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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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Dried blood represents the greatest challenge to cleaning surgical instruments. To meet this challenge, ASTM International Committee D12 on Soaps and Other Detergents has developed a new standard, D 7225 , Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors. The new guide is under the jurisdiction of Subcommittee D12.16 on Hard Surface Cleaning. Water-soluble components of…
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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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Two new ASTM International standards, F 2412, Test Methods for Foot Protection, and F 2413, Specification for Performance Requirements for Protective Footwear, have replaced the former ANSI Z41 standard, Standard for Personal Protection Protective Footwear, which has now been withdrawn. Both of the new ASTM standards are under the jurisdiction of ASTM Committee F13 on Pedestrian/Walkway Safety…
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Dos nuevas normas internacionales de ASTM, F 2412 (Métodos de prueba para protección de los pies) y F 2413 (Especificación sobre requisitos de rendimiento para calzado de protección) reemplazan a la norma anterior, ANSI Z41 (Norma sobre calzado de protección personal), que ha sido retirada. Las dos nuevas normas de ASTM estarán bajo jurisdicción del Comité F13 de ASTM sobre calzado y seguridad de…