Cleanroom Disinfectants and Alcohol for Sterile and Non-Sterile Environments
Cleanroom disinfectants are designed to remove potentially harmful microorganisms from surfaces and equipment. Controlled environments used in the manufacturing of pharmaceuticals need to have a defined cleaning and sanitization program. It is critical to prevent the microbial contamination of these articles. When disinfectants are used in a manufacturing environment care should be taken to prevent the drug product from becoming contaminated with chemical disinfectants as a result of the inherited toxicity of the disinfectants. Aseptic processing cleaning requirements include wipeable floors, walls, and ceilings that have smooth and nonporous surfaces; particulate, temperature, and humidity controls; and cleaning and disinfecting procedures to produce and maintain aseptic conditions.
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.
Our selection of sterile and non-sterile disinfectants and IPA are essential for cleanroom contamination control. Selecting the correct cleaning chemicals can be a difficult process because each environment has unique requirements. We work closely with our manufacturers to make selecting the correct cleaning agent hassle-free. Contact us to speak to one of our knowledgeable sales representatives.