Transporting vaccines and pharmaceuticals across the world presents a number of challenges, and there are many Cold Chain validation issues that companies face.
One of the most significant factors that affect the potency of a vaccine is its environment.
Vaccines shipped from one side of the world to another are exposed to enormous deviations in temperature and also harsh environmental conditions, and consequently are at risk of losing their potency.
Vaccines should be held between the critical 2ºC to 8ºC temperature ranges, and temperatures fluctuating outside these parameters are considered dysfunctional.
Consider the following situation: in the Cold Chain loop, the drugs are shipped from a hot 35ºC Melbourne summer, pass through Singapore where it is not only hot but also incredibly humid, then arrive in Germany at the height of their winter where the external environment is likely to be well into the minus temperatures, for example -10ºC.
The solution is to implement an adequate, validated Cold Chain system that doesn't have any "weak links." And unless you can accurately monitor what's happening to the vaccine in transit in every shipment, how can you possibly improve it?
The ability to continuously data -log shipments in transit with live, immediate access to the temperature data will also speed up the communications between all parties involved in the Cold Chain.
Current systems involve lengthy delays in waiting for data loggers to be posted back across the world so the sender can then download the data, prior to being able to make an executive decision about that shipment.
These delays can be resolved through implementing a web-based system. The Escort Temperature Management system, or ETM, can not only provide this instant information, but also adheres to the FDA 21 CFR PART11 world-wide regulation. User access is controlled by an administrator, who decides what information the Cold Chain parties can see.
To find out more information about how you can implement an efficient and effective Cold Chain system, contact Global Cold Chain Solutions for a demonstration.