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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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Flow characteristics of fine metal powders are important in filling dies for pressing of powder metallurgy compacts, which are later sintered and sometimes machined into finished parts. The flow rate, as measured by a new ASTM standard, determines the flow necessary for a precise quantity of powder to be introduced into the die. The new standard, B964 , Test Methods for Flow Rate of Metal Powders…
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Two recently approved ASTM International standards provide user-friendly tests for properties of sintered metallurgy products. The new standards, developed by Subcommittee B09.04 on Bearings, are ASTM B962 , Test Methods for Density of Compacted or Sintered Power Metallurgy (PM) Products Using Archimedes’ Principle, and ASTM B963 , Test Methods for Oil Content, Oil-Impregnation Efficiency and…
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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…