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 undergo several simulated environmental conditions to check whether the device withstand 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 summarized as;
- Device shall packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage.
- The device shall package in such a way as to minimize the risk posed by contaminants and residues to patients.
- 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. 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 (recognized 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. Since there is no specific standard to follow for the transport validation, the manufacture must choose what are all the test 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. Which means 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.
Some of the common standards and test methods are listed below.
ASTM D4169-05 DC 13 “Air & Motor Freight, Local, Single Package Up to 150 lb
- Schedule (A) Manual Handling- ASTM D5276
- Schedule (C) Compression Testing- ASTM D642
- Schedule (F) Loose-Load Vibration- ASTM D999
- Schedule (I) Low-Pressure / High Altitude- ASTM D4728
- Schedule (E) Random Vibration (Truck & Air)- ASTM D4728
- Schedule (A) Manual Testing- ASTM D4728
The newly released ASTM D7386-08-“Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems”. Is for all type of packaging by single parcel shipping system like UPS and FedEx.
This standard is dependent upon what type of package you are trying to evaluate.
- Small Packaged-Product Bagged for Transport (TS-1)
- Large Flat Packaged Product (TS-2)
- Long Narrow Packaged Products (TS-3)
- All Other Packaged Product (TS-4) (Most Typical)
D951- Test Method for Water Resistance of Shipping Containers by Spray Method
D996- Terminology of Packaging and Distribution Environments
D4332- Practice for Conditioning Containers, Packages, or Packaging Components for Testing
D5265- Test Method for Bridge Impact Testing
D5487- Test Method for Simulated Drop of Loaded Containers by Shock Machines
D6179- Test Methods for Rough Handling of Unitized Loads and Large Shipping Cases and Crates
D6344- Test Method for Concentrated Impacts to Transport Packages
D6653- Test Methods for Determining the Effects of High Altitude on Packaging Systems by Vacuum Method