Evaluation of the efficacy of a self-cleaning automated compounding system for the decontamination of cytotoxic drugs

INTRODUCTION: Low surface contamination levels of hazardous drugs in compounding areas can be used as indicators of exposure and efficacy of cleaning procedures. We report the efficacy results of the KIRO® Oncology self-cleaning automated compounding system for decontamination of cytotoxic drugs, assessed in an oncology health center using a sanitizing method and an alkaline method. METHODS: The study was conducted for six-days over a three-week period. A mixture with known levels of 5-fluorouracil, ifosfamide, cyclophosphamide, gemcitabine, etoposide, methotrexate, paclitaxel, docetaxel and carboplatin was added to the KIRO® Oncology’s compounding area surface before each self-cleaning method was used. Contamination levels were determined, with a surface wipe sampling kit, at the end of the self-cleaning process. RESULTS: Background surface contamination for quantified levels of cytotoxic drugs during routine use of KIRO® Oncology was below limit of quantification (<LOQ) for all drugs, except for carboplatin, which has a very low LOQ (0.2 ng/sample). The quantified drug levels detected on surface wipe samples after self-cleaning using both methods in the KIRO® Oncology’s compounding area surface sections were all <LOQ when spiking with 1 ng/cm(2) (ten times the ‘safe’ reference value), except for carboplatin (alkaline method only), although its levels were still below the ‘safe’ reference value (0.1 ng/cm(2)). For surface contamination levels when spiking with 100 ng/cm(2), both self-cleaning methods had decontamination efficacies >99.8% for all cytotoxic drugs analyzed. CONCLUSION: This study provides evidence on the efficacy of the KIRO® Oncology automatic self-cleaning system for surface area decontamination during the preparation of cytotoxic drugs.