Q PTE: What sort of environmental monitoring program need to be used in aseptic processing?
O'Connor: The goal of an environmental monitoring program is to provide meaningful information on the quality of the aseptic processing.
Typical controls are for airborne particles and nonviable contaminant monitoring (i.e., to analyse the amount of microbes
in the room). Viable contaminant monitoring of surfaces involves touching surfaces with agar plates. Viable monitoring of
personnel and temperature–humidity monitoring are also typical controls to have in place.
Environmental monitoring must be done across all processing shifts (i.e., day and night). All floors, walls and equipment
surfaces need to be tested. The location of the surfaces to be sampled, and the timing and frequency of the sampling, should
be specified in writing, so that it is not just a random process, but rather, a risk-based process. It's also important for
staff to ensure reproducible results.
The heating and ventilation and air conditioning (HVAC) unit should be under control of the building management system. This
system controls the amount of air coming in to the cleanrooms and the differential pressure across the HEPA filters. If any
changes are observed, actions and alerts should be raised to start an investigation and corrective–preventive action plan.