I must establish and implement an environmental monitoring program for our new ISO Class 6 cleanroom that packages medical devices for terminal sterilization by gamma radiation. What do I need to know in order to do this correctly?

While this is a very specific type of facility, the process for developing an environmental monitoring system does not necessarily depend on the class of cleanroom or the type of work conducted. The following offers some steps for establishing a program that would work for most cleanroom situations.

There are several positive advantages of establishing and implementing an environmental monitoring program. An environmental monitoring program can:

• monitor production and laboratory environments,
• evaluate sanitization and disinfection efficacy,
• monitor and qualify cleanroom personnel, and
• validate cleaning processes of and in the cleanroom.

However, the environmental monitoring program is only capable of keeping an eye on what is established, implemented, and maintained.