Modular Sterile Ampoule Filling Line For Vaccines And Biologics,
ISO 14644 Compliance, Quick Change Modular Design, 300bpm Speed
Revolutionize Pharmaceutical Production with Next-Gen Modular
Sterile Ampoule Filling Line
In an era where precision and sterility define pharmaceutical
excellence, our Modular Sterile Ampoule Filling Line redefines industry benchmarks. Designed for vaccine producers,
biologics manufacturers, and high-value injectable drug companies,
this system integrates cutting-edge aseptic technology with
unparalleled adaptability.
Key Innovations:
1️⃣ Zero-Contamination Ecosystem
Equipped with ISO 14644 Class 5 cleanroom-compatible laminar
airflow and robotic glove ports, this ampoule filling line achieves
99.9% sterility assurance levels (SAL) – critical for COVID-19 vaccines, monoclonal antibodies, and cell
therapies.
2️⃣ Smart Modular Design
Switch seamlessly between 1ml insulin ampoules and 50ml IV
solutions with our patented Quick-Switch Cassette System. Reduce changeover time by 70% while maintaining ±0.5% filling
accuracy – a game-changer for CDMO facilities handling
multi-product batches.
3️⃣ Energy-Efficient Precision
Leveraging AI-driven predictive maintenance and servo-driven pumps,
the line operates at 100-300 bottles per minute (bpm) while cutting energy consumption by 35% compared to traditional
systems.
4️⃣ Blockchain-Ready Traceability
Embedded IoT sensors generate real-time batch records compliant
with FDA 21 CFR Part 11 and EU Annex 11, enabling end-to-end
traceability from filling to final packaging.
Main Spec:
| technical parameters |
| |
| product model | LYQCL100+LYASMR
620/43+LYAGF8 |
| size range | 1-20ml national standard ampoules |
| Output(1-2ml) | 16,000-30,000pcs/h |
| Output(5-10ml) | 8000-12000pcs/h |
| Output(20ml) | 5000-7000pcs/h |
| Clarity | ＞99% |
| Breakage rate | ≤1%(whole line) |
| Filling Precision | ±0.5-2%(according to pharmacopoeia standard) |
| Water Consumption and Pressure | 0.2-0.4Mpa / 0.6-1.0m³/h |
| Cleaning CA Consumption and 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 | 3500-4100m³/h |
| Net weight | 7800(kg) |
| Total power | around 72kw 380V 50HZ |
| Outline size | around 9940x2260x2445mm |
Why Choose This System?
- Dual-Defense Sealing: Combines laser pre-sealing and nitrogen flush for
oxygen-sensitive biologics.
- Material Versatility: Processes Type I glass ampoules and cyclic olefin copolymer (COC)
containers.
- Climate-Adaptive: Reinforced thermal control modules ensure stable operation in
Middle Eastern high-temperature environments.
Trusted by pharmaceutical giants across 15 countries, including
vaccine hubs in the UAE and European CDMOs, our ampoule filling
line has processed over 200 million doses with zero critical deviations reported.
Certifications: ISO 9001, CE, GMP (EU & WHO), FDA 510(k) pending.
Customization: Available for lyophilized products, radioactive tracers, and
viscous biologics.
Elevate your aseptic manufacturing today – where modularity meets
uncompromising sterility.
