Evolution of the manufacturing module of the software CHIMIO® : for a better security of the manufacturing process

4 October 2018

Pauline Gueneau, Pauline Pistre, Mérédith Boutet, Corinne Pernot Unité de Pharmacotechnie et Essais Cliniques CHU de Dijon
14 rue Gaffarel 21000 Dijon

The Pharmaceutical and Clinical Trials Unit (UPEC) carries out 37,000 preparations per year (7% for clinical trials), insulators (55% in bags, 40% in syringes, 5% in portable dispensers). The production is managed by computer software CHIMIO®. Currently, the manufacturing process is partially secure thanks to the dematerialized manufacturing card module. This module makes it possible to carry out a qualitative control of the preparations. The principle of this control is based on the verification of the correspondence between the preparation, identified by barcode, of the bottle (s) to be used as well as the final packaging (bar code affixed to the products corresponding to the name, dosage, batch number, treatment number, expiry date). However, the security of the process is insufficient because somes risk steps are not taken into account. Added to this is the desire to replace the dual visual control mobilizing staff and not optimal.

Our aim is to strengthen controls in-process at a lower cost, by improving existing ones.

In this sense, a risk analysis was carried out. The critical points not supported by the software were noted: absence of control and / or insufficient traceability of the contents of the baskets, the reconstitution solvent, the remainder, the quantity of active ingredient, the volume of solvent (syringes / final volume pocket), final control and release stages. Evolutions have therefore been requested from the software publisher.

The manufacturing module thus presents new functionalities. It’s now possible to trace all the manufacturing steps as well as the operators. The vials and the components necessary for the preparation (preparation, administration, final container ...) are scanned in preparation of baskets (data matrix). The follow-up of the balances is optimized by taking into account the expiry date. The reconstitution solvents are traced qualitatively. The introduction of the photography of key steps in process allows a recognition of the volumes (solvent, active principle, volume to withdraw) and ensures a quantitative control: each preparation benefits from a scenario and the software assists the preparer in the realization. The photographs are viewable during the check and archived. A check list release computer completes the device.

The changes made to the software offer a control tool that meets the objectives of qualitative and quantitative control of the entire preparation. Easy to implement (no interface necessary, little parameterization), it is universal, simple, non-destructive and inexpensive. It remains to measure the reliability, and the impact on the time of provision of preparations.

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