Transportqualifizierung am Beispiel der temperaturgeführten aktiven Downstreamlogistik
Dr. Nicola Spiggelkötter1 und Carsten Glos2
Knowledge & Support1, Bad Harzburg, und trans-o-flex ThermoMed2, Weinheim
Qualification of Active Cooling Units – Points to Consider
Temperature-controlled shipments cover a wide range of transports from pharmaceutical manufacturer to grossists, distributors, pharmacies and end users with a definite range of temperature obligatory during transit. Common temperature requirements are +2°C to +8°C, +15°C to +25°C and –15°C to –25°C. The last step of the pharmaceutical preparation is very manifold. Active and passive cooling systems are used to maintain the cold chain. Focus of this article is the validation of active cooling units that are used in vehicles distributing the products.
pharmind 2011, Nr. 10, Seite 1794