Filter Integrity Test System

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.

Testing 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.

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