Study of efficiency of cytotoxic vial biodecontamination into an Oxygen® airlock, using Klercide® product
7 October 2016C. Dubegny, P. Labet, C. Audeval, A. Remoue, C. Devys Institut de cancérologie de l’ouest - Centre René Gauducheau, Service pharmacie,
boulevard Jacques Monod, 44800 Saint Herblain, France
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.
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.
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.
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.