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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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Cyanide is routinely analyzed in water samples, often to demonstrate regulatory compliance; however, improper sample collection or pretreatment can result in significant positive or negative bias potentially resulting in unnecessary permit violations or undetected cyanide releases into the environment. Because of the importance and timeliness of these issues, ASTM Subcommittee D19.06 on Methods…
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ASTM International Committee C28 on Advanced Ceramics and the American Ceramic Society are co-sponsoring a workshop, Needs and Opportunities for Strength and Fracture Standards at Micro and Nano Scales, on Jan. 27, 2008, from 1:00 to 5:00 p.m. at the Hilton Daytona Beach Resort in Daytona Beach, Fla. The workshop will be held in conjunction with the ASTM Committee C28 meetings to be held Jan. 26-…
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While nearly all of the instrumentation employed in the field to measure radioactive materials or radiation exposure rates used to be in the hands of state radiological control agencies or federal government national response organizations, this is no longer the case. Now, law enforcement personnel, first responders and other professionals have radiation detection instruments, though they may not…
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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 D19 on Water will host a workshop on turbidity during the June Committee Week in Norfolk, Va. Subcommittee D19.07 on Sediment, Geomorphology and Open Channel Flow will present the workshop from 1:00 to 5:00 p.m. on June 26, 2007. According to Mike Sadar, D19 member and principal application scientist, Hach Company, Committee D19 has invested several years in the…
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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 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 Subcommittee C28.07 on Ceramic Matrix Composites has formed a task group to address the evaluation of fiber-reinforced ceramic matrix composite structures for a future generation of nuclear energy systems. Subcommittee C28.07 is under the jurisdiction of Committee C28 on Advanced Ceramics. The new task group was formed at the January meeting of Subcommittee C28.07. To advance…