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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 D07 on Wood has approved a new standard, ASTM D7746 , Practice for Calculating the Superimposed Load on Wood-Frame Floor-Ceiling Assemblies for Standard Fire Resistance Tests. ASTM D7746, which was developed by Subcommittee D07.05 on Wood Assemblies , will be used in conjunction with other fire test standards. Standards such as ASTM E119, Test Methods for Fire Tests…
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A proposed revision to ASTM International standard ASTM D5456 , Specification for Evaluation of Structural Composite Lumber Products, would add bamboo as a fiber material that can be used in the manufacture of products covered in the standard. ASTM D5456 is under the jurisdiction of Subcommittee D07.02 on Lumber and Engineered Wood Products, part of ASTM International Committee D07 on Wood. ASTM…
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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 new ASTM International subcommittee, D07.08 on Forests, is now soliciting all interested stakeholders to assist in the development of a proposed new guide for forest management systems. The purpose of the subcommittee, under the jurisdiction of ASTM International Committee D07 on Wood, is to promote knowledge, stimulate research and develop standards pertaining specifically to forests. Industry…
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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 recently approved ASTM International standard recognizes new state of the art technology for reinforcing glued laminated timber beams. The standard, D 7199 , Practice for Establishing Characteristic Values for Reinforced Glued Laminated Timber (Glulam) Beams Using Mechanics-Based Models, was developed by Subcommittee D07.02 on Lumber and Engineered Wood Products, under the jurisdiction of ASTM…
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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…