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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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ASTM International standards E 10 , Test Method for Brinell Hardness of Metallic Materials, and E 18 , Test Methods for Rockwell Hardness of Metallic Materials, have both recently undergone extensive revisions. Both standards are under the jurisdiction of Subcommittee E28.06 on Indentation Hardness Testing, which is part of ASTM International Committee E28 on Mechanical Testing. “The intention…
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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 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…
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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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A new ASTM International standard will assist aerospace companies that are purchasing fine grain titanium alloys. The standard, E 2448, Test Method for Determining the Superplastic Properties of Metallic Sheet Materials, has been developed by ASTM Subcommittee E28.02 on Ductility and Flexure Testing, which is under the jurisdiction of Committee E28 on Mechanical Testing. According to Peter…
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A former military standard has become the basis for a new ASTM standard developed by Committee E11 on Quality and Statistics. The new standard, E 2234, Practice for Sampling a Stream of Product by Attributes Indexed by AQL, will be the first in a series based on a now-withdrawn set of military documents on sampling. Practice E 2234, presently under the jurisdiction of Subcommittee E11.10 on…
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ASTM International Committee E28 on Mechanical Testing has begun work on a proposed new standard to describe the test procedure for determining the superplastic forming properties of a material. The committee is actively seeking participation from interested parties in the development of this document. More information on this new activity can be found by entering WK7114 in the site search box on…