Sterility testing using a closed system transfer device in oncology medication compounding: a novel method for testing partially used vials

Abstract

BackgroundThe National Association of Pharmacy Regulatory Authorities (NAPRA) Model Standards for non-hazardous sterile preparations and the model standards for pharmacy compounding of hazardous sterile preparations, calls for partially used single dose vials to be used or discarded within six hours of first access. This may lead to significant wastage, particularly with less utilized and expensive medications like oncology treatments. If demonstrated that sterility of these partially used vials can be maintained through a compounding procedure, there may be an opportunity to consider their re-uses.ObjectiveThe primary objective is to determine the ability of a compounding procedure, including a closed system transfer device (CSTD), to maintain sterility for partially used vials at two compounding centres at Trillium Health Partners. A secondary objective was to evaluate a novel method for verifying sterility.MethodsA CSTD was incorporated into the standard compounding methods at two hazardous compounding centres. Using growth media to detect any bacterial or fungal contamination that might have occurred during compounding, storage, and repeated access, the vials were tested in various growth conditions.ResultsThere was no growth noted in all compounded samples. The CSTD, when used in our environment with certified personnel, maintained sterility for 14 days, even with repeated access.ConclusionsThis study demonstrates that under our local compounding procedure using CSTD we were able to maintain vial sterility when stored under typical conditions and accessed several times for up to 14 days. This method may be considered to assess a facility’s local compounding procedures and provide valuable information regarding storage and utilization of partial vials, which may result in reduced waste and cost avoidance for the health care system.