Endotoxin Testing and Environmental Monitoring Analysis of Quality Control in Kalbio Global Medika

Abstract

Kalbio Global Medika (KGM) which is a subsidiary of PT Kalbe Farma is one of the primary pharmaceutical companies in Indonesia specializing in the manufacture of sterile parenteral drug products which was built up in 2014. The quality control (QC) department of KGM is divided into five which are Raw material, Microbiology, Finished goods and intermediate, Compliance and Test item control. In the manufacture of pharmaceutical drug products, especially in the production of sterile pharmaceutical products, microbiological and sterility testing as part of the QC testing plays a crucial role to ensure the safety of both the materials used and its finished products. Endotoxin testing and environmental monitoring (EM) analysis are two of the most crucial testing performed in the microbiology of QC department. With the aim of ensuring the absence of pyrogens in both the materials and products as well as evaluating the microbiological quality of critical areas ensuring the aseptic conditions are properly maintained during manufacturing operations, endotoxin testing by gel clot method and EM analysis are routinely performed. Result obtained from endotoxin testing of a water for injection (WFI) sample, media and buffer for erythropoietin, media and buffer for efepoietin and raw material which is citric acid monohydrate shows a successful result with the absence of clot in the sample and presence of clot in the positive product control (PPC). An out of specification (OOS) result of grade D filing room is obtained which requires a further OOS investigation to find its root cause, for the EM analysis result. Therefore, it is significantly crucial to understand ways in preventing contamination and risks of microbial growth in both sterile and non-sterile manufacturing processes.