Steriliser and reprocessing equipment sits right at the centre of infection prevention and control — which is why autoclave validation is one of the first things an accreditation assessor checks, and one of the easiest things to let lapse in a busy facility. Nova Biomedical has provided autoclave and steriliser validation testing for hospitals, GP practices, and aged care providers across Queensland, New South Wales and Western Australia for over 25 years, and we’re ISO9001:2015 certified for the quality systems behind that work.
What’s Included in Our Autoclave & Steriliser Validation Service
- Performance qualification testing against AS 5369 requirements, confirming your steriliser is achieving effective sterilisation cycles.
- Vacuum leak testing and Bowie-Dick testing for vacuum-type autoclaves, checking air removal efficiency.
- Temperature and pressure validation across the load, confirming the sterilising cycle reaches and holds the required parameters.
- Full validation reporting, ready to file alongside your infection prevention and control program documentation.
- Fault diagnosis and repair advice if a unit doesn’t validate, so you have a clear path back to compliant operation.
Who Needs This Service
Any facility reprocessing reusable instruments — GP and specialist practices, day surgeries, hospitals, and aged care providers with on-site sterilising equipment. Steriliser validation is a direct evidence requirement under the NSQHS Standards’ infection prevention and control criteria, and under the RACGP Standards for general practice. See how this fits into NSQHS Standards compliance and RACGP, AGPAL & QIP compliance.
Common Issues We Find
- Validation that’s lapsed without anyone tracking the due date, particularly in smaller practices where one person manages multiple compliance areas.
- Units that pass a basic cycle but fail Bowie-Dick testing — a gap that’s easy to miss without proper validation testing.
- Validation records that aren’t clearly linked to the broader infection control program documentation an assessor will ask to see.
FAQ
How often does an autoclave need to be validated?
Validation is typically required annually, though your facility’s risk assessment and the standards you’re accredited against may call for more frequent checks — we can advise on the right schedule.
What happens if our steriliser fails validation?
We flag it immediately and discuss repair options where practical, so you have a clear plan and can keep reprocessing on track.
Do you service multiple types of sterilising equipment?
Yes, we validate a range of autoclave and reprocessing equipment used across GP practices, day surgeries, hospitals, and aged care facilities.
Can validation be coordinated with our other compliance testing?
Yes — we regularly combine steriliser validation with AS/NZS 3551 electrical safety testing and other scheduled visits to minimise disruption.
Who We Provide This Service To
Autoclave and steriliser validation is essential for hospitals and GP & medical centres running sterilisation equipment as part of their day-to-day operations.
What AS 5369 Autoclave Validation Involves
External autoclave and steriliser validation under AS 5369 is a structured performance qualification process. Our validation program covers:
- Air removal testing — Bowie-Dick or equivalent test to verify the autoclave is effectively removing air from the chamber and load
- Temperature and pressure calibration — checking the autoclave’s sensors against calibrated reference instruments
- Cycle parameter verification — confirming that time, temperature, and pressure meet the required parameters throughout the sterilisation phase
- Biological indicator testing — where required, using biological indicators to demonstrate sterilisation efficacy
- Load testing — testing with representative loads to verify penetration and sterilisation across the full chamber
Our validation reports are structured to meet the documentation requirements of RACGP, AGPAL, QIP, and NSQHS Standards, and include all the data points surveyors look for when assessing sterilisation compliance.
Validation Scheduling
Most accreditation frameworks expect external autoclave validation quarterly or six-monthly, with a comprehensive annual validation. We schedule validation visits to align with your accreditation cycle and can bundle autoclave validation with other annual testing requirements under a PPM contract — one visit covering electrical safety testing, vaccine fridge calibration, and steriliser validation together.
Further Reading
For more detail on AS 5369 requirements, see our guide: Autoclave Validation Under AS 5369: How Often and What You Need to Document.
Book Your Steriliser Validation
If your validation is due or overdue, Nova Biomedical can help get your documentation audit-ready. Contact Nova Biomedical for a quote.
