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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 need for a new test method to determine the effective thermal conductivity of fire resistive materials at high temperatures has prompted ASTM International Committee E37 on Thermal Measurements to begin work on a proposed new standard, WK12643 , Test Method for Slug Calorimetry. The proposed standard is under the jurisdiction of Subcommittee E37.05 on Thermophysical Properties. According to…
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ASTM International Committee E37 on Thermal Measurements is seeking participation in a new subcommittee, E37.09 on Biological Calorimetry. Since its inception, the focus of Committee E37 has been the creation of methods for the calibration and use of thermal analysis instrumentation. One of the first types of thermal analysis instruments that was developed commercially on a large scale was…
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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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Sieve manufacturers produce testing sieves using various sizes of wire cloth, per ASTM International standard E 11, Specification for Wire Cloth and Sieves for Testing Purposes. They also use ASTM standards E 161, Specification for Precision Electroformed Sieves, and E 323, Specification for Perforated-Plate Sieves for Testing Purposes when producing sieves from perforated plate. These…