Shanghai Marya FDA Pharmaceutical Isolation System with Multi-Level Access Control

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.