Distribution Simulation Testing assesses a medical package’s ability to protect and maintain sterility of the products within. This is accomplished by exposing the package to real-life hazardous conditions that it could face through the handling, distribution and storage stages of its journey. The package/container and its contents are subjected to a test plan involving shock, compression, vibration and drop tests as per the guidelines set by ASTM D4169 and ISTA standards. Testing is conducted in a controlled and repeatable laboratory environment.
ASTM D4169 lists the ‘Standard Practice for Performance Testing of Shipping Containers and Systems’ as per current industry/government practices and experience. The containers performance level is determined by putting it through a specified order/sequence of tests, throughout which the package must remain unopened.
ASTM D4169-05 – Testing Sequence and Types:
|2||Compression||ASTM D642||C||Vehicle Stacking|
|4||Low Pressure||ASTM D6653||I||Altitude Simulation (non porous packages)|
The International Safe Transit Association (ISTA) is the author of test procedures that define how packages should perform to ensure protection of their contents. ISTA test procedures are internationally recognized because they are based on leading technology and the most current global transport environment data. The organization provides the final validation of package revisions through its packaged-product performance test procedures. The ISTA test procedures are acceptable in complying with the ISO 11607-1:2006 standard.
ISTA testing standards includes the following:
- ISTA-1A: Non-Simulation Integrity Performance Testing
- ISTA-2A: Partial Simulation Performance Tests
- ISTA-3A: General Simulation Performance Tests