Diffusion / Forward Flow
Measures gas diffusion through a wetted membrane at a defined pressure and is widely used for integrity testing of suitable hydrophilic membrane filters.
Mobile Trolley Filter Integrity Tester ita-02
The ita-02 mobile filter integrity tester is a complete trolley-mounted membrane integrity-testing system designed for routine use across pharmaceutical, biotechnology and other GMP-regulated production environments.
The wheeled trolley allows the complete test station to be moved flexibly between filtration and production locations. The filter-testing instrument itself can also be removed from the trolley frame for servicing or transport.
Pressure measurement
0–6 bar
Primary test methods
Diffusion · BP · WFT
Stored test reports
>12,000
System format
Mobile trolley
Mobile integrity-testing station for pharmaceutical production
The ita-02 is designed for facilities where filter integrity testing is required at multiple production locations.
Rather than carrying a compact instrument by hand, the complete test station is moved between production systems on its wheeled trolley. This provides convenient storage and positioning of the integrity tester while maintaining mobility throughout the production area.
This format is particularly suitable for routine production testing, cleanroom operations, validation work and manufacturing facilities with multiple membrane filtration points.
Filter integrity test methods
Bubble Point Test
Determines membrane pressure behaviour associated with displacement of the wetting liquid from the largest membrane pores.
Combined Diffusion + Bubble Point
Diffusion and Bubble Point testing can be performed as one programmed integrity-test sequence.
Water Flow Test – WFT / WIT
Water Flow testing is available for suitable hydrophobic membrane systems and is historically also known as Water Intrusion Testing.
Pressure Hold / Pressure Decay
Pressure behaviour can be monitored over a defined period for appropriate filter and system integrity applications.
Upstream Volume Measurement
Automatic upstream-volume measurement supports integrity-test calculations where the connected system volume is not already known.
Volume-measurement note: the technical brochure references different volume ranges for different measurement modes and configurations. Confirm the required measurable upstream-volume range for the intended installation.
ita-02 technical specifications
| Model | ita-02 |
|---|---|
| System type | Wheeled mobile trolley membrane filter integrity-testing system |
| Test unit material | Stainless steel 1.4301 |
| Maximum dimensions | Approx. 418 × 585 × 1190 mm |
| Weight | Approx. 55 kg |
| Protection rating | IP65 |
| Power supply | 20 V / 3.3 A mains operation 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 reports | More than 12,000 |
| Internal pressure sensor | 0–6 bar relative, class 0.2 |
| External measurement sensor | 0–6 barg relative, class 0.05 |
| Barometric pressure sensor | 800–1070 mbar relative, class 0.5 |
| Data transfer | USB Type-C, LAN and optional Bluetooth connectivity |
| Languages | English and German |
| Ambient operating temperature | 5–40 °C |
Measurement accuracy
| Pressure Hold Test | ±0.3 mbar |
|---|---|
| Water Flow Test | ≤3% |
| Diffusion Test | ≤4% |
| Bubble Point Test | ±50 mbar |
| Volume Measurement | ≤2% |
Direct capsule and small-filter integrity testing
The ita-02 includes a dedicated filter holder for direct integrity testing of small membrane-filter formats.
Compatible formats can include disposable capsule filters, mini-cartridges, syringe filters and standard capsule configurations.
This makes the trolley system suitable for facilities combining traditional cartridge filtration with single-use capsule filtration.
Filtra 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 filters PES, PVDF, Nylon and comparable wetted membrane systems |
Diffusion / Forward Flow, Bubble Point, combined testing and Pressure Hold according to the validated filter specification |
|
Hydrophobic gas and vent filters PTFE and comparable hydrophobic membrane systems |
Water Flow / Water Intrusion-type testing and other appropriate integrity methods according to the filter's validated limits |
Automatic wetting for capsule and cartridge filters
The ita-02 can optionally be equipped with an automatic membrane-wetting system.
The wetting system uses controlled valves, pressure regulation and a defined flow of wetting agent to prepare the membrane before integrity testing. Wetting time can be configured and stored as part of the relevant test programme.
Separate configurations are documented for cartridge filters and capsule filters used in single-use systems.
Once the controlled wetting procedure is completed, the integrity test can follow immediately, improving repeatability and reducing operator-dependent variation.
Single-use bag assembly testing
With suitable optional low-pressure hardware, the ita-02 platform can also support low-pressure decay testing of sterile single-use bag assemblies.
Additional hardware is required for this application. This extends the system beyond membrane-filter integrity testing and creates a broader testing platform for pharmaceutical single-use processing.
