Physical Dimensions
Weight (nominal)10 kg (21.6 lbs)
Width, height, depth 348 mm x 205 mm x 483 mm (13.7 in. x 8 in. x 19 in.)
Function Tests
Self Test
Flow Check Test
Printer Test
Network Test
Operating System
Linux¹
¹ The source code which falls under the GNU General Public License (GPL) is stored on the USB flash drive supplied with the instrument
Data Capacity
Test Program Storage> 500 programs
Test Result Storage> 10,000 tests
Active User Storage 250 users
Language Options²
US English, English
French
German
Italian
Spanish
Japanese
² Ask your Pall representative for further languages
Communication Ports
USB
RS232C
Ethernet
Wireless ethernet (optional)
Measurement Range/Accuracy
Forward Flow Test 0.1 – 1000 mL/min
Water Intrusion Test 0.03 - 50 mL/min water
Bubble Point Test 400 - 6500 mbar (5.8 – 94 psi)
Forward Flow Test± 3% of value or ± 0.05 mL/min, whichever is the greater
Water Intrusion Test± 3% of value or ± 0.02 mL/min, whichever is the greater
Resolution
Forward Flow Test 0.1 mL/min (0.01 mL/min for flows below 10 mL/min)
Water Intrusion Test 0.01 mL/min
Bubble Point Test 50 mbar (0.7 psi)
Calibration
Flow Measurement± 3% of measurement
Pressure Measurement± 0.33% of full scale
Electrical Data
Voltage Automatically adjusted between 100 - 240 V AC
Input Frequency 50 Hz/60 Hz
Power Typically 75 W, peak 150 W
Fuse 3.15 A, slow blow
External Vent Valve 24 V DC
Screen
Size, Resolution Diagonal 264 mm (10.4 in.), 1024 x 768 pixels
Features Color, illuminated background, adjustable contrast, touch screen
Pneumatic Specifications
Maximum Gas Supply Pressure 8000 mbar (116 psi)
Minimum Gas Supply above Test Pressure (Standard)Flow Range 0.01 - 150 mL/min 1000 mbar (14.5 psi)
Flow Range 150 - 1000 mL/min 2000 mbar (29.0 psi)
Test Pressure Range 50 to 6500 mbar (0.7 to 94 psi)
Pneumatic Connections
Compressed Air Inlet Stäubli Nipple
Compressed Air Outlet Stäubli Coupling
Vent Hose connection 8 mm outer diameter
Internal Printer
Lifetime of Printout> 10 years depending on storage conditions
Paper Width 112 mm (4.4 in.)
Paper Roll Diameter 50 mm (1.9 in.)
Environmental Conditions
Splash Proof To 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)
Test Capabilities Automatic Self Test When the Palltronic Flowstar IV instrument is switched on, an automatic self test is run. This test can be repeated any time during operation of the instrument. During the self test, the instrument does a full diagnosis of its functions:
Auto Test Time
The Auto Test Time function is available for the Forward Flow Test and the Water Intrusion Test. It has been developed and validated to shorten test times while maintaining the reliability of the result. The results of a Forward Flow or Water Intrusion test are being interpreted by this algorithm during the test. If the measured flow rate is evidently below the limit and the measurement is stable, the instrument will interpret this as a passed test. The filter integrity test times can be shortened by more than 50% without any risk of false pass results.
Forward Flow Test
The Forward Flow test is the filter integrity test that is most common in pharmaceutical manufacturing. All major filter suppliers recommend the Forward Flow test as the method of choice for integrity testing of filter cartridge or capsule assemblies. The Palltronic Flowstar IV instrument performs the Forward Flow test quickly and with extreme accuracy. The volume dosed flow meter can perform a Forward Flow test in a range of 0.1 to 1000 mL/min within minutes and with an accuracy of 0.1 mL/min or 3%.
The features of the Forward Flow test function are:
The benefits provided by these features compared to other integrity test instruments are:
Leak Test and Pressure Decay Test The leak test can be used to test for leaks in filter systems or processing systems. It is not an integrity test, since there is no correlation to bacterial retention. The leak rate can be measured either as pressure drop (mbar/min), using the Pressure Decay Test or as flow rate (mL/min), using the Leak Test function of the instrument. Possible applications are:
Electronic Data Handling and Remote Control The Palltronic Flowstar IV integrity test instrument has been designed to be used in a facility that complies with 21 CFR Part 11 for electronic storage of data.
There are three levels of access: Operator, Supervisor and Administrator. Operators have access to the test functions only, Supervisors can also modify test programs and Administrators have full access to all functions and can also perform changes to the system configuration or to the access management. The instrument can be used in two different modes to limit access to the protected functions. When the password controlled access is activated, the supervisor level and the administrator level are each protected by a password. In the login-controlled access mode, each user needs to login to the instrument before having access to its functions. The level of access can be defined for each person separately.
