Marya GMP Cell Preparation Isolator with Advanced Vhps Sterilization Technology

• Customization: Available
• After-sales Service: 1year
• Power Supply: 1kw
• Model NO.: Marya AE
• Certification: CE, GMP
• Warranty: 1 Year
• Machine Power: 1kw
• Sterilization: Vhp Generator
• 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: 380.00cm * 250.00cm * 200.00cm
• Package Gross Weight: 300.000kg

Product Description

  Marya GMP Cell Preparation Isolator
with Advanced VHPS Sterilization Technology

Product Description

     The Marya GMP Cell Preparation Isolator integrates advanced Vaporized Hydrogen Peroxide (VHPS) sterilization technology to deliver aseptic, contamination-free environments for critical cell therapy and biopharmaceutical applications. Designed to meet strict GMP standards, it ensures full compliance for cell processing, gene therapy, and sterile compounding. The isolator features hermetic sealing, real-time monitoring, and rapid decontamination cycles, minimizing downtime while maximizing sterility assurance. Its modular design adapts to diverse workflows, from research to commercial-scale production. Trusted by leading life science facilities, Marya's solution combines cutting-edge sterilization, regulatory readiness, and operational efficiency-setting the benchmark for cell therapy isolation systems.
 

Product Prameter:

Rapid Response

Delivers immediate response to capacity requirements, significantly reducing sterilization cycle times.

High Precision Control

Ensures accurate control of steam pressure and temperature with fluctuations within ±5%.

Unattended Operation

Capable of operating without human supervision, supporting multiple sterilization points simultaneously.

Efficient Waste Management

Offers a typical waste discharge ratio of 2-8%, optimizing resource utilization.

Versatile Pressure Range

Produces steam within a pressure range of 2-5 bar, accommodating diverse sterilization needs.

Performance and features

1. Environmental protection: provide class A clean environment for the whole process of cell production and operation, and meet the sterile requirements of GMP.
2. New VHPS technology: integrated vaporized H₂O₂ biological decontamination system for effective bio-decontamination of operating areas and material channels;
3. Modular design: freely combined multiple functional modules and configurations according to customer needs;
4. 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;
5. Online environmental monitoring: online detection of sterile production environment, which complies with regulatory requirements, with higher sterility assurance;
6. Wireless glove leakage detector: integrated or wireless glove leakage detector is optional;
7. Energy saving and consumption reduction: installed in the environment whose cleanliness is above class D, reducing the construction and operation cost of high-class cleanrooms;
8. Full data record: configured with control system to record key parameter data and ensure traceability
9. High-quality manufacturing materials: the inner chamber is made of 316L or PTFE, and the chamber polishing grade is 0.4μm~0.6μm;
10. 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;
11. CDCV service: sterilization cycle development, validation studies and services;

Feature	Description
VHPS Technology	Integrated vaporized H2O2 biological decontamination system for effective bio-decontamination of operating areas and material channels.
Modular Design	Allows for the free combination of multiple functional modules and configurations based on customer needs.
Online Environmental Monitoring	Real-time detection of the sterile production environment, ensuring higher sterility assurance and regulatory compliance.
Wireless Glove Leak Detector	Optional integrated or wireless glove leak detector for added safety.
Manufacturing Materials	The inner chamber is made of 316L or PTFE, with a chamber polishing grade of 0.4μm~0.6μm.
Decomposition Filter	The air exhaust module can be equipped with a decomposition filter to shorten H2O2 sterilization degradation time and reduce residue concentration levels.
CDCV Services	Offers development, validation studies, and services for sterilization cycles.

Why Choose Shanghai Marya Pharmaceutical Engineering & Project Co., Ltd?

• Quality Assurance: We adhere to the strictest quality standards, ensuring every system meets the requirements of China pharmacopoeia and FDA regulations.
• Innovative Technology: Leveraging the latest advancements in water treatment technology to provide you with the most efficient and reliable solutions.
• Customer Focus: Our solutions are designed with your specific needs in mind, offering customization and flexibility to fit your unique processes.

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