Ampoule Filling and Sealing Machine

Q: What utilities and power requirements are needed for the machine?

The machine requires: Power : 0.5 H.P. to 2 H.P. (model dependent), 230 Volts, Single Phase, 50 Hz (customizable as per local voltage) Gases : Nitrogen (for flushing), LPG and Oxygen (O₂) for sealing burners Optional : Laminar airflow cabinet or RABS/Isolator integration All product contact parts are made of high-quality AISI 316L Stainless Steel , while non-contact parts use SS 304, ensuring cGMP compliance and easy cleaning/sterilization.

Q: What safety and compliance features does the Ampoule Filling and Sealing Machine offer?

The machine is fully cGMP compliant and includes several safety features: 'No Ampoule – No Fill' system to avoid product spillage and contamination Flow meters for precise flame regulation Pre-heating station to eliminate droplets inside the neck Nitrogen purging for oxygen-sensitive products Easy access for maintenance and sterilization of filling units Optional PLC with HMI for automation and 21 CFR Part 11 compliance It is designed for operation in sterile Class 100 environments and minimizes human intervention to maintain product integrity.

Description

The pharmaceutical and cosmetic industries utilise an advanced piece of machinery called an Ampoule Filling and Sealing Machine to fill and seal glass ampoules. Medications, vaccines, and other liquid pharmaceuticals are filled and sealed with it. To preserve sterility and avoid contamination, the sealing procedure guarantees that the ampoules are hermetically sealed. Small, sealed vials called ampoules are used to hold and retain sterile substances like serums or drugs. The Automatic Ampoule Filling Sealing Machine can frequently be altered or adjusted to accommodate a variety of product requirements by handling different ampoule sizes and types.

From cleaning to sealing, ampoules need to be handled precisely. However, pharmaceutical producers often struggle with dependable processing because to tight deadlines, stringent regulations, and delicate containers. Filling and sealing machines for open or closed ampoules that can produce 6,000–24,000 pieces per hour are included in this machine category. These machines ensure flawlessly reproducible and sanitary filling and sealing processes. These machines have a long-standing reputation for dependability and exceptionally excellent quality because of its simple size changeover, filling unit with easy disassembly and sterilisation, and simple integration of a high-performance laminar flow system. Combination versions for vial filling and capping are also offered.

With ampoule lines made for safe flame sealing, precise dosing, and gentle handling, Adinath Inteernational overcomes this difficulty. We customise every solution to fit your configuration, from small to huge batches, and ensure seamless integration with both upstream and downstream systems.

Purpose: These machines fill glass ampoules (small, sealed vials) with precise volumes of liquid or powder and hermetically seal them to ensure sterility and prevent contamination. Ampoules are favored for their ability to protect contents from environmental factors like dust and microorganisms, ensuring high purity and precise dosing.

Working Principle: The machine operates on the slant travel mechanism (in traditional models) or vertical movement (in modern high-speed models). Ampoules are transported at an inclined angle (typically 45°) or vertically through various stations for filling and sealing. The process ensures compatibility with varying ampoule neck dimensions, thicknesses, and ovality.

Process Flow:
1. Loading: Sterilized ampoules are loaded into an infeed hopper, often from a sterilizing tunnel, and fed onto a wire mesh conveyor or receiving rack via a starwheel or cassette.
2. Pre-Gassing: Nitrogen is flushed into the ampoules to displace air and prevent chemical reactions with the contents.
3. Filling: Precision filling needles or pumps (e.g., piston, peristaltic, or servo-driven) dispense a preset volume of liquid or powder (0.5ml to 30ml, depending on the model) into the ampoules with high accuracy (±0.5%). A “no ampoule, no fill” feature minimizes wastage.
4. Post-Gassing: Additional nitrogen flushing may occur to ensure sterility.
5. Pre-Heating: A low-pressure flame warms the ampoule neck to prepare for sealing, removing any droplets on the inner surface.
6. Sealing: The ampoule neck is melted using oxygen and LPG (propane) flames or other methods (e.g., laser in advanced models), creating a hermetic seal. Ampoules are rotated 360° for uniform, dome-shaped sealing. Waste glass tips are clipped and collected separately.
7. Collection: Filled and sealed ampoules are automatically discharged onto a collection tray without manual handling.

Salient Features of Ampoule Filling and Sealing Machine

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

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

Working Principle of Ampoule Filling and Sealing 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 one/two/four/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.

The machine performs the following operations:

Ampoule loading by hopper, star wheel transfers ampoule into transport rack.

One/Two/Four/Six/Eight ampoules advanced each machine stroke.

Centering of ampoules necks during warming, sealing, gas flushing and liquid filling operations.

Rotation of ampoules neck during warming and heating station.

