Stability Testing of a device with sterile fluid pathway claim

#1
Hello,

We manufacture a urine collection device that has attached tubing. We claim sterile fluid pathway for the tubing component only (it is capped at one end, the other end is heat-sealed to the collection bag, which is entirely closed. The entire device is packaged in perforated polybag, so there is no sterile barrier. To demonstrate sterile fluid pathway remains throughout the shelf-life of the device (60-months), I was considering USP<71> testing using the product flush method with both FTM and SCDM at both the initial and final (60-month) time interval. Does this sound reasonable, or is there some other test that I should consider to demonstrate sterile fluid pathway? Thanks in advance!
 
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#2
You may (additionally) consider:
- accelerated aging testing per ASTM 1980-21, which in its latest revision is not only applicable for packaging materials, but also for device materials
- physical integrity testing of your fluid pathway instead/in addition to sterility testing
 
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