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.
Source: USP 1072 DISINFECTANTS AND ANTISEPTICS
Need Help Selecting a Cleanroom Disinfectant?
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.