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Expert
Posts: 1,142
Registered: ‎02-23-2010
0

Re: BUD

Sue,

 

Thanks for the email and your patience.  I understand the challenges you and others are facing with these shortages.  I don't like Buretrols since they are not a closed-system, in my opinion.  A better solution for batching and storing solutions in alternative containers like you are proposing would be to prefill empty IV bags.  I am sure there will a shortage of these products or maybe not but you have a closed-system with bags.  If you need to do this, I would simulate this process using tryptic soy broth (don't use QI Medical broth since it doesn't consistently support microbial growth--my opinion and personal experience) and fill 10 devices and let these buretrols sit in the pharmacy for 14 days to see if you get any growth.  Use media from Hardy Diagnostics or someone else.  If you have no growth, then you have objective data to support the decision to follow ASHP and University of Utah's advice.  Hope this helps.  

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Advisor
Posts: 12
Registered: ‎09-25-2017
0

Re: BUD

Thank you Eric.  We are already experiencing a shortage of empty viaflex bags.  I will do the sterility testing, as suggested and arbitrarily shorten BUD to 24 hours. - Sue M

Expert
Posts: 1,142
Registered: ‎02-23-2010
0

Re: BUD

Sue,

 

You are welcome.  I want to be clear that the media fill procedure I described is NOT a sterility test.  It will test the technique of your staff and the closure integrity of the Burotrels to make sure these containers can be filled aseptically and they are closed and won't allow ambient air/contamination to get into the device.   

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
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Advisor
Posts: 12
Registered: ‎09-25-2017
0

Re: BUD

Understood.  Thank you again for your wisdom and guidance.

 

Sue M