The site’s problem

The building already had SAP and a serialisation system. But labelling and packaging were still documented on paper. The project had to move all seven lines to electronic batch records.

The difficulty was the number of items. More than 220, with new ones every campaign. One MES recipe per item would have meant 220 recipes to qualify, then a new one each time an item arrived. The site could never have kept up. A different way of organising the recipes had to be found before writing the first line.

What we did

We started by looking at how the building actually worked. Behind the 220 items there were only two ways of working: labelling, and packaging. So we designed two recipes, one per manufacturing flow, based on the real operations.

What sets one item apart from another is its data: format, checks to perform, in-process controls to carry out, materials to consume. Within each recipe, that data enables or disables the checks in the MES. All items follow the same logic, each with its own checks. Adding an item means entering its data, not creating a recipe.

We were in charge of the MES design and supervised the developers. We also handled requirements and gap analysis, specifications, electronic batch record development and qualification, then go‑live assistance and post-go‑live support.

The project lasted eighteen months. The lines kept producing throughout.

What it delivered

The two recipes now cover more than 220 items across the seven lines. At each influenza vaccine campaign, new items are added within a few days, without touching the recipes.

Several data integrity issues linked to paper have disappeared. Overall batch release lead time has decreased, even though executing the operations takes slightly longer than before.

A similar need at your site?

Tell us about it. Mathias Louis, Maelo’s founder, will discuss it with you directly.

Contact Mathias