Single channel pump MediMix® for cytotoxic handling

F.A. Chastang, A. Chassin, A. Lalli, A. Hurgon, L. Escalup Curie Institut, Department of Pharmacy, 26 rue Ulm, 75248 Paris Cedex 5

Introduction

The centralization of chemotherapy preparation in hospital pharmacies and the constant growth of this activity require production optimization, as well as work ergonomics improvement and musculoskeletal disorders prevention. For this purpose, an automated machine for the preparation of cytotoxic infusion bags was installed in our oncology pharmacy unit in 2010. In addition, a filling pump was put to the test in our unit in 2016.

Objectives

Qualification of a single channel pump MediMix® (impromdiform) implemented in an isolator.

Methods

Trials were made using the following devices: 60 ml BD Plastipak® syringes and 240 mL (5 mL/h) Baxter® Elastomeric Pumps (EP). 5 filling volumes of glucose 5 % were tested for each device: 5; 10; 20; 40 and 50 mL for the syringes and 50; 100; 140; 180 and 240 mL for the EP. All the preparations were subjected to gravimetric controls. A performance analysis (accuracy, repeatability and intermediate precision) was executed for each volume with 5 repetitions performed on 3 consecutive days. Furthermore a leak test by fluorescein and an evaluation of filling time were carried out.

Results

For syringes, the coefficient of variation (CV) was below 0.5% and the standard deviation (SD) was below 0.04ml for volumes of 5ml to 50ml. For EP, the CV was below 0.1% and SD was below 0.08ml for volumes of 50 ml to 240ml. No leaks were detected. The device doesn’t require a daily recalibration. The dead volume of the transfer set was below 10ml. The filling time was below 3 minutes for EP.

Discussion

This test validates the precision, accuracy, repeatability and reproducibility of the filling performances of the MediMix® for syringes and EP. It can be sterilized by peracetic acid. Moreover its compacity (280x205x50mm - powered by a single cable) and lightweight (3.5kg) convinced us to implement the device in our unit. The Medimix will be dedicated to IV EP and syringes filling (banding doses only), in an isolator equipped with gravimetry.

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