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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 standard being developed by ASTM International Committee F18 on Electrical Protective Equipment for Workers will provide guidance to assist in the required testing of live-line tools. ASTM WK33590 , Guide for In-Service Inspection, Maintenance and Electrical Testing of Insulating Tools (Fiberglass-Reinforced Plastic (FPR) and Wooden Live-Line Tools), is under the jurisdiction of…
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Arc protective blankets are used in many electrical applications to protect workers who are stationed near energized electrical parts. While these blankets have been used for years, there have been no testing criteria for their evaluation. A new ASTM International standard will be used to determine the effectiveness of arc protective blankets in suppressing the combined effect of an arc flash and…
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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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A new ASTM International standard describes a variety of methods that can be used to determine the index of refraction and dispersion of glass. The standard, C 1648 , Guide for Choosing a Method for Determining the Index of Refraction and Dispersion of Glass, will be useful to manufacturers of glass and glass products as well as designers of products in which glass is a critical component. C 1648…
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A new ASTM International standard, F 2621 , Practice for Determining Response Characteristics and Design Integrity of Arc Related Finished Products in an Electric Arc Exposure, is the latest in a series of standards developed by Subcommittee F18.65 on Wearing Apparel to reduce the number of fatalities and injuries caused by electric arcs. ASTM Practice F 2621 provides procedural guidelines for…
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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…