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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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Committee F10 on Livestock, Meat, and Poultry Evaluation Systems invites all interested parties to join in the standards developing activities of a new task group on radio frequency identification (RFID). The new task group, which is under the jurisdiction of Subcommittee F10.20 on Device Performance Criteria, will have its first meeting Nov. 1 at the November Committee Week in Tampa, Fla. The…
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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 B08 on Metallic and Inorganic Coatings has recently approved a revision of one of its most important standards, B 633 , Specification for Electrodeposited Coatings of Zinc on Iron and Steel. B 633 is under the jurisdiction of Task Group B08.08.04 on Soft Metals, which is part of Subcommittee B08.08 on Metallic Coatings. Zinc coatings are used to provide a sacrificial…
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A proposed new standard being developed by ASTM International Committee B09 on Metal Powders and Metal Powder Products offers a solution to the challenge of handling and characterizing very fine powders. Subcommittee B09.02 on Base Metal Powders is developing the proposed standard, WK13023 , Test Method for Determination of Tap Density of Metallic Powders by a Constant Volume Measuring Method. …
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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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Conventionally processed powder metallurgy materials often exhibit open microporosity at the surface. While it is a natural part of the process, this microporosity can affect the measurement of surface finishes. To cover this and other issues that arise from measuring the surface finish of powder metallurgy, ASTM International Committee B09 on Metal Powders and Metal Powder Products has developed…
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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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If you are a user of ASTM B 456, Specification for Electrodeposited Coatings of Copper Plus Nickel Plus Chromium and Nick Plus Chromium, ASTM International Committee B08 on Metallic and Inorganic Coatings would like to hear from you. B 456 is under the jurisdiction of Subcommittee B08.08.03 on Decorative Coatings. "Subcommittee B08.08.03 has received reports that some users are experiencing…