PORT WASHINGTON, N.Y., April 20, 2010 – The sensitive and accurate testing of process membrane filter integrity is critical to ensuring efficient, safe pharmaceutical production and regulatory compliance. Pall Corporation’s (NYSE: PLL) new Palltronic® Flowstar IV filter integrity test instrument offers improved pressure/flow calibration to preserve measurement accuracy while ensuring a faster testing process. Lightweight, compact and ergonomic, the newly designed instrument also features an enhanced touchscreen and user-friendly interface.
The Palltronic Flowstar IV filter integrity test instrument is designed for “best practice” in pharmaceutical production, preserving measurement accuracy with fast, reproducible test results. With Pall’s long-established direct-flow measurement technology (based on volume dosing), users do not need to measure upstream filter assembly volume and pressure decay, reducing testing time. The instrument performs a variety of tests, including Forward Flow, Bubble Point, Water Intrusion, combined Forward Flow/Bubble Point, and Leak and Pressure Decay tests. The test flow measurement is measured directly and calibrated against a flow reference. Forward flow/diffusion and water intrusion tests are run at a constant pressure throughout the entire test time to further ensure accuracy. The volume-dosed flow meter can perform a forward flow test in a range of 0.1 to 1,000 mL/min within minutes and with an accuracy of 0.1 mL/min or 3 percent. Water flow is accurately measured down to 0.03 mL/min.
Design features for the Palltronic Flowstar IV filter integrity test instrument include an ergonomic, light-weight, compact design with a full-color touchscreen. An intuitive and user-friendly interface makes training of operators simple. The instrument also features the latest networking capabilities so users can easily integrate it with a local network. A barcode reader can be connected and used to select test programs or enter data. USB connectivity, an extensive range of remote control and automation options, and optional wireless capabilities provide users with maximum flexibility.
Palltronic Flowstar IV instruments are ideal for laboratories, manufacturing and cleanroom environments. The instrument has been tested to be splash- and dust-proof, making it useful in laboratories where the use of powder or liquid chemicals in close proximity to an instrument is common. To meet cleanroom requirements, there is no cooling fan that might disturb air, and the internal printer is thermal and generates almost no particles during printing. All external components are compatible with common cleaning liquids to reduce surface bioburden.
The Palltronic Flowstar IV filter integrity test instrument can be used in environments compliant with U.S. FDA’s 21 CFR Part 11 regulation for electronic storage of data. Three different access levels help administrators protect sensitive functions from being accessed without authorization.
“The Palltronic Flowstar IV extends Pall’s line of measurement instruments with user-friendly design and conveniences like a color touchscreen, USB ports and wireless networking capabilities,” said Michael Kradolfer, product manager of hardware and instrumentation for Pall’s Life Sciences Division.
The new test instrument was developed in accordance with Good Automated Manufacturing Practices (GAMP) guidelines and is supported by an extensive qualification documentation package. In addition, Pall offers on-site service performed by its trained product support team using globally unified procedures worldwide, including calibration and servicing.
The Palltronic Flowstar IV filter integrity test instrument is available through Pall Life Sciences and can be ordered by phone at 800-717-7255 in the U.S. or +41 (0)26 350 53 00 in Europe. For a complete listing of international offices, visit Pall online at www.pall.com/contact.
Pall Life Sciences provides cutting-edge products and services to meet the demanding needs of customers discovering, developing and producing biotech drugs, vaccines and classic pharmaceuticals. Pall technologies are also used to collect and process blood components and help protect patients from hospital-acquired infections. The company’s membranes and membrane devices optimize detection and sample preparation in the drug research, clinical diagnostics, genomics and proteomics markets. Pall is a leading provider of separation systems, and single-use filtration and purification technologies to pharmaceutical and biotechnology companies to support faster development of new drugs and vaccines that are safer, and require less energy and water to produce.
About Pall Corporation
Pall Corporation (NYSE: PLL) is a filtration, separation and purification leader providing Total Fluid ManagementSM solutions to meet the critical needs of customers in biopharmaceutical; hospital, transfusion and veterinary medicine; energy and alternative energy; electronics; municipal and industrial water; aerospace; transportation and broad industrial markets. Together with our customers, we foster health, safety and environmentally responsible technologies. The company’s engineered solutions enable process and product innovation and minimize emissions and waste. Pall Corporation, with total revenues of $2.3 billion for fiscal 2009, is an S&P 500 company with more than 10,000 employees servicing customers worldwide. Pall has been named a top "green company" by Newsweek magazine. To see how Pall is helping enable a greener and more sustainable future, visit www.pall.com.