Marya Sterilizable Negative Pressure Isolator
for Pharmaceutical Aseptic Filling Lines
Product Description
Marya's sterilizable negative pressure isolator ensures absolute containment for pharmaceutical aseptic filling operations. Designed to meet ISO 14644 and EU GMP Grade A standards, this isolator features integrated HEPA filtration, automated VHP decontamination cycles (6-log reduction), and ergonomic glove ports for operator safety. The airtight stainless-steel construction maintains consistent negative pressure (-20 to -50 Pa) while handling sensitive biologics or cytotoxic drugs. Ideal for vial/syringe filling, our isolator supports seamless integration with RABS and CIP/SIP systems. With real-time particle monitoring and validated decontamination protocols, Marya delivers regulatory-ready solutions for sterile injectables and vaccines. Contact us to configure a system for your fill-finish line.
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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