Palltronic® Flowstar IV

Palltronic® Flowstar IV
USD2555a
Palltronic Flowstar IV
®
Filter Integrity Test Instrument and MUX Extension
The Next Generation Filter Integrity
Test Instrument
The Palltronic® Flowstar IV filter integrity test instrument is
The latest networking capabilities are also incorporated for
the result of Pall's long experience and expert technical
easy integration within a network, and the optional WLAN
knowledge in producing successful, top-quality test
adaptor, USB connectivity plus an extended range of remote
instruments. The Flowstar IV instrument introduces many
control/automation options enable even greater flexibility.
new features, enabling users to test even more filters, reliably
and reproducibly, in less time, saving time and money.
Manufacturing Practices) guidelines, and offering full
Lightweight, compact and ergonomic, the instrument
compliance with 21 CFR Part 11, the Palltronic Flowstar IV
features an enhanced, touch screen and user-friendly
instrument is supported by an extensive qualification
interface, requiring minimal training of operators.
documentation package, including guides for Installation
Improved pressure/flow calibration preserves measurement
accuracy while ensuring faster tests.
2
Developed in accordance with GAMP (Good Automated
and Operational Qualification (IQ/OQ)
Volume-Dosed Flow Measurement
The Palltronic Flowstar IV integrity test instrument is a highly
sensitive measurement instrument for gas pressure and flow.
Highly sensitive pressure sensors are available from many
sources, but highly accurate gas flow sensors for a
measurement range of 0.01 to 1000 mL/min are not.
However, such a range is required for an integrity test
in pharmaceutical production.
The Palltronic Flowstar IV integrity test instrument utilizes
a method that was developed by Pall for use in integrity
test instruments and patented as “volume-dosed flow
measurement technology”. The current version of this flow
meter consists of a valve block with three high precision
pressure sensors, a pressure regulator, three defined
volumes and a specific control algorithm.
One pressure sensor constantly measures the gas
pressure of the filter system, while the other two sensors
are used to verify the pressure of the internal volumes.
As gas diffuses through the wetted filter (as in the Forward
Flow test) the integrity test instrument constantly refills gas
into the filter system. The amount of gas that is dosed in
the defined volumes is accurately determined and equals
The flow rate does not need to be calculated out of
volume determination and pressure decay measurement
The Forward Flow and Water Intrusion Tests are run
at constant pressure over the complete test time
The instrument offers full compliance with regulatory
demands on filter integrity testing.
the diffusion rate of the filter.
In Pall’s standard calibration procedure, the measurement
Accuracy and Calibration
part of the instrument is calibrated as a whole using
The requirements on calibration are described in 21 CFR
accurate flow references. This confirms that all flow
820.72 and the European GMP guide, chapter 4. Pall has
measurement components are working correctly
established calibration procedures to verify pressure and flow
and produce accurate results.
measurement which are qualified over the full measurement
range of the instrument. Palltronic Flowstar IV integrity test
The benefits of this technology are:
instruments can be calibrated in a Pall-qualified laboratory
Integrity test is much faster, as upstream volume
does not have to be measured
allow us to confirm an accuracy of 0.33% for pressure
The flow measurement loop is directly calibrated
measurement and of 3% for flow measurement, in all
or within your manufacturing site. Our traceable references
parts of the world.
www.pall.com/biopharm
3
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
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:
Function of the internal valves
The test is performed at constant pressure
Function and signal of the internal pressure sensors
A volume dosed flow sensor is used
Function of the internal pressure regulator
Check on internal leaks
Progress of the test is shown on screen while other
operations can be performed on the instrument
Internal communication
Validated Auto Test Time function to shorten test times
Integrity of the operating system and the software
All relevant data for the test result is stored on the instrument
Data integrity of user lists, test programs and test results
and can be printed or transferred to a network location.
The full result of each self test is saved and can be printed
at any time. The combination of the self test and a regular
calibration and service guarantee a continuous reliable
operation of the instrument for many years.
