Cleanroom re-qualification (IQ/OQ/PQ)

The work followed a scheduled upgrade to the air-handling systems serving the sterile injectables suite and the adjoining oral-solids areas. Because changes to HVAC and to classified environments are managed under formal change control, the affected rooms were taken through a structured re-qualification rather than a simple restart, so that the state of control could be demonstrated on documented evidence rather than assumed.

“Re-qualification lets us show, on documented evidence, that our classified areas and their HVAC remain in a demonstrable state of control after every planned change.”

Re-qualification followed the established three-stage sequence. Installation Qualification (IQ) confirmed that filters, air-handling units, ducting, instrumentation and control set-points were installed and identified as specified. Operational Qualification (OQ) verified that airflow velocities, air-change rates, room pressure cascades, temperature and relative humidity, and cleanroom recovery times held within their defined limits across the normal operating ranges. Performance Qualification (PQ) then demonstrated sustained compliance over repeated runs under conditions representative of routine manufacturing.

Grading was reconfirmed against the EU/WHO GMP classification scheme, with critical filling zones held to Grade A on unidirectional airflow and the surrounding areas graded B to D as appropriate, and mapped to the corresponding ISO 14644 particle classes. Non-viable particle counts, viable environmental monitoring, airflow-visualisation studies and recovery testing were assessed in the at-rest and in-operation states, with each result recorded against pre-agreed acceptance criteria. All data were captured under ALCOA+ principles to preserve traceability.

The practical benefit is a documented return to a qualified state for the upgraded areas, supporting reliable environmental control for sterile and non-sterile production alike. With the qualification package reviewed and approved, the affected lines are available for routine manufacturing under the site's Pharmaceutical Quality System, and the re-qualification records feed the ongoing monitoring and periodic review that keep the classified areas in a demonstrable state of control.