Evaluation of Professional Practices: chemical contamination in a antineoplastic agent production unit

Introduction

The aim of this study is to measure chemical contamination of the isolator and products coming out in 5 - Fluorouracil (5- FU) and its efficient cleaning.

Methods

Wipe samples were taken from different point of isolator with a filter paper soaked in 0.3 mL WFI water looking for traces of 5-FU.To assess the contamination, the points collected were: manipulator gloves (n=5), plastic bags which contain the wrapping paper in isolator (n=5) and the surface of the cytotoxic preparation (n=10).

The work surface, the control knob and the system to transfer the rubbish out away the isolator were collected after cleaning with Sieve Spray® alone (surfactant, alkylamine in hydroalcoolic solution) (n=9) and after cleaning with water and Sieve Spray® (n=8).

Dosages of 5-FU were made in Lyon, the detection limit was 2 ng by filter paper (ng/pf).

Results

Manipulator gloves were the most contaminated, then the plastic bags and the surface of cytotoxic preparation (The 5-FU was not detectable for 60% of the cytotoxic preparation).
The average of the samplings after cleaning with Sieve Spray® was 160 ng/pf; it was 10 ng/pf after water dilution before cleaning with Sieve Spray®.

Conclusion

Specific measures have been put in place: gloves change for the manipulator helper when he handles the plastic bags which contain the wrapping paper in isolator, replacement reusable system to transfer the rubbish with a single-use system and the implementation of an isolator big cleaning with WFI water then Sieve Spray® every Friday.