Filter Integrity Testing
Filter Integrity Testing
The Palltronic® Flowstar IV filter integrity test instrument is the result of Pall's long experience and expert technical knowledge in producing successful, top-quality test instruments. The Flowstar IV instrument introduces many new features, enabling users to reliably and reproducibly test even more filters and in less time, saving time and money. Lightweight, compact and ergonomic, the instrument now features an enhanced touch screen and user-friendly interface, requiring minimal training of operators.
Improved pressure/flow calibration preserves measurement accuracy while ensuring faster tests. The latest networking capabilities are incorporated for easy integration within a network, and the optional WLAN adaptor, USB connectivity plus an extended range of remote control/automation options enable even greater flexibility. Developed in accordance with GAMP (Good Automated Manufacturing Practices) guidelines, and offering full compliance with 21 CFR Part 11, the Palltronic Flowstar IV instrument is supported by an extensive qualification documentation package, including guides for Installation and Operational Qualification (IQ/OQ).
Having access to agile and proprietary service and support is pivotal to every facility. Pall Corporation has over 75 years of experience in providing repair, calibration, maintenance, and other services. Whether you work in research, process development, clinical or commercial manufacturing, we have a service plan tailored to you. We understand and are knowledgeable of the criticality surrounding planning to service biotechnology capital equipment, which is why we provide a tiered level of support in our Pall service plans to provide the assistance you need to protect your investment and optimize your workflow productivity.
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 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.
Calibration
Protect and ensure your measurements are accurate
The Pall Protective Plan is a cost-effective solution to assure you that your measurements are accurate within the specification limits that led you to select the instrument in the first place. Pall’s GMP-trained service engineers are experts on our equipment and will calibrate your system for repeatability, inspection readiness, and full traceability, ensuring confidence in the measurement results you’re getting.
Note: Pall recommends calibrating the instrument at least once a year, with a full service after three years.
Repair Services
In the event of system failure or untimely user error, there is a rapid and reliable solution available to get you up and running. Certified Service Engineers – professionals with up-to-date training and instant access to our technical knowledge library Parts availability – Service Engineers have factory-tested parts, and proprietary hardware and software tools on hand to help expedite repairs.
Training
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 personalized training program.