UK Autoclave Validation Consultant

Consultancy Support for Steam Sterilization and Thermal Validation

Years Experience

Support 24/7

Free Online Consultation
“Confidence in Sterilization process is delivered by process optimization, process control, monitoring, periodic review and routine testing.”
Chris Maughan
Chris Maughan

UK and Ireland
Sterilization Consultant

Chris is the founder and lead consultant at Thermal Compliance, with over 20 years specialising in Autoclave Validation. He is a member of of the British Standards Institution (BSI) and International Organization for Standardization (ISO - TC/198 Moist Heat Sterilization).

He can help setup your process, ensuring you meet the following standards and guidance:
  • EN285
  • ISO 17665 
  • EU GMP Annex 1
  • PDA Technical Report 1
  • PDA Technical Report 48
  • AAMI/ANSI ST79
  • ISO 11140 - Chemical Indicators
  • ISO 11138 -Biological Indicators 

How can we help?

Outstanding features for highly customizable Courses, Units, Lessons, and Quizzes.

User Requirement Specification (URS)

Ensure your autoclave is specified correctly. Knowledge of your loads and process, will drive the URS ensuring long term compliance

Load Design and Orientation 

Optimise the load layout and orientation to aid air removal and prevent wet loads.

Load Drying Optimization

With complex wrapping procedures, cycles often require complex load drying design. We can help reduce the length of this process and improve performance.

Air Removal Optimization

Residual air can inhibit steam penetration into load items. The air removal process can be optimised to improve performance and meet equilibration time criteria.

Load Wrapping and Sealing

Understand your loads and Grade Transfers (eg A-C-A). Selecting the most suitable method of load transfer or wrapping and sealing systems.

Validation Services

We can also provide validation services, whether it is fast fault finding services to full qualification.

Autoclave Wet Load Root Cause Analysis

Wet Loads increase the risk of contamination to the load and your cleanrooms. Potentially they could be an indication of wet steam and should be investigated if they occur. We can prevent them!

Biological indicator Failure Investigation

A Biological Indicator growth should be investigated fully. We can help fully investigate biological indicator failures and help prevent false positives.

Autoclave Superheat RCA

Superheated steam isn't suitable for moist heat sterilisation. It can occur due to the steam distribution system design, load items or cycle design. We can help resolve superheat in your autoclave loads. 

Autoclave Air Removal Failure Investigation

Porous Load cycles require the removal of air at the start of the cycle. Residual air can inhibit sterilization conditions occurring. We can help!

European GMP Annex 1 Autoclave Consultancy

If you are looking to meet EU GMP Annex 1 requirements for Moist Heat Sterilization we can help with Training, Consultancy and Validation Services.
Cycle Design
Air Detectors
EN285 Testing
Load Wrapping and Orientation
Validation Services
Training
Can we help?

Ask an Autoclave Validation Expert!

Book a Free 30 Minute Consultation with our Autoclave Consultant today!
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