Autoclave Validation Services -Engineer Led, Standards-driven

GMP autoclave qualification for porous loads and terminal sterilisation (fluids in sealed containers). We bring an experienced engineer, the right test equipment, and clear protocols to design, validate and optimise your cycles to EN 285, ISO 17665, ISO 19253,  EU GMP Annex 1, PDA Technical Reports 1 & 48.

Regions: UK & Ireland (MHRA/HPRA‑aligned), with FDA expectations covered.

Wireless Dataloggers

Validation Systems

Annual Calibrations

Autoclave Qualification - Compliant with MHRA, HPRA and FDA Requirements

We specialise in autoclave validation for GMP-regulated pharmaceutical and biotechnology environments, ensuring full compliance with MHRA, HPRA, and FDA requirements.

We optimise autoclave cycles to ensure efficient cycles complying to Annex 1, EN285, EN17665, PDA Technical Reports 1 and 48. 
Write your awesome label here.

Specialist Autoclave Validation Engineers 

Our Engineers have significant experience in the validation of sterilisation processes on a wide variety of loads and sterilisers.

We can deliver full validation projects or supply engineers to join your team.
Empty space, drag to resize

Autoclave Validation Equipment

We use a variety of validation equipment, ensuring we use the optimal sensors for your process.

Our fully validated systems include Kaye AVS, Kaye Validator 2000, Ellab Tracksense pro Dataloggers and Ellab E-Val Pro.
Empty space, drag to resize

Validation Documentation

We can work to our protocols and procedures or your own. With optimised reporting to ensure clear, compliant and legible results.
Empty space, drag to resize

Autoclave Troubleshooting

Wet Loads

Wet Loads are a common problem, but they don't need to be. They can be prevented by appropriate load design, cycle development and optimisation. 

Superheat

Superheat in your autoclave can come from a number of sources. If your seeing high temperatures during sterilisation contact us, we can help!

Air Removal

Air Removal issues are demonstrated by poor equilibration time. We can assist in identifying and resolving the cause of your failures.

Biological Indicator

Failed Biological Indicators can result in long investigations. We can assist in identifying the root cause and resolving the problem.
How can we help?

Pharmaceutical Autoclave Validation Services

From URS to Requalification

We can help generate your URS, Execute the SAT, FAT, IQ & OQ. Perform Cycle Development, Air Detector Setups, Performance Qualification and Re-Qualifications.

EN285 Testing / Steam Quality Testing

We can assist with Air Detector Setups, EN285 Testing, Steam Quality Testing, Small/Full Load Thermometric tests and Load Dryness tests

 Porous Load and Terminal Sterilization Autoclave Validation

Our engineers can help with the qualification of your Autoclave. We work with Porous and Fluids loads machines and can help with generating the URS through to Re-Qualification.

Autoclave Consultancy

If your having problems with your autoclave, please get in touch. We can help resolve issues with Wet Loads, Biological Indicator Failures, Superheat Failures, Air Removal Failures and Equilibration time failures.

Frequently asked questions

How do you resolve Wet Porous Autoclave Loads?

  • Wet loads are increasingly common due to complex load items and sterile barrier systems. They are a critical issue and should be address immediately. Fortunately we have significant experience with wet loads and can help resolve these issues with a combinations or prevention, condensate management and advanced drying setups.

If you have experienced wet loads and ended up with long (3hour+) cycles, please get in touch. We can often significantly reduce the drying phase of the cycle.

Useful Blog posts on Wet Loads:

How do you resolve Equilibration Time Failures?

High equilibration times are caused by residual air or sensors in contact with heavy metal items.

If your issues are related to air removal then we can assist with optimising your autoclaves air removal profile.

Can you help with Biological Indicators?

Our engineers are trained in the processing of biological indicators including  Spore Strips, Self contained Biological Indicators (SCBIs) and liquids biological indicators (Ampoules).

We can also provide 55-60°C Incubators (Biological Indicator Incubation) , 2-8°C Refrigerators (Biological Indicator Storage) and finally we have offer SCBI incubators for Mesa Labs and Steris.

Learn more about Biological Indicator

Useful Blog posts on Biological Indicators:

What standards do you perform Autoclave Validation work to?

We work to your requirements, typically this would include:

  • EN 285:2015 +A1:2021— Sterilization. Steam sterilizers. Large sterilizers.
  • ISO 19253 (under development) — Sterilization of health care products — Moist heat — Requirements for sterilizers used for the terminal sterilization of aqueous liquid in sealed containers.
  • ISO 17665:2024 — Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
  • ISO 11138 series (Biological indicators)
  • EU GMP Annex 1— EudraLex Volume 4: EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use — Annex 1: Manufacture of Sterile Medicinal Products
  • EU GMP Annex 15 — Qualification and Validation.
  • PDA Technical Report 1— Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control.
  • PDA Technical Report 48— Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance.
  • AAMI ST79— Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

Can you use our Protocols and equipment?

Absolutely, our engineers are experienced with all of the main validation systems both thermocouple based and wireless sensors.

We can provide Validation Engineers to temporarily join your team.

Do you validate both porous and fluids cycles?

Yes, we are experienced with both Porous and Liquids loads. 

Can you set up and qualify EN 285 air detectors?

We setup air detectors in line with EN285:2015 and can optimise your cycle to meet and exceed EN285 requirements. Our engineers have significant experience with both Temperature and Pressure type air detectors.
Useful blog posts on Air Detectors:

What Autoclave Routine Testing Should we perform and when?

Porous load Autoclaves need daily air removal tests (Bowie Dick Tests), regular vacuum leak tests and  ideally air detector checks.. Quarterly/yearly add thermometric checks and steam quality (dryness, superheat, non-condensable gases).

Fluids (Closed container liquids) autoclaves don’t require Bowie Dick or Air Detector tests. The focus is on automatic control and thermometric tests. Vacuum leak rate tests are performed, if they are used within the cycle for example a shallow vacuum at the start of the cycle or during the cooling phase.


Routing Testing Typical Frequency
Warm Up Cycle Daily
Bowie Dick Test Daily
Leak Rate Test Weekly
Automatic Control Test Weekly
Air Detector Function Test Weekly


Useful routine testing blog posts: