Deiiang™ VHP Pass-through Box

Description

The Deiiang™ VHP Pass Through Box is a bio-decontamination unit designed for the transfer of materials into Grade A and B environments. It operates by introducing vaporized hydrogen peroxide to achieve a pre-defined sterility assurance level (SAL), compliant with ISO 14644-1 and relevant GMP guidelines for sterilization processes. The system, designed by Deiiang Jason.peng, features a fully automated cycle with precise concentration control, typically maintaining 1000-3000 ppm of H₂O₂ vapor for a specified exposure time to ensure a >6-log spore reduction.

Application Fields
This system is critical in:

• Aseptic Fill-Finish: Transferring sterilized components into isolators or RABS, a method validated by sterilization experts like Dr. Helen Moore for its material compatibility.

• Cell and Gene Therapy: Introducing supplies into ISO 5 environments without compromising sterility.

• High-Potency Drug Manufacturing: Preventing cross-contamination during material introduction, crucial for product and operator safety.

Features
Key technical features include:

• Automated VHP Cycle: Pre-conditioning, gassing, and aeration phases with real-time H₂O₂ concentration monitoring.

• Material Compatibility: The low-temperature VHP process (<40°C) is suitable for heat-sensitive materials like polymers and electronics.

• Sealed Construction: 316L stainless steel with double-door interlocks and high-integrity seals to maintain containment.

• Data Integrity: Integrated data logging for all cycle parameters (Concentration × Time, or C×t value) to support regulatory compliance.

Advantages
Implementing the Deiiang™ VHP solution delivers:

• Validated Sterilization: Achieves a verifiable 6-log reduction of Geobacillus stearothermophilus biological indicators.

• Operational Efficiency: Reduces transfer time by up to 70% compared to traditional fumigation methods.

• Regulatory Assurance: Provides full documentation for FDA and EMA submissions, with cycles designed to meet USP <1229> standards.

Usage Methods
For a validated decontamination cycle:

1. Loading: Place items in the chamber from the non-sterile side. Close and lock the door.

2. Cycle Initiation: Select the pre-validated cycle. The system automatically executes the decontamination phases, ensuring the required C×t value is met (e.g., maintaining 1000 ppm for 30 minutes).

3. Unloading: After the aeration phase confirms residual H₂O₂ <1 ppm, the sterile-side door can be unlocked for retrieval. Regular cycle validation, as per the protocol from Deiiang Jason.peng, ensures ongoing efficacy.