Airflow Visualization (Smoke Studies)
Visualizing Airflow. Ensuring Product Protection.
Airflow Visualization Studies (Smoke Studies) are performed to demonstrate and document airflow patterns within cleanrooms, Laminar Air Flow (LAF) units, Biosafety Cabinets (BSCs), Restricted Access Barrier Systems (RABS), Isolators, filling lines, and other critical processing areas.
These studies verify that clean airflow effectively protects critical product exposure points, prevents contamination, and supports compliance with current regulatory requirements including EU GMP Annex 1, FDA, WHO, and ISO standards.
What We Do for You
Regulatory Compliance
Airflow visualization studies aligned with:
- EU GMP Annex 1
- FDA Guidance on Sterile Drug Products
- WHO GMP
- ISO 14644
- ASTM E3379-25
- CETA CAG-014
Risk-Based Assessment
- Evaluation of airflow patterns in critical and non-critical zones
- Identification of turbulence, dead zones, and reflux risks
- Assessment under static, dynamic, and worst-case conditions
Inspection Readiness
- High-quality video evidence suitable for regulatory inspections
- Clear, traceable study protocols and reports (On Demand)
- Support during regulatory and customer audits and for mitigation of observation
Our Capabilities
- Static and Dynamic Smoke Studies
- Aseptic Process Simulation Support
- Unidirectional Airflow Verification
- First Air Assessment
- Operator Intervention Studies
- Airflow Recovery Studies
- HVAC Airflow Pattern Evaluation
- Video Recording with High-Definition Documentation
- Regulatory-Compliant Reporting
Our Core Validation Services
We perform airflow visualization studies for a wide range of regulated environments using Neutrally buoyant smoke fog generation and Professional Multi-Angle Videography.
Areas Covered Include:
- Cleanrooms (Grades A, B, C, D)
- Aseptic filling lines
- Isolators and RABS
- LAF units and biosafety cabinets
- Weighing booths and dispensing areas
- Sterilization and material transfer zones
Study Capabilities:
- Neutrally buoyant smoke generation compliant with cleanroom use
- Multi-angle videography
- Static and dynamic condition assessment
- Simulation of routine and worst-case operations
- Operator intervention and equipment movement studies
Airflow Visualization Scope Includes
- Study planning and protocol preparation (On Demand)
- Identification of critical airflow zones
- Smoke visualization under defined conditions
- Multi-angle video recording and documentation
- Assessment of airflow direction, velocity behavior, and recovery
- Identification of turbulence, stagnation, and cross-contamination risks
- Study report with conclusions and observations (On Demand)
- Support for deviations, CAPA, and remediation activities
Systems, Industries & Complexity We Handle
We support airflow visualization studies for:
- New facilities and cleanroom commissioning
- Existing facilities and routine requalification
- Facility modifications and layout changes
- Equipment installation and upgrades
Where We Perform Studies
Sterile Filling Lines
Vial & Ampoule Filling Machines
PFS Machines
Isolators
RABS
Laminar Air Flow Units
Biosafety Cabinets
Sampling Booths
Dispensing Booths
Weighing Booths
Cleanrooms (Grade A, B, C & D)
Pass Boxes
Why Clients Trust Us
- Strong understanding of cleanroom design and contamination control principles
- Expertise in GMP-compliant airflow visualization and facility qualification
- High-quality neutral fog studies with clear visual evidence
- Practical, inspection-focused documentation
- Collaborative approach with QA, Engineering, HVAC, and Operations teams
Key Deliverables
After completion of the study, You receive:
- 1. Approved Study Protocol
- 2. Smoke Study Video (HD Format)
- 3. Photographic Documentation
- 4. Observation Sheets
- 5. Airflow Assessment Report
- 6. Deviations & Recommendations (if applicable)
- 7. Final Validation Report
Why Choose Cleanstep?
Advance Equipment | Trusted expertise | Proven methodology | Regulatory confidence | Reliable delivery.
- 1. Advanced Visualization Technology with modern kit. Including Microrite Kit, Antari Kit, BI kit
- 2. Regulatory-Compliant Execution
- 3. Comprehensive Reporting & Online Review
- 4. Dedicated Experienced Professionals.
- 5. Delivery of Multiple Projects Simultaneously
Need Regulatory-Compliant Airflow Visualization Studies?
Partner with Cleanstep Pharma and Engineering Solutions for professionally executed smoke studies that help ensure product protection, regulatory compliance, and inspection readiness.
Contact us today to discuss your qualification or requalification requirements
