Filter Characterization
Millipore employs a variety of testing methods to ensure the performance and effectiveness of its microporous filters and filter systems. Use these links to learn more about the testing methods Millipore uses to characterize key filter properties:
- Integrity Testing
- Pore Size Determination
- Pore Density
- Visual Characteristics
- Thickness
- Bubble Point
- Diffusion Testing
- Pressure Hold Testing
- Wettability
- Flow Time
- Extractables
- Pyrogenicity
- Retentiveness
- BET
- Capillary Flow Time
- Gurley Test
- Klemm Factor
- Tensile Strength and Elongation
- Sealing Properties
- Sealing Properties for Specific Membranes
Characterization testing at Millipore starts with a functional definition of the filter and is completed using methods specific to the applications that particular filter will be used in under “worst case” scenarios. For example, sterilizing-grade filters, particularly those used to process large volume parenterals (LVPs) and small volume parenterals (SVPs), must remove all viable microorganisms from the filtrate stream and are subject to rigorous testing using the test organism Brevundimonas diminuta.
The FDA requires that filters used in the processing of parenterals also be integrity-tested and corresponding documentation included with batch product records.