Advantages of using a peristaltic pump for dose banding of cytotoxic drugs

Introduction
Three possible procedures were evaluated to study feasibility of preparing cytotoxic drugs by dose banding, with or without peristaltic pump.

Equipment and method
Simulation of 5FU bag production was conducted with 0.9% NaCl. The processes tested were: (1) Manual repetition of the same preparation, (2) Preparation of a uniform master batch followed by distribution into 100 ml sub-batches by manual manufacturing (2a) or using a peristaltic pump (Baxa) (2b). In order to compare the 3 processes, 10 preparations were made in each condition 1, 2a and 2b, and triplicated. Analytical control was simulated by each unit being sampled (1) or on the master batch (2a and 2b). Comparison of the processes by variance analysis covered time, exactness and precision of filling. The optimum conditions for use of the pump (speed and calibration volume) were determined on filling of 1 litre of NaCl for 3 speeds [maximum (1min45/1l), intermediate (2min15/1l) and slow (8min46/1l)] and 2 calibration volumes [10 and 40 ml].The results were analysed by ANOVA test.

Results
For the choice of pump parameters, the ANOVA test shows the significant influence of the speed (p<10^-8) and calibration volume (p<10^-6) on the volume delivered. Due to the interaction between these 2 factors (p<10^-5), the choice of an intermediate speed and calibration volume at 40 ml allowed satisfactory filling time and precision to be obtained. The results of the comparison between the 3 processes (1, 2a and 2b) are shown in the following table:

Discussion/Conclusion
Whatever the process, the exactness and precision of the filling volumes are equivalent (absence of significant difference). However, there is a significant difference (p<10^-7) on the overall time (manufacturing time and analysis time) in favour of the automated process. Preparation of a master batch allows for improved quality by producing a batch answering to hospital preparation status and reduces the analysis time. The volumetric pump also makes for timesaving while also making the task less arduous for staff.