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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 ASTM International standard will provide an up-to-date method for the aluminum industry to analyze samples by inductively coupled plasma-atomic emission spectroscopy. The proposed new standard, WK35993 , Test Method for Analysis of Aluminum and Aluminum Alloys by Inductively Coupled Plasma Atomic Emission Spectrometry (Performance Based Method), is being developed by Subcommittee…
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ASTM Committee E10 on Nuclear Technology and Applications has approved two new ASTM standards, ASTM E2628 , Practice for Dosimetry for Radiation Processing, and ASTM E2701 , Guide for Performance Characterization of Dosimeters and Dosimetry Systems for Use in Radiation Processing. Both standards are under the jurisdiction of Subcommittee E10.01 on Radiation Processing: Dosimetry and Applications…, ASTM Committee E10 Next Meeting:, Jan. 24-27, January committee week, San Antonio, Texas, Technical Contact:, (E2628) John Logar, Ethicon Inc., Somerville, N.J., Phone: 908-218-5638; jlogar8@its.jnj.com ; (E2701) Rod Chu, Ottawa, Ontario, Canada, Phone: 613-565-2305; rodchu@rogers.com, ASTM Staff Contact:, Joe Koury, Phone: 610-832-9804; jkoury@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #84 58/Jan2010
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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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A proposed new standard is being developed for the industrial radiation processing industry and irradiation research facilities where absorbed-dose measurement is critical. The proposed standard, WK15409 , Practice for Dosimetry in Radiation Processing, is under the jurisdiction of Subcommittee E10.01 on Radiation Processing: Dosimetry and Applications, which is part of ASTM International…
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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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Questions raised at a dosimetry symposium in 1998 have led to the development of a proposed new ASTM International standard, WK13464 , Guide for Performance Characterization of Dosimeters for Use in Radiation Processing. WK13464 is under the jurisdiction of Subcommittee E10.01 on Radiation Processing: Dosimetry and Applications, part of ASTM International Committee E10 on Nuclear Technology and…
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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…