Marya Complete Sterile Isolator Barrier System for Drug Manufacturing and Quality Assurance

• Customization: Available
• Application: Chemical Industry, Clinical Diagnosis, Cosmetic Industry, Food Industry, Pharmaceutical Industry
• Certification: CE, GMP, ISO
• Model NO.: Marya-AB
• Control System: Fully Automatic
• Customized: Customized
• Material: Stainless Steel
• Machine Power: 1kw
• Sterilization: Vhp Generator
• Compliance: GMP
• Rtp Valve: Optional
• Vhp Residue Levels: 1 Ppm
• Professional Customization: Provided
• Cdcv Service: Provided
• Manufacturing Materials: 316L or PTFE
• Chamber Polishing Grade: 0.4um~0.6um
• Transport Package: Export Wooden Cases
• Specification: Standard/customized
• Trademark: Marya
• Origin: China
• Production Capacity: 5000pieces/Year
• Package Size: 350.00cm * 250.00cm * 200.00cm
• Package Gross Weight: 400.000kg

Product Description

Marya Complete Sterile Isolator Barrier System for
Drug Manufacturing and Quality Assurance

Product Description

Introduction:
         The Marya Complete Sterile Isolator Barrier System is a revolutionary solution for drug manufacturing and quality assurance. This system creates a fully enclosed, sterile environment that effectively isolates the drug production process from external contaminants. It minimizes the risk of microbial and particulate intrusion, ensuring the highest quality of pharmaceutical products. Equipped with advanced monitoring and control features, the isolator maintains precise environmental conditions. Its robust construction and user - friendly design simplify operation and maintenance. Ideal for aseptic filling, compounding, and other critical processes, Marya's system enhances product safety and regulatory compliance.

 

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;

 

Product Parameter

Cleanliness	ISO4.8
Temperature and humidity	Conventional 18-26ºC/45%-65%, can be customized according to the pharmaceutical process
Differential pressure	Regular 20-50pa
Air flow rate	0.36m/s-0.54m/s
Air flow type	Vertical one-way flow
Sterilazation effect	log6 and above
Leakage rate	0.5%

 

Detailed Photos

 

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