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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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ASTM International Committee E21 on Space Simulation and Applications of Space Technology is requesting input on upcoming revisions for two standards under the jurisdiction of Subcommittee E21.05 on Contamination . The two standards to be revised are ASTM F21 , Test Method for Hydrophobic Surface Films by the Atomizer Test, and ASTM F22 , Test Method for Hydrophobic Surface Films by the Water-…
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A new ASTM International standard, adopted from an American Concrete Institute test method, will be used to help ensure the safety of construction projects. ASTM C1741 , Test Method for Bleed Stability of Cementitious Post-Tensioning Tendon Grout, is under the jurisdiction of Subcommittee C09.41 on Hydraulic Cement Grouts , part of ASTM International Committee C09 on Concrete and Concrete…
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Piston ring/liner interface can contribute as much as half the total friction loss in internal combustion engines, with the resulting wear leading to reduced energy efficiency and raised emissions. A new ASTM International standard provides a method to more accurately measure small amounts of wear on curved piston ring segments and their counterfaces after lubricated bench-scale testing. “Coupled…
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ASTM Committee G02 on Wear and Erosion is including a field trip in the plans for its Dec. 8-9 meeting in Jacksonville, Fla. Committee members will be visiting the Tribology Laboratory in the mechanical engineering department at the University of Florida in Gainesville. The Tribology Laboratory is actively involved in a wide variety of tribological research and tribology education projects. The…
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A new ASTM standard will be useful to slide and engine companies, as well as makers of bushing materials, in studies that involve the measurement of system friction forces. The new standard, ASTM G203 , Guide for Determining Friction Energy Dissipation in Reciprocating Tribosystems, was developed by Subcommittee G02.50 on Friction, part of ASTM International Committee G02 on Wear and Erosion.…
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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…