FILTER INTEGRITY TESTER AND FILTER CARTRIDGE
Filter integrity testing is addressed directly in EU GMP Annex 1 (2022 revision, effective August 2023), which requires pre-use post-sterilization and post-use integrity testing of sterilizing filters. PDA Technical Report No. 26 (Sterilizing Filtration of Liquids) provides the accepted methodology for bubble point, diffusion flow, and water intrusion testing. FDA's guidance on sterile drug products produced by aseptic processing reinforces the expectation of routine, auditable filter integrity records tied to batch documentation.
Our Solution
【Neuronbc V10 V8.0 V6.5 V4.0 model automatic Filter Integrity Tester】performs bubble point, diffusion flow, water intrusion, and pressure hold testing on a single automated platform, supporting filter formats and housing sizes across Sterilizing Grade filters:
· Pleated Sterile Filter Cartridge
· Filter Cartridge
· Disc Membrane Filter
· Capsule Filter -Single-use Sterile Capsule Filter)
· Hollow Fiber Filter
· Sterile Plate Filter
· High Flow Sterile Filter Cartridge
As the manufacturer, we control calibration, firmware, and pressure-sensor sourcing end to end, which allows us to offer:
The V10 and V8.0 V6.5 V4.0 model Integrity Tester got built to wipe out these slowdowns with smart machine help:
Precision: Machine-run control of pressure drop or diffusive flow checks cuts out personal judgments from outcomes.
Repeatability: All tests stick to the same set steps in managed settings.
High-speed process: Every test cycle is time-stamped, tied to operator ID and filter lot number, and exportable in a 21 CFR Part 11-ready format, giving QA a defensible audit trail during inspection.
Features and Benefits of Automation in Testing
|
Feature |
Benefit |
|
Self-Running Tests |
Needs less human work. Gives steady results. |
|
Data Recording |
Meets strict rules for saving electronic records. |
|
Precise Sensors |
Provides correct and repeatable outcomes. |
|
Easy-to-Use Screen |
Makes it simple for workers with different skills. |
Automation is great for busy workplaces. It saves time and ensures accuracy.
Applications of Automated Testers
Medicine Production: Ensures clean filtration for drugs and biologics.
Large Biology Projects: Checks filters in big systems like bioreactors.
Following Rules: Meets high standards for data in regulated workplaces.
The NEURONBC V8.0 is a top choice. It has improved data tracking to meet new rules.
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FAQ
Q1: What is the difference between bubble point, diffusion flow, and water intrusion testing?
A1: Bubble point identifies the pressure at which air first passes through the largest wetted pore, giving a fast pass/fail check. Diffusion flow measures the rate of gas diffusing through a wetted membrane below the bubble point, suited to larger-area filters. Water intrusion is a non-destructive method for hydrophobic (vent) filters that does not require alcohol wetting.
Q2: How often does a filter need to be integrity tested?
A2: Current expectations under EU GMP Annex 1 call for testing after sterilization and before use, and again after use, for each sterilizing-grade filter in an aseptic process.
Q3: Can one instrument test both hydrophilic and hydrophobic filters?
A3: Yes, provided the instrument supports the wetting-fluid-specific test methods each filter type requires - water intrusion for hydrophobic vent filters, and bubble point/diffusion for hydrophilic liquid filters.
Q4: Does automated filter integrity testing satisfy 21 CFR Part 11 on its own?
A4: The instrument's data output needs to support audit trails, e-signatures, and access controls; the surrounding SOPs and validation still need to close the loop for full Part 11 compliance.