Zebragard™ Hydrophilic/Hydrophobic PVDF Membrane Barrier Filter
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Zebragard™
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Zebragard™
A polyvinylidene fluoride (PVDF) membrane filter designed to facilitate inline pre-use, post sterilization integrity testing (PUPSIT) for final fill and finish applications, the Zebragard™ filter offers exceptional flow rates and maximum sterile boundary assurance in single-use systems.
The Zebragard™ barrier filter is an absolute-rated PVDF filter that features the dual characteristics of both the sterilizing grade 0.2 µm hydrophilic SteriLUX® and hydrophobic Steridyne® membranes. The Zebragard™ filter’s unique striped and pleated membrane design allows high flow rates and faster air flow recovery at low pressures after filter wetting. These characteristics simplify sterile filter wetting, flushing, and integrity testing in aseptic filling systems while maintaining sterility and removing the constraints of alternate methods, such as flush bags or catch cans.
Design Features
- Modified PVDF membrane for inherent water wettability
- Highest documented flow rates of any PVDF membrane barrier filter
- Extremely low protein and preservative binding
- Compatible with a wide range of solvents, acids, and chemicals
- Extremely low extractables
- Repeatedly steam sterilizable in situ
- Meets ASTM bacterial validation standards
- Cleanroom manufactured
Frequently Asked Questions
What is the Zebragard™ barrier filter?
The Zebragard™ filter is an absolute-rated polyvinylidene fluoride (PVDF) membrane filter that combines the sterilizing grade 0.2 µm hydrophilic SteriLUX® membrane and the hydrophobic Steridyne® membrane in one device. It is designed for single-use systems where sterile boundary assurance and high flow rates are required.
What are the typical applications for the Zebragard™ filter?
Zebragard™ filters are used for pre-use post sterilization integrity testing (PUPSIT) of single or redundant sterile filtration systems, aseptic processing, and extractables flushing through a sterile boundary to drain.
How does the Zebragard™ filter support PUPSIT?
The Zebragard™ filter supports inline PUPSIT by allowing integrity testing after sterilization and before the product passes through the filter. Its PVDF membrane is designed for this inline pre-use, post sterilization testing workflow in final fill and finish applications.
What makes the Zebragard™ membrane design unique?
The Zebragard™ membrane uses a striped and pleated design. This structure allows high flow rates and faster air flow recovery at low pressures after the filter is wetted, which shortens the time needed to return the filter to a testable, flowing state.
How does the Zebragard™ filter simplify wetting, flushing, and integrity testing?
Faster air flow recovery at low pressures simplifies sterile filter wetting, flushing, and integrity testing in aseptic filling systems. The filter removes the need for flush bags or catch cans, which are alternate methods that add components to the sterile process.
What flow rates does the Zebragard™ filter achieve?
The Zebragard™ filter has the highest documented flow rates of any PVDF membrane barrier filter. Its flow performance comes from the modified PVDF membrane, which is wettable without additives, and the striped and pleated membrane structure, which increases usable membrane area for flow.
Can the Zebragard™ filter be steam sterilized?
Yes, the Zebragard™ filter can be repeatedly steam sterilized in situ. Its PVDF membrane and polymer components are chemically stable under steam exposure, which supports repeated sterilization cycles without changing the membrane.
Does the Zebragard™ filter meet bacterial validation standards?
Yes, the Zebragard™ filter meets ASTM bacterial validation standards. It is cleanroom manufactured, and its modified PVDF membrane has extremely low protein and preservative binding and extremely low extractables.
What other products are commonly used with the Zebragard™ filter?
The Zebragard™ filter is commonly used in single-use systems alongside Single-Use Systems, M-Flex® TPE Tubing, M-Sil™ Braid Reinforced Silicone Tubing, and BioFlex® Fluid Path Assemblies. These products support the sterile fluid paths that connect the filter to upstream and downstream steps in aseptic filling workflows.
