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Sartorius Corporation
filter testing and validation
Company offers a dedicated, special team of scientists and technicians for its Validation Services Program. Called the CONFIDENCE( program, this comprehensive set of protocols and tests can be customized to meet any customer's requirements - no matter how complicated. In addition to validating its own filters the company can validate other manufacturer's filters using test methodology that conforms to the rigorous standards demanded by regulatory agencies. The program encompasses a variety of tests including:
Bacterial Challenge (including viability) Testing
Tests involve laboratory devices that literally scale up to full process filters.
Product Wet Integrity Test Values
Test data is generated using three filter elements from three different lots.
Chemical Compatibility Tests
Company tests the durability of filter membranes post product exposure.
Extractables Analysis
Company provides testing in actual product formulations and not just "model" solutions or solvents.
Sartorius Corporation
Biotechnology Division
131 Heartland Blvd.
Edgewood, NY, 11717
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From a vision to a vial in 12 months -
Process development and... 
