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External contamination of vials containing cytotoxic agents supplied by pharmaceutical manufacturers

Pharmacy Department, Centre Régional de Lutte Contre le Cancer Léon Bérard, 28 rue Laënnec, 69008 Lyon, France

Laurence Gilles, PharmD

Pharmacy Department, Centre Régional de Lutte Contre le Cancer Léon Bérard, 28 rue Laënnec, 69008 Lyon, France

Claude Ardiet, PharmD

Pharmacy Department, Centre Régional de Lutte Contre le Cancer Léon Bérard, 28 rue Laënnec, 69008 Lyon, France

Jean François Latour, PharmD

Pharmacy Department, Centre Régional de Lutte Contre le Cancer Léon Bérard, 28 rue Laënnec, 69008 Lyon, France

Objectives. The aim of this report was to study the external contamination of vials of 5-fluorour-acil, cyclophosphamide, ifosfamide, etoposide, doxorubicin and docetaxel. It also investigated the possible contamination of 5-fluorouracil outer packaging.

Methods. External contamination was measured on vials containing 5-fluorouracil, etoposide, cyclophosphamide, ifosfamide, doxorubicin and docetaxel. Samples from the outer wall of the vials were obtained by immersing and rotating the stoppered vials for 30 seconds in water for injections.

Results. All vials tested were contaminated with quantities varying from 0.5 ng to 2.4 g per vial, depending on the supplier. The outer packaging containing 25 vials of 5-fluorouracil was contaminated with 1.5 g, but no contamination was detected on the plastic packaging of etoposide.

Conclusion. These results demonstrate that the environment of operators may be contaminated, even in the absence of any handling error, and that contamination is present even before the cytotoxic reconstitution has begun. This source of exposure to cytotoxics may account for the contamination detected in the urine of operators. We demonstrate the necessity of protecting effectively all skin surfaces that are likely to come into contact with antineoplastic agents when unpacking the vials. Wearing long disposable gloves with adequate thickness (such as surgical gloves) is strongly recommended, from the very moment operators enter the preparation room. In general, the contamination of operators can only be controlled efficiently when all possible sources of contamination are considered, and suitable protection facilities are used (safety cabinet or isolator).

Key Words: contamination • cytotoxic agent • environment • exposure • vial

Journal of Oncology Pharmacy Practice, Vol. 9, No. 1, 15-20 (2003)
DOI: 10.1191/1078155203jp102oa


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