Porous and Fluids Load - Autoclave Validation Services
We specialise in Autoclave Validation, regularly working with the following manufacturers: Fedegari, Getinge, Steris, Ascot, Belimed, Steelco and Astell.
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 are essential. We can qualify your autoclave to EN285:2015, EN17665, PDA Technical Report 01 and PDA Technical Report 48 to meet MHRA, HPRA and FDA expectations.
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Our engineers have vast experience in dealing with many different load presentations including:
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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
Porous Load Cycle Design and Development
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Superheat
Autoclave Fluids Load Cycle Design
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Equilibration Time Failures
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Biological Indicators (BIs)
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Autoclave Validation Training Courses
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We provide validation training courses from our offices in North Yorkshire, at your site or online.
Our training courses include:
For more information please download a PDF or take a look at our training page. ![]()
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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)1748 327 247. 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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