Palltronic® FlowMod Filter Integrity Test Instrument

http://www1.pall.com/images/FlowMod_image(1).jpg Palltronic® FlowMod Filter Integrity Test Instrument

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Within the pharmaceutical industry there is a growing use of automated manufacturing techniques and electronic storage of critical batch records. The Palltronic FlowMod instrument has been designed as a standalone device to be integrated into pharmaceutical manufacturing equipment (e.g. freeze driers or autoclaves) for fully automated filter integrity testing in-situ.

The Palltronic FlowMod instrument is a filter integrity test instrument designed for remote control by a Programmable Logic Controller (PLC) or other high-level control system. All operator interface is via the PLC or high-level control system which can be used to initiate a self-test or filter test and when completed, the Palltronic FlowMod instrument transmits the test result, the device serial number and other information back to the PLC.

The instrument is supplied with RS232C and Profibus connections. For the RS232C connection, drivers for all major PLC manufacturer makes and models are available. The Palltronic FlowMod instrument is based on the proven Palltronic Flowstar XC Integrity Test instrument. All measurement and test functions are the same for both instruments. Details are described in the corresponding validation guide USTR 2184.

• Forward Flow, Bubble Point and Water Intrusion test can be performed by the same device
• Process automation can minimize operator involvement, saving time and reducing possibilities for error
• Direct flow measurement allows the shortest test times at highest safety and accuracy
• Pressure and flow calibration according to GAMP guidelines
• Designed for interface with all major makes and models of PLC, minimizing software development time and costs
• Large flow range available – measures from 0.05 mL/min up to 2,000 mL/min with the 'High Flow' option
• Integrity test results can easily be incorporated into batch records and stored centrally on the PLC or SCADA system
• Filter integrity test data can be configured by the PLC or SCADA system to be compliant with 21CFR Part 11
• Calibration and servicing are performed by specialized Pall personnel at appropriate intervals

Physical Dimensions

Weight	11.5 kg (25.4 lb)
Approximate Height, Weight, Depth	360 mm x 350 mm x 185 mm (14 in. x 13 in. x 7 in.)

Filter Tests

Forward Flow Test, Bubble Point Test, Water Intrusion Test

Function Test

Self Test

Communication Ports

Profibus DP 9-pin SubD
RS232 (V24) serial, asynchronous, DB9-connection

Accuracy

Measuring Range

Forward Flow Test	FFS02FM: 0.1 mL/min – 200 mL/min, FFS02HFM: 0.1 mL/min – 2,000 mL/min
Water Intrusion Test	0.05 – 50 mL/min
Bubble Point Test	700 – 6000 mbar (10 – 87 psi)

Resolution

Forward Flow Test	0.1 mL/min
Water Intrusion Test	0.01 mL/min
Bubble Point Test	50 mbar (0.72 psi)

Calibration Limits

Flow Measurement	± 3% of measurement
Pressure Measurement	± 0.33% of full scale

Electrical Data

Power	Voltage automatically adjusted between 90 – 230 V AC
Frequency	50 Hz to 60 Hz
Alternative Power	24 V DC
Power Output (Typically)	70 W
Fuse	1.6A inert
External Vent Valve	24 V
External Pressure Transducer	4 – 20 mA (0 - 3 bar / 0 - 43.5 psi)

Pneumatic Specifications

Maximum Gas Supply Pressure	8000 mbar (116 psi)
Minimum Gas Supply Pressure Above Test Pressure:
FFS02FM Flow Range	0.01 – 60 mL/min 1000 mbar (14.5 psi)
	60 – 120 mL/min 1500 mbar (21.7 psi)
	120 – 200 mL/min 2000 mbar (29.0 psi)
FFS02HFM Flow Range	0.01 – 200 mL/min 1000 mbar (14.5 psi)
	200 – 1000 mL/min 2000 mbar (29.0 psi)
	1000 – 1500 mL/min 3000 mbar (43.5 psi)
	1500 – 2000 mL/min 4000 mbar (58.0 psi)

Pneumatic Connections

Compressed Air Inlet	Stäubli nipple RBE03.6150
Compressed Air Outlet	Stäubli coupling RBE03.2904
2 Vents	Hose connection: 8 mm outer diameter

Environmental Conditions

Splash Proof	IP54
Operating Temperature	5 °C to 50 °C ( 41 °F to 122 °F)
Storage Temperature	-20 °C to 70 °C (-4 °F to 158 °F)
Humidity	95% RH (no condensation)

Calibration and Service

Calibration Interval	1 year maximum
Service Interval	3 years*