Shanghai Marya Pharmaceutical Isolator for Production Line Sterility Assurance and Quality Enhancement

Product Description

Shanghai Marya Pharmaceutical Isolation System for
Production Line Sterility and Quality

Product Description

Introduction:
         The pharmaceutical isolation system is integrally installed on the sterile filling machine or other equipment to form a controlled enclosure or barrier that completely isolates operators and products. By equipping this system for sterile filling, the risk of drug contamination will be effectively reduced and the quality of drugs be greatly improved.
 

 

Performance and feature

• Comprehensive product portfolio: isolation systems for water injection, powder injection, prefilled syringe and sterile powder production lines;
• Stable and reliable environment: reliable and stable class A environment, which meets cGMP, FDA, ISO, ISPE, and pharmacopoeia requirements;
• New VHPS technology: the latest H₂O₂ sterilization system, which can achieve rapid sterilization, control the concentration and saturation of H₂O₂, with good sterilization reproducibility;
• 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;
• Independent temperature and humidity control mode: with the integrated independent air conditioning system, it can realize that the internal temperature and humidity in the chamber is not affected by the external environment;
• MOCK-UP: complete wood model verification service, ergonomic operation qualification and 3D model display service in the middle of the project.
• Sterilization process development support: qualification and validation services for sterilization cycle development of the whole process can be provided;
• Customization: support customized isolation system design, and provide systematic closed isolation solutions and CE certification services;
• Integrated monitoring system: integrated monitoring systems of temperature and humidity, differential pressure, air speed, H₂O₂ concentration, optical grating, particles and airborne viable bacteria, etc.;
• Multiple sterile transfer solutions: multiple and combined sterile transfer solutions are available to meet customers' diversified production needs;
• Complete life cycle support: covering consulting, project design, installation scheme design and verification design, etc.;
• Wireless glove leakage detector: multi-head wired glove leakage detector or wireless glove leakage detector is optional;
• CDCV service: sterilization cycle development, validation studies and services;

 

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  Advantages:

  • Comprehensive Protection: Ensures a stable and reliable A-grade environment, crucial for maintaining product integrity and operator safety.
  • Advanced Sterilization: The VHPS technology provides rapid and reproducible sterilization, essential for aseptic processes.
  • Intelligent Controls: The Siemens PLC+IPC system offers intelligent monitoring and control, reducing the risk of human error and enhancing process reliability.
  • Customization and Flexibility: Tailored solutions to fit specific production needs, ensuring optimal performance and efficiency.
  • Regulatory Compliance: Designed to meet international standards, ensuring product quality and safety.
  • End-to-End Support: From consultation to validation, Marya provides full lifecycle support, ensuring seamless integration and operation.

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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