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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 ASTM standard will be useful in covering the level of defects that exist in hot rolled rod coil. The proposed standard, ASTM WK37796 , Specification for General Requirements for Hot Rolled Rod Coil, is being developed by Subcommittee B02.07 on Refined Nickel and Cobalt and Their Alloys , part of ASTM International Committee B02 on Nonferrous Metals and Alloys . According to Larry Paul…, ASTM Committee B02 Next Meeting:, Nov. 12-14, 2012, November Committee Week, Atlanta, Ga., Technical Contact:, Larry Paul, ThyssenKrupp VDM USA, LLC, Peru, Ind., Phone: 765-689-0215; larry.paul@thyssenkrupp.com, ASTM Staff Contact:, Jeffrey Adkins, Phone: 610-832-9738; jadkins@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9286
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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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The creation of new nickel base alloys in pipe and tube forms, used in the oil and power industries, was the driving force for developing a new ASTM International standard, ASTM B983 , Specification for Precipitation Hardened or Cold Worked, Seamless Nickel Alloy Pipe and Tube. ASTM B983 was developed by Subcommittee B02.07 on Refined Nickel and Cobalt and Their Alloys , part of ASTM…
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Users of standards involving kinetic parameters need reference materials to qualify individual laboratories and to validate procedures and software. A new ASTM International standard will provide such parameters to accommodate apparatus configurations and kinetic models. ASTM E2781 , Practice for Evaluation of Methods for Determination of Kinetic Parameters by Thermal Analysis, was developed by…, ASTM Committee E27 Next Meeting:, Nov. 15-17, November Committee Week, Tampa, Fla., Technical Contact:, Roger Blaine, Corvallis, Ore., Phone:, 302-559-6827; roger.l.blaine@gmail.com ASTM Staff Contact:, Scott Orthey, Phone: 610-832-9730; sorthey@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8893
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ASTM International Committee B02 on Nonferrous Metals and Alloys is currently working on a proposed new ASTM International standard for zinc alloys being used for spin casting. The proposed standard, ASTM WK30745 , Specification for Zinc Alloys for Spin Casting, is being developed by Subcommittee B02.04 on Zinc and Cadmium. According to Bernard Potts, president of Village Casting Inc., and a…
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Proposed ASTM Kinetic Parameters Standard Being Developed by Hazard Potential of Chemicals CommitteeA proposed new standard being developed by ASTM International Committee E27 on Hazard Potential of Chemicals will provide needed reference materials for instruments, applications and software used for the evaluation of kinetic data used for hazard evaluation. The proposed new standard, ASTM WK27880 , Practice for Evaluation of Methods for Determination of Kinetic Parameters by Thermal Analysis,…, ASTM Committee E27 Next Meeting:, Nov. 15-17, November Committee Week, Tampa, Fla., Technical Contact:, Roger Blaine, Corvallis, Ore., Phone: 302-559-6827; roger.l.blaine@gmail.com, ASTM Staff Contact:, Scott Orthey, Phone: 610-832-9730; sorthey@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8611
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A proposed new ASTM International standard will provide a definable quality specification for both producers and consumers of secondary Prime Western Grade zinc metal. WK16399 , Specification for Prime Western Grade-Recycled (PWG-R) Zinc Metal Produced from Recycled Zinc Secondary Material, is being developed by Subcommittee B02.04 on Zinc and Cadmium, part of ASTM International Committee B02 on…
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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…