Our Validation Services – Shipping Validation Envirotainer RKN e1

Aphex recently undertook a body of work for a biologics company based in Dublin whereby they were required to pick a suitable mode of transportation for their time and temperature sensitive material. This project involved following the client’s VMP, and assessing the various shipper options available to them. The decision was made to go with the tried and trusted Envirotainer RKN e1 system (pictured below). An overview of the documentation generated included a User Requirement Specification (URS), an IOQ protocol and report, as well as a Process Validation Protocol and Report. Once the system was qualified by Aphex, we rationalised the number of shipping runs that would be carried out during the hot and cold seasons via a risk assessment. Please see picture below showing the temperature trend of the Envirotainer RKN e1 once it was loaded with the client’s time and temperature sensitive material. The trend is from our own Lives Xpert Log system where we positioned data loggers on the consignment as well as positioning one data logger outside of the unit to obtain a read of the ambient temperature throughout the transit profile. As you will notice there was a spike in the temperature in one location in particular. Lucky for us we included in the protocol a section to include photographic evidence of the data loggers in position during loading and unloading. During the unloading event, one of the data loggers fell off of the consignment, thus providing us with spurious readings. As a consequence of this we raised a deviation and performed a quality impact assessment. Without the photographic evidence it would have been difficult to identify the root cause. Immediate thoughts would have been potential equipment failure, however, the Envirotianer RKN e1 is solid as a rock. Moral of the story, if it’s not documented, then it didn’t happen!


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