Steam Sterilizer Validation

Steam Sterilizer Validation

Steam sterilization is the benchmark sterilization method for reusable medical devices and many single-use products. Validating a steam sterilizer to the required standard requires specialist expertise in thermodynamic testing, biological indicator selection, and load configuration — all of which IETQAN’s team brings to every project. Our Steam Sterilizer Validation services are conducted in accordance with ISO 17665 and EN 285, covering:

• Installation Qualification (IQ) — confirming correct installation, utilities, and documentation.
• Operational Qualification (OQ) — demonstrating that the sterilizer consistently achieves and maintains the validated cycle parameters across its operating range.
• Performance Qualification (PQ) — verifying that the sterilization process achieves the required SAL for defined product loads under routine operating conditions.

We issue full validation reports with all raw data, summary analysis, and conclusions in a format ready for direct inclusion in your regulatory submission.