Ampoule Filler and Sealer

Q: What is an Ampoule Filler and Sealer Machine?

An Ampoule Filler and Sealer is a specialized pharmaceutical packaging machine designed to automatically fill sterile liquids (such as injectables, vaccines, or serums) into pre-sterilized glass ampoules and then hermetically seal them using a high-temperature flame or gas-oxygen sealing process. It ensures precise filling volumes, maintains product sterility, and prevents contamination, making it essential for high-speed production in the pharmaceutical and injectable manufacturing industries.

Q: What industries commonly use Ampoule Filler and Sealer machines?

These machines are primarily used in the pharmaceutical industry for filling injectable drugs, vaccines, antibiotics, and biological products. They are also widely applied in: Veterinary medicines Cosmetic injectables (e.g., hyaluronic acid) Chemical and research laboratories requiring sterile liquid packaging The machine ensures compliance with stringent sterility and regulatory standards such as cGMP and WHO guidelines.

Q: Is Ampoule Filler and Sealer cGMP, MHRA, FDA and WHO-GMP Compliant?

Yes — Adinath International Ampoule Filler and Sealer complies to cGMP, MHRA, FDA and WHO-GMP standards, with optional CE marked equipments and 21 CFR Part 11 software compliance for the HMI/PLC. Machine contact parts having Stainless Steel 316L grade materials with validation documents having IQ, OQ, DQ validation protocols as optional. Organization is ISO 9001:2015 certified.

Q: Does Adinath International provide Ampoule Filler and Sealer internationally?

Yes, Adinath International Ampoule Filler and Sealer export this machine to more than 48 countries of this world including America, Europe, Asia, Middle East, Africa, CIS and Australia sub continents. Please visit our clientele page for complete list of our customers worldwide. Located at Ahmedabad, India having world class infrastructure .

Description

Ampoule Filler and Sealer is a specialized machine used primarily in the pharmaceutical, biotech, cosmetic, and chemical industries to fill and seal glass ampoules with liquid or solid (powder) drugs or products. These machines ensure precise, sterile, and efficient filling and sealing of ampoules, maintaining product integrity and compliance with stringent regulatory standards such as cGMP (Current Good Manufacturing Practices). Below is a detailed description of an Ampoule Filler and Sealer Machine, its features, and its operational process: Ampoule Filler and Sealer Machines are designed to automate the process of filling glass ampoules (small sealed vials) with precise amounts of liquid or powder and then sealing them to protect contents from contamination, environmental dust, and microorganisms. They are critical for producing sterile injectable solutions, veterinary medicines, cosmetic serums, agro-insecticides, and other chemicals, ensuring accurate dosing and safe storage. These machines cater to various production scales, from small laboratory setups to high-volume industrial lines, and are built to handle a range of ampoule sizes (typically 1ml to 30ml) and types (open-mouth or closed/pre-sterilized Type D ampoules).

Production Volume: Choose the number of heads based on required output.

Ampoule Type: Ensure compatibility with open or closed ampoules.

Filling Mechanism: Select piston pumps for viscous liquids, peristaltic pumps for sterile solutions, or servo-driven systems for precision.

Regulatory Compliance: Verify adherence to cGMP, FDA, or other standards.

Maintenance and Accessibility: Options for machines with large openings and minimal changeover parts for ease of maintenance.

Salient Features of Ampoule filler and sealer

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 Ampoule Filler and Sealer

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.

Pre-Gassing:
- Nitrogen is flushed into the ampoules to remove atmospheric air and prevent oxidation.

Filling:
- Ampoules are filled with a precise volume of liquid or powder using piston pumps, peristaltic pumps, or servo-driven systems.
- Neck centering ensures accurate filling without spillage.

Post-Gassing:
- Additional nitrogen flushing may occur to further protect the contents.

Pre-Heating and Sealing:
- Ampoules are pre-heated with low-pressure flames to prepare the glass for sealing.
- The sealing station uses high-pressure flames (oxygen + LPG) to melt and seal the ampoule necks, with rollers rotating the ampoules for uniform sealing.
- Waste ampoule tips are clipped and ejected into a separate container.

Technical Specification of Ampoule Filler and Sealer

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 Ampoule Filler and Sealer

Accuracy and Precision: Ensures exact dosing (±0.5% fill accuracy), critical for pharmaceuticals.

Sterility: Nitrogen flushing and sealed designs prevent contamination.

High Efficiency: Automated processes reduce manual intervention, labor costs, and errors.

Versatility: Handles various ampoule sizes (1ml to 30ml) and materials (liquids, powders, pellets).

Compliance: Meets cGMP, FDA, CE, and ISO standards for safety and hygiene.

Fast Changeover: Minimal parts changes for different ampoule sizes, reducing downtime.

Durability: Stainless steel construction ensures long-term reliability.

Key Features of Ampoule Filler and Sealer

Construction and Materials:
- Frame: Built on a sturdy stainless steel (SS) square pipe frame, often with SS coverings in a matte finish for durability and aesthetic appeal.
- Contact Parts: Made from high-quality SS 316L to ensure compatibility with pharmaceutical standards and resistance to corrosion.
- Non-Contact Parts: Typically constructed from SS 304 for cost-effectiveness and durability.
- Large Opening Area: Located at the bottom for easy cleaning and maintenance, ensuring compliance with hygiene standards.

Filling Mechanisms:
- Operates on principles such as volumetric piston pumps, peristaltic pumps, or servo-driven systems for precise filling (accuracy of ±0.5%).
- Capable of filling 0.5ml to 30ml in a single dose, with minimal changeover parts required for different ampoule sizes (e.g., 1ml to 10ml or up to 30ml in some models).
- Features like “no ampoule, no filling” reduce product wastage and ensure accuracy.

