Environmental Monitoring: A Comprehensive Handbook, Volume II

Environmental monitoring programs are appropriate for manufacturing of sterile products and non-sterile products. The most stringent application of these procedures is for sterile products manufactured by aseptic processing, while less stringent procedures may be appropriately employed for terminally sterilized products, and even less stringent procedures for non-sterile products. Volume 2 covers: Establishing Ongoing Monitoring, Surveillance and Evaluation Programs, Establishing Alert and Action Levels: The Analysis of Environmental Monitoring Data, Trending Data/Reporting Data, Environmental Monitoring Investigations, Change Control and Preventative Maintenance, Typical Procedures Required for an Environmental Control Program, What is Required Following Remodeling, Environmental Monitoring in Non-Sterile Product Manufacturing, Introduction to Rapid Microbial Methods for Environmental Monitoring, and Rapid Methods for Water Monitoring