Marya High-Efficiency Pharma Isolator for cGMP Production Environments

• Customization: Available
• Certification: GS, RoHS, CE, ISO9001
• Noise: 40-60db
• Model NO.: MARYA AC
• Application: Industrial
• Control Mode: Touch
• Usage: Fragrance, Dust Removal, Smoke Removal, Humidification
• Machine Power: 1kw
• Material: Stainless Steel
• Sterilization: Vhp Generator
• Control System: Automated Control
• Compliance: GMP
• Rtp Valve: Optional
• Vhp Residue Levels: 1 Ppm
• High Protection Level: Oeb 5 (Oel<1ug/M³)
• Professional Customization: Provided
• Cdcv Service: Provided
• Manufacturing Materials: 316L or PTFE
• Transport Package: Export Wooden Cases
• Specification: Standard/customized
• Trademark: Marya
• Origin: China
• HS Code: 8409919100
• Production Capacity: 5000pieces/Year
• Package Size: 340.00cm * 150.00cm * 200.00cm
• Package Gross Weight: 300.000kg

Product Description

Marya High-Efficiency Pharma Isolator for cGMP Production Environments

Product Description

Introduction:
         Marya's High-Efficiency Pharma Isolator is designed specifically for cGMP production settings. Ideal for handling highly active, toxic, and allergenic substances during weighing, dispensing, and feeding. The closed barrier system isolates operations, safeguarding operator health. With a Class C internal cleanliness level, it meets all process and cGMP standards. This isolator finds extensive use in medical, pharmaceutical, chemical, and food industries, providing a reliable solution for safe and efficient production.

 

Key Features:

• High protection level: up to the highest OEB 5 (OEL<1ug/m³);
• Professional customization: according to different process requirements (explosion-proof function is optional), we provide the most suitable isolator design and complete MOCK-UP early in the design and three-dimensional display in the middle of a project.
• Intelligent: intelligent control system, a number of expansion ports, such as printing, storage, etc., and can be integrated into SCADA system;
• Perfect WIP system: the bottom of the chamber is designed to be inclined and the internal arc angle R≥20, without hard-to-clean places;
• Automatic regulation and emergency system: when leakage occurs, the isolator automatically gives an alarm and adjusts the fan frequency to ensure that the air speed of crack is greater than 0.5m/s.
• Various material transfer: configurable RTP (Rapid transfer ports) and online waste discharge port (bagging system);
• Safe filter replacement: PUSH-PUSH filters of the air handling system can be replaced safely to protect personnel's safety.
• Real-time monitoring of door status: it can monitor the door opening online and continuously monitor the inflatable sealing of the door;
• CDCV service: sterilization cycle development, validation studies and services;
• High-quality manufacturing materials: the inner chamber is made of 316L or PTFE, and the chamber polishing grade is 0.4μm~0.6μm; the brands of all key components are international first-class such as Camfil, EBM, SIEMENS, etc.
  

  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
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

 

Detailed Photos

Company Profile