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The Confidence® E&L validation portfolio includes everything from assessment to testing to safety evaluation, supporting a risk-based validation approach.
Confidence® sterile filter validation includes physicochemical, microbiological, and E&L testing for all bioburden reduction or sterilizing grade filters.
Confidence® Validation Services provide GLP and non-GLP virus clearance studies for any purification technology, as well as expert consultation.
Confidence® single-use system validation is available for a wide range of products used in applications such as final filling, freezing, and thawing, mixing, storage or shipping.
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.
Benefits:
- Customer specific services: Our customized approach considering the customer process
- Proven years of experience: Sartorius has been offering validation studies for more than 25 years
- Unique expertise in E&L: No unknown extractables in Sartorius products
- Cost efficiency: The validation scope is defined through a risk-based approach