Qualification of a robotic system for antiblastic drug compounding: evaluation of the chemical contamination with a fluorescein solution

Objective
To deal with the constant increase of the production of chemotherapy, a robotic system for antiblastic drug compounding Pharmoduct^® has been purchased to improve productivity. Several tests (analytical assay, media fill test, chemical contamination test) need to be performed to qualify the automated system before use. The aim of our study is to assess the chemical contamination on the surfaces and components of the robot.

Material and method
A fluorescein test was performed. Cycles were carried out replacing chemotherapy vials by fluorescein solution vials. To be as representative as possible of the future activity, 3 cycles per day were performed during 3 days. Production was simulated using three different final containers (syringe, prefilled bag, infusor) and different volums injected. Number and size of fluorescein spots were revealed by exposure to ultraviolet (UV) light before the cycles, between each step and at the end of the preparation.

Results
30 prefilled bags, 30 syringes and 30 infusors were obtained in three days. No chemical contamination has been revealed on surfaces or on robot components. Some fluorescence was observed in the trash duct and was attributed to dust.

Conclusion - Discussion
Our study allowed us to validate the safety of our robotic system regarding chemical contamination. Standard protocol of cleaning can be performed, without any risk for the area demonstrated. The test revealed the presence of dust in the robot. This observation will be confirmed by particle measurement. Evaluation of chemical contamination could be performed every year to ascertain the integrity of the system.

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