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General Chapters: PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS, pharmaceutical compounding.#Pharmaceutical #compounding
pharmaceutical compounding RESPONSIBILITY OF COMPOUNDING PERSONNEL Compounding personnel are adequately skilled, educated, instructed, and trained to correctly perform and document the following activities in their sterile compounding duties: CSP MICROBIAL CONTAMINATION RISK LEVELS The CSPs are compounded with aseptic manipulations entirely within ISO Class 5 (see Table 1 ) or better air quality using only sterile ingredients, products, components, and devices. The compounding involves only transfer, measuring, and mixing manipulations with closed or sealed packaging systems that are performed promptly and attentively. Manipulations are limited to aseptically opening ampuls, penetrating sterile stoppers on vials with sterile needles and syringes, and ...
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