I can't think of any regulatory guidance specific to this question, but can share some expereinces.
PFS stability can be limited by the components of the PFS themselves, not just the stability of the liquid product. Also, consider the expiration date of the WFI product used to fill the PFS when establishing the PFS shelf-life. If the PFS containing WFI is packaged with a dry powder product, the PFS expiry would ideally not be the limiting factor.
With a PFS containing WFI that has passed sterility testing at release, container closure integrity would be the most important, and perhaps only, attribute to monitor on stability.
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Dan Willingmyre
Vir Biotechnology, Inc.
Associate Director, Stability & Data Analytics
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Original Message:
Sent: 02-07-2024 17:25
From: Anonymous Member
Subject: Shelf-life for PFS containing WFI?
This message was posted by a user wishing to remain anonymous
Does anyone have suggestions for regulatory guidance specifically on shelf-life considerations for pre-filled syringes containing sterile water for injection?
NOTE: This question was initially submitted to the AAPS Stability Community's email distribution list and shared anonymously here in the Stability Discussion Topics with the permission of the questioner.