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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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Finding ways to assure the quality and safe handling of fire extinguishing agents has led to the development of two new ASTM International standards, D 7323 , Practice for Handling, Transportation and Storage of IG-100 (Nitrogen), and D 7325 , Practice for Handling, Transportation and Storage of IG-541, N2, Ar, CO2. The new standards were developed by Subcommittee D26.09 on Fire Extinguishing…
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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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Providing users with an assurance of quality and ensuring the safe handling, transport and storage of fire extinguishing agents are the purposes of a new ASTM International standard, D 7327 , Specification for HFC Blend B (CH2FCF3, CHF2CF3 and CO2). The new standard was developed by Subcommittee D26.09 on Fire Extinguishing Agents, which is part of ASTM International Committee D26 on Halogenated…
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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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Subcommittee D26.09 on Fire Extinguishing Agents is dedicated to developing standards that provide end users with an assurance of quality in fire extinguishing agents, as well as to ensure the safe handling, transport and storage of such agents. The subcommittee, which is under the jurisdiction of ASTM International Committee D26 on Halogenated Organic Solvents and Fire Extinguishing Agents, is…
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A new standard developed by ASTM International Committee F37 on Light Sport Aircraft covers the instructions a kit producer must provide to a consumer regarding how to assemble and safely flight-test a recreational aircraft to ensure compliance with applicable ASTM standards. The new standard, F 2563 , Practice for Kit Assembly Instructions of Aircraft Intended Primarily for Recreation, is under…
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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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Executives from the Federal Aviation Administration (FAA) met with ASTM International members and staff at this years Airventure - a premier show and convention in the aviation world, hosted by the Experimental Aircraft Association (EAA). The briefing provided an update to the FAA on the status of ASTMs standards initiatives in the aviation sector. Among the representatives for the…