Pharmaceutical transport - why mapping of a trailer is so crucial?
The transport of pharmaceuticals requires the participants of the supply chain to comply with strict temperature conditions at every stage of distribution. Appropriate temperature must be maintained not only in warehouses, warehouses or reloading chambers, but also in means of transport used to transport the medicinal product. In order to maintain a constant temperature in the cargo compartment of the vehicle, a number of tests and tests are performed.
Mapping of the cargo space of vehicles used in the transport of medicines
The transport of medicines at controlled temperature can only be operated by qualified vehicles, i.e. those that have the required documents and tests. One of them is the mapping of the temperature distribution in the cargo space, which is a basic requirement in pharmaceutical transport set by the guidelines of Good Distribution Practice.
GDP certified carriers are responsible for ensuring and maintaining special transport conditions, which are:
- maintaining the appropriate temperature for the transport of drugs
- air humidity at the required level
To meet these requirements, the temperature distribution in the cargo area is mapped.
Mapping is a study of microclimate stability (temperature and humidity) in isotherms at representative points (with the highest risk of fluctuations) in representative atmospheric conditions (highest and lowest possible temperature and humidity).
Safety of ensuring the right temperature for the transport of medicinal products thanks to mapping
Maintaining constant temperature conditions is the basis for the transport of pharmaceutical products. Temperature requirements must be maintained from pick-up point to drop-off point.
If an inadequate temperature is maintained in the cargo compartment of the vehicle, it can cause:
- material losses - costs related to the disposal of damaged products, explanatory processes
- intangible losses - loss of health or life of the patient
In order to minimize the risk associated with temperature deviations, tests of temperature distribution in the cargo space are carried out. Such a test confirms that the cooling or heating units maintain the temperature in the entire cargo space at the appropriate level, and it is not affected by external conditions (both extreme winter and summer conditions).
What is the process of mapping the means of transport used to transport medicines?
The study of the temperature distribution begins with the fact that temperature recorders are placed at designated points. These places should be located in critical areas, i.e. around the ceiling, walls, in the vicinity of heat sources or near doors.
Sensors collect data at designated measurement points and record temperatures over a designated period of time. The confirmation of the mapping process is a detailed report with the research methodology and, preferably, a graphical representation of the temperature distribution in the mapped cold store. The summary of the tests allows you to check whether the tested cold store meets the requirements and can be qualified for transport at a controlled temperature and whether it does not require any modifications.
What to look for in the temperature mapping process?
In order to ensure the highest quality of transport services for drugs, we strive to meet the restrictive requirements regarding the mapping of the means of transport, which are set both by the requirements of the Regulation of the Minister of Health and by customers from the pharmaceutical industry:
- to reflect the entire process of transporting pharmaceutical products, it is recommended to conduct a temperature distribution test for a minimum of 24 hours
- the test should be carried out in extreme temperature conditions (summer and winter conditions) to reflect the weather conditions in the countries to which transports are made
- as part of the mapping process, unit failure and door opening tests should be carried out to check after what time the temperature will change and how long it will take to return the temperature to the set level
Transport of drugs at controlled temperature is a type of transport that is carried out in accordance with the pharmaceutical law and DPD requirements. The requirements of the above standards impose on the carrier the necessity to conduct examinations and tests that will guarantee the safety of maintaining the appropriate temperature throughout the transport and ensure that the temperature control devices are operational and calibrated.
As a GDP-certified carrier, we have a fleet of vehicles that meets even the highest customer requirements related to the methodology of mapping pavements used for transports at controlled temperature. Our vehicles have a report on 24-hour tests of the temperature distribution in the cargo space, including tests of door opening, temperature stability and unit failure.
Pharmaceutical transport is the type of transport in which we specialize - if you have any questions or want to learn more about how we provide the right conditions for transport - please contact us! Tel. +48 519 756 785