Cytotoxic Surface Contamination in a Chemotherapeutic Preparation Unit: Method Development

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

Objectives

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.

Methods

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.

Results

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.

Discussion-Conclusion

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.

Discussion forum

GERPAC provides for its members a discussion forum specifically devoted to technology in hospital pharmacy

Access forum

GERPAC
Association Loi 1901
Siège social : Chez Jean-Yves Jomier / 8ter rue Léon Bussat, 64000 PAU
Immatriculation formation N° 72 64 035 30 64
Contact us Legal notes - Management of personal data