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
Auto Test Time
The Auto Test Time function is available for the Forward Flow
Filters with asymmetric membranes can be tested more
reliably at constant pressure
Test and the Water Intrusion Test. It has been developed and
Test times are very short, usually below 10 minutes
validated to shorten test times while maintaining the reliability
Progress of the test can be monitored in real time
of the result. The results of a Forward Flow or Water Intrusion
Unstable test conditions are detected
test are interpreted by this algorithm during the test.
Accurate and reproducible test results are obtained
If the measured flow rate is evidently below the limit, and the
measurement is stable, the instrument will interpret this as a
Water Intrusion Test
passed test. The filter integrity test times can be shortened
The Water Intrusion test is widely spread in pharmaceutical
by more than 50% without any risk of false pass results.
manufacturing to perform inline integrity testing of sterilizing
grade gas filters with hydrophobic membranes. The Palltronic
Forward Flow Test
Flowstar IV instrument is specially made and validated to
The Forward Flow test is the filter integrity test that is
perform this very sensitive water intrusion test. The water
most common in pharmaceutical manufacturing. All major
intrusion test profits from the features and benefits of the
filter suppliers recommend the Forward Flow test as the
Forward Flow test.
method of choice for integrity testing of filter cartridge or
capsule assemblies.
4
The additional benefits are:
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 accurately measures a water flow as low
as 0.03 mL/min
Bubble Point Test
The Palltronic Flowstar IV integrity test instrument can
determine the Bubble Point of a filter. The gas flow rate
is measured at increasing pressure steps, and the Bubble
Point is the transition of diffusive gas flow through wetted
filter pores to bulk gas flow through de-wetted filter pores.
The features of the Bubble Point test are:
A gross leak test is performed at the beginning
of the test phase
Gas flow is measured very fast in incremental steps
Full Bubble Point curve is determined
All test parameters are documented with test results
The benefits of this are:
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
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:
Reproducible test results are obtained
All types of membranes from small disc to cartridge
can be tested
Combined Forward Flow and
Bubble Point Test
The instrument can also determine the Forward Flow and
Bubble Point value in a single test. The test procedure has
been refined to shorten test times of the combined test
Diagnosis of filter systems after failed tests
Installation check on filter systems or processing systems
Leak tests on processing equipment during qualification
The Palltronic Flowstar IV integrity test instrument can
perform all kinds of gas pressure tests. It is capable of
performing those tests reliably and accurately and of
providing reproducible results.
without compromising the accuracy of the result.
www.pall.com/biopharm
5
Unique Design
The Palltronic Flowstar IV instrument is a highly sensitive
measurement instrument which is designed for use in all
locations including the laboratory or inside the process
suite or cleanroom.
Splash and Dust Proof
The use of powder or liquid chemicals in close proximity to
Cleanroom Environment
The instrument has been specifically designed to be used
in any kind of cleanroom. There is no cooling fan that
would disturb the air in a cleanroom. The internal printer
is a thermal printer, generating almost no particles during
printing. All external components are compatible with
common cleaning liquids to reduce surface bioburden.
an instrument is very common in a laboratory. The Palltronic
Flowstar IV integrity test instrument has been tested to be
splash and dust proof (IP54 rated). The outside of the
instrument can be easily cleaned.
User Interface
The user interface is one of the major benefits of the
Palltronic Flowstar IV integrity test instrument. The 10.4 in.
(264 mm) color touch screen displays all functions that
are needed for routine use of the instrument. Use of the
instrument is straightforward and intuitive, and all the most
common language options are available.
The menu has been optimized for routine use of the
instrument, and all relevant parameters are displayed on
the screen at all times. This allows the operator to easily
access the required functions and to avoid mistakes that
can occur if relevant data is spread over too many screens.
Operators who are trained users of existing Palltronic
Flowstar instruments can use the Palltronic Flowstar IV
integrity test instrument without further training.
6
Electronic Data Handling and Remote Control
The Palltronic Flowstar IV integrity test instrument has been
be electronically signed. Configuration, test programs, user
designed to be used in a facility that complies with 21 CFR
data and test results can be easily exported to a computer
Part 11 for electronic storage of data.
network or an external flash drive.
