BioProcess Testing

The BioProcess Institute is highly experienced in Performance, Exposure, and Analytical Testing on both single-use and multi-use components. Our keen awareness, trade-secreted methods, and profound knowledge in all areas of bioprocess testing are our competitive advantage.

Our niche is customized BioProcess testing methodology and we want you to benefit from our experience.  We perform testing services for both End Users and Suppliers/Manufacturers on a variety of bioprocessing components including: single-use assemblies, hygienic gaskets, hoses, valves, diaphragms, tubing, and filters.

We believe the process is the priority. We are uniquely equipped to provide Suppliers with a well-informed and independent assessment of how the product performs and how its performance and expected endurance compares to others on the market.

Suppliers come to us for BioProcess Testing services including:

  • Prototype Testing and Development to Help Single-Use
  • Application Range Determination
  • Qualification Testing
  • Critical Attributes
  • Supplier Certification of Conformance (e.g. USP Class VI, ISO)
  • Capability to Meet Requirements (BPE)
  • Supplier Performance Certification
  • Voice of Customer (VOC)
  • Supplier Process Capabilities (SPC)

We help End Users select the correct component or material for their process lines and product goals.

End Users come to use for Testing services including:

  • Investigations/Emergency Response Testing
    • Testing to solve a problem
    • Consulting
  • Non-Conformance/Corrective And Preventive Action (CAPA)
  • Identifying the Best Components and How to Use Them
  • Application Range Determination
  • Cleanability Testing
bioprocess testing