Integrity Testers
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)
Integritest® 5 automated test instrument
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:
- Improved test algorithm for faster, simpler testing
- Intuitive software with help screens for every step
- Flexible displays, run information, and test collections to suit your process
- Networking functions such as multi-unit management and synchronization
Exact-Air™ II automatic water-based test unit for hydrophobic filters
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:
- User-friendly software with touch screen display
- Control of filling, testing, draining, and cleaning-in-place operations
- Ease of validation
- Bubble point and diffusion testing on hydrophilic filters
Related Product Resources
- Datasheet: Integritest® 5
The Integritest® 5 delivers a simple and intuitive user experience, while providing optional depth of flexibility to fit your process.
- Data Sheet: Integritest® 5 Instrument Services
Our IQ/OQ service ensures that the installation and operational qualification of your Integritest® 5 system is fully documented.
- Spare Parts List: Integritest® 5 Instrument
Select and manage the spare parts required for your system, our experts have performed a risk assessment to determine which parts to keep in stock.
- Application Note: Integrity Test Troubleshooting - Beyond Rewet and Retest
The Exact-Air™ II System, paired with the Integritest® 5 tester, uses the HydroCorr™ method, a highly sensitive water-based integrity test for hydrophobic membrane filters.
- Spare Parts List: Exact-Air™ II System
Maintain optimal performance and minimize downtime and manage the spare parts required for your system, our experts have performed a risk assessment to determine which parts to keep in stock.
- Application Note: Integrity Test Troubleshooting - Beyond Rewet and Retest
Integrity testing is a critical operation, especially for sterilizing grade filters used in biopharmaceutical processing. When performed correctly, an integrity test is a fast, definitive, non-destructive way to assure filter retention performance. Fortunately, there are few ways a non-integral filter will pass the integrity test, making it unlikely that a non-retentive filter would not be detected. U
- Brochure: Process Development and Drug Manufacturing
We provide comprehensive services for drug development and manufacturing, including technical and regulatory expertise and process development support.
Related Webinars
- Webinar: Defining a Strategy for the Validation and Qualification of Sterile Filtration Processes for Investigational Medicinal Compounds
Investigational New Drug (IND) applications must contain information allowing an assessment of whether or not the product is reasonably safe for initial testing in humans.
- Webinar: Demystifying Bioreactor Contamination Risks
Mitigation of bioreactor contamination risk is complex. People can be lulled into a sense of security that serum-free media eliminates that risk. However presence of contaminants such as mycoplasma can be devastating, leading to extensive investigation and downtime.
- Webinar: Filter Integrity Testing Best Practices
Sterile filtration is commonly employed for microbial removal and plays a pivotal role in assuring final product sterility.
- Webinar: Quality by Design Principles in Aseptic Processing: Have You Minimized Your Sterile Filtration Risk?
In aseptic processing of pharmaceutical products, it is critical that drug products are free from bacteria and other microorganisms to ensure patient safety. Sterilizing-grade filters are commonly used to meet this requirement.
- Webinar: Sterile Filtration Validation Best Practices
Regulations and regulatory guidance for the qualification and validation of sterile filtration processes are specific and well developed.
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