EFFECT OF TREATMENT ON PRODUCTIVITY AND QUALITY OF PURIFIED WATER SYSTEM USED IN PHARMACEUTICAL APPLICATION

Abstract

Water is widely used as a raw materials, ingredient, and solvent in the processing, formulation, and manufacture of pharmaceutical product. WHO guideline (TRS 970A) strongly recommended that the production of water for pharmaceutical use, must always start with potable water. The compounds that are susceptible to foul the reverse osmosis (RO) membranes may be plagued with impurities of inorganic suspended solids, sand, oil, clays, bacteria, and dissolved organic matters in feed of potable water. Those impurities can effect on productivity of RO which is the main represented parameter can measure the overall performance of the purified water system quantitatively. This study was carried out on purified water system of Alkan Pharmaceutical (now – Hikma Pharma) industries located in industrial zone of 6th October city. The main objective of this research was to investigate the effect of pretreatment steps using different disinfectants (NaOCl, and H2O2), the position of injection port of Sodium Meta Bisulfate (SMBS - (5%)) before and after depth filter on the microbial contamination results. Results showed that the effect of sodium hypochlorite (30 ml/hr) on disinfection yield microbial count lower than the USP Alert limit (300 CFU/ml) for more than 140 days after system start up, while hydrogen peroxide failed after 80 days. Finally, if a water purification system is designed, operated, and maintained properly, it should not be plagued by microbial contamination. However, if special attention is not dedicated to the control of microbial growth, problems will very likely result in less productivity of purified water system.