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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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A recently published ASTM International standard covers a new type of resilient flooring tile product based on a polyester binder. ASTM F2982 , Specification for Polyester Composition Floor Tile, was developed by Subcommittee F06.80 on Specifications , part of ASTM International Committee F06 on Resilient Floor Coverings . “ ASTM F2982 sets forth an explicit set of compositional and performance…, ASTM Committee F06 Next Meeting:, May 22-23, 2013, May Committee Week, Indianapolis, Ind., Technical Contact:, Thomas Erisman, Armstrong World Industries, Lancaster, Pa., Phone: 717-396-5354; tcerisman@armstrong.com, ASTM Staff Contact:, Stephen Mawn, Phone: 610-832-9726; smawn@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9271
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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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Non-destructive moisture meters are now widely used in determining moisture levels in concrete, gypsum concrete and other types of floor slabs. A new ASTM International standard qualifies the types of meter suitable for this purpose and provides guidelines for how, where and when such moisture meters are used and what limitations exist. The new standard, ASTM F2659 , Guide for Preliminary…, ASTM Committee F06 Next Meeting:, Nov. 10-11, New Orleans, La., Technical Contact:, Sean Fallon, Dublin, Ireland, Phone: +011-353-1-285-1861; seanfallon@ireland.com, ASTM Staff Contact:, Stephen Mawn, Phone: 610-832-9726; smawn@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #870/Oct2010
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Special considerations need to be made for flooring in multi-purpose rooms, particularly those in child care buildings, elementary schools and long-term care facilities. ASTM International Committee F06 on Resilient Floor Coverings is currently developing a proposed new standard for such flooring. WK24836 , Specification for Active Area, Multipurpose Flooring, is under the jurisdiction of…
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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 new ASTM International standard describes a variety of methods that can be used to determine the index of refraction and dispersion of glass. The standard, C 1648 , Guide for Choosing a Method for Determining the Index of Refraction and Dispersion of Glass, will be useful to manufacturers of glass and glass products as well as designers of products in which glass is a critical component. C 1648…
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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…