LAMINAR AIR FLOW HOOD VALIDATION SERVICES

LAMINAR AIR FLOW HOOD VALIDATION SERVICES

Aero Biotech offers comprehensive, certification and maintenance of unidirectional flow devices (also known as laminar flow hoods or clean benches). Our skilled technicians are authorized to perform warranty repairs for all major equipment manufacturers. All unidirectional flow device testing is performed in accordance with established Aero Biotech SOPs, which we update to remain compliant with applicable local, federal and international certification requirements, current good manufacturing practices [cGMPs], and our own ISO 9001-certified quality system. Clean bench testing and certification is performed in accordance with applicable guidelines from IEST, ISO, and manufacturers' specifications.

Primary tests performed include:

• HEPA filter integrity testing - documents leakage or defects and demonstrates that no contamination will enter the work area through the supply filter.
• Airflow velocity profile – documents airflow uniformity and demonstrates that the unit is operating at a sufficient velocity
• Non-viable particle counting – performed in accordance with ISO 14644-1 or EU Annex 1 and reports the amount of particulate, if any, within the work zone

Optional tests include:

• Airflow smoke pattern testing – airflow patterns are observed using a neutrally buoyant visible medium to verify unidirectional airflow and to ensure lower quality air does not enter the unit.
• Light testing – ensures fluorescent lighting levels are sufficient to prevent operator fatigue and ensures UV lighting is operating adequately
• Vibration testing – ensures product is not subject to damage due to vibration
• Sound testing – verifies hood operation/usage will not contribute to worker fatigue