Validation of refrigerated vehicles and trailers.

Validation of refrigerated vehicles, trailers and cars for transporting pharmaceuticals.

We perform validation of cargo spaces of refrigerated vehicles for the transport of thermolabile materials and pharmaceuticals. The result of the validation is a validation report which proves that the cargo space meets the temperature conditions for storage and transportation of materials. These are mainly refrigerated vehicles for the transport of pharmaceuticals and other medical devices.

Validační zpráva je doklad, kterým dopravce prokazuje, že je vozidlo vhodné a splňuje požadované teplotní limity. Validace je nejčastěji požadována kontrolními úřady, jako je SÚKL, WHO, SZPI či jiný kontrolní orgán. Validaci chladícího vozu však může požadovat i některý z výrobců či odběratelů, kteří kladou nároky na dodržování povolených teplotních limitů.

Validation is performed according to the procedure in the scope:

• operational qualification OQ
• process qualification PQ

What tests does the validation include?

An internal procedure is observed that meets all the requirements for the correct performance of the validation. In almost all cases, the test includes:

• A static test in the empty state of the cargo space.
• A static test when the cargo space is loaded.
• A test during driving.
• Simulation of loading and unloading.
• Test with simulation of failure.

Tests can of course be added individually, according to customer requirements.

Equipment and method of validation

We use accurate, fast-response devices with temperature sensors that can efficiently cover the mapped area. All sensors have accredited calibration. The calibration certificates of the sensors are internationally accepted under the international multilateral agreements EA MLA and ILAC MRA.

Certificate of accreditation

During validation, emphasis is placed on the most accurate measurement possible. The installation of the temperature sensors in the refrigerated part of the vehicle takes into account the design of the measured area. In particular, information on whether the space is separated by a partition, where the entrance to the cargo space is and where unloading and loading takes place. The number and location of the refrigeration unit exhausts is also important.

The internal validation procedure is used to ensure that the validation is performed correctly.

What do you need to know and what to prepare for?

The testing and measurement process is mainly time-consuming. During the validation it is necessary to simulate the real operation of the vehicle. It is therefore good to know:

• What is the temperature range that has to be observed?
• If the vehicle operates in more than one temperature mode, it is important to know the individual temperature ranges.
• What is the longest distance the vehicle will travel?
• What time of year do you want to validate? Most often validation is performed in winter and summer.
• If the customer can provide a driver to perform the test during the drive, it is possible to give a discount on the validation.

Kontakty a informace

More detailed information about temperature maps you can find in the related subcategories. For interest, consultation or quotation, please contact us by email or phone.