Hi all,
I am currently working on a DV study where Performance and Stability testing will be conducted separately. For the Performance part, I plan to include devices to demonstrate the mechanical interaction between the product and the packaging system.
Since the devices are very expensive, I am considering not using devices during the Stability part. My rationale is based on ISO 11607-1, Section 8.3.6, which states:
"Unless it is demonstrated that the contents adversely interact with the sterile barrier system, then previously documented testing shall be sufficient."
My interpretation is that if the Performance study successfully demonstrates that the product does not adversely affect the sterile barrier system, then including devices in the Stability study may not be necessary.
Does this rationale seem acceptable, or would you still recommend using devices in both the Performance and Stability studies?
Thank you in advance for your support and feedback.
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Delia Ramirez Avila CPP
Packaging Engineer
Cordis
El Paso TX
(656) 186-1388
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