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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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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 practice provides necessary steps when writing new or revising existing standards that use saturated calomel electrode (SCE) for determining electrode potentials. ASTM’s corrosion of metals committee ( G01 ) developed the standard, soon to be published as G220. “This standard provides useful information for those writing new or revising existing standards where electrode…, Media Inquiries:, Jaime Martorana, tel +1.610.832.9796; jmartorana@astm.org, Committee Contact:, Krista Robbins, tel +1.610.832.9689; krobbins@astm.org Release #11138 ###
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A new ASTM International standard will help determine impurities in monoethylene glycol (MEG). ASTM’s committee on aromatic, industrial, specialty, and related chemicals ( D16 ) developed the standard, which will soon be published as D8311. MEG is used predominantly as a raw material in the production of polyester fibers, but it is also commonly used as a heat transfer fluid and a component in…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Melissa Marcinowski, tel +1.610.832.9626; mmarcinowski@astm.org Release #11024 ###
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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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ASTM International has published a new standard that aims to improve the reliability and sustainability of iron water pipes that provide clean drinking water. The organization’s corrosion of metals committee ( G01 ) developed the new standard ( G218 ). According to ASTM International member Mike Horton, there are many standards (related to coatings and cathodic protection) that help protect…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Krista Robbins, tel +1.610.832.9689; krobbins@astm.org Release #10903
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A new test method (D8266) will help analyze impurities of a certain compound (bisphenol A) used in polycarbonate and epoxy resin, helping support the manufacturing and trade of many plastic products. Impurities in bisphenol A can slow down polymerization and result in impurities of the final product, according to Huang Yu, a junior engineer at Sinopec. She says that the test helps determine trace…