GMP Cleanroom Contamination Investigation for Stem Cell Facility
Investigating Persistent Contamination Within a Critical GMP Environment
A leading stem cell processing facility operating within a GMP-controlled cleanroom environment experienced recurring contamination concerns affecting critical operational processes.
Despite extensive cleaning activities, decontamination procedures, and internal precautionary measures, the contamination events continued to occur without a clearly identifiable source.
Aeris Flow was engaged to carry out an independent technical investigation to determine the root cause of the contamination and assess whether hidden environmental or infrastructure-related factors were contributing to the issue.
Project Highlights
GMP Stem Cell Processing Facility
- • Contamination investigation
- • Environmental diagnostics
- • HEPA integrity testing
- • Microbiological monitoring
- • Root cause analysis
- • Technical consultancy
Healthcare & Cell Therapy
Identifying a Hidden Contamination Pathway
Initial environmental investigations:
- Pressure differential verification
- Pressure cascade assessment
- Airflow volume measurements
- Air change rate calculations
- GMP airborne particle classification testing
Compliance verification findings:
- Pressure cascades were stable
- Airflow performance was compliant
- Air change rates were acceptable
- Cleanroom achieved required airborne particle standards
- Contamination issue persisted despite compliant results
Despite pressure cascades being stable and airborne particle counts being fully compliant, the persistent contamination issue continued—indicating a hidden pathway.
Expanding the Investigation Beyond Standard Testing
Technical review identified that the contamination concerns were associated with larger particulate contamination events beyond the primary focus of standard airborne particle classification testing.
Microbiological & environmental monitoring included:
- Active air sampling
- Settle plates
- Contact plates
- Surface swabbing
- Environmental microbiological monitoring
- Identification of elevated contamination findings
- Investigation focus narrowed to local infrastructure
The results identified elevated contamination findings concentrated within one specific cleanroom area, allowing the investigation to narrow focus toward the environmental infrastructure serving that location.
Identifying the Source of Contamination
Aeris Flow subsequently arranged controlled access to the affected area in order to carry out detailed physical and performance checks.
Because the missing component was located behind the terminal diffuser assembly, the issue was not visually obvious during routine operational activities and required specialist technical investigation to identify. The HEPA filters themselves remained fully compliant and undamaged.
Aeris Flow installed a replacement cap, completed integrity verification activities, and advised the client on environmental recovery and controlled cleaning procedures prior to returning the area to service.
During HEPA integrity testing, Aeris Flow identified that the upstream sample port cap on one of the terminal HEPA filter housings was missing, creating an uncontrolled contamination pathway.
Restoring Environmental Confidence & Operational Stability
Following corrective action and environmental recovery procedures, the contamination events ceased and the facility was able to continue operations without recurrence of the previously observed contamination concerns.
The project demonstrated the importance of structured technical investigation and specialist environmental understanding within high-risk GMP environments.
Key Results & Achievements:
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