Water for Injection Hold Time Study in Room Temperature

Abstract

During the internship, the main project done is the Water for injection hold time study at room temperature. Water for injection is a type of pure water used in pharmaceutical production that has been treated using distillation. Water for injection is used for cleaning equipment, mixing solutions, and validating cleaning. The study aims to investigate the condition of water for injection for a period of 2 weeks to determine the hold time of water for injection and monitor the various parameters as described by Farmakope Indonesia. The six parameters described as appearance, pH, conductivity, Total organic Carbon (TOC), bioburden, and endotoxin. The results of the project revealed that the condition of the water for injection overall is kept stable throughout the two weeks using the laminar air flow and the sterile gloves used in sampling. However, vapors of alcohol used in the room to sterilize equipment results in increasing levels of TOC to build up. This study helps the company to keep up with their productivity in the events that water for injection in unavailable for a period of time