Decontamination of advanced aseptic processing environments
2016
INTRODUCTION
The control of microbial contamination is a critical requirement for environments used in aseptic
processing. The first inclination of many practitioners (and unfortunately many regulators) is
to seek sterility for that environment as that would seemingly assure the greatest potential for
success. Expectations for sterility (or near sterility) of the environment are implied by statements
found in US Food and Drug Administration’s (FDA’s) latest aseptic processing guidance (1).
That guidance document includes such statements as:“Samples from Class 100 (ISO 5) environments should normally yield no microbiological contaminants.”
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