Smoke studies and airflow visualisation.
Dynamic and at-rest airflow visualisation studies for sterile manufacturing environments — supporting EU GMP Annex 1, FDA and ISO 14644-3 qualification requirements.
Cleanrooms & Suites
Unidirectional and turbulent airflow visualisation across ISO 5 to ISO 8 production environments.
Isolators & RABS
Dynamic smoke studies inside isolators, cRABS and oRABS during representative interventions.
LAF & Filling Lines
Laminar flow integrity verification at the point of fill, capping and stoppering.
Critical Interventions
Visualisation of operator interventions, glove port use and tool transfers within Grade A.
A defensible evidence package for your qualification file.
Each smoke study is executed under an approved protocol with documented acceptance criteria. Output is structured for direct inclusion in IQ/OQ/PQ packages and Annex 1 contamination control strategies.
- High-definition video documentation of each test scenario
- Smoke generator selection appropriate to the room class (DEHS / glycol / dry ice)
- Test protocol aligned with EU GMP Annex 1 and ISO 14644-3
- Photographic and time-stamped evidence package
- Written assessment of unidirectional flow integrity
- Recommendations for airflow remediation where applicable
Plan your next smoke study campaign
Share your room layout, equipment schedule and target dates — we will scope the protocol and execution window.