Marya GMP-Compliant Negative Pressure Isolator
in Gene Therapy Viral Vector Manufacturing
Product Description
Marya's compact negative pressure isolator provides an aseptic containment solution for sterile vaccine production, eliminating cross-contamination risks between batches. Designed for Grade A/B cleanrooms, this disposable isolator features integrated HEPA filtration (ISO 5), pre-validated gamma-irradiated polymer walls, and ergonomic glove ports for closed processing. The maintenance-free system ensures consistent negative pressure (-15 to -40 Pa) during live virus handling or mRNA vaccine filling, with seamless disposal after use. Compatible with automated filling lines and RABS interfaces, it reduces validation burden while meeting FDA/EMA guidelines for single-use systems. Ideal for pandemic-response manufacturing, the isolator includes built-in particle monitoring ports and sterile transfer adapters for rapid changeover.
Product Prameter:
| Feature |
Description |
| Protection Level |
OEB 5 (OEL < 1ug/m³) |
| Customization |
Professional design, early MOCK-UP, and 3D project display |
| Intelligent Control |
Smart system with expansion ports |
| WIP System |
Inclined chamber bottom, R≥20 internal arc angles |
| Emergency System |
Automatic leak detection and fan frequency adjustment |
| Door Status Monitoring |
Real-time door opening and sealing monitoring |
| Material Transfer |
RTP and online waste discharge port options |
Key Features:
Customization and Integration:
- Modular Design: Allows for the integration of various modules to create a customized isolation system.
- Accessories: Configurable with different shelves, cleaning water guns, and dehumidification systems to suit specific needs.
- Control System: Features automatic control of gas pressure, water and oxygen content, and self-adaptive cleaning air circulation.
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