GxP Autoclave Validation Services
Porous and Fluids Load Autoclaves
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.
Our engineers have vast experience in dealing with many different load presentations including:
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 Failures and how our engineers can help
Wet Loads Failures
Porous Load Autoclave Cycle Design and Development
Equilibration Time Failures
Fluids Load Autoclave Cycle Development
Biological Indicator Failure
Autoclave Validation Training Courses
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.