Validation of the Effectiveness of UV Light in Water System

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.

According 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. The 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.

Related: Ultra Violet Light Disinfection in Pharmaceuticals

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 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.