Marya Sterile GMP/FDA Barrier Testing Inspection Isolator for Biologics and Vaccine Production

• Customization: Available
• Application: Chemical Industry, Clinical Diagnosis, Cosmetic Industry, Food Industry, Pharmaceutical Industry
• Certification: CE, GMP, ISO
• Model NO.: MY-AD
• Control System: Fully Automatic
• Customized: Customized
• Material: Stainless Steel
• Machine Power: 1kw
• Sterilization: Vhp Generator
• Compliance: GMP
• Rtp Valve: Optional
• Vhp Residue Levels: 1 Ppm
• Professional Customization: Provided
• Cdcv Service: Provided
• Manufacturing Materials: 316L or PTFE
• Chamber Polishing Grade: 0.4um~0.6um
• Transport Package: Export Wooden Cases
• Specification: Standard/customized
• Trademark: Marya
• Origin: China
• HS Code: 8409919100
• Production Capacity: 5000pieces/Year
• Package Size: 350.00cm * 250.00cm * 250.00cm
• Package Gross Weight: 400.000kg

Product Description

Marya Sterile GMP/FDA Barrier Testing Inspection Isolator for Biologics and Vaccine Production

Product Description

Introduction:
         Marya Sterile GMP/FDA Barrier Testing Inspection Isolator for Biologics and Vaccine Production. It functions as a crucial decontamination tool, segregating operators and machinery, suitable for sterile testing and product dispensing. By minimizing environmental impacts, it boosts inspection reliability, adheres to international regulations like EU GMP/FDA, and supports both continuous and batch operations, ensuring top-notch quality and compliance for pharmaceutical processes.

 

Key Features:

• New VHPS technology: control the concentration and saturation of H₂O₂; good sterilization reproducibility; shorten the sterilization time of the chamber;
• Modular design: including transfer chamber, operation chamber, bacteria collector and other functional modules and configurations; easy to install and transport;
• Intelligent control system: Siemens PLC+IPC control system; intelligent alarms of pressure, H₂O₂ solution concentration, temperature and humidity, air speed and other monitoring parameters; the system has multi-level access control; comply with FDA 21 CFR part 11 requirements;
• CDCV service: sterilization cycle development, validation studies and services;
• Wireless glove leakage detector: integrated or wireless glove leakage detector is optional;
• Energy saving and consumption reduction: optimized design of airflow handling system; energy consumption of eight-hour continuous operation reduces by 20%;
• Real-time monitoring of door status: it can monitor the door opening online and continuously monitor the airtight seal of the door;
• High-quality manufacturing materials: the inner chamber is made of 316L or PTFE, and the chamber polishing grade is 0.4μm~0.6μm;
• Decomposition filter: the air exhaust module can be equipped with a decomposition filter can effectively shorten the degradation time after H₂O₂ sterilization, and effectively reduce the concentration level of residues;
• Simple maintenance: the maintenance surface is on the front, and the space required for the laboratory is not big.

 

• 

  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.

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

 

Detailed Photos

 

Company Profile