Millipore Technical Publications |
 | Data Sheet - SDS1007EN00 | |
Drug Product-Based Integrity Testing: | ||
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| Millipore provides minimum integrity test specifications for filters wet with standard wetting fluids: water for hydrophilic filters and alcohol for hydrophobic filters. These wetting fluids are ideal for pre-use integrity testing; however, after use the filter is wet with the pharmaceutical preparation (product) it was used to filter. Most drug products have a surface tension that is different from that of the standard wetting fluid and in most cases this alters the integrity test results. Delays in production and product release caused by false negative test results can be minimized by drug product-based integrity testing. Likewise, product that tends to increase bubble point may cause a filter, which would not have met minimum specification, to pass. Click PDF above for complete document. | |
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