Ecology, Environment and Conservation Paper

Vol. 28, May Suppl. Issue 2022; Page No.(277-282)


Asha Subba, Manoranjan Pandey, Karma G. Dolma, Sangeeta Jha and Ajeya Jha


Quality is a predominant theme in pharmaceutical production. As the most important raw material used inpharmaceutical industry, water quality remains central to the efforts to build quality in final products.Sikkim, the latest hub of pharmaceutical industries, has water streams the main source of water for them.This study had been undertaken to ascertain the magnitude of pathogenic microbial pollution to whichPharmaceutical industries in Sikkim are exposed to, and the challenges this poses to their water purificationprocess. Our conclusions in this respect are that presence of pathogenic microbes in feed water topharmaceutical country is extremely high. While ranking the water purification process steps using riskpriority number, determined on the basis of expert opinion of quality assurance managers. Missing ofSodium Hypochlorite dosing emerged as the most critical step in this respect, followed by Pipe inducedmicrobial growth and malfunctioning Reverse Osmosis (RO) membrane malfunctioning. Implications forthe quality professionals and regulatory authorities are that the extent of microbial pollution is extremelyhigh and that some steps in purification process are highly critical and validation process should take thisinto consideration.