Surface contamination in a Chemotherapeutic Preparation and Control Unit
7 October 2016
The aim of this study was to assess contamination due to cytotoxic drugs (CD) in our Chemotherapeutic Preparation and Control Unit (20 000 preparations/year) by measuring levels of drug residues on surfaces.
According to their physico-chemical characteristics, frequency of preparation and amount prepared, selected CD are 5-Fluorouracil (5-FU), cyclophosphamide (CPM) and paclitaxel (PTX). Wipe samples are performed according to a validated method. Whatman® paper was previously wetted with a 10% methanol solution and desorbed with the same solution. According to risk cartography, three steps in process are considered: preparation area, flows area and analytical laboratory control. CD are simultaneous quantified by a validated liquid chromatography method with UV detection. Limit of quantification are 500 ng/mL for 5-FU and TXL and 5 000 ng/mL for CPM. Concentration units (ng/mL) were converted into mass/area units (ng/cm2).
Recovery rates were 100% for CPM and 80% for 5-FU and PTX. A total of 25 samples of surfaces have been analyzed. Only 2 samples presented detectable cytotoxic contamination. No contamination was detected in the preparation area. PTX was found in the waste transfer airlock (0.37 ng/cm2). In laboratory control, only a 10 vials PTX research was positive (5.8 ng/cm2). In contrast, analysis of 80 vials from a day production was negative.
The absence of surface contamination in workplace area validates our preparation process. However, this study demonstrated TXL contamination in two sites. After results communication and formation, new samples were performed 4 months after this study. Non contamination was found. This result validates our cleaning protocols. However, analytical sensitivity could be a limit of our work.