Development of Cytotoxics Formulating Machine

Feasibility study started in 2002 in colaboration with major dutch hospital producing around 20.000 preprerations per annum.

This feasibility study resulted in the following User Requirement Specifications:

• Adaptable to different makes (and thus sizes) of IV bags, syringes and vials
• Interface with prescription software
• Capable of doing one preperation per 2 minutes
• Capable of handling both fluid and powder formed cytotoxics (reconstitution)
• Adaptable to isolator or LAF cabinet
• Resistant to desinfecting methods of VHP and peracetic acid
• Enhancing preperation quality due to automated production
• Reducing errors due to automated production and integrated balance

The feasibility study was followed by a design study which resulted in a prototype cytotoxics automate constructed in april 2005.
The automate consists of the following main components:syringe manipulator (robotic hand), guides for movement of the manipulator in 3 directions (2x horizontal 1 vertical) and fixations for the storage of IV bags, syringes and vials.
All components are specifically designed for reasons of decontamination and flexibility.
For quality control the automate has an integrated balance to check the volume retrieved from the vials (specific densities of cytotoxics are stored in the automates database).

The syringe/vial manipulator can imitate the pumping/milking so that no venting needle is required.

The syringe manipulator is also capable of connecting and disconnecting to luer lock systems (unscrewing needles, connecting to lines of infusor, needleless systems).

Validation tests regarding accuracy and adaptibility to different makes of syringes (BD, Codan, BBraun, Terumo) and IV bags (Baxter, Fresenius, Aquettant, Macoflex) were performed (detailed info in the short oral scientific conversations).

The tests performed were :

• Filling of vial by syringe (pumping/milking, no venting needle)
• Filling of syringe from IV bag
• Filling of syringe by vial (pumping/milking, no venting needle)

At present the preproduction machine has been constructed and will be tested from octobre 2006 at Descartes . This machine is on display for demo’s at the Gerpac.

• Integration with Chimio ®software for French market during 2006

• Integration of the machine in a controlled area ensuring chemical containment for protection of the handler and the product during 2006 and 2007.

• Adapting the machine for the handling of other portable administration devices (eg. infusors)

Summary of testresults :

• Volume range 10 to 50 ml : utilizing only 50 ml syringe
• Volumes < 10 ml: use syringe of 10 ml
• Due to automated handling very constant accuracy (little variation)
• Accuracy between 0.5% and 2%, average 1 %

Conclusions

The CFM can be used to perform automated production of chemotheraopy from both fluids and powder form cytotoxics to be delivered in IV bags and syringes.

Due to its integrated balance there is a mean to quarantee quality control over the administered quantities.
The CFM machine can be interfaced with the prescription software Chimio from Computer Engineering for the French market.
Due to the automates accuracy only 2 sizes of syringes are required. Volumes upto 10 ml should de handled with a 10 ml syringe and above 10 ml with a 50 ml syringe.
The machine can also be used for antibiotics preparation and radiopharmaceuticals.