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ASTM International and the Parenteral Drug Association recently signed a Memorandum of Understanding that launches a pilot to streamline efforts and conserve resources as both organizations develop technical guidance for the pharmaceutical industry. Katharine Morgan, executive vice president, ASTM, and Richard M. Johnson, president, PDA, signed the MOU. “The MOU between ASTM International and PDA…, ASTM Committee E55 on Manufacture of Pharmaceutical Products Next Meeting:, April 28-30, 2015, Lisbon, Portugal, Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, ASTM Staff Contact:, Christine DeJong, tel +1.610.832.9736; cdejong@astm.org Release #9815 ###
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, ASTM to Partner with ASC to Foster EPD Development, ASTM International will be collaborating with industry to develop Environmental Product Declarations (EPDs) across the 90+ industry markets they support, including sealants. The Adhesive and Sealant Council (ASC) will be partnering with ASTM International to raise awareness of this effort, educate industry on the value of Type III EPDs, and proactively engage industry in developing Product…, ASTM Staff Contact:, Tim Brooke, Phone: 610-832-9729; tbrooke@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9370
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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 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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Sealant manufacturers will use a new ASTM International standard to evaluate new products and changes to these products due to exposure to weather. The new standard, ASTM C1735 , Test Method for Measuring the Time Dependent Modulus of Sealants Using Stress Relaxation, is under the jurisdiction of Subcommittee C24.20 on General Test Methods , part of ASTM International Committee C24 on Building…, ASTM Committee C24 Next Meeting:, Jan. 8-10, 2012, Ft. Lauderdale, Fla., Technical Contact:, Christopher C. White, Ph.D., National Institute of Standards and Technology, Gaithersburg, Md., Phone: 301-975-6016; christopher.white@nist.gov, 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 #9005
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ASTM International Committee F41 on Unmanned Maritime Vehicle Systems will meet on Aug. 17, 2011, at the Walter E. Washington Convention Center in Washington, D.C. The meeting will take place in conjunction with the AUVSI Unmanned Systems North American 2011 Conference. The F41 executive subcommittee meeting will begin at 7:00 a.m. on Aug. 17. in room 149A. In addition, all interested parties are…
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The use of rolling devices can provide a means to evaluate the adhesion of weather seals, for quality control in new installations, general evaluation of existing installations, and the investigation of water and air leakage through building enclosures. In order to better facilitate the use of rolling devices, ASTM International Committee C24 on Building Seals and Sealants is developing a…
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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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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…