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ASTM International’s manufacture of pharmaceutical and biopharmaceutical products committee ( E55 ) has approved a new standard that will help advance the use of continuous manufacturing (CM) technologies in the biopharmaceutical industry. In a CM process, individual unit operations are integrated into a connected flow which provides multiple efficiencies in terms of scale and productivity. “…, 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 #11543 ###
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ASTM International’s catalysts committee ( D32 ) has approved a new standard that describes a practice for analyzing particle size and shape of catalyst materials. The new practice will soon to be published soon under designation D8392. According to ASTM International member Paul O’Brien, the standard fills a need for guidance on use of dynamic flow imaging instrumentation to calibrate and verify…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Kelly Paul, tel +1.610.832.9745; kpaul@astm.org Release #11535 ###
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ASTM International’s roofing and waterproofing committee ( D08 ) has approved a new standard that provides guidelines and limitations for below-grade foundation waterproofing systems. The new standard ( D8425 ) specifically covers applications of sodium bentonite needle-punched geotextile waterproofing systems. According to ASTM member Stacy Byrd, the standard provides general installation…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Frank McConnell, tel +1.610.832.9686; fmcconnell@astm.org Release #11526 ###
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A proposed ASTM International standard will help advance the concept of lyophilization (freeze-drying) as it is used in the pharmaceutical and biotechnology industries. ASTM’s committee on manufacture of pharmaceutical and biopharmaceutical products ( E55 ) is developing the proposed standard. “The proposed standard will promote a deeper understanding of the science and engineering of…
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A proposed ASTM International standard will be used to aid physical integrity testing of single-use systems (SUS) in the pharmaceutical and biopharmaceutical industries. SUS equipment has become a popular alternative to stainless steel equipment that has been generally used for biopharmaceutical manufacturing processes. ASTM International’s committee on manufacture of pharmaceutical and…
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A new ASTM International standard will aid the pharmaceutical industry by describing best practices in monitoring process and product condition during freeze-drying. ASTM’s committee on manufacture of pharmaceutical and biopharmaceutical products (E55) developed the standard, which focuses on methods that apply to both laboratory and production environments. “The new standard provides guidance on…, Media Inquiries:, Jaime Martorana, tel +1.610.832.9796; jmartorana@astm.org , Committee Contact:, Travis Murdock, tel +1.610.832.9826; tmurdock@astm.org Release #11246 ###
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A new ASTM International standard will help keep foreign particles out of biopharmaceuticals during the single use system (SUS) manufacturing process. ASTM’s committee on manufacture of pharmaceutical and biopharmaceutical products (E55) developed the standard, which will soon be published as E3230. According to ASTM International member Klaus Wormuth, over the last 10 years, single-use…, 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 #11021 ###
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In light of COVID-19 (coronavirus) and growing safety concerns for members and staff, ASTM International announced today that previously scheduled April standards development meetings in Boston (March 29-April 3) and Prague (April 27-30) have been canceled. The decision was based on several factors, including, but not limited to: Continued review of information and recommendations from the U.S.…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org Release #10993
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A new ASTM International standard will provide performance requirements for designers and manufacturers of eye protectors for racket sports. ASTM’s committee on sports equipment, playing surfaces, and facilities ( F08 ) developed the new standard ( F3164 ). The new standard covers both prescription and non-prescription eye protective devices for racquetball, squash, and/or tennis. Requirements…, , Media Inquiries: , Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact: , Joe Koury, tel +1.610.832.9804; jkoury@astm.org Release #10875
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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