Aseptic simulation test challenged with microorganisms for validation of pharmacy operators

Area of Science:

• Pharmaceutical Sciences
• Microbiology

Background:

• Aseptic technique is critical in sterile pharmaceutical compounding to prevent microbial contamination.
• Media-fill tests are a standard method for evaluating the effectiveness of aseptic techniques.

Purpose of the Study:

• To assess the aseptic technique of pharmacy operators using simulated media-fill tests.
• To identify deviations from standard protocols in sterile compounding.

Main Methods:

• Simulated aseptic processes were performed using tryptone soya broth, with deliberate contamination of vial stoppers by Enterococcus faecalis.
• Prepared items (vials, syringes, minibags) and finger dabs were incubated for 14 days to detect turbidity and microbial growth.
• Controls and visual inspections were used, with post-incubation filtration and agar plating for clear media.

Main Results:

• Forty percent of operators failed the aseptic technique assessment.
• 2.3% of 300 preparations and 16.7% of finger dabs showed contamination with Enterococcus faecalis.
• No correlation was found between operator experience and media-fill test outcomes.

Conclusions:

• Optimized media-fill tests effectively detect minor protocol deviations in aseptic technique.
• The study provides evidence of improper aseptic practices among pharmacy operators.
• Enhanced testing methods are crucial for ensuring the safety of compounded sterile preparations.