2ml Ampoule Filling Machine

Description

2ml Ampoule Filling Machine is a specialized pharmaceutical device designed for the precise filling and sealing of 2ml glass ampoules, commonly used for injectable drugs, serums, or other liquid medications in pharmaceutical, biotech, cosmetic, and chemical industries. Below is a detailed description based on available information:

Loading: Sterilized 2ml ampoules are loaded into a hopper and fed via a starwheel onto a transport rack.
Pre-Nitrogen Flushing: Nitrogen is flushed to displace oxygen and prevent contamination.
Filling: Precise liquid dispensing using piston or peristaltic pumps.
Post-Nitrogen Flushing: Additional nitrogen flush to ensure sterility.
Pre-Warming: Ampoule necks are heated to prepare for sealing.
Sealing: Flames melt the ampoule neck for hermetic sealing, with rollers ensuring uniformity.
Collection: Sealed ampoules are automatically collected on a tray or conveyor.

This machine ensures compliance with cGMP standards for sterile injectable filling. If you need details on specific models, pricing, or comparisons with multi-head machines, let me know!

Salient Features of 2ml Ampoule Filling Machine

Compact model as per cGMP standard.
Higher production output up to 12000 Ampoules per hour.
“No Ampoule – No Filling” system.
Machine equipped with pre-warming station.
Full accessibility allows easy maintenance.
Flow Meters for regulating flames easily.

All contact parts made from High Quality Stainless Steel 316L & Non-contact parts made from Stainless Steel 304.
Minimum change over parts from 1ml to 10ml ampoule size.
Ampoule neck centering during gas flushing and filling operations.
Possibility of nitrogen gas flushing before, during and after filling.
Minimum change over time, little maintenance, easy cleaning.

Working Principle of 2ml Ampoule Filling Machine

Empty washed & sterilized ampoules loaded onto infeed hopper of the machine. From where it has been received to receiving rack through starwheel/cassette. The moving rack which moves horizontally collect eight ampoules from the receiving rack and transfer the ampoule to the machine in left to right in an inclined position. During ampoule movement Pre-gassing, Filling, Post Gassing, Pre-heating & Sealing Station perform filling and sealing operations. At the end duly filled and sealed ampoules get collected automatically onto collection tray of the machine.

Technical Specification of 2ml Ampoule Filling Machine

Model	AFS-1	AFS-2	AFS-4	AFS-8
No. of Head	Single	Two	Four	Eight
Syringes	One	Double	Four	Eight
Ampoule Sizes	1 ml to 30 ml	1 ml to 30 ml	1 ml to 20 ml	1 ml to 20 ml
Filling Speed	Up to 25 ampoules/minute	Up to 50 ampoules/minute	Up to 100 ampoules/minute	Up to 200 ampoules/minute
Filling Precision	± 1%	± 1%	± 1%	± 1%
Filling Pump	Piston Pump	Piston Pump	Piston Pump	Piston Pump
Burner Gas	LPG & Oxygen (O₂)	LPG & Oxygen (O₂)	LPG & Oxygen (O₂)	LPG & Oxygen (O₂)
Nitrogen Arrangement	Before & After Filling	Before & After Filling	Before & After Filling	Before & After Filling
Number of Fill Nozzles	One	Two	Four	Eight
Number of Nitrogen Nozzles	Two	Four	Eight	Sixteen
Number of Sealing Burners	Two	Four	Eight	Sixteen
Power Required	0.5 H.P.	1 H.P.	1 H.P.	2 H.P.
Power Voltage	230 Volts, Single Phase, 50 Hertz, 4 Wire System	230 Volts, Single Phase, 50 Hertz, 4 Wire System	230 Volts, Single Phase, 50 Hertz, 4 Wire System	230 Volts, Single Phase, 50 Hertz, 4 Wire System
Contact Parts	Made from Stainless Steel 316L	Made from Stainless Steel 316L	Made from Stainless Steel 316L	Made from Stainless Steel 316L
Overall Dimension	915mm (L) x 610mm (W) x 965mm (H) approx.	915mm (L) x 760mm (W) x 965mm (H) approx.	1200mm (L) x 1070mm (W) x 965mm (H) approx.	2200mm (L) x 1400mm (W) x 1100mm (H) approx.

* Power voltage can be adjusted as per customer’s domestic power voltage requirements.
* Rights of technical improvements & modification reserved.
* Illustrations & dimensions are shown for information purpose only.

Types of Ampoule Filling Machine

Automatic Ampoule Filling Sealing Machine

Laboratory Ampoule Filling Sealing Machine

Closed Ampoule Filling Machine

Open Mouth Ampoule Filling Machine

Onion Skin Ampoule Filling Machine

Single Head Ampoule Filling Machine

Double Head Ampoule Filling Machine

Four Head Ampoule Filling Machine

Six Head Ampoule Filling Machine

Eight Head Ampoule Filling Machine

Applications of Ampoule Filling Machine

Benefits of 2ml Ampoule Filling Machine

Accuracy: Ensures exact 2ml dosing, critical for pharmaceuticals.

Efficiency: High-speed operation with minimal manual intervention.

Sterility: Hermetic sealing and nitrogen flushing maintain product purity.

Versatility: Handles various liquids, from free-flowing to viscous.

Durability: Stainless steel construction resists corrosion and contamination.

Key Features of 2ml Ampoule Filling Machine

Purpose and Application:
- Designed to fill and seal 2ml glass ampoules (open or closed type) with liquid drugs or serums, ensuring sterility and precision.
- Widely used in pharmaceutical production for injectables, vaccines, or cosmetics like serums and anti-aging products.