All the changes that are performed on the system or the programs are recorded in the audit trail. The test results can be electronically signed. Configuration, test programs, user data and test results can be easily exported to a computer network or an external flash drive.
Interface Connections A number of connections at the back of the instrument allow interfacing with different systems. The USB port can be used to connect an external printer, mouse, keyboard, barcode reader or a flash drive. The serial ports can be used to interface with other Palltronic instruments or a PLC. An ethernet port and a wireless network adaptor can be used to link to a computer network. There are also additional ports for an external pressure sensor and an external vent valve on the side of the instrument.
Remote Operation The Palltronic Flowstar IV integrity test instrument is equipped with a number of interface connections and it can be connected to a PLC using the internal adapters. The integrity test instruments can then be fully controlled by the PLC, and adapters are available for all common communication protocols. The instrument can also be connected to a computer network using the on-board ethernet port or the on-board wireless LAN adaptor. Data can be transferred to the network in a controlled manner. The instrument can also be fully controlled from a SCADA system using the available OPC server protocols.
A Profibus card (only suitable for installation by a Pall trained service engineer) is available for use with either Standard or Wireless versions, part number PDFSS04.
Remote Printing Instead of using the internal printer, the print data can be directed to an external printer. Either a printer that is connected directly to the instrument via the USB port or a network printer can be used. The instrument is also capable of generating the printout as a file, using common data formats, such as PDF or XML or both
Weight (nominal)10 kg (21.6 lbs)
Width, height, depth 348 mm x 205 mm x 483 mm (13.7 in. x 8 in. x 19 in.)
Function Tests
Self Test
Flow Check Test
Printer Test
Network Test
Operating System
Linux¹
¹ The source code which falls under the GNU General Public License (GPL) is stored on the USB flash drive supplied with the instrument
Data Capacity
Test Program Storage> 500 programs
Test Result Storage> 10,000 tests
Active User Storage 250 users
Language Options²
US English, English
French
German
Italian
Spanish
Japanese
² Ask your Pall representative for further languages
Communication Ports
USB
RS232C
Ethernet
Wireless ethernet (optional)
Measurement Range/Accuracy
Forward Flow Test 0.1 – 1000 mL/min
Water Intrusion Test 0.03 - 50 mL/min water
Bubble Point Test 400 - 6500 mbar (5.8 – 94 psi)
Forward Flow Test± 3% of value or ± 0.05 mL/min, whichever is the greater
Water Intrusion Test± 3% of value or ± 0.02 mL/min, whichever is the greater
Resolution
Forward Flow Test 0.1 mL/min (0.01 mL/min for flows below 10 mL/min)
Water Intrusion Test 0.01 mL/min
Bubble Point Test 50 mbar (0.7 psi)
Calibration
Flow Measurement± 3% of measurement
Pressure Measurement± 0.33% of full scale
Electrical Data
Voltage Automatically adjusted between 100 - 240 V AC
Input Frequency 50 Hz/60 Hz
Power Typically 75 W, peak 150 W
Fuse 3.15 A, slow blow
External Vent Valve 24 V DC
Screen
Size, Resolution Diagonal 264 mm (10.4 in.), 1024 x 768 pixels
Features Color, illuminated background, adjustable contrast, touch screen
Pneumatic Specifications
Maximum Gas Supply Pressure 8000 mbar (116 psi)
Minimum Gas Supply above Test Pressure (Standard)Flow Range 0.01 - 150 mL/min 1000 mbar (14.5 psi)
Flow Range 150 - 1000 mL/min 2000 mbar (29.0 psi)
Test Pressure Range 50 to 6500 mbar (0.7 to 94 psi)
Pneumatic Connections
Compressed Air Inlet Stäubli Nipple
Compressed Air Outlet Stäubli Coupling
Vent Hose connection 8 mm outer diameter
Internal Printer
Lifetime of Printout> 10 years depending on storage conditions
Paper Width 112 mm (4.4 in.)
Paper Roll Diameter 50 mm (1.9 in.)
