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

Abstract

Accepted: 28 February 2021 / Published online: 19 March 2021 © The Author(s) 2021, corrected publication 2021 Abstract Background The 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. 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. [...]beyond extending BUD, implementing CSTDs has additional benefits. Growth media and incubation conditions In order to test for growth of Gram-positive bacteria, Gramnegative bacteria, anaerobic microorganisms, yeast and mold, two types of growth media were used; Tryptic Soy Broth (TSB) and Fluid Thioglycollate Medium (FTM).