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While the continuous quality verification concept is still quite new, it has the potential to become an important approach to assuring product quality in the pharmaceutical industry. With this in mind, ASTM International Committee E55 on Manufacture of Pharmaceutical Products has approved a new standard, E2537 , Guide for Application of Continuous Quality Verification to Pharmaceutical and…
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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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Users of laboratory services and other interested parties are invited to participate in the development of a new practice that will promote uniformity in quality management practice for all standards under the jurisdiction of ASTM International Committee D05 on Coal and Coke. Subcommittee D05.30 on Quality Assurance is developing the proposed new standard, WK14563 , Establishing the Competence of…
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ASTM International Committee B08 on Metallic and Inorganic Coatings has recently approved a revision of one of its most important standards, B 633 , Specification for Electrodeposited Coatings of Zinc on Iron and Steel. B 633 is under the jurisdiction of Task Group B08.08.04 on Soft Metals, which is part of Subcommittee B08.08 on Metallic Coatings. Zinc coatings are used to provide a sacrificial…
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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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Sampling is a difficult but essential part of the coal production process. ASTM International Committee D05 on Coal and Coke hopes to streamline that process with the publication of new standard D 7256/D 7256M, Practice for Mechanical Collection and Within-System Preparation of a Gross Sample of Coal from Moving Streams. Practice D 7256/D 7256M is under the jurisdiction of Subcommittee D05.23 on…
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ASTM International Committee D05 on Coal and Coke is currently seeking participation in the development of a proposed new standard, WK10700 , Test Method for Total Moisture in Coal Reduced to 2.36 mm (No. 8 Sieve) Topsize Through Determination of Air-Drying Loss by Microwave Oven. The proposed new standard is under the jurisdiction of Subcommittee D05.21 on Methods of Analysis. While air-drying…
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ASTM Committee D05 on Coal and Coke is currently developing a proposed new standard, WK10380, Practice for Establishing the Competence of Laboratories Using ASTM Procedures in the Sampling and Analysis of Coal and Coke. The proposed standard will specify requirements for establishing, operating and evaluating a laboratory that provides services in the areas of sample collection and preparation…