- Equipment Maintenance
- Pre-Owned Laboratory Equipment
- United Kingdom
Thermal Compliance Ltd
Thermal Compliance Ltd, founded in 2007, is an independent equipment and service provider offering validation, calibration, equipment hire and temperature mapping to the pharmaceutical, biotechnology and healthcare sectors.
We specialise in autoclave validation to UK, EU and International Standards for the biotechnology, healthcare and pharmaceutical industries. Our experience and expertise allow us to offer clear, compliant and transparent autoclave validation packages to our clients. We have in depth knowledge of all current EU and US regulatory requirements and can qualify your autoclave to EN285:2006, EN17665 and PDA Technical Report 01 in order to meet FDA, IMB and or MHRA expectations.
Validation services and support we offer include:
- Installation/Operation Qualification (IQ, OQ)
- Performance Qualification (PQ) &
- Re-Qualification (RQ)
- EN 285:2006 Testing
- Audits and consultancy support
- HTM 01-05 Testing
We use GE Kaye Validator 2000 and wireless data loggers capable of recording results every second, this gives a detailed analysis of your temperature critical environment.
Our knowledge of industry guidelines for the US and EU are key to our ability to offer you a clear and compliant validation approach and process.
We perform temperature mapping on healthcare, laboratory, process and storage equipment including:
- Freeze Driers
- Depyrogenation Tunnels
- Liquid Nitrogen Tanks
TCL offer a wide variety of equipment for rental or purchase to help improve your testing processed.
We also offer GE Kaye Validator thermal validation data logging systems for rental along with thermal baths from -80°C to 400°C, IRTD-400s and thermocouples.
We do not impose a minimum hire period, all rented equipment is delivered in protective casing and additional accessories are also available.
Please feel free to contact us to discuss how Thermal Compliance can help you with your testing needs and processes.