What are the Proprietary Bag & Vial System 797 Compounding requirements? In order to be subject to BUD for low risk compounds do the preparation of these require compounding in a clean room or can they be prepared in an ISO5 PEC, DCA in a segregated compounding area? Where can I find guidelines for preparing such products?
USP Chapter 797 has specific language to properly manage these bag and vial systems. You need to refer to the package insert for handling and BUD directions for specific products. I have attached a copy of the chapter in case you need one. It is critical to refer to this document frequently.
Our Baxter rep quoted us 15 days on 50 ml AND 100 ml mini-bag plus once the vial has been attached. I have seen references to 50 ml=15 days and 100 ml=30 days elsewhere. Does anybody have any Baxter documentation confirming the 30 days for the 100 ml mini-bag plus?
