standards focus on interchangeability of the hardware, but do not address the reliability of the seal. ASTM International Committee E42 on Surface Analysis is now working on a proposed standard on the subject, WK21206 , Specification…
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A 2002 workshop on galling wear held by ASTM International Committee G02 on Wear and Erosion provided the impetus for the development of a new standard, ASTM G196 , Test Method for Galling Resistance of Material Couples. The new standard is under the jurisdiction of Subcommittee G02.40 on Non-Abrasive Wear. According to Scott Hummel, Ph.D., associate professor, head of the department of…
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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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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has created a new subcommittee, E55.03 on General Pharmaceutical Standards, which will address issues on quality within a broad framework of chemistry, manufacturing and control. The scope of the new subcommittee is the development of general principles, practices and related standards for managing…
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A proposed new standard currently being developed by ASTM International Committee F01 on Electronics will prove to be useful to the tantalum sputtering target industry. The proposed standard, WK9490, Test Method for Reporting Crystallographic Orientation of Sputtering Target Materials, is under the jurisdiction of Subcommittee F01.17 on Sputter Metallization. "The tantalum sputtering target…