Autoclave Validation Services

At Thermal Compliance Ltd. we specialise in Autoclave Validation to UK, EU and International Standards for the pharmaceutical, biotechnology and healthcare sectors.  Our experience and expertise will give you a clear, compliant and transparent autoclave validation package.  Awareness of current EU and US regulatory requirements is essential. We can qualify your autoclave to EN285:2015, EN17665, PDA Technical Reports 01 and 48 to meet MHRA, HPRA and FDA expectations.
We specialise in Autoclave Validation, regularly working with the following manufacturers:  Fedegari, Getinge, Steris, Ascot, Belimed, Steelco and Astell.
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  • Porous, Fluids and Waste Autoclave Qualification
  • Installation/Operation Qualification (IQ, OQ)
  • Cycle/Load Development (CD)
  • Autoclave Load Patterns and Load Presentation
  • Autoclave Wrapping Procedures
  • Performance Qualification (PQ)
  • Re-Qualification (RQ)
  • EN 285:2015 Testing
  • Pressure & temperature air detector set up
  • Audits and consultancy support (RCAs etc)
  • Steam Quality Testing
  • Terminal Sterilisation (TS)
  • HTM 2010 and HTM 2031Testing
Our engineers have vast experience in dealing with many different load presentations including:
  • Syringe Load
  • Ampoule Load
  • Bottles Load
  • Vials Load
  • DPTE / Rapid Transfer Port Canisters
  • Hybrid Loads with Fluids and Porous Locations
  • Stoppers Loads
  • Complex Loads
We use the Amphenol Kaye Validator 2000 or Ellab Tracksense Pro system for Autoclave Validation. The Ellab system has several benefits allowing us to substantially reduce the validation timelines. If you would like to know more about how our Ellab system expedite autoclave validation please read our Managing Directors article in European Pharmaceutical Manufacture magazine https://www.epmmagazine.com/opinion/down-to-the-wire/

Autoclave Issues and How our Engineers can help

Wet Loads
  • Perform Steam Quality Testing
  • Investigate Autoclave Cycle Design
  • Review Autoclave Load Presentations
  • Review Wrapping of Load Items
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Porous Load Cycle Design and Development
  • Optimise Cycle Design for Efficiency
  • Air Removal Design for Complex Loads
  • Air Detector Setup
  • EN285:2015 Testing
  • ​Development of Drying phases
  • Increase Sterilisation performance and reduce cycle duration
Superheat
  • Perform Steam Quality Testing
  • ​Investigate Localised Superheat
  • Review the Cycle Design
  • Inspect the Steam Distribution System
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Autoclave Fluids Load Cycle Design
  • Air Ballasted Cycles for Syringes and Unique Packaging
  • Load Probe Equivalence Studies
  • Heat Distribution Tests
  • Complex Load and Cycle Development
  • Validation
  • Development of Cooling Phases
Equilibration Time Failures
  • Review the Design of the Autoclave Cycle
  • Root Cause Analysis
  • Review Probe Positioing
Biological Indicators (BIs)
  • Root Cause Analysis into BI Growth
  • Biological Indicator Selection
  • Processing, Handling and Control
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Wired or Wireless Dataloggers

At Thermal Compliance we use both Wired and Wireless Dataloggers dependent on client requirements.

Most people will be used to using Kaye Validators but using wireless dataloggers is still relatively new within the industry. If you would like to know more about the different systems, please contact us and chat to one of our Validation engineers on +44 (0)1833 908 002.

Alternatively our Managing Director Chris Maughan has written an article for European Pharmaceutical Manufacturer (EPM) Magazine. In it he discusses the benefits and limitations of Wireless systems and Wired systems, if you would like to read it please click the link below:

Using Wireless Dataloggers for Autoclave Validation
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