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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 air quality committee ( D22 ) is developing a proposed standard that will aid in the removal of gases that are harmful to both people and to the environment. The proposed standard covers the proper destruction of gaseous fugitive emission by thermal oxidizer or catalyst. According to J. David Halley, chair of ASTM’s gaseous fuels committee ( D03 ), chemical manufacturers are…
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A new ASTM International standard describes a range of techniques that can be used to analyze formaldehyde concentrations in indoor air. ASTM’s air quality committee ( D22 ) developed the standard, which will soon be published as D8407. A naturally occurring organic compound, formaldehyde is an ingredient in many materials, such as resins used for particleboard and coatings. “Formaldehyde is a…
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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 proposed ASTM International standard will help in analysis for trace metals using air and wipe sampling practices. ASTM’s air quality committee ( D22 ) is developing the proposed standard ( WK72704 ). The proposed standard covers the digestion of airborne and surface dust samples (collected using air and wipe sample practices) and associated quality control samples for the determination of…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Ashley Wiand, tel +1.610.832.9551; awiand@astm.org Release #11027 ###
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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 proposed ASTM International standard-guide could help examine the range of commercially available methods for analyzing formaldehyde concentrations in indoor air. While formaldehyde is a naturally occurring substance, chronic long-term exposure can potentially lead to health issues, according to the World Health Organization’s report on formaldehyde in indoor environments. ASTM…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Ashley Wiand, tel +1.610.832.9551; awiand@astm.org Release #10964