Study of chemical contamination of batch preparations of anticancer drugs in isolator

Objective

70% of the production of our unit is performed in advance thanks to batch preparations (BP) giving out. A previous study of the chemical contamination related to the mode of campaign production has shown its restriction to the isolator. The aim of this work is to evaluate the risk of chemical contamination during a preparation campaign of BP and the quality of the related cleaning.

Method

3 cleaning methods were tested in 2 BP campaign types (6 campaigns in total):

• CS: Current method with Surfasafe© disinfectant,
• OS: Optimized with Surfasafe© disinfectant,
• OK: Optimized with Klerclean© detergent.

In each campaign, 2 cytotoxic drug tracers were manipulated in a row: fluorouracil then cyclophosmamide (FU/CY) and FU then gemcitabine (GE).

5 critical surfaces in isolator were tested, before and after bio-cleaning and by standardized sampling: infusion bags storage areas: at the beginning (Iso center), and at the end of the preparation (Before Sas); equipment: pump, scale; workbench (WB).

After swabs desorption, cytotoxic drugs were dosed by LC-MSMS.

Results

Frequency and extent of the original contamination of the tested areas are presented here:

Global and specific decontamination is presented in the following table:

Discussion/conclusion

Contamination of the different areas is low or occasional for end of production storage area and workbench, showing their good protection. On the other hand, a particular attention has to be brought to the equipment and the central area of the isolator.

Optimized cleaning method with disinfectant shows globally better results for the elimination of the chemical contamination. It will be implemented in our practices.

These variable results should be confirmed by repeated data.