For comparison: Conventional cold chain monitoring

Daily, thousands of temperature sensitive pharmaceutical products are being shipped at temperatures between 2° to 8°C. Data loggers accompany most of them in order to securely retrace climate conditions during transportation.
 
In general, the pre-programmed data loggers are placed with the goods in a suitable position. Then after transportation, the data loggers are unpacked and analyzed by means of specific software. This software produces a report including graphics for the duration of the journey that is often sent back to the sender for review. The sender is then able to make a judgment on the condition of the goods and provide authority to use. Up until now, neither the software, nor the data file nor the analysis reports were standardized. The various systems (local PC, Internet, RFID) were not compatible with each other and generated incompatible file formats as no international standard was established. This makes long-term preservation of data and reports challenging.
 

Comparison on the total cost
With conventional systems, the following items are essential but are huge factors contributing to the overall cost.

  • System introduction including user training
  • Installation and maintenance of the analysis software (up-date roll-outs, end user support)
  • Generation of individual standard operating procedures (SOP)
  • Qualification of software and interface (IQ/OQ)
  • Secure compliance with GLP/GMP and FDA (21 CFR 11)
  • Archiving and long-term preservation of data
 
Thanks to LIBERO, the PDF Logger®, logistics costs will be optimized and cost efficiency will be increased.