This booklet was excerpted from
Environmental Monitoring: A Comprehensive Handbook, Volume 2, edited by Jeanne
Environmental Monitoring for Sterilization Process Development
Manufacturing of pharmaceutical products and sterile medical devices requires
an environment in which the number of viable particles is controlled, and which
is constructed and used in a manner to minimize the introduction, generation
and retention of such particles. An understanding of the viable microorganisms
on a finished device is necessary and required to support a sterilization validation
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