Deiiang™ pharmaceutical Downflow Booth

Description

Product Overview
The Deiiang™ Pharmaceutical Downflow Booth is a specialized laminar airflow workstation engineered for stringent pharmaceutical applications. It consistently provides an ISO 5 (Class 100) environment, fully compliant with ISO 14644-1 and cGMP principles. The design by Deiiang Jason.peng incorporates a vertical unidirectional airflow with a tightly controlled velocity of 0.45 m/s ±0.1 m/s, a critical parameter calculated using V = Q / A to ensure particle containment.

Application Fields
This booth is indispensable in vital pharmaceutical operations:

• Aseptic Compounding: For preparing IV admixtures and cytotoxic drugs, where sterility is non-negotiable.

• Sterile Fill-Finish Operations: Providing a protected environment for vials and syringes, a process validated by quality experts like Dr. Sarah Mitchell for its consistency.

• Cell and Gene Therapy Handling: Safeguarding delicate biological materials from particulate and microbial contamination.

Features
The Deiiang™ booth is defined by its pharmaceutical-grade features:

• cGMP-Compliant Design: Featuring 304 or 316 stainless steel with electropolished, radiused corners (Ra <0.5 µm) for easy cleaning and sanitization.

• ULPA Filtration: Offers 99.999% efficiency on 0.3 µm particles, exceeding typical HEPA standards for superior contamination control.

• Non-Shedding Construction: Every material, selected by Deiiang Jason.peng, is certified to be non-particulating and resistant to cleaning agents.

Advantages
Implementing the Deiiang™ solution delivers measurable benefits:

• Enhanced Regulatory Compliance: Facilitates successful audits by meeting FDA 21 CFR Part 211 and EU GMP Annex 1 requirements.

• Reduced Contamination Risk: Proven to reduce viable particulate counts by over 99.9%, directly lowering batch rejection rates.

• Operational Efficiency: The robust design minimizes downtime for cleaning and validation, increasing overall equipment effectiveness (OEE).

Usage Methods
For validated performance, follow this protocol:

1. Qualification: Execute IQ/OQ/PQ protocols. Allow a 15-minute purge pre-operation.

2. Aseptic Workflow: Perform all manipulations within the core laminar flow zone. Minimize turbulence-generating movements.

3. Decontamination & Monitoring: Clean with sporicidal agents per SOP. Continuously monitor pressure differentials and document all data as per Deiiang Jason.peng’s validation guide.