Validation of Eurotranspharma refrigerated trucks

Validation of refrigerated trucks for Eurotranspharma: ensuring good distribution practices in healthcare logistics

Eurotranspharma is a multinational logistics company specializing in the distribution of temperature-controlled healthcare products. As a result, it must comply with very strict legislative requirements under European and Czech legislation, in particular the GDP (Good Distribution Practice) rules. These emphasize ensuring temperature stability during transport and storage so that medicines and medical supplies are delivered in safe and controlled conditions.

 "We have been working with your company for about two years now, and I particularly appreciate your flexibility, reliability, and fair approach—whenever we needed something, we found a common solution and everything was done as agreed. We are satisfied with both the quality of the services provided and the communication."

— Tomáš Ďurďa | Managing Director | Eurotranspharma

Project description

To ensure compliance with GDP, Eurotranspharma needed to develop temperature maps and validate the refrigerated spaces used for transport.

The aim was to verify that the cargo space met the specific temperature requirements for the transport of sensitive materials, based on data from a network of calibrated sensors.

Temperature mapping and validation are now essential steps for all entities that handle medicines or medical supplies. Without them, it is impossible to prove that transport is carried out in accordance with good distribution practice (GDP)

Solution from KALIST AKL s.r.o.

KALIST AKL, which has been operating on the Czech market for more than 15 years, was selected as a partner thanks to its experience in the field of calibration, validation, and measurement of environmental temperature homogeneity.

The following were used as part of the project:

• calibrated measuring instruments and recording technology from an accredited calibration laboratory,
• methodologies complying with GDP requirements and European standards,
• validation procedures including both static and dynamic measurements in real operating conditions.

Kalist adapted the solution to the specifics of the logistics environment – temperature stability was measured in various temperature regimes, in empty and loaded cargo spaces, including simulations of real loading, transport, and power failure.

Result and benefit

The project resulted in the preparation of a validation protocol containing data on sensor placement, temperature graphs, tables of measured values, and statistics used to evaluate and confirm compliance with the quality and safety requirements for reprocessed products and compliance with all legislative requirements.

The cooperation has brought:

• certainty for Eurotranspharma's customers that their products are transported in accordance with GSP,
• full traceability and verifiability of conditions during audits. 

KALIST AKL is a reliable partner for all companies that need refrigerated vehicle validation, meter calibration, or temperature map processing. Thanks to its many years of experience and accredited calibration laboratory, it can offer solutions that meet the most stringent standards of healthcare logistics.

If you are interested in our services, please do not hesitate to contact us. We are happy to assist you.