There are three levels of access - Operator, Supervisor and
Interface Connections
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.
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, 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
The instrument can be used in two different modes to limit
wireless network adapter can be used to link to a computer
access to the protected functions. When the password
network. There are also additional ports for an external
controlled access is activated, the supervisor level and the
pressure sensor and an external vent valve on the side
administrator level are each protected by a password. In the
of the instrument.
login-controlled access mode, each user needs to login to
the instrument before having access to its functions. The
Remote Operation
level of access can be defined for each person separately.
The Palltronic Flowstar IV integrity test instrument is equipped
with a number of interface connections, and it can be
All the changes that are performed on the system or the
programs are recorded in the audit trail. The test results can
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 adapter. 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.
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.
www.pall.com/biopharm
7
Palltronic Flowstar IV MUX Extension
Available separately, the Palltronic Flowstar IV MUX extension
The volume-dosed flow measurement technology utilized by
is an innovative, time-saving companion to the Palltronic
the Palltronic Flowstar IV instrument enables filter test times
Flowstar IV instrument. Up to four filters can be attached to
to be reduced by half or even more, without compromising
each Palltronic Flowstar IV MUX extension and up to nine
the very high accuracy of results. Real-time sensing of flow
extensions can be ‘chained’ together, allowing for the
stability and automatic control of test times ensures safe,
automatic, sequential testing of multiple filters at once.*
accurate test results for every test in the shortest possible
The operator simply connects the filters to the Palltronic
Flowstar IV MUX extension(s) and programs the test
parameters - any combination of integrity-testable filter sizes
and test types can be used. The first Palltronic Flowstar IV
MUX extension attached to a Palltronic Flowstar IV
time. Automated testing of up to thirty-six filters at once
minimizes operator involvement, and filters can also be
disconnected from the Palltronic Flowstar IV MUX extension
immediately after each test is completed, allowing for
maximum flexibility.
instrument becomes the master (Pall Part number
The Palltronic Flowstar IV MUX extension is an ideal solution
FFS04MUXM) and all subsequent systems attached to
for production areas and facilities where large amounts of
the master are slaves (Pall Part Number FFS04MUXS).
filters are tested offline. With up to thirty-six channels able to
be programmed and activated independently, this even
Key Advantages
Each Palltronic Flowstar IV MUX extension provides a
four-channel extension to the Palltronic Flowstar IV integrity
test instrument – saving operator time
System software and hardware enables multiple tasks
to be performed at once – improving test efficiency
Any combination of filter size and type can be connected –
offering total flexibility
8
allows the user to exchange filters and select new test
programs while existing channels are undergoing integrity
tests. These features combine to provide a simple, reliable
yet highly-efficient method for high-throughput filter testing.
*The Palltronic Flowstar IV instrument must be running software version
2.0c or later to support the Palltronic Flowstar IV MUX extension
functionality.
Service and Support
Qualification
The instrument has been designed following the GAMP
guidelines. The Palltronic Flowstar IV integrity test instrument
is classified as a software category 3 and hardware category
1 instrument in accordance to GAMP 5. The components
have been carefully selected for long term availability and
There are Pall-qualified service centers throughout the world.
Please contact your local representative to find the most
suitable way to calibrate and service your instruments.
All components used in the Palltronic Flowstar IV integrity test
instrument have been carefully selected and tested for quality.
Training
reliable functionality. All relevant functions have been
thoroughly validated. A description of the main functions
and an operational qualification (OQ) are usually sufficient to
qualify the instrument. An extensive documentation package
with all the relevant documents is available.
On-site training is also available for the Palltronic Flowstar IV
integrity test instrument. Training is also available on
instrument validation, filter validation, integrity testing basics
and regulatory requirements. We are happy to assist you
with a custom-designed training program.
