Evaluating Sterility of Single Dose Vials on an Automated Compounding Device

Background: Current guidelines for sterile compounding require that single dose vials of pharmaceuticals must be discarded after 6 hours when accessed in an ISO Class 5 environment. At this time, no studies have evaluated the sterility of single dose vials at any time after opening. Objective: The purpose of this study is to evaluate the sterility of single dose vials attached to an automated compounding device for up to 24 hours and accessed and maintained within a cleanroom environment. Methods: This is a prospective, observational study evaluating the sterility of 32 pooled samples of manufactured single dose injectable drugs attached to an automated compounding device for up to 24 hours and maintained within an ISO Class 5 environment in an ISO Class 7 buffer area. Each pooled sample was comprised of the remaining contents of 10 single dose vial additives that were used for total parenteral nutrition (TPN) and attached to the compounder within the previous 24 hours. Samples were evaluated using membrane filtration sterility testing and incubated for 14 days per USP <71> requirements. Results: The results revealed zero failed sterility samples. Single dose vials remained attached to the compounder for an average of 23.8 hours (±0.1 hours). The average volume per sample was 879 mL (±105.1 mL). Manipulation of vials during the compounding process included an average of 20.4 manipulations (±1.4). Conclusions: Single dose injectable drugs attached to an automated compounding device within an ISO Class 5 cleanroom environment may remain sterile for up to 24 hours. Future studies are needed with a larger sample size and under continued dynamic working conditions to provide further evidence to extend the beyond use date within USP <797>.