Hydrogen peroxide sterile delivery window

TL-STB series hydrogen peroxide sterile transfer window

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TL-STB系列过氧化氢无菌传递窗
TL-STB Series Hydrogen Peroxide Aseptic Transfer Window | Product Details

Background Introduction

As stated in Article 7 of the "2010 GMP Appendix 1 Sterile Products" issued by SFDA: "Minimize the risk of product or material being contaminated by particles or microorganisms." This raises requirements for small items between clean areas and clean areas, between non-clean areas and clean areas, reduces the number of door openings in clean rooms, and minimizes contamination and cross-contamination in clean areas.

As stated in Article 7 of the "2010 GMP Appendix 1 Sterile Products" issued by SFDA: "Minimize the risk of product or material being contaminated by particles or microorganisms." This raises requirements for small items between clean areas and clean areas, between non-clean areas and clean areas, reduces the number of door openings in clean rooms, and minimizes contamination and cross-contamination in clean areas.


Technological Innovation: The vaporized hydrogen peroxide aseptic transfer window produced by our company sterilizes all exposed surfaces inside the transfer window through integrated vaporized hydrogen peroxide sterilization, replacing traditional ultraviolet disinfection methods. The transfer window's built-in filter laminar flow protection creates an airlock when opening the double-leaf door, preventing cross-contamination.

1 As stated in Article 7 of the "2010 GMP Appendix 1 Sterile Products" issued by SFDA: "Minimize the risk of product or material being contaminated by particles or microorganisms." This raises requirements for small items between clean areas and clean areas, between non-clean areas and clean areas, reduces the number of door openings in clean rooms, and minimizes contamination and cross-contamination in clean areas.

Working Principle

Hydrogen peroxide aseptic transfer windows utilize the advantage that hydrogen peroxide in gaseous state at room temperature has greater sporicidal capability than in liquid state. After generating free hydroxyl radicals, they attack cellular components including lipids, proteins, and DNA structures, achieving sterilization requirements. Mainly applied in pharmaceutical industry for material transfer between sterile areas of different classifications, achieving aseptic material transfer requirements.

Sterilization Mechanism: Hydrogen peroxide in vaporized state generates free hydroxyl radicals, effectively attacking microbial cellular components (lipids, proteins, and DNA), achieving efficient sterilization effects.

Technical Specifications

Power Supply
AC220±22V 50Hz±1Hz
Power
1600W
Chamber Material
SUS 316L Stainless Steel
Chamber Cleanliness
CLASS A
Sterilant
35% Food-grade Hydrogen Peroxide Solution
Kill Rate
Killing rate of 6-log for Geobacillus stearothermophilus and Bacillus subtilis var. niger
Sterilization Cycle
≤50min
Operation Mode
Continuous Operation
Airflow
Vertical Unidirectional Flow
Various Sensors
Customized (domestic/imported)
Filter
H14 Class
Model
Customized

Product Models

Product Model Transfer Window Internal Dimensions Transfer Window External Dimensions Transfer Window Size vs. Human Comparison
TL-STB150 500×700×500mm 1000×900×1800mm 1000
TL-STB400 700×700×800mm 1200×900×2100mm 1200
TL-STB600 800×800×1000mm 1500×1250×1650mm 1500

Note: More models can be customized according to user requirements

Customization Service: In addition to standard models, we can provide non-standard customization services according to specific customer requirements, including size adjustments, sensor selection, special function integration, etc.

Product Advantages

GMP Compliance
Compliant with 2010 GMP Appendix 1 Requirements
Sterilization Technology
Vaporized Hydrogen Peroxide Sterilization, superior to traditional UV disinfection
Cross-contamination Protection
Dual-leaf door interlock, preventing cross-contamination
Cleanliness Maintenance
H14 class filters, maintaining CLASS A cleanliness
Efficient Sterilization
Killing rate of 6-log for Geobacillus stearothermophilus
Rapid Transfer
Sterilization cycle ≤50min, improving transfer efficiency

Application Areas

The TL-STB series hydrogen peroxide aseptic transfer windows are mainly used for material transfer between sterile areas of different classifications in the pharmaceutical industry, suitable for the following scenarios:

  • Sterile Bulk Drug Production Areas
  • Sterile Preparation Filling Areas
  • Biological Product Production Areas
  • Vaccine Production Areas
  • Cell Therapy Product Production Areas
  • High-activity Drug Production Areas
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