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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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ASTM International’s Committee E13 on Molecular Spectroscopy and Separation Science will hold its February meeting in conjunction with the 58th Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy (Pittcon 2007) from Feb. 25-27 at the McCormick Place Convention Center in Chicago, Ill. All E13 meetings will be held in room N-129. During the conference and exhibit portion 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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According to Jerry Workman, chair of new ASTM International Subcommittee E13.16 on Chemical Sensors, one place to begin to understand the current and future importance of chemical sensors is the classic television show, Star Trek. “Mr. Spock, the science officer on the Starship Enterprise, routinely used his Tricorder to make measurements of atmospheric gases, soil samples, living tissue and…
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ASTM International Subcommittee E13.15 on Analytical Data is currently working on a proposed new standard, WK6371, Analytical Information Markup Language (AnIML). Subcommittee E13.15 is under the jurisdiction of Committee E13 on Molecular Spectroscopy and Separation Science. AnIML is a markup language for describing analytical chemistry result data and metadata that can be used for data…
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ASTM International Committee E13, formerly known as E13 on Molecular Spectroscopy and Chromatography, has recently undergone a restructuring that reflects changes in technology and the scope of the analytical sciences industry. Along with a title change, the scope of Committee E13 has been expanded to include the advancement of fields of analysis to include molecular spectroscopy and separation…
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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…