Palltronic® AquaWIT System

The Palltronic® AquaWIT system offers major benefits for integrity testing of hydrophobic gas filters. All stages of the water intrusion test can now be performed fully automatically on gas filters and on line. The operator simply connects the Palltronic AquaWIT unit to the filter system, inputs test parameters on the easy to use touchscreen and starts the test sequence. The filling, testing, draining and drying is performed without further operator involvement and a detailed test result is saved and printed.

With Pall direct flow measurement technology and a "hydraulic bridge" link to the test filter, accurate and reproducible results are ensured even during changes in environmental temperature.

"It is expected that there be some program for integrity testing this (vent) filter to assure that it is intact." "There are methods for integrity testing of vent filters in place."
FDA Guidance Document on High Purity Water Systems for Pharmaceutical Use 1996

"The integrity of critical gas and air vent filters should be confirmed after use"
European GMP

Materials of Construction

• Stainless Steel - product wet: DIN 1.4404¹
• Stainless Steel - frame: DIN 1.4301²
• Seals: EPDM

Physical Dimensions

• Weight empty: 100 kg (220 lb)
• Height, Width, Depth: 1100 mm, 580 mm, 840 mm (43 in., 22 in., 33 in.)
• Water tank volume: 14 Liters (3.7 US gallons)

Filter Tests

• Water Intrusion Test (fully-automatic)
• Forward Flow Test (semi-automatic)
• Bubble Point Test (semi-automatic)
• Combined FF / BP Test (semi-automatic)

Function Tests

• Self Test
• Flow Check Test
• Valve Check

Other Functions

• Clean-in-place
• Steam-in-place
• Level sensors for automatic filling and draining of filter system
• Pressure sensor to measure hydrostatic pressure
• Temperature measurement of water or steam in tank
• Adjustable filter system filling and draining pressures
• Adjustable filter and Palltronic AquaWIT system drying pressures and times
• Air Clean
• Test result storage - up to 100 tests
• Test programs - up to 140 test programs
• 24 User IDs

Standard Language

• English, French, German, Italian, Spanish, US English

Units

• psi, mbar, kPa, Kp/cm²

Communication Ports

• COM1 RS232C for external printer or PC
• COM2 (optional) parallel port for remote operation

Measuring Range

• WIT: 0.05 - 50 ml/min water
• FF: 0.1 - 200 ml/min
• BP: 700 - 6000 mbar (10 - 87 psi)

Resolution

• WIT: 0.01 ml/min
• FF: 0.01 ml/min
• BP: 50 mbar (0.72 psi)

Calibration Limits

• Within 3% of reference value

Accuracy

• Forward Flow test 3%
• Water Intrusion test +/- 0.02 ml/min

Electrical Data

• Mains Voltage: 90 - 230 Volts
• Mains Frequency: 50 - 60 Hz
• Power: 200 W
• Interface: 1 x RS232C, serial, asynchronous, DB9 auxiliary
• External Vent Valve: 24 V

Electrical Safety

• CE Marked
• Maximum Steam Temperature 125 °C (257 °F)

Design Specifications

• AD Merkblatter

Pneumatic Specifications

• Maximum gas supply pressure: 8 bar (116 psi)
• Minimum gas supply pressure for automatic: WIT test 6 bar (87 psi)
• Test pressure range: 20 - 6000 mbar (0.3 - 87 psi)

Connections

• Compressed air inlet: Stäubli³ nipple RBE03.6150
• Compressed air outlet: Stäubli coupling RBE03.2904
• Water line to fill filter: 1" TriClamp
• Water line to fill tank: 1" TriClamp
• Water drain (bottom level): 1" TriClamp

Environmental Conditions

• Splash proof: IP54
• Operating Temperature: +5 °C to +40 °C (+41 °F to 104 °F)
• Storage Temperature: -20 °C to +70 °C (-4 °F to + 158 °F)
• Humidity: 95% rh (no condensation)

Touchscreen Specifications

• Size: 238 mm (9.4 inch) 640 x 480 pixel
• Features: black & white, illuminated background, adjustable contrast

¹DIN 1.4404 element composition limits are comparable to 316L.
²DIN 1.4301 element composition limits are comparable to 304.
³Stäubli is a trademark of Stäubli, AG

 

Direct Flow Measurement using a Hydraulic Bridge

Accurate and reliable

In validation studies flow was measured at different environmental temperatures using a small filter with a typical water intrusion fiow rate of 0.04 ml/min to represent worst case conditions. Even under conditions where the environmental temperature of the filter was 20 °C (36 °F) higher than water temperature, an accurate test result was obtained.

Validation work has also shown that accurate measurements can be performed using filter installations at a distance of at least 10m (33 ft) and a height of 6 m (19 ft) or more. Pall can assist in qualifying the Palltronic AquaWIT device for individual purposes.

Hydraulic Bridge

The hydraulic bridge removes all air from the upstream filter system and tubing. Flow measurement is then performed in a more controlled environment within the Palltronic AquaWIT unit. Stable results can be obtained even when environmental temperatures are changing by 10 °C (18 °F) or more. Direct flow and real time measurement further adds to the accuracy, speed and reliability of the test result.

A Versatile System

The Palltronic AquaWIT unit has been designed to test vent filters in positions with difficult access where environmental temperatures may be fluctuating. The hydraulic bridge permits the Water Intrusion test to be performed on:

• Filters in elevated positions; for example, product storage and WFI tanks
• Filters which are inside equipment; for example lyophilizers or sterilizers which are difficult to access
• Several different filter installations testing from a fixed point

Water Intrusion Testing from a fixed point

Palltronic AquaWIT System

• Part Number: AW02