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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 new ASTM International subcommittee has been created to develop standards that will be meaningful and accurate performance indicators to measure work-related injury and illness performance throughout the world. Subcommittee E34.55 on Occupational Safety and Health Performance Improvement is under the jurisdiction of ASTM International Committee E34 on Occupational Health and Safety. “Measuring…
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A newly approved ASTM International standard will advance the cause of architectural preservation. The new standard, ASTM C1713 , Specification for Mortars for the Repair of Historic Masonry, was developed by Subcommittee C12.03 on Specifications for Mortars, part of ASTM International Committee C12 on Mortars and Grouts for Masonry Units. John Wathne, structural engineer and president of…
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ASTM International Subcommittee E34.50 on Health and Safety Standards for Metalworking Fluids has developed three new standards. Two of the recently approved ASTM standards cover aspects of water-miscible metalworking fluids, while the third concerns prevention of dermatitis in the wet metal removal fluid environment., Prevention of Dermatitis, Dermatitis is an inflammatory response of the skin to a chemical or physical agent. While redness, swelling and itching are typical signs of dermatitis, symptoms can be more severe as well. A new ASTM standard, ASTM E2693 , Practice for Prevention of Dermatitis in the Wet Metal Removal Fluid Environment, discusses dermatitis and its causes and presents a comprehensive approach to dermatitis…, Metalworking Fluids, Two new E34.50 standards address the detection of microbial contamination in metalworking fluids: ASTM E2657 , Test Method for Determination of Endotoxin Concentrations in Water-Miscible Metalworking Fluids, and ASTM E2694 , Test Method for Measurement of Adenosine Triphosphate in Water-Miscible Metalworking Fluids. Both ASTM E2657 and ASTM E2694 measure biological contamination in metalworking…, Participation Invited, The subcommittee is currently looking for participants for an interlaboratory study for ASTM E2657 and ASTM E2694 . “We plan to use a single set of MWF for both standards, so labs who are interested in either or both are welcome to participate,” says Passman. “A few labs will run both the ILS’s for both standards, while most will run one or the other.” Subcommittee E34.50 is part of ASTM…
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All interested parties in the glass industry are invited to participate in the development of a proposed new standard guide for the safe handling of annealed glass. The new standard will be developed by a task group within ASTM Committee E34 on Occupational Health and Safety. A small group from industry and OSHA met in Rossford, Ohio, in March to discuss this new activity. The task group plans 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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Information and product destruction services is a rapidly growing industry. In order to develop standards to serve the needs of this industry, ASTM International Committee E34 on Occupational Health and Safety has formed Subcommittee E34.25 on Mobile and Plant-Based Security Destruction Equipment Safety Requirements. All interested parties are invited to participate in the standards developing…
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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…