Biocontamination Control Techniques for Purified Water System : Pharmaguideline

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Biocontamination Control Techniques for Purified Water System

Learn How to control the development of biofilm and microbial growth in pharmaceutical water system? and temperature of water, deadlege, sanitation and use of UV light in water system.
Water treatment, storage and distribution system for preparation and distribution of purified water should have the properties to control microbiological contamination. Techniques should be employed during the qualification of water system.
•  The water systems that are operated at 70-80 °C are less susceptible to the microbial contamination then the systems operated at ambient temperature because microbes has optimum growth on ambient temperature.

Related: Reverse Osmosis Water Purification System

•  A spray ball should be used to prevent the source of contamination in head space of storage tank.

•  Vent filter should be used to avoid the contamination of the storage tank from the outer air entering into the tank. Filter should be of 0.2 μm pore size and should be validated. Vent filters should be sanitize time to time by appropriate sanitizing agents.

Related: Cleaning and Disinfection of a New Purified Water Syatem

•  Water should be continuously circulated into the distribution system to avoid the formation of biofilms i.e. the layer of the microbial population around the inner surface of the pipelines.

Related: Chemical Sanitization of RO Systems and Biofilm Removal

•  Velocity of the water flow should be considered during the validation of water system and same should be maintained during the normal operation of the water system.
•  Dead legs should not be more then 1.5 times of the pipework diameter. It will help to avoid the stagnant water in dead legs.
•  If water system is maintained at ambient temperature, it should be sanitize at least once in a week with hot water i.e. >70 °C or other suitable sanitizing agent. If chemical sanitizing agent is used then it should be validated for its cleaning procedure to remove from the system.

Related: Passivation of Purified Water System/ WFI System

•  Ultraviolet light should be used before the return loop to minimize the contamination entering through the water returning into the storage tank.

Also see: Guide To Inspections of High Purity Water Systems

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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