Evaluating the Efficacy of QAT-Based Disinfectants on Microbial Environment in Pharmaceutical Industries, India

Abstract

Pharmaceuticals industries strictly follow the regulatory guidelines by various bodies like USFDA, WHO, GMP etc. QAT-based disinfectants are widely used in pharmaceutical industries and are generally effective at reducing microbial loads. This study investigates the efficacy of Quaternary Ammonium Compound (QAT)-based disinfectants in controlling microbial contamination in pharmaceutical cleanrooms across three facilities in India-Himachal Pradesh, Maharashtra, and Sikkim over 2022 and 2023. The research focuses on seasonal variations in microbial load and the challenges posed by specific bacterial and fungal contaminants. The results highlight increase in microbial counts in the year 2023 in all facilities, with Staphylococcus sp, Kocuria sp., and Micrococcus being the dominant bacteria, particularly in areas of higher human traffic and equipment use. The Maharashtra facility presented a more complex contamination profile, with the presence of both bacterial and fungal species, including Aspergillus and Stachybotrys, which are known to thrive in humid conditions and form resilient biofilms. The Sikkim facility revealed a diverse microbial spectrum, including Gram-negative bacteria such as Pseudomonas stutzeri and Enterobacter aerogenes, which pose heightened risks due to their ability to persist in damp environments and resist disinfection. The study underscores the importance of regular personnel training to ensure correct handling of disinfectants. It recommends a rotational disinfection strategy combining QATs with other biocidal agents to address a wide variety of microbial bioload and maintain pharmaceutical cleanrooms. The findings provide crucial insights for optimizing disinfection practices, ensuring compliance with cleanroom standards, and safeguarding product quality and safety.