09-20-2017 08:59 PM
We have a CAI that is located outside our cleanroom for compounding 1st dose or one time CSP. It is a Nuaire CAI. The problem is it is a high traffic area within a few feet or our pharmacy receiving and storage area. I looking to recommend a structural change for the CAI such as some type of enclosure around the CAI. What suggestions would you recommend. Also with the upcomping revision to USP 797 what would that revision suggest?
09-21-2017 07:43 AM
As you know, locating the CAI in a traffic area is not ideal. Right now, the proposed revisions are going to require isolators to be located in an ISO Class 7 buffer room with ISO Class 8 anteroom to use BUD dating longer than 12-hours room temperature/24-hour refrigerated.
09-28-2017 05:13 PM - edited 09-28-2017 05:15 PM
California BOP already requires a CAI to be in an ISO 7 clean room to qualify for Medium & Low risk BUD's, otherwise it's only a 12 hour BUD. Frustrating, since we have one and can't get the room to qualify.
09-29-2017 09:22 AM
Thanks for your comment about the California Board of Pharmacy. It is critical that you know what your state board of pharmacy requires because those regulations will supersede USP 797/800.