Calibration and Service
The Palltronic Flowstar IV integrity test instrument can be
calibrated at any Pall-certified service center or directly on
site. Calibration equipment, procedures and training are
available. Pall recommends calibration of the instrument
at least once a year, with a full service after three years.
www.pall.com/biopharm
9
Options
The Palltronic Flowstar IV integrity test instrument is available
in three different versions. The basic version is designed as
a standalone integrity test instrument. The standard version
offers all the networking options and can be fully automated.
The wireless version includes an internal WLAN adaptor.
Features of the Palltronic Flowstar IV Instruments
Part Number
Optimized user interface
Multitasking menu
Designed for use in highly
demanding pharmaceutical
production
Suitable for use in cleanroom
Splash and dust proof (IP54)
Self test
Volume dosed flow measurement
Calibration for flow and pressure
Basic integrity test capability
(FF, BP, combined FF/BP, WIT,
Leak Test, Pressure Decay Test)
Password access control
USB port ((printer, barcode reader,
flash drive)
Printing to USB printer
PDF printing to USB flash memory
Serial port*
Login-based access control
Electronic signatures in compliance
with 21 CFR part 11
Configuration of parameter names
Configuration of main menu
Fieldbus◆ adapter* for automation
OPC server for automation
Ethernet port
Printing to network printer
PDF printing to network drive
WLAN adapter
Basic
Standard
Wireless
FFS04B
✔
✔
✔
FFS04S
✔
✔
✔
FFS04R
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
*must be specified at time of ordering
10
Technical Specifications
Palltronic Flowstar IV Instrument
Physical Dimensions
Communication Ports
(nominal) Weight: 10 kg (21.6 lbs)
USB
Width, height, depth: 348 mm x 205 mm x 483 mm
(13.7 in. x 8. in. x 19 in.)
RS232C
Filter Tests
Forward Flow Test
Bubble Point Test
Combined Forward Flow / Bubble Point Test
Water Intrusion Test
Other Tests
Leak Test (Flow measurement based for volume < 50 L)
Pressure Decay Test (Leak test for volumes up to 200 L)
Function Tests
Self Test
Flow Check Test
Ethernet
Wireless ethernet network (optional)
Accuracy
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
Measuring Range
Forward Flow Test: 0.1 - 1000 mL/min
Water Intrusion Test: 0.03 - 50 mL/min
Bubble Point Test: 400 - 6500 mbar (5.8 - 94 psi)
Leak Test: 0.1 – 1000 mL/min
Pressure Decay Test: 50 – 6500 mbar
Printer Test
Network Test
Other Functions
Resolution
Forward Flow Test: 0.1 mL/min
(0.01 mL/min for flows below 10 mL/min)
Cleaning function
Water Intrusion Test: 0.01 mL/min
Test program Transfer function
Bubble Point Test: 50 mbar (0.7 psi)
Configuration Transfer function
Pressure Decay Test: 1 mbar
Access management Transfer function
Test result export function
Backup function
Calibration
The calibration of the Palltronic Flowstar IV instrument
includes a calibration of the pressure transducers and
Language Options
English, French, German, Italian, Spanish,
US English, Japanese
the flow measurement calibration limits:
Pressure measurement: ± 0.33% of full scale
Flow measurement: ± 3% of measurement
Language files on the instrument are constructed such
that other languages may be added as necessary.
www.pall.com/biopharm
11
Palltronic Flowstar IV Instrument (continued)
Electrical Data
Voltage: automatically adjusted between 100 - 240 V AC
External USB printer
Input Frequency: 50 Hz / 60 Hz
External Network printer (A printer type HP P1505N
or compatible is recommended. The printer should be
capable of handling the printer language PCL5e)
Power: typically 75 W (peak 150 W)
Fuse: 3.15 A slow blow
External Vent Valve: 24 V DC
Screen
Size: diagonal 264 mm (10.4 in.)
