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Sterilized medical devices are indispensable to doctors and surgeons around the world. Peel pouches, otherwise known as preformed sterile barrier systems, are used to keep these devices sterile during all physical handling. These pouches can be made with a wide variety of material and are produced by many different suppliers, but the trait all pouches must share is the ability to protect devices…
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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 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…