Various regulatory 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).* With many biopharmaceutical manufacturers now testing filters before and after use, there is a need for non-destructive test methods that are fast, reliable, and repeatable. The Integritest® 5 automated test instrument meets this need by enabling non-destructive integrity testing to be performed inline or offline on filtration devices, with the flexibility to add a paired Exact-Air™ II water-based test unit for hydrophobic filters.
*EMA Annex 1; FDA Aseptic Processing cGMP guidance (2004)
Our latest model since introducing the first commercial automated integrity test instruments more than 25 years ago, the Integritest® 5 uses pressure decay measurements to determine filter integrity. Along with a system volume measurement, one pressure decay measurement is taken to determine the relevant flowrate for diffusion and HydroCorr™ tests. The Tangent Method is used to determine a filter bubble point from a series of pressure decays performed at increasing transmembrane pressures. Optimum pressures at which to take measurements are based on test parameters and ongoing readings, reducing the number of measurements needed to reliably map the filter’s profile and return an accurate result.
Key features include:
Based on Remote Volume Technology, the Exact-Air™ II System is an automatic integrity test unit with an intermediate volume located between the filter to be tested and the testing device. Paired with the Integritest® 5 tester, it improves test accuracy and reproducibility under extremely critical temperature conditions.
By using the HydroCorr™ test method, a highly sensitive water-based integrity test for hydrophobic membrane filters, the Exact-Air™ II System offers users a unique opportunity to improve reliability, accuracy, reproducibility, and frequency of air filter testing, even under challenging operating conditions.
Key features include:
Application Note: Integrity Test Troubleshooting - Beyond Rewet and Retest
Tech Brief: Bubble Point Testing with Integritest®
Webinar: Defining a Strategy for the Validation and Qualification of Sterile Filtration Processes for Investigational Medicinal Compounds
Webinar: Demystifying Bioreactor Contamination Risks
Webinar: Filter Integrity Testing Best Practices
Webinar: Quality by Design Principles in Aseptic Processing: Have You Minimized Your Sterile Filtration Risk?
Webinar: Sterile Filtration Validation Best Practices