Ethylen oxide sterilization
STERISERVICES, certified by the notified body LNE/G-MED, offers a large range of processes :
Sterilization process validation in compliance with the ISO 11135 (2014),
Routine sterilization process with supplying of biological indicators and reading on site,
Ethylene oxide treatment and decontamination,
Aeration of the products in heated room.
STERISERVICES sterilizes products of the customer in reserved load : 1 customer per sterilization cycle.
This means a perfect acknowledgement of the load during the validation cycles and after a good reproductibility of sterilization conditions during routine cycles.
General technical specifications :
Two doors sterilizers,
Pre-heating, conditionning under vacuum and gas contact phases are integrated in the same unit for a complete traceability.
Vacuum cycle with a gas mixture neutralised with nitrogen (non flamable conditions).
Some products treated with ethylene oxide
Compresses, resistant gown, bandages, drape, medical sets, customized kit, orthopaedics implants, ocular protection, tubes, catheters, access ports implantable, mesotherapy kits, manifolds, extension line, tattoo needles, plastic and metallic instruments, gloves, intra ocular implants, injectors, breast implants, sterile items for clean room…
STERISERVICES specificities :
between 5 sterilization units, systematically in dedicated load, that will suit your routine volumes (10 available volumes : 1,0m3, 1,5m3, 2 Euro pallets, 4 Euro pallets, 6 Euro pallets, 12 Euro pallets, 16 Euro pallets), 3 desorption rooms with a surface of 120m2 each.
The experience and knowledge to develop sterilization cycles that suit your products,
The flexibility of sterilization cycles planning,
concerning the ethylene oxide sterilization regulations thanks to a dedicated, experimented and highly reactive team,
Vacuum cycle in gaseous mixture inert with nitrogen (non-flammable).
The confidence from a lot of health world customers.
The support and the confidentiality in your entire project.