VHP通行證箱

1. Product Overview

The VHP Pass Box (Vaporized Hydrogen Peroxide Sterile Pass Box) is a sealed transfer device designed for biological decontamination of material surfaces. Using Vaporized Hydrogen Peroxide (VHP) as the sterilizing agent, it operates at low temperature and atmospheric pressure to achieve high-efficiency surface sterilization. It is ideal for transferring items from low-grade clean areas to high-grade clean areas.

This equipment addresses the inadequate sterilization effectiveness of traditional UV pass boxes, achieving Log6 kill rate (99.9999% sterilization). It is a critical aseptic transfer solution that fully complies with GMP requirements.

2. Working Principle

The core working principle of the VHP Pass Box is based on Flash Evaporation technology, which rapidly converts liquid hydrogen peroxide into hydrogen peroxide vapor for thorough surface sterilization.

The working cycle consists of five stages:

Stage 1: Chamber Leak Detection. Pressurize the chamber to check airtightness; ensure leakage rate ≤0.5%VOL/h at 100Pa before sterilization.

Stage 2: Preheating and Dehumidification. Supply clean, dry air into the chamber to maintain low humidity, optimizing VHP sterilization efficacy.

Stage 3: Sterilization Cycle. Inject hydrogen peroxide vapor, maintain target concentration for 30-60 minutes; verify with chemical and biological indicators.

Stage 4: Residue Removal. Stop VHP input, activate residue removal system; catalytically decompose and ventilate until H₂O₂ residual ≤1ppm.

Stage 5: Class A Laminar Flow. Maintain laminar airflow to ensure aseptic environment during material transfer.

Sterilization Validation: Using Bacillus stearothermophilus ATCC 7953 as biological indicator, achieving 10⁻⁶ Sterility Assurance Level (SAL).

3. Product Structure and Components

The VHP Pass Box consists of the following core components:

Chamber: Interior made of 316L stainless steel, exterior of 304 stainless steel. Corrosion-resistant and easy to clean, with mirror-polished interior and rounded corners for no dead space.

VHP發生器： ； 集成式閃蒸系統，在低溫下蒸發過氧化氫溶液，產生高效殺菌氣體。

Circulation Fan: Low-noise centrifugal fan that drives gas circulation for uniform VHP distribution.

HEPA Filtration System: Supply HEPA H14 and exhaust HEPA H14 filters, ensuring all air entering and exiting the chamber is filtered to prevent secondary contamination.

Sealing System: Inflatable high-density gasket that expands during operation to ensure absolute chamber sealing.

聯鎖系統： ； 電磁聯鎖，防止同時開門，避免交叉污染。

Control System: PLC with HMI touchscreen (Siemens or equivalent), featuring three-level access control, electronic signature, audit trail functionality, and SCADA data acquisition support.

Sensor System: ； 包括溫度和濕度感測器、壓差感測器和過氧化氫濃度感測器，用於實时線上監測，以確保精確的過程控制。

4.特點和優勢

First, High Sterilization Efficiency. Flash evaporation technology ensures efficient hydrogen peroxide conversion. Log6 kill rate validated by biological indicators. Fast cycle time of 1-2 hours for complete aseptic transfer.

Second, High Safety. ； 充氣密封確保在滅菌週期內絕對密封。 獨立的通風裝置可防止設施暖通空調系統污染。 殘餘H ₂O₂ & le；迴圈完成後1ppm，對操作員和環境安全。

第三，無死角設計。 ； 集成鏡面拋光內飾，大半徑圓角。 水准層流確保H均勻 ₂O₂ 氣體分配。 可選的移動穿孔架可從各個方面進行徹底消毒。

Fourth, High Automation. Siemens PLC control with color touchscreen operation. Three-level access control, electronic signature, and audit trail functionality. Compliant with 21 CFR Part 11 and GMP computerized system validation requirements. Sterilization parameters can be printed and recorded for archive management.

Fifth, Easy Installation and Maintenance. Main components and pipelines arranged on single side, requiring only one-side maintenance space. Removable HEPA filter design for easy replacement.

5. Technical Specifications (Standard)

Chamber Material: Interior 316L stainless steel, exterior 304 stainless steel.

Surface Finish: ； 鏡面拋光，Ra小於0.6μ； m、圓角。

HEPA篩檢程式等級： ； 供應HEPA H14，排出HEPA H14。

Sterilant: ； 30-35%食品級過氧化氫溶液。

Sterilization Efficacy: Log6 kill rate (Bacillus stearothermophilus ATCC 7953).

Cycle Time: Less than 120 minutes.

Residual Concentration: ； 小於或等於1ppm。

Chamber Cleanliness: Complies with EU GMP Class B / ISO Class 5.

