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Can a pharmacy become USP <797> compliant simply by purchasing a compounding aseptic isolator(s) or CAI?

April 26, 2017aseptic compliant compounding isolator pharmacy purchasing USP

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Can a pharmacy become USP <797> compliant simply by purchasing a compounding aseptic isolator(s) or CAI?

2 Answers

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Isolators alone will not ensure compliance with USP <797>. Using an isolator for sterile compounding addresses only part of the requirements for USP <797>. Issues such as process validation, training, BUD determination, product quality maintenance after the CSP (compounded sterile product) leaves the pharmacy, caregiver training, patient monitoring, QA program, etc. remain the same as for products compounded in standard laminar flow hoods.

0

Posted

Isolators alone will not ensure compliance with USP <797>. Using an isolator for sterile compounding addresses only part of the requirements for USP <797>. Issues such as process validation, training, BUD determination, product quality maintenance after the CSP (compounded sterile preparation) leaves the pharmacy, caregiver training, patient monitoring, QA program, etc. remain the same as for products compounded in standard laminar flow hoods.