ISO-11135 For ETO Sterilization
What is ISO 11135?
ISO 11135:2014 specifies requirements for the development, validation, and routine control of an ethylene oxide (OE) sterilization process for medical devices. This standard applies to both industrial settings and healthcare facilities, acknowledging the critical balance between process efficiency and patient safety.
Implementation of the Sterilization Process
The sterilization process is executed by high-precision ETO Sterilizers installed within a factory or dedicated sterilization station. To ensure maximum safety, the control system is typically installed in a separate room, remotely managing the process based on pre-defined parameters and stringent safety requirements.
Gas Requirements & Safety
The sterilization agent used is typically Pure Ethylene Oxide (OE) mixed with nitrogen or carbon dioxide. At BOCON, we suggest an EO gas percentage of no less than 30% to maintain sterilization efficacy; otherwise, the chamber structure must be significantly strengthened.
- Highly Toxic: Requires strict atmospheric monitoring.
- Flammable: Potentially explosive from 2.6% volume in air.
- Risk Management: Handling, storage, and usage must be managed with extreme care and compliant equipment.
Stages of the ETO Sterilization Process
According to ISO 11135, the ethylene oxide sterilization cycle is divided into three critical stages:
Validation of EO Sterilization (ISO 11135)
Process Validation is a mandatory requirement to prove the process consistently yields sterile products. It consists of 3 primary stages:
- coeficiente intelectual (Installation Qualification): Verification that equipment is installed correctly.
- OQ (Operational Qualification): Verification that equipment operates within defined limits.
- PQ (Performance Qualification): Consisting of MPQ (Microbiological) and PPQ (Physical) to demonstrate the process works for your specific product load.