797 and glove boxes

Started by ethyl
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ethyl

Go suck on a Zoloft.
15+ Year Member
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What is your institutions requirements when it comes to using a glove box? Do you still put on mask, hat, shoe covers and gloves? How lenient can you be with garb while using a glove box and still be 797 compliant?

"Personnel preparing CSPs in either a CAI or CACI should perform the full garb-
ing and hand hygiene procedure..., unless the isolator manufac-
turer can provide written documentation, based on validated environmental test-
ing, that any components of PPE or personnel cleansing are not required."

I would love if the manufacturer for our glove box could show only a need for handwashing and gloves.