Surface contamination of antineoplastic drug vials: Comparison of unprotected and protected vials

Studies have demonstrated that the outside of vials containing antineoplastic drugs are contaminated.1–3 It also has been suggested that personnel of hospital pharmacies may be contaminated when preparing antineoplastic drugs even if safety guidelines are followed during preparation.4,5 In response to these findings, some but not all pharmaceutical manufacturers introduced methods to prevent exposure from outside contamination.6 Methods used to prevent exposure have included safety sheeting systems, where the entire vial is packed in a break-proof plastic container or plastic shrink wrap. We compared contamination levels of these safety sheeting systems. Between 2000 and 2008, 634 vials from 55 batches of vials containing antineoplastic drugs were examined. Vials containing platinum compounds, fluorouracil, cyclophosphamide, and ifosfamide were included. The vials were taken from nine pharmacies in the area of Munich, Germany. A standardized routine prevented cross-contamination during the process of obtaining the samples. Well-established methods were used for analysis.7 Different gas chromatographic—mass spectrometric methods were used for cyclophosphamide, ifosfamide (limit of detection, 3 ng/vial) and fluorouracil (limit of detection, 3 ng/vial). Platinum compounds were measured by voltammetry (limit of detection, 0.05 ng/vial).