Prefilled Syringe Filling Machine
Fully Automatic Prefilled Syringe Filling Machine is designed for high-value biologics, aesthetic materials, and medical solutions. Compliant with GMP and ISO 13485 quality management standards. Featuring modular design, it supports 1mL-20mL syringes (glass/COP materials) and enables high-precision filling (±1% CV) and vacuum stoppering for hyaluronic acid, vaccines, saline solutions, and other sterile applications
Technical Specifications
Pre-filled Syringe Filling Machine
| Parameter | Details |
|---|---|
| Applications | Hyaluronic acid, monoclonal antibodies/vaccines, IV solutions (e.g., saline), collagen (high/low viscosity liquids) |
| Filling Volume | 0.1mL-30mL (customizable) |
| Accuracy | ≤±1% (adjustable based on viscosity) |
| Production Speed | 1,200-4,000 syringes/hour (multi-channel parallel operation) |
| Sealing Method | Vacuum stoppering + capping (anti-oxidation) |
| Control System | Siemens PLC + 10" creen (multi-language support) |
| Material | 316L stainless steel contact surfaces, ceramic pumps (corrosion-resistant) |
| Certifications | CE, TÜV, ISO 9001, GMP (with third-party validation reports) |
Key Features
Prefilled Syringe Filling Machine
1. Precision Filling Technology
Servo-driven ceramic pump: Supports 0.1mL micro-dosing (e.g., vaccines) to 30mL large-volume liquids (e.g., IV solutions), viscosity range 0.5-50,000cP
Vacuum anti-drip system: Dual sealing for needle tips to prevent oxidation and cross-contamination
2. Full-process Aseptic Control
C-RABS isolation system (optional): ISO Class 5 cleanroom integration, particle count ≤3,520/m³.
3. Smart Production Management
Data traceability: Real-time recording of filling volume, batch numbers, and equipment status (FDA 21 CFR Part 11 compliant).
Self-diagnosis: 32 safety mechanisms including no-container stop and blockage alerts
Applications
Pre-filled Syringe Filling Machine Applications
① Aesthetic Medicine Industry
Hyaluronic Acid/Dermal Fillers: Compatible with cross-linked high-viscosity formulas (e.g., microsphere-based fillers), accuracy ±0.5mL
Collagen: Bubble-free filling mode for non-Newtonian fluids.
② Biopharmaceuticals
mRNA Vaccines: Low-temperature filling module (-20°C to 5°C) to preserve drug activity.
Monoclonal Antibodies/Cell Therapies: Nitrogen-purged environment (O₂ <0.1%).
③ Medical Devices
Prefilled Catheter Flushers: High-speed saline/heparin filling (4,000 syringes/hour)
Certifications & Warranty
Global Compliance: EU CE-MDD, FDA cGMP audits (EDMF documentation available).
Warranty: 1-year full machine coverage, 3-year extended warranty for critical components (servo motors, PLC), 48-hour global technical support.
FAQ
Q: Does the Pre-filled Syringe Filling Machine support switching between different prefilled syringe filling machine specifications?
A: Includes quick-change tooling kits (20-minute switch between 1mL↔10mL), compatible with BD, Gerresheimer syringes.
Q: How is the aseptic environment ensured?
A: Validation services (media fill tests, HVAC certification) and optional VHP sterilization ports.
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