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Ae Palltronic Flowstar XC Filter Integrity Test Instruments
Palltronic Aquawit XC System
Palltronic Flow Check Device
Palltronic Training Program
Drivers for Palltronic Filter Integrity Test Instruments
Palltronic Filter Manager
Ae Palltronic Flowstar XC Filter Integrity Test Instruments
Palltronic Flowstar XC instruments perform accurate and precise measurement of the upstream Forward Flow, Bubble Point, Water Intrusion and combined Forward Flow/Bubble Point tests.
The Palltronic Flowstar XC instrument is a unitized, compact and splash-proof filter integrity test instrument especially designed for use in the most demanding production environments.
Featuring the latest in touch-screen technology, the Palltronic Flowstar XC system is extremely user-friendly, with simple menu-driven data input. The new Palltronic XC system can store up to 500 test programs and up to 10,000 test results, which makes it ideal for large-volume manufacturing and multi-product processes in the pharmaceutical industry. Its increased memory capacity provides maximum data-handling flexibility and security.
Features and Benefits
- Direct-flow measurement eliminates errors and time associated with traditional pressure hold test technology
- Extensive validation documentation and qualification of hardware and software ensures compliance with industry and regulatory requirements
- Easy-to-follow commands for user-friendly operation
- Data security and electronic signature features compliant with CFR 21 part 11
- Unitized, durable construction with splash-proof design allows testing in any environment
- Large, graphic LCD display enables easy reading of real time test measurements
- Unique external vent valve prevents liquid back flow into the unit for increased service reliability
- Hard copy printout, with date and time displayed, facilitate documentation requirements
- Password-protected for added security
- Self-Test verifies proper functioning of software and internal components to streamline maintenance and labor requirements
•Datasheet: Palltronic® Flowstar XC Filter Integrity Test Instruments
The Palltronic Aquawit XC 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 XC 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.
Features and Benefits
- Accuracy and Reliability
In validation studies flow was measured at different environmental temperatures using a small filter with a typical water intrusion flow rate of 0.04 mL/min to represent worst case conditions. Even under conditions where the environmental temperature of the filter as 20 °C (36 °F) higher than water temperature, an accurate test result was obtained. - 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. - Versatility
The Palltronic Aquawit XC system has been designed to test vent filters in positions with difficult access where environmental temperatures may be fluctuating.
•Datasheet: Palltronic® Aquawit XC System
The Palltronic Flow Check device enables allows a fast and simple check to be performed on an integrity test instrument to show that it is measuring flow correctly. A Flow Check test can be performed as often as the user requires in order to ensure complete confidence in the integrity test instrument. The user simply connects the device to their integrity test instrument, performs a Flow Check test (available with Palltronic Flowstar and Aquawit instruments), or a Forward Flow or Diffusion Test. The flow measured by the integrity test instrument is then compared with the calibrated flow of the Flow Check device. Each Palltronic Flow Check unit is supplied with a Calibration Certificate, with the calibrated flow value permanently marked on the device. Full operating instructions and Stäubli* fittings are supplied with every device.
Features and Benefits
- Allows for fast and simple checks of integrity test instrument flow measurement
- Fully portable, lightweight and easy to use
- Can be used with all integrity test instruments which give a flow value
- High precision capillary, with calibrated flow, ensures accurate readings
- Internal Pall Gaskleen® filter protects components for increased service life
- Robust, sanitary stainless steel design makes it ideal for the BioPharmaceutical industry
- Easy to use Stäubli* connections and fittings
*Stäubli is a trademark of Stäubli AG.
•Datasheet: Palltronic® Flow Check Device
The Missing Piece from your 21CFR 11 Compliance Puzzle
Part I. Basics of Integrity Test – Classroom Presentation
- Why integrity test?
- Types of integrity tests: Bubble Point, Forward Flow, Pressure Hold and Water Intrusion
- Factors influencing integrity-testing: Temperature, Upstream Volume and Wetting Agent
- Automated vs. Manual integrity-testing
- Design features of automated device
- Operating Instructions and SOP
- Perform BP, FF and/or WIT
- External Vent Valve Assembly
- Flow Check device
Maintenance and Troubleshooting
- Cleaning procedures and practices
- Review error messages and fixes
- Look for filter failure mode
- Line pressure requirements
•Datasheet: Palltronic® Training Program
Drivers for Palltronic Filter Integrity Test Instruments
Controlled Integrity-testing with a Programmable Logic Controller
Description
Drivers for the Palltronic filter integrity test instruments enable a PLC to remotely control the integrity test device. The Programmable Logic Controller (PLC) can initiate a self test or filter test and when completed, the Palltronic device transmits the test result, the device serial number and other information back to the PLC. This information can then be stored in a Supervisory Control and Data Acquisition (SCADA) system using the data received by the PLC to form part of a comprehensive batch record.
A standard package includes: driver software supplied on CD-ROM, full installation instructions and a 2 m (26 ft) communications cable between the PLC and integrity test device.
Features and Benefits
- Process automization can minimize operator involvement, saving time and reducing errors
- Integrity test results can easily be incorporated into batch records and stored centrally on the PLC or SCADA system
- Full integration of the Palltronic device into the normal operation of the plant allows control of the test device from outside critical or difficult-to-access areas
- The PLC or SCADA system can be configured to be compliant with 21 CFR 11 Part 11 when storing test results
•Datasheet: Drivers for Palltronic® Filter Integrity Test Instruments
Automated Filterability Test Unit
The Palltronic Filter Manager is an automated filterability test unit which can be used to test direct flow filters either at constant pressure or at constant flow. This allows to simulate exactly your processes, and such a unit can be used for modeling of filtration processes either during scale-up or during scaling down for trouble shooting processes or validation test work.
Palltronic Filter Manager, an instrument especially designed for laboratory environment is compact, flexible and splash-proof. The latest touch-screen technology makes the unit extremely user-friendly with simple menu-driven data input.
Features and Benefits
- Designed to perform either constant flow test or constant pressure test
- Up to 2 filters can be tested in series
- Available in 3 different conformations for ease of use
- Results displayed in both tabular and graphical format
- Output (in L/m2 of membrane area) will be calculated for each filter
- Splash proof design allows testing in a laboratory environment
- Storage of up to 50 tests in the hard drive
- Hard copy printout with date and time displayed helps documentation requirement
- Provides the technological controls to meet the regulatory requirements of 21 CFR Part 11
- Automatic Self Test to check proper functioning of software and internal components
- Extensive validation documentation and qualification of hardware and software for compliance with industry and regulatory requirements
- Designed for easy servicing
•Datasheet: Palltronic® Filter Manager
