Annals of Occupational Hygiene Advance Access published online on July 28, 2008
Annals of Occupational Hygiene, doi:10.1093/annhyg/men050
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Cyclophosphamide Contamination Observed on the External Surfaces of Drug Vials and the Efficacy of Cleaning on Vial Contamination
1 Pharmaceutical Practice Research Unit, Department of Pharmacy, CHU Sainte-Justine, 3175, chemin de la Côte Sainte-Catherine, Montreal, Quebec H3T 1C5, Canada
2 Clinical Laboratory Unit, Department of Human Toxicology, Institut National de Santé Publique du Québec, Quebec City, Canada
3 Association pour la Santé et la Sécurité au Travail, Secteur Affaires Sociales, Montreal, Quebec, Canada
* Author to whom correspondence should be addressed. Tel: +1-514-345-4931; fax: +1-514-345-4820; e-mail: karine.touzin.hsj{at}ssss.gouv.qc.ca
Objective: Evaluate contamination on the external surfaces of cyclophosphamide vials available on the Canadian market during storage in pharmacy departments and the efficacy of decontaminating the external surfaces of vials using various cleaning techniques.
Methods: The study consisted of three phases: the quantification of cyclophosphamide on the external surfaces of 10 vials of Procytox® and 10 vials of Cytoxan® available on the Canadian market with or without prewashing (Phases I and II) and the quantification of cyclophosphamide on the surfaces of 30 deliberately contaminated empty sterile vials cleaned using three different washing techniques (Phase III). The quantification of cyclophosphamide was conducted using ultra performance liquid chromatography with tandem mass spectrometry.
Results: In Phase I, we observed that 9 of 10 vials of Procytox® and 4 of 10 vials of Cytoxan® had traces of cyclophosphamide. The average concentration of cyclophosphamide measured on the vials was higher for Procytox® than it was for Cytoxan®. In Phase II, we observed that simply by washing vials with water we could effectively eliminate the presence of contamination on 6 of 10 Procytox® vials and on 10 of 10 Cytoxan® vials. Phase III demonstrated the efficacy of using a cloth soaked in soapy water to clean the contaminated vials.
Conclusion: This pilot study demonstrates the presence of contamination on the external surfaces of cyclophosphamide vials from two manufacturers on the Canadian market. It suggests that cleaning vials from manufacturers and wholesalers may help to reduce the risk of occupational exposure. There is a need for a pilot study to establish guidelines on decontamination agents and cleaning process to eliminate the presence of contamination on vial surfaces.
cyclophosphamide • decontamination • external contamination • quantification • sampling • vial
Received April 15, 2008; in final form June 19, 2008