Aseptic Processing: A Primer - Pharmaceutical Technology

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PharmTech Europe

Aseptic Processing: A Primer
PharmTech speaks to Ray O'Connor from the National Institute for Bioprocessing Research and Training (NIBRT) for an overview of aseptic processing.

Pharmaceutical Technology Europe

Environmental monitoring

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.


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