Surface Wipe Sampling of Hazardous Medicinal Products: A European Interlaboratory Comparison Study

Abstract

Workplace monitoring of hazardous medicinal products (HMPs) using surface wipe sampling is becoming common practice in many European hospitals and pharmacies. However, no independent quality control is available to validate wiping procedures and analytical methods. This study aimed to conduct a Europe-wide interlaboratory comparison (ILC) program to independently and blindly assess laboratory performance and variability in HMP detection. Four European laboratories participated in the study. Six HMPs-cyclophosphamide, etoposide, gemcitabine, ifosfamide, methotrexate, and paclitaxel-were prepared at four concentrations (5000, 2000, 200, and 20 ng/mL) and applied to a 400-cm2 stainless-steel surface, then wiped by the coordinating body according to each laboratory's protocol. Wipe samples were distributed to individual laboratories, where blind analyses were conducted. Target criteria for accuracy and recovery were set at 70%-130% and 50%-130%, respectively. Of the 80 samples, 69 (86%) met accuracy targets, and 70 (88%) met recovery targets. Accuracy was often overestimated for the lowest concentrations of cyclophosphamide, etoposide, methotrexate, and paclitaxel by Laboratory A. Laboratory D showed low accuracy for paclitaxel at three lower concentrations. Among the 10 samples that did not meet recovery targets, all were below 50% and involved etoposide and paclitaxel. This ILC program demonstrates a viable method for evaluating laboratory performance in HMP detection, offering an external validation mechanism for surface wipe sampling methods. A future goal is to establish a global ILC program with a designated coordinating body for managing it effectively.