Selection and microbial control of disinfectants and validation of disinfectant microbial efficacy in the pharma & biopharmaceutical industry: a case study

Author(s): Naresh Kumar I.*, Mahesh Kulkarni, Hari Babu B.

Abstract

We have evaluated the efficacy of different neutralizing solutions for use in disinfectant efficacy assays. Our approach used for comparisons between the recoveries of low inocula in different treatment populations. The challenge organisms employed were those described by the Bacilloid special for use in determining germicidal, bactericidal, sporicidal, and fungicidal activity of disinfectants. The manufacturing processes are carried out in controlled environment for which we have classified areas. The microbial load in the classified area must be controlled to ensure asepsis. For this classified areas are regularly disinfected to ensure that the microbial loads are kept under control. The disinfectants are used for sanitization of floors, walls, ceilings, surfaces and other articles in the classified areas of laboratories. It is important to check the disinfectant efficacy before it is used in our facility. This is checked by various methods. The disinfectant used at facility across the sits is Bacillocid special 0.5% v/v for routine monitoring and 2.0% v/v for fumigation purpose. The Bacillocid special contains: 1, 6 Dihydroxy, 2-5 Dioxahexane - 11.2g, Glutaraldehyde – 5.0g, Benzalkonium chloride – 5.0g and Alkyl urea derivatives – 3.0g. Bacillocid special is a disinfectant that is specially designed for the disinfection of high risk areas. It has got excellent cleansing properties, a broad spectrum germicidal action with corrosion inhibitors and cleanser hence this is selected for disinfection. The study was conducted at one location of facility, but the environmental isolates of all facilities were used as a challenged organisms hence the study outcome are applicable for facilities.

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