Ethylene oxide (EO) sterilization
At TAISSIS CONCEPT , the safety and quality of medical products are a priority. That is why we offer ethylene oxide (EO) sterilization services, performed under strictly controlled conditions and in full compliance with the international standard ISO 11135:2014.
Compliance with these standards guarantees that our processes are safe, reproducible and compliant , ensuring the sterility of medical products and the end user's protection.
Ethylene oxide (EO) sterilization
At TAISSIS CONCEPT , the safety and quality of medical products are a priority. That is why we offer ethylene oxide (EO) sterilization services, performed under strictly controlled conditions and in full compliance with the international standard ISO 11135:2014.
Compliance with these standards guarantees that our processes are safe, reproducible and compliant , ensuring the sterility of medical products and the end user's protection.
The sterilization process
For each sterilization cycle, TAISSIS CONCEPT applies a rigorous initial validation and periodic revalidation program, in accordance with the requirements of the ISO 11135:2014 standard.
Facility and equipment qualification (IQ, OQ, PQ),
to confirm functionality and safety.
Determination of critical parameters:
EO concentration, temperature, relative humidity, exposure time.
Sterility and EO residue testing,
to guarantee that the products are sterile and completely safe for use.
Monitoring and recording data for each cycle,
ensuring full traceability.
Periodic revalidations,
which confirms the consistency and reproducibility of the process over time.
Capacity and infrastructure
Sterilization is carried out in a sterilization chamber, with a capacity of 12 pallets, specially designed to provide:
• optimized loading and uniform distribution of sterilizing gas,
• permanent control of pressure, temperature and humidity,
• advanced safety and monitoring systems,
• flexibility for batches of various sizes.
This modern infrastructure allows us to efficiently manage different volumes, from small batches to complex orders.
Why choose TAISSIS CONCEPT for EO sterilization?
Full compliance
with international standards and MDR.
Validated and monitored processes
for reproducible and safe results.
Modern infrastructure
with 12 pallet sterilization chamber.
Optimized safety, efficiency and costs
for each customer.
Full traceability and compliant documentation
regulations in force.
