PD063 - GLOVE CONTAMINATION IN STERILE COMPOUNDING: EFFECTIVENESS OF CORRECTIVE INTERVENTIONS

PD063

GLOVE CONTAMINATION IN STERILE COMPOUNDING:

EFFECTIVENESS OF CORRECTIVE INTERVENTIONS

M. Pereira^1,*, M. Alves², A. Mirco²

¹Pharmacy, ULSLO, HSC, ²Pharmacy, ULSLO, Lisbon, Portugal

Rationale: Glove microbiological contamination during sterile compounding is a significant source of microbiological risk, with direct implications for product quality and patient safety. Routine monitoring is essential to ensure compliance with aseptic practices and to assess the impact of corrective measures.

Methods: A total of 209 glove samples were collected over a one-year period (January 1st - December 31st, 2025) using end-of-shift contact plate sampling (RODAC plates with blood agar). Contamination rates were evaluated quarterly. Based on initial findings, corrective interventions aligned with EU GMP Annex 1 and USP <797>, including systematic glove replacement after one hour of compounding activity, were progressively implemented throughout the year.

Results: Quarterly contamination rates were 7%, 7%, 6%, and 2%, demonstrating a significant and progressive decline. Microbial counts were generally low. The predominant isolates were Staphylococcus spp., Bacillus spp., and Micrococcus spp., with occasional fungal isolates (n=5). Following implementation of corrective measures, contamination levels remained within acceptable limits.

Conclusion: Continuous microbiological monitoring of gloves, combined with targeted, guideline-based corrective interventions, led to a substantial reduction in contamination rates in a sterile compounding setting. These findings reinforce the role of systematic quality assurance programs in mitigating aseptic process failures and protecting patient safety.

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Disclosure of Interest: None declared