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ASTM International Committee E55 on Manufacture of Pharmaceutical Products has developed a new standard that covers the life cycle of pharmaceutical and biopharmaceutical manufacturing systems. The new standard, E 2500 , Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment, is under the jurisdiction of Subcommittee E55.03 on…
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Plastic pipe and components are used with low pressure oxygen and enriched air for a variety of applications, including medical and healthcare, agriculture (fish farming), welding and fabrication, waste water treatment and others. Despite this widespread use, there are currently no standards that help in the materials selection and design features of these systems. ASTM International Committee…
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The ASTM International committee formerly known as E55 on Pharmaceutical Application of Process Analytical Technology has undergone a change in title and scope that reflects the intent of the committee to be more inclusive of all the tools, instrumentation and sciences that might be used by the industry in the management of pharmaceutical manufacturing processes. The committee is now known as E55…
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While the polymer-based siding industry developed around the use of polyvinyl chloride, the last two decades have seen the introduction and rise in use of polypropylene as a siding material. Because of this, siding producers and polypropylene suppliers began to discuss the need for an ASTM standard for this type of siding. These discussions have resulted in the development and recent approval of…
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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has now approved its first practice. ASTM E 2474 , Practice for Pharmaceutical Process Design Utilizing Processing Analytical Technology, is under the jurisdiction of Subcommittee E55.02 on PAT System Implementation and Practice. Practice E 2474 covers process design, which is integral to process…
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ASTM International Committee D20 on Plastics is currently developing a proposed new standard that will be used for the determination of flammability characteristics of polymeric materials under laboratory conditions. The proposed standard, WK9492 , Test Method for Determining Flammability Characteristics of Plastics and Other Solid Materials Using Microscale Combustion Calorimetry, will be useful…
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Quality control scientists, plant processing engineers and polymer formulation scientists are likely users of a new ASTM International standard, D 7210 , Practice for Extraction of Additives in Polyolefin Plastics. The standard was developed by Subcommittee D20.70 on Analytical Methods, which is under the jurisdiction of Committee D20 on Plastics. Practice D 7210 covers a variety of extraction…
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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has created a new subcommittee, E55.03 on General Pharmaceutical Standards, which will address issues on quality within a broad framework of chemistry, manufacturing and control. The scope of the new subcommittee is the development of general principles, practices and related standards for managing…
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ASTM International Committee G04 on Compatibility and Sensitivity of Materials in Oxygen Enriched Atmospheres originally developed the standard, G 88, Guide for Designing Systems for Oxygen Service, in 1984. Since that time, G 88 has been regarded as one of the leading design guides for oxygen systems throughout all industries that use oxygen. While the original version of the standard contained…