Resolution: 1024 x 768 pixels
Features: Color, illuminated background,
adjustable contrast, touch screen
Pneumatic Connections
Compressed air inlet: Stäubli Nipple
Compressed air outlet: Stäubli Coupling
Vent: Hose connection 8 mm outer diameter
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 - 6500 mbar (0.7 - 94 psi)
Internal Printer
Thermal printer
Printer resolution: 832 dots/line
Lifetime of printout: >10 years depending
on storage conditions
Printer Speed: 12 mm/sec (0.5 in./sec)
printout with graphic
Paper Width: 112 mm (4.4 in.)
Paper roll diameter: 50 mm (1.9 in.)
12
External Printing Function
Virtual printing to PDF or XMF file format
Environmental Conditions
Splash Proof: IP54
Operating Temperature: +5 °C to +50 °C
Storage temperature: -20 °C to +70 °C
Humidity: 95% RH (no condensation)
Operating System
Linux (The source code which falls under the GNU
General Public License (GPL) is stored on the USB
flash disk supplied with the instrument).
Palltronic Flowstar IV MUX Extension
Physical Dimensions
Weight:
– Palltronic Flowstar IV MUX extension (Master): 3.9 kg
(8.6 lb)
– Palltronic Flowstar IV MUX extension (Slave): 3.7 kg
(8.2 lb)
Width, height, depth: 218 mm x 146 mm x 285 mm
(8.6 in. x 5.7 in. x 11.2 in.)
Communication Ports
Master
– Special CAN BUS port 1 for communication with slave
or Palltronic Flowstar IV instrument
Slave
– Special BUS port 1 for communication with the Palltronic
Flowstar IV instrument or the next slave
Pneumatic Connections
Compressed Air Inlet: Stäubli Nipple
Compressed Air Outlet: Stäubli Coupling
Vent: Hose Connection
Pneumatic Specifications
Maximum gas supply pressure: 8000 mbar (116 psi)
Test pressure range: 50 to 6000 mbar (0.7 to 87 psi)
Environmental Conditions
Splash Proof: IP54
Operating Temperature: +5 °C to +50 °C
Storage Temperature: -20 °C to +70 °C
Humidity: 95% RH (no condensation)
– Special BUS port 2 for communication with next slave
or master
Electrical Data
Palltronic Flowstar IV MUX System Master only
– Voltage: automatically adjusted between 90 - 264 V AC
– Input Frequency: 47 / 63 Hz
– Power: typically 40 W
– Fuse: 1 A
Master and Slave
– Remote Vent Valve: 24 V DC
To see how Pall is helping enable a greener, safer and more sustainable
future, visit www.pall.com/green.
Visit us on the Web at www.pall.com
E-mail us at [email protected]
Corporate Headquarters
Port Washington, NY, USA
+1.800.717.7255 toll free (USA)
+1.516.484.5400 phone
[email protected] e-mail
European Headquarters
Fribourg, Switzerland
+41 (0)26 350 53 00 phone
[email protected] e-mail
Asia-Pacific Headquarters
Singapore
+65 6389 6500 phone
[email protected] e-mail
International Offices
Pall Corporation has offices and plants throughout the world in: Argentina, Australia, Austria,
Belgium, Brazil, Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan,
Korea, Malaysia, New Zealand, Norway, Philippines, Poland, Russia, Singapore, South
Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam.
Distributors in all major industrial areas of the world. To locate the Pall office or distributor
nearest you, visit www.pall.com/contact.
The information provided in this literature was reviewed for accuracy at the time of publication. Product data may be subject to change without notice. For current information consult
your local Pall distributor or contact Pall directly.
© 2014, Pall Corporation. Pall,
, and Palltronic are trademarks of Pall Corporation. ® indicates a
trademark registered in the USA and TM indicates a common law trademark. ENABLING A GREENER FUTURE
and Filtration. Separation. Solution. are service marks of Pall Corporation. ◆Fieldbus is a trademark of the
Fieldbus Foundation. Stäubli is a trademark of Stäubli AG.
1/14, PDF, GN13.5881
USD2555a
Was this manual useful for you? yes no
Thank you for your participation!

* Your assessment is very important for improving the work of artificial intelligence, which forms the content of this project

Download PDF

advertisement