BioPharm: What sort of environmental monitoring program needs 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 analyze 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.
ANALYTICS AND TESTING
BioPharm: Various analytics and testing are involved in aseptic processing, including sampling, validation, and identification. Can
you talk about some of the major considerations manufacturers need to keep in mind for this part of aseptic processing?
O'Connor: Sampling is an important part that involves testing to determine whether your process is in control throughout manufacturing.
Before approving a process, it must be validated, which requires an extensive battery of tests on the product, including characterization,
identification, and contamination minimization. One key factor for taking samples of biologics is to ensure that the product
is not contaminated while samples are taken, which could lead to false positives.
Samples are also taken after the product has been sterile-filtered for sterility testing. If the product does not pass sterility
test, it will be a failed batch and will be rejected.