Study of efficiency of cytotoxic vial biodecontamination into an Oxygen® airlock, using Klercide® product

Introduction

The supply of cytotoxic vials in a centralized unit reconstitution (URC) is possible thanks to a decontamination airlock where a sterilization cycle of hydrogen peroxide reached 53 minutes. This procedure is not suitable for an emergency situation so we propose to use another decontamination airlock, called Oxygen®, to pass into the URC, a few quantities of vials very quickly (16 min). The objective of the study is to demonstrate the efficiency of Klercide® decontamination (6% of hydrogen peroxide) on vials at room temperature in this airlock.

Method

22 glass vials of 125 ml are disposed in a wire basket inside the airlock.
The cycle is divided into 3 phases :

• a product spray phase of 2.3 ml Klercide® (1 min),
• a contact phase (5 min)
• and a ventilation phase (10 min).

Bacteriological samples on agar gel are taken on 5 vials at 2 different points (the cap and the bottom) by means of an applicator. Those 5 vials are chosen according to their position compared to the situation of the spray nozzle. The samples are taken before and after the sterilization cycle. This operation is repeated on 3 sets of 22 vials. Then the samples are incubated for 5 days at 30°C.

Results

Respectively, 93% (14/15 – p=2.06*10-7) and 80% (8/10 – p=7.14*10-4) of the levies on the cap and the bottom are negative after the experiment. Concerning the bottom of the vials, 5 levies were negative before decontamination.

Conclusion

The effectiveness of the decontamination cycle by Klercide® is significant. However, it is necessary to complete the validation by increasing the sample size and using biological indicators.