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, 颇尔 publication USTR 2184.
优势
-
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 颇尔 personnel at appropriate intervals
Physical Dimensions
重量 | 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
Forward Flow Test | ± 3% or ± 0.05 mL/min, whichever is the greater |
Water Intrusion Test | ± 3% or ± 0.02 mL/min, whichever is the greater |
Measuring Range
Forward Flow Test |
FlowMod instrument (Standard Model):0.1 mL/min – 200 mL/min FlowMod instrument (High-Flow Model): 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
电源 | 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: |
|
Flow Range (Standard Model) |
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) |
|
Flow Range (High-Flow Model) |
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 rated |
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* |
Instrument | Part Number |
palltronic FlowMod instrument (Standard Model) with DeviceNet option palltronic FlowMod instrument (Standard Model) with Serial Connection option palltronic FlowMod instrument (Standard Model) with PROFIBUS option |
|
palltronic FlowMod instrument (High-Flow Model) | |