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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 standard will be helpful to those designing thermal insulation systems for cryogenic piping and equipment for liquefied natural gas (LNG)-fueled ship applications. ASTM’s committee on ships and marine technology ( F25 ) developed the new standard. “Correctly specifying the thermal insulation system for pipe and equipment on LNG-fueled ships is challenging,” says ASTM…, Media Inquiries:, Jaime Martorana, tel +1.610.832.9796; jmartorana@astm.org, Committee Contact:, David Lee, tel +1.610.832.9681; dlee@astm.org Release #11140 ###
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A new standard from ASTM International’s ships and marine technology committee (F25) is designed to assist and support the maritime industry in addressing cyber risks by leveraging existing safety management systems (SMS). The new standard (soon to be published as F3449) would include guidelines to improve cyber safety, address vulnerability, recommend and outline training, and raise knowledge…, 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 #11057 ###
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A proposed ASTM International standard will support the effective operation, maintenance, and health of shipboard marine sanitation devices (MSDs). ASTM’s ships and marine technology committee (F25) is developing the proposed standard (WK73063). According to ASTM International member Todd Ripley, the proposed guide will provide information and clarity to support the health and maintenance of…, 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 #11038 ###
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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 provides guidelines for using lithium-ion batteries on ships. The organization’s ships and marine technology committee ( F25 ) developed the standard ( F3353 ). ASTM International member Thane Gilman notes that the new standard was created primarily to support large lithium-ion battery installations, including those that may provide propulsion, ship’s service…, 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 #10766