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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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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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ASTM International’s concrete pipe committee ( C13 ) has approved a new standard that will help in manufacturing circular concrete pipe that is installed using pipe jacking techniques. The type of pipe covered by the new standard is typically used to convey sewage, industrial wastes, stormwater, or utilities. Engineers, precast concrete pipe manufacturers, and jacking contractors will be the…
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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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New ASTM International Standard Is First for Testing Corrosion Effects in Manufacturing of AdditivesA new standard developed by ASTM International’s concrete pipe committee ( C13 ) is the first standard test for determining the effectiveness of antimicrobial additives on the corrosion of concrete. “This standard presents test methods to help determine effects of biogenic acidification on concrete products and/or the efficacy of antimicrobial products to resist microbially-induced corrosion in…, Media Inquiries:, Jaime Martorana, tel +1.610.832.9796; jmartorana@astm.org, Committee Contact:, Jimmy Farrell, tel +1.610.832.9661; jfarrell@astm.org Release #11124 ###
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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 serve as a guide for standards related to determining the effects of biogenic sulfuric acid on concrete products. ASTM’s concrete pipe committee approved the standard, which is soon to be published as C1894. According to ASTM International member Mel Marshall, the new standard fills the need for a guide that discusses microbially induced corrosion (MIC) of…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Jimmy Farrell, tel +1.610.832.9661; jfarrell@astm.org Release #10898
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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