Transport validations are performed to examine the suitability of packaging compatibility and safety. The transportation and the storage must not affect the properties of medical device ie, the device must be damage free, maintain sterility, no physical damage, no biological contamination and function as intended. In the transport validation test, the medical device package undergoes several simulated environmental conditions to check whether the device withstands without any damage to its properties.
MDR annex I general safety and performance requirements (GSPR), specifies the transportation and storage requirements of medical devices. The requirements can be summarised as;
- Device shall package in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage.
- Device having a specific microbial state shall be packaged to ensure that they remain in that state when placed on the market and remain so under the transport and storage conditions.
- The package shall ensure that retain the sterile condition, till the pack is broken.
It is mandatory to perform transport validation for the devices which are intended to be sterile while placing in the market. It would be well enough if you can demonstrate the packaging is safe enough for effective transportation for a non-sterile medical device. Since there is no specific standard to follow for the transport validation, the manufacture must choose what are all the tests to perform to their device to demonstrate safe and effective transporting. If you can demonstrate that your device is ok with bubble wrap, then that is also fine.
The transport validation test can also be performed by outsourced laboratories with simulated environmental conditions. Some of the transportation tests which are listed in the standard ASTM D4169 (recognised by FDA) are below.
- Drop Test
- Vibration Test
- Compression test/ Vehicle stacking
- Altitude test
- Climatic conditions test
- Horizontal impact tests
The appropriate tests are selected according to, the shipment size, mode of transport, shipping routes, environmental conditions and acceptable safety margins. How to demonstrate the safety is all up to you, some of the solutions i can suggests are below.
- Perform suitable test depends on the risk assessment like drop test, vibration test etc to demonstrate to meet the devices characteristics and performance is not adversely affect during transport and storage.
- Consider packaging solutions adapted by similar/equivalent device during the transportation in the market.
- Package the device and send it out with standard couriers to most unsure locations and get it back.
- The appropriate storage conditions are established by stability studies of the device.