A Failed Transport Test Often Begins with the Packaging Design
If your packaging fails during a transport test, what is the first thing you question?
For many teams, it is the test itself. Perhaps the vibration exposure was too long. Maybe the drop height did not reflect the actual distribution route, or the forces applied by the test equipment were simply too severe. Sometimes that may be true. But often, the test is only revealing a weakness that was already there. The packaging may be damaged during transport testing, but the real problem may have started much earlier, when the packaging system was designed. If the system was not developed to withstand the expected conditions of transport, handling, and storage, failure during testing should not come as a surprise.
That is why successful transport validation starts long before the packaged product reaches the laboratory. It starts with the packaging design.
What Happens After a Product Leaves the Factory?
Once a medical device leaves the production line, much of what happens next is outside the manufacturer’s direct control.
The product may be moved to a warehouse, stacked on a pallet, handled by a forklift, loaded onto a truck, transferred through several distribution centres, and transported in different vehicles before it reaches its destination. Along the way, it may remain in storage for days or even weeks. During this journey, the packaging is not exposed to just one major impact. More often, it experiences hundreds of smaller stresses: continuous vibration, stacking pressure, repeated shocks, frequent handling, and changes in temperature and humidity. Individually, these stresses may not seem particularly severe. Together, however, they can find the weakest point in the packaging system.
This is what transport validation is intended to assess. By representing expected distribution conditions in a controlled laboratory environment, it provides evidence that the product and its packaging can complete the journey without losing safety, functionality, or integrity.
Transport Testing Cannot Compensate for Poor Packaging Design
A reliable result depends on more than performing the transport test correctly.
Under ISO 11607-1, the packaging system should be designed with the product, sterilization process, intended use, and expected storage and distribution conditions in mind. The materials and packaging configuration should be suitable for the stresses likely to occur during handling, transport, and storage. For sterile medical devices, the system must also protect the sterile barrier until the point of use. When damage appears during a transport test, the test conditions should certainly be reviewed. But the assessment should not stop there. The packaging design itself should also be questioned. Were the materials suitable? Was the packaging configuration appropriate for the product? Was the distribution environment properly considered during development? Can the sterile barrier remain intact throughout the product’s journey?
Transport testing is where earlier design decisions are put to the test. It shows whether the packaging system that looked suitable during development can actually withstand the realities of distribution.
ISO 11607-1 and ISO 11607-2 Address Different Questions
Once the packaging system has been selected, the focus shifts to ISO 11607-2.
At this point, the question is no longer, “Have we chosen the right packaging?” It becomes, “Can we produce this packaging consistently, with the same level of quality every time?”
This is where the sealing process, equipment performance, process parameters, operator practices, and process repeatability need to be evaluated. In practical terms, ISO 11607-1 addresses whether the packaging system is suitable for the product and its intended lifecycle. ISO 11607-2 addresses whether the packaging process can repeatedly create that system at the required quality. The distinction may sound simple, but it is often overlooked. A well-chosen packaging material does not automatically guarantee a reliable package. In the same way, a well-controlled sealing process cannot correct a packaging design that was unsuitable from the beginning.
The Same Test Plan Will Not Work for Every Product
Another common mistake is using the same transport test plan for every project.
Products do not all face the same distribution risks. Weight, dimensions, packaging configuration, sterilization method, pallet arrangement, shipping route, distribution network, target market, and storage conditions can all affect what a packaged product experiences during transport. A lightweight device shipped locally in a small box does not have the same risk profile as a heavy, sterile product transported internationally through several distribution centres.
For this reason, a transport validation strategy should not begin with a standard list of tests copied from a previous project. It should begin with an understanding of the product’s actual distribution journey and the risks associated with it.
Passing the Simulation Is Only Part of the Story
A transport simulation recreates the mechanical and environmental stresses that a packaged product may encounter. But completing the simulation is not the final objective.
The real questions come afterward.
Does the packaging still protect the sterile barrier? Has the journey affected the product’s performance? Is the device still safe and functional when it reaches the user? These questions can only be answered through appropriate post-transport evaluation of both the packaging and the product. When transport validation is considered early in product development, potential weaknesses can be identified before the product reaches the market. Packaging materials can be reconsidered, configurations can be improved, and unnecessary failures can be avoided.
Transport validation then stops being a final test that the project simply needs to “pass.” Instead, it becomes what it should be: meaningful evidence that the product and its packaging are genuinely ready for the journey ahead.
