Open Mouth Ampoule Filling Machine

Q: What is an Open Mouth Ampoule Filling Machine?

An Open Mouth Ampoule Filling Machine is a specialized monobloc pharmaceutical machine designed to fill and seal pre-opened (open mouth) glass ampoules. It automatically fills sterile liquids into Type B or Type C open-mouth ampoules and then hermetically seals them using LPG and Oxygen flame. This machine is ideal when ampoules are already opened or supplied in open form, offering high precision, nitrogen flushing, and contamination-free processing for injectables.

Q: What are the key features of your Open Mouth Ampoule Filling Machine?

Key features include: Designed specifically for Type B and Type C open mouth ampoules Monobloc construction with filling and sealing in one unit Nitrogen purging before, during, and after filling for better product stability Pre-warming station and precise neck centering for uniform sealing “No Ampoule – No Fill” and “No Ampoule – No Seal” safety systems cGMP compliant design with Stainless Steel 316L contact parts PLC control with HMI (in higher models) and easy-to-clean structure Dead tray for upright collection of sealed ampoules These features ensure high sterility, low breakage, and reliable performance.

Description

Open Mouth Ampoule Filling Machine is a specialized piece of pharmaceutical equipment designed for the precise filling and sealing of open-mouth glass ampoules, typically used for packaging liquid injectable drugs, cosmetics, agro-insecticides, veterinary medicines, and other chemicals. These machines are engineered to ensure sterility, accuracy, and compliance with cGMP (current Good Manufacturing Practices) standards, making them essential in industries requiring high-quality, contamination-free packaging. Below is a detailed description of the machine, its operation, and key features based on available information: Open Mouth Ampoule Filling Machines are automated or semi-automated systems designed to handle open-mouth glass ampoules (typically Type B or Type C) ranging in size from 1ml to 30ml. These machines perform a sequence of operations including ampoule loading, nitrogen purging, liquid filling, pre-heating, and sealing, all on a single platform (monobloc design). They are built to accommodate variations in ampoule neck dimensions, thickness, and ovality, ensuring precise filling and hermetic sealing to prevent contamination.

Open Mouth Ampoule Filling Machine operates on the principle of slant traveling, where ampoules are transported at an inclined angle during filling and sealing processes to optimize handling and ensure uniform operations. They are constructed with high-quality materials, such as Stainless Steel 316L for contact parts and Stainless Steel 304 for non-contact parts, to meet cGMP requirements and ensure durability and sterility. Open Mouth Ampoule Filling Machines are critical for the efficient, sterile, and precise filling and sealing of glass ampoules in pharmaceutical, biotech, cosmetic, and other industries. With advanced features like nitrogen flushing, multiple filling mechanisms, and high-speed outputs, these machines ensure product safety and compliance with stringent regulatory standards.

Salient Features of Open Mouth Ampoule Filling Machine

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

Ampoule neck centering during gas flushing and filling operations.
Possibility of nitrogen gas flushing before, during and after filling.
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.
Minimum change over time, little maintenance, easy cleaning.

Working Principle of Open Mouth 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 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.Waste tips are ejected into a separate stainless steel collector.

Nitrogen Purging:
- Ampoules are moved to a pre-nitrogen flushing station, where inert gas (nitrogen) is injected to displace oxygen and prevent oxidation.

Filling:
- The ampoules advance to the filling unit, where filling nozzles (piston, servo, or peristaltic pumps) dispense a precise volume of liquid.
- Neck centering ensures accurate filling without spillage.

Post-Nitrogen Flushing:
- A second nitrogen flush removes residual oxygen, enhancing product stability.

Pre-Heating and Sealing:
- Ampoules move to the pre-heating station, where a low-pressure flame warms the glass to prepare for sealing.
- At the sealing station, a high-temperature flame (LPG and oxygen) melts the ampoule neck, and rollers rotate the ampoule for a uniform, hermetic seal.

