In pharmaceutical there is confusion between the term Sterile and Aseptic. Sometimes these two terms used interchangeably. For example in case of environment classification some people might say sterile area and some use the term aseptic area. There is difference between these two terms.
What is the difference?
Sterile means any article, object, surface which is freed from all types of microbial contamination is called sterile. Sterile means complete absence of microorganisms (bacteria, fungus and their spores etc.).
Aseptic means free from pathogenic microorganisms. It means when we call anything aseptic it means that it is free from pathogenic microorganisms but it doesn’t mean that microbes are not present there. Microorganisms are present there but, they are not pathogenic means they are not disease forming.
So, this is the basic difference between both terms. If we talk about classification of area where sterile product are being manufactured it is better to say aseptic area not sterile area. Even in pharmacopoeias and guidelines the microbial limit of A class area which is the critical and most clean area for sterile product manufacturing is <1 cfu. But we can’t consider it sterile. That’s why there is always a threat of sterile product contamination in aseptic area if proper practices are not followed.