What are SGH MEDICAL PHARMA's activities at the Saint-Marcellin (Isère) site?

Christian UGNON : We specialize in the design and production of customized or standard plastic medical devices (dosage, drug administration, consumables, transport solutions, etc.) for the pharmaceutical, life sciences and diagnostics sectors. We have ISO 8/7 rooms at our disposal. Our new cleanroom , built by VÊPRES , has enabled us to expand and transfer our activities to a pharmaceutical facility handling active ingredients.

What were the special features of this project?

CU: The first particularity of this project is above all the fact that it is cleanroom intended for a single customer, a global player in animal health, for whom we are producing a veterinary drug.

And from a technical point of view?

CU: The first challenge was to respect a very specific humidity level. The humidity level had to be between 55% and 70% to comply with our customer's specifications and the production of his product. The creation of this room was also a little unusual in that it had to be set up in a constrained environment, in a space that had previously been a storage area. The project therefore involved rehabilitating and transforming it into a production area, a laboratory with a cleanroom, infrastructures, structures and an overhead crane. Last but not least, this was a project where many modifications had to be made throughout the process, including the integration of the overhead crane, for example.

Does the pharmaceutical sector impose special requirements?

CU: Indeed, this is a sector with a very demanding regulatory framework for design and operation, governed by the Good Manufacturing Practice standard. On this room, for example, there's a monitoring system that ensures continuous surveillance of production conditions to guarantee vacuum levels, temperature and humidity levels, in order to comply with regulations and production conditions that must ensure that batches comply with requirements. All this is mandatory for batch release and marketing. I would add that our employees have also undergone specific training to work in this new production unit. This training was provided by an external organization and validated by our head pharmacist.

What did you learn from VÊPRES ?

CU: It was a demanding job, but one that went extremely well in terms of our specifications and those of our customer. VÊPRES proved to be efficient and responsive throughout the project. It's a project that's changed a lot, and each time they've been able to adapt, while staying on schedule. There was not a single day's delay. That's quite a feat given the complexity of the project. I'd also like to underline the quality of communication and exchanges, as well as the professionalism of the teams on site, who are perfectly organized, rigorous and, above all, scrupulously respect safety instructions.

So satisfaction is the order of the day?

CU: In addition to our excellent collaboration with VÊPRES, I would say that the best proof of a successful project is the satisfaction of our customer. And when he came to our premises, he congratulated us on the quality of the room and the production of his products. That's the best proof of success.