Injectable Ampoule Filling Machine

Q: What ampoule sizes and production capacities does the machine support?

The machine supports ampoule sizes from 1 ml to 30 ml (model dependent). We offer four main models: AFS-1 (Single Head) : Up to 25 ampoules/min (1,500/hour) AFS-2 (Two Heads) : Up to 50 ampoules/min (3,000/hour) AFS-4 (Four Heads) : Up to 100 ampoules/min (6,000/hour) AFS-8 (Eight Heads) : Up to 200 ampoules/min (12,000/hour) All models deliver ±1% filling accuracy using volumetric piston pumps and can handle LPG + Oxygen or oxy-hydrogen for sealing. Custom power voltage options are also available.

Q: What key features ensure accuracy and sterility in the filling process?

Key features include: Nitrogen gas flushing before, during, and after filling with ampoule neck centering “No Ampoule – No Filling” and “No Ampoule – No Seal” safety systems Pre-warming station for perfect flame sealing All contact parts made of SS 316L and non-contact parts of SS 304 Flow meters for easy flame regulation Minimum change-over time and parts for different ampoule sizes These ensure high sterility, minimal product wastage, and compliance with cGMP standards.

Q: What industries is this machine suitable for, and what are its main benefits?

This machine is ideal for the pharmaceutical, biotechnology, veterinary, cosmetic, and chemical industries . Main benefits include: High filling precision (±1%) with minimal wastage Superior sterility through nitrogen flushing and immediate sealing Compact cGMP design with easy cleaning and low maintenance Quick changeover and flexibility for different ampoule sizes High production output (up to 12,000 ampoules/hour) while maintaining regulatory compliance It is perfect for both small-scale R&D and large-scale commercial production.

Description

Injectable Ampoule Filling Machine is a specialized piece of pharmaceutical equipment designed for the precise, sterile, and automated filling and sealing of glass or plastic ampoules with injectable liquids, such as vaccines, antibiotics, or other pharmaceutical solutions. These machines are critical in industries like pharmaceuticals, biotechnology, and cosmetics, Their robust design, precise filling mechanisms, and integration with washing and sterilization systems ensure compliance with stringent regulatory standards while maximizing efficiency. Whether for small-scale R&D or large-scale production, these machines offer flexibility, accuracy, and reliability tailored to diverse industry needs. Below is a detailed description of the machine, its features, and its operation, based on industry standards and available information.

This advanced machine integrates multiple critical operations — pre-gassing, liquid filling, post-gassing, pre-heating, and flame sealing — in a single compact unit. Built on the principle of slant traveling of ampoules, it ensures smooth, gentle handling with minimal breakage while maintaining the highest level of sterility and product integrity.

Salient Features of 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 Injectable Ampoule Filling Machine

The operation of an injectable ampoule filling machine typically follows these steps:

Loading: Sterilized ampoules are loaded into a hopper or unscrambler, which feeds them onto a conveyor or starwheel.

Washing (Optional): Ampoules are cleaned using ultrasonic washing or water/air jets to remove contaminants.

Sterilization: Ampoules pass through a sterilization tunnel (dry heat or steam) to ensure sterility.

Filling: Ampoules are positioned under filling nozzles, where precise volumes of liquid are dispensed using piston, peristaltic, or servo-driven pumps. Nitrogen flushing may occur before and after filling to prevent oxidation.

Sealing: Ampoules are heated and sealed using combustible gases, with pre-heating and cooling stages to ensure a secure seal.

Collection: Sealed ampoules are collected on trays or conveyed for inspection and labeling without manual touching.

Technical Specification of Injectable 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

Advantages of Injectable Ampoule Filling Machine

High Precision: Achieves fill accuracy of ±0.5%, ensuring consistent dosing.

Sterility: Aseptic processing and nitrogen flushing minimize contamination risks.

Efficiency: High-speed models and automation reduce labor and increase output.

Versatility: Handles various ampoule sizes, types, and liquid viscosities.

Durability: Stainless steel construction ensures long-term reliability and easy maintenance.

Key Features of Injectable Ampoule Filling Machine

Purpose and Application:
- Used to fill and seal ampoules (small, sealed vials) with liquid or sometimes powder for injectable drugs, ensuring sterility and precise dosing.v
- Applications span pharmaceuticals (e.g., vaccines, injectables), biotechnology, cosmetics (e.g., serums), and laboratory settings for storing sensitive reagents or chemicals.

Capacity and Output:
- Suitable for filling ampoules ranging from 1 ml to 30 ml in volume, with some machines capable of handling up to 250 ml for specific applications.
- Output varies by model:
  - Single-head machines: ~1,500 ampoules/hour, ideal for lab-scale or pilot production.
  - Multi-head machines (e.g., two, four, six, eight, or twelve heads): Up to 36,000 ampoules/hour for high-speed, large-scale production.
  - High-speed models can achieve up to 400 ampoules/minute.

Design and Construction:
- Built with stainless steel 316L for contact parts to ensure sterility and compliance with cGMP standards, and stainless steel 304 for non-contact parts.
- Compact, monoblock designs integrate filling and sealing in one unit, minimizing contamination risks.
- Features large openings for easy cleaning and maintenance, with some models equipped with pendant-style control panels for accessibility.
- Often includes a laminar airflow (LAF) system or isolator for aseptic conditions.

