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Negative-pressure Isolator

MARYA negative-pressure isolator is used for weighing, dispensing, batching, sampling and other operations of highly active, allergenic and toxic drugs, protecting operators from the harm of drugs and preventing drug dust from polluting the environment. The internal environment cleanliness is Class C and meets process and cGMP requirements. Widely used in the medical fields, pharmaceutical fields, chemical fields, food industry, etc.
Generally, it consists of an operating cabin, a continuous bagging system, an RTP valve system, a control system, a cleaning system, a sterilization system.

Core Advantages
Core Technology
Technical Parameters
Application Scenarios
Optional Systems

▸ Features

● The internal air pressure is lower than the external environmental pressure, forming a negative pressure environment, and the air can only flow into the isolator in one direction
● High protection level: up to the highest OEB5(OEL< 1 ug/m3)
● Professional customization: according to different process requirements(explosion-proof function is optional), we provide the most suitable isolator design and complete MOCK-UP early in the design and 3D display in the middle of a project.
● Intelligent: a number of expansion ports such as printing, storage, etc. Can be integrated into SCADA system.
● Automatic regulation and emergency system: when leakage occurs, the isolator automatically gives an alarm and adjusts the fan frequency to ensure that the air speed of crack is greater than 0.5 m/s.
● Material transfer: configurable RTP and online waste discharge port.
● Perfect WIP system: the bottom of the chamber is designed to be inclined and the internal arc angle R≥20, without hard-to-clean places;
● Safe filter replacement: PUSH-PUSH filters of the air handling system can be replaced safely to protect personnel’s safety.
● Real-time monitoring of door status: it can monitor the door opening online and continuously monitor the inflatable sealing 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; the brands of all key components are international first-class such as Camfil, EBM, SIEMENS, etc.

▸ Specifications

Negative pressure range in the cabin	-20~-150Pa
Number of air changes	≥20T/h
Protection class	OEB4,OEB5
Power Supply	AC220V,50Hz
Noise	≤85dB(A)
Illumination	≥350lux

▸ Use case scenarios

Medical Field	Pharmaceutical Field	Research Laboratory	Other Fields
Used to isolate patients with infectious diseases, to prevent the spread of pathogens to medical staff and other patients; it can also be used in negative pressure operating rooms to reduce the risk of infection during surgery and ensure the safety of the surgical environment.	Used for operations such as weighing, packaging, batching, and sampling of highly active, allergenic, and toxic drugs to protect operators from the harm of drugs and prevent drug dust from polluting the environment.	In biosafety laboratories, it is used to raise infectious experimental animals, conduct research and experiments on viruses, bacteria and other microorganisms, ensure that pathogens will not leak out of the laboratory during the experiment, and ensure the safety of experimental personnel and laboratory environment.	In some industrial production processes with high environmental requirements, such as electronic chip manufacturing and food processing, it is used to prevent external pollutants from entering the production environment and ensure product quality.

Negative pressure range in the cabin -20~-150Pa
Number of air changes ≥20T/h
Protection class OEB4,OEB5
Power Supply AC220V,50Hz
noise ≤85dB(A)
illumination ≥350lux
▸ Medical Field:
Used to isolate patients with infectious diseases, to prevent the spread of pathogens to medical staff and other patients; it can also be used in negative pressure operating rooms to reduce the risk of infection during surgery and ensure the safety of the surgical environment.

▸ Pharmaceutical Field:
Used for operations such as weighing, packaging, batching, and sampling of highly active, allergenic, and toxic drugs to protect operators from the harm of drugs and prevent drug dust from polluting the environment.

▸ Research Laboratory:
In biosafety laboratories, it is used to raise infectious experimental animals, conduct research and experiments on viruses, bacteria and other microorganisms, ensure that pathogens will not leak out of the laboratory during the experiment, and ensure the safety of experimental personnel and laboratory environment.

▸ Other Fields:
In some industrial production processes with high environmental requirements, such as electronic chip manufacturing and food processing, it is used to prevent external pollutants from entering the production environment and ensure product quality.

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

Tanzanian Vice President Visits Marya Pharmaceutical EPC Project

NBA (Zimbabwe National Biotechnology Authority) conducts FAT at MARYA’s Factory

NOVO NORDISK client Visit

Clients visit the factory's liquid preparation system

Argentine client visits for FAT in MARYA

Successful Cases

Zimbabwe Vial Filling Line

Malaysia Prefilled Syringe Filling line

Argentina Vial and Ampoule line

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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:

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