N1b: Validating Ventilated Balance Enclosure Containment Performance

Ernest N. Morial New Orleans Convention Center 

In an era of increasingly potent compounds and leaner lab operations, can your engineering controls keep up? This presentation dives into a real-world containment validation study conducted in a high-throughput pharmaceutical contract research lab-where hundreds of analysts rely on ventilated balance enclosures (VBEs) to safely handle active pharmaceutical ingredients.

Using a task-based study design with a surrogate compound and multiple operators, the team assessed airborne exposure under realistic lab conditions. The findings show statistically significant variability in exposure by operator and day, but all results remained well below the occupational exposure limit.

Learn how rules based performance criteria from ISPE were applied to confidently validate containment without relying on time weighted averages or excessive conservatism. If you're facing questions about PPE policy, engineering control effectiveness, or how to balance compliance with practical lab realities, this presentation will give you data-driven answers-and a blueprint for how to do it yourself.

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Aerosol and airborne particulate monitoring

Exposure Assessment

Labs – Health & Safety, Testing

Risk assessment and management

Ventilation