GMP Temperature Mapping and Validation Services
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Thermal Compliance provides temperature mapping, humidity mapping, CO2 Mapping and validation services for temperature critical equipment. We perform testing over a range of -196 to 400°C and 0 to 95% RH.
We use Amphenol Kaye Validator 2000, Ellab Tracksense Pro, Ebro and Vaisala Veriteq data logging systems capable of logging every second to give a detailed analysis of your temperature critical environment performing work to either our Standard Operating Procedures (SOPs) and protocols or clients own documentation.
Our knowledge of industry guidelines for US and EU such as the Orange guide, ICH guidelines and ASTM E2500, is key in providing you with a clear and compliant validation approach. |
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We generate and execute Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Re-Qualification protocols, with testing including:
We perform temperature mapping and validation on pharmaceutical, biotech, healthcare, process, laboratory and storage equipment including:
Laboratory, Process and Product Storage: Incubators; CO2 Incubators; Shaking Incubators; Stability Cabinets; Humidity Chambers; Ovens; Fridges; Freezers; Ultra Low Temperature Freezers; Cold Stores; Freezer Rooms; Warehouses; Liquid Nitrogen Tanks (LN2); Steam In Place (SIP) and Lyophilisers (Freeze Driers), |
Work can be performed to Thermal Compliance protocols or work to your own onsite protocols. We deliver a comprehensive validation package including calibration certificates, annotated detailed raw data reports, graphs, photographs, probe location diagrams and detailed report.
We use a variety of different systems to perform temperature mapping based on client requirements, accuracy, response time and volume of work to be completed. We use Ellab Tracksense Pro, Kaye Validator 2000, Vaisala Veriteq and Ebro dataloggers. All of our systems have been validated and are 21 CFR Part 11 compliant.
We use a variety of different systems to perform temperature mapping based on client requirements, accuracy, response time and volume of work to be completed. We use Ellab Tracksense Pro, Kaye Validator 2000, Vaisala Veriteq and Ebro dataloggers. All of our systems have been validated and are 21 CFR Part 11 compliant.