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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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A pair of new ASTM International standards developed by ASTM International Committee F26 on Food Service Equipment will be used to replace U.S. Department of Defense military standards. Subcommittee F26.04 on Mechanical Preparation Equipment developed the standards, F 2645 , Specification for Bun Slicing Machines, and F 2646 , Specification for Bread Slicing Machines. According to Richard…
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The heating performance and energy consumption of commercial radiant patio heaters is the subject of a new ASTM International standard. F 2644 , Test Method for Performance of Commercial Patio Heaters, was developed by Subcommittee F26.06 on Energy and Productivity Protocols, which is part of ASTM International Committee F26 on Food Service Equipment. The new standard was originally developed…
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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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Two proposed new ASTM standards will serve as guides for laboratories around the world in establishing a minimum basis of practice for validation and sampling of seized drugs. The proposed standards, WK12734 , Guide for Sampling Seized Drugs for Qualitative and Quantitative Analysis, and WK12735 , Practice for Validation of Seized Drug Analytical Methods, are under the jurisdiction of…
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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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Standards developed by ASTM International Committee F26 on Food Service Equipment are playing an increasingly important role in the industry. F26 standards figure prominently in the Environmental Protection Agency’s Energy Star program, which helps businesses and individuals protect the environment and save money through superior energy efficiency. In addition, F26 has developed a mutually…
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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…