Marya Sterile Isolator for Aseptic Testing FDA & cGMP Compliant with Vhps Technology

• Application: Chemical Industry, Clinical Diagnosis, Cosmetic Industry, Food Industry, Food Safety, Forensic Science, Pharmaceutical Industry
• Certification: CE, GMP, ISO
• Control System: Fully Automatic
• Model NO.: MARYA AA
• Customized: Customized
• Material: Stainless Steel
• Machine Power: 1kw
• Sterilization: Vhp Generator
• 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
• Chamber Polishing Grade: 0.4um~0.6um
• Transport Package: Inner Water Proof Bag, Outer Sea Worth Case
• Specification: Standard/customized
• Trademark: Marya
• Origin: China
• Production Capacity: 5000pieces/Year

Product Description

Marya Sterile Isolator for Aseptic Testing
FDA & cGMP Compliant with VHPS Technology

Product Description

Introduction:
         As a decontamination equipment separating operators and machines and complying with the requirements of Class A environment, the sterile isolator is mainly used for the protection of sterile testing, sterile product dispensing and other key process. It can reduce the background or environment requirements, improve the reliability of inspection results, meet the requirements of China GMP and Pharmacopoeia, EU GMP/FDA and cGMP/USP-NF, and can carry out "continuous" or "batch" operation.
 

 

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.

 

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  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

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