V
vsethuram
Hi everyone,
Our company is about to commence validations including Ethylene Oxide sterilization validation (overkill method), shelf life testing (ASTM F1980) and transportation validation (ASTM D4169 DC13) for a single use medical device.
The device will be packaged in Tyvek 1073B / PE Film pouch with Chevron seal. I am having trouble getting the correct size of Tyvek pouch in time, so I’m thinking of use a bigger pouch (470mm x 220mm) for sterilization validation and shelf life validation. 470mm x 100mm will be used in production. Both sized pouches will be the exact same grade, from the same pouch vendor and will be sealed using the same validated sealing machine.
Can I justify the use of the bigger pouch for the validation? Obviously, I do not want to redo all / any of the validations because we used the incorrect size pouch. Are there any concerns relating to Bioburden / bioburden recovery / EO residuals that could be impacted by the use of the bigger pouch? Any other pitfalls I need to be aware of?
Thanks for your feedback,
Vish
Our company is about to commence validations including Ethylene Oxide sterilization validation (overkill method), shelf life testing (ASTM F1980) and transportation validation (ASTM D4169 DC13) for a single use medical device.
The device will be packaged in Tyvek 1073B / PE Film pouch with Chevron seal. I am having trouble getting the correct size of Tyvek pouch in time, so I’m thinking of use a bigger pouch (470mm x 220mm) for sterilization validation and shelf life validation. 470mm x 100mm will be used in production. Both sized pouches will be the exact same grade, from the same pouch vendor and will be sealed using the same validated sealing machine.
Can I justify the use of the bigger pouch for the validation? Obviously, I do not want to redo all / any of the validations because we used the incorrect size pouch. Are there any concerns relating to Bioburden / bioburden recovery / EO residuals that could be impacted by the use of the bigger pouch? Any other pitfalls I need to be aware of?
Thanks for your feedback,
Vish