Aseptic Fill-Finish Solutions
High-Precision Pre-filled Syringe Filling Machines
From R&D to High-Volume Production: European Quality, Smart Pricing. Your Partner for Aseptic Fill-Finish Success.
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±0.5% Filling Accuracy: Protect your valuable biologics & vaccines with precision that exceeds industry standards.
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Flexible & Scalable: Handle glass/plastic syringes, vials, and cartridges on one versatile platform.
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Full GMP & 21 CFR Part 11 Compliance: Validation-ready solutions with complete documentation packages.
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20-Year Expert Guidance: From concept to production, I'm personally committed to your success.
HIJ Machinery
±0.5%
Fill Accuracy
3,600
Units/Hour
100%
GMP Ready
Complete Range
Explore Our Pre-filled Syringe Filling & Closing Systems
Whether you are a startup lab or a large-scale CMO, we have a system engineered for your specific needs—from semi-automatic tabletop models to fully integrated robotic lines.
Popular
Prefilled Plastic Syringe Filling & Capping Machine
High-speed system for nested plastic syringes with integrated capping for complete fill-finish automation.
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Speed: Up to 3,600 pcs/hr
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Filling Range: 0.5ml - 20ml
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Format: Nested Plastic Syringes (COP/COC)
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Best For: High-volume manufacturing, CMOs, Vaccines
Prefilled Syringe Vacuum Filling & Plugging Machine
Advanced vacuum technology ensures bubble-free filling for sensitive biologics and high-viscosity products.
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Speed: Up to 2,400 pcs/hr
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Filling Range: 1ml - 50ml
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Format: Glass & Plastic Syringes (Nested/Bulk)
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Best For: Biologics, Monoclonal Antibodies, Viscous Products
High Output
Double Head Prefilled Plastic Syringe Filling Machine
Dual-lane design doubles your throughput while maintaining precision and GMP compliance for large-scale production.
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Speed: Up to 7,200 pcs/hr (dual-lane)
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Filling Range: 0.5ml - 10ml
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Format: Nested Plastic Syringes (COP/COC)
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Best For: Large CMOs, Mass Vaccination Programs
Double Head Prefilled Syringe Vacuum Filling Machine
Combines dual-lane efficiency with vacuum technology for maximum output and zero-bubble filling quality.
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Speed: Up to 4,800 pcs/hr (dual-lane)
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Filling Range: 1ml - 50ml
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Format: Glass & Plastic Syringes (Multi-format)
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Best For: High-volume Biologics, Premium Pharmaceuticals
Not Sure Which System Is Right for You?
Let's have a conversation. I'll review your product specifications, production targets, and regulatory requirements to recommend the perfect solution for your needs.
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The HIJ Difference
More Than a Machine—
A Partnership Engineered for Your Success
We Solve Your Toughest Challenges
We don't just sell machines. With 20 years of experience, we specialize in handling sensitive biologics, high-viscosity products, and ensuring bubble-free filling with advanced vacuum technology.
Designed for Sterility & Compliance
Our systems feature RABs/Isolator integration, no-touch transfer, and crevice-free designs to meet the strictest cGMP and FDA requirements for sterile manufacturing.
One Partner, One Integrated Line
From syringe denesting and filling to stoppering, labeling, and plunger rod insertion, we deliver a single, unified solution with one point of contact and guaranteed performance.
30-40% Cost Savings, Zero Compromise
Get the precision, reliability, and documentation of a top European brand without the premium price tag. We make world-class technology accessible.
Ready to Transform Your Production?
Let's Design Your Perfect Fill-Finish Solution Together
Share your production requirements, and I'll personally craft a tailored solution that delivers European quality, ensures regulatory compliance, and fits your budget perfectly.
Schedule My Free Consultation
Response within 24 hours
Direct access to Forester
No-obligation quote
Personal Commitment
A Message From Our Founder
Verified Founder
Forester Xiang
Founder & Chief Engineer
HIJ Machinery
"I've spent 20 years in the trenches, solving the very fill-finish challenges you face today. When you work with HIJ, you get more than a machine; you get my personal commitment to ensuring your project is a success from start to finish. I am your direct line for technical consultation and support."
20+
Years Experience
200+
Projects Delivered
50+
Countries Served
Direct access to 20 years of fill-finish expertise
Application-Specific Solutions
Advanced Solutions for Every Application
From sensitive biologics to high-viscosity formulations, our systems are engineered to handle your specific product with precision and compliance.
