Appnote: Fast, flexible leak testing for single-use bioprocessing

Accurate simplified testing for small volumes and differing configurations improving on traditional pressure decay methods

A revolution in bioprocessing is underway in the form of single-use technologies.  Single-use offers the promise of lower costs, improved flexibility and shorter cycle times.  But what happens when a single-use bag or component fails? System integrity is critical for any bioprocess, but traditional methods using pressure-decay measurements may fail to ensure the system is free of leaks. Integrity testing can now be accomplished easily and quickly with a modern Alicat Scientific Whisper Series Mass Flow Meter or Controller.

Fast and accurate leak checking can be a complicated process requiring a rather complex setup. When the Device Under Test (DUT) is subjected to a constant pressure within a closed system, any resulting flow is a direct measure of the leak rate. This test requires both stable pressure control at the DUT and accurate flow measurement to test for leakage. Leakages are most easily revealed and measured when the meter generates minimal pressure drop, the frictional resistance that the device introduces into the gas line.

Flexboy single use bag

For years, Alicat Scientific has provided a two-unit leak checking system using a PC3-Series remote sensing pressure controller to maintain the required test pressure at the DUT and an M-Series mass flow meter to measure the leak rate. This method is more sensitive than pressure decay, but can be simplified further.

Recently, Alicat has pioneered the simplified testing for leaks using a single Whisper series mass flow controller. This simplified process makes testing the myriad bags and containers used in single-use bioprocessing easier and more flexible. With full-scale pressure drops as low as 3.6 mbar (0.052 psid) and turned-down pressure drops as low as 0.018 mbar, the Whisper allows precise and responsive control with minimal frictional resistance.

For leak checking smaller test volumes, such as valves or sensors, a single MCW-Series mass flow controller that is set to control for pressure will maintain a constant pressure at the DUT while providing accurate mass and volumetric flow readings in real time. Configured this way, the Whisper serves the functions of both a pressure controller and a mass flow meter in one device. Alicat’s Whisper now makes leak checking for the small volumes needed for single-use technologies even faster…and simpler. This configuration also makes changing the configuration to test different devices, or testing infrequently, very achievable. A method even more sensitive than pressure decay, and much simpler and less expensive than multi-unit systems. From Alicat: The fastest flow controller company in the world.

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