The use of data loggers made sense for the transport of temperature-sensitive pharmaceuticals, according to Christian Strauch, Senior Surveyor, Pharma Claims Expert at Battermann & Tillery GmbH.
In a recent IUMI article, a shorter version of an article on the B&T web site, Strauch observed that research, development and production of a drug usually lay in the hands of a pharmaceutical company, but that this circumstance changed the moment the product left the manufacturer’s facilities. At this point the sphere of influence was handed over to logistics service providers for shipment. This could pose “a significant challenge given the strict requirements surrounding temperature-sensitive products”.
Full documentation of compliance with the required temperatures was indispensable, Strauch said. Deviations, grey areas or recording gaps often led to a total loss of the goods. The qualified person, who decides on whether pharmaceuticals are released for sale, confirms the efficacy, quality and safety of a medicinal product prior to its release and is prohibited by law from releasing questionable pharmaceuticals.
If for example a recording gap resulted in a grey area that could not be resolved, impairment of the goods could not be ruled out. The qualified person would be obligated to assume a worst-case scenario, which often resulted in the destruction of the goods.
Incorrect or incomplete temperature recordings could result from technical failures. Even very mundane reasons, such as incorrectly placed sensors can trigger inaccurate or incomplete temperature records. In such cases, additional data loggers installed close to the product could provide reliable information. Recording devices installed in conveyances generally recorded ambient temperatures. In the event of short temperature fluctuations, the ambient temperature changes much more rapidly than the temperature in the immediate vicinity of the product. If sub-optimum temperatures temporarily prevail by mistake, and the error is detected and corrected swiftly, data loggers can be used to prove that the temperature of the cargo remained in the required range, said Strauch.
“In conclusion, the use of data loggers makes sense for the transport of temperature-sensitive pharmaceuticals. Their primary purpose is to provide a complete record of the temperature throughout transit thus enabling informed decisions regarding the usability and marketability of a product. As a result, very costly total losses may be averted”, said Strauch.
For the full version of this article https://www.ba-ty.com/news/