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Posts: 32
Registered: ‎05-05-2011

Sterile Water Shortage

This question is somewhat similiar to what others have been asking in this forum, but not quite the same.  Due to the shortage of Sterile Water for Injection, we currently only have 2L bags as our supply.  Once used for reconstitution, we are giving these bags a 6 hour BUD which is quite wasteful.  A suggestion was made to make smaller (250 or 500mL) bags from these 2L bags - I can understand why, and know we could assign a 9 day refrigerated BUD to these smaller bags.

However, the problem I have is: what BUD can we give product that is reconstituted from these manipulated bags?  I know the smaller water bags would again have the 6 hour BUD after initial entry, but am trying to come up with an answer to the BUD of the reconstituted drug.  (my initial thought would be 24 hours, but don't really have anything definitive to base my answer on)


Any thoughts would be greatly appreciated.