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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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ASTM International has published a new American National Standard, ASTM E2659 , Standard Practice for Certificate Programs. This standard provides much-needed guidance to certificate issuers on how to develop a quality certificate program and to consumers on how to identify such a program. In addition, the standard is designed to serve as the benchmark of quality for industry accreditation of…
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All interested parties are invited to attend the first meeting of ASTM International Subcommittee E36.30 on Personnel Certificate Programs on June 23 at the Hyatt Regency Convention Center in Denver, Colo. The new subcommittee is part of ASTM International Committee E36 on Laboratory and Inspection Agency Accreditation, which will be meeting in Denver June 23-24. ASTM Subcommittee E36.30 will…
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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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An ASTM International task group on battery separator materials is currently working on the latest in a series of standards being developed for alkaline battery separators. The proposed new standard, WK13587 , Test Methods for Sampling and Testing Materials That Are Used for Alkaline Battery Separators, is under the jurisdiction of Subcommittee D09.19 on Dielectric Sheet and Roll Products, which…
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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…