Anmol Dwivedi*, Raven Karodi, Mahesh Manohar Mali, and Kunal Omprakash Warwatkar

M pharmacy, Quality Assurance Technique, Dr D. Y. Patil College of Pharmacy, Akurdi, Pune - 411044 India *Corresponding Author: Anmol Dwivedi E-mail: anmoldwivedi2020@gmail.com Mobile no: 6265023137

ABSTRACT

Objective : Maintaining and regulating the sterility of pharmaceutical manufacturing operations requires both cleaning and disinfecting surfaces. The antiseptics and disinfectants are employed to limit the development of microorganisms to lessen contamination in the finished product. Choosing disinfectants, making sure that the ones chosen have the appropriate qualities, and routinely evaluating the disinfectants’ efficacy are some of the more laborious responsibilities encountered by pharmaceutical companies. The disinfectant was investigated and approved for use in sterile industrial facilities in this study. The W.H.O. and USP. regulation requirements served as the foundation for the validation. The effectiveness of the disinfectants was examined using three different techniques: swab analysis, membrane filtration and direct inoculation, and agar diffusion, commonly referred to as the ditch plate method. Findings: These techniques showed that the disinfectant was effective against common fungi and bacteria. The disinfectant 1%v/v solution began to function in both swab analysis and membrane filtration in less than ten minutes. The corresponding disinfectant’s zone of inhibition was perfectly formed using the agar diffusion method. In conclusion, the protocols outlined in IP and W.H.O. criteria were followed to validate the disinfectant. The outcomes of various techniques were determined to be promising, the procedure was verified, and the disinfectant proved effective for the intended use.

Key words : Validation, Disinfectant, Antimicrobial agent, Efficacy, Microbial Contamination.

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