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Single-Use and Filter Validation Services

Accelerate and simplify your path to market by using our BioReliance® Validation Services to select, test, and validate your filters, assemblies, and single-use systems for drug manufacturing and processing. You can rely on our experience to avoid regulatory observations and delays in your approval process. 

  • Proven expertise and deep knowledge of biopharmaceutical processing, process technology, and regulatory requirements for global markets
  • Technology leadership with almost 50 years’ experience designing, manufacturing, and implementing filtration for pharma/biopharma manufacturing
  • Global standards and localized services, with laboratories in five major geographic centers providing expertise in your time zone and language
  • Commitment to the latest filtration, single-use and membrane technologies, based on proven methods and established protocols
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Choosing the Right Validation Service

Helping you choose the right validation services, our validation project managers possess intimate knowledge of global and local regulations and industry best practices. We can assist you in developing and implementing an appropriate validation strategy – determining what, how, and when to test, spanning upstream, downstream, or final fill operations.

Discover an Easier Way to Choose the Right Validation Services

Upstream to the Compounding Tank/Mixing Bag

  • Chemical compatibility
  • Extractables/patient safety

Final Storage Single-Use Assembly

  • Chemical compatibility
  • Extractables/patient safety/leachables
  • Non-permeation test

Final Sterilizing Filters and/or Single-Use Assembly

  • Bacterial retention validation
  • Bubble point/diffusion determination
  • Chemical compatibility
  • Extractables/patient safety/leachables
  • Binding study
  • Particle shedding study
  • Vmax™ confirmation i.e. filter fouling evaluation
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Bioburden Reduction Filter

  • Chemical compatibility
  • Extractables/patient safety
  • Bubble point/diffusion determination

Sampling System

  • Chemical compatibility
  • Functionality test
  • Non-permeation test

Regulatory Guidance

Recommendation, based on the pharmaceutical application and risk assessment

Trust our Global Services Network

As part of our industry-leading validation services for biopharmaceutical manufacturers, we offer these specialized capabilities at laboratories worldwide.

  • Bacterial Retention Testing
  • Chemical Compatibility Testing
  • Filter Integrity Testing
  • Extractables and Leachables
  • Validation Services Consultancy
  • Validation Service Levels

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Bacterial Retention Testing
Required by regulatory bodies worldwide, bacterial retention testing (BRT) is a critical step in filter validation. Our skilled validation specialists conduct BRT using each end-user’s worst-case biopharmaceutical processing conditions to ensure a best-case outcome.
Chemical Compatibility Testing
Our physical and chemical compatibility testing services help you comply with GMP guidelines worldwide, proving that your biopharmaceutical filters and single-use systems are not reactive, additive, or absorptive upon contact with drug product.
Filter Integrity Testing
Our integrity testing for sterilizing-grade filters can help you set a test specification for your drug product, then check for leaks or filter damage using pre-use and post-use testing as recommended or required by regulatory agencies and the Parenteral Drug Association (PDA).
Extractables and Leachables
Proving that extractables and leachables from your process aren’t harmful to the final drug product is easier with BioReliance® Validation Services. Our extractables and leachables (E&L) services thoroughly evaluate all contact materials and processes to mitigate concerns about process fluids.
Validation Services Consultancy
For local assistance and rapid response to your filtration validation needs, BioReliance® Validation Services offers a global network of highest-quality laboratories with in-country and in-region experts at strategic geographic centers.
Validation Service Levels
Discover an easier way to global compliance with our validation services, simplifying your process from the start with two predefined service levels and globally harmonized testing.
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