ABSTRACT
A contamination control program that has identified the necessity of an environmental monitoring program and how it should be implemented. Today, many regulatory documents expect that passive air sampling will be conducted. Some even believe that these samples are the best indicator of what is happening in the environment, as it mimics how contamination may “fall onto” the product. The situation is complicated by the fact that there are very few regulatory requirements for environmental monitoring. In most cases, the regulations cited for issues with environmental monitoring is 21CFR 211.113 “Control of microbiological contamination.” Due to these types of issues, it becomes critical that the subject matter experts at your site clearly know the regulations and can accurately and clearly explain these differences in requirements. Microbiological methods specifically for collection of samples from: water, air, compressed gases, surfaces, personnel, and clean steam as appropriate.
