Pharmaceutical Cleanroom Recommissioning
Supporting GMP Compliance Through Technical Recovery & Recommissioning
A leading pharmaceutical manufacturer required independent technical support following concerns surrounding the performance, commissioning quality, and operational readiness of a newly installed GMP cleanroom facility.
The facility consisted of multiple GMP environments ranging from Grade B to Grade D cleanrooms supported by dedicated air handling and pressure-controlled systems.
Aeris Flow was appointed to independently assess the facility condition, establish a performance baseline, identify critical deficiencies, and implement a structured recommissioning strategy to achieve operational compliance.
Project Highlights
GMP Grade B to Grade D Cleanrooms
- • Recommissioning
- • Airflow balancing
- • Pressure cascade verification
- • HEPA integrity testing
- • GMP performance verification
Pharmaceutical Manufacturing
Establishing Performance & Identifying Critical Deficiencies
Initial evaluations included:
- Airflow performance assessment
- Pressure differential verification
- Pressure cascade evaluation
- Air change rate calculations
- Cleanliness classification testing
- AHU performance assessment
- HEPA filter condition review
- Environmental condition mapping
- Service installation inspections
Critical issues identified:
- Unstable room pressure conditions
- Improperly sealed ceiling systems
- Poorly secured ductwork connections
- Loose balancing dampers
- Significant smoke leakage during HEPA integrity testing
- Inconsistent airflow performance
- Installation defects affecting environmental stability
In several areas, ceiling tiles displaced during door operation due to uncontrolled pressure fluctuations — indicating substantial deficiencies within the airflow balancing and containment strategy.
Comprehensive Rebalancing & System Recovery
Aeris Flow implemented a structured recommissioning programme focused on restoring environmental stability, airflow integrity, and GMP performance compliance.
Corrective actions included:
- Full airflow rebalancing
- Pressure cascade reconfiguration
- Ceiling system resealing
- Ductwork rectification
- Damper inspections and securing
- Verification of terminal HEPA installations
- Environmental performance optimisation
- Independent verification of Magnehelic gauge installations
During terminal HEPA filter integrity testing, significant smoke leakage was identified throughout surrounding warehouse and office areas.
All identified deficiencies were documented, rectified, and independently verified prior to continuation of the recommissioning process.
Independent GMP Performance Verification
Following corrective works and system rebalancing, comprehensive validation testing was completed to confirm that the facility achieved the required operational performance and environmental conditions aligned with GMP expectations.
Testing confirmed that the facility achieved the required operational performance and environmental conditions aligned with GMP expectations.
Restoring Operational Confidence
Through multiple phases of assessment, rectification, recommissioning, and independent verification, the facility was successfully brought into a compliant operational state suitable for pharmaceutical production activities.
The successful recovery of the cleanroom facility established Aeris Flow as an ongoing technical partner for the client. Since project completion, Aeris Flow has continued to provide:
Need Support With Cleanroom Performance or GMP Compliance?
Whether you require recommissioning, airflow troubleshooting, pressure cascade verification, or independent GMP validation support, Aeris Flow provides specialist technical expertise for regulated environments.
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