Cleanroom validation and smoke mapping
At Agidens, we support pharmaceutical and biotech companies with high-quality cleanroom validation, always in compliance with GMP, GLP and ISO standards. An essential part of this are our smoke studies: tests that make airflow visible in critical areas such as biosafety cabinets, LAF units, isolators and entire cleanrooms.
Realistic smoke tests, in line with the strictest standards
Our smoke mappings are carried out under dynamic conditions, as required by CGMP and USP <797>. This means:
- All relevant equipment is present
- The maximum number of operators is simulated
- All aseptic operations are simulated
This shows that airflows are unidirectional, stable and free from turbulence, which is an absolute requirement for sterile production.
Two types of smoke, always safe and targeted
Depending on the application, we deliberately choose the most suitable type of smoke:
WFI-based smoke:
Ultra-pure, non-contaminating and completely safe in GMP environments. Ideal for aseptic areas where product contact is possible.
Glycol-based smoke:
Stable and long-lasting, ideal for complex airflow analyses or large cleanrooms.
Both smoke types are applied exclusively in accordance with the highest safety and quality standards.
Convincing visuals
What sets us apart is the way we document our smoke mappings. We provide synchronously recorded video footage from 2 to 4 angles, clearly presented and ready for use in qualification dossiers or audits.
As the FDA itself states: “A video is worth more than a thousand pictures: it enables auditors to assess airflows and aseptic operations themselves.”
Why smoke studies are essential
Smoke mappings provide crucial insights into particle control and airflow dynamics. They are essential to demonstrate to auditors that processes comply with the strictest standards.
- FDA audits show that many deficiencies are due to:
- No testing under operational conditions
- Insufficient visualization of interventions
- Gaps between HEPA filters and barriers
- Incorrect smoke generation or positioning
With Agidens, you avoid these pitfalls and are assured of an audit-proof result.
Your partner in compliance and quality
Our approach is all about transparency, traceability and reliability. You will receive not only test results but also convincing visual evidence that your processes are robust and compliant. Get in touch and discover how Agidens is your partner in compliance and quality.
