Autoclave Validation: IQ, OQ and PQ in Plain Language
Routine tests show today’s cycle worked. Validation proves, with calibrated instruments, that this steriliser sterilises your loads in your room — and keeps proving it after repairs and moves.
Type-testing, validation and routine monitoring
Three kinds of evidence are often mixed up. Type-testing is done by the manufacturer on the model, to show it meets its standard — EN 13060 for small sterilisers, EN 285 for large ones. Validation is done on your machine, where it is installed, with your loads. Routine monitoring then shows that each day and each load stayed within the validated limits. ISO 17665 sets out this structure for moist-heat sterilisation: define the process, qualify the equipment, then control it routinely.
| Evidence | Done by | Question it answers |
|---|---|---|
| Type-testing | The manufacturer, on the model | Can this model sterilise the load types its class claims? |
| Installation qualification (IQ) | Supplier or validation engineer, on site | Was the right machine installed correctly, with the right services? |
| Operational qualification (OQ) | Validation engineer, on site | Does it reach and hold its cycle parameters within limits? |
| Performance qualification (PQ) | Validation engineer, with your loads | Do your actual loads reach sterilising conditions every time? |
| Routine monitoring | Clinic or department staff | Did today’s cycles stay within the validated limits? |
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What each stage checks
Installation qualification (IQ)
The model, serial number and chamber match the order and the declaration of conformity. Power, water, drainage and ventilation meet the maker’s specification. Safety devices such as the door interlock and pressure relief valve are in place, and the manuals, software version and calibration certificates are recorded.
Operational qualification (OQ)
The empty chamber is tested with independent, calibrated temperature and pressure sensors. Every cycle must reach its set temperature and pressure and hold them for the full time, and the machine’s own sensors must agree with the reference instruments. Air-removal, vacuum leak and Bowie-Dick or helix tests are run and recorded.
Performance qualification (PQ)
Your real or representative loads — the densest instrument set, pouches, hollow items, textiles — are run with sensors in the hardest-to-reach places. Each load configuration is repeated, commonly three times in a row, to show the result is consistent. The configurations that pass become the loading rules staff must follow.
Who validates, and with what
- An engineer trained in steriliser validation, from the supplier, the manufacturer or an independent company — not the person who runs the machine every day.
- Reference thermocouples or wireless data loggers and a pressure sensor, calibrated against traceable standards. In Malaysia, ask whether the calibration laboratory is accredited under SAMM, the Standards Malaysia scheme for ISO/IEC 17025 laboratories.
- A written protocol agreed before testing: which cycles, which loads, where the sensors go and what counts as a pass.
- A signed report with the raw data, any failures and how they were resolved.
- For tabletop clinic autoclaves, many clinics rely on the manufacturer’s type-testing plus installation checks and routine monitoring; hospitals, day-surgery centres, laboratories and manufacturers usually validate on site. Follow what your licensing body, accreditation scheme or infection-control policy expects.
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When to revalidate
- Periodically — commonly once a year, as a requalification.
- After the steriliser is moved, even within the same building.
- After repairs or replacements that can affect the cycle: controller or software, sensors, heating element or steam generator, vacuum pump, valves or the door seal assembly.
- When you add a new load type, packaging or rigid container, or change how loads are arranged.
- After an unexplained failed spore test, Bowie-Dick test or a run of wet packs, once the cause is fixed.
- When services change — new water treatment, a new steam supply or electrical work on the circuit.
Records to keep
Keep the records together, for as long as your policy and licensing requirements specify. An auditor reads them as one story: the machine was qualified, it has stayed within those limits, and every change was followed by a check.
- The IQ, OQ and PQ protocols and signed reports, including the raw sensor data.
- Calibration certificates for the reference instruments used and for the steriliser’s own sensors.
- Photographs or diagrams of each validated load configuration, posted where staff load the machine.
- Cycle printouts or electronic logs for every load, linked to the load numbers on the packs.
- Daily Bowie-Dick or helix and leak test results, and every spore test result.
- Service reports, repairs and deviations, with the corrective action taken.
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Related guides
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Frequently asked questions
What do IQ, OQ and PQ stand for?
Does a small clinic autoclave need validation?
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Is a Bowie-Dick test the same as validation?
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