Validation of qualified sterile filters for use as sterilizable filters with Sartorius Bacterial Challenge Learn More: http://ow.ly/k4K550C3NYL
In this video, you will learn about the basics of bacterial challenge testing. We also highlight the importance of validation and how a qualified sterile filter is different from a sterilizing-grade filter in bio-pharma manufacturing.

Qualified sterile filters cannot be used as sterilizing-grade filters in a bio-pharma manufacturing process without proper validation. For validation, regulatory bodies such as the U.S. Food and Drug Administration (FDA) require a bacterial challenge test (BCT). During a BCT, the sterile filter with a maximum pore size of 0.2 µm must retain at least 10^7 colony-forming units of Brevundimonas diminuta per cm² of effective filtration area under reasonable worst-case conditions according to ASTM F838-15a.

Sartorius Confidence® Validation Services has more than 25 years’ experience in filter validation. We are able to simulate all manufacturing parameters and approaches and handle any product solution. Our validation services perfectly complement Sartorius filters used in bio-pharma manufacturing.