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Products

Linkage Production Line Isolator

The pharmaceutical isolation system is integrated and installed on aseptic filling machines or other related pharmaceutical equipment to construct a controlled enclosed structure or physical barrier, achieving a complete separation between operators and the drug production process. By implementing this system in the aseptic filling process, the potential risk of drug contamination during production can be significantly reduced. This ensures and substantially enhances drug quality from the source, making certain that the drugs meet stringent quality standards and regulatory requirements.

Core Advantages
Core Technology
Technical Parameters
Application Scenarios
Optional Systems

▸ Performance and features

1.Comprehensive product portfolio: isolation systems for water injection, powder injection, pre-filled syringe and sterile powder production lines;
2.Stable and reliable environment: reliable and stable class A environment, which meets cGMP, FDA, ISO, ISPE, and pharmacopoeia requirements;
3.New VHPS technology: the latest H2O2 sterilization system, which can achieve rapid sterilization, control the concentration and saturation of H2O2, with good sterilization reproducibility
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.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;
6.Integrated monitoring system: integrated monitoring systems of temperature and humidity, differential pressure, air speed, H2O2 concentration, optical grating, particles and airborne viable bacteria, etc.;
7.Multiple sterile transfer solutions: multiple and combined sterile transfer solutions are available to meet customers’ diversified production needs;
8.Wireless glove leakage detector: multi-head wired glove leakage detector or wireless glove leakage detector is optional

▸ MARYA Unique Services

1. MOCK-UP service:

Complete wood model verification service, ergonomic operation qualification and 3D model display service in the middle of the project.

2.Sterilization Process Development Support Service:
Qualification and validation services for sterilization cycle development of the whole process can be provided;

3.Customized Service:

Support isolation system design, and provide systematic closed isolation solutions and CE

4.Complete Life Cycle Support:

Covering consulting, project design, installation scheme design and verification

5.CDCV Service:
Sterilization cycle development, validation studies and services;

▸ Specifications

Material	All 304 stainless steel outside and 316L stainless steel inside
Cleanliness level	CLASS A
Wind speed	0.45m/s+20%
Leakage rate	≤ 0.5% VOL/h (below 100pa)
Pressure control range	-100pa~+100pa
Sterilization efficiency	6lg
VHP residue removal efficiency	≤1ppm
noise	≤85dB(A)
illumination	≥350LUX

▸ Use case scenarios

We integrate isolators, filling machines, decontamination equipment and HVAC technology to secure highly efficient, safe processes for your aseptic processing requirements.
Vial filling line with isolator

Cartridge filling line with isolator

Prefilled Syringe filling line with isolator

Material	All 304 stainless steel outside and 316L stainless steel inside
Cleanliness level	CLASS A
Wind speed	0.45m/s+20%
Leakage rate	≤ 0.5% VOL/h (below 100pa)
Pressure control range	-100pa~+100pa
Sterilization efficiency	6lg
VHP residue removal efficiency	≤1ppm
noise	≤85dB(A)
illumination	≥350LUX

We integrate isolators, filling machines, decontamination equipment and HVAC technology to secure highly efficient, safe processes for your aseptic processing requirements.

● Vial filling line with isolator
● Cartridge filling line with isolator
● Prefilled Syringe filling line with isolator

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?

Get In Touch With Us.

We Will Be Happy To Discuss Our Solutions And Services With You.

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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:

Linkage Production Line Isolator

pharmaceutical isolation system

isolation system

H2O2 sterilization system

Linkage Production Line Isolator Manufacturer

None

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Sterile testing Isolator

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