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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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A recently approved revision to ASTM International standard C 150 , Specification for Portland Cement, includes three significant technical changes to the document. The changes are part of a joint effort between ASTM and the American Association of State and Highway and Transportation Officials to harmonize C 150 with AASHTO’s standard, M 85, Specification for Portland Cement. C 150 is under the…
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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 B08 on Metallic and Inorganic Coatings has recently approved a revision of one of its most important standards, B 633 , Specification for Electrodeposited Coatings of Zinc on Iron and Steel. B 633 is under the jurisdiction of Task Group B08.08.04 on Soft Metals, which is part of Subcommittee B08.08 on Metallic Coatings. Zinc coatings are used to provide a sacrificial…
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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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If you are a user of ASTM B 456, Specification for Electrodeposited Coatings of Copper Plus Nickel Plus Chromium and Nick Plus Chromium, ASTM International Committee B08 on Metallic and Inorganic Coatings would like to hear from you. B 456 is under the jurisdiction of Subcommittee B08.08.03 on Decorative Coatings. "Subcommittee B08.08.03 has received reports that some users are experiencing…
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After a 35-year-absence, the natural cement industry is being revived and, along with it, a long-withdrawn ASTM International standard. Until it closed in 1970, the Century Cement Company in Rosendale, N.Y. was the last company to manufacture natural cement. Up to that point, Rosendale had been the center of the industry, the source of more than half of all natural cement produced in the U.S.…
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A new test method developed by ASTM International Committee C01 on Cement provides information about the behavior of cement that can be used in the process of selecting cementing materials for specific applications. The standard, C 1608, Test Method for Chemical Shrinkage of Hydraulic Cement Pastes, is under the jurisdiction of Subcommittee C01.31 on Volume Change. Test Method C 1608 was…