Integrity Testing
Reliable 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
メディアリソース
- ウェビナー［英語］：Defining a Strategy for the Validation and Qualification of Sterile Filtration Processes for Investigational Medicinal Compounds
- ウェビナー［英語］：Demystifying Bioreactor Contamination Risks
- ウェビナー［英語］：Filter Integrity Testing Best Practices
- ウェビナー［英語］：Quality by Design Principles in Aseptic Processing: Have you minimized your sterile filtration risk?
- ウェビナー［英語］：Sterile Filtration Validation Best Practices
- ウェビナー［英語］: Sterile Filtration
