Business

Equipment

Specification
Model Name QVA I
Exterior Material SUS304 (Chamber Exterior), SUS316/L (Chamber Interior)
Overall Dimensions 2218 × 1210 × 2633
Chamber Internal Dimensions MAIN 1797 × 792 × 745
TRANSFER HATCH 792 × 772 × 722
HEPA Filter Specification H14 Grade (99.997%)
Main 480 × 1060 × 90
Transfer Hatch 305 × 305 × 90
Built-in Compressor 7 bar DC 24V, 3.5 kg
Environmental Temp/Humidity Range Temperature -40℃ ~ 60℃ / Humidity 0% ~ 100%
Chamber Pressure Sensor ±3,000 Pa
Air Flow Sensor 0 ~ 20 m/s
Hydrogen Peroxide Measurement Range 0 ~ 1,000 ppm (standard)
HVAC Connection Specification Main Supply 6S / Exhaust 8S
Transfer Hatch Supply 6S / Exhaust 4S
Power Requirement / Consumption AC 220 Volts 50/60Hz, 10Amps
Control System PLC & HMI 10.1 inch
Hydrogen Peroxide Concentration 30 ~ 35%
Hydrogen Peroxide Capacity 1L
Electronic Scale 6 kg
Hydrogen Peroxide Injection Rate 4 g/min
Outlet Gas Temperature 60℃ ~ 70℃
Loading Shelves Main Chamber Sliding Trays
(2 Tiers & SUS 316 Baskets 4 ea)
Transfer Hatch Sliding Trays
(Available in 2 Tiers)
Data Storage & Output USB storage & printer output

A sterility testing isolator must reliably maintain a completely sterile condition until the test is completed.
The reliability of sterility testing is primarily determined by the testing environment, which has the greatest impact on the results. The isolator must structurally prevent external contamination to ensure continuous sterility.

Fully sterilizing the internal space is only the initial step. Maintaining sterility depends on effectively controlling contamination risks arising from the external environment, operator intervention, and material transfer throughout the entire testing process.
This requires advanced engineering that integrates structural design, airflow control, pressure differential stability, and containment technology.

GMEBIO’s isolator is designed to deliver fast and accurate sterilization, ergonomic user convenience, and compatibility with various HVAC systems, providing a reliable and validated sterile testing environment suitable for GMP-compliant applications.

Key features

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    Customizable Laboratory Equipment Integration
    : Compatible with various brands of sterility test pumps, particle counters, and microbial air samplers (optional)

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    RGB LED: Easy identification of cycle steps

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    Optimized Tray System
    : Designed for maximum loading capacity and efficient sterilization of various sterility testing instruments

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    Data Storage & Output
    : USB & HDD storage, thermal printer output

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    Flexible HVAC System Integration
    : With optional catalyst, supports room exhaust or connection to HVAC exhaust systems

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    Real-Time Cycle Data
    : Graph data output based on user-defined time settings

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    Rapid Sterilization System
    : Ensures validated sterilization with faster cycle operation, improving productivity

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    Reduced Consumable Costs
    : Supports refill with reagent-grade hydrogen peroxide from user-selected brands

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    Cleanliness Control
    : Laminar flow circulation structure maintains clean environment

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    Custom Glove Design
    : User-selectable glove options available

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    High-Quality Sensors
    : Airflow, H₂O₂, RH/Temperature/Pressure, and differential pressure sensors

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    Audit Trail & 21 CFR Part 11 Compliance
    : Supports Computer System Validation (CSV) in accordance with DI and GAMP 5 standards

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    Transfer Hatch Structure
    : High-efficiency design enabling continuous execution of multiple QC tests

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    Touch Screen Interface
    : Simple operation through user-centered UX/UI design

Optional Features

  • Airborne Particle Counter
    : Real-time monitoring of particles inside the isolator
  • Glove Leak Tester
    : Automatically detects pinholes and damage in gloves to ensure airtight integrity
  • Active Air Sampler
    : Precisely collects and measures airborne microorganisms
  • Sterility Test Pump
    : Dedicated system for sterility testing inside the isolator

* Customizable Laboratory Equipment Integration (optional user-selectable equipment)
  Sterility test pump, particle counter, and microbial air sampler available for separate purchase and installation

September 2026

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