Quality Control of Water Testing Monitoring at PT Kalbio Global Medika

Abstract

Water is a crucial component used for substance, raw material or starting material in the production, processing and formulation of pharmaceutical products. Due to its unique chemical properties, water is able to dissolve or suspend many different contaminants that might react to the intended product substance. Therefore, monitoring water quality is important. Water in PT Kalbio Global Medika are divided into Water for Injection (WFI), Pure Steam (PS), Purified Water (PW), Raw Water (RW), Softened Water (SW), Type I water (T1), and Type III water (T3). Each type of water has different parameters to be tested and their own specification. The parameters include identification, conductivity, TOC (Total Organic Compound), pH, and determination of nitrate, iron, silicate, and chlorine. The identification assay was performed by observing the visible appearance. Conductivity, TOC, and pH were determined by using the instrument of conductivity meter, TOC analyzer, and pH meter. The content of nitrate, iron, silicate, and chlorine were performed by observing the visible color change as a result of chemical reaction. The difference is that chlorine testing was measured by Spectroquant Ⓡ Prove. Nitrate content was measured by the visible color which was compared to the standard. Meanwhile, iron and silicate content was measured by comparing the most similar color to the color chart. All of 360 water samples tested met the specifications for identification, TOC, nitrate and pH, while one sample did not meet the specification for conductivity testing. Chlorine, silicate, and iron determination are only applicable for RW and SW