Sterilizing Filter Integrity Testing Checklist

Filter Validation

Establish sterilizing performance.

• Is bacterial retention validated using Brevundimonas diminuta at a minimum challenge of 10^7 CFU per cm2 of effective filtration area? *
• Is product-specific bacterial retention validation performed under actual or worst-case process conditions? *
• Are filter compatibility, extractables, and adsorption of the product assessed? *
• Is the correlation between the physical integrity test limit and bacterial retention established? *

Integrity Test Method and Limits

• Is the integrity test method (bubble point, diffusive flow, or pressure hold) defined with validated pass limits? *
• Are integrity test parameters product-wetted where the product is used to wet the filter? *
• Select the primary integrity test method used.

Pre-Use and Post-Use Testing

• Is a pre-use post-sterilization integrity test (PUPSIT) performed or its omission risk-assessed and justified? *
• Is a post-use integrity test performed on the sterilizing filter before batch release? *
• Are integrity test failures investigated for batch sterility impact? *

Equipment and Records

• Is the automated integrity test instrument calibrated and qualified? *
• Are integrity test results recorded and reviewed by the quality unit as part of batch disposition? *