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Pre-Filled Saline Syringe Flush Filling Production Line

The Pre-Filled Saline Syringe Flush Filling Production Line is a dedicated automated production system for manufacturing pre-filled catheter flushers and pre-filled syringes. It completes the whole process including 0.9% sodium chloride solution filling, stoppering, and sealing, ensuring full sterility and tight sealing of finished products. It is key equipment in the pharmaceutical sterile filling industry.

Core Advantages
Core Technology
Technical Parameters
Application Scenarios
Optional Systems

Compliance & Traceability: Meets GMP Validation Requirements
- The machine is equipped with a PLC-based intelligent control system, enabling real-time monitoring and full traceability of all production parameters, including cleanliness, flushing pressure, and filling volume. It can automatically generate production reports, assisting enterprises in completing the full validation process of IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification). This helps ensure successful compliance with pharmaceutical industry regulations and mitigates production compliance risks.
- The machine features a modular design with a compact structure, facilitating CIP (Clean-in-Place) and SIP (Sterilize-in-Place). It supports the production of various pharmaceutical liquids such as vaccines, biological products, and sterile flush solutions. The machine allows quick changeover between different models of syringes/catheters, meeting the requirements of pharmaceutical enterprises for large-scale, standardized aseptic production. We uphold the essential standards of aseptic compliance, improve production efficiency, reduce operational and maintenance costs, assist manufacturers in producing high-quality sterile medical consumables that meet industry standards, and strengthen their core market competitiveness.
Full-Process Aseptic Closed-Loop: Eliminates Secondary Contamination
- Aseptic Filling: The system adopts an isolated closed filling design, ensuring no exposure during liquid transfer. Equipped with a rotary ceramic pump and servo control system, the filling accuracy is controlled within ±1%. It is compatible with prefilled syringes of various volumes ranging from 0.1 to 20 mL, minimizing liquid waste and dosage deviation.
- Integrated Automatic Operation: The machine integrates filling, stoppering, and sealing into a fully automated process with no manual intervention. An online seal integrity detection system ensures leak detection accuracy ≤ 0.01 mL, and non-conforming products are automatically rejected, ensuring that every finished product meets aseptic standards.
- Flexible Adaptability: The modular design offers a compact structure, easy cleaning, maintenance, and upgrade. It supports rapid changeover between different sizes of catheters and multiple types of liquid (e.g., vaccines, insulin, sodium chloride flush solution). Parameters can be customized according to enterprise requirements, accommodating both large-scale batch production and small-batch custom orders.
Intelligent Control
- Equipped with an intuitive human-machine interface (HMI), the system enables real-time monitoring of equipment operating status, aseptic environmental parameters, and filling accuracy. Parameters can be stored and retrieved, ensuring full production traceability, facilitating quality control and compliance audits, and reducing operational, maintenance, and training costs.
Material Compliance: Meets Medical-Grade Biocompatibility Standards
- All components that come into contact with the liquid are made of medical-grade stainless steel 316L (in compliance with GB/T 1220-2019), with a surface roughness Ra ≤ 0.4 μm. The surfaces are electropolished to provide resistance to acids, alkalis, and chemical corrosion, with no leaching of harmful substances. The materials are validated to ISO 10993 for biocompatibility of medical devices, eliminating the risk of liquid contamination originating from the material itself, thereby meeting the strict material compliance requirements for the production of sterile medical consumables.
Syringe Feeding & Positioning: The automatic feeding system precisely positions the syringe to ensure the stability of the filling process.
Pharmaceutical Liquid Filling: Servo-controlled filling system guarantees precise dosage accuracy, minimizes product loss, and achieves bubble-free filling. Supports liquid, viscous solutions, and suspension formulations.
Stoppering & Sealing: High-precision automatic rubber stopper insertion maintains the sealing and sterility of the syringe.
Visual Inspection: Optional syringe light inspection machine, integrated camera system to automatically detect foreign matters, air bubbles and abnormal filling volume in the syringe.
Packaging & Palletizing: Smart packaging line automates cartoning, labeling, and palletizing, reducing manual intervention.

Filling Range	0.1ml-20ml(can be customized according to syringe type)
Filling Mode	Customized (metal pump, peristaltic pump, ceramic pump)
Filling Accuracy	±1%
Silicone Oil Spraying Accuracy	0.5mg-2mg
Production Capacity	2000-30000 pcs/hour
Pass Rate	≥99.5%
Capping Pass Rate	≥99.5%
Equipment Noise	≤70db
Power Supply and Power Rating	380V 50HZ

This filling line is widely used in core fields such as pharmaceutical manufacturing and medical consumable production. It is particularly suitable for manufacturers of prefilled plastic syringes and disposable catheter flushers. The line can be employed for filling products that demand extremely high aseptic conditions, including clinical catheter flush solutions, vaccines, biological products, and aesthetic skin booster injections.
▸ Sterility Enhancement System
Isolator + BIBO System: to improve aseptic level of filling environment for highly sensitive drugs.
Automatic Cleaning and Sterilization System (CIP/SIP): to realize automated on-line cleaning and sterilization and reducing downtime.
Nitrogen Filling Unit: to isolate the drug solution from oxygen.

▸ Intelligent Inspection System
Weighing Feedback System: to calibrate the filling volume by real-time weighing, ensuring higher accuracy.
Configurable vacuum filling system for high-viscosity products.
Configurable high performance no bottle no filling, no bottle no capping and linked bottle squeeze stop function.

▸ Automation System
Optional twisted rod labeling machine: automatically insert the plunger rod into the syringe, and complete the syringe labeling, getting ready for final use;
Optional auto-calibration function to realize fully automated filling volume adjustment.

▸ Data Management System
Robot palletizing system: automatically completes the palletizing of finished boxes to improve packaging efficiency.
Audit tracking system: configured with Siemens industrial control machine and WinCC system to realize full recording and tracing of production data.
Laser coding system: print batch number, expiration date and other information on the syringe for easy traceability.
Tailored solutions available for specialized production requirements.

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

Argentina Vial and Ampoule line

Malaysia Prefilled Syringe Filling line

Zimbabwe Vial Filling 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.

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Pre-Filled Syringe Filling Line

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