Sealing Technology:
- Uses oxygen and LPG (propane) or other combustible gases for flame-sealing, with flow meters to regulate flame intensity.
- Includes pre-heating and sealing stations to warm ampoules and create secure seals, often with rotation of ampoule necks for uniform sealing.
- Some models offer nitrogen flushing before, during, and after filling to minimize oxidation and contamination.
- Specialized sealing options, such as onion skin sealing, are available for specific applications in pharmaceuticals and cosmetics.

Automation and Control:
- Equipped with PLC (Programmable Logic Controller) and HMI (Human-Machine Interface) control panels for automated fill volume adjustments and easy operation.
- Pendant-type electrical control panels enhance safety and accessibility.
- Features like automatic error detection and HMI troubleshooting improve operational reliability.

Production Capacity:
- Available in various configurations with single, two, four, six, or eight heads, catering to different production needs:
  1. Single-head: Ideal for lab-scale production (e.g., 1500 ampoules/hour).
  2. Multi-head (e.g., eight-head): Suitable for high-speed production (up to 36,000 ampoules/hour).
- Output ranges from 15 to 300 ampoules per minute, depending on the model and head configuration.

Additional Features:
- Neck Centering: Ensures accurate filling and sealing by aligning ampoule necks during gas flushing and liquid filling.
- Cooling Systems: Prevent overheating, extending machine lifespan.
- Stainless Steel Hood: Channels out fumes during the sealing process for safety.
- Integration: Easily integrates with upstream (e.g., sterilization tunnels) and downstream (e.g., inspection or labeling machines) equipment.
- Safety Features: Includes safety valves, pressure reducers, and laminar airflow or isolator options for sterile environments.

FAQ for Ampoule Filler and Sealer

What is an Ampoule Filler and Sealer Machine?

An Ampoule Filler and Sealer is a specialized pharmaceutical packaging machine designed to automatically fill sterile liquids (such as injectables, vaccines, or serums) into pre-sterilized glass ampoules and then hermetically seal them using a high-temperature flame or gas-oxygen sealing process. It ensures precise filling volumes, maintains product sterility, and prevents contamination, making it essential for high-speed production in the pharmaceutical and injectable manufacturing industries.

What are the key features of your Ampoule Filler and Sealer?

Our Ampoule Filler and Sealer comes with several advanced features including:

High-precision volumetric or peristaltic filling systems for accurate dosing
Automatic ampoule feeding, filling, sealing, and ejection
Flame-based sealing technology for leak-proof, tamper-evident closure
No-bottle-no-fill and no-ampoule-no-seal safety systems
PLC control with touch-screen HMI for easy operation and parameter adjustment
Compatibility with various ampoule sizes (typically 1ml to 20ml)
GMP-compliant design with stainless steel construction for easy cleaning and sterilization

Which ampoule sizes can your machine handle?

Our Ampoule Filler and Sealer is designed to handle a wide range of standard ampoule sizes, commonly from 1ml to 20ml. Many models support quick changeover parts for different neck diameters and volumes. For exact compatibility with your required sizes, please contact us with your specific ampoule dimensions—we can customize or recommend the best configuration.

What industries commonly use Ampoule Filler and Sealer machines?

These machines are primarily used in the pharmaceutical industry for filling injectable drugs, vaccines, antibiotics, and biological products. They are also widely applied in:

Veterinary medicines
Cosmetic injectables (e.g., hyaluronic acid)
Chemical and research laboratories requiring sterile liquid packaging

The machine ensures compliance with stringent sterility and regulatory standards such as cGMP and WHO guidelines.

How does the Ampoule Filling and Sealing process work?

The process typically follows these steps:

Pre-sterilized ampoules are loaded onto the infeed conveyor or hopper.
Ampoules are transferred to the filling station where a precise volume of liquid is dispensed (volumetric or time-pressure method).
Filled ampoules move to the sealing station, where the neck is heated by an oxygen-gas flame to melt and fuse the glass, creating a hermetic seal.
Sealed ampoules are then cooled and discharged automatically.

The entire operation is continuous and synchronized to maintain high output while ensuring product integrity and minimal breakage.

Is Ampoule Filler and Sealer cGMP, MHRA, FDA and WHO-GMP Compliant?

Yes — Adinath International Ampoule Filler and Sealer complies to cGMP, MHRA, FDA and WHO-GMP standards, with optional CE marked equipments and 21 CFR Part 11 software compliance for the HMI/PLC. Machine contact parts having Stainless Steel 316L grade materials with validation documents having IQ, OQ, DQ validation protocols as optional. Organization is ISO 9001:2015 certified.

What is the lead time for Ampoule Filler and Sealer?

Manufacturing lead time is generally 7 to 14 weeks from order confirmation. Further it takes 2 to 8 weeks for international shipping depending upon destination. Order can be expediate sooner or later as per specific buying requirements. Destination specific certifications like US FDA, EU, ANVISA, SFDA. CE can add 3 to 6 weeks additionally.

Does Adinath International provide Ampoule Filler and Sealer internationally?

Yes, Adinath International Ampoule Filler and Sealer export this machine to more than 48 countries of this world including America, Europe, Asia, Middle East, Africa, CIS and Australia sub continents. Please visit our clientele page for complete list of our customers worldwide. Located at Ahmedabad, India having world class infrastructure.

Does After Sales Support provided for Ampoule Filler and Sealer?

Service of skilled engineers and technicians provided for technical support of supplied equipments. Installations, commissioning, training and IQ, OQ, DQ validations performed by qualified engineers. Remote support through video call, phone, email and other modes provided for international installations. Spare parts of Ampoule Filler and Sealer stocked at our premises in Ahmedabad and shipped immediately after ordering. Standard 12 months manufacturing warranty included with supplied equipment.