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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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ASTM International Committee E21 on Space Simulation and Applications of Space Technology is requesting input on upcoming revisions for two standards under the jurisdiction of Subcommittee E21.05 on Contamination . The two standards to be revised are ASTM F21 , Test Method for Hydrophobic Surface Films by the Atomizer Test, and ASTM F22 , Test Method for Hydrophobic Surface Films by the Water-…
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ASTM E2369 Provides Means for Healthcare Workers to Collect and Transfer Patient Data The Office of the National Coordinator for Health Information Technology (ONC), part of the United States Department of Health and Human Services, has included an ASTM International standard as part of its formal certification criteria for electronic health record (EHR) technologies. The standard, ASTM E2369…
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An ASTM International standard used for effective and timely electronic messaging of health care records has now been adopted as a standard for structured summary health record exchange included in new regulations associated with the Health Information Technology for Economic and Clinical Health Act provision of the American Recovery and Reinvestment Act of 2009 (ARRA/HITECH). ASTM E2369 ,…, Technical Contact:, Dr. David C. Kibbe, The Kibbe Group L.L.C., Pittsboro, N.C. Phone: 913-205-7968; kibbedavid@mac.com, ASTM Staff Contact:, Dan Smith, Staff Manager , Phone: 610-832-9727; dsmith@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8451/Jan2010
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ASTM International Committee E31 on Healthcare Informatics notes the innovative use of the Continuity of Care Record within the Google Health application launched on May 20. Formally known as ASTM E2369 , Specification for Continuity of Care (CCR), the CCR standard is an XML-based format for access to, transport of and interoperable exchange of core summary health information. The CCR is intended…
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ASTM International and AIIM, the international authority on Enterprise Content Management, have now published the Best Practices Guide – PDF Healthcare ( AIIM/ASTM BP-01-2008 ). This document describes a proposed, voluntary, industry-wide reference tool and guideline to describe the features and functionality of the Portable Document Format (PDF) for the healthcare industry. It is designed 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…
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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…