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Ampoule And Vial Filling Machine

This integrated line consists of a vertical ultrasonic cleaning machine, a tunnel-type hot air circulation sterilization oven, and a vertical filling and sealing machine suitable for both ampoules and vials. It is designed for the production of small-volume injections in 1-20ml ampoules and vials. The line can perform a series of automated processes including bottle rinsing, ultrasonic cleaning, water flushing, air flushing, drying and sterilization, cooling, pre-nitrogen filling, liquid filling, post-nitrogen filling, and sealing for both ampoules and vials during pharmaceutical production. With an advanced design concept, rational structure, and stable performance, this integrated line provides equipment technical support for sterile drug production, complying with the relevant requirements of the current Good Manufacturing Practice (GMP) regulations.
  • INTRODUCTION
  • PARAMETER

This integrated line is designed for the combined production processes—including washing, sterilization, filling, and sealing—of ampoules and vials in small-volume injectable workshops. (The machine can also be tested and debugged as a standalone unit.) The overall design meets advanced international and domestic standards, featuring a rational structure, high automation, stable and reliable operation, high production efficiency, and full mechatronic integration. Materials in contact with pharmaceutical liquids are made of AISI316L stainless steel, while other parts use AISI304 stainless steel. Local components are made of materials that do not contaminate the drugs or the environment. The entire design and manufacturing process complies with FDA and current GMP standards.

The integrated line consists of a vertical ultrasonic cleaning machine, a sterilization and drying oven, and an ampoule filling and sealing machine. It is equipped with coordinated linkage mechanisms and components that enable stepless speed regulation and precise control to ensure process requirements are met.

The line operates at high speed with a high yield rate, is easy to operate and maintain, and runs smoothly without impact, malfunctions, bottle jamming, or breakage.

Multiple safety devices are installed to ensure operator safety and machine integrity.

Validation ports are reserved at key locations.

The entire line is controlled by a PLC, with individual units operated via touch screens for programmed production.

Buffer mechanisms are integrated into the PLC program at the connection points between machines, ensuring reliable and stable operation.

The line is equipped with a "no bottle, no filling" function.

A centralized lubrication system is included to simplify oiling at various lubrication points.

The safety system of the entire line meets international safety standards. Operation and mold replacement are straightforward, and maintenance is convenient.

The machine features alarm and fault display functions.


Ampoule-Vial Dual-Purpose Integrated Production Line: Maximum Flexibility for Sterile Manufacturing

 

Introducing a new paradigm in pharmaceutical production: the Ampoule-Vial Dual-Purpose Integrated Production Line. This innovative system eliminates the need for separate, dedicated equipment by seamlessly handling both glass ampoules and a wide range of vials (including serum and lyophilization vials) on a single, unified platform. Engineered for facilities that require agile, multi-format aseptic production, this line delivers unparalleled flexibility without compromising the sterility or precision required for injectable drugs.

At the core of this revolutionary line is a highly adaptable ampoule and vial filling machine. This sophisticated piece of engineering can be quickly reconfigured to switch between the hermetic sealing of ampoules and the stoppering and capping of vials. Whether you need a high-speed vial filling machine for batch processing or a versatile system for diverse product portfolios, this line is the ultimate solution.


Key Features & Benefits:

 

  • Dual-Format Agility: Dramatically reduce changeover times and capital expenditure. This single line empowers you to produce both ampoules and vials, allowing you to respond swiftly to market demands and optimize your production schedule for maximum asset utilization.

  • Uncompromised Aseptic Integrity: Designed as a fully integrated pharmaceutical vial filling machine, the line maintains a continuous, validated sterile environment from container washing through to final sealing. It incorporates advanced sterilization tunnels and a Class A protective environment at the critical filling and sealing zone.

  • Precision Filling & Sealing: The heart of the system is the versatile ampoule and vial filling machine. It ensures pinpoint volumetric accuracy for even the most sensitive formulations. The machine intelligently adapts its process—performing a pull-seal for ampoules and applying a stopper and overseal for vials—all with flawless execution.

  • Robust Pharmaceutical-Grade Construction: Built to the most stringent cGMP standards, this pharmaceutical vial filling machine is constructed from 316L stainless steel and other compliant materials. It is designed for easy cleaning, sterilization, and long-term reliability in a demanding production environment.

  • Future-Proof Your Investment: This line is more than just a vial filling machine; it is a strategic asset. Its inherent flexibility protects your investment against changing product pipelines and packaging trends, ensuring your manufacturing capability remains state-of-the-art for years to come.


Ideal for:

 

  • Pharmaceutical Contract Manufacturing Organizations (CMOs)

  • Biotech companies with diverse injectable product portfolios

  • Production of vaccines, antibiotics, hormones, and lyophilized powders

  • Any facility requiring high-mix, low-volume or high-volume sterile production

Consolidate Your Capabilities. Multiply Your Potential.

Stop managing multiple, single-format lines. Consolidate your ampoule and vial production into one efficient, reliable, and future-proof system. This integrated line, featuring a world-class ampoule and vial filling machine, provides the flexibility of a specialized vial filling machine with the added capability for ampoule production.

Upgrade to the ultimate pharmaceutical vial filling machine solution. Contact us today to discover how our dual-purpose technology can transform your sterile manufacturing operations.


Ampoule process flow

 

vial process flow

Technical parameters of bottle washing machine

 

Parameter Specification
Production Capacity Ampoule: 400 bottles/min
Vial: 250 bottles/min
Suitable Specification Ampoule: 1ml-10ml
Vial: 8-15ml
Breakage Rate ≤ 0.1%
Cleaning Quality (Clarity) No visible white particles, color spots, fibers, or glass fragments; other visible foreign matters < 1 per bottle.
Gripping Error Rate ≤ 0.05%
Bottle Output Counting Error ≤ 0.01%
Residual Water 0.1g (measured by drying method)
Visual Inspection Pass Rate 100%
Water Consumption 0.4-0.6 m³/h (at pressure ≤ 0.2-0.3 MPa)
Compressed Air Consumption 40-50 m³/h (at pressure ≤ 0.25-0.35 MPa)
Power Capacity 15 KW, 380V
Dimensions 2000 × 2204 × 1350 mm
Weight 2400 KG

 

Technical parameters of hot air circulation oven

 

Parameter Specification
Suitable Specification 1-20ml Ampoules/Vials
Production Capacity (Ampoule) 400 bottles/min (1-20ml)
Effective Conveyor Belt Width 620 mm
Sterilization Temperature 280°C - 320°C
FH Value > 1365
Sterilization Time ≥ 5 min
Temperature Probe Accuracy ≤ ±2°C
Temperature Distribution (Empty, Sterilization Section) ≤ ±5°C
Temperature Distribution (Loaded, Sterilization Section) ≤ ±7.5°C
Bottle Outlet Temperature ≤ Ambient Temperature + 15°C
Exhaust Air Volume 3000 - 4100 m³/h
Power Capacity 71 kW (including 60 kW for electric heating)
Overall Dimensions 4538 × 1465 × 2445 mm
Net Weight 3500 kg

 

Main specifications and technical parameters of the capping machine

 

Parameter Specification
Bottle Specification 8-15ml Vial (Requires parts changeover)
Production Capacity 250 bottles/min (Adjustable)
Number of Capping Heads 10 heads, 3 rollers each
Capping Qualification Rate ≥ 98%
Bottle Breakage Rate ≤ 0.01%
Oscillator Power 40 - 120 W
Total Power 2.5 kW
Machine Weight 1500 Kg
Overall Dimensions 1300 × 2300 × 2450 mm
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