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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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Biofilm, self-organized communities of bacteria that can have both positive and negative effects in a variety of industries, is the subject of a new ASTM International standard, E 2562 , Test Method for Quantification of Pseudomonas aeruginosa Biofilm Grown with High Shear and Continuous Flow Using CDC Biofilm Reactor. The new standard is under the jurisdiction of Subcommittee E35.15 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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Responding to a new emphasis by regulatory agencies that firms manufacturing drug products demonstrate the efficacy of disinfectants used in controlled environments, ASTM International Committee E35 on Pesticides and Alternative Control Agents has begun to develop a proposed new standard, WK12880 , Guide for Evaluation of Clean Room Disinfectants. WK12880 is under the jurisdiction of Subcommittee…
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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…