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Filter Integrity Test System

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.

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

ParameterTechnical 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

ParameterTechnical 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

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