What is the difference between the term “aseptic” and the term “sterile” as it relates to connections?
By Webster’s definition, the terms are synonymous, meaning free from microorganisms. By application, we use the term “aseptic” to describe a process or technique that is designed to prevent the access of microorganisms and the term “sterile” to refer to a validated process or technique that has successfully passed a microbial challenge with the appropriate indicator organism at the appropriate concentration of Colony Forming Units (CFU). The sterility assurance level of most sterilization technologies, Gamma, E-beam, ETO, Autoclave, is 1×106 CFU; that is, the biological indicator strips of each indicator organism has that level of bacteria loading. The above discussion relates to connections in the following way: processes, devices or techniques that are not or cannot be appropriately or reasonably challenged using a microbial agent are considered “aseptic.” Open connections that take place in a clean room or at a clean bench usually fall into this category. Processes, devices, or tech
