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A proposed new ASTM International standard will provide an important process step to be used in the manufacture of protein-based drugs, such as antibodies and fusion proteins, made to inactivate retroviruses. The proposed standard, ASTM WK36552 , Practice for Inactivation of Retrovirus by pH, is being developed by Subcommittee E55.04 on General Biopharmaceutical Standards , part of ASTM…
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While the use of digital evidence is fairly common in contemporary criminal investigation, there are still relatively few degree programs in computer forensics. A new standard developed by ASTM International Committee E30 on Forensic Sciences provides a road map for post-secondary institutions to develop degree programs in computer forensics. The new standard, ASTM E2678 , Guide for Education and…
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Manufacturers of toluene, mixed xylenes and p-xylene are often required to determine the type and amount of impurities that remain from manufacture. A new ASTM International standard, D7504 , Test Method for Trace Impurities in Monocyclic Aromatic Hydrocarbons by Gas Chromatography and Effective Carbon Number, can now be used as an internal quality control tool where these products are produced…
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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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Chemical plants and contract and research laboratories will all be likely users of a new ASTM International standard, D 7183 , Test Method for Determination of Total Sulfur in Aromatic Hydrocarbons and Related Chemicals by Ultraviolet Fluorescence. D 7183 was developed by Subcommittee D16.04 on Instrumental Analysis, part of ASTM International Committee D16 on Aromatic Hydrocarbons and Related…
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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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Two proposed new ASTM standards will serve as guides for laboratories around the world in establishing a minimum basis of practice for validation and sampling of seized drugs. The proposed standards, WK12734 , Guide for Sampling Seized Drugs for Qualitative and Quantitative Analysis, and WK12735 , Practice for Validation of Seized Drug Analytical Methods, are under the jurisdiction of…
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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…