The Critical Moment Your Cleanroom Can Fail And How We Make Sure It Doesn’t

The Hidden Risk in Biosafety Cabinets

Airborne contamination is a persistent threat in pharmaceutical manufacturing and sterile compounding. The presence of particles can critically compromise product sterility, cause costly recalls, and threaten patient safety.

While cleanrooms are designed to control contamination, equipment inside them can sometimes impose a hidden source of risk. A critical vulnerability occurs during the routine operation of biosafety cabinets when the sash window is moved.

This seemingly small action may disrupt airflow and can release particles into the surrounding cleanroom. Most cabinets are certified only under static conditions, but real-world use is dynamic. Without proper verification under actual operating conditions, this risk remains unaddressed.

Independent Testing That Matters

To address this, Esco’s LA2 G-Series G4 Class II Biological Safety Cabinet has been independently tested by TÜV, following ISO 14644-1:2015 for cleanrooms and ISO 14644-14:2016 for equipment suitability.

Testing explicitly included particle emission measurements during both idle operation and sash movement. The tested unit represents the LA2 G G4 model variations, which share identical components—including filters, glass, stainless steel, electro-galvanized steel, motor, blower, and power supply—thereby ensuring consistent passing results across the full range of Esco Class II Biological Safety Cabinets.

Results That Raise the Industry Standard

Test results showed no detectable particle spikes for particles ≥0.5 μm or ≥5.0 μm during any test phase. The cabinet is compatible with ISO Class 4 cleanroom classification both while idle and during sash movement. For facilities regulated under USP <797> and <800>, this means reduced contamination risk, audit-ready assurance, and continuous protection for operators, products, and environments.

ISO 14644-1:2015 restricts particles to a maximum of 352 per cubic meter at ≥0.5 μm in Class 4 environments. Maintaining this during sash movement is a significant achievement.

Raising the Bar for Cleanroom Protection

TÜV verified LA2 G-Series Class II Biosafety Cabinet sets a new industry benchmark. It delivers proven, repeatable ISO 4 protection in both static and dynamic conditions, including the critical sash movement phase.

For pharmaceutical manufacturers and sterile compounding facilities seeking reliable contamination control, the LA2 G-Series offers unmatched assurance and compliance confidence. The cleanroom standard has been raised, and Esco is proud to be the first to prove it.