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How to Remove Pathogens from Water Systems


The process to remove pathogens from the purified water system and water for injection system by sanitization.
Pathogens are the microorganisms which are capable the cause disease. All of these microorganisms are harmful for human. Those can survive into the purified water as well as the water for injection. The pathogenic bacteria found in water system are E.coli, Salmonella and Pseudomanas. Generally these are attached in the filtration membranes of water system such as Reverse Osmosis membranes and Ultra-filtration membranes or sometimes a biofilm can be formed in pipelines of water system.

Related: Types of Water in Pharmaceuticals

Remove Pathogens from Water systems

Some times when we analyze the purified water or water for injection (WFI) for the microbial limit test pathogens are found in the sample. In that case we should re-analyze the sample first to sure the occurrence the presence of pathogenic bacteria in water system.

When such a condition is occurred the whole water system should be cleaned. First of all whole system should be sanitize with hot water (80⁰C) for a period of 4-5 hours. All the user and sampling points should also be flushed by continuous draining of hot water for 15-20 min to remove pathogens properly. Drain the water and flush the system at least two times with ¼ of the water storage tank. Fill the tank with fresh water. RO system and ultra-filtration membranes should not be sanitize with hot water. This process is applicable only on water re-circulating loop connected with water storage tank.

Related: Cleaning and Disinfection of a New Purified Water System

After the sanitization, sample should be taken from every user point and should be analyzed for all pathogens as per the standard operating procedure for purified water/WFI testing.

If pathogens are found again in the water samples then system should be sanitize first with nitric acid solution (5%) followed by formaldehyde, chlorine or hydrogen peroxide (5%) to remove pathogens. For the better results these can be used with hot water. Ultra violet light in return loop plays a vital role to keep pathogenic bacteria away from water system. System should be cleaned properly and should be analyzed for traces of the used chemically before using water in manufacturing process.

Water system should be validated remove pathogens properly for a period of minimum of seven day before using again in pharmaceutical production.

Also see: Validation of Purified Water System
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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Kamran Asim said...

Excellent stuff

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