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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 E07 on Nondestructive Testing has approved a new standard that can be used for the same applications as the now-cancelled MIL-STD-2154, Process for Inspection, Ultrasonic, Wrought Metals. The new standard, E 2375 , Practice for Ultrasonic Examination of Wrought Products, is under the jurisdiction of Subcommittee E07.06 on Ultrasonic Testing Procedures. Practice E…
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ASTM International Committee E07 on Nondestructive Testing has developed a new standard, E 2491, Guide for Evaluating Performance Characteristics of Phased-Array Ultrasonic Examination Instruments and Systems. Guide E 2491 , which is under the jurisdiction of Subcommittee E07.06 on Ultrasonic Method, is intended to be used for comparing instruments and systems, as well as for detecting long-term…
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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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New ASTM Nondestructive Testing Standard Presents Digital Images for Inspection of Aluminum CastingsDeveloping new ASTM standard E 2422, Reference Digital Images for Inspection of Aluminum Castings, wasn’t just a matter of digitizing the images used in current standard E 155, Reference Radiographs for Inspection of Aluminum and Magnesium Castings. According to Michael Horky, principal level III, RT, Boeing Commercial Airplanes, to create the new standard, task group members had to understand…
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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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A new, two DVD set, "Reference Radiograph E 2422, Standard Digital Reference Images for Inspection of Aluminum Castings," is now available for purchase from ASTM International. The images illustrate the types and degrees of discontinuities that may be found in aluminum-alloy castings. This two DVD set consists of 13 digital files, software to load the desired format, and specific instructions…