Electronic reports and data integrity
The ita-02 is designed for documented integrity testing in GMP-regulated manufacturing environments.
- More than 500 stored test programmes
- More than 12,000 stored test reports
- Integrated thermal report printer
- Real-time graphical display of measurement values
- Time-stamped electronic PDF reports
- PC software for report management
- Mobile report-management capability
- Integrated backup functionality
- Traceability and data-integrity functions
21 CFR Part 11, GMP & Qualification Support
The ita-02 is designed for regulated pharmaceutical and biotechnology production environments requiring traceable integrity tests, electronic documentation and qualification support.
21 CFR Part 11
The documented system includes functionality intended to support
requirements for regulated electronic records and data integrity.
Cyber Resilience Act
The system is documented as compliant with requirements of the EU Cyber
Resilience Act.
IQ / OQ
Qualification support is available for Installation and Operational
Qualification.
PQ support
Performance Qualification can be supported at the installed production
system together with commissioning and operator training.
IQ, OQ, PQ, calibration and commissioning
IQ verifies correct installation, completeness of components and associated documentation.
OQ verifies functions, operating modes and measurement accuracy using calibrated reference instruments.
PQ can be performed at the customer's installed system together with commissioning and operator training. Filter-specific parameters and test programmes can then be established and verification tests performed on the actual filtration systems.
Annual inspection and calibration of the measurement sensors and pressure-control system are recommended.
it-02 vs ita-02: which mobile integrity tester?
| it-02 | ita-02 | |
|---|---|---|
| Mobility | Hand-portable mobile tester | Wheeled mobile trolley system |
| Format | Compact standalone instrument | Complete mobile production workstation |
| Weight | Approx. 11.5 kg | Approx. 55 kg |
| Movement | Carried to the filter or test location | Rolled between production stations |
| Typical environment | Laboratory, cleanroom and flexible production testing | Routine pharmaceutical production testing |
| Capsule testing | Direct capsule testing | Direct capsule testing |
| Battery operation | Available | Available |
| Automatic wetting | Optional | Optional |
How to configure the ita-02
The appropriate configuration depends on the membrane filter, process and qualification requirements.
- Hydrophilic liquid filter or hydrophobic gas / vent filter
- Cartridge, capsule or other membrane-filter format
- Required Diffusion, Bubble Point, WFT or Pressure Hold method
- Need for automatic membrane wetting
- Need for sterile single-use bag testing
- Connection and adapter requirements
- Electronic reporting requirements
- IQ / OQ documentation requirements
- PQ, commissioning and training requirements
Configure an ita-02 mobile production test system
Send us your membrane type, filter format, integrity-test method, production process and qualification requirements. We can configure the ita-02 for cartridge filters, capsule filters, hydrophilic and hydrophobic membranes and selected single-use testing applications.
ita-02 Filter Integrity Tester FAQ
Is the ita-02 a mobile filter integrity tester?
Yes. The ita-02 is a wheeled mobile integrity-testing station designed to move between production locations. The test unit can also be removed from the trolley frame when required.
What is the difference between it-02 and ita-02?
Both systems are mobile. The it-02 is a compact hand-portable tester, while the ita-02 is a complete trolley-mounted workstation designed to be rolled between production stations.
Which integrity tests can the ita-02 perform?
The system supports Diffusion / Forward Flow, Bubble Point, combined Diffusion + Bubble Point, Water Flow Test, Pressure Hold / Pressure Decay and upstream-volume measurement.
Can the ita-02 test capsule filters?
Yes. A dedicated holder enables direct connection of compatible capsule filters, mini-cartridges and other small membrane filters.
Can the ita-02 test hydrophobic PTFE filters?
Yes. Water Flow / Water Intrusion-type testing is available for suitable hydrophobic membrane-filter systems.
Is automatic filter wetting available?
Yes. Automatic wetting configurations are documented for cartridge filters and for capsule filters used in single-use systems.
Can the ita-02 support single-use bag testing?
Yes, with suitable optional low-pressure hardware. Additional equipment is required for sterile bag leak-testing applications.
Does the ita-02 support 21 CFR Part 11?
The documented system includes electronic-reporting, traceability and data-integrity functions intended to support regulated requirements associated with 21 CFR Part 11.
Can the ita-02 run on battery power?
Yes. The mobile trolley system supports either low-voltage mains operation or a rechargeable battery.
Are IQ, OQ and PQ services available?
Yes. IQ and OQ qualification support is available, while PQ can be supported at the installed production system together with commissioning and operator training.