Smoke Studies
What are Smoke Studies?
Smoke Studies are a key tool for validation of sterile processes. Through visualisation of the air flows and their interaction with operatives and materials, it is possible to objectively document compliance with GMP guidelines and identify any critical issues which could compromise production quality.
Smoke Studies
The four phases specified by the standard
Phase 1
As Built
Inspection of the conditions of the system when installed but not yet started up.
Phase 2
At Rest
Analysis of the air flows with machinery active but at rest.
Phase 3
Dynamic at rest
Analysis of the system in operation, but with operators not present
Phase 4
In operation
Analysis of the air flows with operators present and working on the production line
Smoke Studies
The updated Annex 1 to EU-GMP (2022)
The most recent update to the European guidelines introduced more stringent requirements for visual documentation in sterile settings: a change which reinforced the core importance of our work, reaffirming its technical reliability and methodological rigour. Air flow visualisation studies are now no longer simply good practice, but are considered a formal tool for demonstrating the robustness of the process conditions. More specifically, the update to Annex 1:
- Introduces the requirement to carry out airflow visualisation studies in both static and dynamic conditions in order to assess stability
- Requires that these studies be documented through video recordings, also demonstrating the activities of the operatives and interactions with equipment and materials
- Encourages the use of multiple video cameras and different filming points in order to obtain a complete and reliable assessment of the critical points of the process.
Smoke Studies
Operational Method and Multi-Camera System
In order to guarantee the clarity and reliability of the footage, ZeroFrame uses water-based (WFI) foggers, contrasting backgrounds to increase the visibility of the smoke traces, and synchronised multi-camera systems. All filming is planned on the basis of the critical areas of the process: the result is clear video evidence which can be used directly in audits or inspections.
