Autoclave Validation for Sydney, NSW & ACT Dental Practices
Universal Dental performs AS 5369:2023-compliant autoclave validation by factory-certified technicians. Specialists in Dentsply Sirona and Melag steam sterilisers — on site across Sydney, Newcastle, Wollongong and Canberra. Signed Validation Certificate and full OQ & PQ Report delivered digitally.
What is autoclave validation?
Autoclave validation is the documented process of verifying that a steam steriliser performs reliably and reaches the temperatures, pressures and hold times required to actually sterilise instruments. For Australian dental practices, validation is mandatory under AS 5369:2023 and must be performed at least annually by a competent person using calibrated reference equipment.
Validation is not the same as a routine service or a calibration. A service maintains the autoclave's mechanical condition — gaskets, valves, water reservoir, sensors. Calibration adjusts measurement instruments so their readings are accurate. Validation, by contrast, proves with documented evidence that the cycle delivers the conditions needed to kill microorganisms across a real-world load.
For dental practices, a full validation includes three qualification stages:
- Installation Qualification (IQ) — verifies the autoclave is installed and configured correctly
- Operational Qualification (OQ) — verifies it operates correctly across its cycle range
- Performance Qualification (PQ) — verifies it sterilises a representative load consistently
The three stages together produce the documented evidence required by AS 5369:2023, by your accreditation body (e.g. ACSQHC), and by your professional indemnity insurer.
AS 5369:2023 — what the standard requires
The current Australian standard for sterilisation in healthcare settings, replacing AS/NZS 4815.
AS 5369:2023 Reprocessing of reusable medical devices and other devices in health service organisations sets out the requirements for reprocessing instruments — including the validation of steam sterilisers. It replaced AS/NZS 4815 in 2023 and is the standard your dental practice is now obliged to follow.
The standard sets out:
- The qualification stages required for a valid sterilisation process (IQ, OQ, PQ)
- The frequency of revalidation — typically annual, with re-qualification triggered by major service, relocation, or changes in load
- The records that must be maintained and how long they must be retained
- The competence and independence requirements for the person performing the validation
- The use of process challenge devices (PCDs) for cycle verification
Amendment 1 to AS 5369:2023 was published in January 2026 and tightens specific aspects of the verification protocol — including the requirement that PCDs meet ISO 11140-6. Validations performed from early 2026 onward should incorporate Amendment 1.
The three stages of a validation
Installation Qualification, Operational Qualification, Performance Qualification — what each one tests and proves.
Installation Qualification
IQ verifies the autoclave is installed correctly and that all utilities — water quality, electrical supply, drainage, ventilation — are within manufacturer specification. Performed at first commissioning, after relocation, and after major service or repair.
Operational Qualification
OQ confirms the autoclave operates correctly across its full cycle range. Includes vacuum and air-removal tests, steam leak test, Bowie-Dick or helix test (per cycle type), and cross-checking the autoclave's pressure and temperature sensors against calibrated reference instruments.
Performance Qualification
PQ demonstrates the autoclave consistently sterilises a real-world load. Three consecutive cycles are run with calibrated thermocouples placed at multiple points within a representative load. Every point must reach and hold the required sterilisation conditions for the full hold time.
What we test, document and certify
Every Universal Dental validation includes the complete AS 5369 test suite and a signed paperwork pack.
Cycle & performance tests
- Vacuum and air-removal performance
- Steam leak test
- Daily-test routines (Bowie-Dick or helix PCD)
- Process Challenge Device verified against ISO 11140-6
- Pressure sensor cross-check against calibrated reference
- Temperature sensor cross-check at multiple points
- Penetration profile across a reference load
- Three-cycle PQ with calibrated thermocouples
- Cycle integrity end-to-end (start through pressure dump valve)
Your validation pack
- Signed Validation Certificate (AS 5369:2023 compliant)
- Full OQ & PQ Report including thermocouple traces
- Calibration certificates for all reference instruments, traceable to national standards
- Reproducibility data across the three PQ cycles
- Service Record stub for the autoclave log book
- Issued digitally; printed copies available on request
Dentsply Sirona & Melag specialists
Universal Dental technicians are factory-trained and authorised to service the full Dentsply Sirona and Melag steriliser ranges sold into Australian dental practice. Deep specialisation in two brands rather than passing knowledge of many.
Dentsply Sirona
Factory-trained service and validation across the complete Dentsply Sirona DAC steriliser range — from current models through to earlier units still in clinical service.
- DAC Premium
- DAC Premium Plus
- DAC Professional
- Earlier DAC Universal units
Melag
Factory-certified servicing and validation across the full Melag Vacuklav and Cliniklav lines, including the latest B+ models and Premium variants.
- Vacuklav 23 B+, 24 B+, 31 B+
- Vacuklav 41 B+, 43 B+, 44 B+
- Cliniklav 25 and Premium variants
- Earlier compatible Melag units in good service condition
Not sure if your model is included? Call us on (02) 8313 0559 with the serial number and we'll confirm.
Service areas: Sydney, NSW & ACT
On-site validation across the Sydney metropolitan area and regularly to regional NSW and the ACT. Batched regional visits help keep travel costs down for practices outside the metro.
