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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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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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ASTM International Committee E13 on Molecular Spectroscopy and Separation Science invites all interested parties to join in the ongoing revision of ASTM E1578 , Guide for Laboratory Information Management Systems (LIMS). ASTM E1578 is under the jurisdiction of Subcommittee E13.15 on Analytical Data . According to James B. Powers Jr., managing partner, Bridge Associates LLC, and chair of the E13.…
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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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All interested parties, particularly end users from the forensics sciences, are encouraged to join in the development of a proposed new ASTM standard, WK18814 , Guide for Relative Intensity Correction of Raman Spectrometers. WK18814 is being developed by Subcommittee E13.08 on Raman Spectroscopy, which is under the jurisdiction of ASTM International Committee E13 on Molecular Spectroscopy and…
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Since the early 1980s, multivariate analytical techniques have been increasingly used in a variety of industries. A new ASTM International standard, E2617 , Practice for Validation of Empirically Derived Multivariate Calibrations, answers a need for standards for these techniques. Subcommittee E13.11 on Multivariate Analysis, under the jurisdiction of ASTM International Committee E13 on Molecular…
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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…