ABSTRACT
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.”
