Diffusion / Forward Flow Test
Measures gas diffusion through a wetted membrane at a defined pressure. This method is widely used for integrity testing of suitable hydrophilic liquid membrane filters.
Compact Mobile Filter Integrity Tester it-02
The it-02 portable filter integrity tester is a compact, hand-portable mobile system for integrity testing of hydrophilic and hydrophobic membrane filters in pharmaceutical, biotechnology and other regulated filtration environments.
With a stainless-steel IP65 enclosure, rechargeable-battery capability, 7-inch touchscreen and integrated test reporting, the it-02 can be carried directly to filtration points throughout laboratories, cleanrooms and production facilities.
Pressure measurement
0–6 bar
Primary test methods
Diffusion · BP · WFT
Stored test results
>12,000
Weight
Approx. 11.5 kg
Portable integrity testing at the filter location
The it-02 is designed for applications where the integrity tester must be moved easily between different filter systems and test locations.
Unlike a trolley-mounted test station, the compact instrument can be carried directly to the test point and transported in its protective mobile case. Battery operation further supports flexible use where mains power is not immediately available.
The instrument can be used with membrane cartridges, capsule filters, mini-cartridges, disposable filters and other compatible membrane-filter formats.
Filter integrity test methods
Bubble Point Test
Evaluates the pressure at which wetting liquid is displaced from the largest membrane pores. A combined Diffusion + Bubble Point programme is also available.
Water Flow Test – WFT / WIT
The Water Flow Test, historically also referred to as Water Intrusion Test, is available for suitable hydrophobic membrane-filter applications.
Pressure Drop Test
Measures pressure change during a defined test sequence and provides another non-destructive method for appropriate filter or system integrity applications.
Upstream Volume Measurement
The instrument can measure the upstream volume of a connected filter system to support automated integrity-test calculations and setup.
Combined Test Programmes
Diffusion and Bubble Point testing can be combined into one programmed test sequence to reduce operator handling between tests.
it-02 technical specifications
| Model | it-02 |
|---|---|
| System type | Compact hand-portable mobile membrane filter integrity tester |
| Cabinet material | Stainless steel 1.4301, electropolished and splash protected |
| Dimensions | Approx. 220 × 300 × 245 mm |
| Weight | Approx. 11.5 kg |
| Protection class | IP65 |
| Power supply | 20 V / 3.3 A low-voltage mains adapter or rechargeable battery |
| HMI | 7-inch capacitive TFT touchscreen |
| Display | 1280 × 720 pixels |
| Operating system | Protected Linux operating system |
| Stored test programmes | More than 500 |
| Stored test results | More than 12,000 |
| Internal pressure sensor | 0–6 bar, class 0.2 |
| External pressure sensor | 0–6 bar relative, class 0.05 |
| Barometric pressure sensor | 800–1070 mbar relative, class 0.5 |
| Data transfer | USB Type-C and Bluetooth |
| Languages | English and German |
| Ambient operating temperature | 5–40 °C |
Measurement accuracy
| Pressure Drop Test | ±0.6 mbar |
|---|---|
| Water Flow Test | ≤3% |
| Diffusion Test | ≤4% |
| Bubble Point Test | ±50 mbar |
| Volume Measurement | ≤2% |
Filter-specific limits: test pressure, wetting medium, stabilisation time, test duration and acceptance criteria must be selected according to the validated specification of the membrane filter being tested.
Direct capsule filter integrity testing
A dedicated filter holder on the rear of the it-02 allows small membrane filters to be connected directly to the instrument.
Compatible formats can include capsule filters, approximately 50 mm disposable filters, mini-cartridges and syringe filters. This makes the it-02 particularly useful for laboratory development, pilot-scale filtration and pharmaceutical single-use filtration systems.
Filtra also supplies PES, PTFE, PVDF, Nylon and polypropylene capsule filters for laboratory, pilot and process filtration.
Hydrophilic and hydrophobic membrane testing
| Membrane application | Relevant integrity-test approach |
|---|---|
|
Hydrophilic liquid membranes PES, PVDF, Nylon and comparable wetted membranes |
Diffusion / Forward Flow, Bubble Point, combined testing and applicable pressure-based tests according to the validated filter specification |
|
Hydrophobic gas and vent membranes PTFE and comparable hydrophobic membranes |
Water Flow / Water Intrusion-type testing and other validated methods specified for the individual filter |
Optional automatic membrane wetting
The it-02 can be configured with an automatic wetting system for compatible membrane filters.
Pressure-assisted wetting helps prepare the membrane consistently before the integrity test, reducing operator-dependent variation. Dedicated wetting configurations are available for both cartridge filters and capsule filters.
