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Pharmaceutical Cleanroom HVAC system

Pharmaceutical clean room HVAC system (Heating, Ventilation, and Air Conditioning) is an air handling system designed specifically for pharmaceutical production environments. It ensures compliance with Good Manufacturing Practice (GMP) and related regulatory requirements and guarantees drug quality and safety by precisely controlling temperature, humidity, cleanliness, airflow organization, and pressure gradient.

Core Advantages
Core Technology
Technical Parameters
Application Scenarios
Optional Systems

▸ Key components and functional features

KEY COMPONETS	FUNCTIONAL FEATURES
High-efficiency air filtration system	● Use HEPA (high-efficiency air filter) or ULPA (ultra-high-efficiency air filter) to filter particles. ● Configure a three-stage filtration system of pre-filtration → medium-efficiency filtration → high-efficiency filtration
Temperature and humidity control unit	● continuously send a certain amount of processed air into the clean room to eliminate internal and external heat and humidity interference. ● Meet different process requirements.
Pressure gradient managementsystem	● Prevent cross contamination through positive pressure/negative pressure control ● The pressure difference between clean and non-clean areas is ≥10Pa, and the pressure difference between adjacent clean areas is ≥5Pa ● The biosafety laboratory adopts a gradient negative pressure design to prevent the spread of pathogens
Directional airflow organizationsystem	● Vertical unidirectional flow or horizontal unidirectional flow design to ensure that the wind speed in the key operation area is 0.3-0.5m/s ● Turbulent mixing is used in non-unidirectional flow areas, and the number of ventilation times reaches 15-25 times/ hours
Hazardous gas treatmentmodule	● Configure activated carbon adsorption and chemical filtration devices to treat process waste gases such as VOCs ● The exhaust of the biological safety cabinet must be discharged after high-efficiency filtration
Energy saving and intelligent control system	● Heat recovery technology，energy saving rate of 60%. ● Variable frequency speed regulation: The fan uses a VFD inverter to adjust the speed according to the load (energy saving 30-50%)

▸ Compliance requirements

ISO 14644-1 (clean room classification standard)
EU GMP Annex 1 (sterile drug production)
FDA cGMP (current US drug production specification)

▸ Typical application scenarios

● Sterile preparation production (injection, lyophilized powder injection)
● Biological product production (vaccines, monoclonal antibody drugs)
● API refining (high-activity API processing)
● Medical device clean assembly (implantable devices)

▸ Why choose MARYA

● Production Equipment
We have strong technical force and excellent production equipment, including laser cutting machine, numerical control punching machine, numerical control bending machine, plate shearing machine, numerical control milling machine, automatic leveling machine, bending production line, automatic hollow glass window production line, automatic door plate strip sealing machine, automatic spraying production line and other processing equipment, as well as various precision testing instruments and equipment.

● Product Market
Marya scope of business 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.

● Rich Experience
Our experienced engineering team with more than 20 years experience in cleanroom design and construction can ensure that process and materials for your plant is designed and manufactured in the most cost-effective manner with reliablequality to fulfil GMP/FDA/ISO/SGS requirement.

● MARYA Service
Continuous technical and service support: No matter what products and services you buy from our company, no matter when your project is completed, we will continue to provide you with operation, maintenance, spare parts supply and factory upgrading consulting services. If necessary, our technicians can provide technical support and services to all Marya customers directly or remotely.

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

Tanzania Cleanroom Project

Malta Cleanroom Project

Bangladesh Cleanroom Project

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:

HVAC Air Duct System

air duct

hvac system

cleanroom pipeline engineering

None

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Cleanroom Air Handling Unit (AHU)

Contact MARYA Engineers to Claim Your Free GMP compliant Sterile Pharmaceutical Production Line Solution