Validation Services - Confidence®

Compliance with Regulatory Requirements

Sartorius has provided validation services to the biopharmaceutical industry for more than 25 years. We have a deep understanding of the regulatory landscape and take a consultative approach with you. This makes us the perfect partner to address your validation-related challenges, even after your project is completed.

Your key benefits are:

  •  Validation studies as fast as 6 weeks
  •  Unique expertise in E&L: No unknowns, no open questions for Sartorius products
  •  Cost efficiency through a risk-based approach

Our Offering for Your Regulatory Safety

Whether you’re implementing single-use systems or conventional equipment, Confidence® offers you the necessary validation services. Our services include a wide range of tests for all process components: bags, container closure systems, mixing systems, sterile filters, transfer systems, membrane adsorbers, virus filters and many more. 

Virus clearance validation services

Virus Clearance Services

Confidence® Virus Clearance Services completes all virus clearance steps with short turn-around times, as fast as six weeks.

  •  Feasibility studies  
  •  Process design/process optimization and design of experiments (DoE)
  • GLP Virus Clearance Studies

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Extractables & Leachables Testing

Thanks to our unique expertise in the field of E&L, we know exactly which compounds can be found in our Sartorius products.  

  • Extractables Assessment 
  • Extractables Study
  • E&L Storage Study
  • Leachables Testing
  • Safety Evaluation

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Sterile Filtration and Single-Use System Validations 

Our validation experts support you to identify validation needs and the appropriate testing scope for all filters and SUS.

  • Microbiological studies
  • Physico-chemical studies
  • Shipping and storage validation

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Particle Validation Standards

We provide certified and customized sets for visual inspection training programs to ensure that final drug products are "essentially free" or "practically free" of particles.

  • Loose particles
  • Defect test kits

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Consult Our Experts

Consult Our Experts