Feedback on nominative parenteral lipids-vitamins admixtures production using LOGIPREN® software
Pharmacie Centrale CHU Angers, 4 rue Larrey, 49933 Angers Cedex 9
IGAS report n° 2014-168R imposes the production of parenteral nutritive mixture by Hospital pharmacies, with the objective to better control microbiological contamination risk. Concerning lipids-vitamins admixtures (composition: Smoflipid®+/- Vitalipid® +/- Soluvit®), many teams work on standardized preparations, but because of short stability, the legal constraints for such preparations are not always respected. In the present work, we report the use of LOGIPREN® software to produce nominative preparations.
To implement nominative lipids-vitamins syringes compound and control for neonates using LOGIPREN® software.
A Gantt chart was performed for project management. Briefly, the different steps of the project consisted of LOGIPREN® software training, team communication, process definition and then aseptic process validation by media fill test, staff training and accreditation, verification of the sterility of the preparation in the final packaging, organization with neonatal unit for prescription, draft of quality papers.
Results and discussion
The software allows medical prescription, pharmaceutical validation, manufacturing sheet and label generation, batch number and expiry date generation, and administration traceability. To complete, it was necessary to create an Excel® table to sum each ingredient total volume necessary for production, and to generate the delivery receipt.
LOGIPREN® is easy to handle, whatever the step. We report one difficulty: to be in accordance with Fresenius compatibility data, Soluvit® powder must be firstly solubilized in Vitalipid®. LOGIPREN® software is not able to take into account the hidden contribution of Vitalipid® used to solubilize Soluvit®, this resulting in a slight overdose of Vitalipid®.
Sterility assay in final syringe was tested in accordance to chapter 2.6.1 of European Pharmacopeia 10th Ed. with PVDF specific low binding membrane for oil and cream, and adapted rinse steps with fluid K. The microbiological stability was validated at 5 days in final packaging (syringe).
Finally, using the above described process, the time to produce one syringe is estimated to 8 minutes, this time including prescription validation, production preparation, decontamination step, syringe filling and identification.
After 4 months of use of LOGIPREN® software to produce lipids-vitamins parenteral mixtures, no significant problems were identified.