Air Changes: ； 大於或等於每小時80。

洩漏率： ； 100Pa時小於或等於0.5%VOL/h。

密封性標準： ； 符合ISO 10648-2標準。

控制系統： Siemens PLC with HMI touchscreen.

Power Supply: AC220V/50Hz or AC380V/50Hz.

譟音水准： ； 小於或等於70dB（A）。

Standard Chamber Sizes (Interior Width × Depth × Height):

Model VHPB-125: 500×500×500 mm, suitable for laboratory small batch transfer.

型號VHPB-200： ； 600&次； 600&次； 600毫米，適用於一般製藥和實驗室使用。

Model VHPB-350: 700×700×700 mm, suitable for medium batch transfer.

Model VHPB-500: 800×800×800 mm, suitable for production material transfer.

Model VHPB-800: 900×900×1000 mm, suitable for large batch or large item transfer.

Model VHPB-1200: 1200×1000×1000 mm, suitable for pallet or bulk material transfer.

6. Product Classification

Standard VHP Pass Box: Integrated VHP generator with complete sterilization, ventilation, and laminar flow functions. Suitable for pharmaceutical manufacturing and aseptic laboratories.

VHP滅菌室： ； 體積大，可進行託盤滅菌。 適用於生物製藥原料藥和疫苗生產。

隔離器VHP傳遞箱： Integrated with isolator system, double-door sealed design. Suitable for aseptic filling lines and cell therapy product manufacturing.

Biosafety VHP Pass Box: Biosafety-level sealing, suitable for BSL-3 laboratories and other high-containment biosafety facilities.

7. Application Areas

VHP Pass Boxes are widely used in industries and scenarios with stringent sterility requirements.

Pharmaceutical Industry: Aseptic transfer of raw material and excipient outer packaging into Grade B or A areas. Transfer of production tools and molds. Transfer of culture media, buffers, and sterile materials. Compliant with GMP Annex 1 requirements for sterile products.

Biopharmaceutical and Vaccine Production: Aseptic transfer of cell cultures and viral vectors. Material transfer in vaccine manufacturing processes. GMP production of gene therapy products.

Biosafety Laboratories: Material transfer in BSL-2 and BSL-3 laboratories. Sealed transfer of pathogenic microorganism samples. Safe removal of experimental waste.

醫療設施： ； 手術器械和植入物的無菌轉移。 無菌配藥藥房的資料轉移。

Laboratory Animal Facilities: Sterile transfer of animal cages and bedding. Material sterilization transfer in SPF animal rooms.

Transferable items include: Material drums and open containers. Operating tools and laboratory instruments. Environmental monitoring equipment (petri dishes, air samplers). Sealed packaged items.

8.與傳統UV通盒的比較

Sterilization Principle: Traditional UV pass box uses UV irradiation; VHP pass box uses vaporized hydrogen peroxide gas.

Coverage: Traditional UV pass box provides surface-only coverage with shadow areas; VHP pass box provides gas distribution with complete coverage.

殺傷率： ； 傳統的UV傳遞箱達到中低水准（Log3-4）； VHP密碼箱達到高級（Log6）。

Suitable Items: Traditional UV pass box is suitable only for flat, smooth surfaces; VHP pass box is suitable for all shapes, including complex geometries.

Validation: ； 傳統的UV傳遞盒難以量化； VHP傳遞箱允許使用生物指示劑進行定量驗證。

GMP合規性： ； 傳統的UV傳遞盒合規性有限； VHP通行箱完全符合現行GMP要求。

9. Selection Guide

Item Size: ； 根據最大物品尺寸選擇腔室尺寸。

無菌要求： ； 確認是否需要Log6滅菌能力。

Installation Environment: Verify wall opening dimensions and installation method; reserve maintenance space.

Control System: ； GMP環境需要稽核跟踪和電子簽名功能。

驗證支持： ； 選擇提供IQ、OQ和PQ驗證檔案的供應商。

標準合規性： ； 確保符合GMP、ISO 14644、ISO 10648-2和其他適用標準。

10.安裝和維護

安裝要點： ； 在牆上開一個合適的洞。 確保安裝水准，密封良好。 預留單側維護空間（最小600mm）。 連接電源、壓縮空氣和排氣筦道。

Daily Maintenance: Clean interior and exterior surfaces daily. Regularly inspect sealing gasket integrity. Periodically calibrate sensors (temperature, humidity, hydrogen peroxide concentration). Conduct regular HEPA filter integrity testing (PAO leak test). Replace HEPA filters as required. Validate sterilization cycle efficacy with biological indicator challenge tests.