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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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Members of ASTM International Committee F40 on Declarable Substances in Materials now have free access to a powerful regulatory database that houses all regulations related to Declarable Substances. F40 members who log in to their MyASTM page on the ASTM International Web site ( www.astm.org ) will find a link to the Enhesa database. Enhesa is a global environmental, health and safety…
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Changes in the composition of glass that recyclers receive has led to the need for a simple, quick and accurate method of sorting out incoming waste glass that contains arsenic, lead and other heavy metals. ASTM International Committee F40 on Declarable Substances in Materials is working on a proposed standard, WK15289 , Test Methods for Analysis of Heavy Metals in Glass Using X-Ray Fluorescence…
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Participation is being sought for the development of a proposed new standard, WK15434 , Test Method for Analysis of Tin-Based Solder Alloys Using Optical Emission Spectrometry. The proposed standard is being developed by Subcommittee F40.01 on Test Methods, which is part of ASTM International Committee F40 on Declarable Substances in Materials. According to Dirk Wissmann, product manager,…
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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 F40 on Declarable Substances in Materials has recently approved its second standard, F 2577 , Guide for Assessment of Materials and Products for Declarable Substances. The guide, which is under the jurisdiction of Subcommittee F40.02 on Management Practices and Guides, follows F 2576 , Terminology Relating to Declarable Substance in Materials, which was approved in…
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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 standard developed by ASTM International Committee F37 on Light Sport Aircraft covers the instructions a kit producer must provide to a consumer regarding how to assemble and safely flight-test a recreational aircraft to ensure compliance with applicable ASTM standards. The new standard, F 2563 , Practice for Kit Assembly Instructions of Aircraft Intended Primarily for Recreation, is under…
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ASTM International Committee F40 on Declarable Substances in Materials has recently approved their first standard, F 2576 , Terminology Relating to Declarable Substances in Materials. The standard, which will serve as the committee’s lexicon of terms, abbreviations and units, is under the jurisdiction of Subcommittee F40.91 on Terminology. Nine terms are listed in the standard, which will be…