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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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Subcommittee G02.10 on Erosion by Solids and Liquids, part of ASTM International Committee G02 on Wear and Erosion, is interested in hearing from anyone who uses cavitation erosion testing in their work. The objective of this survey is to help the subcommittee determine the current degree of interest in and importance of cavitation erosion test methods. The subcommittee is especially interested…
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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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Sterilized medical devices are indispensable to doctors and surgeons around the world. Peel pouches, otherwise known as preformed sterile barrier systems, are used to keep these devices sterile during all physical handling. These pouches can be made with a wide variety of material and are produced by many different suppliers, but the trait all pouches must share is the ability to protect devices…
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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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A new ASTM International standard, F 2490 , Guide for Aircraft Electrical Load and Power Source Capacity Analysis, has been accepted by the Federal Aviation Administration (FAA) as a means of compliance with 14 CFR 23.1351(a) (2), Electrical System Capacity for Part 23 (and Predecessor) Aircraft. Guide F 2490 was developed by Subcommittee F39.01 on Design, Alteration, and Certification, which is…
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A task group of ASTM International Committee G02 on Wear and Erosion is seeking interested parties to participate in the revision of ASTM G 32, Test Method on Cavitation Erosion Using Vibratory Apparatus. The standard and the task group are under the jurisdiction of Subcommittee G02.10 on Erosion by Solids and Liquids. The task group is specifically seeking participants with any of the following…
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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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ASTM International Committee F39 on Normal and Utility Category Airplane Electrical Wiring Systems has approved its first standard, F 2490, Guide for Aircraft Electrical Load and Power Source Capacity Analysis. The new guide covers how to prepare an electrical load analysis to meet Federal Aviation Administration requirements. "This standard is a model for a consistent method of determining the…