Automated Cartridge Filling and Stoppering Machine for Biopharmaceuticals
Products Description
ALWELL Automated Cartridge Filling and Stoppering Machine is an advanced, high-precision solution engineered specifically for the biopharmaceutical and life sciences industries. Designed in strict compliance with FDA, EU GMP, and cGMP standards, this fully automated system is ideal for processing high-value biologics, insulin, growth hormones, monoclonal antibodies (mAbs), and dental anesthetics.Equipped with flexible dosing technologies-including high-precision ceramic piston pumps and low-shear peristaltic pumps-the machine guarantees an exceptional filling accuracy of ≤±1%, protecting shear-sensitive protein structures from degradation. Its state-of-the-art vacuum-assisted stoppering system evacuates residual air before stopper insertion, delivering 100% bubble-free sealing to ensure long-term drug stability.Featuring a sleek, laminar-airflow-friendly footprint, the unit seamlessly integrates with LAF, oRABS, and Aseptic Isolator barrier systems to maintain Class A (ISO 5) environmental integrity. With tool-less, rapid format changeovers for various cartridge sizes (1.5ml, 3ml, and custom sizes) and optional 100% IPC checkweighing, ALWELL delivers an end-to-end, ultra-clean, and reliable turnkey solution for modern sterile packaging lines.
Key Features
Precision & Accuracy
Utilizing high-end servo-controlled systems to ensure a filling precision of ±1%, minimizing waste of high-value biologics and GLP-1 medications.
Vacuum Stoppering Technology
Specially designed for high-viscosity gels (like Hyaluronic Acid), our vacuum technology ensures a bubble-free filling process and perfect stopper placement.
RTU Flexibility
Fully compatible with Ready-to-Use (RTU) nest boxes, allowing seamless switching between cartridges, syringes, and vials on a single line.
User-Friendly PLC Control
Set and monitor all parameters-fill volume, speed, and temperature-with ease on the color touchscreen. The intuitive interface simplifies operation and reduces training time.
Robust & Compliant Construction
Manufactured with durable, corrosion-resistant stainless steel in all product-contact areas, the machine meets cGMP standards. Its hygienic design ensures easy cleaning and maintenance.
Modular & Adaptable Design
The number of filling heads can be customized to match your production capacity. The system supports various filling modes (e.g., piston, peristaltic) to suit your specific product requirements.
Technical Specifications
| Parameter | Details |
|---|---|
| Model | YS-PFS Series / Automated Cartridge filling machine |
| Filling Volume Range | 1.5ml, 1.8ml, 3ml, 5ml Cartridges (Glass) / Custom Sizes |
| Filling Accuracy | ±1% |
| Production Capacity | 1,000 - 6,000 pcs/hour (customized) |
| Power Supply | 380V 50HZ |
| Power Consumption | 2KW - 3KW |
| Automation Level | Fully Automatic |
| Control System | PLC with HMI Touchscreen |
| Key Components | Servo Motor, Precision Pump, PLC Controller |
| Stoppering Method | Advanced Vacuum-assisted Stoppering (100% Bubble-free) |
| Special Features | Adjustable Filling Speed |
Industries Served
types of Cartridge Filling Machine
This versatile filling machine is ideal for a wide range of applications:
Biopharmaceuticals
Aseptic Filling for Biologics,GLP-1, Insulin, Hormones, and Vaccines.
Medical Aesthetics
Hyaluronic Acid (HA), Collagen, and Skin Boosters.
Chemical Industry
Reliably fills adhesives, sealants, and other viscous chemical products.
Medical Devices
Dental Anesthesia, Saline Flush, and Cartridge-based delivery systems.
Quality Assurance & Support
We provide a comprehensive 1-year warranty backed by responsive video technical support.
Key components are rigorously tested, and we can provide factory acceptance videos prior to shipment.
Our dedicated after-sales team is committed to delivering timely and expert service to keep your operations running smoothly.
Maximize Your Filling Line Efficiency
Don't let outdated equipment limit your productivity. Our filling experts will provide you with a custom solution tailored to your needs and volume.
Reach out now to discuss your requirements and see how we can help.
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Q1: Can the machine handle high-viscosity gels without bubbles?
A1: Yes, our vacuum filling and stoppering technology is specifically engineered for high-viscosity materials like Hyaluronic Acid, ensuring a bubble-free result.
Q2: Does ALWELL provide validation documents for pharmaceutical audits?
A2: Absolutely. We provide full DQ/IQ/OQ/PQ documentation to help your facility pass GMP and FDA audits smoothly.
Q3: How does the machine handle shear-sensitive proteins and delicate biologics during filling?
A3:We offer customized low-shear peristaltic pump systems with single-use medical-grade silicone tubing. The fluid path contains no mechanical valves or dynamic seals, completely preventing shear force degradation and cross-contamination.
Q4:What mechanism ensures 100% bubble-free sealing during cartridge stoppering?
A4:The system utilizes vacuum-assisted stoppering technology. Before inserting the rubber plunger, the chamber evacuates air from the cartridge neck. The vacuum pulls the plunger into place while drawing out trapped air, ensuring a tight, air-bubble-free seal to protect drugs from oxidation.
Q5：How fast can format changeovers be performed between different cartridge sizes (e.g., 1.5ml to 3ml)?
A5:Thanks to our tool-less quick-clamp design and pre-saved HMI recipe parameters, a complete format changeover (including nests, pumps, and stoppering tools) can be performed by a single operator in under 30 minutes.
Q6:What validation support and documentation (IQ/OQ/PQ) do you provide for cGMP compliance?
Q7:We provide a full, audit-ready validation document package aligned with GAMP 5 and FDA 21 CFR Part 11 standards. This includes FAT/SAT protocols, IQ (Installation Qualification), OQ (Operational Qualification), 316L material traceability certificates, and software validation documentation.
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