What are the Activities of SGH MEDICAL PHARMA at the Saint-Marcellin (Isère) Site?

Christian UGNON : We specialize in the design and production of custom or standard plastic medical devices (e.g., dosing, drug administration, consumables, transport solutions) for the pharmaceutical, life sciences, and diagnostic sectors. To achieve this, we operate ISO 8/7 cleanrooms. Our new cleanroom, constructed by VÊPRES, enables us to expand our capabilities and execute a significant transfer of activity, positioning us as a pharmaceutical establishment capable of handling active pharmaceutical ingredients.

What were the specific characteristics of this project?

CU : The primary distinguishing feature of this project is that it involves a cleanroom specifically designed for a single client, a global leader in animal health, for whom we manufacture a veterinary medicinal product.

And from a technical perspective?

CU : The initial challenge involved adhering to highly specific humidity requirements. The relative humidity level needed to be maintained between 55% and 70% to comply with both our client's specifications and the product's manufacturing parameters. Furthermore, the implementation of this cleanroom presented unique complexities due to its integration within a constrained area of the company, transforming what was previously a storage zone. The project thus entailed rehabilitating and converting this space into a production area, complete with a laboratory, a cleanroom, essential infrastructure, and an overhead crane. Ultimately, this project necessitated numerous modifications throughout its lifecycle, including, for instance, the integration of the overhead crane.

Does the pharmaceutical sector impose specific requirements?

CU : Indeed, this sector operates under a highly stringent regulatory framework for both design and operation, governed by Good Manufacturing Practices (GMP) guidelines. Within this facility, for instance, a comprehensive monitoring system ensures continuous surveillance of production conditions, guaranteeing appropriate pressure differentials, temperature, and humidity levels. This adherence is critical for complying with regulations and maintaining production conditions that yield batches meeting all specified requirements. Such measures are mandatory for batch release and market authorization. I would also note that our personnel have undergone specialized training to operate within this new production unit, with this training provided by an external organization and validated by our qualified person (responsible pharmacist).

What are your key takeaways from VÊPRES' intervention?

CU : This was a demanding project, yet it progressed exceptionally well, aligning perfectly with both our specifications and those of our client. VÊPRES demonstrated remarkable efficiency and responsiveness throughout the entire project lifecycle. Despite numerous evolutions, they consistently adapted while adhering strictly to the planned schedule, resulting in zero days of delay. This is a significant achievement given the project's inherent complexity. I also wish to commend the quality of communication and collaboration, as well as the professionalism of the on-site teams, who were impeccably organized, meticulous, and, crucially, scrupulously compliant with all safety directives.

Has satisfaction been achieved?

CU : Beyond our excellent collaboration with VÊPRES, I would assert that the ultimate testament to a project's success is client satisfaction. Upon visiting our facilities, our client commended us on the quality of the cleanroom and the production of their products. This, to me, is the most compelling evidence of a successful outcome.