STERI CHEM: DESIGNER AND MANUFACTURER OF INDUSTRIAL ETHYLENE OXIDE STERILIZATION SYSTEMS

Since its creation in 1986, STERI CHEM has experienced a continuous growth and holds today a position of leading European manufacturer in the Ethylene Oxide sterilization processes.

STERI CHEM intervenes in all development the creation steps of ethylene oxide sterilizers. Since the feasibility study, implantation, process design (preconditioning, sterilisation, degassing), integrating the analysis of security risks: definition of ATEX zones, ventilation and anti-pollution.

Safety is our first concern. In addition to the engineering devices, we have developed a full range of services such as training, validation, maintenance.

Our extensive experience, combined with a continuous improvement through R & D programs, enable STERI CHEM to be your reliable partner. Our list of references reflect this commitment to our customers: B. BRAUN, STERIGENICS, ISOTRON, STERI SERVICES, VYGON, GAMBRO, BASTOS VIEGAS, TETRA MEDICAL, CSSR...

More and more Ethylene Oxide sterilization technology is recognized as reliable and cost effective process (capital as well as operation costs). This has enabled a better integration and rationalization of Ethylene Oxide sterilization process within general manufacturing processes.

SAFETY AND REGULATORY ASPECT

Over the last few year, the European Nerus and regulation enabled Medical Devices manufacturers to have dramatically improved the safety levels of Ethylene Oxide usage in indicated context to rationalize the ethylene oxide sterilisation process while increasing its level of security.

STERI CHEM is certified ISO 9001, meet the following requirements:

• Design/ Construction :
  • EN 14 22
  • ATEX
  • FDA 21 CFR Part 11
• Process/ Validation
  • EN 550
  • ISO 11 135
• Sécurity/ Pollution control such as :
  • Existing European standards (TA Luft)
  • Exposure of the staff < 1 ppm (VME)