PhaRmaK-Beratung UG, an independent service provider for pharmaceutical consulting and training, has certified the Cool and Cool–PurFerro quality refrigerated semi-trailers made by Kögel. This pharma certificate can be used by Kögel customers as proof for shipping agents that the refrigerators meet the pharmaceutical standards according to GDP 2013 and are thus ideally suited for transporting medicinal products.
When it comes to transporting medicine, infusions, vaccines and medical devices, the pharmaceutical industry requires optimal conditions and proof of an unbroken cooling chain. Very specific temperature regulations and laws apply to these consignments, most of which are worth several hundred thousand euros.
To meet these stringent requirements, the refrigerated semi-trailers can be equipped with the Kögel Telematics system and with a powerful cooling system. The telematics system ensures the unbroken documentation of the cooling chain, thanks to its integrated memory function and the direct transmission of data to the telematics internet portal. Several specially calibrated temperature sensors cover the entire temperature range from –25° to +25° centigrade inside the refrigerated semi-trailers.
The pharmaceutical certificate thus meets all the requirements that the vehicle manufacturer needs to fulfill in respect of the refrigerated semi-trailers. This includes installation qualification (IQ) and operational qualification (OQ). The performance qualification (PQ) must be handled on site by the customer. At this point the entire process - from warehouse to the end customer - is reviewed.