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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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The use of rolling devices can provide a means to evaluate the adhesion of weather seals, for quality control in new installations, general evaluation of existing installations, and the investigation of water and air leakage through building enclosures. In order to better facilitate the use of rolling devices, ASTM International Committee C24 on Building Seals and Sealants is developing a…
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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…
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ASTM International Committee E55 on Manufacture of Pharmaceutical Products has developed a new standard that covers the life cycle of pharmaceutical and biopharmaceutical manufacturing systems. The new standard, E 2500 , Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment, is under the jurisdiction of Subcommittee E55.03 on…
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The ASTM International committee formerly known as E55 on Pharmaceutical Application of Process Analytical Technology has undergone a change in title and scope that reflects the intent of the committee to be more inclusive of all the tools, instrumentation and sciences that might be used by the industry in the management of pharmaceutical manufacturing processes. The committee is now known as E55…
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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has now approved its first practice. ASTM E 2474 , Practice for Pharmaceutical Process Design Utilizing Processing Analytical Technology, is under the jurisdiction of Subcommittee E55.02 on PAT System Implementation and Practice. Practice E 2474 covers process design, which is integral to process…
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ASTM International Committee C24 on Building Seals and Sealants invites interested parties to participate in the development of a proposed new standard that will use photographs to illustrate various types of sealant failures. WK11731 , Guide for Diagnosing Sealant Failure by Comparison to Reference Photographs, is under the jurisdiction of Subcommittee C24.10 on Specifications, Guides and…
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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has created a new subcommittee, E55.03 on General Pharmaceutical Standards, which will address issues on quality within a broad framework of chemistry, manufacturing and control. The scope of the new subcommittee is the development of general principles, practices and related standards for managing…
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ASTM International Committee C24 on Building Seals and Sealants is currently working to fill a need for a weatherproofing sealant field test standard. The result, proposed standard WK7800, Guide for a Non-Destructive, Continuous, Field Test of Installed Weatherproofing Sealant, features a field test that has been used by sealant professionals for years, but has not, up to this point, been…