Physical testing

Assess filter performance
Discover our physical testing services, including filter integrity testing and chemical compatibility assessments, to confirm the fitness of your filters and single-use assemblies. Our comprehensive evaluations verify filtration system integrity and performance under operational conditions, ensuring compliance and reliability for your drug manufacturing processes
Explore our range of physical testing to safeguard your manufacturing process
Validate filtration system performance under real-world conditions. Our physical testing services—from bubble point testing to fouling evaluations—provide the data you need for confident manufacturing decisions and smoother product release
Filter integrity test
Includes bubble point and diffusion tests for filter integrity, tailored to your process fluid specifications. Confirming filter integrity with your process fluid (vs. standard fluid) minimizes production delays and ensures timely product release
Chemical compatibility
Our testing services assess the chemical compatibility of filter devices and single-use assemblies after prolonged exposure to drug products. We provide evidence that process fluids and conditions do not compromise filter integrity or performance, helping ensure they are fit for use and compatible with your process.
Binding study
Our binding studies demonstrate that the filters do not remove unacceptable amounts of critical product compounds. We simulate your product’s filtration under defined process conditions and implement tailored sampling plans to analyze actives, preservatives, and key ingredients.
Vmax™ confirmation/filter fouling evaluation
Our services include Vmax™ confirmation and filter fouling evaluations to verify filter suitability for processing specific batch volumes within defined time and flow rates. Based on prior Vmax™ studies, we determine the filter safety factor and assess fouling risks, ensuring reliable and efficient operations.
Related resources
- Webinar: Navigating EU GMP Annex 1: Effective strategies for single-use challenges in bioprocessing
This webinar describes a scientific, risk-based approach to change management and a roadmap for biomanufacturers to expedite changes in their post-approval processes.
- Brochure: Global validation services
Regulatory guidance documents provide a framework to manufacturers for the production of drugs that are safe for administration to patient