Background The increased use of chemotherapy drugs forces hospitals to rationalise their production. Automated systems are one of the possible solutions.
Purpose To evaluate the performance of the PharmaHelp (Fresenius) automated system for accuracy (trueness and repeatability) and productivity comparing different working conditions.
Material and methods Accuracy was studied by automated filling of 10 different volumes of IV bags from 0.5 to 250 mL. Working conditions studied were the filling position, size of syringes (20/60 mL), working day and manufacturing methods (dose banding/individualised doses). Gravimetric and chemical analyses (phenylephrine as tracer) were used for the measure of accuracy. Productivity was evaluated by the production time for batches of 10 IV bags of different filling volumes. Results were discussed according to accuracy limits of ±3%, ±5%, ±10% (IC95).
Results The filling was true for all studied volumes (97–103%). The minimum volumes allowing accurate preparation were 100, 3 and 1 mL in the limits of 3%, 5% and 10%, respectively. The repeatability was not influenced by the filling position (Student’s t-test, p = 0.36, n = 180) or the working day (Student’s t-test, p = 0.14 day 1/2, p = 0.46 day 1/3, p = 0.09 day 2/3, n = 540). Accuracy was the same for the 2 manufacturing methods (Student’s t-test, p = 0.12, n = 360 (individualised doses), n = 180 (dose-banding)) and the 2 sizes of syringes (Student’s t-test, p = 0.46, n = 270). The production time depended on the injected volume and the size of the syringe. The production of 10 bags took 45 ± 112 min on average, 30% for the manual steps (pre-processing: 24%, post-processing: 6%) and 70% for the automated step.
Conclusion The automated system produced IV bags from liquid active components. The filling was accurate from a volume of 3 mL for <±5% and 1 mL for <±10% limits. Results confirmed the potential of such automated systems to increase productivity and to guarantee the safety of patients and operators.
References and/or acknowledgements No conflict of interest.
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