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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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ASTM International Committee E18 on Sensory Evaluation has been working on developing a series of widely used, fundamental discrimination tests into ASTM International standards. Some of these tests that are now approved standards include E2263 , Standard Test Method for Paired Preference Test, E 2139, Test Method for Same-Different Test, and E 1885 , Test Method for Sensory Analysis-Triangle…
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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 process hazard analysis prior to the startup of a chemical processing facility is essential to prevent catastrophic incidents due to thermal runaway reactions. A proposed new ASTM standard, WK9584, Guide for Assessing Potential Hazards of Synthesis Reactions Using Reaction Calorimetry, will help to standardize how the results from reaction calorimetry experiments are used in a process hazard…
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ASTM International Committee E18 on Sensory Evaluation of Materials and Products is currently working on a proposed new standard, WK8435, Practice/Guide for Measuring and Tracking Sensory Descriptive Panel and Panelist Performance. WK8435 will be used to assist sensory professionals in selecting, screening, and identifying training needs for new and existing panels and assessors. In addition,…
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ASTM Committee E18 on Sensory Evaluation of Materials and Products is currently working on a proposed new standard that outlines the experience and education necessary to become a sensory professional. The proposed standard, WK7661, is tentatively titled Guide for Sensory Proficiency, and is under the jurisdiction of Subcommittee E18.05 on Sensory Applications General -- General . According to…
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ASTM International Committee E18 on Sensory Evaluation of Materials and Products has begun to develop a new proposed Guide for Panelist Feedback. The proposed standard will provide guidance on how to address various issues involved in delivering performance and information feedback to discrimination and descriptive/attribute testing panels. Information on the proposed guide, which is under the…