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Aseptic Ampoule Filling Line for Sensitive Biologics EU-GMP Certified, 99.9% Sterility Assurance, 0.5% Precision

Categories Ampoule Filling Machine
Brand Name: Lingyao
Model Number: LYAPL1-20-I
Certification: CE, ISO, GMP
Place of Origin: China
MOQ: 1 unit
Price: USD 150,000-350,000 per unit
Payment Terms: D/A,D/P,T/T,Western Union,MoneyGram
Supply Ability: 1 unit per month
Delivery Time: 180 work days
Packaging Details: carton, wood carton, pallets
Quality Assurance & Compliance: CE, GMP, ISO, etc..
Aseptic Guarantee: ISO 14644-1 Class 5,Isolator technology with VHP
Precision & Accuracy: High-precision filling +/- 0.5-1%
Automation Level: Fully automated
Scalability & Flexibility: 1-20ml glass ampoules
Smart Precision Control: Micro-dosing pumps (±0.5% accuracy for 1-20ml biologics like vaccines or monoclonal antibodies)
After-sales Service & Technical Support: 1-2 years guarantee maintenance, free spare parts available, and troubleshooting assistance to minimize downtime
Energy Efficiency: water, energy aligned with sustainability goals
Data Integrity & Traceability: 21 CFR Part 11
Material Compatibility: SS316
Proven Track Record: Available
Machine Name: Vial Filling Line
Function: Vials Washing, Sterilization, Filling, Plugging, Capping
Filling Volume: 2-30ml
Filling Liquid Type: Vaccine
Output Capacity: 6000-26000 BPH
Vials Material: Glass
Filling Accuracy: +/-0.5%
Breakage Rate: <0.5%
Nitrigon Filling: Yes
CIP/SIP: Yes
Oven Cooling Style: Water Cooling
Plugging Style: Half
Capping Head: Multi
LAF: Yes
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Aseptic Ampoule Filling Line for Sensitive Biologics EU-GMP Certified, 99.9% Sterility Assurance, 0.5% Precision

Aseptic Ampoule Filling Line for Sensitive Biologics EU-GMP Certified, 99.9% Sterility Assurance, 0.5% Precision


Revolutionize Your Sterile Injectable Production with Our Aseptic Ampoule Filling Line

In the heart of biopharma hubs, precision and sterility are non-negotiable. Our Aseptic Ampoule Filling Line redefines excellence for sensitive biologics—from mRNA vaccines to gene therapies.

Why European Pharma Giants Trust Us:
Zero-Contamination Assurance
Integrated isolators and VHP decontamination cycles ensure 99.9% sterility, critical for EMA-regulated products like insulin or oncology injectables.

Nanoscale Precision for Micro-Dosing
Patented peristaltic pumps deliver ±0.5% accuracy, even for viscous solutions (e.g., hyaluronic acid fillers or peptide-based drugs).

Sustainable & Cost-Effective
Energy recovery systems cut operational costs by 15%, while FDA/EU-GMP compliance future-proofs your facility audits.

Adapt to Market Demands Instantly
Switch between 1ml single-dose COVID boosters and 20ml diagnostic reagents in <30 minutes—no downtime, no compromise.

Ampoules 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

Ideal For:

  • High-value biologics: Vaccines, monoclonal antibodies, cell therapies
  • Niche applications: Radiopharmaceuticals, orphan drugs (small batches)
  • Cosmetic injectables: Dermal fillers, vitamin cocktails


Solution-Service:

Lingyao, We are where you are!


We are qualified to provide the following services:

  • 7 days/24 hours Quick Service Response
  • Site Installation, Commissioning, SAT and Training
  • Accompanying production services
  • Periodic Maintenance and Emergency
  • Preventative Maintenance
  • Remote Access
  • Annual Maintenance Contract (AMC)
  • Spare Parts Supply
  • Modernization through Upgrade and Refurbishment

Our team:

  • Service manager
  • Mechanical technicians
  • Electrical technicians
  • Commissioning engineers
  • Validation engineers
  • Production supervisors

Accompanying production services. is acharacteristic service that Lingyao can provide to support our clients:

  • Move Forward commercial production smoothly and fast
  • Minimize material and utilities lost
  • Hand to hand training of operation and maintenance
Quality Aseptic Ampoule Filling Line for Sensitive Biologics EU-GMP Certified, 99.9% Sterility Assurance, 0.5% Precision for sale
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