Thermal Validation
What is Thermal Validation in the Pharma Industry?
It refers to the process of verifying the performance of equipment used to control temperature-sensitive processes. This includes processes such as storage, transportation, and production of pharmaceutical products. The aim of thermal validation is to ensure that these processes are consistent and that the temperature is kept within specified limits to ensure product quality and efficacy.
The thermal validation process involves data loggers, temperature probes, and other monitoring devices to measure and record the temperature of the equipment and the product being stored or transported.
Our top thermal validation services include:
- Equipment qualification: Verifying that the equipment used in temperature-sensitive processes is suitable for the intended use and can keep the desired temperature within specified limits.
- Monitoring and data collection: Using data loggers, temperature probes, and other monitoring devices to measure and record the temperature of equipment and products during storage, transportation, and production.
- Data analysis: Evaluating the data collected from monitoring and data collection to verify that the temperature control system is functioning within the desired range and can support a consistent temperature over time.
- Documentation and reporting: Documenting the results of thermal validation assessments, including any deviations or issues found, and preparing reports that summarize the findings.
- Re-validation: Regularly re-evaluating the equipment and processes used in thermal validation to ensure ongoing compliance with regulations and to keep product quality.