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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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All interested parties are welcome to join in the ongoing revisions to ASTM D3953 , Specification for Strapping, Flat Steels and Seals. The standard is under the jurisdiction of Subcommittee D10.25 on Palletizing and Unitizing of Loads , part of ASTM International Committee D10 on Packaging . According to its scope, ASTM D3953 covers flat steel strapping and seals intended for use in closing,…, ASTM Committee D10 Next Meeting:, April 15-17, 2013, April Committee Week, Indianapolis, Ind., Technical Contact:, Anthony Mariano, Independent Metal Strap Co. Inc., East Hill, N.Y., Phone: 516-621-0030; amariano@indmetalstrap.com, ASTM Staff Contact:, Diane Trinsey, Phone: 610-832-9661; dtrinsey@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9309
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All interested parties, particularly end users, resin manufacturers and film converters, are invited to participate in the revision of ASTM International standard ASTM D4649 , Guide for Selection and Use of Stretch Wrap Films. The standard is being updated by Subcommittee D10.25 on Palletizing and Unitizing of Loads , part of ASTM International Committee D10 on Packaging . ASTM D4649 covers…, ASTM Committee D10 Next Meeting:, April 14-17, 2013, April Committee Week, Indianapolis, Ind., Technical Contact:, James V. Bisha, Ph.D., Ongweoweh Corp, Cayuga Heights, N.Y., Phone: 607-266-7070; jbisha@ongweoweh.com, ASTM Staff Contact:, Diane Trinsey, Phone: 610-832-9661; dtrinsey@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindler@astm.org Release #9287
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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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ASTM International Committee E13 on Molecular Spectroscopy and Separation Science invites all interested parties to join in the ongoing revision of ASTM E1578 , Guide for Laboratory Information Management Systems (LIMS). ASTM E1578 is under the jurisdiction of Subcommittee E13.15 on Analytical Data . According to James B. Powers Jr., managing partner, Bridge Associates LLC, and chair of the E13.…
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Interested parties are invited to participate in the development of a proposed new ASTM International standard that will, once approved, facilitate consistent test methods and more reproducible results in hazardous materials package testing. The proposed new standard, ASTM WK32937 , Guide for Determining Acceptable Nonhazardous Filling Substances for Packagings Subjected to the United Nations…
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Adding Another Level of Safety in Patient Care ASTM Subcommittee D10.32 on Consumer, Pharmaceutical and Medical Packaging has recently completed an significant revision to ASTM D4774 , Specification for User Applied Drug Labels in Anesthesiology, and approved a new standard, ASTM D7709 , Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters.…
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ASTM International Committee D10 on Packaging will conduct a workshop on Packaging on Oct. 12 from 1:00 to 5:30 p.m. CDT at the Grand Hyatt San Antonio in San Antonio, Texas. The workshop will be held during the standards development meetings of Committee D10. Following a welcome by Marilyn Baker, senior innovation consultant in global quality, The Coca-Cola Co., and a current member of ASTM…
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While drug products must be tested for chemical and physical stability in their market packages, the testing process can be long and expensive. A proposed new ASTM International standard under the jurisdiction of Committee D10 on Packaging will provide a quick and accurate method to minimize the necessary package testing. The proposed standard, WK21601 , Test Method for Measuring Water Vapor…
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While the use of radio frequency identification transponders has become common for inventory tracking purposes, RFID system performance can be affected by product and packaging materials. A new ASTM standard can be used to provide a framework for testing RFID system performance that can be applied to, and compared across, all RFID manufacturer systems in any industrial application that involves a…