Validation of the Effectiveness of UV Light in Water System : Pharmaceutical Guidelines

Validation of the Effectiveness of UV Light in Water System

Validation of effectiveness in water system is very important because it helps to produce water for manufacturing of pharmaceutical drugs.
UV radiation is an important component when it comes to the control of microbial contamination. To ensure the efficiency of UV light in purified water is kept at optimum, most of the time, validation of effective working of UV light in pharmaceutical water system needs to be carried out.

The major aim in doing this validation is to demonstrate that when the UV light purification process is being operated under the ideal and set conditions, it produces water that is high in purity and also has a high degree of assurance.

UV light for Water SystemAccording to FDA - Food and Drug Administration, validation can be defined as established and documented evidence that provides high assurance degree that a specific process under investigation produces a product that meets predetermined quality characteristics and specifications consistently.

In pharmaceutical industries, the quality of water is very important and a major concern. The reason being water is an ingredient that is used in almost all the operations that are carried out in this industry. Having pure water ensures that the equipment is not spoiled and the product being produced remains pure.

For UV light to be effective, the absorbed UV light must be enough to kill all the micro-organisms. UV light kills micro-organisms by preventing reproduction and also disrupting the DNA after it goes through the cell.


In determining the effectiveness of the UV light, test ports are utilized. This is carried out through obtaining water samples and assessing whether the organisms reduction expected from the UV instruments being used is achieved. Microbiological analyses before and after the water have undergone UV light treatment are the center of this validation.

UV devices that are used in most cases are never absolute in the reduction of the micro-organisms present. They only help in making a contribution to the reduction of micro-organisms by 1, 2, or 3 logs. Sometimes, the reduction is achieved up to a level that is close to 100 cfu/ml.

In order to make sure that the UV light water purification method is highly effective, maintenance is something that cannot be ignored. Maintenance will entail periodic replacements of UV lamps or when it is indicated by the online intensity meters available.

In most cases, manufacturers suggest that the UV lamps be replaced every 8000 to 9000 working hours. This an approximate of one year. This is not an ideal thing to do because the quartz sleeves available in most lamps may absorb some of the ultraviolet radiation from the lamps and hence accumulate impurities in the raw water. Examples of these impurities include rouge and other fine particles. Therefore it is ideal to replace the lamps after every six months. Ballasts that provide power to UV lamps should also be replaced every 2 to 3 years.

Calibration of UV intensity meters should be periodically performed. This calibration involves adjusting of 100% transmission value each and every time when the sleeves and lamps are replaced.

In general, the validation of the effectiveness of UV light involves the following: determining how effective the UV light is by carrying out tests and then taking action to improve and maintain the functionality at optimum operation.





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.
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  1. What is the use of a UV purifier when it cannot perform a 5 log reduction? You need to cross check the Robert Koch's postulate number 2, Inoculation and Isolation of the same organism... That means you must use it on a suspension of microorganisms stated in USP such as E.coli, Salmonella abony,S.aureus, Ps.aeruginosa, B.subtilis, C.albicans, Asp.niger & Clostridium. The suspension count before exposure to UV light must be 3 X 10000000 i.e., (3X 10 to the power of six) number of organisms. after exposure to UV light, the recovery must be checked in the water sample which must show at least a 5-6 log reduction in the bacterial counts. Even the intensity of UV lamp must be checked. There must be a log book to maintain the number of hours for which the UV light is on must be also checked. or else, what is the use of UV Light. In my opinion, it must be 100% efficient and kill al, the bacteria and it is possible also, because, after all the processes the water has undergone, the final purifiction is with UV, and by this time, in reality, a quantity of nearly 5-10 Kl quantum of sample may probably have about 5-6 bacteria in the tank and a microbiologists interest is to recover these 5-6 bactria.On exposure to UV light, even these will be obliterated and the grade of water will be exactly like WFI. In case any clarifications are needed, please mail me to [email protected] The person who has commented is a Ph.D., in Pharmaceutical technology from the Edinburgh University and possesses an experience of 28 years in Sterile injectable both API & Finished product formulatiions in India & in Europe.

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