Südpack Medica has expanded its Normandy facility as part of its strategy to produce high-quality primary packaging for pharmaceuticals and sterile barrier systems for medical device and diagnostic applications.
Südpack has almost doubled the size of the Coulmer plant’s ISO Class 7 and 8 cleanroom production areas and is now certified to ISO 13485 for medical devices and diagnostics and ISO 15378 for primary packaging materials under GMP (good manufacturing principle) conditions, the film and packaging manufacturer said.
The expanded factory, which has taken three years to complete and was described by Südpack as its largest single investment project at the time, now enables higher-volume production under cleanroom conditions across the entire process chain.
The site also manufactures the company’s MedGuard product range, which spans pouch systems and other packaging concepts for applications such as implants, surgical kits, wound care products, and surgical textiles.
Sterilised medical devices
In addition, it supplies header bags specifically designed for large-volume medical devices that typically undergo ethylene oxide sterilisation.
Südpack said the expansion underscored its ‘strong commitment’ to the Orne region and to Europe and played a ‘major role’ in developing future-ready, EU Packaging and Packaging Waste Regulation-compliant solutions for the life sciences sector, including recyclable mono-PE concepts designed to replace conventional polyamide/PE laminates.
Südpack Medica is part of the Südpack group, which was founded in 1989, and focuses on plastics-based packaging for sterile goods.
This includes the production of coextruded flexible and rigid films, which are used as base and lidding films, and of premade pouches for a wide variety of applications.
These are manufactured at four sites in France, Germany, Switzerland, and the Netherlands.
