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ASTM International Committee E55 on Manufacture of Pharmaceutical Products is currently developing a proposed standard that will document a set of process steps that can reproducibly inactivate or remove any potential retrovirus in new biological products, particularly antibodies and antibody-like compounds. The proposed standard, ASTM WK39883 , Practice for Process of Inactivation of Enveloped…, ASTM Committee E55 Next Meeting:, April 9-11, 2013, Genzyme-A Sanofi Company, Haverhill, Suffolk, United Kingdom, Technical Contact:, John Schreffler, Ph.D., Morphotek Inc., Exton, Pa., Phone: 610-423-6557; jschreffler@morphotek.com, ASTM Staff Contact:, Christine DeJong, Phone: 610-832-9736; cdejong@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9327
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Purified terephthalic acid, often known simply as PTA, is in high demand as the key raw material for the manufacture of polyester fiber, resin and film. Two proposed ASTM standards are currently being developed that will be used to find major impurities in PTA product. The two proposed standards are ASTM WK36121 , Test Method for Determination of p-Toluic Acid and 4-Carboxybenzaldehyde in…, ASTM Committee D16 Next Meeting:, Jan. 30-31, 2013, January Committee Week, Jacksonville, Fla., Technical Contact:, Yuhong Zhang, China Petrochemical Corp., Shanghai, China, Phone: 011-86-21-68462281; zhangyh.sshy@sinopec.com, ASTM Staff Contact:, Christine DeJong, Phone: 610-832-9736; cdejong@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9266
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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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Wet blue and wet white are intermediate products used by tanneries that process natural hides and skins into leather. Natural fats and oils need to be largely removed from wet blue and wet white for leather processing to be done properly, but no standard had previously existed to evaluate the effectiveness of such removal. ASTM International Committee D31 on Leather has now developed such a…
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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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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…