Cleanroom Airflow Testing and Visualization
We perform airflow visualization studies and cleanroom airflow testing in line with ISO 14644 airflow visualization standards. These studies ensure contamination control and regulatory compliance in critical environments.
Comprehensive Airflow Visualization Studies
We assess airflow in cleanrooms, barrier systems, and classified interfaces such as Grade A/ISO Class 5 and Grade B/ISO Class 7. These studies verify contamination control effectiveness and provide documented evidence of GMP compliance.
Advanced Visualization with Neutrally Buoyant Tracers
Using tracers compliant with ISO 14644-3:2005, we evaluate airflow direction, turbulence, and recovery patterns. This identifies potential cross-contamination risks that are not detectable through routine environmental monitoring.
Professional Video Recording and Documentation
We capture high-quality video evidence of airflow patterns and supplement it with detailed reports. Documentation is structured to withstand FDA, EMA, and MHRA inspections and integrates into your contamination control strategy.
1. Planning & Alignment
We define study objectives, risk points, and acceptance criteria in line with ISO 14644 and GMP requirements.
2. Validation
Airflow direction, turbulence, and recovery are documented to confirm contamination control effectiveness.
3. Documentation
The reports include a concise summary of study results, documented video evidence of observed airflow patterns
4. Regulatory Readiness
The packages are structured to withstand review by regulatory agencies and support inspection readiness
Our Process
See Our Approach to Airflow Visualization and Regulatory Compliance
Why Partner with SOKOL GxP Services?
100+ validation and airflow visualization projects completed
Documentation aligned with FDA and Annex 1 expectations
Member of Life Sciences Pennsylvania (LSPA)
Experienced in pharma, biotech, and life sciences facilities
1. Planning & Alignment
We define study objectives, risk points, and acceptance criteria in line with ISO 14644 and GMP requirements.
2. Commissioning
Visualization and video capture equipment are prepared and calibrated to ensure reliable results.
3. Risk Assessment
Visualization and video capture equipment are prepared and calibrated to ensure reliable results.
4. Qualification (IQ/OQ/PQ)
Visualization protocols are executed under at-rest and operational conditions, simulating interventions and disturbances.
Our Process
