Qualification of an automated compounding device (IMF MediMixmulti®) for pediatric parenteral nutrition (PPN) production.
In order to secure the production of pediatric parenteral nutritions (PPN), we acquired an automated compounding device. The aim is to perform its qualification before using it daily.
Materials et methods
The automated compounding device is a 12-way processor-controlled. 3 different types of syringes can be adapted on the automated compounding device (10, 20 and 50 ml). The qualification of this equipment includes 3 steps:
* Installation qualification (IQ): it’s a calibration performed by the manufacturer.
* Operational qualification (OQ): it’s a weighing test of volumes of two solutions of extreme density (water for injection and D50%) and solutions that will be used in our daily configuration. The filling speed test and lowest volume delivered were performed by the manufacturer.
* Performance qualification (PQ) which includes 3 parts:
1) the repeatability: one formulation of PPN is produced by one operator, six times on the same day
2) the reproducibility: 5 bags of 5 formulations of PPN are produced by 3 different operators on 3 different days
3) the media fill test (MFT) assess the asepsis of the process. The medium used is Soybean-Casein digest. 3 batches of 4 bags of PPN were produced by 3 different operators on the same week. To design the PPN formulation, we used the average volume of each solution recorded over a two-month period.
Validation of IQ and part of OQ are recorded in the manufacturer’s test report. During OQ, 5 volumes were tested on each channel. The error between the measured weight and the theoretical weight was calculated and compared to the deviation tolerated by the manufacturer. This revealed a problem concerning the delivery of small volumes. The filling speed was adjusted for the channels concerned. Concerning the PQ, the results meet our requirements: bag weight < 3%, sodium and potassium concentrations < 10%, osmolarity < 10%.
No microbiological contamination was reported in the bags produced during the MFT (14 days of incubation).
Each step of the qualification process is now completed. The automated compounding device meets our requirements for a daily use. A staff training and an update of the quality manual will follow to allow its daily use.