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Advisor
Posts: 23
Registered: ‎04-28-2010

Sterile Water hang time

We hang a liter bag of sterile water in the glovebox and use it for reconstitution.  The glovebox is left on 24/365, is it okay to leave the bag hanging and replace after 24 hours? The evening technician changes the gloves at end of shift, so there is a break in containment.  Should the bag be removed, wiped down and passed back through the air chamber? Thanks.

Expert
Posts: 1,168
Registered: ‎02-23-2010

Re: Sterile Water hang time

Maegan,

 

A sterile water should not be removed from the isolator and if there is a break in containment, then it should be discarded at that time.  It is a single-dose container and should be discarded after 6 hours consistent with the language in USP 797.  It costs less than 1 dollar but can be a reservoir source of contamination. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Frequent Visitor
Posts: 1
Registered: ‎10-13-2010

Re: Sterile Water hang time

Eric,

 

What if there is not a break in containment in the glove-box?  How long would the water bag be good for?  Thanks.

 

Andy Ault

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Expert
Posts: 1,168
Registered: ‎02-23-2010

Re: Sterile Water hang time

6 hours since it is considered a single-dose container.  What does the package insert say re: disposal after puncture?

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.