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.
Buffer | Media Preparation
Fermentation
Purification
Concentration | Buffer Exchange
Sterile Filtration
Storage
Final Filling
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
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
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