Filling Mechanism:
- Utilizes various filling technologies for precision:
  - Piston pump filling: Volumetric dosing for accurate filling of liquids with varying viscosities.
  - Peristaltic pump filling: Ideal for sensitive liquids, allowing tool-less adjustments via touch-screen interfaces.
  - Servo-driven filling: Offers programmable fill volumes with high accuracy (±0.5%).
  - Time-pressure filling or mass-flow filling: Used for specific applications requiring customized dosing.
- Fill volume ranges from 0.5 ml to 25 ml in a single dose, adjustable via control panels or HMI (Human-Machine Interface).
- Features like no ampoule, no fill and no ampoule, machine stop systems optimize material use and prevent errors.

Sealing Process:
- Ampoules are sealed using combustible gases (e.g., oxygen, LPG, or natural gas) to melt the glass tip after filling, ensuring an airtight seal to prevent contamination.
- Pre-heating and post-heating stations ensure perfect sealing, with some machines equipped with cooling systems to avoid overheating.
- Nitrogen flushing (pre- and post-filling) is often included to displace oxygen, enhancing product stability and shelf life.

Operation and Automation:
- Fully automatic models: Include integrated processes like ampoule washing, sterilizing, filling, sealing, and sometimes labeling, reducing manual intervention.
- Semi-automatic models: Suitable for smaller-scale operations, requiring some operator involvement.
- Equipped with PLC (Programmable Logic Controller) and touch-screen HMI for real-time monitoring, error detection, and parameter adjustments.
- Features like starwheels, eccentric racks, or grippers ensure precise ampoule handling and centering during filling and sealing.

Sterilization and Aseptic Processing:
- Often part of a complete production line that includes:
  - Ultrasonic washing: Cleans ampoules to remove contaminants.
  - Sterilization tunnels: Use dry heat, steam, or hot water to ensure sterility.
  - Depyrogenation: Removes pyrogens to meet regulatory standards.
- Designed to operate in Class 100 cleanroom environments with isolators or RABS (Restricted Access Barrier Systems) for aseptic conditions.

Flexibility and Customization:
- Handles both open-mouth and closed-mouth ampoules (Type B and Type C), with some machines capable of processing vials as well.
- Tool-less format changes for different ampoule sizes (e.g., 1 ml to 30 ml) enhance production flexibility.
- Combi machines can process both ampoules and vials, increasing versatility.

Safety and Compliance:
- Equipped with safety features like pressure reducers, safety valves, and stainless steel hoods to channel fumes during sealing.
- CE-certified and 21 CFR Part 11-compliant models available for regulatory adherence.
- Designed for operation under laminar flow protection to maintain sterility.

Additional Features:
- Pre-warming stations: Ensure smooth sealing by pre-heating ampoule necks.
- Waste tip collectors: Manage glass waste from sealing.
- Variable speed control: Adjustable via AC frequency drives for precise operation.
- Unscramblers and conveyors: Automate ampoule feeding and transport, reducing manual handling.

FAQ for Injectable Ampoule Filling Machine

What is an Injectable Ampoule Filling Machine?

An Injectable Ampoule Filling Machine is a high-precision, fully automatic pharmaceutical equipment designed to fill sterile injectable liquids (such as vaccines, antibiotics, and other solutions) into glass ampoules and immediately seal them using flame sealing. It integrates pre-gassing, filling, post-gassing, pre-heating, and sealing stations in a compact cGMP-compliant design. The machine ensures sterility, accuracy, and efficiency while minimizing contamination risks through features like nitrogen flushing and “No Ampoule – No Filling” safety systems.

What ampoule sizes and production capacities does the machine support?

The machine supports ampoule sizes from 1 ml to 30 ml (model dependent). We offer four main models:

AFS-1 (Single Head): Up to 25 ampoules/min (1,500/hour)
AFS-2 (Two Heads): Up to 50 ampoules/min (3,000/hour)
AFS-4 (Four Heads): Up to 100 ampoules/min (6,000/hour)
AFS-8 (Eight Heads): Up to 200 ampoules/min (12,000/hour)

All models deliver ±1% filling accuracy using volumetric piston pumps and can handle LPG + Oxygen or oxy-hydrogen for sealing. Custom power voltage options are also available.

What key features ensure accuracy and sterility in the filling process?

Key features include:

Nitrogen gas flushing before, during, and after filling with ampoule neck centering
“No Ampoule – No Filling” and “No Ampoule – No Seal” safety systems
Pre-warming station for perfect flame sealing
All contact parts made of SS 316L and non-contact parts of SS 304
Flow meters for easy flame regulation
Minimum change-over time and parts for different ampoule sizes

These ensure high sterility, minimal product wastage, and compliance with cGMP standards.

How does the Injectable Ampoule Filling Machine work?

Empty, washed, and sterilized ampoules are loaded into the infeed hopper. They move via a starwheel to a receiving rack and then to the moving rack in an inclined position. As ampoules travel left to right, the machine performs:

Pre-gassing (nitrogen)
Precise liquid filling
Post-gassing
Pre-heating of the neck
High-speed rotation and flame sealing

Filled and sealed ampoules are automatically collected upright in a tray. The slant design reduces breakage and ensures smooth, contamination-free operation.

What industries is this machine suitable for, and what are its main benefits?

This machine is ideal for the pharmaceutical, biotechnology, veterinary, cosmetic, and chemical industries. Main benefits include:

High filling precision (±1%) with minimal wastage
Superior sterility through nitrogen flushing and immediate sealing
Compact cGMP design with easy cleaning and low maintenance
Quick changeover and flexibility for different ampoule sizes
High production output (up to 12,000 ampoules/hour) while maintaining regulatory compliance

It is perfect for both small-scale R&D and large-scale commercial production.

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