06-11-2014 05:38 PM
We are designing a new clinic facility in which pharmacy will have a small space for supporting an infusion clinic. We have a large IV room in main campus hospital and are very familiar with USP 797 compliant rooms. However, we have no experience with CAI. The infusion clinic will infuse non-hazardous infusions. The infusions will be completed within 12 hours of prep. The preparations will be classified as low risk. The architects placed the CAI in a non hepa filtered room, away from other pharmacy activities. The sink is placed just inside the segregated room but the architects did not put in a door. Is a door required? Should the sink be inside the room with the CAI? They currently are as far apart as possible but in the same room. The CAI we are considering is NuAire.
Thanks for your help!
06-16-2014 11:13 PM
Thanks for the email. What state are you in? Some State Boards of Pharmacy are requiring CAIs to be in an ISO class 8 room which is not required by USP 797. Also, you are not limited with a 12 hour BUD when using a USP 797 compliant isolator. NuAire is a good company and makes compliant CAIs. The sink is OK and the door is not necessary as long as the room is a "restricted area" away from traffic. Hope this helps. I attached a couple of articles for your consideration.