Autoclave Validation Services

Steam Sterilization Validation for Porous and Fluid Loads to MHRA, HPRA, and FDA Standards. Compliant with EN 285, EN 17665, PDA Technical Reports 1 & 48.

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. 
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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.
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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.
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Validation Documentation

We can work to our protocols and procedures or your own. With optimised reporting to ensure clear, compliant and legible results.
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How can we help?

Pharmaceutical Autoclave Validation Services

Sterilization Training and Support

We offer Advanced Autoclave Validation training for you and your team. Delivered at your facility, from our training centre, live online or via our pre-recorded online training. 

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.

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. Watch our free 'Wet Loads' webinar to learn more.

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.

 Information

Address
18 Harelands Courtyard Offices
Richmond
North Yorkshire
DL10 5NY
UK
Phone
+441748327247
E-mail
info@thermalcompliance.co.uk

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