Sterile Isolator
As a decontamination equipment separating operators and machines and complying with the requirements of Class A environment, the sterile isolator is mainly used for the protection of sterile testing, sterile product dispensing and other key process. It can reduce the background or environment requirements, improve the reliability of inspection results, meet the requirements of China GMP and Pharmacopoeia, EU GMP/FDA and cGMP/USP-NF, and can carry out "continuous" or "batch" operation.
- Product Description
- Technical Features
- Technical Parameters
- Optional Systems
- Application Scenarios
- Video
-
Performance and features：
- New VHPS technology: control the concentration and saturation of H2O2; good sterilization reproducibility; shorten the sterilization time of the chamber;
- Modular design: including transfer chamber, operation chamber, bacteria collector and other functional modules and configurations; easy to install and transport;
- 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;
- CDCV service: sterilization cycle development, validation studies and services;
- Wireless glove leakage detector: integrated or wireless glove leakage detector is optional;
- Energy saving and consumption reduction: optimized design of airflow handling system; energy consumption of eight-hour continuous operation reduces by 20%;
- Real-time monitoring of door status: it can monitor the door opening online and continuously monitor the airtight seal of the door;
- High-quality manufacturing materials: the inner chamber is made of 316L or PTFE, and the chamber polishing grade is 0.4μm~0.6μm;
- 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;
- Simple maintenance: the maintenance surface is on the front, and the space required for the laboratory is not big.
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
NOVO NORDISK client Visit
Argentine client visits for FAT in MARYA
INTERESTED IN MARYA?
Get In Touch With Us.
We Will Be Happy To Discuss Our Solutions And Services With You.
Contact Now
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:
Sterile Isolator
Previous:
Contact MARYA Engineers to Claim Your Free GMP compliant Sterile Pharmaceutical Production Line Solution
Looking for a worry-free, labor-saving, and cost-saving solution? Want to get product catalogs and price lists? Please fill out the form below or send an email and our professional team will contact you within 12 hours.
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
