Monitoring of a cleanroom must to be done to meet regulatory requirements for both nonviable and viable particles. There are many ways to contaminate a cleanroom, such as outside contamination, manufacturing failures, and even human contaminations. Total particle contamination is a mixture of nonviable and viable particles. Generally, nonviable particles are monitored continuously, whereas viable particles are monitored on a less frequent basis. In modern aseptic manufacturing, both types should be sampled continuously in order to obtain the most accurate data and to monitor a cleanroom’s condition. An ideal monitoring program provides the sampling data required and ensures data integrity with the use of an automated system to track any changes. The system used to track and record data must also meet certain requirements, i.e. personnel ID and change details. These actions meet the requirements of 21 CFR Part 11 and should be incorporated into any automated Environmental Monitoring System.
Learning Objectives
1. What are the key regulations related to an Environmental Monitoring System
2. How to incorporate particle and microbial sensors into an Environmental Monitoring System
3. They types of data and reports that should be expected from an Environmental Monitoring System.
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