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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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The creation of new nickel base alloys in pipe and tube forms, used in the oil and power industries, was the driving force for developing a new ASTM International standard, ASTM B983 , Specification for Precipitation Hardened or Cold Worked, Seamless Nickel Alloy Pipe and Tube. ASTM B983 was developed by Subcommittee B02.07 on Refined Nickel and Cobalt and Their Alloys , part of ASTM…
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ASTM International Committee B02 on Nonferrous Metals and Alloys is currently working on a proposed new ASTM International standard for zinc alloys being used for spin casting. The proposed standard, ASTM WK30745 , Specification for Zinc Alloys for Spin Casting, is being developed by Subcommittee B02.04 on Zinc and Cadmium. According to Bernard Potts, president of Village Casting Inc., and a…
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A proposed new ASTM International standard will provide a definable quality specification for both producers and consumers of secondary Prime Western Grade zinc metal. WK16399 , Specification for Prime Western Grade-Recycled (PWG-R) Zinc Metal Produced from Recycled Zinc Secondary Material, is being developed by Subcommittee B02.04 on Zinc and Cadmium, part of ASTM International Committee B02 on…
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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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A project originally intended to develop a uniform template for the language within a series of standards has resulted in the approval of a new standard, B 949 , Specification for General Requirements for Zinc and Zinc Alloy Products. The new standard is under the jurisdiction of Subcommittee B02.04 on Zinc and Cadmium, which is part of ASTM International Committee B02 on Nonferrous Metals and…
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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 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…