Despite advances in technology, chemical-based temperature indicators are still widely used across the pharmaceutical sector - and while the price of the indicators may well be tempting, the risk you expose yourself to by using them is high.
How they work
Chemical-based indicators normally have one threshold, and they will tell you if your shipment has been subject to temperatures above “x”°C. Most are time vs. temperature, so what you will see is an indication as to how long the shipment has been above “x”°C. These indicators cannot normally be stopped. Once activated, they are always active - which makes them useless for record keeping.
Some chemical indicators require conditioning. For instance, if the indicator is designed to show you when the temperature has been above 8°C, then you must store the indicator below 8°C —meaning that you are likely storing your monitoring product alongside the very product it will monitor in transit, taking up valuable fridge space better used for your product.
Once active, always active
As previously mentioned, you cannot stop a chemical indicator once it is active. As far as keeping historic records of your shipments is concerned, these indicators are absolutely useless because the indicator will start to signal a problem the moment you remove it from controlled shipment conditions.
Has it? Did it? I've no idea!
Most indicators will change color if a certain temperature has been breached, however this may not always be clear to the eye. It may have partially changed color or not quite be the color it should be. This eludes to the biggest problem with indicators in that the results can be based purely on someone's judgement. Is there any real fact? That's debatable. So maybe you had a problem, maybe not. Is it worth the risk?
The benefits of going electronic
Firstly reliability - You do not need to pre-condition electronic monitoring devices, so that fridge space you had for your indicators can now be used for something more worthy. Also under the heading of reliability, we have accuracy. We can measure the accuracy of an electronic device, leaving no uncertainty as to whether or not the device is fit for purpose. Then of course we have data — actual data, such as graphs, tables, time and date stamps. If there has been a problem with your shipment, you will be able to see exactly when the problem occurred.
With electronic devices you have so much more flexibility and reliable, accurate data from which to make your decisions. Furthermore, with electronic devices it is possible to calibrate them, whereas it is impossible to calibrate a chemical indicator — leaving you with that uncertainty factor.
In cases where it is not always possible to use a device that requires data to be downloaded to a computer, Cryopak has a solution to offer the basic need of a chemical indicator with the reliability and accuracy of an electric device. The K1 Electronic Temperature Indicator fills this gap by offering the user “at a glance decision making’” from its LEDs. The K1 removes the uncertainty often associated with temperature indicators, giving a clear “Pass” or “Fail” – giving the user complete peace of mind that their decision will be based on fact and not an interpretation of potentially misleading information.
Click here to learn more about the K1 by Cryopak.
Author: Tom Harrington, Sales & Distribution Manager