Filling Mechanism:
- Utilizes advanced filling technologies such as volumetric piston pumps, servo-driven pumps, or peristaltic pumps for accurate dosing (0.5ml to 25ml in single dosing, adjustable for 2ml).
- Features co-eccentric nozzles for quick and precise filling, with a “No Ampoule – No Fill” system to prevent wastage.
- Optional nitrogen flushing before and after filling to minimize contamination and ensure product stability.

Sealing Process:
- Employs a high-precision sealing system using oxygen and LPG (propane) flames to hermetically seal ampoules, protecting contents from external contaminants.
- Includes pre-warming and sealing stations with rollers to rotate ampoules for uniform sealing, reducing defects.
- Some models feature two flame sets: one for preheating and another for final sealing, ensuring a secure melt of the ampoule neck.

Construction and Compliance:
- Built with high-quality stainless steel (SS 316L for contact parts, SS 304 for non-contact parts) to meet cGMP standards, ensuring hygiene and durability.
- Designed with a monoblock structure, combining filling and sealing in one unit for compactness and efficiency.
- Features a toughened glass cabinet or laminar airflow for sterile class 100 environments in some models.

Automation and Control:
- Fully or semi-automatic operation with minimal human intervention, often equipped with PLC-based control and touch-screen HMI for easy adjustment of fill volume, speed, and sealing parameters.
- Includes safety features like automatic stop functions for malfunctions, no ampoule detection, or machine idle status to reduce waste and ensure safety.

Production Capacity:
- Capable of filling 30 to 90 ampoules per minute (approximately 1,800 to 5,400 per hour) for 2ml ampoules, depending on the model (e.g., single, double, or multi-head).

Ampoule Handling:
- Features a slant travel design to accommodate variations in ampoule neck dimensions and thickness, ensuring compatibility with standard 2ml ampoules.
- Includes an in-feed hopper and starwheel for automatic ampoule loading, with transport racks moving one, two, or more ampoules per cycle.
- Post-sealing, ampoules are collected on a tray or conveyor without manual handling, minimizing contamination risks.

Additional Features:
- Compact design with minimal floor space requirements, ideal for small to medium-scale production.
- Easy maintenance with large openings for cleaning and tool-less format changes for different ampoule sizes (1ml to 30ml with change parts).
- Energy-saving technology with automatic shut-off when idle.
- Optional integration with washing and sterilization tunnels for a complete production line.

Customization and Variants:
- Available in single-head, double-head or multi-head (up to eight heads) configurations to suit production needs.
- Can be customized for 1ml, 5ml, 10ml, or 20ml ampoules with minimal changeover time.
- Some models offer combi functionality to handle both ampoules and vials.

Safety and Standards:
- Complies with international standards like GMP, CE, and ISO.
- Equipped with safety features like pressure reducers, safety valves, and stainless steel hoods to manage fumes during sealing.

FAQ for 2ml Ampoule Filling Machine

What is a 2ml Ampoule Filling Machine?

A 2ml Ampoule Filling Machine is a high-precision automatic monobloc machine specially designed for filling and flame sealing sterile liquid injectables into 2ml glass ampoules. It integrates nitrogen flushing (pre- and post-filling), accurate volumetric piston filling, neck pre-heating, and LPG + Oxygen flame sealing in one compact unit. This machine is widely used in pharmaceutical production for small-volume parenterals such as vaccines, antibiotics, and other injectable formulations. It fully complies with cGMP, USFDA, and WHO standards.

What is the production capacity of the 2ml Ampoule Filling Machine?

The 2ml Ampoule Filling Machine is available in multiple head configurations:

Single Head: Up to 25 ampoules per minute (~1,500 per hour)
Two Heads: Up to 50 ampoules per minute (~3,000 per hour)
Four Heads: Up to 100 ampoules per minute (~6,000 per hour)
Eight Heads: Up to 200 ampoules per minute (~12,000 per hour)

Custom high-speed models can reach up to 36,000 ampoules per hour. It delivers consistent filling accuracy of ±1% for 2ml ampoules.

Can the 2ml Ampoule Filling Machine handle only 2ml size or other volumes as well?

The machine is optimized for 2ml ampoules, but it can comfortably handle ampoule sizes from 1ml to 5ml (and up to 30ml with change parts). The filling range is flexible from 0.5ml to 25ml, allowing manufacturers to use the same machine for different small-volume injectable products with quick tool-less changeover.

What are the key features of the 2ml Ampoule Filling Machine?

Key features include:

Precise filling optimized for 2ml ampoules with ±1% accuracy
Nitrogen flushing before, during, and after filling to ensure product stability
Neck centering system for accurate dosing and sealing
Slant traveling principle for gentle handling and minimal glass breakage
Tool-less quick changeover with minimal parts
All product contact parts made of SS 316L
Pre-heating station and precise flame control
“No Ampoule – No Fill/Seal” safety system
Compact monobloc design with easy cleaning and validation

What are the main benefits of the 2ml Ampoule Filling Machine?

Main benefits include:

High filling accuracy and repeatability for 2ml volume with very low wastage
Excellent sterility assurance through nitrogen flushing and automation
Reduced glass particle generation and breakage due to slant design
Fast format changeover for different ampoule sizes
Compact footprint ideal for cleanroom environments
High production efficiency with low maintenance
Full cGMP compliance making it suitable for regulated pharmaceutical markets

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