Cytotoxic Surface Contamination in a Chemotherapeutic Preparation Unit: Method Development

9 October 2015

H. De Blander, A. Facchin, S. Edet, A. Sarrazin, A. Jacolot, M. Rigal, C. Padoin Unité de Préparation et de Contrôle des Chimiothérapies anticancéreuses
Pharmacie, Hôpital Avicenne, HUPSSD, AP-HP, Bobigny


The aim of this study is to develop and validate a method of sampling and dosing of cytotoxic drugs to evaluate environmental and personal exposure to these drugs and optimize our production currently made in two separate isolators limiting cross-contamination between cytotoxic drugs and antibodies.


Cytotoxic drugs (CD) tested were chosen according to their physico-chemical characteristics, frequency of preparation and amount prepared. Risk cartography of sampling is carried out including critical points. Sampling method is developed with a test molecule and further extended to chosen molecules.
HPLC-DAD dosing method is validated and recovery rates are calculated.


Cytotoxic drugs selected are 5-Fluorouracil (5-FU), cyclophosphamide (CP) and paclitaxel (PTX). Three areas of sampling are determined: preparation (isolators, gloves, bags), flows (transfer airlocks, worktops, floor) and analytical control. The sampling technique is validated with a deposit of ciprofloxacin (CPX) wiped with Whatman® paper, a wetting and dilution solvent (NaOH 0,03M + ACN 10%). In these conditions, recovery rates are 87% for CPX, 98 % for 5-FU, 92% for CP and 64 % for PTX. Retention times are 5.0 min for 5-FU, 7.7 min for CP and 10.8 min for PTX. Linearity is established from 0.5 to 25 µg/ml for 5-FU, 5-220 µg/ml for CP and 2-100 µg/ml for PTX. Limits of quantification are 0.5, 5 and 2 µg/ml respectively for 5-FU, CP and PTX. Accuracy and reproducibility are demonstrated for each CD.


This method allows to obtain satisfying recovery rates. Simultaneous dosage of these 3 CD is validated within defined concentrations areas. Quantification limits of our analytical method are comparable to those reported in literature. Surface contamination analysis could be performed with this method.

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