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Validation Services Consultancy

Validation Services Consultancy

BioReliance® Validation Services are offered from an expansive global network of highest-quality laboratories and in-country/in-region experts located in strategic geographic centers. This enables us to provide local assistance and rapid response to your filtration validation needs.

In addition to performing the most common validation studies, our experts can provide consultancy support with specialized validation studies designed to your requirements. We can assess risks to your filtration process and develop a comprehensive and compliant validation strategy that meets the needs of the country in which you manufacture – as well as the countries in which your drug product will be marketed. We also support all MilliporeSigma filtration devices and single-use components (bags, connectors) and assemblies.

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Trust our Global Services Network

To learn more about our industry-leading validation services for biopharmaceutical manufacturers, look into these specialized capabilities performed at our laboratories worldwide.

  • Single-Use and Filter Validation Services
  • Bacterial Retention Testing
  • Filter Integrity Testing
  • Extractables and Leachables
  • Chemical Compatibility
  • Validation Service Levels
Related Services
Emprove® Program
Confidently speed your way through the regulatory maze and fast track your new drug to market with the Emprove® Program. High-quality products, comprehensive documentation, and superior customer support facilitate your efforts in qualification, risk assessment, and process optimization.
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.
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.
Related Product Categories
Final Sterile Filtration & Filling
Enhance final filtration and sterile fill processes with pre-sterilized, single-use systems for optimized operations.
Single-Use Assemblies
Streamline biopharma manufacturing with Mobius® 2D and 3D single-use assemblies. From transport to final fill, achieve flexible fluid management.
Related Applications
Monoclonal Antibody Manufacturing
Monoclonal antibody manufacturing is a highly templated approach used to produce mAb-based immunotherapies. Robust, scalable process solutions are required at every step to ensure high therapeutic concentration and process safety, while meeting speed-to-market and cost containment concerns.
Classical Pharmaceutical Formulation & Manufacturing
Manufacturing the final dosage form of a small molecule drug requires robust quality and design in development of the formulation and production of the final product. Explore solutions and best practices to advance and accelerate small molecule pharmaceuticals, from development to commercialization.
Gene Therapy Manufacturing
Growing use of gene therapies is driving rapid innovation in an evolving global market. Manufacturers bringing new gene therapies to life face complex challenges, requiring an experienced partner capable of integrating vector manufacturing, testing, safety, process development, and regulatory compliance.
Vaccine Manufacturing
From early phase development, through downstream purification to large scale vaccine production: learn more about vaccine process development and application expertise.
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