Abstract
This article reviews the evolution of performance standards for aseptic processing as defined by regulatory, pharmacopoeial, and industry activities. The increasing rigor of the expectations for sterility testing, environmental monitoring, and process simulation have made for improvements in capability for sterile manufacturing. The document explains why contemporary requirements are such that satisfying them requires a shift in operating practice from manned clean rooms to isolation technology.
- Closed systems
- Aseptic processing
- Isolation technology
- Sterility testing
- Environmental monitoring
- Process simulation
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