ETO Sterilizer Validation
ETO Sterilizer Validation
Ethylene oxide (ETO) sterilization is one of the most widely used methods for sterilizing heat- and moisture-sensitive medical devices. However, the complexity of the process — involving precise control of EO concentration, temperature, humidity, and exposure time — demands rigorous validation to demonstrate that it reliably achieves the required Sterility Assurance Level (SAL) of 10⁻⁶. Our ETO Sterilizer Validation programme is conducted in accordance with ISO 11135 and covers the complete validation lifecycle.
We take charge of creating and organising the implementation of sterilisation process validation studies on your premises or at a sterilisation facility that you have contracted. Partner with IETQAN for meticulous ETO Sterilizer Validation services and have peace of mind knowing your instruments meet industry standards and regulatory requirements.
Installation Qualification (IQ)
Installation Qualification documents that the ETO steriliser and its supporting utilities have been delivered, installed, and configured in accordance with the manufacturer's specifications and the user's requirements.
Our IQ deliverables include verified utility connections (gas, vacuum, steam, electrical), instrument calibration certificates, drawing reviews, and as-built documentation — providing the baseline for subsequent OQ and PQ studies.
Performance Process Qualification (PPQ)
Performance Process Qualification demonstrates that the validated sterilisation cycle reliably delivers the required sterility-assurance level for a defined product load under routine operating conditions.
We execute fractional, half-cycle and full-cycle runs, biological-indicator placement, and residual-EO/ECH verification per ISO 11135 — producing the qualification report needed for product release and regulatory submission.
Microbiological Performance Qualification (MPQ)
Microbiological Performance Qualification confirms that the sterilisation cycle achieves the required microbial-inactivation profile against the worst-case challenge organism and bioburden of the actual product.
Our MPQ programme combines biological-indicator survival/kill studies, bioburden recovery, and product-family grouping rationale so the validated cycle can be confidently extended across qualifying SKUs.