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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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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 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 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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STP 1468, Elemental Analysis of Fuels and Lubricants: Recent Advances and Future Prospects , is a new publication now available for purchase from ASTM International. Included in the volume are 23 peer-reviewed papers that provide the latest information on the elemental analysis of fuels and lubricants. Six sections cover the following topics: Overview--covers total quality management…
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Verifying the results of application software used to calculate the mechanical properties of materials is the subject of a new standard developed by ASTM International Committee E08 on Fatigue and Fracture. The new standard, E 2443, Guide for Verifying Computer-Generated Test Results Through the Use of Standard Data Sets, is under the jurisdiction of Subcommittee E08.03 on Advanced Apparatus and…
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A new CD-ROM, "ASTM Standards Related to Biodiesel Fuel Blend Stock (B 100) for Middle Distillate Fuels," is now available from ASTM International. The work includes the latest edition of D6751, Standard Specification for Biodiesel Fuel (B100) Blend Stock for Distillate Fuels as well as 35 other referenced ASTM standards. Among the standards are two practices for sampling petroleum and petroleum…
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Many structures, such as aircraft or other lightweight vehicles, are made from thin-ductile structural materials that exhibit low crack-front constraint, which allows for extensive plastic yielding of the material around a crack front. However, many current standards, such as E 399, Test Method for Linear-Elastic Plane-Strain Fracture Toughness K Ic of Metallic Materials, or E 1820, Test Method…
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Interested laboratories can now register for two New ASTM Interlaboratory Crosscheck Programs. The two programs are: Hydraulic Fluids/Oils, and In-Service Hydraulic Fluids and Oils. Both Crosscheck Programs will provide statistical quality assurance tools that will enable laboratories to maintain or improve a high level of performance in conducting routine ASTM tests by comparing results with…