Efficient, Accurate and
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Specialising in Large Projects
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GMP Temperature Mapping and Validation
At Thermal Compliance, we specialise in the validation of controlled temperature units. Our engineers are highly experienced in a wide variety of equipment, from Liquid Nitrogen Freezers to Dry Heat Ovens.
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We work to Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP). We work with Pharmaceutical, Healthcare and Life science companies.
Documentation and Software
We believe in a flexible approach and are happy to work to Thermal Compliance Protocols and SOPs or your own site documentation. Our protocols are bespoke to your process and equipment, and we are happy to assist in writing documentation to your requirements.
We can advise on acceptance criteria which is tailored to your critical process parameters, from the User Requirement Specification (URS) through to the Installation Qualification Operational Qualification (IQOQ), Performance Qualification (PQ) and the ongoing Requalification (RQ).
Our reports include raw data generated by our software, clearly displaying results and customised to your requirements. Our reports can include:
We can advise on acceptance criteria which is tailored to your critical process parameters, from the User Requirement Specification (URS) through to the Installation Qualification Operational Qualification (IQOQ), Performance Qualification (PQ) and the ongoing Requalification (RQ).
Our reports include raw data generated by our software, clearly displaying results and customised to your requirements. Our reports can include:
- Minimum, Maximum and Average Temperature for each location and globally
- Mean Kinetic Temperature (MKT), if required
- Full detailed reports listing every log
- Clear graphical data, detailing every sensor
- All Calibration Certificates (UKAS or UKAS Traceable)
- Loaded and Empty Distribution Studies
- Loaded and Empty Penetration Studies
- Door Open, Power Off and Pull Down Studies
- Clear Sensor Location Diagrams
- Non-Conformance Reports
If you would like to know more about our documentation, please let us know. We have executed temperature mapping protocols performed in our training and development laboratory, one of our engineers would be happy to visit site and go through these with you.
Temperature Mapping Dataloggers
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We use the latest datalogging technology to ensure our clients have the best possible data, with accuracies from ±0.05°C. The systems we use are 21 CFR Part 11 compliant and are calibrated to UKAS or Traceable to National Standards. The software generates clear and concise reports speeding up the review process. We use Ellab, Kaye and Vaisala dataloggers, to ensuring we have the best system for your application. For more information about the temperature mapping systems we use, please visit our dataloggers page. |
ATEX Certified Loggers for Potentially Explosive Environments
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Our engineers work in a wide range of sites and we have a large amount of test equipment to suite our clients requirements. For ATEX environments we use Ellab Tracksense Pro X dataloggers. These sensors have a permitted range of -60 to 105°C within an ATEX Environment. Tracksense Pro X loggers have been certified to ATEX IEC 80079-34. If you would like to know more about how we can help you, please call us or email info@thermalcompliance.co.uk |
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