Microbiology Environmental and Sterility Monitoring for Compounding Areas Policy

13 pages. Defines the microbiological service the laboratory provides to sterile compounding, with a nine element service agreement, six sampling methods and their practical pitfalls including disinfectant neutralization, and incubation and reading rules. Covers alert and action level responses, identification of recoveries by source type, personnel monitoring, sterility testing with growth promotion and method suitability, process simulation support, trend reporting and a nine step exceedance investigation