Elimination of waste ampoule tips by clippers and ejection into a separate container.

Technical Specification of Ampoule Filling and Sealing 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 Precison	± 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 Arranegment	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 Ampoule Filling and Sealing Machine

High Precision: Ensures accurate dosing (±0.5% fill accuracy), critical for pharmaceuticals.

Sterility and Contamination Control: Nitrogen flushing and hermetic sealing protect contents from environmental factors.

Ease of Maintenance: Large openings and robust stainless steel construction simplify cleaning and upkeep.

Versatility: Suitable for liquids, powders, or pellets across multiple industries.

Key Components of Ampoule Filling and Sealing Machine

Capacity and Speed: Machines are available in single, two, four, six, eight, or twelve-head configurations, with outputs ranging from 10 to 30,000 ampoules per hour, depending on the model and production needs.

Materials: Contact parts are made of high-quality stainless steel for GMP compliance, while non-contact parts use stainless steel 304 for durability and easy cleaning.

Automation and Control: Modern machines feature PLC systems with HMI or touch-screen interfaces for real-time parameter adjustments, error detection, and troubleshooting.

Sterility: Operations are conducted in sterile class 100 environments, often under laminar airflow, RABS, or isolator enclosures to prevent contamination.

Flexibility: Machines accommodate ampoules from 1ml to 30ml and support various filling mechanisms (e.g., piston pumps, peristaltic pumps, or servo-driven systems). They can handle both open-mouth and closed (Type D) ampoules.

Safety and Efficiency: Features like flow meters for flame regulation, cooling systems to prevent overheating, and pressure reducers for gas circuits enhance safety and machine longevity.

Customization: Models are available for small, medium, or large-scale production, with options for integration with existing lines, laminar airflow cabinets, or CIP/SIP systems.

FAQ for Ampoule Filling and Sealing Machine

What is the Ampoule Filling and Sealing Machine and what is it used for?

The Ampoule Filling and Sealing Machine is a high-precision, automatic or semi-automatic system designed to fill sterile liquid products into glass ampoules and then hermetically seal them using flame sealing. It is widely used in the pharmaceutical, biotech, and veterinary industries for injectable formulations. The machine ensures sterility by incorporating nitrogen gas flushing before, during, and after filling, along with a “No Ampoule – No Fill” system to prevent wastage and contamination. Models range from single-head (AFS-1) to eight-head (AFS-8) configurations, making it suitable for both laboratory-scale and medium-to-high production volumes.

What is the production capacity and which ampoule sizes can it handle?

Production capacity varies by model:

AFS-1 (Single Head): Up to 25 ampoules per minute
AFS-2 (Double Head): Up to 50 ampoules per minute
AFS-4 (Four Head): Up to 100 ampoules per minute
AFS-8 (Eight Head): Up to 200 ampoules per minute

The machine handles glass ampoules from 1 ml to 30 ml (model dependent), with a filling range of 0.5 ml to 30 ml in a single dose. It offers ±1% filling accuracy (up to ±0.5% in optimized conditions) and supports quick change-over for different sizes with minimal change parts.

How does the Ampoule Filling and Sealing process work?

Ampoules are loaded into the infeed hopper and transferred via starwheel or conveyor. The process includes:

Nitrogen pre-gassing to remove oxygen
Precision filling using piston pumps with neck centering
Nitrogen post-gassing for added sterility
Pre-heating of the ampoule neck with a low-pressure flame
Flame sealing using LPG and Oxygen burners while rotating the ampoule 360° for a uniform, dome-shaped hermetic seal
Automatic collection of sealed ampoules and clipping of waste glass tips

The entire operation runs on a slant or vertical travel mechanism under laminar airflow for maximum sterility.

What utilities and power requirements are needed for the machine?

The machine requires:

Power: 0.5 H.P. to 2 H.P. (model dependent), 230 Volts, Single Phase, 50 Hz (customizable as per local voltage)
Gases: Nitrogen (for flushing), LPG and Oxygen (O₂) for sealing burners
Optional: Laminar airflow cabinet or RABS/Isolator integration

All product contact parts are made of high-quality AISI 316L Stainless Steel, while non-contact parts use SS 304, ensuring cGMP compliance and easy cleaning/sterilization.

What safety and compliance features does the Ampoule Filling and Sealing Machine offer?

The machine is fully cGMP compliant and includes several safety features:

“No Ampoule – No Fill” system to avoid product spillage and contamination
Flow meters for precise flame regulation
Pre-heating station to eliminate droplets inside the neck
Nitrogen purging for oxygen-sensitive products
Easy access for maintenance and sterilization of filling units
Optional PLC with HMI for automation and 21 CFR Part 11 compliance

It is designed for operation in sterile Class 100 environments and minimizes human intervention to maintain product integrity.

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