Open Mouth Ampoule Filling Machine

An 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.

The 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 Machine Video

Key Features

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

Operational Process

1. Ampoule Loading:

   • Sterilized open-mouth ampoules are loaded into the infeed hopper manually or via a conveyor from a sterilizing tunnel.

   • A starwheel or cassette transfers ampoules to a transportation rack in sets of 1, 2, 4, or 8, depending on the machine’s head configuration.
2. Nitrogen Purging:

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

3. 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.

4. Post-Nitrogen Flushing:

   • A second nitrogen flush removes residual oxygen, enhancing product stability.

5. 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.
6. Collection:

   • Filled and sealed ampoules are automatically collected in an upright position on a dead tray or conveyor for further processing (e.g., inspection or labeling).

   • Waste tips are ejected into a separate stainless steel collector.

Applications

• Pharmaceutical Industry: Filling and sealing injectable liquids, such as vaccines, antibiotics, and other sterile drugs.

• Biotechnology and Biochemical: Handling sensitive reagents and biologics.

• Cosmetics: Packaging serums, essences, or other liquid products.

• Veterinary Medicine: Filling ampoules with animal health products.

• Agrochemicals: Packaging insecticides or other chemical solutions.

Advantages

• 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.

Considerations for Selection

When choosing an Open Mouth Ampoule Filling Machine, consider:

• Production Volume: Select the number of filling heads (1, 2, 4, 6, or 8) based on required output (e.g., lab-scale vs. high-speed production).

• Ampoule Size: Ensure compatibility with the desired ampoule range (1ml to 30ml).

• Filling Mechanism: Choose between piston, servo-driven, or peristaltic pumps based on liquid type and precision needs.

• Sterility Requirements: Opt for models with laminar airflow, RABS, or isolators for enhanced sterility.

• Regulatory Compliance: Verify cGMP, CE, or 21 CFR Part 11 compliance for pharmaceutical applications.

• Maintenance and Changeover: Look for quick-change parts and easy-clean designs to minimize downtime.

Conclusion

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.

Types of Ampoule Filling Machines

• Laboratory Ampoule Filling Machine
• Closed 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
• Onion Skin Ampoule Filling Machine

Salient Features of Open Mouth Ampoule Filling Machine

• Compact model as per cGMP standard.

• Higher production output up to 12000 Ampoules per hour.

• 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.

• “No Ampoule – No Filling” system.

• Ampoule neck centering during gas flushing and filling operations.

• Possibility of nitrogen gas flushing before, during and after filling.

• Full accessibility allows easy maintenance.

• Machine equipped with pre-warming station.

• Flow Meters for regulating flames easily.

• Minimum change over time, little maintenance, easy cleaning.

Process Operation 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. For detailed working process please explore automatic ampoule filler video in top right section of this page.

Technical Specification of Ampoule Filling Machine

* 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.