Environmental Monitoring: A Comprehensive Handbook, Volume I

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 I covers: Practical Issues in Designing and Implementing an Environmental Control Program, Compliance Issues for Environmental Monitoring, Environmental Control Systems used in Parenteral Facilities, Cleanroom Microbiology, Establishing a Disinfection Program, Practical Aspects of Cleaning, Sanitizing and Disinfecting Rooms and Surfaces, Masterplan for Microbiological Monitoring, Cleaning/Sanitization Qualification, Microbiological Risk Analysis, Method Validation, and Validation of Water Systems