Safeguard the quality of your filtration processes with the Filter Integrity Tester from Flow Test – precise, reliable, and easy to operate. Ideal for pharma, food, biotech, and all applications where safety and compliance are essential.
Filter Integrity Tester
Description
Filter Integrity Testing Machine – Precision for Your Filter Testing
The Flow Test „it-01G“ perfectly meets today’s requirements for filter integrity testing. Whether integrated into a PUPSIT system (Interner Link zur Produktseite PUPSIT), or used as a stand-alone solution for testing single-use vent filters, the instrument delivers outstanding performance and flexibility.
Key features include:
- Versatile testing methods
- High accuracy and reproducibility
- Full compliance with 21 CFR Part 11 / Annex 11
- Intuitive, user-friendly operation
- Lightweight, compact, and fully portable design
Check Your Membrane Filtration Systems
The it-01 filter integrity testing machine is designed for reliable integrity testing of membrane filters. It also enables the measurement of unknown volumes, such as the net volume of filtration systems ranging from 0.1 to 35 L. In addition, the device can be used as a calibration manometer for verifying pressure sensors (measuring ranges: 0–4, 0–6, and 0–8 bar).
Supported test methods include:
- Diffusion Test (Forward Flow) according to DIN 58356 Part 2
- Bubble Point Test
- Combined Diffusion & Bubble Point Test
- Pressure Decay Test
- Low-Pressure Decay Test* – e.g. for sterile bag testing
- Water Intrusion Test (WIT)
- WIT for large-scale filtration systems (up to 150 L)*
- Automated filter wetting procedures
- Volume measurement (e.g. upstream volume)
* Additional hardware required
Filter testing can also be performed directly on the instrument. A dedicated filter holder is integrated at the rear of the device, allowing all common filter types – from syringe filters to standard capsule filters – to be mounted and tested directly on-site.
Benefits of Filter Integrity Testing for Your Production
Filter integrity testing plays a key role in ensuring product quality and process safety in manufacturing environments. Users benefit in several important ways:
- Quality assurance: Reliable verification of membrane filter integrity (e.g. Bubble Point and Forward Flow) ensures consistent and validated filtration performance.
- Compliance: Supports full compliance with regulatory standards such as 21 CFR Part 11 and EU GMP Annex 1.
- Process safety: Enables early detection of filter defects, damage, or installation errors, reducing the risk of contamination and product loss.
- Efficiency gains: Automated testing workflows shorten test cycles while minimizing manual effort and operator-related errors.
Frequently Asked Questions
Which standards and regulations apply?2026-04-27T12:55:32+00:00
EU GMP Guide – Annex 1 “Manufacture of Sterile Medicinal Products”
The EU GMP Guide (EudraLex, Volume 4, Annex 1) requires that the integrity of a sterilized filtration system is verified prior to sterile filling operations.
US FDA Guidance – Aseptic Processing
While the FDA does not explicitly require a mandatory pre-use integrity test as defined in EU GMP regulations, it recommends performing filter integrity testing after filtration or installation, as well as at appropriate stages of the process, to ensure the early detection of leaks or damage.
FDA 21 CFR Part 11 – Audit Trail Requirements
21 CFR Part 11 governs the use of electronic records and electronic signatures in the pharmaceutical and biotechnology industries. It requires a secure, computer-generated audit trail that automatically records all GMP-relevant actions and data changes in a complete, tamper-evident, and fully traceable manner.
How should I properly maintain and clean the filter integrity testing device?2026-04-27T12:53:53+00:00
The stainless steel housing of the device can be easily cleaned with isopropanol. In addition, the pneumatic system can be decontaminated by hydrogen peroxide (H₂O₂) gassing, ensuring reliable hygienic conditions and system integrity.
How is the filter integrity testing device calibrated?2026-04-27T12:52:05+00:00
To ensure a consistently high quality standard, all sensors and the pressure control system must be inspected and calibrated by the manufacturer after six months of initial operation and annually thereafter.
These services are carried out on-site by the manufacturer or an authorized service provider within Germany and neighboring countries. All required measuring instruments are certified with DKD or PTB calibration certificates and are subject to regular metrological monitoring.
Is the device suitable for mobile use?2026-04-27T12:48:22+00:00
The it-01 filter integrity tester is compact and fully portable, making it ideally suited for mobile applications. It can also be used for filter testing in hard-to-access locations such as tanks, autoclave rooms, or freeze dryers.
| Housing material | Stainless steel 1.4301, electropolished |
| Dimensions (without handle) | 200 mm x 300 mm x 155 mm |
| Weight | 8.6 kg |
| Protection class | IP 55 |
| Power supply | 7.5 V / 3.3 A |
| Input device | USB alphanumeric keyboard |
| Software protection | EPROM-secured system |
| Printer | Impact printer, plain paper, 24 characters/line |
| Test program storage | 100 methods |
| Pneumatic connections | Stäubli RBE 03 / stainless steel 1.4404 |
| Internal pressure sensor | 0–6 bar (rel. class 0.2), optional 0–4 or 0–8 bar |
| Barometric sensor | 800–1090 mbar (class 0.5) |
| External pressure sensor | 0–6 bar (rel. class 0.15), optional 0–4 or 0–8 bar |
| Supported languages | German, English, French, Spanish, Italian, Danish |
| Pressure units | mbar |
| Water flow | µL/t (measurement time) |
| Diffusion | mL/min (normalized to 1000 mbar, 20°C) |
| Volume | mL |
| Supported test methods | Water Intrusion Test (WIT)
Diffusion Test (Forward Flow) Pressure Decay Test Bubble Point Test Combined Diffusion & Bubble Point Test Net volume measurement |
| Cleaning & maintenance | Sensor and valve cleaning via steam sterilization of the external pressure sensor and filling valve. Internal valves are flushed at 80°C. |
| Measurement accuracy: | |
| – Water Intrusion Test (WIT) | ±4% of reading (≥ 0.1 mL/min = 100 µL/min), max. resolution 0.005 mL (5 µL) |
| – Diffusion test | ±5% of reading (≥ 5 mL/min), according to DIN 58356 Part 2
Max. resolution 0.1 mL |
| – Bubble Point test | ±1% of full scale |
| Ambient temperature | 5 – 40°C |
| Storage temperature | 2 – 50°C |
| Relative humidity | 0-80% |
