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Especially in the design phase of medical devices, considering the transportation conditions prevents you from encountering problems that may cause cost and time loss later.

You should start by determining the specifications, such as the type of box you will use for your product, how many products will fit in it, and what its weight will be, and then determine the risks that may occur to your shipping box. The main purpose here is to examine the suitability and safety of the packaging for your medical device. Your medical device should not be physically damaged, protected from biological contamination, and, if sterile, its sterility should not be compromised by problems that may occur during transportation.

In transport validation tests, your product is exposed to a simulated environment of mechanical impacts that may occur during transportation.

If you are conducting 2017/745 MDR compliance studies or are in the design process of a new medical device, you may want to consider your transport validation study for the following items while meeting the requirements in your GSPR checklist.

• 7. Devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer.
• 11.3. Devices labelled as having a specific microbial state shall be designed, manufactured and packaged to ensure that they remain in that state when placed on the market and remain so under the transport and storage conditions specified by the manufacturer.
• 11.4. Devices delivered in a sterile state shall be designed, manufactured and packaged in accordance with appropriate procedures, to ensure that they are sterile when placed on the market and that, unless the packaging which is intended to maintain their sterile condition is damaged, they remain sterile, under the transport and storage conditions specified by the manufacturer, until that packaging is opened at the point of use. It shall be ensured that the integrity of that packaging is clearly evident to the final user.

Also, in terms of MDR, it must be demonstrated that the packaging for medical devices is sufficiently safe for effective transport. Finally, the tests performed on the product may differ from those performed on non-sterile products, as the risks of exposure to transport hazards may be different for sterile medical devices. This is entirely related to the functions and intended use of your product.

Since there is no standard for medical devices in transport validation, the manufacturer must choose the tests to be applied to their devices to demonstrate safe and effective transport. 

In general, real-time transportation scenarios are performed, which we have seen quite often. Products are sent to a point and brought back. Boxes were dropped from a certain height. The products were photographed, and reports were made. The results of this method only covered the season of transportation and the vibration range of the truck used. Unfortunately, one of the problems we have encountered over time is that when a new route is determined for export, when a different transport vehicle is wanted to be used, or when you want your product to be transported from the hottest place to the coldest place in the world, seeing that the packaging does not perform as desired is a problem that never comes to mind. However, it is quite sad that our medical devices, which we have worked hard to design and sell, fail at the last point due to unsafe packaging and box.

The ASTM D4169 standard, last updated in 2022 and recognized by the FDA, recommends a series of simulations to prevent such situations. According to the standard, products are subjected to environmental conditions. The temperature and humidity values of the environmental conditions may vary according to the climatic conditions of the countries to be exported. The following simulation tests can then be applied. The tests that may be appropriate may vary depending entirely on the characteristics of the medical device, the size of the shipping boxes, modes of transportation, and shipping routes. Generally, the following tests are applied.