02-10-2018 10:54 AM
Due to the ropivacaine 0.2% (PF for epidural) shortage, we are planning to compound from 0.5% ropivacaine PF. They are administed via syringe pump.
What would be the appropiate BUD? We are very cautious about compounding the product since it is for epidural.
We are planning to make them on-call per patient basis with a BUD of 12 hours if made in a segregated compounding area (ISO-5 BSC, not in a cleanroom). Do we need to do sterility or stability studies?
We do have a 797 cleanroom that runs for 8 hours only due to staffing constraints. We were thinking batching them in the cleanroom would not extend the BUD since it is preservative free. We also have limited supply of the 0.5% and didn't want to batch to avoid wastage.
I guess my main question is would it be better to make them on-call in the segregated area or batch them in the Cleanroom (797 room)?
Our usage can vary from 2-15 syringes per day (Ropivacaine 0.2% 60 mL syringe)
I would appreciate some guidance on this. Thank you all.
02-12-2018 11:55 AM
Your needs seem to require a solution that conserves scarce resources and minimizes waste while producing the best product you can for your patients.
You could make many “mini” batches and only make them in your USP-797 compliant clean room. You could give them a medium risk compounding BUD of 9 days in the fridge and 30 hours at room temperature without the necessity of doing sterility or stability studies. This is taking into account that the item is preservative free.
Additionally, due to the route, you need to filter the resultant solution as it is going into its final container with a 0.2-micron filter.
There is primary literature on the compounding of ropivacaine.
Best of luck.
02-12-2018 01:09 PM
Richard is spot on. You can't batch any CSPs in a segregated compounding area. You also need to do a filter integrity test/bubble-point on the filter after use. Thanks.