Database

Sterigenics Belgium (Fleurus) sa

Solution provided
Technology
Supplier identity
General description

Sterigenics is the world’s leading provider of contract sterilization services for the medical device and pharmaceutical industries by offering processing capacity in all the leading sterilization technologies, including: Ethylene Oxide (EO), Gamma and Electron Beam (E-Beam).
The Sterigenics Belgium (Fleurus) facility is situated south of Brussels, near to Charlerloi.
This gamma facility consists of two independent industrial irradiators, both designed to maximize the dose uniformity.

Type of Supplier
Service Provider - Professional Advisor /Consultant / Legal / AccountingOther
Region
Region of Wallonia, BE
Regional access broker
  • Annick Pierrard, Interface Enterprises-University of Liège
Activity description
Terms of availability for SMEs

Sterigenics Fleurus provides technology to allow secure, cost effective :
• micro-organism-reduction services for food ingredients, spices, frozen food (frog legs and mechanically recovered poultry meat), cosmetics, pet foods, and food packaging (bag-in-box)
• sterilization of medical devices, drug device combinations, packaging and materials for the pharmaceutical industry,
• terminal sterilization of API’s, tissues, biodegradable implants and pharmaceutical products
• virus reduction for frozen serum and other biopharmaceutical products
A specialized team offers High Technology Sterilization Solutions with involvement from early R&D initiatives through clinical studies, including process development, requisite dosing determination, validation documentation and regulatory support. For the pharmaceutical and biologic manufacturer it is a breakthrough worth knowing that we are expert in cold chain management with storage capabilities in an onsite -18°C warehouse, and irradiation in cryo-containers with the use of dry ice without impacting dose delivery

Quality labels and accreditations

The same Quality System operates at every facility
– ISO 9001:2008 & ISO13485:2003
– Notified Body is BSI in EMEAA
EU GMP certified : AFMPS Pharma registration for processing of clinical batches and routine batches of medicines for human and veterinary use
FDA registered for pharmaceutical sterilization
Japanese PAL registration

Training and Staff possibilities
No
Contact information
Name
Bénédicte
Surname
Antonov
Function
Customer Service
Phone number
+32 71 82 25 13
Address
Zoning Industriel, Avenue de l’Espérance
6220  FLeurus
Belgium