Marya cGMP Aseptic Isolation System Sterility Test Isolator for Pharmaceutical Sterile Products

Product Description

Marya cGMP Aseptic Isolation System Sterility Test Isolator for
Pharmaceutical Sterile Products

Product Description

Introduction:
The sterile isolator is a cutting-edge decontamination equipment designed to separate operators from machines, meeting the stringent requirements of Class A environments. It is primarily used to protect critical processes such as sterile testing and the dispensing of sterile products. This advanced system reduces the need for stringent background environmental conditions, enhancing the reliability of inspection results. It complies with multiple international standards, including China GMP and Pharmacopoeia, EU GMP/FDA, and cGMP/USP-NF, and supports both "continuous" and "batch" operations.

 

Performance and Features

1. Advanced VHPS Technology
   • Offers precise control over H2O2 concentration and saturation.
   • Ensures excellent sterilization reproducibility and reduces chamber sterilization time.
2. Modular Design
   • Incorporates various functional modules such as transfer chambers, operation chambers, and bacterial collectors.
   • Easy installation and transportation, providing flexibility for different application needs.
3.  Intelligent Control System
   • Equipped with a Siemens PLC + IPC control system.
   • Smart alarms for critical parameters like pressure, H2O2 solution concentration, temperature, humidity, and airflow speed.
   • Multi-level access control compliant with FDA 21 CFR Part 11.
4. CDCV Service
   • Comprehensive sterilization cycle development and validation services.
5. Wireless Glove Leakage Detector
   • Optional integrated or wireless glove leakage detector for enhanced safety.
6. Energy Saving and Consumption Reduction
   • Optimized airflow handling system reduces energy consumption by 20% during eight-hour continuous operation.
7. Real-time Door Status Monitoring
   • Online monitoring of door opening status and continuous monitoring of door airtight seals.
8. High-Quality Manufacturing Materials
   • Inner chambers made of 316L or PTFE with a polishing grade of 0.4µm-0.6µm for superior cleanliness.
9. Decomposition Filter
   • Exhaust module with a decomposition filter to shorten degradation time post-HO sterilization and reduce residue concentration.
10. Simple Maintenance
    • Front-facing maintenance surface with minimal laboratory space requirements.
       

Feature	Description
Technology	New VHPS technology for precise H2O2 control and rapid sterilization
Design	Modular, including transfer chamber, operation chamber, bacteria collector
Control System	Siemens PLC+IPC with intelligent alarms and multi-level access control
CDCV Services	Comprehensive sterilization cycle development and validation
Glove Leak Detector	Optional integrated or wireless glove leak detector
Door Status Monitoring	Real-time door opening and sealing monitoring
Manufacturing Materials	316L or PTFE inner chamber with 0.4μm~0.6μm polishing grade

 

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  Conclusion
  The sterile isolator is an indispensable solution for enhancing safety and efficiency in pharmaceutical production and testing. Its advanced features, combined with compliance to global standards, make it an ideal choice for pharmaceutical manufacturers aiming to optimize their aseptic processes.

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