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Thermal Validation

Thermal Validation

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Engineer validating a steam sterilizer

Verifying temperature distribution and uniformity

Thermal validation involves assessing and verifying temperature distribution and uniformity in critical equipment and processes, to ensure consistent operation within specified parameters and applicable sterility assurance requirements.

Wired and wireless systems

We provide wired thermocouple systems and wireless data loggers for monitoring and recording thermal cycles, with wired systems facilitating real-time data acquisition.

Thermal validation is also undertaken for vessels and other temperature-sensitive equipment and processes, to verify compliance with specified operating parameters. It may also be carried out through temperature mapping and steam quality testing.

Temperature mapping

Temperature mapping deploys a grid of calibrated sensors to identify temperature variations, including hot and cold spots, across storage and production areas. It assesses temperature distribution across large storage spaces and high racks, including areas near doors, ceilings and HVAC vents.

In cleanrooms, temperature mapping verifies the ability of HVAC systems to maintain specified temperature uniformity despite heat loads generated by personnel and machinery. The resulting data helps assess environmental control and determine suitable locations for permanent continuous monitoring probes.

Steam quality testing

Steam quality testing assesses the quality of utility steam used in autoclaves, to ensure it meets specified requirements for effective sterilisation. It evaluates three key parameters:

≤ 3.5%Non-condensable gasesMinimises the risk of air pockets.
≤ 25 °CSuperheatEnsures appropriate steam conditions.
0.90–0.95Dryness valueFor porous loads (≥ 0.90 for non-porous loads), to minimise the risk of wet packs and ensure effective steam penetration.

Instruments

Kaye thermal validation system Thermal Validation Systems View products Kaye ValProbe RT ValProbe RT Wireless Loggers View product GAMPWLD26C mapping datalogger GAMPWLD26C Mapping Datalogger View product

Related pages

Pharmaceutical thermal validation Medical device thermal validation Lyophilizer thermal validation Retort validation

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