Impact of process on chemical environmental contamination of a cytotoxic production unit
6 October 2017C. Roessle1, T. Chouquet1, A. Acramel1, B. Dectot2, N. Jourdan3, L. Goldwirt1, H. Sauvageon1,2 1 Laboratoire de pharmacologie-biologie, Hôpital Saint-Louis, AP-HP, France
2 Laboratoire de contrôle, Hôpital Saint-Louis, AP-HP, France
3 UPAC, Hôpital Saint-Louis, APHP, France
Centralisation of injectable cytotoxic preparation limits exposure of manipulators and environment to anticancer agents. Two processes are used to smooth our activity: magistral preparation (MP) and hospital preparation (HP) through campaigns in a dedicated isolator.
Material and methods
A prospective study over eight days has been completed. Isolator, release and assignment benches (Inside Controlled Athmosphere area (ZAC)), and delivery area and control laboratory (Outside ZAC), were chosen as critical locations. For each, 3 sampling areas have undergone standardized wiping using 2 swabs at a distance from the biocleaning, after production. A compendium (number of preparations, reflecting the activity), is carried out. Sixteen cytotoxics are subjected to dosage by LC-MSMS after desorption of the wipes. This includes cyclophosphamide (CPM), gemcitabine (GMC) and doxorubicine (DOXO) were HP.
15 samples were drawn on site. The level of contamination (0 to 472pg / cm²) does not appear to be correlated with the site (Dacarbazine: release: 19pg / cm² [2.7-51.5] vs transit: 41 [6.4-82.9]) nor the level of activity (average: 266.5 preparations per day). In the isolator, a HP campaign increases the level of contamination: CPM: (30 preparations/day: from 2.4 to 206.7 pg / cm², GMC: 5 / d from 1 to 42.2 pg / cm², and DOXO: 13/day, from 0.14 to 0.6 pg / cm²). On the other hand, outside the isolator, the level of contamination remains low (eg CPM: 0-0.8 pg / cm² including days of campaign production).
HP campaigns are more risky processes but contamination remains confined within the isolator. The weak contamination found for DOXO can be explained by its coloring which creates awareness of the cleaning process. Non-ZAC areas have the same levels of contamination. A review of the procedures for cleaning the isolator after an HP campaign, or the frequency of replacement of gloves during a campaign is required.