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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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Richard W. Neu, Ph.D., a professor in the Wodruff School of Mechanical Engineering at the Georgia Institute of Technology in Atlanta, Ga., has received the ASTM International Award of Merit from Committee E08 on Fatigue and Fracture . The Award of Merit and its accompanying title of fellow is ASTM’s highest organizational recognition for individual contributions to standards activities. Neu, who…
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Fatigue fretting is the process of crack formation and progressive crack growth at a location in a mechanical system where two components are in contact and undergoing a vibratory loading. A new ASTM International standard provides insight on what conditions promote fretting fatigue and offers approaches to design an experiment to assess it. ASTM E2789 , Guide for Fretting Fatigue Testing, was…, ASTM Committee E08 Next Meeting:, May 16-20, May Committee Week, Anaheim, Calif., Technical Contact:, Richard W. Neu, Georgia Institute of Technology, Atlanta, Ga., Phone: 404-894-3074; rick.neu@gatech.edu ASTM Staff Contact: Jeff Adkins, Phone: 610-832-9738; jadkins@astm.org ASTM PR Contact: Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #8809
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Creep-fatigue testing simulates the loading and temperature conditions experienced by turbine components of aircraft engines, nuclear reactor components and fossil power plant components during service. With increasing need for cyclic operation during peak power demands, reliable creep-fatigue test data is necessary for the life assessment of aging power plants. A new ASTM standard, ASTM E2714 ,…
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A proposed new ASTM standard will assist in establishing tests for fretting fatigue, an issue at attachments and joints in a variety of mechanical, aeronautical and biomedical engineering systems and devices. WK24298 , Guide for Fretting Fatigue Testing, is being developed by Subcommittee E08.05 on Cyclic Deformation and Fatigue Crack Formation, part of ASTM International Committee E08 on Fatigue…, ASTM Committee E08 Next Meeting:, May 17-20, 2010, May Committee Week, St. Louis, Mo., Technical Contact:, Richard W. Neu, Georgia Institute of Technology, Atlanta, Ga., Phone: 404-894-3074; rick.neu@gatech.edu, ASTM Staff Contact:, Jeff Adkins, Phone: 610-832-9738; jadkins@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8430/Dec2009
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Data produced from the use of a proposed new ASTM International standard will be employed in the design of new, more efficient aircraft engines as well as for piping, steam and gas turbines used in power generation. The proposed new standard, WK21984 , Test Method for Creep-Fatigue Crack Growth Rate Testing, is being developed by Subcommittee E08.06 on Crack Growth Behavior, part of ASTM…
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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…