Aseptic Ampoule Filling Line for High Precision Vaccine and Biologics EU GMP Compliant, 99.9% Sterility Assurance

Certification:CE, ISO, GMP
Model Number:LYAPL1-20-I
Minimum Order Quantity:1 unit
Delivery Time:180 work days
Payment Terms:D/A,D/P,T/T,Western Union,MoneyGram
Place of Origin:China
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Address: No. 115 Zhujia road, Lujia town,Kunshan,Jiangsu Province
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Aseptic Ampoule Filling Line for High Precision Vaccine and Biologics EU GMP Compliant, 99.9% Sterility Assurance


Revolutionize Your Sterile Ampoule Production with Smart Aseptic Filling
The Aseptic Ampoule Filling Line is engineered to meet Europe’s stringent pharmaceutical standards, combining cutting-edge isolator technology with AI-driven process control. Designed for critical applications like mRNA vaccines and monoclonal antibodies, this line ensures 99.9% sterility assurance through HEPA-filtered laminar airflow and real-time particulate monitoring.

Why European Clients Choose This Line:
Zero Cross-Contamination – Closed-system RABS (Restricted Access Barrier System) with glove ports for operator safety.
Adaptive Format Switching – Automatically adjusts between 1ml insulin ampoules and 20ml diagnostic reagents in ≤3 minutes.
Green Manufacturing – Heat recovery from sterilization tunnels reduces energy waste by 18%.
Blockchain Traceability – Embedded IoT sensors log every ampoule’s fill weight, seal integrity, and sterilization parameters for EU MDR compliance.


Aseptic Ampoule Filling Line Spec:

technical parameters
 
product modelLYQCL100+LYASMR
620/43+LYAGF8
size range1-20ml national standard ampoules
Output(1-2ml)16000-22000pcs/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 Pressure0.2-0.4Mpa / 0.6-1.0m³/h
Cleaning CA Consumption and Pressure0.3-0.6Mpa / 35-80m³/h 0.3-1.0Mpa / 35-80m³/h
Sealed gasGas(liquefied gas)+oxygen, oxyhydrogen generation gas, natural gas
Oxygen consumption0.2-0.3Mpa,1.2-1.5m³/h
Gas consumption0.1-0.3Mpa,1.5-2.5m³/h
Exhaust volume3500-4100m³/h
Net weight7800(kg)
Total poweraround 72kw 380V 50HZ
Outline sizearound 9940x2260x2445mm


Real-World Application Spotlight
A Swiss biotech firm reduced fill-loss by 37% using this line’s pulsed volumetric filling technology, crucial for €10,000+/liter gene therapies. The machine’s anti-vibration platform also minimized liquid splashing during high-speed filling of adjuvanted flu vaccines.

Technical Edge

  • 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.
China Aseptic Ampoule Filling Line for High Precision Vaccine and Biologics EU GMP Compliant, 99.9% Sterility Assurance supplier

Aseptic Ampoule Filling Line for High Precision Vaccine and Biologics EU GMP Compliant, 99.9% Sterility Assurance

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