One of the key advantages of using an isolator for an aseptic processing application is that it makes a physical barrier between the operator and the core aseptic processing area. Additional main benefit is that an isolator can be totally sealed before aseptic activity starts, allowing for the exposed interior surfaces within to be bio-decontaminated, typically, via hydrogen peroxide (H2O2) vapour or mist.
When isolators were initially introduced in the pharmaceutical industry, the validation of the bio-decontamination technique was mainly patterned after methodology used for steam sterilizer validation. Biological indicators (BIs), typically containing over one million microbes per sample, were used to challenge the bio-decontamination process.
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