Linkage Production Line Isolator
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.
- Product Description
- Technical Features
- Technical Parameters
- Optional Systems
- Application Scenarios
- Video
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Performance and features：
- 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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Supports various pharmaceutical product linkage line operations
We integrate isolators, filling machines, decontamination equipment and HVAC technology to secure highly efficient, safe processes for your aseptic processing requirements.
Years rich Industry Experience
Production Bases
Successful Projects in 60 Countries
Loyal Clientele
Invited to the Embassy of the United Republic of Tanzania in Guangzhou to discuss projects
NBA (Zimbabwe National Biotechnology Authority) conducts FAT at MARYA’s Factory
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Full-process Consulting Services
Whether you are preparing to build a new pharmaceutical factory, build a cleanroom that complies with local GMP regulations, or purchase pharmaceutical equipment to develop a new production line, whether it is a separate cleanroom or pharmaceutical machine project, or a one-stop solution, Marya's professional teams in the fields of pharmaceutical technical process, process equipment, decoration engineering, HVAC engineering, pipeline engineering, utility equipment, intelligent automatic control systems, project cost and other fields can provide you with full-process technical consulting services, and solve your needs one-on-one.
2D/3D Design Modeling Services
Marya project design team is composed of professional CAD and BIM engineers with more than 20 years of comprehensive industry experience and can provide you with comprehensive design services, including but not limited to process layout drawings, technical process charts, 3D models and animations, air conditioning system scheme design, construction drawing design, plant/pharmaceutical machine layout drawings, etc.
Machine Customization Services
Based on the individual needs of clients in different countries, Marya helps you clarify specific needs, match appropriate models, and customize one stop filling solutions for sterile small-volume preparations, large-volume injections, oral liquids/syrups, solid preparations, etc.
Validation Services (FAT/SAT)
Marya will appoint an engineer with rich project management experience as the person in charge, who will be fully responsible for project management and liaison work. After the equipment is manufactured, our engineers and the buyer's representatives will participate in the FAT test. After the equipment arrives at the buyer's site, it will be installed and debugged. After the equipment reaches optimal operation, the buyer will conduct SAT testing and inspection.
Key words:
Linkage Production Line Isolator
pharmaceutical isolation system
isolation system
H2O2 sterilization system
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CONTACT INFO
NO211, North Fute Road, Pudong area, Shanghai, China, 200131
CONTACT
Shanghai Office: NO211, North Fute Road, Pudong area, Shanghai, China, 200131
Changsha Office: Room 23069, Block 6, Forte Star Shine World, Yuhua District, Changsha, Hunan province
Factory 1: Hunan Marya Technology Co., Ltd. Address: No. 7 Plant, SANY Industrial Park, No. 1, SANY Road, Changsha Pilot Free Trade Zone, Hunan Province, China, 410100
Factory 2: No 555, Yupan Road, Weitang Town, Xiangcheng District, Suzhou, Jiangsu Province, China
Factory 3: 15-A, Venture Capital Industrial Square, Yanghe Road, Suzhou Industrial Park
