Definition of "sterile" in aseptic packaging
Aseptic packaging refers to a package that does not contain live microorganisms. When providing aseptic packaging, microbial contamination should be reduced to a minimum. However, in actual situations, even in accordance with the requirements of the packaging quality system, the packaging produced under standard manufacturing conditions may have a small amount of microbial contamination. Such packaging does not achieve pure sterility, and only after sterilization can the microbial contamination be completely eliminated and the sterilized packaging turned into aseptic packaging.
The sterilizing kinetics of microorganisms remaining on sterile packaging using physical methods or chemicals can often be illustrated by an exponential relationship between the number of viable microorganisms and the degree of sterilization treatment. This also means that, regardless of the degree of sterilization, microorganisms will always survive with a limited probability. For an applied sterilization process, the probability of microbial survival is determined by the number of microorganisms, resistance, and the environment in which the microorganisms are present during processing. It can be seen that the sterility of any of the sterilized packaging of one of the aseptic packages is not guaranteed, but the sterility of the sterile packaging can be determined based on the probability of the microorganisms surviving on product status.