Cleaning and disinfection assessment is an important part of cGMP in any pharmaceutical industry. To validate the efficacy of disinfectants used in disinfection procedure, in order to reduce surface contaminations, we tested invitro the action of commercial disinfectants. The qualification of procedure was carried out on a screening test in order to measure effectiveness of the test disinfectants. A clean surface becomes easier to disinfect and so the cleaning and disinfection programs complement each other. Disinfection efficacy and validation studies has been carried in accordance with the United States Pharmacopeia Disinfectants and Antiseptics protocol. The test organisms used include standard strains mentioned in USP . Standard Use Dilution test protocol was followed, before and after disinfection and the microbial load was assessed to calculate the Log₁₀ reduction index. Subsequently, we developed and validated a disinfection procedure on using approximately 10⁶–10⁷ total colony forming units per test. Our results showed a bactericidal, fungicidal, and sporicidal efficacy coherent to the acceptance criteria suggested by United States Pharmacopeia . The correct implementation of our cleaning and disinfection procedure, respecting stipulated concentrations and contact times, led to a reduction of more than 4 Log₁₀ for all microorganisms used. The qualification of procedure was carried out on a screening test in order to measure effectiveness of the disinfectants, chosen according to their principle of action.

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