As bacteria and other contaminants generally cannot penetrate holes smaller than 15 µm, helium integrity tests confirm that the bioreactor will remain sterile. These tests are highly sensitive, able to detect leaks down to 10 µm. Traditionally, manufacturers of single-use bioreactors perform leak tests using helium integrity testing. To confirm the reactor is free of leaks before the next batch, leak-testing is conducted after cleaning and sterilization cycles. They are also fitted with valves, clamps, and seals, which have the potential to wear and leak. The bioreactors have a large number of penetrations and inlets for equipment including gas lines, stirrers, and sensors. Stainless steel bioreactors, meanwhile, must be leak-tested to confirm that all seals and connection points are fully closed. Together, these measures ensure the integrity of the bioreactor, significantly minimizing the health and safety risks as well as the costly, time-consuming losses associated with compromised products. For single-use bioreactors, leak testing ensures that no holes were created in the plastic bioreactor bag during either manufacture or handling: these reactors should be leak tested by the manufacturer and also at point-of-use (once all handling and installation is complete, but before production begins). Leak testing is therefore critical to ensuring human safety and batch compliance.īoth single-use plastic and multi-use stainless steel bioreactors must be leak-tested. Leaks can also lead to contamination of the production area and can interfere with the cell culture. A leak in a bioreactor may be present for a long period of time before it is detected, potentially introducing harmful viral loads to human operators. Leak test bioreactors to ensure operator safety and process integrityīioreactors present significant biosafety risks, especially when used to produce viral vaccines. Portable flow meters are a convenient tool to leak test bioreactors, using methods that are quantitative, non-invasive, and highly precise. By Alicat Scientific Portable flow meters to leak test bioreactorsīioreactors must be leak tested to ensure all seals are tight and that there are no holes or gaps in equipment.
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