Fine-tuning and operational testing of the prototype Cytotoxic Formulation Machine (CFM), an automated cytotoxic preparation system

The prospect of automation is interesting in two respects, as it offers the possibility of raising quality levels and increasing productivity while relieving technical personnel of the need to perform repetitive tasks.

In partnership with the company MDS we are currently working on the technical fine-tuning and operational testing of the CFM (performance, productivity, autonomy, quality system, agitation time). The choice of a specific short needle has allowed us to reduce drips, aerosols and unused product. The evolution of loading adaptors has enhanced the CFM’s flexibility for different ranges of pouches and flasks. The progress made with the control software and in dealing with mistakes has improved the overall reactivity and security of the machine.

The accuracy and precision of the samples obtained are satisfactory (<5%) for volumes of between 3 and 60ml, even for viscous solutions or solutions containing polysorbates. The rate of production is 20 preparations/hour (for 5FU-type pouches) with one operator overseeing the process from the collection of the sterilised material to the arrival of the finished preparation. Human input is needed for the positioning and draining of the dropper, weighing and loading and unloading operations. The safety of the process is guaranteed by the RFID system, which ensures clear identification and traceability of the products. Gravimetric testing and labelling of the preparations is possible. The agitation times for reconstitution of powdered products have been approved by visual and analytical checks (between 2 and 8 minutes).

Design of the extractor, alignment of the system interface with the CHIMIO software and installation of a video recognition system are all currently underway.

Diapos-Adaptation et qualification du CFM