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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 plastic piping systems committee ( F17 ) has approved a new standard that will aid in the manufacture of piping systems to transport fluids and gases. “Entities and companies needing a corrosion-resistant piping system for the transport of aggressive fluids at elevated temperatures will be interested in this new standard,” says ASTM member Tom Walsh, Walsh Consulting Services…
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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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New Test Method for Evaluating Resistance of Polypropylene Pressure Piping to Disinfectants ApprovedASTM International’s plastic piping systems committee ( F17 ) has approved a new standard test method that will help ensure polypropylene pressure piping materials are suitably resistant to the presence of disinfectants in potable water systems. “In North America, we use much higher levels of disinfectants such as chlorine in our potable water systems than in most other countries,” says ASTM…
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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 plastic piping systems committee ( F17 ) has approved a standard that will aid in the design of a new fabricated pipe fittings made from crosslinked polyethylene (CX-PE). The new standard will soon be published as F3525. ASTM International member Robert Samplonius says that F3525 is part of a movement to develop several standards applicable to the specification and…
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A new standard guide developed by ASTM International’s nanotechnology committee ( E56 ) seeks to familiarize laboratory scientists with background information and technical content necessary to image and identify engineered nanomaterials in cellular and noncellular samples. The standard ( E3275 ) is specific to the use of the darkfield microscopy/hyperspectral imaging analysis technique. In this…, Media Inquiries:, Jaime Martorana, tel +1.610.832.9796; jmartorana@astm.org, Committee Contact:, Kathleen Chalfin, tel +1.610.832.9717; mlynyak@astm.org Release #11273 ###
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New standard practices and specifications developed by ASTM International’s plastic piping systems committee ( F17 ) establish requirements and test methods for polyamide-12 (PA12) materials, pipe, and fittings. PA12 line pipe is made using polyamide-12, a specialty type of nylon plastic with exceptional strength and durability compared to other plastics used in pressure piping systems. The new…, Media Inquiries:, Jaime Martorana, tel +1.610.832.9796; jmartorana@astm.org, Committee Contact:, Robert Morgan, tel +1.610.832.9732; rmorgan@astm.org Release #11271 ###
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A new ASTM International standard will support the characterization of engineered gold nanoparticles used in advanced technologies, including biomedical applications. ASTM’s nanotechnology committee ( E56 ) developed the new standard ( E3269 ). Gold nanoparticles are being used in electronics, catalysis, and advanced coatings, but the largest application has been for biomedical purposes. These…, Media Inquiries:, Jaime Martorana, tel +1.610.832.9796; jmartorana@astm.org , Committee Contact:, Kathleen Chalfin, tel +1.610.832.9717; kchalfin@astm.org Release #11258 ###
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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 ###