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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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Stormwater hydrodynamic systems are used to remove settable solids that could cause contamination from stormwater runoff. A proposed new ASTM International standard will be used to specify test material with a common target particle size distribution for use in testing HDS systems. The proposed new standard, ASTM WK39909 , Specification for Surrogate Test Solids for Measuring Performance of…, ASTM Committee C27 Next Meeting:, Dec. 10-11, 2013, December Committee Week, Jacksonville, Fla., Technical Contact:, Adam A. Stevens, CONTECH Engineered Solutions, Scarborough, Maine, Phone: 207-885-9740; stevensa@contech-cpi.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 #9323
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Accidents involving the handling of annealed glass have heightened interest in standards that could improve safety in the glass industry. In response, ASTM International Committee E34 on Occupational Health and Safety has approved a new standard, ASTM E2875/E2875M , Guide for Personal Protective Equipment for the Handling of Flat Glass. The new standard was developed by Subcommittee E34.35 on…, ASTM Committee E34 Next Meeting:, Oct. 24-25, 2012, October committee week, Atlanta, Ga., Technical Contact:, Michael Marsala, Guardian Industries Corp., Auburn Hills, Mich., Phone: 248-340-2322; mmarsala@guardian.com, ASTM Staff Contact:, Kevin Shanahan, Phone: 610-832-9737; kshanahan@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9257
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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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While there are many commercially available stormwater treatment products currently on the market, there is no universal testing standard that would allow the performance of these products to be accurately compared. A proposed new ASTM International standard will fill this need, providing a testing method for stormwater treatment products that use filtration as a primary treatment process. ASTM…
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A watertight septic system ensures its integrity, and demonstrating that integrity is important because such systems have over time become more complex, expensive and critical to both system owners and to the environment. A new ASTM International standard fills a need for an in-field installation test for septic systems. The new standard, ASTM C1719 , Test Method for Installed Precast Concrete…, ASTM Committee C27 Next Meeting:, Dec. 6-7, 2011, December Committee Week, Tampa, Fla., Technical Contact:, Michael R. Miller, Press-Seal Gasket Corp., Fort Wayne, Ind., Phone: 260-918-1626; mmiler@press-seal.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 #9008
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A new ASTM International subcommittee has been created to develop standards that will be meaningful and accurate performance indicators to measure work-related injury and illness performance throughout the world. Subcommittee E34.55 on Occupational Safety and Health Performance Improvement is under the jurisdiction of ASTM International Committee E34 on Occupational Health and Safety. “Measuring…
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ASTM International Subcommittee E34.50 on Health and Safety Standards for Metalworking Fluids has developed three new standards. Two of the recently approved ASTM standards cover aspects of water-miscible metalworking fluids, while the third concerns prevention of dermatitis in the wet metal removal fluid environment., Prevention of Dermatitis, Dermatitis is an inflammatory response of the skin to a chemical or physical agent. While redness, swelling and itching are typical signs of dermatitis, symptoms can be more severe as well. A new ASTM standard, ASTM E2693 , Practice for Prevention of Dermatitis in the Wet Metal Removal Fluid Environment, discusses dermatitis and its causes and presents a comprehensive approach to dermatitis…, Metalworking Fluids, Two new E34.50 standards address the detection of microbial contamination in metalworking fluids: ASTM E2657 , Test Method for Determination of Endotoxin Concentrations in Water-Miscible Metalworking Fluids, and ASTM E2694 , Test Method for Measurement of Adenosine Triphosphate in Water-Miscible Metalworking Fluids. Both ASTM E2657 and ASTM E2694 measure biological contamination in metalworking…, Participation Invited, The subcommittee is currently looking for participants for an interlaboratory study for ASTM E2657 and ASTM E2694 . “We plan to use a single set of MWF for both standards, so labs who are interested in either or both are welcome to participate,” says Passman. “A few labs will run both the ILS’s for both standards, while most will run one or the other.” Subcommittee E34.50 is part of ASTM…
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All interested parties in the glass industry are invited to participate in the development of a proposed new standard guide for the safe handling of annealed glass. The new standard will be developed by a task group within ASTM Committee E34 on Occupational Health and Safety. A small group from industry and OSHA met in Rossford, Ohio, in March to discuss this new activity. The task group plans to…
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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…