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Posts: 0

Re: USP 797 Environmental Sampling Webinar



Thanks for replying.  As a pediatric hospital when we use bags of Ranitidine or frozen antibiotics we spike the bags with mini-spike dispensing pins or dispensing pins with Safsite valves and draw our doses up in syringes under a laminar flow hood.  We only use these bags for a 6 hour period. 

My real question is concerning the dilutions we compound.  For example, we reconstitute 500 mg vials of Azithromycin and add them to 250 ml bags of D5W for a resulting 2 mg/ml concentration which, according to Trissel is stable under refrigeration for 7 days.  These bags are also used as described above with a dispensing pin added and multiple doses drawn up in syringes from the bag.  What I want to know is, based on USP 797, how long can we use these compounded bags?  



Posts: 1,179
Registered: ‎02-23-2010

Re: USP 797 Environmental Sampling Webinar



I would handle these dilution bags in a similar manner as the pre-mixed bags.  The USP committee is working on language to address this particular issue.  It would be my recommendation to be conservative when using these bags.  You should consider doing your aseptic technique media fill testing using a bulk bag of TSB with a dispensing pin, pull 10-20 syringes daily for three days, followed by a 14 day incubation to see how robust this process is aseptically. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.