The integrity test can then follow immediately after the controlled wetting procedure.
Single-use bag assembly leak testing
With the optional low-pressure test module, the it-02 platform can also be extended to leak testing of sterile single-use bag assemblies.
The documented low-pressure unit operates between 50 and 500 mbar and can also be applied to selected small storage tanks and fermenters. An integrated vacuum pump enables evacuation of the connected bag before testing.
This allows membrane-filter integrity testing and selected single-use assembly leak testing to form part of the same broader quality-control platform.
Test reporting and data integrity
The it-02 is designed for documented filter testing in regulated pharmaceutical and biotechnology environments.
- More than 12,000 test results can be stored internally
- Integrated front-mounted thermal printer
- Automatic or manual report printing
- Desktop software for receiving, managing and archiving test reports
- PDF report storage
- Mobile report management for compatible smartphones and tablets
- Secure timestamps on electronic reports
- Original test data remains stored on the instrument
GMP, 21 CFR Part 11 & Qualification Support
The it-02 combines membrane integrity testing with electronic documentation, traceability and qualification support for regulated pharmaceutical and biotechnology environments.
21 CFR Part 11
The system is designed to support regulated electronic-record and data
integrity requirements.
Cybersecurity
The documented platform addresses requirements associated with the
EU Cyber Resilience Act.
IQ / OQ
Qualification documentation packages can be supplied for Installation and
Operational Qualification.
PQ support
Performance Qualification support can be provided for the installed filter
system and test application.
Calibration, IQ, OQ and PQ
Annual inspection and calibration of the pressure sensors and pressure control system are recommended to maintain measurement accuracy.
Qualification support can include Installation Qualification, Operational Qualification and support for Performance Qualification of the installed filter system.
Test programmes and parameters can be established according to the filter, application and validated integrity limits.
Standard scope of delivery
- it-02 portable filter integrity tester
- Reference vessel
- 67 W / 20 V power supply
- Outlet tube
- Air regulator with 8 µm filter and inlet tube
- Mobile transport case
it-02 vs ita-02: two mobile integrity-testing systems
| it-02 | ita-02 | |
|---|---|---|
| Mobility | Hand-portable mobile tester | Wheeled mobile trolley system |
| Format | Compact standalone instrument | Complete mobile production test station |
| Weight | Approx. 11.5 kg | Approx. 55 kg |
| Movement | Carried directly to the filter location | Rolled between production stations |
| Best suited to | Flexible laboratory, cleanroom and production testing | Routine integrity testing across multiple production stations |
| Capsule testing | Direct capsule and small-filter testing | Direct capsule and small-filter testing |
| Battery operation | Available | Available |
| Automatic wetting | Optional | Optional |
Configure your it-02 integrity-testing system
Send us your membrane type, filter format, test method, production environment and qualification requirements. We can configure the it-02 for cartridge filters, capsule filters, hydrophilic or hydrophobic membranes and selected single-use assembly testing.
it-02 Filter Integrity Tester FAQ
Is the it-02 a mobile filter integrity tester?
Yes. The it-02 is a compact hand-portable mobile integrity tester designed to be carried directly between filter locations. A protective transport case is included in the documented standard scope.
What tests can the it-02 perform?
The it-02 supports Diffusion / Forward Flow, Bubble Point, combined Diffusion + Bubble Point, Pressure Drop, Water Flow Test and upstream-volume measurement.
Can the it-02 test capsule filters?
Yes. A dedicated holder allows compatible capsule filters, disposable filters, mini-cartridges and syringe filters to be connected directly to the tester.
Can the it-02 test PTFE hydrophobic filters?
Yes. The platform supports Water Flow / Water Intrusion-type integrity testing for suitable hydrophobic membrane-filter applications.
Is automatic membrane wetting available?
Yes. Optional automatic wetting configurations are available for compatible capsule and cartridge filters.
Can the it-02 test single-use bags?
With the optional low-pressure module, the platform can perform leak testing of sterile single-use bag assemblies. Additional hardware is required.
Does the it-02 support 21 CFR Part 11 requirements?
The system includes electronic reporting, traceability and data-integrity functions designed to support regulated electronic-record requirements.
Can the it-02 operate on battery power?
Yes. The compact tester can operate from a rechargeable battery or its 20 V low-voltage mains supply.
Are IQ, OQ and PQ services available?
Qualification documentation can be supplied for IQ and OQ, with PQ support available for the installed filter and test application.
What is the difference between the it-02 and ita-02?
Both systems are mobile. The it-02 is a compact hand-portable tester, whereas the ita-02 is a complete wheeled trolley-based integrity-testing station for routine production use.