Cleanrooms and clean air devices should be routinely monitored in operation and the monitoring locations based on a formal risk analysis study and the results obtained during the classification of rooms and/or clean air devices. The following are materials that will help ensure compliance for sterile production.

Download the accompanying presentation, "Conducting a Gap Analysis of your Sterile Products," presented at IVT's 2nd Annual Aseptic Processing, Cleaning Validation, and Environmental Monitoring Conference, Amsterdam, Netherlands, October, 2011