DYNAMICS OF WATER PURIFICATION SYSTEMS AND MICROBIAL ANALYSIS IN PHARMACEUTICAL INDUSTRY

Author(s): Sri Krishna Chaitanya.J* , Karuna. J and Gyana Prasuna.R

Abstract: Water purification system and contamination free water plays a key role in pharmaceutical parenteral drug product manufacturing. The water used as excipient in drug manufacturing undergoes several purification procedures and qualitative checks for identification of microbial contamination. To identify the efficiency of water purification systems and water quality, microbial trending is performed by collecting and correlating the microbial analysis results. Trend evaluation identifies the level of microbial contamination in pure water and water for injection grades. Based on the outcome of trend, corrective and preventive measures are implemented to reduce the recurrence of microbial contamination. After implementation of corrective and preventive measures, microbial results trending is performed. Trending results shows that the microbial recurrence and contamination levels are reduced. The complete study is an evident that the frequent trending of microbial results helps in reducing the microbial contamination and improves the water quality in pharmaceutical parenteral drug manufacturing industry.

PAGES: 569-578  |  42 VIEWS  61 DOWNLOADS