Marya Advanced Flexible Isolator System for Pharmaceutical Aseptic Processing Applications

Customization: Available
After-sales Service: Video Online, Field Installation
Warranty: 1 Year

Product Description

Basic Information
Model NO. Marya AF Machine Power 1kw
Material Stainless Steel Control System Automated Control
Sterilization Vhp Generator Compliance GMP
Manufacturing Materials 316L or PTFE Origin China
Production Capacity 5000pieces/Year Package Size 340.00cm * 150.00cm * 200.00cm
Product Description

The Marya Advanced Flexible Isolation System delivers superior containment for critical aseptic pharmaceutical processes. This innovative system features modular, adaptable designs to meet diverse production needs while maintaining ISO 5/Class A environmental conditions.

Engineered with HEPA-filtered laminar airflow and ergonomic glove ports, it ensures optimal operator protection and product sterility. The system supports manual and automated operations, integrating seamlessly with filling lines for vaccines, biologics, and sterile injectables.

Flexible Isolator System View 1
Flexible Isolator System View 2
Technical Parameters
Parameter Item Specifications
Cleanliness ISO 4.8
Temperature and Humidity Conventional 18-26ºC / 45%-65% (Customizable)
Differential Pressure Regular 20-50pa
Air Flow Rate 0.36m/s - 0.54m/s
Air Flow Type Vertical one-way flow
Sterilization Effect log6 and above
Leakage Rate 0.5%
Key Features & Customization
Key Features Illustration
  • Modular Design: Allows for the integration of various modules to create a customized isolation system.
  • Versatile Accessories: Configurable with different shelves, cleaning water guns, and dehumidification systems.
  • Advanced Control System: Automatic control of gas pressure, water and oxygen content, and self-adaptive air circulation.
  • Regulatory Readiness: Designed for R&D, clinical, and commercial production with full cGMP compliance.
Workshop & Quality Control
Production Process
Quality Inspection
Workshop Environment
Certificates
Product Category & Project Cases
Product Categories
Project Case 1
Project Case 2
Exhibition View
Packaging & Shipping
Secure Packaging Process
Frequently Asked Questions
What cleanliness level does the Marya Flexible Isolator achieve?
The system achieves ISO 4.8 (Class A) environmental conditions, ensuring a high-purity environment for critical aseptic pharmaceutical processes.
How is the sterilization process handled within the system?
The system integrates a VHP (Vaporized Hydrogen Peroxide) Generator, capable of achieving a sterilization effect of log6 and above.
Is the isolation system compliant with international pharmaceutical standards?
Yes, the Marya Advanced Flexible Isolation System is fully compliant with cGMP standards and designed for use in regulated pharmaceutical environments.
Can the temperature and humidity be adjusted?
Standard settings are 18-26ºC and 45%-65% humidity, but these can be fully customized according to the specific requirements of your pharmaceutical process.
What materials are used for the construction of the isolator?
The manufacturing materials primarily include high-grade 316L Stainless Steel or PTFE to ensure durability and chemical resistance.
What types of pharmaceutical products is this system suitable for?
It is ideal for handling vaccines, biologics, and sterile injectables during R&D, clinical trials, and full-scale commercial production.

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