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Products

Sterile testing 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.
By using this isolator, the demands placed on the background or environment can be significantly reduced, 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.

Core Advantages
Core Technology
Technical Parameters
Application Scenarios
Optional Systems

▸ Features and Performance
1.New VHPS technology: control the concentration and saturation of H2O2; good sterilization reproducibility; shorten the sterilization time of the chamber;
2.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
3.Modular design: including transfer chamber, operation chamber, bacteria collector and other functional modules and configurations; easy to install and transport.
4.Wireless glove leakage detector: integrated or wireless glove leakage detector is optional;
5.Energy saving and consumption reduction: optimized design of airflow handling system; energy consumption of eight-hour continuous operation reduces by 20%
6.Real-time monitoring of door status: it can monitor the door opening online and continuously monitor the airtight seal of the door;
7.High-quality manufacturing materials: the inner chamber is made of 316L or PTFE, and the chamber polishing grade is 0.4μm~0.6μm;
8.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;
9.Simple maintenance: the maintenance surface is on the front, and the space required for the laboratory is not big.
10.CDCV service: MARYA Provide sterilization cycle development, validation studies and services

Why MARYA

Trusted Worldwide

20 +

Years rich Industry Experience

3 +

Production Bases

60 +

Successful Projects in 60 Countries

300 +

Loyal Clientele

Company Honors and Certificates

CE Bottle unscrambler and labeling machine

Some of Our Customers

Well - known visiting Clients

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

Successful Cases

Argentina Vial and Ampoule line

Malaysia Prefilled Syringe Filling line

Zimbabwe Vial Filling Line

INTERESTED IN MARYA?

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Services

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.

Customer FAQ

Are you manufacturer or trader? Where are your factory located?

We are manufacturer. Our factory is located in Changsha and Suzhou.

What certificate do you have?

We have CE, ISO, ROHS, SGS etc.

What documents will you provide?

Usually we will provide DQ, IQ, PQ, OQ, FAT, SAT, operation manual, maintenance instruction,layout drawing.etc.

What is the production lead time?

Standard 25-60 days after deposit received and technical data confirmed, we can make special arrangement for better shipment if needed;
Standard 60-150 days after deposit received and technical data confirmed based on different machines, we can make special arrangement for better shipment if needed.

How long is your warranty? Can we extend?

12 months after installation and commissioning or 18 moths from the day that the equipment arrived on site. Prevail in the first arrival date.
Warranty can be extended with extra charge.

Have you done similar projects overseas?

Marya’s business map covers more than 60 countries and regions around the world, such as the United States, Russia, Bulgaria, Britain, Portugal, Poland, Switzerland, ltaly, New Zealand, Malta, Moldova, Malaysia, Uzbekistan, lran, Egypt, Saudi Arabia, UAE, Ecuador, Dominica, Panama, Uruguay, Argentina, Tanzania, Zimbabwe, Ethiopia, Indonesia, Bangladesh, and others, and we gained good reputation.

Key words:

Sterile Isolator

Sterile Testing Isolator Manufacturer

Sterile Testing Isolator Supplier

Sterile Testing Isolator Factory

Pharmaceutical Isolator

Pharmaceutical Isolator System

Isolator System Manufacturer

Linkage Production Line Isolator

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Negative-pressure Isolator

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