Specific PUPSIT assemblies, configurations, and procedures should be included in a risk assessment to determine if and to what extent they pose such a risk to product sterility and what controls can be employed to reduce that risk and what studies can be used to validate the effectiveness of those controls. It should be noted that PUPSIT usually involves the installation and manipulation of fittings downstream of the sterilizing filter which if not designed, maintained, or performed properly could compromise the down-stream sterile pathway. Because the PUPSIT assembly and procedure provide additional process complexity and variables - that can pose a risk to the sterile product pathway and product sterility - the assembly and resulting activities should be included in each of the PUPSIT relevant APS studies.