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Senior Member
Posts: 1
Registered: ‎04-28-2010

BUD when using single dose vials to prepare syringes

Can you use single dose vials to prepare batches of syringes in ISO 5 conditions?  (Example: bulk vial of isovue used  to draw up 5ml syringes for later use) If so  is the BUD the same as for medium risk?

VB
Occasional Contributor
Posts: 6
Registered: ‎07-14-2010

Re: BUD when using single dose vials to prepare syringes

Can someone comment about this question?

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VIP
VIP
Posts: 44
Registered: ‎06-30-2011

Re: BUD when using single dose vials to prepare syringes

To the best of my knowledge you can use a single dose vial to prepare batches of syringes in an ISO 5 environment but you will need to follow USP797 BUD guidelines for CSP under low-risk level.  That is, 48 hours at room temperature, 14 days in the refrigerator or 45 days frozen.

Carlos M Marin, RPh
Lead Pharmacist/IV Room/Oncology
Overlook Medical Center
99 Beauvoir Ave
Summit, NJ 07901
MailBox #277
O: (908) 522-2294
F: (908) 908-522-2583
carlos.marin@atlantichealth.org

It is not a case we are treating; it is a living, palpitating, alas, too often suffering fellow creature. ~John Brown
Expert
Posts: 1,168
Registered: ‎02-23-2010
0

Re: BUD when using single dose vials to prepare syringes

The response from Carlos is spot on!  Yes can use single-dose vials for batched CSPs. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Senior Member
Posts: 3
Registered: ‎05-20-2011
0

Re: BUD when using single dose vials to prepare syringes

For low -risk, "...not more than two entries into any one sterile container or package or sterile product".   If we use a dispensing pin to withdraw from the sterile single-use vial several times, would that make it a medium-risk product?  How is entry defined?  Puncturing the port or withdrawals?

 

Thanks,

Jen B

 

VIP
VIP
Posts: 44
Registered: ‎06-30-2011
0

Re: BUD when using single dose vials to prepare syringes

Jen,

 

From the definition, I take it to mean entries, not withdrawals.

 

For low -risk, "...not more than two entries into any one sterile container or package or sterile product".  

 

There are, however, other things to consider.  For example, if we use a dispensing pin in the PEC with a single dose vial, we will never re-use that vial later even if we leave it in the ISO Class 5 PEC sealed.  The potential for contamination is too great with the puncture hole that the pin makes, therefore, we simply discard it.  We use the dispensing pin here only when we know that we will use the entire contents of the vial for CSP. 

 

Our policy is to not use a dispensing pin with multiple dose vials since the puncture hole made by the pin potentially can lead to contamination of the product once removed from the ISO Class PEC envrionment. 

Carlos M Marin, RPh
Lead Pharmacist/IV Room/Oncology
Overlook Medical Center
99 Beauvoir Ave
Summit, NJ 07901
MailBox #277
O: (908) 522-2294
F: (908) 908-522-2583
carlos.marin@atlantichealth.org

It is not a case we are treating; it is a living, palpitating, alas, too often suffering fellow creature. ~John Brown
Expert
Posts: 1,168
Registered: ‎02-23-2010
0

Re: BUD when using single dose vials to prepare syringes

I need to clarify my response to Carlos.   You can use SDVs to make batched CSPs, HOWEVER, they need to be considered MEDIUM-RISK level.  This is inherent in the chapter's definition.  I didn't completely read Carlo's post.  Batched CSPs are NOT low-risk level.  Sorry for the confusion. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Ana
Regular Visitor
Posts: 1
Registered: ‎07-08-2011
0

Re: BUD when using single dose vials to prepare syringes

Due to the national shortage of Astramorph supply is not expected until  December 2012.  In order to maximize our present supply we are discussing preparing syringes from the single dose vial and using BUD of  high risk preparation because of the intrathecal mode of administration.  We have been unable to find information on special considerations when preparing intrathecal doses and therefore would like your opinion on the following process we are considering:     

 

The Astramorph 10mg/10mL vial will be use to prepare 0.5mg/0.5 mL tuberculin syringes in the IV hood under an ISO class 5 environment utilizing aseptic technique.  All syringes will be prepared at one time & the vial will be discarded.  The unit dosed syringes will be stored in the in the pharmacy's IV room  refrigerator and given a 3 day expiration/BUD.  Once the syringe are moved from the Pharmacy refrigerator to the Anesthesia Pyxis, the pharmacy staff will change the expiration date to 24h.

 

We would greatly appreciate your opinion.  Thank you.     

Advisor
Posts: 31
Registered: ‎10-03-2013
0

Re: BUD when using single dose vials to prepare syringes

Eric:

 

Would medium-risk compounding BUD be applied to SDV that contain "no preservatives" , if we are batching, for example, Ascorbic acid 15 syringes of 3 ml each from a 50 ml vial...Since it has no preservatives added, will the BUD of these syringes made be 9 days under refrigeration?? (given that they were compounded in an Isolator **ISO 5 conditions** and following usp 797 guidelines?). Please clarify when you have a chance if the presence of preservatives in a vial (SDV) will be of significance in terms of assigning BUD'S?

Thanks

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

Re: BUD when using single dose vials to prepare syringes

Maria,

 

Would medium-risk compounding BUD be applied to SDV that contain "no preservatives" , --> Yes as long you have chemical stability that exceeds the default BUDs.  if we are batching, for example, Ascorbic acid 15 syringes of 3 ml each from a 50 ml vial...Since it has no preservatives added, will the BUD of these syringes made be 9 days under refrigeration?? (given that they were compounded in an Isolator **ISO 5 conditions** and following usp 797 guidelines?). Please clarify when you have a chance if the presence of preservatives in a vial (SDV) will be of significance in terms of assigning BUD'S? -->  If there are preservatives in the vial, it would be a multi-dose vial (MDV).  You would need chemical stability data to support the storage of the drug outside of its orginal tested container in the final container (vial or syringe).  The chapter is not clear on the BUD of a repackaged CSPs from a MDV.  I would be conservative and treat the doses as medium-risk.  Hope this helps. 

 

Thanks

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.