Filter Integrity Testing

Performing a filter integrity test on either a sterilizing-grade filter, a mycoplasma reduction filter or a virus filter is one of the most critical test procedures in pharmaceutical manufacturing. The integrity test result is very important to confirm filter performance and claimed filtrate quality. With over 30 years of experience as a leading supplier of high-quality integrity test products and services, Pall understands the importance of integrity testing to our customers. Our team of scientists and engineers continues to closely observe trends in pharmaceutical filter testing. This allows us to keep our test instruments up to date and offer technology designed to the latest quality standards, supported by a comprehensive validation and support package, plus integrity test training. A Guide to Pall’s Integrity Test Instruments All of Pall’s instruments were developed for use under GMP regulations. Our unique flow measurement technology, specially designed for filter integrity testing, assures very high measurement accuracy over the entire flow range expected to be measured in a pharmaceutical process. For each instrument, the user interface is clear and easy to use, allowing the user to access all required functions quickly and simply. Extensive validation and qualification documents are available. The Palltronic® Flowstar IV Integrity Test Instrument Pall’s recommended instrument for the pharmaceutical market. The latest product of Pall's long experience and expert technical knowledge in producing successful, top-quality test instruments, it enables users to test even more filters in less time, reliably and reproducibly, saving time and money.

Lightweight, compact and ergonomic, the Palltronic Flowstar IV instrument features an enhanced, full-color touch screen and user-friendly interface that requires minimal training of operators. Improved pressure/flow calibration enables faster tests while preserving measurement accuracy. The latest networking capabilities are also 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 GMP qualification documentation package, including guides for Installation and Operational Qualification (IQ/OQ).  

Click here for the product brochure (PDF, 1.75 Mb) or visit the product page.  

Do you need help with what factors to consider when selecting an integity test instrument? Download our helpful guide (PDF, 275 kb) 

Pall offers an interactive course designed for manufacturing operators and other relevant staff to assure an understanding of the integrity test from basics of filtration and integrity testing, regulatory requirements, various types of integrity tests, instruments used, troubleshooting, and hands-on application. For more information, click here.

Other Integrity Test Systems and Instruments

Palltronic® AquaWIT XC Integrity Test System
The instrument of choice for automated testing of hydrophobic gas filters. Many issues with the highly-sensitive Water Intrusion test can be resolved by using this type of automated testing system. Traditional Forward Flow and Bubble Point tests can also be performed.

Palltronic® Flowstar XC Integrity Test Instrument
The predecessor to the Palltronic Flowstar IV instrument, and the instrument of choice for filter integrity testing in the pharmaceutical industry for more than a decade.

Palltronic® MUX Integrity Test Unit
Allows the automated sequential testing of up to eight filters. Eight independent integrity tests can be programmed and executed in a sequence. The results of all tests can be be stored and printed. The Palltronic MUX unit is controlled by the Palltronic Flowstar XC instrument.

Palltronic® FlowMod Integrity Test Instrument
Designed for use as a standalone unit to be integrated into pharmaceutical manufacturing equipment (e.g. freeze driers or autoclaves) for fully automated filter integrity testing in-situ.

Palltronic® Flowstar II Integrity Test Instrument
An ideal solution for when a Palltronic instrument is desired, but electronic signatures and data storage are not required.

Integrity Test Training and Certification

Accurate testing of filter integrity is critical to ensuring efficient, safe pharmaceutical production and regulatory compliance. Pall can help you meet these requirements by providing high quality training through experienced instructors to assure immediate application of integrity test principles and techniques in your operation. Click here to learn more about Pall's Integrity Test Training course.