Thermal Validation

Interested in checking the prevailing temperature and/or relative humidity in an entire room?

By conducting a temperature study at various points, you can gain insight into the temperature distribution, hot and cold spots, and whether measured values remain within a set bandwidth.

By having the measurement carried out by an accredited organisation (accredited by the Dutch Accreditation Council), the results of the measurements can be demonstrably traced to national and international standards.

Why a Thermal Validation?

With a thermal validation you create insight into the temperature limits of your equipment/rooms that are used for critical processes. In many cases, your regulatory authority will ask you to demonstrate what your temperature limits are. In some cases this must even be demonstrated in different seasons and in a number of cases the studies must be performed with different loads. So-called ‘open door’ and ‘power-down’ analyses may also be performed to demonstrate the robustness of systems. Whatever your wishes and requirements are, Kalibra will always draw up a custom protocol so that all guidelines and expectations are clearly communicated.

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Determining the Temperature Profile

During a thermal validation, Kalibra will perform a mapping to determine the temperature profile of the room or device. By conducting measurements in multiple positions, the homogeneity and stability of the temperature in the room can be determined.

The number of positions at which measurements are taken, and the length of the inspection(s) can be determined in mutual consultation and always meets the requirements of, for example, the GDP, GLP, GMP, or WHO. If the temperature in the conditioned zone depends on the ambient condition (outside air temperature), the measurements must be carried out in different seasons.

Depending on the desired accuracy and technical possibilities, the inspections can be performed with wireless loggers or thermocouples. Depending on the choices made here, the air temperature and/or product temperature can be measured.

 

In Which Rooms and On Which Equipment Do We Conduct Thermal Studies?

Kalibra specialises in conducting thermal studies on various types of equipment and spaces in various markets, such as (accredited) laboratories, pharmacy, and the food industry.

Common spaces and equipment on which thermal studies are performed include:

  • (CO2) incubators and ovens;
  • Refrigerators and freezers;
  • Ultra low freezers;
  • Walk-in cold stores and freezers;
  • Warehouses;
  • Transport vehicles;


Certainty and Traceability Thanks To Thermal Validations

When performing its validations, Kalibra uses (inter)national guidelines. We are happy to discuss the guidelines that are relevant to your company. We will incorporate this in a protocol that will form the basis of the thermal studies we carry out. In this way we ensure a relevant thermal validation in line with your wishes.