Implementation of an aseptic processing test under isolator

Introduction

Chemotherapies are sterile preparations for which terminal sterilization or sterilization by filtration are not adapted. Sterility is guaranteed by aseptic processing realized under isolator. Good Preparations Practices require aseptic filling test realization to valid the preparation process. This test simulates all preparation steps with a culture medium.

Aim

Develop an aseptic filling test to indicate that chemotherapy preparation process guarantee sterility and to valid the manipulators.

Material and method

The manipulators have realized three preparations following the order sheet (2 bags and 1 syringe), respecting the habitual preparation process. Chemotherapy was substituted by water for injection and glucose was the solute used. 3 ml of each preparation were transferred in an hemoculture blood bottle BacT/Alert aerobic and in an hemoculture blood bottle BacT/Alert anaerobic (culture medium with casein-soja hydrolysate).
The bottles were incubated in the incubator BacT/Alert for 15 days at 35°C. This incubator authorized an automated microbial detection.

Results

The culture medium fertility was confirmed by addition of a bacterial strain in each bottle, after having previously follow the whole process (decontamination / sterilization / injection of water for injection and glucose) : positive blood cultures.
8 manipulators and 2 pharmacist were tested.
No microbial growth were observed, after 6 and 15 incubation days.

Discussion/Conclusion

This test allows the validation of the chemotherapy aseptic processing preparation with isolator. Thanks to the low cost and his simplicity, it would be realized annually for each operator, to qualify every new operator and in case of change in the process step.