Efficiency of 4 solutions in removing 23 conventional antineoplasic drugs from stainless steel surface

3 October 2019

Nicolas SIMON1,2, Nicolas GUICHARD1, Pascal ODOU2, Bertrand DECAUDIN2, Pascal BONNABRY1, Sandrine FLEURY-SOUVERAIN1
1 Pharmacy, Geneva University Hospitals and School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Geneva, Switzerland.
2 Univ. Lille, CHU Lille, EA 7365 – GRITA – Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille, France.

To compare the efficiency (EffQ) of 4 solutions to remove 23 conventional antineoplastic drugs (CAD) widely used in chemotherapy compounding unit from surfaces.

A solution containing 23 CAD (4 alkylating agents, 8 antimetabolites, 2 topo-I inhibitors, 6 topo-II inhibitors and 3 spindle poisons) was used. Contamination ranging between 2 and 20 ng/cm2 depending on the drug was spread on 100 cm2 stainless steel surfaces and then dried during a 1h-period under a laminar airflow hood and protected from light. Decontamination was performed using 10 x 10 cm wipes (TexwipeTM 3210, ITW Texwipe) moisten with 300 µL of solution. Four solutions were tested: S1 = KlercideTM (70% isopropanol); S2 = AnioxysprayTM (ethanol-hydrogen peroxide 91.6-50.0 mg/g); S3 = 10-2M sodium dodecyl sulfate/isopropanol 80/20 and S4 = 0.5% sodium hypochlorite. Two modalities were tested 6 times: single wipe motion from top to down or vigorous wiping. Experiments were conducted by a single operator under a class II biosafety cabinet. Residual contamination was measured with a validated LC-MS/MS method (Guichard, 2019). Solutions efficiency (in %) was computed as follows: EffQ = 1–(quantity after decontamination/quantity before decontamination), expressed as median (min–max) for the 23 CAD and 6 experiments.
EffQ was compared between the 4 solutions by a Kruskall-Wallis test. Decontamination modalities were compared for each solution and by CAD with a Mann-Whitney test. Significance levels were 5%.

EffQ were significantly different between solutions for single wipe motion decontamination: 79.9% (69.3–100), 86.5% (13.0–100), 85.4% (56.5–100) and 100% (52.9–100) for S1, S2, S3 and S4 (p<0.0001). Differences were also significant for vigorous decontamination: EffQ of 84.3% (66.0–100), 92.3% (68.7–100), 99.6% (84.8–100) and 100% (82.9–100) for S1, S2, S3 and S4 (p<0.0001).
Compared to standard application, vigorous decontamination significantly increased EffQ for S3 only (p=0.007) with differences observed on fludarabine (p=0.028), ganciclovir (p=0.028) and irinotecan (p=0.04). Effq on taxanes were higher in such a case without reaching significant difference.

Efficiencies in removing contaminants depend on the solution used but also on the application modality. EffQ are higher with S3 and S4 after standard or vigorous application. Vigorous application increases significantly the efficiency for S3. Further studies in real-life are required to confirm these results.

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