Validation Services

Confidence® Validation Services 

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 we take a tailored and consultative approach with every customer. 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 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)
  •  Support of GLP studies

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Extractables & Leachables Studies

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

  • Extractables evaluation
  • Extractables & safety assessments
  • E&L long-term/storage studies for different container materials  
  • Leachables screening

Consult Our Experts

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

Consult Our Experts

Assessments and Regulatory Consultancy

Profit from our validation experience and receive expert guidance.  

  • Consultancy in respect to process validation
  • Support in process risk analysis
  • Statements referring to process changes

Consult Our Experts

Consult our Validation Service Experts