Environmental monitoring is a critical part of the sterility assurance of drug products. It is a highly regulated field, especially in viable air monitoring.
Regulations create a dilemma for the manufacturer as they require frequent/continuous monitoring to take place as close as possible to critical control points without adding any risk to the final product or the test itself. 1
Current sampling methods do not have the capability to fulfill all regulatory requirements. They either provide a snapshot of the manufacturing process, or impose a risk to the process through frequent handling interference when performed close to sampling points identified by risk assessment.
The concept of continuous monitoring, now a worldwide-accepted standard for non-viable particle testing, should be transferred to viable air monitoring to improve monitoring effectiveness while removing most handling interference.