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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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Personal protective equipment manufacturers, material manufacturers and end users with an interest in impact resistance are encouraged to contribute to the development of a proposed new standard on measuring transmitted impact force on protective clothing. The proposed standard, ASTM WK38096 , Test Method for Measuring Transmitted Impact Force Through Materials Used in Protective Clothing, is…, ASTM Committee F23 Next Meeting:, Jan 29-31, 2013, January Committee Week, Jacksonville, Fla., Technical Contact:, Angela Fisher, Wells Lamont Industrial, Palatine, Ill., Phone: 612-940-1316; afisher@wellslamont.com, ASTM Contact:, Ashley Wiand, Phone: 610-832-9551; awiand@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9268
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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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Sealant manufacturers will use a new ASTM International standard to evaluate new products and changes to these products due to exposure to weather. The new standard, ASTM C1735 , Test Method for Measuring the Time Dependent Modulus of Sealants Using Stress Relaxation, is under the jurisdiction of Subcommittee C24.20 on General Test Methods , part of ASTM International Committee C24 on Building…, ASTM Committee C24 Next Meeting:, Jan. 8-10, 2012, Ft. Lauderdale, Fla., Technical Contact:, Christopher C. White, Ph.D., National Institute of Standards and Technology, Gaithersburg, Md., Phone: 301-975-6016; christopher.white@nist.gov, ASTM Staff Contact:, Stephen Mawn, Phone: 610-832-9726; smawn@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9005
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New Standard for Chemical Permeation Testing Approved by ASTM Personal Protective Clothing CommitteeChemical protective clothing has been widely used to protect skin from health hazards that can be found in the workplace or during a terrorist attack. A new ASTM International standard provides directions in using a computer program, called a permeation calculator, to analyze data following a permeation test, in order to determine when chemicals have gotten inside the clothing. The new standard,…
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Due to risk of infection from blood-borne pathogens such as human immunodeficiency virus and hepatitis C, hypodermic needle sticks pose a life-safety risk to healthcare professionals, law enforcement officials, sanitation workers and others. A new ASTM International standard addresses the unique mechanics of hypodermic needle puncture as related to protective clothing. ASTM F2878 , Test Method…
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All interested parties are invited to participate in the standards developing work of Subcommittee F23.50 on Certification and PPE Interoperability, part of ASTM International Committee F23 on Personal Protective Clothing and Equipment. The subcommittee, which was formed in 2009, is currently working on a proposed new standard, WK27616 , Practice for a Product Certification Process. According to…
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A proposed new ASTM International standard for liquid threats on protective clothing will cover the specific needs of law enforcement officers. The new standard, ASTM WK25965 , Test Method for Liquid Threat Sprayed on a Mannequin, is being developed by Subcommittee F23.30 on Chemicals, part of ASTM International Committee F23 on Personal Protective Clothing and Equipment. Fire and hazardous…
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The ability to provide the correct amount of protection is one of the important elements in the development of protective clothing worn by individuals who apply pesticides as part of their jobs. While overprotection in hot climatic conditions can result in heat stress and low compliance, some of the existing design-based requirements can result in too little protection, as material performance…, CONTACT:, ASTM Committee F23 Next Meeting:, Jan. 26-28, 2010, January committee week, San Antonio, Texas, Technical Contact:, Anugrah Shaw, University of Maryland Eastern Shore, Princess Anne, Md., Phone: 410-651-6064; ashaw@umes.edu, ASTM Staff Contact:, Stephen Mawn, ASTM International, Phone: 610-832-9726; smawn@astm.org, ASTM PR Contact:, Barbara Schindler, ASTM International, Phone: 610-832-9603; bschindl@astm.org Release #84 54/Jan2010