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

Applications:

(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.

Product Information:

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.

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 and Consumables

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.

Operating Instructions

Ensure compressed air pressure is within 4500–8000 mbar before operation.

Water intrusion tests require only deionized water or water of equal quality; avoid alcohol or other liquids.

Hydrophilic filters must be fully wetted before testing; wetting liquids must be compatible with process.

Avoid large temperature fluctuations to maintain accurate gas flow measurements.

System self-check is recommended on first startup; periodic calibration of Flowstar IV flow meters is advised.

When using MUX modules, ensure filter housings are securely connected without trapped air.

Experimental Procedure

Water Intrusion Test (WIT)

Connect the filter housing to the system.

Check the water tank level and prepare deionized water.

The system automatically fills the filter and seals it.

Apply air pressure and measure the water evaporation rate.

Drain the system and automatically generate an electronic test report.

Forward Flow Test (FF) and Bubble Point Test (BP)

Fully wet the filter membrane.

Measure the liquid or gas flow through the membrane and record flow data.

For BP testing, gradually increase pressure until continuous bubbles appear.

The system automatically determines pass/fail for integrity and generates an electronic report.

MUX Expansion Module Operation

Connect 1–4 filter housings to the MUX module.

The system automatically cycles through each filter, recording and storing all test data.

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)