Abstract
A new pharmaceutical aseptic vial filling system has been developed based on isolator technology that is also well suited to use in conventional clean rooms. The results of experiments designed to test the microbiological quality of the environment provided by the new filling system in conjunction with an isolator demonstrate that the isolator enclosed filler can be readily decontaminated and that it can maintain an aseptic environment for at least one month under worse case conditions.
- Aseptic processing
- isolator technology
- air velocity
- particulate air quality
- environmental control
- validation
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