Evaluation of the impact of disinfection policy on the environmental monitoring results in a pharmaceutical factory

Abstract

Backgrand:Water in the pharmaceutical industry is important everywhere.Water is one of the most important components and a significant part of the final product in sterile pharmaceutical products, So monitoring the microbial quality is of great importance. Aim: In this research, proper disinfection policies at the level of a pharmaceutical company and sterilization were investigated in a practical way, and the results of various parameters were examined. Material and methods: Sampling of different stages of the water system according to the factory protocol was carried out in two groups, three months before and one month after the disinfection process. The specimens were cultured in two R (R2A) and T (TSA) media under microbial cultures. Endotoxin testing was performed with LAL test and gel clot method. Disinfection of resins with 0.1% peracetic acid, distilled water reservoir with 8% nitric acid and total brushing and steaming route.regeneration of ion exchange columns whit HCl 6% and NaOH 4%. Results: In the results of microbial count, there is a significant difference between the two groups before and after the washing and disinfection of the water system. The results of the LAL test in distilled water before disinfection , sometimes reported positive, but after the disinfection all the results of the LAL test were negative.

Discussion: Given the clear and meaningful result in microbial counting and LAL testing, it is concluded that the disinfection process should be carried out at short intervals and strictly in the site for the production of sterilized products, in order to obtain standardized injectable water.