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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 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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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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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…
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Dried blood represents the greatest challenge to cleaning surgical instruments. To meet this challenge, ASTM International Committee D12 on Soaps and Other Detergents has developed a new standard, D 7225 , Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors. The new guide is under the jurisdiction of Subcommittee D12.16 on Hard Surface Cleaning. Water-soluble components of…
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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 D10 on Packaging has formed a new task group to investigate the possibilities of radio frequency identification (RFID) as a means of tracking packages. The task group is under the jurisdiction of Subcommittee D10.18 on Miscellaneous Packaging. The purpose of the task group is to develop standards to evaluate the performance of RFID tags used on packaging and…