Changing global supply chains and increasingly complex biopharmaceutical formulations make filter validation more critical, and more challenging, than ever before. Regulatory guidelines, such as PDA Technical Report (TR) 26, can often lack clarity, while the cost of failure can mean serious delays in getting your product to market.

The Eurofins BioPharma Product Testing (BPT) network of laboratories helps you de-risk your filter selection and qualification processes. Our cGMP-compliant filter validation services provide the robust scientific evidence required to prove filter performance and integrity under real manufacturing conditions.

Whether you’re qualifying a newly sourced filter due to supply chain changes, or optimizing your current filtration process, our services are designed to demonstrate sterility assurance, product compatibility, and consistent performance. 

We replicate worst-case process conditions in accordance with industry standards, including PDA TR 26, ensuring meaningful, defendable data. Our team also designs worst-case validation studies based on your specific process parameters. 

Eurofins BPT provides rapid turnaround and local laboratory support to meet tight timelines, study design and project guidance from experienced validation experts, and detailed reporting that aligns with global regulatory expectations.

It is our ability to simulate real-world manufacturing environments that helps you avoid surprises later in development. By testing filters under actual or worst-case operating conditions, our experts will ensure your filtration systems aren’t a delay for you getting your product to market.