An Important Component of an Environmental Monitoring Program in a Pharmaceutical Manufacturing Environment (243)
A large proportion of products labeled as sterile are manufactured by aseptic processing rather than terminal sterilization. Because aseptic processing relies on the exclusion of microorganisms from the process stream and the prevention of microorganisms from entering open containers during processing, product bioburden as well as the bioburden of the manufacturing environment are important factors governing the risk of unacceptable microbial contamination. The terms aseptic and sterile are not synonymous. “Sterile” is a medieval word derived from the Latin sterilis (unfruitful), meaning, in modern terms, free from living germs or viable microorganisms that have the potential to reproduce. In contemporary aseptic healthcare product manufacturing, “aseptic” describes the process for handling sterilized materials in a controlled environment designed to maintain microbial contamination at levels known to present minimal risk.1 Therefore, the importance of adequate and effective microbiological controls cannot be overstated enough.
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