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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 asset management committee ( E53 ) is developing a new standard practice for conducting inventories. It utilizes Inventory by Exception (IBE) to allow the physical inventory process to only focus on locating assets that were not touched or physically inventoried. The new standard ( E3298 ) is used to verify items on record using IBE, which decreases the number of assets…, Media Inquiries:, Jaime Martorana, tel +1.610.832.9796; jmartorana@astm.org, Committee Contact:, Jennifer Tursi, tel +1.610.832.9653; jtursi@astm.org Release #11275 ###
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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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A new ASTM International standard aims to provide a needed set of practices for infrastructure management. ASTM International’s asset management committee has developed the standard, which will soon be published as E3210. According to ASTM International member Marty Rowland, the new standard will help elected officials or executives of cities or counties determine effective ways of measuring…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Jennifer Tursi, tel +1.610.832.9653; jtursi@astm.org Release #10890
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A new ASTM International standard aims to help owners and operators of heavy motorized equipment – such off-road construction, self-propelled warehouse trucks, tractors and aircraft support equipment -- to manage their assets. Accountability will be evident through standard performance measures, such as cost savings, increased asset visibility and utilization, extended asset life, petroleum and…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Jennifer Tursi, tel +1.610.832.9653; jtursi@astm.org Release #10885
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ASTM International’s asset management committee ( E53 ) has approved a new standard with guiding principles for creating an asset management career development program (soon to be published as E3140). According to committee members, the standard outlines the education, training, and experience needed to support the mission and objectives of an entity’s asset-management operations. “We needed a…