Modular Sterile Ampoule Filling Line 300bpm Speed for Vaccines and Biologics with ISO 14644 Compliance
Price:
USD 150,000-350,000 per unit
MOQ:
1 unit
Delivery Time:
180 work days
Brand:
Lingyao
Product Description
Modular Sterile Ampoule Filling Line for Pharmaceutical Production
This advanced modular sterile ampoule filling line is engineered for vaccine producers, biologics manufacturers, and high-value injectable drug companies. The system integrates cutting-edge aseptic technology with exceptional adaptability to meet the highest pharmaceutical standards.
Key Technical Features
Zero-Contamination Ecosystem
Features ISO 14644 Class 5 cleanroom-compatible laminar airflow and robotic glove ports, achieving 99.9% sterility assurance levels critical for COVID-19 vaccines, monoclonal antibodies, and cell therapies.
Smart Modular Design
Patented Quick-Switch Cassette System enables seamless switching between 1ml insulin ampoules and 50ml IV solutions, reducing changeover time by 70% while maintaining ±0.5% filling accuracy.
Energy-Efficient Operation
AI-driven predictive maintenance and servo-driven pumps deliver 100-300 bottles per minute (bpm) operation while reducing energy consumption by 35% compared to traditional systems.
Advanced Traceability
Embedded IoT sensors generate real-time batch records compliant with FDA 21 CFR Part 11 and EU Annex 11, providing end-to-end traceability from filling to final packaging.
Technical Specifications
| Parameter | Specification |
|---|---|
| Product Model | LYQCL100+LYASMR 620/43+LYAGF8 |
| Size Range | 1-20ml national standard ampoules |
| Output (1-2ml) | 16,000-30,000 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 | 0.2-0.4Mpa / 0.6-1.0m³/h |
| Cleaning CA Consumption/Pressure | 0.3-0.6Mpa / 35-80m³/h 0.3-1.0Mpa / 35-80m³/h |
| Sealed Gas | Gas (liquefied gas) + oxygen, oxyhydrogen generation gas, natural gas |
| Oxygen Consumption | 0.2-0.3Mpa, 1.2-1.5m³/h |
| Gas Consumption | 0.1-0.3Mpa, 1.5-2.5m³/h |
| Exhaust Volume | 3,500-4,100m³/h |
| Net Weight | 7,800 kg |
| Total Power | Approximately 72kw, 380V, 50HZ |
| Outline Size | Approximately 9940x2260x2445mm |
Product Images
Advanced Capabilities
Dual-Defense Sealing Technology
Combines laser pre-sealing and nitrogen flush for oxygen-sensitive biologics, ensuring maximum product protection.
Material Versatility
Processes Type I glass ampoules and cyclic olefin copolymer (COC) containers with equal precision.
Climate-Adaptive Performance
Reinforced thermal control modules ensure stable operation in challenging environments, including Middle Eastern high-temperature conditions.
Certifications & Compliance
ISO 9001, CE, GMP (EU & WHO), FDA 510(k) pending
Customization Options
Available for lyophilized products, radioactive tracers, and viscous biologics to meet specific production requirements.
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Get in Touch
Have questions about our products or want to discuss a custom order? Our team is ready to help you.
Company
Suzhou Lingyao Intelligent Equipment Co., Ltd.
Location
No. 115 Zhujia road, Lujia town,Kunshan,Jiangsu Province
Contact Person
Jerry