Passive Kühlung von pharmazeutischem Transportgut Inwieweit können erhaltene Ergebnisse dazu genutzt werden, um allgemeingültige Aussagen zur Transportsicherheit zu machen? Michael Pfeiffer Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim/Rhein Korrespondenz: Dr. Michael Pfeiffer, Global Quality Services, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173, 55216 Ingelheim/Rhein (Germany), e-mail: michael.pfeiffer@boehringer-ingelheim.com Passive Cooling in Pharmaceutical Transportation/Use of obtained results for the Assessment of Transport Safety Goods to be transported were kept at varying external temperature conditions within a pre-defined temperature “range” of (5 ± 3) °C by means of pre-cooled, 4 °C, thermal packs. From the results obtained, similarities were tried to derive with respect to similar behaviour of goods being exposed to different external temperature conditions. To recognize similarities might be important as with the Arzneimittel- und Wirkstoffherstellungsverordnung (ordinance on medicinal products and active pharmaceutical ingredients manufacture, AMWHV) coming into force in Germany end of 2006 it is expected by authorities, that the harmlessness of the transport with respect to the quality of the goods been transported has to be proven in all cases. As there are numerous factors, e. g. fall, collision, light intensity, temperature, realtive humidity etc. to be considered in the transport of goods, every single transport had – theoretically – to be assessed restrospectively for possible negative impact on these goods. As it is not possible to retrospectively assess each single transport, the investigations been published here were used for possible prospective predictions. As variable factor, “temperature” was chosen, as temperature might have a major influence on the goods during transport. Similarities could only be shown in a few cases and correlation could hardly be proven. As it is, despite of the results presented, furthermore not possible to retrospectively assess possible influences of each transport onto transported goods, additional investigations are to be performed. Whether these investigations are to be performed by the haulage- or by the pharmaceutical companies was not subject of this publication, and is further dependant on the content of the individual contract between pharmaceutical manufacturer and haulage company [3]. Key words Influence of temperature on transport • Ordinance on medicinal products and active pharmaceutical ingredients manufacture (AMWHV) • Transport • Validation |
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pharmind 2011, Nr. 3, Seite 582
