Proposal for a secure automated 5 Fluorouracil elastomeric pump preparation method with the MediMixfour volumetric filling device®
Each year, in our preparation unit, approximately 40,000 therapeutic units (TU) are manually produced, according to good preparation practices. Complementary control methods are implemented during and at the end of process, depending on the type of TU. The amount of 5 Fluorouracil (5FU) elastomeric pumps fillings represents 10% of our activity with a non-optimal control (visual during process and product final weight).
In a difficult context with time constraint inherent to increased activity in a tight flow, chronic lack of human resources and increased risks of musculoskeletal disorders (MSDs), solutions to optimize our production are sought. With this aim, a multi-channel volumetric filling processor-controlled compounder is evaluated in elastomeric pumps serial preparations.
Material and methods
Processor-controlled compounder qualification carried out on 3 elastomeric pumps references with Fluorescein solution in laboratory then 5FU solution in isolator. Recording of manual or automated preparation times, taking into account experience of pharmacy technicians. Weighing controls carried out during the process. Calculation of Return On Investment (ROI).
Preparation times for the 3 references with processor-controlled compounder show an average time saving of 25%, including the weighing control steps, for series corresponding to 2 days of production. No contamination on elastomeric pumps housing is detected by the fluorescent lamp. The ROI is favourable at 16.1% taking into account the devices costs, human resources and equipment depreciation over 5 years.
MediMixfour® is a device that meets our needs for productivity and patient safety (dose accuracy with in-process weighing) and for nurses (development of a dispensing valve to ensure prime with neutral solution, no external contamination on elastomeric pump). For the pharmacy technicians, it enables to limit risk of TMS by avoiding exposing hands to an average force of 110 N described for this type of elastomeric pump (comfort situation: 20 to 30N). This processor-controlled compounder is enthusiastically greeted by the team. A new procedure linking dematerialized preparation sheets and weighing control is currently under development within our unit.