Depyrogenation of vials

as per industrial practice depyrogenated vials re-use not allowed, kindly share any rational or guidance

Sir,as usual in injectable facility,reprossing is not acceptable.
There is such no guidelines available but, depyrogenation is based on in house study.so ,if you clearly want to reprossing of vials , you have to mention in Dossier/ ANDA, NDA submittion.
Qbr 21 , allow reprossing of process,but should be justified in Dossier. Keep in mind that there’s no impact on shelf life of vials, particulate matter, toxicity, stage from where you want to re- process.
Once, product is filled, that cannot be acceptable/ allow to reused.

All means sir, you have to simulate the process with its impact assessment, Risk assessment.

Definitely, if you want! You can do.


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