Venturi-Assisted Horizontal Laminar Extraction Solution

The proposed system introduces continuous, low-velocity horizontal laminar airflow aligned with vial travel direction, creating a controlled pressure gradient across the vial opening.

Key effects:

• Air is actively drawn out of the vial

• Internal air does not stagnate

• Directional airflow is deterministic

• Flow patterns remain consistent in both static and dynamic states

 

Vertical laminar flow remains the dominant protective mechanism from above, while horizontal extraction provides active purge and stability.

System Architecture and Smoke Study Advantage

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Horizontal airflow is delivered through:

• Redundantly HEPA-filtered ducts

• Continuous channels along the open vial path

• Symmetric placement relative to vial centerline

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Critically, the lower horizontal ducts are geometrically aligned with the overhead HEPA laminar airflow field.

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This alignment:

• Converts complex 3D airflow interactions into straight, vertical-to-horizontal flow paths

• Eliminates recirculation pockets commonly observed in traditional systems

• Produces clean, repeatable smoke trajectories

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Critical Needle Zone Gap

A short, controlled interruption in horizontal flow is maintained at the filling needle interface to prevent interaction with the fill stream.

Immediately downstream:

• Horizontal extraction resumes

• Air displaced by filling is captured

• The vial returns to active purge until stoppering

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This transition remains visually and physically stable during smoke visualization.

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Airflow Velocity Targets

Vertical Laminar Flow (ISO 5 Critical Zone):

• Target velocity: 0.45 m/s (90 ft/min)

• Acceptable range: 0.36–0.54 m/s

• Uniformity across diffuser face ±10%

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Horizontal Laminar Extraction:

• Target velocity: 0.15–0.25 m/s (30–50 ft/min)

• Laminar, non-turbulent

• Balanced across opposing ducts

• Maintains controlled pressure gradient without disturbing fill accuracy

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Pressure Differential:

• Horizontal extraction pressure: −5 to −15 Pa relative to vial interior

• No net positive pressure within open vial during filling

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CFD Narrative and Smoke Study Correlation

Computational Fluid Dynamics modeling confirms that the combined airflow configuration produces:

• Straight, unbroken streamlines from overhead HEPA filters into the lower extraction ducts

• No recirculation zones in static or dynamic conditions

• Identical airflow topology whether the line is stopped or running

• Predictable particle trajectories with reduced residence time

• Immediate capture of disturbances downstream of the needle zone

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Because airflow geometry does not materially change between static and operational states, smoke study results directly correlate to production conditions.

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Reduction in Production Delays

This design materially reduces production disruption by:

• Allowing smoke studies to be completed in fewer iterations

• Reducing the need for repeated requalification after minor changes

• Increasing confidence that static studies represent live operation

• Shortening validation windows

• Minimizing extended line shutdowns

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In practice, facilities can expect:

• Faster airflow qualification

• Fewer corrective actions from airflow visualization

• Reduced QA intervention frequency

• Improved inspection readiness

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Thermal and Microbiological Synergy

When combined with reduced sterile room temperatures:

• Laminar flow stability improves

• Smoke visualization clarity increases

• Microbial growth rates decrease

• HVAC energy consumption drops

• Human presence becomes unnecessary in ISO 5 zones

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Robotic systems operate unaffected, further stabilizing airflow behavior.

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Regulatory Positioning

This approach:

• Strengthens contamination control strategy narratives

• Demonstrates engineering-based risk reduction

• Improves reproducibility of airflow visualization

• Aligns static qualification with dynamic reality

• Exceeds baseline Annex 1 expectations without introducing novel risk

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It reframes smoke studies from a recurring production disruption into a repeatable, low-impact validation exercise.

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Strategic Outcome

Traditional laminar systems rely on airflow dilution and probabilistic protection.

This architecture delivers active extraction, deterministic airflow, and validation efficiency.

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The result is:

• Lower contamination risk

• Fewer production delays

• Faster regulatory readiness

• Extended asset usability

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