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Integrity Testing

Merck:/Freestyle/interactive/it5/it50.jpgReliable and Repeatable

FDA Guidelines require integrity testing of sterilizing filters used in the processing of sterile solutions such as large volume parenterals (LVPs) and small volume parenterals (SVPs).

There are two classifications of integrity testing: destructive and non-destructive. We not only perform destructive testing as a lot release criteria on samples from each manufacturing lot of fabricated sterilizing-grade filters, but also conduct non-destructive testing on sterilizing-grade filters prior to sale to ensure integrity.  

    Integritest® 5 Instrument

    Accurately and reliably verify the integrity of your filters and processing equipment with the portable, easy-to-implement, and automated Integritest® 5. The Integritest® 5 delivers an intuitive user experience, while providing optional depth of flexibility to fit your process. 

    Millipak® and Millidisk® Barrier Filters

    Millipak® and Millidisk® Barrier Filters contain separate layers of hydrophobic and hydrophilic 0.22 μm Durapore® membrane and are designed to facilitate in-line pre-use integrity testing of a sterilized liquid filter system.

    Available Formats
    Sterile Filtration Learning Center - Learn More

    Sterile Filtration
    Learning Center

    Learn More