Technical Specification of Open Mouth 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 Open Mouth Ampoule Filling Machine

High Precision: Accurate filling volumes (0.5ml to 30ml) with minimal wastage due to features like the “No Ampoule, No Fill” system.

Sterility: Nitrogen flushing and immediate sealing prevent contamination, ensuring product purity.

Flexibility: Handles a wide range of ampoule sizes (1ml to 30ml) with minimal changeover time.

High Output: Capable of processing up to 36,000 ampoules/hour in high-speed models, ideal for large-scale production.

Ease of Maintenance: Full accessibility, quick changeover parts, and robust stainless steel construction simplify cleaning and upkeep.

Compliance: Meets cGMP standards, with optional CE certification and 21 CFR Part 11 compliance for regulatory needs.

Key Features of Open Mouth Ampoule Filling Machine

Filling and Sealing Capacity:
- Suitable for filling open-mouth glass ampoules ranging from 1ml to 30ml.
- Filling capacity typically ranges from 0.5ml to 25ml in a single dose, with some models capable of filling up to 30ml.
- Production output varies by model:
  - Single-head machines: Up to 1,500 ampoules/hour (lab-scale).
  - Two-head machines: Up to 3,000 ampoules/hour.
  - Four-head machines: Up to 6,000–7,200 ampoules/hour.
  - Six-head machines: Up to 9,000 ampoules/hour.
  - Eight-head machines: Up to 12,000–17,000 ampoules/hour, with high-speed models reaching up to 24,000–36,000 ampoules/hour.

Filling Mechanisms:
- Offers multiple filling options, including:
  - Piston pump filling (volumetric, for precise dosing).
  - Servo-driven filling (adjustable via touch screen for high accuracy).
  - Peristaltic pump filling (ideal for sterile and sensitive liquids).
- Features like ampoule neck centering ensure precise filling without spillage or contamination.

Nitrogen Flushing:
- Equipped with pre- and post-nitrogen flushing stations to displace oxygen and maintain product sterility, particularly for air-sensitive liquids.
- Nitrogen purging occurs before and after liquid filling to prevent oxidation and contamination.

Sealing Process:
- Utilizes a two-stage sealing process:
  - Pre-heating station: Uses a low-pressure flame to warm the ampoule tip, removing any liquid droplets to ensure a clean seal.
  - Sealing station: Employs a mixture of LPG (propane) and oxygen for 360-degree flame sealing, achieving a uniform, dome-shaped closure.
- Specially designed rollers rotate ampoules during sealing for consistent results.

Design and Construction:
- Monobloc design integrates filling and sealing operations in a single unit for efficiency.
- Stainless Steel 316L contact parts ensure compatibility with sterile liquids and compliance with cGMP standards.
- Stainless Steel 304 non-contact parts provide durability and corrosion resistance.
- Compact footprint with optional castor wheels for mobility and large openings for easy cleaning and maintenance.
- Some models include a toughened glass safety cabinet or laminar air flow (LAF) system for sterile Class 100 environments.

Automation and Control:
- Features like PLC systems with touch screen HMI (Human-Machine Interface) allow for easy adjustment of fill volumes and monitoring of operations.
- No Ampoule, No Fill system prevents wastage of costly liquids by stopping filling if an ampoule is absent.
- Servo-based PLC control in advanced models enables precise volume adjustments and error monitoring.

Additional Features:
- Flow meters for easy regulation of sealing gases (LPG and oxygen).
- Waste tip collector made of high-quality stainless steel for safe disposal of ampoule tips.
- Quick changeover parts minimize downtime when switching between ampoule sizes (1ml to 10ml or up to 30ml).
- Optional IQ/OQ documentation and 21 CFR Part 11 compliance for regulatory requirements.
- Some models support integration with RABS (Restricted Access Barrier Systems) or isolators for enhanced sterility.

