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A new ASTM International standard could help pharmaceutical manufacturers support product quality through sampling done with certain instruments. ASTM International’s committee on manufacturing pharmaceutical and biopharmaceutical products ( E55 ) developed the new standard ( E3177 ), which covers both the sample from which data is taken and the sample that is taken for reference. “This standard…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Travis Murdock, tel +1.610.832.9826; tmurdock@astm.org Release #10650
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ASTM International’s committee on medical and surgical materials and devices (F04 ) is developing a standardized guide for pre-clinical testing considerations for materials used to regenerate muscle. This guide (WK64460 ) will provide scientifically-based information concerning repairing and regenerating muscle when defects are caused by trauma, such as blast injuries. “These types of injuries…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Kathleen Chalfin, tel +1.610.832.9717; kchalfin@astm.org Release #10615
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ASTM International’s committee on medical and surgical materials and devices (F04) approved a new guide that seeks to improve the cleaning of medical devices. The standard provides methods for simulated soiling of reusable medical devices for the purpose of improving cleaning instructions. The guide (F3293) offers methods for how to identify clinically relevant areas of the device to soil, time…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Kathleen Chalfin, tel +1.610.832.610-8329717; kchalfin@astm.org Release #10572
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A proposed ASTM International standard aims to promote a shared understanding of the science and engineering behind pharmaceutical freeze-drying. The proposed standard ( WK63507 ) is being developed by ASTM’s committee on the manufacture of pharmaceutical and biopharmaceutical products ( E55 ). According to ASTM member Arnab Ganguly, uncertainty over the best practices in these areas of freeze-…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Travis Murdock, tel +1.610.832.9826; tmurdock@astm.org Release #10571
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A new ASTM International standard outlines a way to quantitatively determine the extent and causes of cracking in a building sealant. The new standard (soon to be published as C1851) was developed by ASTM International’s committee on building seals and sealants ( C24 ). “When you see a weathered sealant, it is usually cracked, crazed, or crumbled,” says ASTM International member Chris White, a…, About ASTM International, Committed to serving global societal needs, ASTM International positively impacts public health and safety, consumer confidence, and overall quality of life. We integrate consensus standards – developed with our international membership of volunteer technical experts – and innovative services to improve lives… Helping our world work better. , Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, David Lee, tel +1.610.832.9681; dlee@astm.org Release #10510
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A new ASTM International subcommittee will focus on the process of lyophilization, often referred to as freeze-drying, in the pharmaceutical industry. The group (E55.05) will be part of the committee on pharmaceutical and biopharmaceutical products (E55). The Advanced Lyophilization Technology Hub (LyoHub), a group of manufacturers, researchers, and others in the pharmaceutical and food…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Travis Murdock, tel +1.610.832.9826; tmurdock@astm.org Release #10500
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A new ASTM International standard will help manufacturers and regulators better understand how building sealants change once they have been compressed or stretched. The new standard ( C1815 ) was developed by ASTM International’s committee on building seals and sealants ( C24 ). “Think about the last time you rolled out pizza dough,” says ASTM International member Christopher White, a research…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, David Lee, tel +1.610.832.9681; dlee@astm.org Release #10425
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A new ASTM International standard covers a high- strength alloy that could be used for cardiovascular stents as well as trauma, spinal, and face-related surgical implants. “This powder-metallurgy alloy has a good combination of high strength and high ductility when compared to other metallic implant materials,” said ASTM International member John Disegi, a consultant at Advanced Biomaterial…, Standardization News, magazine. Also see this overview: Standards for Healthcare Services, Products, and Technology To purchase standards, contact customer relations (tel +1.877.909.ASTM; sales@astm.org )., Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Kathleen Chalfin, tel +1.610.832.9717; kchalfin@astm.org
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ASTM International’s committee on medical and surgical materials and devices ( F04 ) has updated its standard on elbow prostheses to include testing guidance. This is the first time that any standards organization in the world has incorporated testing into a specification for these products, according to the committee. The revision to the specification for total elbow prostheses ( F2887 ) will…, ASTM Committee on Medical and Surgical Materials and Devices (F04) Next Meeting:, Nov. 14-17, 2017, November Committee Week, Atlanta, Ga., Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Technical Contact:, Brian Kincaid, Zimmer Biomet, Warsaw, Ind., +1.574.372.3922; brian.kincaid@zimmerbiomet.com, ASTM Staff Contact:, Kathleen Chalfin, +1.610.832.9717; kchalfin@astm.org R elease #10322
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A new guide aims to help predict how building sealant systems will perform over time using accelerated testing methods. The new standard (soon to be published as C1850, Guide for Improved Laboratory Accelerated Tests to Predict the Weathering and for Developing Methods to Predict the Design Life of Building Sealant Systems) was developed by ASTM International’s committee on building seals and…, ASTM Committee C24 on Building Seals and Sealants Next Meeting:, June 11-13, 2017, June Committee Week, Toronto, Ontario, Canada, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Technical Contact:, Christopher White, National Institute of Standards and Technology, Gaithersburg, Md., tel +1.301.975.6016; christopher.white@nist.gov, ASTM Staff Contact:, Julia Moynihan, tel +1.610.832.9681; jmoynihan@astm.org R elease #10287