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16 December 2020

#Focus on Pharma: Coldtainer for pharmaceutical and biomedical industry

In the pharmaceutical field, Coldtainer professional mobile refrigerators are used for temperature-controlled transport of medicines and biological materials. From the maintenance of blood bags to the distribution of drugs, Coldtainer ensures the highest safety standards in compliance with the current regulations (GDP 2013/C 68/01, WHO 961/2011). Now days, health institutions are facing the rapid organization of mass vaccination campaigns against the Covid19 virus and Coldtainer provides offering its own range of products (in the past, the refrigerated isothermal containers have been used for mass-vaccination in critical areas). In particular, the FDH and NDH models with automatic cooling and heating system are suitable for biomedical transport because they guarantee constant temperature even under adverse environmental conditions. For accurate monitoring of the internal temperature, the optional EVlink module is available to display the operating data via the app. Furthermore, the possibility of having the protective cover for the EVCO controller and locking the handles, protects Coldtainer mobile refrigerators from the risk of tampering. For the most recent requirements the T0300 model, a passive isothermal container designed for maintaining the temperature at -80 ° C through the use of dry ice, is currently in production.

Coldtainer’s target group includes clinical analysis companies, public health authorities, universities and research centres, civil protection and military medical corps and logistic companies specialized in the distribution of medicines and biological material. The mentioned institutions use mobile refrigerators for the temperature-controlled transport of samples for laboratory analysis or clinical trials (with strict protocols to ensure the integrity of the materials) but also for blood and organs. On several occasions, Coldtainer refrigerated isothermal containers have been used by international government forces for the distribution of medicines and vaccines in emergency situations, such as the vaccination campaign of Syrian refugees awaiting political asylum.

The Coldtainer isothermal refrigerated containers can also be used for the transport of pharmaceutical and/or biological products, but are not classifiable as “Medical devices” in their own and therefore are not subject to the specific norms and directives. The use of Coldtainer professional mobile refrigerators makes it possible to comply with the provisions of the Guidelines of March 7th, 2013 on best practices for the distribution of medicinal products for human use, art. 9 (GDP). For the transport of diagnostic or clinical samples inside the Coldtainer mobile refrigerators it is necessary to follow the UN 3373 technical specifications (biological substances, category B) and use a 3-level packaging system, with the secondary container certified according to ADR regulation.

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