The differences between sterile and aseptic technique are easily misunderstood, and sometimes used interchangeably. The key distinction between the two is essential for favorable outcomes during pharmaceutical and cleanroom operations. Certain pharmaceutical products must be sterile, including injections, ophthalmic preparations, irrigation solution, and haemodialysis solutions (WHO – 2009)
Is a Cleanroom Sterile?
The answer to this question requires an exacting and quantifiable measurement of microbial contaminants. Our ability to measure contaminants is only as meaningful as our ability to detect them. Given the limitations of sampling equipment, a lack of precision of counting methods and sampling volumes do not provide quantitative information regarding the assurance of sterility.
Human operators are by far the greatest perpetrators of introducing microbes to sterile products or surfaces. Proper gowning, training, and cleanroom practices provide a platform for cleanroom asepsis and sterility, but still cannot guarantee the final outcome.
The objective of aseptic processing is to maintain the sterility of product during the handling or preparation process. Therefore, aseptic processing doesn’t generate sterile outcomes from non-sterile products, it only maintains sterility throughout the manufacturing, packaging, or compounding process.
What is the Definition of Sterile?
Sterile conditions require the complete absence of microorganisms including bacteria, fungus, and their spores. For cleanroom applications, that means that a 70% IPA solution doesn’t kill bacterial or fungal spores, and therefore not an effective remedy.
What is the Definition of Aseptic?
Sterile conditions require the complete absence of microorganisms including bacteria, fungus, and their spores. For cleanroom applications, that means that a 70% IPA solution doesn’t kill bacterial or fungal spores, and therefore not an effective rememdy.
Key Definitions and Differences between Sanitization and Disinfection
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.
Cleaning Agent—An agent for the removal from facility and equipment surfaces of product residues that may inactivate sanitizing agents or harbor microorganisms.
Disinfectant—A chemical or physical agent that destroys or removes vegetative forms of harmful microorganisms when applied to a surface.
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.