Qualification of Pharmaceutical Staff for Handling Cytotoxic Safety Cabinets: Simulation at the Heart of Certification

Introduction and context
The preparation of sterile injectable anticancer drugs in cytotoxic safety cabinets (CSCs) must the requirements of Good Preparation Practices Training on the rules for using a CSC and staff qualification in aseptic handling through the performance of an media fill test (MFT) is mandatory for operator accreditation.

Objective
This study aims to develop a health simulation program to support the qualification of pharmaceutical staff in the use of CSCs and aseptic handling in a sterile environment.

Materials and methods
The process spans from opening the CSC to its closure. Critical steps were identified (opening and closing, biocleaning, technical specifications related to the use of a PSC, aseptic practice, microbiological monitoring, and traceability), and a high-fidelity immersive simulation program was developed (cadre de référence pour le développement de scénarios – SoFraSims). The target audience included pharmacy technicians (PPH), residents, and pharmacists. Each pair (1 operator and 1 assistant) performed a series of 3 preparations (2 bags and 1 syringe), where the anticancer drugs were replaced by tryptic soy broth (TSB) to validate an MFT. Evaluation was based on the success of the MFT (clarity of the containers in daily visual inspection after 7 days at between 20–25°C, then 7 days at between 35–37°C) and a certification by visual observation of a trained evaluator at each critical stage using an observation grid inspired by the United States Pharmacopeia (USP chapter 797).

Results
Each simulation scenario lasted one hour. Eighteen operators (5 PPH, 6 residents, and 7 pharmacists) and 18 assistants (5 PPH, 7 residents, and 6 pharmacists) were evaluated. A total of 67% (12/18) of operators were certified in the visual assessment, of whom 42% (5/12) required additional training. In comparison, 78% (14/18) of assistants were qualified, with 29% (4/14) requiring additional training. 100% of the reasons for non-certification were related to poor practices (aseptic handling rules, equipment peeling). All MFTs (18/18) were validated (clarity). A certification signed by the unit manager was issued upon success.

Discussion and conclusion
The implementation of this program is part of an approach to secure preparations and manage risks. It is adapted to regulatory requirements and meets initial and ongoing training. each operator can only occupy one position at a time and must therefore participate twice to complete training. This presents challenges due to time and organizational constraints in the daily production setting.

Keywords: certification, simulation, aseptic

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