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

Validation services quote request

To receive a quote for services, please complete the form below. If you have requests for multiple products, you will need to complete a quote request form for each one. To facilitate the process, we recommend logging into your account above and forms will pre-fill with your contact details.

Important notice:

• If you are accustomed to our processes or otherwise comfortable with online submissions, please complete the quote request form in one session.
• However, if you are new to this process or prefer an offline approach, kindly contact us to request the Excel version.
• Should you have any questions, please contact us and a team member will contact you directly.