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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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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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Joe Koury, staff manager for ASTM International Committee E52 on Forensic Psychophysiology, will speak at the annual seminar of the American Association of Police Polygraphists on April 17 at the Hotel Albuquerque at Old Town in Albuquerque, N.M. This meeting will follow the April 14-15 meetings of Committee E52, which will take place at the some hotel. In his presentation, Koury will provide an…
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An ASTM International task group on battery separator materials is currently working on the latest in a series of standards being developed for alkaline battery separators. The proposed new standard, WK13587 , Test Methods for Sampling and Testing Materials That Are Used for Alkaline Battery Separators, is under the jurisdiction of Subcommittee D09.19 on Dielectric Sheet and Roll Products, which…
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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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Two newly approved ASTM standards are filling a gap that has existed for tests for battery separators. The new standards, D 7129, Test Method for Determination of Ammonia Trapping in a Grafted Battery Separator, and D 7131, Test Method for Determination of Ion Exchange Capacity (IEC) in a Grafted Battery Separator, are under the jurisdiction of Subcommittee D09.19 on Dielectric Sheet and Roll…
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Forensic Psychophysiology Committee in ASTM International Aims at Reducing Perjury with New StandardThe aim of a new ASTM standard developed by Committee E52 on Forensic Psychophysiology is to assist the judicial system in reducing incidents of perjury. The new standard, E 2324, Guide for PDD Paired Testing, is under the jurisdiction of Subcommittee E52.05 on Psychophysiological Detection of Deception (PDD). According to George Baranowski, founder, Mindsight Consultants, the guide could be…
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ASTM International Committee D09 on Electrical and Electronic Insulating Materials will host a presentation of the European Unions Restriction of Hazardous Substances (RoHS) Directive during their meeting in Philadelphia, Pa. on March 15. The meeting will run from 3:00 to 5:00 p.m. and will be followed by a social hour. Electrical equipment marketed in the EU after July 1, 2006, must comply…