Biofilms are protected communities of bacteria and other microbes that stick to the inner walls of pharmaceutical water pipes and tanks.
They grow inside a sticky self-made shield, making them up to 3,000 times harder to kill with standard cleaners than floating bacteria. They cause chronic contamination in purified water and water for injection (WFI).
๐๐ก๐ฒ ๐๐ข๐จ๐๐ข๐ฅ๐ฆ๐ฌ ๐๐ซ๐จ๐ฐ
- ๐๐๐๐ ๐ฅ๐๐ ๐ฌ ๐๐ง๐ ๐ฉ๐จ๐จ๐ซ ๐๐๐ฌ๐ข๐ ๐ง: Pipes with unused stub ends or slow flow create calm spots where microbes settle.
- ๐๐จ๐ฎ๐ ๐ก ๐ฌ๐ฎ๐ซ๐๐๐๐๐ฌ: Tiny scratches or poor welds on stainless steel give bacteria a place to grab hold.
- ๐๐จ๐ฐ ๐ง๐ฎ๐ญ๐ซ๐ข๐๐ง๐ญ๐ฌ: Ironically, ultra-pure water systems have low nutrients that cause bacteria to stick tightly to surfaces to scavenge food.
- ๐๐ญ๐๐ ๐ง๐๐ง๐ญ ๐ฐ๐๐ญ๐๐ซ: System shutdowns or low usage periods allow colonies to multiply fast
Biofilms are problematic to pharmaceutical water systems. If a biofilm develops then an out-of-control situation is likely to emerge.
Such a situation can often only be detected from point-of-use samples and since several excursions are required to alert of the probability of a biofilm, the biofilm will most likely have become significantly established at this point in time.
In a well-maintained pharmaceutical water system, how might biofilms form? There will be differences between new (and poorly conceived) water systems and established (but compromised) water systems.
Biofilm formation in new water systems is often a product of poor design. This may relate to the type of material used for the pipework; the finish of the pipework; the diameter of the pipe; the velocity of the circulating water or the presence of dead-legs (bends in the pipe where the water velocity slows)
๐๐๐ญ๐ก๐จ๐๐ฌ ๐๐จ ๐๐ซ๐๐ฏ๐๐ง๐ญ ๐๐ก๐ ๐
๐จ๐ซ๐ฆ๐๐ญ๐ข๐จ๐ง ๐๐ ๐๐ข๐จ๐๐ข๐ฅ๐ฆ ๐๐ง ๐๐๐ญ๐๐ซ ๐๐ฒ๐ฌ๐ญ๐๐ฆ๐ฌ
- Making Sure The Insides of Tanks and Pipes Are Smooth
- Ensure Continuous Water Movement in Tanks and Rapid Flow in Pipe-Work
- . Valves Must Also Be Made Properly So That Water Doesnโt Stay in Them
- Fix Leaks When They Are Identified to Stop Bacteria from Entering the System
- Use Filters on The Air Vents of Water Tanks
- Use Coatings on Pipes and Tanks Where Necessary
A well-designed water system, combined with regular monitoring, validated sanitisation, and preventive maintenance, is essential for controlling biofilms and maintaining the microbiological quality of pharmaceutical water.