Environmental Conditions
Splash Proof To 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)
Test Capabilities Automatic Self Test When the Palltronic Flowstar IV instrument is switched on, an automatic self test is run. This test can be repeated any time during operation of the instrument. During the self test, the instrument does a full diagnosis of its functions:
- Inlet gas pressure
- Function of the internal valves
- Function and signal of the internal pressure sensors
- Function of the internal pressure regulator
- Check for internal leaks
- Internal communication
- Integrity of the operating system and the software
- Data integrity of user lists, test programs and test results
Auto Test Time
The Auto Test Time function is available for the Forward Flow Test and the Water Intrusion Test. It has been developed and validated to shorten test times while maintaining the reliability of the result. The results of a Forward Flow or Water Intrusion test are being interpreted by this algorithm during the test. If the measured flow rate is evidently below the limit and the measurement is stable, the instrument will interpret this as a passed test. The filter integrity test times can be shortened by more than 50% without any risk of false pass results.
Forward Flow Test
The Forward Flow test is the filter integrity test that is most common in pharmaceutical manufacturing. All major filter suppliers recommend the Forward Flow test as the method of choice for integrity testing of filter cartridge or capsule assemblies. The Palltronic Flowstar IV instrument performs the Forward Flow test quickly and with extreme accuracy. The volume dosed flow meter can perform a Forward Flow test in a range of 0.1 to 1000 mL/min within minutes and with an accuracy of 0.1 mL/min or 3%.
The features of the Forward Flow test function are:
- The test is performed at constant pressure
- A volume dosed flow sensor is used
- Progress of the test is shown on screen while other operations can be performed on the instrument
- Validated auto test time function to shorten test times
The benefits provided by these features compared to other integrity test instruments are:
- No need for time consuming volume measurement before testing
- No loss of accuracy due to inexactly determined volume
- Filters with asymmetric membranes can be tested more reliably at constant pressure
- Test times are very short, usually below 10 minutes
- Progress of the test can be monitored in real time
- Unstable test conditions are detected
- Accurate and reproducible test results are obtained
- The undefined upstream volume has no influence on the accuracy of the test result
- The change in water level during the test does not influence the accuracy of the result
- The very sensitive volume dosed flow measurement technology allows to accurately measure a water flow of down to 0.03 mL/min
- A gross leak test is performed at the beginning of the test phase
- Gas flow is measured very fast at small steps
- Full Bubble Point curve is determined
- All test parameters are documented with test results
- False pass results due to insufficient filter wetting are avoided
- False pass results in filters with small defects are avoided
- Test result is obtained very quickly
- Reproducible test results are obtained
- All types of membranes from small disc to cartridge can be tested
Leak Test and Pressure Decay Test The leak test can be used to test for leaks in filter systems or processing systems. It is not an integrity test, since there is no correlation to bacterial retention. The leak rate can be measured either as pressure drop (mbar/min), using the Pressure Decay Test or as flow rate (mL/min), using the Leak Test function of the instrument. Possible applications are:
- Diagnosis of filter systems after failed tests
- Installation check on filter systems or processing systems
- Leak tests on processing equipment during qualification
Electronic Data Handling and Remote Control The Palltronic Flowstar IV integrity test instrument has been designed to be used in a facility that complies with 21 CFR Part 11 for electronic storage of data.
There are three levels of access: Operator, Supervisor and Administrator. Operators have access to the test functions only, Supervisors can also modify test programs and Administrators have full access to all functions and can also perform changes to the system configuration or to the access management. The instrument can be used in two different modes to limit access to the protected functions. When the password controlled access is activated, the supervisor level and the administrator level are each protected by a password. In the login-controlled access mode, each user needs to login to the instrument before having access to its functions. The level of access can be defined for each person separately.
All the changes that are performed on the system or the programs are recorded in the audit trail. The test results can be electronically signed. Configuration, test programs, user data and test results can be easily exported to a computer network or an external flash drive.
Interface Connections A number of connections at the back of the instrument allow interfacing with different systems. The USB port can be used to connect an external printer, mouse, keyboard, barcode reader or a flash drive. The serial ports can be used to interface with other Palltronic instruments or a PLC. An ethernet port and a wireless network adaptor can be used to link to a computer network. There are also additional ports for an external pressure sensor and an external vent valve on the side of the instrument.
Remote Operation The Palltronic Flowstar IV integrity test instrument is equipped with a number of interface connections and it can be connected to a PLC using the internal adapters. The integrity test instruments can then be fully controlled by the PLC, and adapters are available for all common communication protocols. The instrument can also be connected to a computer network using the on-board ethernet port or the on-board wireless LAN adaptor. Data can be transferred to the network in a controlled manner. The instrument can also be fully controlled from a SCADA system using the available OPC server protocols.
A Profibus card (only suitable for installation by a Pall trained service engineer) is available for use with either Standard or Wireless versions, part number PDFSS04.
Remote Printing Instead of using the internal printer, the print data can be directed to an external printer. Either a printer that is connected directly to the instrument via the USB port or a network printer can be used. The instrument is also capable of generating the printout as a file, using common data formats, such as PDF or XML or both