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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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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 proposed new ASTM International standard will improve the accuracy and usefulness of radiometry-related uncertainty estimates in a wide range of fast developing solar renewable energy applications, such as system performance and acceptance testing, resource assessment and solar energy system design engineering. The proposed standard, ASTM WK36479 , Practice for Uncertainty Evaluation of…
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Manufacturers of solar radiometers and testing laboratories for solar energy, materials and durability testing will be among the primary users of a new ASTM International standard that outlines procedures using indoor test methods to calibrate radiometers with dissimilar detectors. The new standard, ASTM G207 , Test Method for Indoor Transfer of Calibration from Reference to Field Pyranometers,…, ASTM Committee G03 Next Meeting:, Jan. 29-31, 2012, January Committee Week, Atlanta, Ga., Technical Contact:, Daryl Myers, National Renewable Energy Laboratory, Golden, Colo., Phone: 303-384-6768; daryl.myers@nrel.gov, 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 #8965
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A new ASTM International standard provides a more detailed and complete description of a test protocol that has been used for more than 40 years in code requirements and specifications for fire-retardant-treated wood. This test is now also used in some codes for building products that are not wood. The new standard, ASTM E2768 , Test Method for Extended Duration Surface Burning Characteristics of…
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Consumers who are purchasing building materials for homes want to be assured that the materials are mold resistant. A proposed new ASTM standard will allow for a mold-resistance rating to be given to specific materials, depending on how the materials perform to the test method. The proposed new standard, ASTM WK32079 , Test Method for Determination of Mold Growth on Building Products Designed for…
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While standards for outdoor calibration techniques for solar radiometers exist, there are currently no general standards that deal with issues of indoor calibration transfers between radiometers of different design. A proposed new ASTM standard, ASTM WK27263, Test Method for Indoor Transfer of Calibration from Reference to Field Pyranometers, will address in detail issues associated with…
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Explorations into alternative forms of energy have increased interest in standards for solar energy applications. ASTM International Committee G03 on Weathering and Durability has recently approved a new standard in this area, G197 , Table for Reference Solar Spectral Distributions: Direct and Diffuse on 20° Tilted and Vertical Surfaces. ASTM G197 was developed by Subcommittee G03.09 on…
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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…