Email:
info@huakegroup.inNegative-pressure isolator
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- Product Description
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Technical Note:
This system is specifically designed for biopharmaceutical, fine chemical, and research institutions. It provides professional protective solutions tailored to the handling of highly toxic, highly reactive, and highly sensitizing substances, fully complying with the requirements of the Environmental, Health, and Safety (EHS) management system. Its core operating principle involves maintaining a continuous negative pressure inside the system (pressure differential ranging from -30 to -100 Pa), thereby establishing a physical sealing barrier that effectively prevents the risk of hazardous substance leakage.In critical processes such as drug dispensing, raw material weighing, formulation preparation, and hazardous waste disposal, the equipment achieves three levels of protection through directional airflow control:
1. **Personal Protection**: Completely isolate operators from direct contact with hazardous substances to prevent risks of respiratory exposure and skin contact.
2. **Environmental Protection**: Integrates a HEPA/ULPA filtration system (filtration efficiency ≥99.999% @ 0.3μm) with an activated carbon adsorption unit to achieve dual interception of aerosols and volatile organic compounds.
3. **Experimental Assurance**: A stable and clean operating environment ensures weighing accuracy of ±0.1 mg, thereby guaranteeing the reliability of experimental data.The system is equipped with an intelligent differential-pressure monitoring module that provides real-time display and recording of key parameters such as the pressure gradient and airflow velocity within the operating cabin. When system integrity is compromised, the module immediately triggers both audible and visual alarms. This equipment has been widely adopted across the entire biopharmaceutical value chain—including innovative drug development, cell therapy product preparation, and antibiotic production—meeting the safety requirements for handling hazardous materials under GLP/GMP regulations.
Core specifications:
1. **Smart Environmental Monitoring System**
Equipped with a built-in multi-parameter sensor array, it monitors chamber pressure (accuracy ±1 Pa), temperature (±0.5℃), and humidity (±3% RH) in real time, dynamically maintaining the preset safe operating range.2. **Efficient Filtration Maintenance Mechanism**
Equipped with a quick-release filter module, it allows a single operator to complete HEPA/ULPA filter replacement within 15 minutes, fully complying with biosafety operating procedures throughout the entire process.3. **Multi-layered Security Protection System**
- Abnormal condition alarm: Monitors 12 parameters in real time, including power supply stability and door seal integrity. In the event of an abnormal operating condition, a three-level audio-visual alarm is triggered within 0.5 seconds.
- Airtight transfer system: Integrates RTP (Rapid Transfer Port) with an α/β dual-door valve to provide airtight protection throughout the entire material transfer process.
- Operational safety assurance: Interlocking logic control for critical operations such as equipment start-up, shutdown, and material transfer is implemented via PLC control.4. **Data Traceability Management Module**
Automatically records and stores operational data such as pressure curves and alarm events, supports historical record retrieval and audit trail functionality, and ensures that data packets comply with the FDA 21 CFR Part 11 electronic records regulations.5. **Extended Feature Configuration**
- Optional glove integrity tester available to automatically detect microperforations (≥200 μm) in isolator gloves.
- Supports customized solutions such as cavity dimensions (depth: 500–2000 mm), observation window layouts, and combinations of stainless steel/high-polymer materials, tailored to meet specific process requirements.
The system features a modular design that enables flexible functionality expansion and easy maintenance, comprehensively addressing the protective needs for handling hazardous substances in biopharmaceutical companies—from research and development all the way through to production.
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