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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 Committee E21 on Space Simulation and Applications of Space Technology is requesting input on upcoming revisions for two standards under the jurisdiction of Subcommittee E21.05 on Contamination . The two standards to be revised are ASTM F21 , Test Method for Hydrophobic Surface Films by the Atomizer Test, and ASTM F22 , Test Method for Hydrophobic Surface Films by the Water-…
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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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Since 1998, when ASTM International Committee F05 on Business Imaging Products first approved standard F 1856 , Practice for Determining Toner Usage for Printer Cartridges, there has been a rapid increase in the use of color in office printing. In order to address this important change, Subcommittee F05.04 on Electrostatic Imaging Products has developed F 2632 , Practice for Determining the Toner…
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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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The ability to determine the number of pages an ink jet printer cartridge will print in its lifetime is essential for anyone who manufactures or remanufactures them. A new ASTM International standard, F 2555 , Practice for Determining Page Yield of Ink Jet Printer Cartridges — Continuous Printing Method, has been developed to aid in this endeavor. Practice F 2555 is under the jurisdiction of…
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ASTM International Committee F05 on Business Imaging Products is currently seeking participation in the development of proposed new standards under the jurisdiction of Subcommittee F05.07 on Ink Jet Imaging Products. Users, original equipment manufacturers and ink producers are needed to assist in the following task groups: F05.07.01 This task group is working on developing a user-friendly…
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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…