Sydney metro
- Inner Sydney & CBD
- Eastern Suburbs
- Lower North Shore & Upper North Shore
- Northern Beaches
- Inner West
- Western Sydney & Parramatta
- South Western Sydney & Liverpool
- Sutherland Shire & St George
- Hills District
Regional NSW & ACT
- Newcastle & the Hunter Region
- Central Coast
- Wollongong & the Illawarra
- Southern Highlands
- Canberra & the ACT
- Blue Mountains
If your practice is outside these regions, contact us — we can usually arrange travel for established customers or batch validations to make a visit cost-effective.
How it works — the validation process
From first contact to certified validation in five steps, typically completed in one on-site visit.
1. Initial enquiry
Phone, email, or the booking form. We confirm your autoclave model, serial, practice location, and your availability.
2. Scheduling
We book a date that works around your clinic schedule — early mornings, lunch windows, or after-hours where needed.
3. On-site validation
3–4 hours per autoclave. We perform IQ verification, full OQ test suite, and three PQ cycles with calibrated thermocouples placed in a representative load. The unit is back in service the same day.
4. Documentation
Validation Certificate, signed OQ & PQ Report with thermocouple graphs, and Service Record issued digitally. Printed copies on request.
5. Annual reminder
We schedule a reminder eleven months out so revalidation never sneaks up on you.
Pricing and what's included
We quote per autoclave based on your specific model, your practice location, and any additional services (e.g. annual preventative service performed alongside the validation). Pricing typically reflects time on site (3–4 hours), travel for regional locations, and the documentation pack.
Sydney-metro practices with a single autoclave attract our standard single-visit rate. Multi-machine practices get reduced per-machine rates when we validate two or more units in one visit. Regional and ACT practices can batch visits with neighbouring clinics to share travel, or take advantage of our scheduled regional service days.
We don't publish a single fixed price because the right number depends on your context. Contact us with your autoclave model and suburb and we'll come back with a written quote.
Frequently asked questions
Is autoclave validation mandatory for Australian dental practices?
Yes. AS 5369:2023 is the current standard for reprocessing reusable medical devices in healthcare settings, and dental practice falls within its scope. Most professional indemnity insurers and accreditation bodies also require evidence of validation as a condition of cover or accreditation.
How often does an autoclave need to be validated?
Annual revalidation is the standard requirement under AS 5369:2023. Re-qualification is also required after a major service, after relocation, after a significant change in load type, or after any event that could affect the cycle (e.g. a sensor replacement). In practice, most dental clinics book a single annual validation visit.
What's the difference between validation, servicing and calibration?
Servicing is mechanical maintenance — replacing gaskets, checking valves, inspecting the water system. Calibration adjusts measurement instruments so their readings are accurate. Validation is the documented proof, using calibrated reference equipment, that the cycle delivers the conditions needed to actually sterilise a real load. All three are different and complementary; AS 5369 specifically requires validation.
What is AS 5369:2023 and what replaced AS 4815?
AS 5369:2023 Reprocessing of reusable medical devices and other devices in health service organisations is the current Australian standard for sterilisation in healthcare. It replaced AS/NZS 4815 in 2023. If your documentation still references AS 4815, it's out of date. Amendment 1, published January 2026, further tightens specific verification protocols including PCD compliance with ISO 11140-6.
What is the difference between IQ, OQ and PQ?
IQ (Installation Qualification) confirms the autoclave is installed correctly. OQ (Operational Qualification) confirms it operates correctly across its cycle range. PQ (Performance Qualification) confirms it consistently sterilises a real-world load. Together they make up a full validation under AS 5369:2023.
How long does a validation take on site?
Typically 3–4 hours per autoclave. The unit is usable again the same day. We schedule around your clinic so chair time isn't disrupted — early mornings, lunch windows, and after-hours visits are all options.
What documentation do I receive after a validation?
You receive a signed AS 5369:2023-compliant Validation Certificate, a full OQ & PQ Report with thermocouple data and graphs, calibration certificates for all reference instruments, and a Service Record stub for your autoclave's log book. Documents are issued digitally, with printed copies available on request.
Which brands and models do you validate?
We specialise in two brands: Dentsply Sirona (DAC Premium, DAC Premium Plus, DAC Professional and earlier DAC Universal units) and Melag (Vacuklav 23 B+, 24 B+, 31 B+, 41 B+, 43 B+, 44 B+, Cliniklav 25 and Premium variants). Factory-trained and authorised on both. If you're not sure your model is included, call us with the serial number.
Do you provide validation outside Sydney?
Yes. We regularly travel to Newcastle, the Hunter, the Central Coast, Wollongong, the Illawarra, the Southern Highlands, and Canberra. Regional practices can batch visits with neighbouring clinics or take advantage of our scheduled regional service days to keep travel costs down.
What happens if my autoclave fails validation?
The technician documents the fault, quotes any required repair on the spot, and re-tests once the repair is complete — typically on the same visit if parts are on the van. If a more substantial repair is needed, we coordinate a return visit and only re-issue the certificate once the autoclave passes.
Are your reference instruments calibrated and traceable?
Yes. We use MadgeTech thermocouple loggers and reference pressure instruments calibrated to national standards. Calibration certificates accompany every validation report — the data behind your certificate stands up to inspection.
How do I book?
Use the booking form on this page, call us on (02) 8313 0559, or email info@universaldental.com.au. We'll come back to you within one business day to confirm a date.
Book your autoclave validation
Send us your autoclave model and location — we'll come back to you within one business day to confirm a date.