With PUPSIT, we have to use a higher pressure on the filter to test it. Is there not a risk to “push” microorganisms through the filter with this higher pressure, even if the filter is not damaged?

The so-called blow-through theory, when organisms supposedly are pushed through a membrane by elevated pressure has yet to be proven. It has been determined that organisms like mycoplasma can be pushed through a membrane at elevated pressures, but typically one would...

Considering that most of the critical filters need to be flushed post sterilization before use and considering this flush will require most of the components being used for PUPSIT why do you say that PUPSIT is adding complexity to the filtration system?

Filters that are steam sterilized in-situ do not need to be flushed as the steam would flush out any potential leachables. Gamma sterilized system may need to be flushed with a small portion of the product if the first milliliter going directly into a vial. This would...