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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 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 C15 on Manufactured Masonry Units has created a new subcommittee, C15.11 on Adhered Manufactured Stone Masonry Veneer. The purpose of C15.11 is to develop and maintain product specifications and installation guidelines for adhered manufactured stone masonry veneer. According to Brenda Harris, chair of the new subcommittee, adhered manufactured stone masonry veneer…
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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…
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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 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 C24 on Building Seals and Sealants is currently working to fill a need for a weatherproofing sealant field test standard. The result, proposed standard WK7800, Guide for a Non-Destructive, Continuous, Field Test of Installed Weatherproofing Sealant, features a field test that has been used by sealant professionals for years, but has not, up to this point, been…