Fundamental aspect to consider when programming alerts of a datalogger for pharmaceutical shipments

Data loggers are essentially used for monitoring temperature and humidity levels, recently trackers also light, shock and geo location parameters during the storage, transportation, and manufacturing of pharmaceutical products. This ensures that pharmaceutical products are kept within the required temperature and humidity ranges to maintain their potency and efficacy. In few words they maintain product integrity during storage and transportation.

The pharmaceutical industry is heavily regulated, and data loggers play a crucial role in ensuring compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). Data loggers provide documented evidence of proper storage conditions, which is necessary for regulatory audits and inspection, but programming them correctly with the right alarms is crucial.

All alarms need to be in line with the required temperature range in which the product or the package is exposed or transported. Excursions from the required temperature range are considered an event. On the market we have a wide range of device types that can be programmed in different ways and with multiple event alerts. The definition of these event alerts is very important and can be single event and cumulative event.

A single event alarm is triggered when a measurement value exceeds a setpoint only in one single event. This means that the alarm is triggered when the measurement value crosses the setpoint for a defined period of the alarm delay.?For example, if a temperature data logger is set to trigger an alarm when the temperature exceeds 25°C for 5 minutes, the alarm will be triggered only when the temperature reaches 25°C and over a minimum of consecutive 5 minutes, if it if less than 5 minutes, the single event will not be recognized.

A cumulative alarm, on the other hand, is triggered when a measurement value remains above or below a setpoint cumulating several events. This means that the alarm will be triggered when a total amount out of range has been reached. For example, the device is programmed for alerting excursions over 8°C for 30 minutes, the alarm will be triggered when the 30 min will be reached, in one consecutive event or also in more events cumulating the excursion timings up to 30 min.? Ex 10min no alert +5min. no alert +16min.--> alert

The start delay is also a very important setting, which allows you to set a delay period before the datalogger starts creating alarms at the beginning of the monitoring. This can be useful in situations where you want to ensure that the initial measurement value (that is out of the required range) must not trigger an alarm.

Example, when the datalogger was stored out of the cold chain and need to be acclimatized in the box or cold room, or if we warm the device up with our hands or if the refrigerated vehicle needs to be precooled.

Ask our customer service about programming features when you purchase your device at MdG, for more info please contact us at [email protected].