Regulatory basis
Required by the FDA (21 CFR), the EMA and EU GMP Annex 1
Fog medium
Di-fog from distilled water or WFI – residue-free and thermally inactive
Areas of application
Cleanrooms, isolators, RABS, safety cabinets, laminar flow units
Deliverable
A complete Navigator – video documentation including script and evaluation
What is an airflow visualization?
An airflow visualization makes air currents in pharmaceutical production rooms visible using a special di-fog. The fog follows the airflow exactly and allows the flow behaviour at critical points of the equipment to be documented on video without gaps.
Why are airflow visualizations mandatory?
For the aseptic manufacture of medicinal products, evidence of a unidirectional, laminar airflow is a legal requirement. The FDA (21 CFR Part 211), the EMA and EU GMP Annex 1 all require documented visualization of the airflow – particularly in critical zones where the product is exposed.
Without this documentation, approvals and audits in aseptic production are generally not possible.
Our approach
1. Script
Together with your QA team we draw up a precise script defining all points to be visualised, the operating states and the camera positions. The script also serves as a review document for auditors.
2. Execution
The airflow visualization is carried out under real production conditions. Our di-fog is at room temperature and therefore prevents flow distortion caused by thermal effects. No particle residue, no impact on your aseptic zone.
3. Navigator (documentation)
As the final document we prepare a complete Navigator: annotated video material, measurement records and an evaluation that can be transferred directly into your QMS.
Technical properties of the fog
- Residue-free – no particle contamination after the visualization
- Thermally inactive – no flow distortion through heat convection
- WFI based – produced from distilled water or Water for Injection
- Room temperature – prevents falsification of the flow pattern