Qualification of Bio-Pharmaceutical Equipment. Qualification Approach: Performance Qualification of Compressed Air and Nitrogen Gas system of Bio-Pharma Utilities

      Аннотация: Qualification of equipment based upon new installation or due requirement of company. Qualification is an essential approach of the pharmaceutical quality system. Production is mainly depends on the performance of the equipment. Performance of the equipment is only possible when the equipment is properly qualified, verified and maintained. A well designed qualification program assures the consistence performance of the equipment, saves valuable time and cost. Qualification is a never ending process so it is a cyclic process. Appropriate documentation of the qualification program is very important as lack of the documented evidence does not give any meaning to qualification. Compressed air is used for a number of production and packaging applications, including blowing off and drying bottles prior to filling, conveying pills, providing air for pneumatically controlled valves and cylinders, fermentation, as well as breathing air. Nitrogen use in sterile manufacturing to prevent microbial growth contamination of products. Both utilities are very critical so need to qualify to maintained regulatory requirement.

Ключевые слова: Qualification of Equipment, compressed air system, Nitrogen Gas System, Performance Qualification, Bio Pharma Utilities