Hold time of unfiltered sterile product formulation

Quality Assurance
1

Dear All,
Ideally Media bulk hold time to be conducted first or product hold time to be conducted…
Which time act as a base for hold time study of unfiltered bulk in aseptic filtration process…

Thanks

2

Media fill Bulk hold Time should be considered on first priority bases ,bz media fill simulation study is the base of injectable facility operations.
This will cover your biological challenge…in worse case

1 Like
3

But in case of terminally sterilized Large volume parenteral products,how can we determine unfiltered solution hold time study