Objective:
To describe the procedure for the container closure integrity testing by dye ingress method on water filled vials. WFI filled vials shall use for container closure integrity testing instead of product filled vials (liquid and lyophilized products) by using same fill volume and container closure system to avoid cytotoxic product handling.
Scope
This protocol is applicable for the container closure testing of the WFI filled vials at the {Company Name}, {Location}.
