Aseptic Ampoule Filling Line EU GMP Compliant 16000-22000 pcs/h Output for 1-20ml Vaccine Production
Price:
USD 150,000-350,000 per unit
MOQ:
1 unit
Delivery Time:
180 work days
Product Description
Advanced Aseptic Ampoule Filling Line for Pharmaceutical Production
EU GMP Compliant Sterile Processing Solution
This advanced aseptic ampoule filling line delivers 99.9% sterility assurance for high-value biologics, vaccines, and pharmaceutical products. Engineered to meet Europe's stringent pharmaceutical standards, the system combines cutting-edge isolator technology with intelligent process control for critical applications including mRNA vaccines and monoclonal antibodies.
Key Operational Advantages
Zero Cross-Contamination: Closed-system RABS (Restricted Access Barrier System) with glove ports ensures operator safety and product integrity.
Rapid Format Switching: Automatically adjusts between 1ml insulin ampoules and 20ml diagnostic reagents in ≤3 minutes.
Energy Efficient Operation: Heat recovery from sterilization tunnels reduces energy waste by 18%.
Complete Traceability: Embedded IoT sensors log every ampoule's fill weight, seal integrity, and sterilization parameters for EU MDR compliance.
Technical Specifications
| Parameter | Specification |
|---|---|
| Product Model | LYQCL100+LYASMR 620/43+LYAGF8 |
| Size Range | 1-20ml national standard ampoules |
| Output (1-2ml) | 16,000-22,000 pcs/h |
| Output (5-10ml) | 8,000-12,000 pcs/h |
| Output (20ml) | 5,000-7,000 pcs/h |
| Clarity | >99% |
| Breakage Rate | ≤1% (whole line) |
| Filling Precision | ±0.5-2% (according to pharmacopoeia standard) |
| Water Consumption/Pressure | 0.2-0.4 Mpa / 0.6-1.0 m³/h |
| Cleaning CA Consumption/Pressure | 0.3-0.6 Mpa / 35-80 m³/h |
| Sealed Gas | Gas (liquefied gas) + oxygen, oxyhydrogen generation gas, natural gas |
| Oxygen Consumption | 0.2-0.3 Mpa, 1.2-1.5 m³/h |
| Gas Consumption | 0.1-0.3 Mpa, 1.5-2.5 m³/h |
| Exhaust Volume | 3,500-4,100 m³/h |
| Net Weight | 7,800 kg |
| Total Power | Approximately 72 kW, 380V 50HZ |
| Outline Size | Approximately 9,940 x 2,260 x 2,445 mm |
Advanced Technical Features
Smart Alarms: Predictive maintenance alerts for pump wear or seal degradation
CIP/SIP Ready: Validated clean-in-place cycles meet EMA guidelines
Dual-Language HMI: English/German touchscreen with 21 CFR Part 11 audit trails
Anti-Vibration Platform: Minimizes liquid splashing during high-speed filling operations
Pulsed Volumetric Filling: Reduces fill-loss by up to 37% for high-value therapies
Product Images
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Get in Touch
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Company
Suzhou Lingyao Intelligent Equipment Co., Ltd.
Location
No. 115 Zhujia road, Lujia town,Kunshan,Jiangsu Province
Contact Person
Jerry