Medical Device Transport Validation
Medical device transport validation is performed to examine the suitability of packaging compatibility and safety. The transportation and the storage must not affect the properties of medical device i:e, the device must be damage free, maintain sterility no physical damage, no biological contamination and function as intended.
In the medical device transport validation test, the device package undergo several simulated environmental conditions to check whether the device withstand without any damage to its properties.
MDR / IVDR CE Marking Requirements:
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 medical device transport validation which are intended to be sterile while placing in the market.
The medical device 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 medical device 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 we 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 testing of the device.
Medical Transport Validation Standards
ASTM D4169-05 DC 13 “Air & Motor Freight, Local, Single Package Up to 150 lb
- 1. Schedule (A) Manual Handling- ASTM D5276
- 2. Schedule (C) Compression Testing- ASTM D642
- 3. Schedule (F) Loose-Load Vibration- ASTM D999
- 4. Schedule (I) Low-Pressure / High Altitude- ASTM D4728
- 4. Schedule (E) Random Vibration (Truck & Air)- ASTM D4728
- 6. 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.
ASTM D4169-05 DC 13 “Air & Motor Freight, Local, Single Package Up to 150 lb
- 1. Schedule (A) Manual Handling- ASTM D5276
- 2. Schedule (C) Compression Testing- ASTM D642
- 3. Schedule (F) Loose-Load Vibration- ASTM D999
- 4. Schedule (I) Low-Pressure / High Altitude- ASTM D4728
- 4. Schedule (E) Random Vibration (Truck & Air)- ASTM D4728
- 6. Schedule (A) Manual Testing- ASTM D4728
Standards for Different Type of Medical Device Package
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 Products (TS-4) (Most Typical)
ASTM Standards:
- D951- Test Method for Water Resistance of Shipping Containers by Spray Method
- D996- Terminology of Packaging and Distribution Environments
- D4332- Practice 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 Shipping Packages
- D6653- Test Methods for Determining the Effects of High Altitude on Packaging Systems by Vacuum Method
Medical device manufacturers must stay informed about changes in regulations and standards to ensure ongoing compliance. We provide complete solutions for medical device transport validation to our MDD/IVDR/510K customers.