Analytical control of anticancer agents via sample-free near infrared spectroscopy : first feedback

Context
To optimize the quality control process in a centralized anticancer preparation unit, a new sample-free spectroscopic control technique was tested. Not yet implemented in France, this technique could replace double visual inspection.

Objective
The aim of this study was to identify the advantages and limitations of this new method under real-life conditions, after 3 months’ use.

Methods
5 cytotoxics and 5 monoclonal antibodies commonly prepared in the unit were selected. For each molecule, diluents and final containers were identified in order to establish the calibration curves. During this phase, the double visual control process was maintained. The analyses were carried out without sampling, directly through the final administration device, bag or syringe.

Results
The major advantage of this technique lies in the absence of sampling : simple detection through the final container, before visual examination and batch release, should enable identification of the molecule and its concentration, without any risk of bacteriological and chemical contaminations due to sample collection and handling. However, the impossibility of performing the analysis through the overpack means that preparations have to be handled outside the isolator, exposing the controlled atmosphere area (CAA) to potential chemical contamination. Moreover, the analysis of some molecules seems to be highly sensitive to temperature, sometimes preventing correct product identification. In order to optimize the passage of the infra-red beam, the overfilling of the bags was reduced. Calibration was carried out centrally by the operator, and required around 50 points per molecule before validation and routine use. The 2-minutes analysis and the double control maintained in parallel necessitated the reorganization of the staff on duty. Finally, we would like to highlight the operator’s responsiveness, as well as the ease of use of the connected interface enabling centralized calibration.

Discussion-Conclusion
To date, only subcutaneous Daratumumab syringes have been validated for routine control. The next step is to finalize the calibration of current preparations, and then extend it to other molecules and infusion-type administration systems. Finally, this solution seems to be interesting, but the potential chemical contamination of the CAA has to be evaluated and controlled.

Key words : quality control, technology, safety