| Peter Jackson at Elpro reviews the challenge of managing cold chain records in regulated environments, and discovers how it is being made easier
True innovations in cold chain monitoring are a rare occurence and, since 1990, the pharmaceutical industry has continued to use conventional dataloggers. Over time, these devices have evolved and become more accurate, smaller and less expensive. The PDF logger that we talk about in this editorial, however, can be regarded as making a milestone in this area: no longer is software required at the destination in order to evaluate data; this saves precious time and considerably speeds up the work process.
The perishable nature of many pharmaceutical products means that it is often necessary to keep records of the temperatures experienced during transportation for regulatory purposes. This means selecting and implementing a suitable monitoring system for the task in hand, whilst considering factors such as:
- Specification and functionality temperature range should be monitored, and accuracy, alarms, delays, log interval, data storage and structure of report examined.
- Installation, training and validation needs to be carried out at all sites using the equipment.
- SOP needs to be written for the equipment being used.
- What happens if excursions occur? analysis, MKT, special reports, and remedial action.
- Calibration is it required, how often is it required, who does it, and where?
- Logistics how do you get the recorded data to the people that need it?
There are many solutions available for generating records and several ways of performing the task. The technology involved has generally moved forward slowly and this is for good reason. The critical nature of this data means that unnecessary risk is naturally avoided in favour of a tried and tested solution. With the traditional method, temperature sensors and chart recorders were used. This provided a simple and convenient paper chart of the recorded temperatures. However, the perceived shortfalls of these devices include the consumable items requiring replacement such as pens and charts, the amount of paper collected, and the possible misinterpretation of charts and the mechanical nature and size. The records are quite simple to handle in a regulatory compliant way as typically only a signature is required before archiving. |
