Marya Professional Pharma Isolator for GMP-Compliant Drug Production

• Customization: Available
• Application: Chemical Industry, Clinical Diagnosis, Cosmetic Industry, Pharmaceutical Industry
• Certification: CE, GMP
• 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
• 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 Professional Pharma Isolator for GMP-compliant Drug Production

Product Description

Introduction:
         The Marya Pharma Isolator is designed to meet the GMP-compliant drug production needs. It allows for the customization of essential instruments within a Class A environment, tailored to customer processes. With an ergonomic design, it ensures easy operation. This isolator guarantees the sterility throughout the drug production process, enabling operations like separation and extraction. Paired with our in-house developed management system, it is ideal for both batch production and clinical trials of cell therapy drugs. As a closed and integrated operating system, it not only fulfills GMP sterile production requirements but also serves as a substitute for traditional GMP laboratories. By integrating multiple functional devices, it creates a sterile environment conducive to high-quality drug manufacturing.

 

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.

 

Detailed Photos

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