The German Medicinal Products Act has specific requirements concerning storage and transport of pharmaceutical products. The following passage can be found in Article 7 of the regulation: “ Raw materials, compounds and end products as well as samples must be stored in such a way that quality is not adversely affected and that mix-ups are avoided. Critical parameters concerning the storage and transportation must be checked and recorded so that compliance with the requirements can be confirmed. […] The storage containers and the internal transport containers must be designed so that the quality of their contents is not affected.“
The Cool Liner Pharma provides an exact model of how these legal requirements can be met. This is verified by Pharmaserv GmbH & Co. KG as well as the European Institute for Pharma Logistics GmbH. Pharmaserv certifies the Krone trailer at the Lübtheen production plant. In functional tests carried out over several days, the Cool Liner equipped with Krone telematics is tested under the toughest conditions. Numerous data loggers are placed in pre-defined positions in the vehicle superstructure to provide continuous monitoring of the temperature data and thereby a homogeneous temperature distribution in the superstructure. In addition, continuous external monitoring and control is carried out using the Krone telematics portal. The result: The values required by Pharmaserv, such as high thermal efficiency and even cold air circulation, along with stringent hygienic requirements are easily met using a combination of high grade components and expert workmanship.
In addition, Krone has also received the EIPL certificate for the Cool Liner. This certificate is issued by the European Institute for Pharma Logistics GmbH which specialises in knowledge transfer and services at the interface between the pharmaceutical and the logistics industries. Krone offers the pharmaceuticals certified Cool Liner with a variety of equipment options. The trailer body is available with side walls of 60 mm or 45 mm thickness. The fridge units can be installed for single or multi-temperature operation. The Carrier Vector 1950 T as well as Thermon King SLXe 400 and SLXe Spectrum are available ( each with optional remote evaporators).
The advantages at a glance
- Aufwand für IQ (Installations-qualifizierung) und OQ (Funktionsqualifizierung) entfällt (in der Praxis für jedes Fahrzeug erforderlich).
- Sicherheit bzgl. Pharma-Tauglichkeit des Trailers.
- Zeit- und Kostenersparnis.
- Im Bedarfsfall Unterstützung bei PQ (Leistungsqualifizierung).