Evaluation of the cross-contamination risk inside a production unit. A prospective observational study
(2025) , 25 pages
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- Abstract
- Background: In hospital pharmacy settings, cytotoxic drugs and monoclonal antibodies (MABs) are often prepared within the same isolator, raising concerns about potential cross-contamination. The hazardous nature of cytotoxic drugs necessitates strict handling procedures. Recent guidelines, such as the PIC/S 2014 directive to be enforced in Belgium by 2026, emphasize the segregation of hazardous drug preparation activities. However, resource constraints may limit implementation in many hospitals. Objective: This study aimed to assess internal and external cross-contamination risks when preparing monoclonal antibodies and cytotoxic drugs inside the same isolator. We also aimed to assess current production practices inside hospital pharmacies in Belgium. Methods: An online survey was distributed to Francophone hospital pharmacies to evaluate current practices and identify the most commonly used CSTDs (Chemfort®, Phaseal®, Equashield®). Laboratory testing was conducted on 97 samples (43 IV bags and 43 glove swabs) for the presence of 5-Fluorouracil (5-FU), platinum-based drugs, and cyclophosphamide. Liquid samples assessed internal contamination, while glove swabs assessed external contamination. Results: No internal contamination was detected in any of the IV bags. However, 60% of glove swabs tested positive for external contamination: 100% for platin-based drugs, 46% for 5-FU, and 0% for cyclophosphamide. External contamination levels varied by operator and CSTD, with higher contamination observed when operators used unfamiliar devices. Conclusion: Under standard working conditions and with appropriate procedural controls, internal cytotoxic contamination of IV bags is unlikely even when Monoclonal Antibodies are prepared within the same isolator. However, external contamination remains a concern, highlighting the importance of regular staff training, proper CSTD usage, environmental monitoring, and adherence to cleaning protocols. These findings suggest that effective risk mitigation strategies may reduce the need for infrastructure modifications mandated by upcoming PIC/S guidelines.
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Stavarache, D., & et al. (2025). Evaluation of the cross-contamination risk inside a production unit. A prospective observational study. https://hdl.handle.net/2078.5/275165