VHP 패스 박스

1. Product Overview

VHP 패스 박스 (증기화된 과산화수소 Sterile Pass Box)는 물질 표면의 생물학적 소염을 위해 설계된 밀봉된 전송 장치입니다.증기화된 과산화수소 (VHP)를 살균제로 사용하여 고효율적인 표면 살균을 달성하기 위해 낮은 온도와 대기압에서 작동합니다.저급 청소 지역에서 고급 청소 지역으로 항목을 이동하는 데 이상적입니다.

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:

단계 1: 방 누출 감지. & nbsp;방 압력 공기 밀도를 확인;누출 비율을 보장하십시오 ≤살균 전에 100Pa에 0.5%VOL/h.

단계 2: 전열 및 제습. & nbsp;낮은 습도를 유지하기 위해 깨깨끗하고 건조한 공기를 VVHP 살균 효과를 최적화하기 위해 VVVHP 살균 효과를 유지하기 위해 방으로 공급합니다.

단계 3: 살균 주기. & nbsp;초산화수소 증기를 주입하고, 30-60 분 동안 목표 농도를 유지합니다;화학 및 생물학 지표로 확인.

단계 4: 잔류물 제거. & nbsp;VHP 입력을 중단하고, 잔류물 제거 시스템을 활성화합니다;촉매적으로 분해하고 H까지 환기₂O₂ 남은 ≤1ppm입니다.

단계 5: 클래스 A 라미너 흐름. 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

VHP 패스 박스는 다음과 같은 핵심 구성 요소로 구성되어 있습니다.

방: 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 Generator: Integrated flash evaporation system that vaporizes hydrogen peroxide solution at low temperature to produce high-efficiency sterilizing gas.

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: & nbsp;작동 중에 확장되는 절절대적인 절절대 절대 절대 절단절단적인 절절단적인 절대적인 절단 절단적인 절대적인 절단적인 절대 실실링을 보장하기 위해 절대적인 절대적인 절대

Interlock System: Electromagnetic interlock that prevents simultaneous door opening and avoids cross-contamination.

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

Sensor System: Includes temperature and humidity sensors, differential pressure sensors, and hydrogen peroxide concentration sensors for real-time online monitoring to ensure precise process control.

4. Features and Advantages

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. Inflatable sealing ensures absolute containment during sterilization cycles. Independent ventilation unit prevents contamination of facility HVAC system. Residual H₂O₂ ≤1ppm after cycle completion, safe for operators and environment.

Third, No Dead Corner Design. Integrated mirror-polished interior with large-radius rounded corners. Horizontal laminar flow ensures uniform H₂O₂ gas distribution. Optional mobile perforated shelves enable thorough sterilization from all sides.

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. 기술 사양 (표준)

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

Surface Finish: Mirror polished, Ra less than 0.6μm, rounded corners.

HEPA Filter Grade: Supply HEPA H14, exhaust HEPA H14.

Sterilant: 30-35% food-grade hydrogen peroxide solution.

살균 효율: & nbsp;로그6의 죽이율(Bacillus stearothermophilus ATCC 7953)

주기 시간: & nbsp;120분 미만입니다.

Residual Concentration: Less than or equal to 1ppm.

방 청결성: Complies with EU GMP Class B / ISO Class 5.

공기 변화: Greater than or equal to 80 per hour.

Leakage Rate: Less than or equal to 0.5%VOL/h at 100Pa.

Tightness Standard: Complies with ISO 10648-2.

Control System: & nbsp;HMI 터치스크린을 가진 시멘스 PLC.

전력 공급: & nbsp;AC220V/50Hz 또는 AC380V/50Hz.

Noise Level: Less than or equal to 70dB(A).

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

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

Model VHPB-200: 600×600×600 mm, suitable for general pharmaceutical and laboratory use.

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.

모형 VHPB-1200: & nbsp;1200 & 시간;1000×팔레트 또는 대량 재료 이동에 적합한 1000 mm.

6. 제품 분류

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

VHP Sterilization Chamber: Large volume, capable of pallet sterilization. Suitable for biopharmaceutical bulk drug substance and vaccine production.

Isolator VHP Pass Box: & nbsp;절연기 시스템과 통합, 이중 문 밀봉된 디자인.무세 채우기 라인과 세포 치료 제품 제조에 적합합니다.

생물 안전 VHP 패스 박스: & nbsp;BSL-3 실험실 및 기타 높은 수준의 생물 안전 시설에 적합한 생물 안전 수준의 밀봉.

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.

Medical Facilities: Sterile transfer of surgical instruments and implants. Material transfer in sterile compounding pharmacies.

실험실 동물 시설: & nbsp;동물 케이지와 침대의 무균 전송.SPF 동물 방에서 재료 살균 전송.

Transferable items include: & nbsp;물자 드럼과 열린 컨테이너.운영 도구 및 실험실 장비.환경 모니터링 장비 (페트리 접시, 공기 샘플러).밀봉된 포장된 항목.

8. Comparison with Traditional UV Pass Box

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.

Kill Rate: Traditional UV pass box achieves low to medium level (Log3-4); VHP pass box achieves high level (Log6).

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

검증: Traditional UV pass box is difficult to quantify; VHP pass box allows quantitative validation with biological indicators.

GMP Compliance: Traditional UV pass box has limited compliance; VHP pass box is fully compliant with current GMP requirements.

9. Selection Guide

Item Size: Select chamber size based on maximum item dimensions.

Sterility Requirement: Confirm whether Log6 sterilization capability is required.

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

Control System: GMP environment requires audit trail and electronic signature functionality.

Validation Support: Select supplier that provides IQ, OQ, and PQ validation documentation.

Standards Compliance: Ensure compliance with GMP, ISO 14644, ISO 10648-2 and other applicable standards.

10. Installation and Maintenance

Installation Key Points: Cut appropriate opening in the wall. Ensure level installation with proper sealing. Reserve single-side maintenance space (minimum 600mm). Connect power supply, compressed air, and exhaust ducting.

Daily Maintenance: & nbsp;매일 내부 및 외부 표면을 청소하십시오.정기적으로 실링 가스켓 무결성을 검사하십시오.센서(온도, 습도, 초산화수소 농도)를 정기적으로 교정.정기적인 HEPA 필터 무결성 테스트 (PAO 누출 테스트) 를 수행합니다.필요에 따라 HEPA 필터를 교체하십시오.생물학적 지표 도전 테스트로 살균 주기 효과를 검증하십시오.