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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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In response to changing emissions restrictions and consumer expectations, ASTM International Committee D15 on Engine Coolants is now developing a proposed new standard, WK16003 , Specification for Engine Coolant Grade 1,3-propanediol (PDO). This task group is under the jurisdiction of Subcommittee D15.07 on Specifications. Edward Eaton, D15 member and chief engineer, Amalgatech, says that as…
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ASTM International standards E 10 , Test Method for Brinell Hardness of Metallic Materials, and E 18 , Test Methods for Rockwell Hardness of Metallic Materials, have both recently undergone extensive revisions. Both standards are under the jurisdiction of Subcommittee E28.06 on Indentation Hardness Testing, which is part of ASTM International Committee E28 on Mechanical Testing. “The intention…
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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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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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A new ASTM International standard will assist aerospace companies that are purchasing fine grain titanium alloys. The standard, E 2448, Test Method for Determining the Superplastic Properties of Metallic Sheet Materials, has been developed by ASTM Subcommittee E28.02 on Ductility and Flexure Testing, which is under the jurisdiction of Committee E28 on Mechanical Testing. According to Peter…
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ASTM International Committee E28 on Mechanical Testing has begun work on a proposed new standard to describe the test procedure for determining the superplastic forming properties of a material. The committee is actively seeking participation from interested parties in the development of this document. More information on this new activity can be found by entering WK7114 in the site search box on…