Vaccines & Biologics Solutions
Engineered for the most sensitive formulations requiring gentle handling, precise temperature control, and absolute sterility assurance.
Why It Matters
Biological products are highly susceptible to degradation from mechanical stress, temperature fluctuations, and contamination. Our systems protect product integrity while ensuring regulatory compliance.
Gentle Product Handling
Servo-driven peristaltic pumps eliminate shear stress and protein denaturation during filling.
Precise Temperature Control
Jacketed hoppers and pathways maintain 2-8°C for cold chain products with ±0.5°C accuracy.
Single-Use Fluid Paths
Optional disposable contact parts eliminate cross-contamination and reduce cleaning validation.
cGMP Compliant Design
Full IQ/OQ/PQ documentation, 21 CFR Part 11 ready, and FDA-approved material certifications.
High-Viscosity Products (e.g., Hyaluronic Acid)
Specialized pumping, heating, and nozzle designs ensure accurate, drip-free filling of challenging formulations up to 50,000 cP.
Why It Matters
High-viscosity products require significantly higher pressure and specialized nozzle designs to prevent dripping, air entrapment, and dosing inaccuracies.
High-Pressure Servo Pumps
Up to 10 bar filling pressure with <0.5% accuracy for formulations up to 50,000 cP.
Heated Hoppers & Pathways
Jacketed heating systems maintain optimal viscosity (up to 80°C) for consistent flow.
Specialized Nozzle Designs
Anti-drip nozzles with positive shut-off valves ensure zero product waste between cycles.
Vacuum Bubble Removal
Integrated vacuum system eliminates air bubbles for cosmetic-grade fill quality.
R&D & Clinical Trials Solutions
Flexible, small-batch systems designed for development labs with minimal product loss, quick changeover, and comprehensive batch documentation.
Why It Matters
During R&D and clinical phases, product is expensive and scarce. You need flexibility to test multiple formulations with detailed traceability for regulatory submissions.
Compact Tabletop Models
Small footprint designs fit in cleanroom laminar flow hoods for aseptic small-batch production.
Minimal Product Loss
Low dead volume systems (<5ml priming) preserve precious development batches.
Quick Changeover
Tool-free part swapping enables format changes in under 15 minutes without validation.
Detailed Batch Reporting
Auto-generated reports with weight checks, time stamps, and operator IDs for IND/NDA submissions.
Containment Solutions for Potent APIs
Full integration with Restricted Access Barrier Systems (RABs) and isolators to protect operators and products during handling of cytotoxic or potent compounds.
Why It Matters
Potent compounds (OEL <1 µg/m³) require specialized containment to protect operators while maintaining product sterility. Our systems meet both safety and aseptic standards.
RABs/Isolator Integration
Seamless integration with Grade A/B barrier systems for both sterility and containment (ISO 5).
No-Touch Transfer Systems
Automated loading/unloading via RTP (Rapid Transfer Ports) eliminates operator exposure.
Negative Pressure Containment
Continuous air monitoring with -15Pa differential ensures outward contamination prevention.
Operator Safety Certification
Full SMEPAC/DIERS compliance testing with documented OEL validation reports.
Need a Custom Configuration for Your Application?
Every product is unique. Share your formulation characteristics, production targets, and regulatory requirements—I'll engineer a tailored solution that addresses your specific challenges.
Request Custom Engineering Review
Take Action Now
Ready to Build Your Perfect Syringe Fill-Finish Line?
Don't settle for a standard machine. Let's configure a solution that perfectly matches your product, process, and production goals.
Get Your Custom Solution in 3 Simple Steps
Share your requirements, and I'll personally review your project within 24 hours to provide a detailed technical proposal and competitive quote.
What We'll Discuss:
- Your product specifications (viscosity, temperature, fill volume)
- Required production capacity and automation level
- Syringe format (glass/plastic, size, pre-filled/empty)
- Regulatory requirements (FDA, EMA, WHO GMP)
- Integration with existing equipment (RABs, isolators, etc.)
- Budget constraints and timeline expectations
24-Hour Response
Direct to Forester
No Obligation
Prefer to Speak Directly?
WhatsApp
Phone (China)
Headquarters
Ruian City, Zhejiang Province, China
Trusted by Industry Leaders
20+
Years Experience
200+
Projects Delivered
50+
Countries Served
30-40%
Cost Savings
Forester's Personal Guarantee
Every quote includes my direct involvement in technical review, ensuring your solution is engineered for success—not just sold.
