A new investment to obtain the Pharmaceutical Facility certification
The plastics manufacturing group is increasing production capacity at its Saint-Marcellin facility with a new ISO 8 cleanroom, while aligning processes with Good Manufacturing Practices (GMP) to achieve pharmaceutical facility certification. The new production lines will allow SGH Medical Pharma to offer a range of innovative products containing active pharmaceutical ingredients.
France, Saint-Marcellin, 14 June 2023 – SGH Medical Pharma, an international group specializing in the design and manufacturing of medical devices and consumables for the pharmaceuticals, life sciences and diagnostics markets, is building a new ISO 8 cleanroom at its Saint-Marcellin facility.
Investing to provide quality products made in France
The construction of the new production unit, which will cover a 1,000 m² area, is being overseen by SGH Medical Pharma’s in-house teams. The cleanroom will have three main areas – injection, assembly, and packaging – and should be operational by the end of the year. Production should begin early 2025 at the latest, following extensive tests in 2024.
“The market for medical devices for the pharmaceutical and diagnostic sectors is growing steadily in Europe. Our international customers are looking for partners based close to their markets, who can also offer high-quality, innovative products. We therefore focus on extending our production capacity in France, where we have a well-established reputation for our know-how and capacity to innovate. All our facilities are based in France’s leading manufacturing region, giving us access to an advanced industrial ecosystem to support our expansion plans. This cleanroom is part of an ambitious project that will contribute to France’s industrial renewal,” comments CEO Jérôme Empereur.
The move aligns perfectly with the aim of obtaining a pharmaceutical facility certification for the Saint-Marcellin site in Q1 2024. A recently hired pharmacist is working with the group’s regulatory team to set up processes in line with GMP standards.
Certification would be a major step forward for the group, as it would allow SGH Medical Pharma to expand its range and offer its customers products containing active pharmaceutical ingredients.
About SGH Medical Pharma
SGH Medical Pharma is a rapidly growing group. Its aim is to become a leading European plastics manufacturer in medical devices, in vitro diagnosis and drug administration, as well as a key partner to the pharmaceutical, life sciences and diagnostic industries.
It has three manufacturing sites in France: Stiplastics (Isère), Rovipharm (Ain) and Eskiss (Allier), as well as an office in Lyon.
SGH Medical Pharma manufactures a comprehensive range of devices at several facilities certified to ISO 13485, including cleanrooms, and has complementary expertise in marketing, R&D, quality and industrial production for innovative products and medical subcontracting.