We could write a separate guidance document just on environmental monitoring. The locations
where monitoring will be performed should be defined; the action and alert limits need to be
established; and monitoring should be performed using varying frequencies depending on the
level of control necessary for a particular manufacturing area. The need for environmental
monitoring doesn’t necessarily rise to the level of the aseptic processing area where you’d be
monitoring every fill, but certainly there should be some correlation between the activities in the
room and the environmental monitoring. That is, you would want it to be active monitoring. The
level of control, whether you’re talking about a class 10,000 or a class 100,000 room, is really
going to depend on the type of process you’ve got, the types of equipment and systems that are
used. Are you talking about an open system? Are you talking about a closed system? What is the
impact of the environment in the process? How robust is the process? And how many
manipulations are you talking about within the defined area? There are a lot of things that factor
into that. It’s going to be difficult to define it for all cases. Typically, a fermenter is going to be
placed in either a controlled environment or it’s going to placed in a Class 100,000 area. Typical
process areas range from Class 100,000 to Class 10,000. So again, it’s not quite the same level
of control that you would see for an aseptic fill.
If you’re able to complete the vast majority of your batches without contamination due to
environmental organisms, it’s pretty good evidence that whatever your system is adequate, but if
you’re losing a substantial fraction of your batches to environmental contaminants, than you
probably need to be doing more than you’re doing.
