Passive refrigerated packaging prequalification testing versus real life performance

Passive packaging solutions require a rigorous validation process to ensure they meet the required temperature specifications of the pharmaceutical Industry. This includes testing for temperature stability, thermal performance, and other influencing critical factors.

But 37% of validation testing are not being representative to real world use*.

A very important and fundamental variable of the qualification process of a package, is the use or non-use of thermal mass. The result varies significantly by acting on the amount of thermal mass used for pre-qualification.

The second variable that is very important for the result of passive refrigeration packaging, is the positioning of the temperature sampling probes. If the probe measures air, or is immersed in a liquid, or placed in the middle of a large thermal mass, it completely changes the result of the test. It is very important that these aspects are considered when reading a pre-qualification documentation of a passively refrigerated isothermal packaging.

Exposing the test package to external official summer or winter temperature scenarios does not mean that this reflects the real-life exposure. Whatever temperature exposure we will choose will be an estimation of what will the be the real logistic scenario.

Real-life performance of passive packaging systems can be affected by various factors such as extreme weather conditions, long exposure timings, handling deviations, and prologued adverse storage conditions. These factors can impact the system's ability to maintain the required temperature range, leading to potential excursions and compromised product quality.

It is highly suggested, especially for high valuable and regular businesses, to make some real shipment testing, with the pre-qualified packaging and a dummy product involving all stakeholders of the logistic chain part of the transport.

This phase can sometimes lead to few internal assembly adjustments even for pre-qualified packaging’s.

In summary, passive refrigerated packaging validations are essential to ensure the reliability and effectiveness of these systems. However, real-life performance can be affected by various factors, and careful consideration must be given to these factors when selecting and implementing passive packaging solutions.

MdG and its partners can support you with products and consultancies that are going far beyond the standard packing supplier services, by choosing the right product, the right development and analysing also the eventual final adjustments. Feel free to contact us at [email protected] .

*Survey PharmaLogisticsIQ