Consolidated Sterilizer Systems (CSS)
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Operation Qualification (OQ) Services
Operational Qualification (OQ) provides documented evidence that the sterilizer operates in accordance with design specifications. The OQ validation examines the autoclave’s ability to run the sterilization process correctly and to respond appropriately to error conditions, assuring that the sterilizer performs as intended.
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- Alarm conditions and expected results, as well as vacuum leak test performance (if applicable) are verified.
- Empty chamber temperature mapping is performed to verify and document that the temperature range delivered throughout the empty autoclave is within required specifications.
- If required, verification of sterilization efficacy using biological indicators (BI) may be carried out to meet a strict interpretation of the standard. (BI testing with a full load is performed in the Performance Qualification phase.)
- OQ can be performed by a third party using the Consolidated OQ Protocol, or by an authorized Consolidated Steril-Q™ representative following the OQ Protocol.
