I have had a request to 'Double Sterilize' a compounded unit dose syringe as another pharmacy is doing. The physician wants a guarantee that the OUTSIDE of the syringe is Sterile as well as the product in it. It is my understanding that USP 797 is an Aseptic environment ;not a sterile environment. The medication must be kept at 2 -8 degrees centigrade, so autoclaving is out of the question. Any Ideas on how one would accomplish 'double sterile'?
I am not aware of any procedure that you can do in a pharmacy to achieve this criteria. As you aptly pointed out is that we practice aseptic compounding procedures not sterile compounding. Unless the drug-device(syringe) combination is packaged and terminally sterilized, you cannot guarantee that the outside of the syringe is sterile. Most outsourcing pharmacies will claim that the fluid pathways are sterile but not the syringe. Any packaging on compounded doses are dust-covers and are not designed for sterility.
