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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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ASTM International Committee F02 on Flexible Barrier Packaging will hold its next meeting on Sept. 26-27, 2012, at the Hotel Rey Juan Carlos I in Barcelona, Spain. At this meeting, participants will have the opportunity to contribute to the development and revision of a number of standards important to the use and evaluation of flexible barrier packaging. One of the highlights of the meeting will…, Future Trends in Permeation Measurements, , presented by Franz Sturm, Lipke •, U.S. FDA Perspective: The Use of Standards in Premarket Submissions and Auditing the Medical Device Packaging Process, , presented by Pat Weixel, U.S. Food and Drug Administration •, Microbial Barrier Test Methods for Porous Sterile Barrier Materials, , presented by Thierry Wagner, DuPont Medical and Pharmaceutical Protection •, Toward a Package Durability Predictive Model, , presented by Henk Blom, Rollprint Packaging Products •, Package Integrity: Methods of Detection, , presented by Wendy Mach, Nelson Laboratories •, Use of Design Guide F2097 and U.S. FDA Recognition, , Hal Miller, PACE Solutions LLC •, Sterile Medical Device Package Performance Testing and the Nebulous Effect of Vibration in Transit, , presented by Pat Nolan, DDL •, ASTM International: ASTM Mechanics and Overview, , presented by Diane Trinsey, ASTM Committee F02 staff manager All are welcome to attend. Registration and meeting information, including abstracts describing the presentations shown above, can be found at www.astm.org/COMMIT/F02/Barcelona_Meeting_info . Committee F02 develops standards on barrier materials, their properties and package design, development and production. Typical flexible barrier…, ASTM Committee F02 Next Meeting:, Sept. 26-27, 2012, Barcelona, Spain, ASTM Staff Contact:, Diane Trinsey, Phone: 610-832-9661; dtrinsey@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9289
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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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A new ASTM International standard will provide gasket manufacturers a test for measuring creep and compression that can be used for R&D and material comparisons, and as a quality assurance tool. ASTM F2837 , Test Method for Hot Compression Properties of Gasket Materials, was developed by Subcommittee F03.40 on Chemical Test Methods, under the jurisdiction of ASTM International Committee F03…, ASTM Committee F03 Next Meeting:, Oct 12-13, October Committee Week, San Antonio, Texas, Technical Contact:, James Lingenfelder, Gasket Resources Inc., Houston, Texas, Phone: 713-856-9445; jtling@durlon.com, ASTM Staff Contact:, Joseph Hugo, Phone: 610-832-9740; jhugo@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8695/Sept2010
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A new ASTM International standard will have applications in a variety of factories, on artificial turfs and playing surfaces, and even in the classroom. The new standard, G194 , Test Method for Measuring Rolling Friction Characteristics of a Spherical Shape on a Flat Horizontal Surface, was developed by Subcommittee G02.50 on Friction, part of ASTM International Committee G02 on Wear and Erosion…
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Testing the oxygen permeation of packaging material is important for the suppliers of various barrier materials, as well as users of these materials in the food, pharmaceutical and consumer product companies, universities, research organizations and other industries. This kind of testing is covered in a new ASTM International standard approved by Committee F02 on Flexible Barrier Packaging, F2622…
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ASTM International Committee F03 on Gaskets has developed and approved a new standard that can be used to evaluate gasket materials covered by ASTM F104 , Classification System for Nonmetallic Gasket Materials. The new standard, F2716 , Practice for Comparison of Nonmetallic Flat Gaskets in High Pressure Saturated Steam, is under the jurisdiction of Subcommittee F03.10 on Composite Gaskets. ASTM…
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A new ASTM International standard responds to a recent emphasis by regulatory agencies that firms manufacturing drug products demonstrate the efficacy of disinfectants used in controlled environments. The standard, ASTM E2614 , Guide for Evaluation of Cleanroom Disinfectants, was developed by Subcommittee E35.15 on Antimicrobial Agents, part of ASTM International Committee E35 on Pesticides and…
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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…