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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 adhesives committee ( D14 ) has approved a new standard that will serve as a guideline for developing adhesive systems used in the installation of resilient flooring. The new standard ( D8397 ) establishes minimum requirements for adhesives used for installing resilient floor covering, within a climate-controlled structure, when adhered directly and permanently to a…, 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 #11513 ###
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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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Andrew G. Kireta Jr., vice president of market development at the Copper Development Association Inc., in McLean, Virginia, (USA), has started his term as the 2020 chair of the ASTM International board of directors. ASTM International’s board is made of 25 leaders from a variety of companies, associations, universities, government bodies, and other organizations around the world. “ASTM…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org Release #10936
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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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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