As ultra-purified water used in the preparation of parenteral drugs, it’s essential for WFI to be free from impurities.
To achieve this, a WFI loop is a closed distribution system that continuously circulates the media, ensuring it remains within required specifications. However, a WFI loop alone cannot guarantee the quality of the output media. A key challenge is the prevention of biofilms, which are formed by the accumulation of trace bacteria.
As ultra-purified water used in the preparation of parenteral drugs, it’s essential for WFI to be free from impurities
Undetectable, trace amounts of bacteria can enter a WFI loop through microscopic leaks or cracks in the system, or contamination from maintenance. Given the conditions necessary for their growth, including microscopic traces of nutrients, temperature fluctuations, or insufficient cleaning practices, this is how trace bacteria can develop into a biofilm. Precise flow control then becomes crucial to ensure that trace bacteria isn’t given the potential to grow.
Biofilm development
Critical to this process is the prevention of dead zones, which are sections of piping with minimal or no flow. Stagnant water collated in dead zones allows bacteria to settle and multiply, while low flow areas, with less mechanical force to dislodge the bacteria, can also lead to bacteria accumulation.
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