What is Ethylene Oxide Sterilization
Ethylene Oxide (EtO) sterilization is a low-temperature process that uses ethylene oxide gas to effectively eliminate bacteria, viruses, and other microorganisms from medical devices and healthcare products. It is especially suitable for items that are sensitive to heat, moisture, or radiation. EtO sterilization is globally recognized for its deep penetration and material compatibility, making it a preferred method for complex and delicate devices.
Our Ethylene Oxide Sterilization Processing Standards
At Sina-Sterilgamma, we follow strict international standards to ensure sterilization quality and patient safety. Our processes comply with:
- ISO 11135 – Sterilization of health care products using ethylene oxide
- ISO 13485 – Quality management systems for medical devices
- Comprehensive cycle validation, real-time process monitoring, and load traceability
- Strict control of gas concentration, temperature, humidity, and exposure time to ensure effective sterilization with minimal product impact
- We ensure each batch meets the highest standards of sterility assurance, documentation, and regulatory compliance.