Filter Integrity Test System
Category：Filter Cartridge Filtration Tester
Introduction
The Filter Integrity Test System is a high-precision instrument designed for automated integrity testing of liquid or gas filters. The system supports water intrusion testing (WIT) for hydrophobic filters and forward flow/bubble point testing for hydrophilic liquid filters, ensuring repeatable and reliable results. The system can operate automatically and is suitable for GMP environments with strict requirements for electronic records and signatures (21 CFR Part 11). The MUX expansion module can extend testing capability to connect up to four liquid filter housings, enabling parallel multi-filter testing.
Application
(1) Hydrophobic filter integrity testing (water intrusion test).
(2) Hydrophilic liquid filter integrity testing (forward flow and bubble point tests).
(3) Pre-use validation for single-use systems and small-scale process equipment.
(4) Liquid sterilizing filtration systems in pharmaceutical, biotechnology, and life sciences industries.
(5) Gas sterilizing filter integrity verification in the pharmaceutical industry.
(6) Laboratory environments under GMP and 21 CFR Part 11 control.
(7) Verification of various process liquid or gas filters, including laboratory and industrial production processes.
(8) Supports multiple membrane types, including hydrophobic, hydrophilic, and composite membranes.
Standards
ASTM F838 – Membrane bubble point method
ASTM D5199 – Gas and liquid filtration membrane performance testing
ISO 2548 series – Pressure decay and diffusive flow methods
GMP/GDP Filter Validation Guidelines
FDA 21 CFR Part 11 – Data integrity compliance
Product Specifications
| Parameter | Technical Specifications |
|---|---|
| System Size | 1189 × 575 × 856 mm |
| System Weight | Approx. 120 kg (empty water tank) |
| Water Tank Capacity | 18 L (removable, manual/automatic filling) |
| Forward Flow Test Accuracy | ±3% or ±0.05 mL/min (whichever is larger) |
| Water Intrusion Test Accuracy | ±3% or ±0.02 mL/min (whichever is larger) |
| Bubble Point Test Accuracy | ±3% |
| Power Supply | 100–240 VAC, 50/60 Hz, typical power 150 W |
| Compressed Air Pressure | 4500–8000 mbar (58–116 psi) |
| Test Flow Range | FF: 0.1–1000 mL/min; WIT: 0.02–50 mL/min; BP: 400–6500 mbar |
| Test Resolution | FF: 0.1 mL/min (<10 mL/min: 0.01 mL/min); WIT: 0.01 mL/min; BP: 50 mbar |
| Touch Screen | 26.4 cm diagonal, 1024 × 768 pixels, backlit, adjustable contrast |
| Protection Level | IP54 (splash-proof) |
| Environmental Conditions | Operating temperature: 5–50℃; Storage temperature: -20–70℃; Relative humidity: 95% RH (non-condensing) |
MUX Expansion Module Specifications
| Parameter | Technical Specifications |
|---|---|
| Model | AW04 |
| Size | 680 × 650 mm, height approx. 1100 mm |
| Materials | Piping: Stainless steel 1.4435/1.4404; Frame: Stainless steel 1.4301; Clamp gasket: EPDM (FDA); Wet contact hose: PTFE (FDA) |
| Maximum Pre-Installed Filter Quantity | 4 liquid filter housings |
Product Features
Fully automated operation: complete automatic wetting, testing, and drainage of filters.
Time-saving: automatic testing reduces testing time by over 50% while maintaining accuracy.
Safe and environmentally friendly: only water is used; no alcohol required, reducing flammable liquid risk.
Remote operation: supports PLC, SCADA, and OPC UA protocols for centralized control and monitoring.
High-precision flow measurement: ensures accurate and repeatable low flow detection.
Self-diagnostic and verification: daily automatic checks for valves, sensors, internal regulators, and data integrity.
Fault detection: automatic alarms for low flow, abnormal pressure, or leakage, minimizing false readings.
Compatible with multiple membrane types: hydrophobic, hydrophilic, and multi-layer composite membranes.
Paperless record-keeping: results can be stored electronically, printed, and exported as PDF/XML files compliant with GMP.
Accessories
| Name | Model/Specification | Quantity | Unit |
|---|---|---|---|
| Built-in Water Tank | 18 L, removable | 1 | piece |
| Thermal Printer | Paper width 112 mm, roll diameter 50 mm | 1 | set |
| Standard Water Connection | Manual/automatic filling | 1 | set |
| MUX Expansion Module | AW04 | 1 | set |
| Liquid Filter Housing | Pre-installed (optional) | 1–4 | pieces |
| Touch Screen Operating System | Embedded Linux | 1 | set |
| Data/Network Cables | USB, Ethernet | Several | pcs |
| Testing Software | Self-developed system | 1 | set |
| User Manual | Included | 1 | set |
Testing Principle
Water Intrusion Test (WIT): Hydrophobic membranes are fully wetted and subjected to air pressure. The water evaporation rate is measured, correlating with bacterial retention capability.
Forward Flow Test (FF): Hydrophilic membranes are fully wetted, and the liquid or gas flow through the membrane is measured to assess filter integrity.
Bubble Point Test (BP): Pressure is gradually increased until continuous bubbles appear, determining pore size and membrane integrity.
Flow Control and Measurement: Flowstar IV volumetric flow metering technology ensures high accuracy and repeatability.
Safety Control: The system automatically detects low flow, downstream pressure anomalies, and leakage to prevent false readings.
FAQ
1. What is this product?
The Filter Integrity Test System is a high-precision automated instrument designed to evaluate the integrity of liquid or gas filters. It supports water intrusion testing (WIT) for hydrophobic filters and forward flow/bubble point testing (FF/BP) for hydrophilic filters, ensuring repeatable and reliable results. The system is fully automated and compatible with GMP environments requiring 21 CFR Part 11 compliance.
2. What is this product used for?
This system is used for:
Integrity verification of hydrophobic and hydrophilic liquid filters
Pre-use validation of single-use systems and small-scale process equipment
Sterile filtration quality control in pharmaceutical, biotechnology, and life sciences applications
Gas sterilization filter verification in medical and industrial environments
Laboratory and industrial process filter validation, including multi-membrane types
3. Why is this product important?
Filter integrity is critical to ensuring sterility and process safety in pharmaceutical and biotech manufacturing. This system provides standardized, automated, and reliable testing that minimizes human error and guarantees traceable results in compliance with regulatory standards.
4. What industries is this product suitable for?
Pharmaceutical and biopharmaceutical manufacturers
Life sciences research laboratories
Medical device and sterile production facilities
Quality control and process validation laboratories
GMP-compliant manufacturing sites
5. What types of filters can be tested with this system?
The system can test:
Hydrophobic membrane filters (water intrusion test)
Hydrophilic membrane filters (forward flow and bubble point tests)
Single-use and reusable filters in liquid or gas applications
Multi-layer composite membranes
Filters installed in MUX modules for parallel testing (up to 4 filters)
