Abstract

INVESTIGATION, DEVELOPMENT AND VALIDATION OF THE DISINFECTANT USED IN STERILE PHARMACEUTICAL MANUFACTURING FACILITY

Salman J. Latif*, Ashish V. Kulkarni and Prashant D. Ambawade

Abstract

Objective: Cleaning and disinfection of surfaces are crucial process for maintaining the integrity of pharmaceutical manufacturing operations. One of the bigger challenge faced by pharmaceutical manufacturing is with the choice of disinfectants, for ensuring that the disinfectants selected are appropriate for use and that the affectivity of the disinfectants are periodically assessed. For both sterile and nonsterile pharmaceutical product, the severity of the effects of microbial contamination is very much a function of the nature of the contaminated product, its intended use and the number of contaminants. In this study disinfectant (ACITAR) was assessed and validated for its use in sterile manufacturing facility. The validation was based upon the regulation guidelines provided by W.H.O, USP and other guidelines and the disinfectants were proved to be effective in various condition. Methods: Three different methods were used to test the efficacy of the disinfectant, they are-membrane filtration and direct inoculation method, swab analysis method and agar diffusion or ditch plate method. Results: Tests proved that the disinfectant was active against the standard bacteria and fungi. Acitar 5% solution showed its action within 10 minutes in both membrane filtration and swab analysis. Agar diffusion method showed a perfect zone of inhibition for the respective disinfectant. Conclusion: The validation of disinfectant was done in accordance to the procedures given in I.P and W.H.O guidelines. The results from different methods were promising and the process was validated, a protocol was generated and SOP was prepared for the further assessment of disinfectant.

Keywords: Validation, Disinfectant, Antimicrobial agent, Membrane filtration, Microbial Contamination.