Filter validation.

Validation of a sterilizing filtration process is critical since it is impossible with currently available technology to measure the sterility of each filled container; therefore, sterility assurance of the filtered product must be achieved through validation of the filtration process. Validating a pharmaceutical sterile filtration process involves three things: determining the effect of the liquid on the filter, determining the effect of the filter on the liquid, and demonstrating that the filter removes all microorganisms from the liquid under actual processing conditions.