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Hi everyone,
I'm hoping to get some insight on scale-up batch requirements for aseptic products.
Typically for a product you can scale up to10x given that no changes to the equipment, same SOPs, formulation, manufacturing process etc.
and it can be annual reportable, but are there any restrictions for aseptic products? I guess some restriction includes not exceeding the validated hold times for the product due to increase in batch size. Any other restrictions that should be considered?
Thank you and appreciate all the help!