Simulation in pharmaceutical technology education: role of the aseptic filling test in pharmacy technician authorisation

VILLAIN.A ; FEUTRY.F; TOULLIC.C; NAVEAU.M; VILLAIN.J; STROBBE.G; SAKJI.I; MARLIOT.G
Pharmacy, Oscar Lambret Center, 59000 Lille

Introduction
The GPP (Good Preparation Practice guidelines) impose, on one side, a validation of the aseptic process with a simulation thanks to an environment of culture, and on the other hand, a valued formation of the pharmacy technicians.
These two independent and complementary points seem to combine themselves in a global test that can authorize the pharmacy technicians throughout the entire injectable anti-cancer preparation process.

Material and method
Two kits were used: the KLERKIT® (Shield Medicare) for the manipulations and the EZ-ACCUSHOT® kit (Microbiologics) for the fertility tests.
After a theoretical formation of the pharmaceutical technicians, 60 MFT (Media Fill Test) have been randomly integrated to our preparation activity.
To be representative of our activity, these MFT were the exact replica of chemotherapy preparations with pre-filled infusion bag, elastomeric pump, syringe or empty infusion bag. They were computerized and got all the gravimetric control steps.
All the pharmacy technicians (n=10) were responsible of 6 preparations performed in insulator but also, of the preliminary physical and chemical decontamination of the equipments, and of the filling and sterilisation of inox baskets.
During the preparation, a pharmacist was checking the right realisation of the gestures and the right use of the medical devices.

Results
About the 60 preparations/MFT :
• All the pharmaceutical technicians succeeded to realize all the preparations without mistake in the gravimetric control process.
• The pharmacist did not detect any error concerning the use of the preparation medical devices.
• Any microbiological contamination was detected and all the fertility tests were positive.

Conclusion
More than the validation of the aseptical process, the integration of all the variables defining our preparation process (especially the computer-assisted preparation and the gravimetric control) permitted us to use the MFT as an instructive tool which allows the pharmaceutical technician authorisation. This tool will be spread out in the formation of newcomers and also for the On-Call pharmacists who could potentially performed chemotherapies out of opening hours.

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