Validation: Temperature Controlled Units

September 06, 2019

Temp Controlled Units

By: Morgan Hulsey, Director of Validation & Commissioning

Validation of temperature-controlled chambers is a critical component of a robust process and/or facility qualification plan. Validation includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), with temperature mapping being a vital component of OQ and PQ activities. Temperature, and related parameters such as gas percentage or relative humidity, of storage or processing devices is a vital aspect to process outcome and product quality. Temperature mapping, along with associated IQ and unit review activities, provides the assurance needed that your temperature-controlled devices will reliably maintain specified temperature.

What is temperature mapping?

Temperature mapping provides quantifiable data to understand the distribution of temperature throughout temperature-controlled units. Temperature mapping requirements will vary based on expected use of each unit and process critical parameters, but generally include a pre-defined number of monitoring locations to be mapped over a minimum of twenty-four hours. Data is reviewed to provide deviations from min. and max. temperature points, averages, Mean Kinetic Temperature, or other statistical data points relevant to your device and process.
Along with temperature, other parameters (such as relative humidity) may require logging and data analysis.

When should you perform temperature mapping?

Evaluation of temperature-controlled device validation/qualification requirements should be considered as part of the Validation Master Plan for your facility. Where the reliable maintenance of temperature is required to effectively store components or product, validation of temperature-controlled units is generally required. Re-qualification or temperature mapping only may also be considered when full IQ, OQ, PQ is not required.

Technical Safety Services can support the mapping, qualification, or validation of your temperature-controlled devices, in all temperature ranges from freezers to furnaces, nation-wide.  Call us today at 800.877.7742 or contact your local TSS office to discuss how TSS can support your qualification or validation needs.

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