Surface Wipe Sampling of Hazardous Medicinal Products: A European Interlaboratory Comparison Study
Language English Country Great Britain, England Media print-electronic
Document type Journal Article, Comparative Study
Grant support
European Society of Oncology Pharmacy (ESOP)
UIDB/04750/2020
Foundation for Science and Technology (FCT)
LA/P/0064/2020
Foundation for Science and Technology (FCT)
2021.05219.BD
Foundation for Science and Technology (FCT)
LA/P/0045/2020
FCT/MCTES (PIDDAC)
UIDB/00511/2020
FCT/MCTES (PIDDAC)
UIDP/00511/2020
FCT/MCTES (PIDDAC)
UIDB/50020/2020
FCT/MCTES (PIDDAC)
UIDP/50020/2020
FCT/MCTES (PIDDAC)
LM2023069
Ministry of Education, Youth and Sports
PubMed
40324795
PubMed Central
PMC12489289
DOI
10.1002/dta.3902
Knihovny.cz E-resources
- Keywords
- analytical method, antineoplastic drugs, quality control, surface contamination, workplace monitoring,
- MeSH
- Cyclophosphamide analysis MeSH
- Etoposide analysis MeSH
- Gemcitabine MeSH
- Laboratories standards MeSH
- Pharmaceutical Preparations analysis MeSH
- Humans MeSH
- Methotrexate analysis MeSH
- Hazardous Substances * analysis MeSH
- Occupational Exposure analysis MeSH
- Quality Control MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Comparative Study MeSH
- Geographicals
- Europe MeSH
- Names of Substances
- Cyclophosphamide MeSH
- Etoposide MeSH
- Gemcitabine MeSH
- Pharmaceutical Preparations MeSH
- Methotrexate MeSH
- Hazardous Substances * MeSH
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.
Apotheek Haagse Ziekenhuizen The Hague the Netherlands
Centre for Water and Environmental Research University of Duisburg Essen Essen Germany
Department of Hospital Pharmacy Haaglanden Medisch Centrum The Hague the Netherlands
Department of Hospital Pharmacy Haga Teaching Hospital The Hague the Netherlands
Department of Hospital Pharmacy University Clinical Hospital Poznan Poland
EPIUnit ITR Institute of Public Health of the University Porto University of Porto Porto Portugal
Institut für Umwelt and Energie Technik and Analytik e 5 Duisburg Germany
Instrumental Analytical Chemistry University of Duisburg Essen Essen Germany
RECETOX Faculty of Science Masaryk University Brno Czech Republic
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