Cleanroom Rebuild: The Next Chapter Environmental Monitoring Performance Qualification (EMPQ) AB Biotechnology

Introduction

Following the completion of AB Biotechnology’s cleanroom rebuild and the subsequent installation and qualification of equipment in April, the next critical milestone was the execution of the Environmental Monitoring Performance Qualification (EMPQ). Establishing and qualifying a robust environmental monitoring program is essential when commissioning a new manufacturing facility. The EMPQ provides the data needed to confirm that key systems—such as HVAC performance, cleanroom layout, cleaning and disinfection procedures, personnel gowning, product and personnel flow, and equipment operation—function cohesively to maintain the required environmental conditions. Demonstrating consistent environmental control is a major factor in ensuring reproducible product quality and regulatory compliance.
 

EMPQ Design and Risk-Based Approach

The EMPQ protocol was developed using a risk-based methodology to ensure a scientifically sound and efficient qualification process. The cleanroom was divided into a grid layout, with each section assessed against defined criteria including cleanability, personnel presence, material flow, open product handling, operational complexity and room classification. Each grid point was assigned a risk score, which was then used to determine the appropriate monitoring locations, sampling methods, and monitoring frequency. This structured approach allowed for targeted data collection, ensuring that the highest-risk areas received the most attention while maintaining overall representativeness across the facility.
 

EMPQ Execution

The qualification protocol was executed in three phases:

Phase 1 – Baseline Monitoring was conducted to identify indigenous microorganisms present within the cleanroom prior to formal disinfection activities. This phase provided valuable information on the natural microbiological background and served as a baseline for evaluating the effectiveness of subsequent cleaning procedures. 

Phase 2 – At-Rest Monitoring verified that the cleanroom could maintain required environmental conditions in the “at-rest” state—systems running, but no personnel or operations present. This phase confirmed that HVAC system, HEPA filtration and cleaning / disinfection were sufficient to meet the necessary specifications. 

Phase 3 – In-Operation Monitoring was performed during simulated and actual manufacturing conditions to assess the impact of personnel activity, equipment operation and process flow on environmental cleanliness. This phase provided the most realistic assessment of the cleanroom’s performance under routine working conditions and confirmed that the environment remained within established microbiological and particulate limits.
 

 
Supporting Validation Activities 

In parallel with these three phases, additional supporting activities were performed. The cleanroom’s required personnel capacity was confirmed in line with environmental control. The disinfection procedure for incoming consumables was re-validated to ensure the transfer practices prevented contamination ingress. Extensive microbiological speciation was performed on isolates from the monitoring activity to establish any changes in the microbial flora and provide a reference for future monitoring. 

Conclusion

The EMPQ results demonstrated that the cleanroom systems functioned as intended. The risk-based approach proved both practical and economical, enabling targeted monitoring of high-risk areas without compromising overall coverage. Microbiological data indicates a stable and controlled environment under both static and operational states. These outcomes verify that the cleanroom operates in compliance with defined environmental standards, giving a solid foundation to continue into manufacture and further develop the environmental monitoring program.
 

Please get in contact if you would like to see how we can support your projects.
enquiries@abbiotechnology.com