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Abstract

A RESEARCH: EXAMINATION, VALIDATION AND EFFICACY TESTING OF THE DISINFECTANT USED IN STERILE MANUFACTURING UNIT

Tanvi Kumbhar*, Mukesh Mohite and Prashant Ambawade

ABSTRACT

Objective: Cleaning as well as disinfection of surfaces are important steps for maintaining and controlling the sterility of pharmaceutical manufacturing operations. The disinfectants and antiseptics are used to control the growth of micro-organisms thereby reducing the contamination in the final product. One of the more tedious tasks for pharmaceutical organizations is to deal with the selection of disinfectants and ensuring that the disinfectants choice are of desired characteristics and that the effectiveness of the disinfectants are periodically assessed. In this study the disinfectant (TOTASEP) was examined and validated for its use in sterile manufacturing facility. The validation was based upon the regulation guidelines provided by W.H.O and USP. Methods: There were three methods used to investigate the efficacy of the disinfectants, which were membrane filtration and direct inoculation method, swab analysis method and agar diffusion also known as ditch plate method. Results: These methods demonstrated that the disinfectant was active against the standard bacteria and fungi. TOTASEP 1%v/v solution showed its action within 10 minutes in both membrane filtration as well as swab analysis. Agar diffusion method resulted in a perfect zone of inhibition for the respective disinfectant. Conclusion: The validation of disinfectant was achieved according to the procedures provided in IP and W.H.O guidelines. The results from different methods were found to be promising and the process was validated and the disinfectant was found to be efficient for the desired purpose.

Keywords: Validation, Disinfectant, Antimicrobial agent, Efficacy, Microbial Contamination.


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