What is IONISOS Groupe?
IONISOS Groupe is an International contract service company based in France, specialized in radiation sterilization of pharmaceutical primary packaging, API’s, pharmaceutical final products & medical devices.
The origin of the company can be traced back to the year 1956 when the first irradiation facility was built in France, now days the group has four irradiation facilities in France and one irradiation facility in Spain (IONISOS IBERICA) which positions the company as the first service irradiation sterilization provider in the south of Europe.
The irradiation technologies used by the company are two: Gamma Rays and Electron Beam (Beta Rays), being both technologies well known in the industry as reliable sterilization methods. The facilities and their locations are:
- Three Gamma facilities : Dagneux (Lyon Area), Sable (Le Mans Area ) & Pouzauges (Nantes Area).
- Two E-beam Facilities: Chaumesnil, (Troyes Area) & IONISOS Ibérica in Tarancon (Madrid Area).
- The Groupe facilities are completed with an ETO sterilization plant, Sterylene, in Gien ( Orleans Area)
All the irradiation facilities are ISO 13485 – ISO 11137 and GMP certified. In addition one of the facilities has a Pharmaceutical laboratory accreditation, this accreditation gives the possibility to treat API’s and final medical products. FDA DMF (Type V) number registration is also available for several of the irradiation facilities
IONISOS Ibérica E-beam facility has been an active player in the Spanish and Portuguese sterilization markets since 1997, our main objective through all these years has been to offer a quality service to our clients by following all legislation and normative applicable to our activity.
All the IONISOS Iberica organization is involved in the Quality management system and also committed to its continuous improvement.
- Quick & Efficient method
- Treatment of the products in their final packaging
- Physical sterilization method with no quarantine required
- Simple process control
- Cost competitive sterilization method