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A proposed new ASTM International standard will provide an important process step to be used in the manufacture of protein-based drugs, such as antibodies and fusion proteins, made to inactivate retroviruses. The proposed standard, ASTM WK36552 , Practice for Inactivation of Retrovirus by pH, is being developed by Subcommittee E55.04 on General Biopharmaceutical Standards , part of ASTM…
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ASTM International Committee D27 on Electrical Insulating Liquids and Gases is continuing its work on standards for natural esters with the development of a proposed new standard, WK21616 , Test Method for Oxidation Induction Time of Natural Ester Insulating Fluids by Pressure (PDSC) or Regular Differential Scanning Calorimetry (DSC). The proposed standard was submitted under the jurisdiction of…
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As a means of ensuring the safety of electrical wiring systems in airplanes, ASTM International Committee F39 on Normal and Utility Category Airplane Electrical Wiring Systems has recently approved F2639 , Practice for Design, Alteration and Certification of Airplane Electrical Wiring Systems, a standard developed by Subcommittee F39.01 on Design, Alteration and Certification. According to…
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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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A new ASTM International standard, F 2490 , Guide for Aircraft Electrical Load and Power Source Capacity Analysis, has been accepted by the Federal Aviation Administration (FAA) as a means of compliance with 14 CFR 23.1351(a) (2), Electrical System Capacity for Part 23 (and Predecessor) Aircraft. Guide F 2490 was developed by Subcommittee F39.01 on Design, Alteration, and Certification, which is…
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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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During the past five years, certain insulating oils have been found to contain corrosive sulfur that can produce copper sulfide deposits as a function of time and temperature in operating equipment. A proposed revision to ASTM standard D 1275, Test Method for Corrosive Sulfur in Electrical Insulating Oils, will provide a means to certify that new or in service oils either contain or do not…