Clearing Your Doubts
Your Questions on Pre-filled Syringe Systems, Answered
We've compiled answers to the most common technical and commercial questions. For anything else, my direct line is always open.
Excellent question. This is a critical decision based on your product. We offer both technologies and will help you choose the right one. Here's a quick comparison:
| Feature | Servo-Pump Filling | Vacuum Piston-Stoppering |
|---|---|---|
| Best for | High-viscosity (e.g., Hyaluronic Acid), sensitive biologics, large volumes | Low-viscosity aqueous solutions, small to medium volumes |
| Mechanism | Direct liquid displacement with high-precision pumps (peristaltic or rotary piston) | Syringe barrel is evacuated, causing liquid to be drawn in, followed by stopper insertion under vacuum |
| Advantage | Extremely high accuracy (<0.5%), minimal shear stress, handles a wide range of viscosities | Eliminates air bubbles in the syringe, ideal for oxygen-sensitive products, ensures proper stopper placement |
Our Recommendation: For maximum flexibility, especially in R&D, we often recommend servo-pump systems. For high-speed, dedicated production of low-viscosity products, vacuum filling is highly efficient. We'll analyze your URS to determine the optimal solution.
Sterility assurance is our highest priority and is built into our designs from the ground up, fully compliant with cGMP standards. Here's how:
- Laminar Air Flow (LAF): The entire filling and stoppering area is protected by a Grade A (ISO 5) unidirectional laminar flow of HEPA-filtered air.
- Barrier Systems: Our machines are designed for seamless integration with Restricted Access Barrier Systems (RABs) and full isolators.
- Material & Design: All product contact parts are 316L stainless steel, electropolished to <0.5 µm Ra. The machine frame is designed with minimal flat surfaces and no exposed threads to facilitate effective cleaning.
- CIP/SIP Systems: We offer fully automated Clean-In-Place (CIP) and Sterilize-In-Place (SIP) systems for the entire fluid path.
- No Human Intervention: The process is fully automated from nest loading to syringe discharge, eliminating the primary source of contamination.
Yes, absolutely. This flexibility is a core design principle at HIJ. We understand that your product portfolio may evolve, and your equipment must be future-proof.
Our systems are engineered for rapid, tool-free changeover between different syringe types and sizes. This is achieved through:
- Quick-change format parts: The nest holder, gripper heads, and other format-specific parts can be swapped in under 30 minutes without special tools.
- Servo-driven flexibility: All movements are recipe-controlled via the HMI. Switching from a 1ml long glass syringe to a 5ml COP syringe is as simple as loading the correct pre-saved recipe.
- Universal Grippers: We offer optional universal gripper designs that can handle a range of syringe diameters with minimal adjustment.
Simply provide us with the datasheets for all syringe formats you plan to use, and we will deliver a qualified set of change parts with your machine.
Our lead time is significantly more competitive than European manufacturers while maintaining equivalent quality standards. The exact timeline depends on the complexity of your project.
- Standard Tabletop Machines (R&D): Typically 8-10 weeks.
- Semi-automatic Production Lines: Approximately 12-16 weeks.
- Fully Automatic, High-Speed Turnkey Lines (including integration with upstream/downstream equipment): Generally 20-26 weeks.
This timeline includes design finalization (URS), manufacturing, internal assembly, software development, and Factory Acceptance Testing (FAT). We pride ourselves on transparent project management, and you will receive weekly progress updates from our dedicated project manager.
We provide a comprehensive cGMP-compliant validation package that is designed to make your qualification process as smooth and fast as possible. Our standard package includes:
- Design Qualification (DQ): We work with you to ensure our design meets your User Requirement Specification (URS).
- Factory Acceptance Test (FAT): Performed at our facility with you present (in-person or remotely), with a detailed protocol and report.
- Site Acceptance Test (SAT): Support for testing after installation at your site.
- Full IQ/OQ Documentation: A detailed set of Installation Qualification (IQ) and Operational Qualification (OQ) protocols ready for execution by your team. This includes all necessary drawings, material certificates (3.1), calibration certificates, and software validation documentation.
- 21 CFR Part 11 Compliance: Our software includes features like secure electronic records, audit trails, and multi-level user access to meet FDA requirements.
We can also provide on-site support for protocol execution and team training as an optional service. Our goal is to ensure you pass your regulatory audits with confidence.
Have a More Specific Question?
Your project is unique. Let's skip the guesswork. Schedule a direct call with me to discuss your specific technical challenges and project goals.
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