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Pharmaceutical Pure Steam Generator

A pure steam generator is a device that generates pharmaceutical-grade pure steam (PS) based on distillation (i.e., thermal process). It is mainly used for the high-temperature sterilization of clean equipment to meet the CIP/SIP requirements of the equipment.

Working Principle
Core Features
Technical Parameters
Application Industry

Usually, deionized water or purified water is used as the raw water, which is transported to the pollution removal column, pre - heater, heat exchanger and other parts inside the equipment through the feed pump. Industrial steam or heated water enters the heat exchanger to heat the raw water to the evaporation temperature. A strong thermal cycle is formed in components such as the evaporator, causing the water to evaporate and generate steam. Meanwhile, gravity and special separation devices (such as labyrinth separators and spiral centrifugal separators) are used to remove possible small water droplets and impurities in the steam. The opening degree of the industrial steam inlet valve is adjusted by a pneumatic regulator to maintain the pressure of the pure steam constant at the set value.
1.The pure steam production capacity can respond quickly to the demand, greatly shortening the sterilization cycle.
2.Precise control of pure steam output pressure and temperature, with fluctuations within ±5%.
3.It can operate unattended and is suitable for parallel use at multiple sterilization points with different requirements.
4.Typical waste discharge ratio: 2 - 8%.
5.Output range of pure steam generation pressure: 2 - 5 bar.
6.The quality of pure steam meets the requirements of non-condensable gas content, dryness and superheat degree defined in the HTM2010 (EN285) standard.

Design Pressure（MPa)	0.6
Working Pressure(MPa)	0.3~0.5
Distilled Water Output（kg/h）	100~4000kg/h
Distilled Water Temperature(℃)	125~145℃
PH Value	5.0-7.0
Conductivity (at 20 °C)	≤1.0μs/cm
Total Organic Carbon (TOC)	≤250ppb（20℃）
Bacterial Endotoxin	≤0.125 EU/ml
Microbial Limit	Escherichia coli, Salmonella, and Pseudomonas aeruginosa shall not be detected
	The total number of bacteria, molds, and yeasts shall not exceed 2 per 100 ml
	The total number of bacteria, molds, and yeasts shall not exceed 10 per 100 ml
Other indicators of Water for Injection comply with	Chinese Pharmacopoeia (2020 Edition)
	United States Pharmacopeia (USP38)
	European Pharmacopoeia (EP6.8)

① Equipment sterilization: Sterilization of equipment (e.g., fermenters, pipelines), sterile garments, filling parts, culture media, etc.
② SIP (Steam-In-Place) systems: Direct injection into pipelines or containers for in-situ sterilization.
③ Clean environment assurance: Humidification of air in sterile areas.
④ Equipment and surface disinfection: Steam fumigation of critical area surfaces (e.g., isolators, RABS).

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:

Pure Steam Generator

Pharmaceutical Multi-effect Distilled Water Machine

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