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Products (5)
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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.
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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.
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Confidence® Validation Services provide GLP and non-GLP virus clearance studies for any purification technology, as well as expert consultation.
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Confidence® Particle Validation Standards provides certified and customized sets for visual inspection training programs performed at Fill & Finish process.
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Confidence® sterile filter validation includes physicochemical, microbiological, and E&L testing for all bioburden reduction or sterilizing grade filters.
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