Chemical decontamination validation of an isolator using for cytotoxic drugs preparation in view of activity transfer to sterile non cytotoxic drugs preparation

Introduction

The request for approval a new unit of cytotoxic drugs preparation was submitted to the Regional Health Agency before pharmacy department moving. Thus, the cytotoxic drugs preparation was provisionally realized in a new isolator intended at least for sterile non-cytotoxic drugs preparation. As handling cytotoxic drugs is a source of chemical contamination, the absence of residual chemical contamination inside the isolator was verified as a requirement for the activity transfer.

Materials and methods

The whole surface of the isolator was swabbed by 20cm x 20cm section (work plan, transfer locks, shelves) after cleaning according a standardized and validated chemical decontamination protocol [1] (6 successive cleans by 8 sprays corresponding to 8 mL/1500cm² of Klerclean® sprayed directly on the surface). Platinum, compounding of carboplatin, oxaliplatin and cisplatin, was used as a tracer and quantified according a validated method [2] (LD 2 ng platinum / sample).

Results

During one month of use, 1000 antineoplastic drugs have been prepared including 20% of platinum drugs . After the chemical decontamination protocol, no detectable contamination (n = 57) was found in this isolator.

Discussion/conclusion

After the analytical validation of the absence of contamination inside the isolator, the transfer of the production to sterile non cytotoxic preparations has been performed. Although this is not opposable, the research for anticancer drug traces is a useful tool to control our units.