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
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
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
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
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