Selecting a Disinfectant for use in Pharmaceutical Manufacturing Environments

Several points should be considered when selecting disinfectants for use in pharmaceutical manufacturing environments. Among those are:

• Number and types of microorganisms to be controlled
• the spectrum of activity of commercially available disinfectants
• Product/manufacturer claims as a sterilant
• Disinfectant or sanitizer supported by the EPA registrations
• Concentration, application method, and contact time of the disinfectant
• Nature of the surface material being disinfected and its compatibility with the disinfectant
• Amount of organic compounds on the surface that may inactivate a disinfectant
• The possible need to maintain a residual bactericidal activity of the disinfectant on the surface
• The corrosiveness of the disinfectant to equipment with repeated application
• Safety considerations for operators applying the disinfectant; the compatibility of the disinfectant with cleaning agents and other disinfectants
• Planned disinfectant rotation
• The steps that need to be taken to avoid the contamination of pharmaceutical products by a disinfectant

Different Types of Disinfectants

• Antiseptic—An agent that inhibits or destroys microorganisms on living tissue including skin, oral cavities, and open wounds.
• Chemical Disinfectant—A chemical agent used on inanimate surfaces and objects to destroy infectious fungi, viruses, and bacteria, but not necessarily their spores. Sporicidal and antiviral agents are considered a special class of disinfectants.
• Cleaning Agent—An agent for the removal from facility and equipment surfaces of product residues that may inactivate sanitizing agents or harbor microorganisms.
• Decontamination—The removal of microorganisms by disinfection or sterilization.
• Disinfectant—A chemical or physical agent that destroys or removes vegetative forms of harmful microorganisms when applied to a surface. Disinfectants are often categorized as high-level, intermediate-level, and low-level by medically oriented groups based on their efficacy against various microorganisms.
• Sanitizing Agent—An agent for reducing, on inanimate surfaces, the number of all forms of microbial life including fungi, viruses, and bacteria.
• Sporicidal Agent—An agent that destroys bacterial and fungal spores when used in sufficient concentration for a specified contact time. It is expected to kill all vegetative microorganisms.
• Sterilant—An agent that destroys all forms of microbial life including fungi, viruses, and all forms of bacteria and their spores. Sterilants are liquid or vapor-phase agents. Microorganisms differ greatly in their resistance to disinfection agents.

Source: USP 1072 DISINFECTANTS AND ANTISEPTICS