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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 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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During the past five years, certain insulating oils have been found to contain corrosive sulfur that can produce copper sulfide deposits as a function of time and temperature in operating equipment. A proposed revision to ASTM standard D 1275, Test Method for Corrosive Sulfur in Electrical Insulating Oils, will provide a means to certify that new or in service oils either contain or do not…
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ASTM International will launch a new Proficiency Testing Program (PTP) on Dissolved Gas Analyses (DGA) of In-Service Insulating Fluid in February 2006. The program will be offered to laboratories who need a statistical quality assurance tool that will enable them to improve and maintain a high level of performing ASTM standard D 3612, Test Method for Analysis of Gases Dissolved in Electrical…