Aseptic simulation test challenged with microorganisms for validation of pharmacy operators

PURPOSE: Aseptic technique of pharmacy operators was assessed using simulated media-fill tests challenged with microorganisms. METHODS: Simulation of the process was done in accordance with multiple transfer steps using tryptone soya broth. All stoppers of broth medium vials were deliberately contaminated with a challenge micro-organism (Enterococcus faecalis). Each final preparation (vials, syringes, and minibags), including the culture medium, was incubated for 14 days at 32 °C. Vials, syringes, and bags were held in front of light daily for 14 days to detect any visual turbidity. At the end of the 14-day period, all clear culture media were filtered via a 0.45-μm sterile filter, which was then incubated at 32 °C on a tryptone soya agar plate. Bags and vials not subjected to manipulation were incubated simultaneously and served as controls. Visual observation by a pharmacist was conducted during the media-fill test, and finger dabs were taken at the end of the media-fill test to test for contamination. RESULTS: Ten operators previously trained in aseptic technique were assessed. The overall operator failure rate was 40%, and 2.3% of the 300 preparations were contaminated. Similarly, 10 of 60 finger dabs were found to be contaminated with E. faecalis, the challenge microorganism. There was no association between operators' years of experience and media-fill test results. CONCLUSION: Optimized media-fill tests allowed for the detection of minor deviances from standard protocol and helped to provide evidence of improper aseptic technique used by pharmacy operators.