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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 B08 on Metallic and Inorganic Coatings has recently approved a revision of one of its most important standards, B 633 , Specification for Electrodeposited Coatings of Zinc on Iron and Steel. B 633 is under the jurisdiction of Task Group B08.08.04 on Soft Metals, which is part of Subcommittee B08.08 on Metallic Coatings. Zinc coatings are used to provide a sacrificial…
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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 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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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…