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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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In response to requests from fuel producers around the world, ASTM International Committee C26 on Nuclear Fuel Cycle has developed a standard for using the total evaporation method to determine uranium or plutonium composition. The new standard, C 1672 , Test Method for Determination of Uranium or Plutonium Isotopic Composition or Concentration by the Total Evaporation Method Using a Thermal…
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Neutron absorbers have been used for criticality control in spent nuclear fuel pools and in spent fuel transportation casks for decades. However, since the late 1980s, as spent fuel storage pools have been filled, utilities have transferred spent fuel into dry dual-purpose (storage/transportation) canisters. The neutron absorbers used in dual-purpose canisters are subjected to different operating…
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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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A new ASTM International standard, E 2555 , Practice for Factors and Procedures for Applying the MIL-STD-105 Plans in Life and Reliability Inspection, represents the latest work of a task group that is converting a series of old U.S. Department of Defense standards into ASTM documents. The task group is part of Subcommittee E11.30 on Data Analysis, which is under the jurisdiction of ASTM…
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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 Committee C26 on Nuclear Fuel Cycle has recently published a new standard and has begun the development of a proposed new standard. Subcommittee C26.14 on Remote Systems is responsible for the newly approved standard, C 1661 , Guide for Viewing Systems for Remotely Operated Facilities, while Subcommittee C26.02 on Fuel and Fertile Material Specifications is currently at work on…, C 1661, Guide for Viewing Systems for Remotely Operated Facilities, A new ASTM International standard establishes minimum requirements for viewing systems for remotely operated facilities, including hot cells, used for the processing and handling of nuclear and radioactive materials. The standard, C 1661 , Guide for Viewing Systems for Remotely Operated Facilities, was developed by Subcommittee C26.14 on Remote Systems, which is part of ASTM International…, WK14330, Nuclear Fuel Pellet Physical Integrity Limits: Chips, Cracks, Defects, The quality of fuel pellets is currently an important topic being studied throughout the nuclear industry, with study groups such as the Electric Power Research Institute and Institute of Nuclear Power Operations examining the effect of pellet quality on the performance of nuclear fuel. ASTM International Committee C26 on Nuclear Fuel Cycle is addressing the topic of fuel pellets with a proposed…
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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 C24 on Building Seals and Sealants invites interested parties to participate in the development of a proposed new standard that will use photographs to illustrate various types of sealant failures. WK11731 , Guide for Diagnosing Sealant Failure by Comparison to Reference Photographs, is under the jurisdiction of Subcommittee C24.10 on Specifications, Guides and…
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ASTM International Committee E11 on Quality and Statistics has approved a new practice that describes methods for proficiency testing providers to use in analyzing laboratory results obtained in their programs. The standard, E 2489 , Practice for Statistical Analysis of One-Sample and Two-Sample Interlaboratory Proficiency Testing Programs, is under the jurisdiction of Subcommittee E11.20 on Test…