Operational qualification of an automated compounding device of parenteral nutrition : Medimix® IMF

The change of a filling volumetric automated compounding device : Baxa MM12 —> Medimix® IMF required an operational qualification. Pump is used for the preparation of binary parenteral nutrition (PN) admixtures in isolators, by batch (admixture “mother” then “daughter”) and is composed of 12 syringes that can operate individually or simultaneously (sequences). A part of the qualification is to find the optimal speed and to determine for each channel precision, accuracy, repeatability and reproductibility. 2 solvants were used : water for injection (wfi) and 30% glucose (G30) chosen for their density near the nutrients used. The tested volumes were minimum volumes used in production. For the sequences tested (2 and 3), the same parameters were calculated. The optimum flush volume was investigated by assaying 2 plotters, calcium and G30, chosen for their limit of detection. Production was validated by performing 1 batch of 11 bags during 5 days then 3 batches for 1 day. Aseptic Media-Fill Test (MFT) allowed us to check quality of the aseptic process.

The results for each channel are shown below.

Deductions speeds allow precision ≤ 1%. Relative standard deviation (RSD) repeatability and reproductibility are below 1%, except for the volume of 1.2 ml for which the reproducibility RSD is 2.3% but still below 3.3% compared to manual compounding. Channels 2, 3, 5, 9, 10 and 11 are not accurate but bias is low (error ≤ 0.5%) those results are so acceptable. Sequences do not impact with respect to the use of tracks individually. For sequences 2 and 3, results are not exact [1622.6 to 1623.1] to 1620g and [76.4 to 76.5] to 76.8g but error is respectively 0.17 and 0.41%, and the CV 0.02 and 0.08% are low. The retained flush volume is 100 ml. Batches products comply compared with the expected specification assays, weight, pH, and osmolarity. An average of 153 bags from MFT are sterile. Automated compounding device Medimix® meets our expectations for batch production. Performance qualification will define our production rate.