Filter Integrity Testing Instrument, V10 Filter Integrity Tester for Pharmaceutical Sterile Filtration Testing
2. Utilizes an optimized Linux operating system;
3. Optimized testing procedures to reduce test duration;
4. Flexible switching between multiple pressure units (mbar, kPa, psi, kgf/cm²);
5. Features a 10-inch true-color touchscreen and a user-friendly interface for simple, fast, and reliable operation;
6. Equipped with audit trail functionality;
7. Supports up to 1,000 preset programs to accommodate various filter types and diverse on-site testing conditions;
8. Data communication and network interfaces can be expanded based on customer requirements, with support for wireless communication;
9. Test records and audit trails can be queried and exported;
10. Features a bilingual interface (Chinese and English);
Product Description
Zetron Filter Integrity Tester V10 have been developed in accordance with EU GMP Annex 11 Computerized Systems,Good Automated Manufacturing Practice (GAMP)guidelines,manufactured underquality management systems certified to ISO9001. are CEmarked toindicate compliance with relevant European Directives. The instrument hasbeen specifically designed to be used in any kind of cleanroom.
Why You Need Filter Integrity Tester V10? Learn The Regulatory Landscape in 2026
The rules around sterile production keep changing fast. Changes to EU GMP Annex 1 and FDA 21 CFR Part 11 stress data reliability, machine use, and the truth of digital records.
"The integrity of the sterilised filter assembly should be verified by integrity testing before use, to check for damage and loss of integrity caused by the filter preparation prior to use." This line from EU GMP Annex 1 (2022) lays out a plain rule. Every filter for sterilization needs recorded checks before and after use. These checks rely on proven methods like bubble point, diffusive flow, or pressure hold tests.
Hand-done or partly automated tests often miss the mark. Paper logs might get lost. Handwritten notes can turn hard to read or leave gaps. These slip-ups go against ALCOA+ basics-Attributable, Legible, Contemporaneous, Original, Accurate. Such principles now sit at the core of FDA and EMA reviews.
How the Filter Integrity Tester V10 Delivers True GMP Compliance
The Automated Filter Integrity Tester V10 stems from a simple goal. It aims to cut out human mistakes in key steps for filter checks. Automated steps lead workers through each part-picking tests, running them, and confirming results. All this keeps full digital tracking.
Every log from the Automated Filter Integrity Tester V10 follows ALCOA+ guidelines:
- Attributable: Logins tied to specific users connect each move to one person.
- Legible: Results shape into clear PDF reports on their own.
- Contemporaneous: Data grabs happen right as tests run.
- Original: Raw info gets coded and saved in its basic form.
- Accurate: Built-in calibrations on sensors promise steady exactness in readings.
Digital sign-offs and safe change logs come right into the device's core software. Data saving meets FDA 21 CFR Part 11 needs for digital logs and sign-offs. So, no extra setup is required for checks or storage.
Filter Integrity Testing Instrument V10 Filter Integrity Tester for Pharmaceutical Sterile Filtration Testing
Filter Integrity Tester V10 pressurizes a wetted or dry filter with air or nitrogen and measures how the system responds. The physical behavior reflects pore structure and any defects.
Common principles:
1. Bubble Point: Determines the minimum pressure at which gas displaces liquid from the largest pores, producing continuous bubbling. Correlates with maximum pore size and membrane integrity.
2. Diffusive Flow (Forward Flow): Measures steady‑state gas flow through a fully wetted membrane under constant pressure below bubble point. Increased flow indicates larger or additional pores/defects.
3. Pressure Hold / Decay: Monitors pressure drop over time in a closed, pressurized system. Excess decay suggests leaks or membrane defects.
4. Water Intrusion Test (WIT): For hydrophobic gas filters; measures water entering the
Functional parameters
| Test Functionality | Manual bubble point test; basic bubble point test; enhanced bubble point test; pressure holding test; diffusion flow test Test; Water immersion test; Ultrafiltration membrane package test; |
| Audit trail | Multiple event logs, exportable but not editable |
| Pre-stored plans | 10 00 groups |
| Audit trail record storage | ≥5 years storage |
| Number of users | 10 00 |
| Operating system | WindowsCE |
| Record backup | Support USB flash drive to export data (including test curves); |
| Display | - definition 10.1 " color touch screen; |
| Serial port connection method | RS232 serial port, USB port , etc. |
| Usage | Online/Offline |
| Scope of application | Symmetrical/asymmetric membranes, needle filters, capsule filters, flat plate filters, cartridge filters, ultrafiltration membrane packs, ultrafiltration columns; |
| Power supply | 220/110VAC |
| Dimensions | 240(W)320(L)250(H)mm |
| Pressure range | 100~10000mbar |
| Weight | 7.5Kg |
| Test scope | Basic bubble point: 100～10000mbar |
| Diffusion flow: 1~ 1000ml /min | |
| Water intrusion: 0.01~100ml/min | |
| Operating conditions | Ambient temperature: +5°C to +50°C |
| Relative humidity: 10-80% | |
| Test accuracy | Basic bubble point: ± 50mbar |
| Diffusion flow: ±4% | |
| Water immersion: ±0.01% | |
| Print content | Object attributes, test conditions, test content, test results, test curve, test time, electronic signature |
| Testing time | Basic bubble point: 3 to 10 minutes |
| Diffusion flow: 6 to 10 minutes | |
| Water immersion: 6 to 10 minutes | |
| Pressure holding method: 3 to 5 minutes | |
| Storage space | 16G, 1 million historical records |
| Permission levels | Level 4 |
| Display | 10. 1- inch color touch screen |
| External interface | RS232/RS485/USB , etc. |
| Language selection | Chinese/English |
Zetron – Filter Integrity Tester Manufacturer Introduction
Beijing Zetron Technology Co., Ltd. (Zetron Instrument) is a trusted supplier in the field of pharmaceutical testing equipment. We specialize in precision instruments—such as the Filter Integrity Tester V8.0 and V10—that comply with strict regulations set by the FDA and other relevant bodies, ensuring product quality and reliability. Zetron is your trusted partner, offering comprehensive services and customized solutions. Our service team assists with installation, calibration, and maintenance to ensure the long-term, stable operation of your equipment.
Zetron designs and manufactures filter integrity testing instruments that support key test methods such as bubble point, diffusion/forward flow, pressure hold, and water intrusion, used to verify the integrity of sterilizing‑grade filters, HEPA filters, and other critical filtration assemblies. Its product range includes models such as the Integtest V8.0, FIT‑550, FIT‑600, and V10 platforms, aimed at sterile drug production, bioprocess validation, and cleanroom filtration systems.
Customized Filter Integrity Tester Solution
Zetron offers personalized customization of filter integrity testers based on your application scenario and filter types.
If you are evaluating a customized filter integrity tester solution, Zetron typically requires:
- Your filter types and sizes (e.g., cartridge length/area, membrane material, pore size).
- Required test methods (bubble point, diffusion, pressure hold, WIT, ultrafiltration tests).
- Regulatory and data integrity requirements (21 CFR Part 11, audit trail depth, user levels).
- Integration needs (LIMS/QMS, report formats, network connectivity).
- Expected deployment environment (QC lab, production suite, cleanroom grade).
With this information, Our team can propose a tailored instrument configuration (hardware, software, services) and, if needed, an OEM/ODM arrangement aligned with your project timeline and compliance goals.
Zetron delivers innovative solutions that boost efficiency and drive growth for your business success.
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