FAQ for Open Mouth Ampoule Filling Machine

What is an Open Mouth Ampoule Filling Machine?

An Open Mouth Ampoule Filling Machine is a specialized monobloc pharmaceutical machine designed to fill and seal pre-opened (open mouth) glass ampoules. It automatically fills sterile liquids into Type B or Type C open-mouth ampoules and then hermetically seals them using LPG and Oxygen flame. This machine is ideal when ampoules are already opened or supplied in open form, offering high precision, nitrogen flushing, and contamination-free processing for injectables.

What ampoule sizes and production speeds does the Open Mouth Ampoule Filling Machine support?

Our Open Mouth Ampoule Filling Machines typically handle ampoule sizes from 1 ml to 25 ml (or up to 30 ml depending on the model). They are available in single-head, double-head, four-head, and multi-head configurations with output capacities ranging from 30 to 200 ampoules per minute (approx. 1,800 to 12,000 ampoules per hour). Filling accuracy is maintained at ±1% with piston pumps or peristaltic pumps. Quick changeover parts allow easy switching between different sizes.

What are the key features of your Open Mouth Ampoule Filling Machine?

Key features include:

Designed specifically for Type B and Type C open mouth ampoules
Monobloc construction with filling and sealing in one unit
Nitrogen purging before, during, and after filling for better product stability
Pre-warming station and precise neck centering for uniform sealing
“No Ampoule – No Fill” and “No Ampoule – No Seal” safety systems
cGMP compliant design with Stainless Steel 316L contact parts
PLC control with HMI (in higher models) and easy-to-clean structure
Dead tray for upright collection of sealed ampoules

These features ensure high sterility, low breakage, and reliable performance.

What is the difference between Open Mouth and Closed Mouth Ampoule Filling Machines?

Open Mouth Ampoule Filling Machines are used for ampoules that are already open (Type B & C). The machine directly fills the liquid and then seals the open neck with flame. Closed Mouth Ampoule Filling Machines handle pre-sealed (closed) ampoules that require opening (cutting or breaking the tip), filling, and re-sealing. Open mouth machines are generally simpler in the opening stage, offer faster changeover for certain applications, and are preferred when using ready-open ampoules or for specific product types.

Which industries and products use the Open Mouth Ampoule Filling Machine?

The Open Mouth Ampoule Filling Machine is widely used in the pharmaceutical industry for sterile injectables, vaccines, antibiotics, and biological solutions. It is also suitable for:

Veterinary medicines
Cosmetic injectables and serums
Biotech and biochemical products
Agrochemicals and certain chemical liquids

It helps manufacturers meet stringent cGMP and sterility requirements while providing efficient, high-speed production for open-mouth glass ampoules.

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Open Mouth Ampoule Filling Machine

Description

Salient Features of Open Mouth Ampoule Filling Machine

Working Principle of Open Mouth Ampoule Filling Machine

Technical Specification of Open Mouth Ampoule Filling Machine

Types of Ampoule Filling Machine

Applications of Ampoule Filling Machine

Advantages of Open Mouth Ampoule Filling Machine

High Precision: Accurate filling volumes (0.5ml to 30ml) with minimal wastage due to features like the “No Ampoule, No Fill” system.

Sterility: Nitrogen flushing and immediate sealing prevent contamination, ensuring product purity.

Flexibility: Handles a wide range of ampoule sizes (1ml to 30ml) with minimal changeover time.

High Output: Capable of processing up to 36,000 ampoules/hour in high-speed models, ideal for large-scale production.

Ease of Maintenance: Full accessibility, quick changeover parts, and robust stainless steel construction simplify cleaning and upkeep.

Compliance: Meets cGMP standards, with optional CE certification and 21 CFR Part 11 compliance for regulatory needs.

Key Features of Open Mouth Ampoule Filling Machine

FAQ for Open Mouth Ampoule Filling Machine

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Partner with Industry Experts

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