Product Overview
Needle Filling Machine | Precision Filling for Pre-Filled Syringes
Our Automated Needle Filling Machine is an integrated production line designed for the high-speed, high-accuracy filling of pre-filled syringes (PFS). Engineered for the most demanding pharmaceutical and biotech applications, it performs critical functions-including feeding, liquid filling, stopper placement, and cap sealing-within a single, automated system.
The machine is built to operate seamlessly within ISO 5/Class 100 environments and is commonly integrated with RABS or Isolators to ensure maximum sterility assurance. It is the cornerstone of manufacturing for injectable drugs, vaccines, and other sensitive biologics, ensuring full compliance with cGMP, FDA, and EMA regulations.
Technical Specifications
| Parameter | Specification |
|---|---|
| Compatible Syringes | 1mL, 3mL, 5mL, 10mL standard pre-filled syringes (Customizable) |
| Throughput | Up to 11,000 units/hour (Syringe & product dependent) |
| Filling Accuracy | ≤ ±1% (Aqueous solutions); excellent for micro-dosing below 1mL |
| Control System | Color HMI Touchscreen & PLC, with recipe storage |
| Aseptic Assurance | Integrated RABS; Optional full Isolator |
| Product Contact Parts | 316L Stainless Steel, electro-polished surfaces |
| Key Modules | Feeding, Vision Inspection, Filling, Stoppering, Cap Sealing, Discharge |
| Utilities | Customized based on plant layout |
Key Features & Advantages
Needle Filling Machine
Uncompromising Sterility & Product Integrity
No-Drip, Submerged Filling: The filling needle descends into the syringe barrel, filling from the bottom-up. This minimizes aerosol generation, prevents foaming, and eliminates cross-contamination.
Built-in Aseptic Core: Designed for integration with RABS or Isolators, providing a protected Grade A environment for the most critical process steps.
01
Pharmaceutical-Grade Precision
Servo-driven motors paired with high-accuracy ceramic or glass pumps deliver consistent fill volumes from micro-doses to standard volumes.
An intelligent "slow-fast-slow" filling profile adapts to the viscosity of your product, drastically reducing the risk of foam formation.
02
Smart, Flexible & Compliant by Design
Quick Changeover: Change syringe formats in minutes with pre-set recipes stored in the HMI.
100% In-Process Control: Integrated checkweighers, missing-stopper detection, and vision inspection systems guarantee every unit meets quality specs.
Data Integrity: Our software is fully compliant with FDA 21 CFR Part 11, providing complete electronic records and audit trails.
03
Maximized Operational Efficiency
High automation reduces manual intervention, lowering labor costs and human error.
A modular design ensures easy cleaning, maintenance, and future upgrades, delivering a lower total cost of ownership.
04
Primary Applications
Pharmaceuticals
Vaccines, monoclonal antibodies, insulins, growth hormones.
Biotechnology
Gene therapies, cell culture media, clinical trial materials.
Advanced Aesthetics/Cosmeceuticals
Hyaluronic acid fillers, collagen, and premium serums in pre-filled syringes.
Why Partner With Us?
Proven Expertise: Our machines are trusted by leading global pharmaceutical companies, with a track record of reliability and performance.
Full Validation Support: We provide comprehensive documentation packages (DQ/IQ/OQ/PQ) to accelerate your validation and regulatory approval process.
📞 Get a Customized Solution
Fill out the form to concact with our engineering team. We will provide a tailored technical proposal and a detailed quote to meet your specific production needs.
FAQ
Q: What types of liquids are compatible with this Needle Filling Machine?
A: Our equipment is specifically engineered for a wide range of pharmaceutical liquids, with a focus on Normal Saline (0.9% NaCl), Heparin flushes, and high-viscosity gels. The system uses high-precision pumps to ensure stable, bubble-free filling for all Flush Syringe applications.
Q: How does the machine ensure the precision required for pharmaceutical standards?
A: As a professional Pharmaceutical Liquid Filling Machine, our system features advanced servo-driven control and ceramic or peristaltic pumps. We guarantee a filling precision of ≤ ±1%, minimizing the waste of expensive medical solutions and ensuring every PFS (Prefilled Syringe) meets strict dosage requirements.
Q: Can this filling line be customized for different syringe sizes?
A: Yes. ALWELL provides Customized Filling Solutions. By using modular changeover parts, our Integrated Saline Filling Line can handle various syringe volumes (e.g., 3ml, 5ml, 10ml, or 20ml). This flexibility makes it an ideal choice for facilities requiring multi-container compatibility.
Q: Does the equipment comply with international GMP and FDA regulations?
A: Absolutely. Our Aseptic Filling Equipment is designed in full compliance with GMP and FDA standards. The control software supports 21 CFR Part 11, featuring electronic records and audit trails to ensure your production data is secure and ready for regulatory inspections.
Q: What is the typical production speed of the Saline Flush Filling & Labeling Line?
A: Depending on the model and the number of filling heads, our Automatic Filling & Packaging Lines can reach speeds from 2,000 to over 10,000 pcs/hr. We offer both lab-scale R&D units and high-speed mass production lines to match your facility's output goals.
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