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ASTM International’s rubber and rubber-like materials committee ( D11 ) is working on a proposed standard to address variation between laboratories resulting from bias. The standard guide ( WK85445 ) is part of the lineage formed by ASTM D4483 , which has helped committee members improve testing precision within labs over the past several decades. However, according to John Bailey, chair of the…, Media Inquiries:, Gavin O’Reilly, tel +1.610.832.9618; goreilly@astm.org, Committee Contact:, Melissa Marcinowski, tel +1.610.832.9626; mmarcinowski@astm.org Release #11657 ###
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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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ASTM International’s rubber and rubber-like materials committee ( D11 ) has approved a new standard that will aid the use of silica technology in the production of rubber products. The new standard ( D8471 ) covers raw materials, formulation, and mixture procedures for the evaluation and quality control of silica and related technologies, such as silanes and functionalized polymers, in a…, M, e, dia Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Melissa Marcinowski, tel +1.610.832.9626; mmarcinowski@astm.org Release #11534 ###
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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 committee on rubber and rubber-like materials ( D11 ) has approved a new standard for evaluating anesthesia reservoir bags. Anesthesia reservoir bags are used while performing inhalation sedation to provide a reservoir from which additional gas may be drawn should the respiratory demands of a patient exceed the gas flow delivered from the breathing system. According to ASTM…
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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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ASTM International Signs Letter of Cooperation with Indian Rubber Manufacturers Research AssociationRecently, representatives from global standards organization ASTM International and the Indian Rubber Manufacturers Research Association (IRMRA) signed a Letter of Cooperation (LoC). The LoC will lead to a closer working relationship between ASTM and IRMRA. The LoC was signed by Katharine Morgan, president, ASTM International and Dr. Kasilingam Rajkumar, director, IRMRA. The partnership will…, Media Inquiries:, Jaime Martorana, tel +1.610.832.9796; jmartorana@astm.org Release #11142 ###
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A proposed ASTM International standard will help provide specifications and test methods applicable to three-lumen catheters. ASTM’s committee on rubber and rubber-like materials (D11) is developing the proposed standard. The proposed standard establishes performance requirements for the various types of short-term use of a single-use, three-lumen, balloon retention catheter. Lumens are the inner…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Melissa Marcinowski, tel +1.610.832.9602; mmarcinowksi@astm.org Release #11048 ###
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ASTM International’s rubber committee ( D11 ) has formed a new subcommittee that will focus on alternative sources of natural rubber and natural rubber latex. Polymer experts, as well as representatives from regulatory bodies, are encouraged to join in developing new standards within this subcommittee. According to ASTM International member and former board chair Tom Marsh, who will lead the…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Melissa Marcinowksi, tel +1.610.832.9626; mmarcinowski@astm.org Release #11030 ###