Autoclave Validation
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 EN285:2006, EN17665 and PDA Technical Report 01 to meet MHRA, IMB and/or FDA expectations.
Ensuring your autoclave meets the standards we perform:
- Installation / Operation Qualification (IQ,OQ)
- Cycle / Load Development (CD)
- Performance Qualification (PQ) and Re-Qualification (RQ)
- Full EN 285:2006 Testing.
- Pressure and temperature air detector setup
- Audits and consultancy support
- Steam Quality Testing
We have experience with the following autoclave manufacturers:
- Fedegari
- Getinge
- SAL
- Steris
- BMM Weston
- British Steriliser
- Kuhlman
- Ascot
- Astell
- Eschmann
- W&H
- Prestige
Download the Autoclave Validation pdf here
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