The temperature mapping study is a fundamental element for the qualification of cold rooms and / or refrigerated vehicles as well as an essential element for being a supplier to the pharmaceutical industry.
Since 2013 with the introduction by the European Union of GoodDistribution Practice of medicinal products for human use, all players in pharmaceutical logistics must have this documentation. MdG with many years of experience in this field, offers a kit, designed according to the needs and dimensions of the customer’s environment that is easy to install. Our staff dedicated to this service follows the study in real time and warns you if something does not comply, BEFORE issuing the final report. This saves valuable time and significantly shortens the overall time. All data are never downloaded manually and remain intact in compliance with FDA 21 part11 and are transmitted via Rfid datalogger directly to the cloud platform without any need for physical data download.
Il vantaggio di poter gestire l’intero studio via cloud evita inutili rischi e costi di viaggio per il personale coinvolto ed aumenta notevolmente il rapporto costi/benefici per il cliente. The advantage of being able to manage the entire study via the cloud avoids unnecessary risks and travel costs for the staff involved and significantly increases the cost / benefit ratio for the customer. This allowes us to support customers all over the world making us a point of reference on the global level.
What we provide you:
- A kit consisting of all the necessary hardware and necessary equipment customized for the customer’s needs
- The protocols for the correct installation of the loggers
- The necessary operating procedure
- A dedicated staff that follows you step by step throughout the entire study (Summer and Winter)
- All final reports in line with EUGDP, WHO, FDA and IATA CEIV requirements
- A stress test (door opening) and a failure test (motors malfunction)
The study can be carried out on all types of refrigerated vehicles and containers with active refrigeration for sea transport (Reefer) when empty and in operation.
- Big trucks such as road feeder services
Temperature controlled warehouses:
Based on the size and conformation of the environment, our dedicated staff determines the number of sensors required (in line with the WHO technical report) and prepares the kits.
We carry out the study on every controlled temperature environment, whether it is pharmaceutical distributors, airports, freight forwarders, small cold rooms or big warehouses.
We can also carry out mapping studies on freighters and passenger aircrafts by positioning our loggers in the various cargo loading compartments and monitoring certain critical routes.