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

Abstract

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/cm² (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/cm²). For surface contamination levels when spiking with 100 ng/cm², 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.

Keywords: Self-cleaning; automated; compounding; cytotoxic drug; decontamination.

Figure 1.

Some features of the Kiro® Oncology system: (a) two robotic arms to perform separate tasks simultaneously; (b) final containers: infusion bags, syringes, cassettes, or elastomeric pumps; (c) Two peristaltic pumps for diluent filling of empty containers and reconstitution of lyophilized drug vials; (d) Self-cleaning for decontamination of cytotoxic drugs.

Figure 2.

Eight sections of the KIRO® Oncology compounding area on which different drug mixtures were added for the study (upper panel: picture) following the rotation plan for the six working days of the study (lower panel: flowchart of sampling methodology to determine decontamination efficacy, and analytical and wiping recovery rates) (D1 = 1 ng/cm² and D100 = 100 ng/cm²).

Figure 3.

Mean analytical recovery (%) of nine cytotoxic drugs determined in duplicated analytical measurements in wipes with 18,000 ng and 180 ng of each drug, indicating the wipe method uncertainty limits (100% analytical recovery ± uncertainty reported by the test laboratory for Multimethod 2). See Supplementary Table 1 for mean and standard deviation of the cytotoxic drug levels quantified in wipes, and for LOQ and uncertainty reported for each drug for Multimethod 2.

Figure 4.

Mean wiping recovery (%) of nine cytotoxic drugs calculated based on cytotoxic drug levels determined on surface wipe samples before self-cleaning on three independent days for surface contamination levels of 100 ng/cm² and 1 ng/cm², indicating the wipe method uncertainty limits (100% wiping recovery ± uncertainty reported by the test laboratory for Multimethod 2). See Supplementary Table 2 for mean and standard deviation of the cytotoxic drug levels quantified in surface wipe samples.

Figure 5.

Calculated self-cleaning efficacy with sanitizing and alkaline methods for the decontamination of cytotoxic drug level D100 (100 ng/cm²), and maximum detectable self-cleaning efficacy for each drug for this contamination level.

Figure 6.

Calculated self-cleaning efficacy with sanitizing and alkaline methods for the decontamination of cytotoxic drug level D1 (1 ng/cm²), and maximum detectable self-cleaning efficacy for each drug for this contamination level.