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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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Particulate matter emitted during the use of a vacuum cleaner is a significant area of concern that ASTM International Committee F11 on Vacuum Cleaners has dealt with by developing and approving F 2608 , Test Method for Determining the Change in Room Air Particulate Counts as a Result of the Vacuum Cleaning Process. Now, the committee is developing a proposed new standard that addresses the final…
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ASTM International Committee D10 on Packaging will present a Distribution Packaging Workshop on April 7, 2008, from 10 a.m. to noon. The workshop, which is being organized by the committee’s university liaison subcommittee, will occur during the Committee D10 meeting at the ASTM committee week in Anaheim, Calif. Workshop topics will include the following: • Single-Parcel Shipping Environment—…
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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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ASTM International Committee F11 on Vacuum Cleaners has fulfilled an industry need with the approval of a new standard, F 2608 , Test Method for Determining the Change in Room Air Particulate Counts as a Result of the Vacuum Cleaning Process. The standard is under the jurisdiction of Subcommittee F11.23 on Filtration. “The industry determined a need for a test method that is representative of…
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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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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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ASTM International Committee D10 on Packaging is reactivating Subcommittee D10.19 on Recycling/Disposability. All interested parties, particularly those who are concerned and knowledgeable about worldwide packaging and recycling issues, are invited to join in the standards developing activities of D10.19. Jan Gates, subcommittee chair, and principal packaging engineer at Abbott Vascular, hopes…
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ASTM International Committee D10 on Packaging is currently inviting all interested parties to join a new D10 subcommittee, D10.97 on University Liaison. According to S. Paul Singh, professor, school of packaging, Michigan State University, and chair of D10’s division I, the purpose of the new subcommittee is twofold. “We want to allow university programs that teach and research in packaging to be…