Manufacturer of Ampoule Filling Machine

Q: Who is the leading manufacturer of Ampoule Filling Machine in India?

Adinath International (under the Injectable Machines brand) is a trusted and experienced manufacturer of high-quality Ampoule Filling Machines in India. Located in Ahmedabad, Gujarat, we specialize in designing and producing fully automatic ampoule filling and sealing machines that meet stringent international standards. With a strong focus on precision, sterility, and reliability, we supply machines to pharmaceutical companies across India and export to over 60 countries worldwide.

Q: What is the production capacity of your Ampoule Filling Machines?

Our standard models offer the following capacities: AFS-1 (Single Head) : Up to 25 ampoules/min (~1,500/hour) AFS-2 (Two Heads) : Up to 50 ampoules/min AFS-4 (Four Heads) : Up to 100 ampoules/min (~6,000/hour) AFS-8 (Eight Heads) : Up to 200 ampoules/min (~12,000/hour) Higher custom models can achieve up to 36,000 ampoules per hour . Filling accuracy is maintained at ±1% with a filling range of 0.5ml to 25ml.

Q: Is Manufacturer of Ampoule Filling Machine cGMP, MHRA, FDA and WHO-GMP Compliant?

Yes — Adinath International Manufacturer of Ampoule Filling Machine 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 Manufacturer of Ampoule Filling Machine internationally?

Yes, Adinath International Manufacturer of Ampoule Filling Machine 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

Manufacturer of Ampoule Filling Machine designs and produces automated equipment used for filling and sealing glass ampoules, primarily for pharmaceutical, biotech, cosmetic, and chemical industries. These machines ensure precise filling of liquids (0.5ml to 30ml) into ampoules, often incorporating advanced technologies like piston or peristaltic pumps, nitrogen purging, and flame sealing to maintain sterility and accuracy. Key features include:

Infeed System:
- A hopper or feeding turntable where empty, pre-sterilized ampoules are loaded.
- A wire mesh conveyor belt or starwheel transports ampoules to the filling station, often connected to a sterilizing tunnel for continuous operation.
- The system ensures smooth and precise movement of ampoules, accommodating various sizes and shapes.

Filling Station:
- Equipped with high-precision dosing systems, such as:
  - Piston pumps (volumetric, servo-driven, or conventional) for accurate liquid filling.
  - Peristaltic pumps for gentle handling of sensitive liquids, with easy adjustment via HMI (Human-Machine Interface).
  - Mass-flow or time-pressure systems for customized filling.
- Filling needles or nozzles discharge precise volumes (0.5 ml to 25 ml in single dosing).
- Features like bottom-up filling or diving nozzles prevent foaming and ensure accuracy (±0.5% fill accuracy in some models).

Gas Flushing System:
- Nitrogen purging stations flush ampoules with inert gas (e.g., nitrogen) before and/or after filling to remove atmospheric air and prevent chemical reactions or contamination.
- This is critical for oxygen-sensitive or air-sensitive products like pharmaceuticals or radiopharmaceuticals.

Sealing Station:
- Pre-warming and sealing stations use combustible gases (oxygen and LPG/propane) to heat and melt the thin glass neck of the ampoule for hermetic sealing.
- Specially designed rollers rotate ampoules during sealing to ensure uniform closure.
- Safety valves, pressure reducers, and flow meters regulate flame intensity for precise sealing.
- A stainless steel hood channels out fumes during heating, maintaining a clean environment.

Collection and Rejection System:
- Filled and sealed ampoules are automatically collected in trays.
- Defective ampoules (e.g., improperly filled or sealed) are rejected and ejected into a separate container.
- Waste ampoule tips are clipped and discarded to avoid contamination.

Control Systems:
- PLC (Programmable Logic Controller) and HMI systems for real-time monitoring, parameter adjustment, and error detection.
- In-process control (IPC) systems for 0–100% check-weighing to ensure accurate dosing and adjust pump settings automatically.
- Optional integration with SCADA (Supervisory Control and Data Acquisition) or 21 CFR Part 11 compliance for data logging and regulatory adherence.

Frame and Materials:
- Constructed with stainless steel (SS 316L for contact parts, SS 304 for non-contact parts) to meet cGMP standards.
- Compact, monoblock design for space efficiency and easy maintenance.
- Large openings and accessible parts for quick cleaning and minimal downtime.

Optional Features:
- Laminar Air Flow (LAF) or Restricted Access Barrier Systems (RABS) for sterile class 100 environments.
- Isolator enclosures for enhanced aseptic conditions.
- CIP/SIP (Clean-in-Place/Sterilize-in-Place) systems for automated cleaning without disassembly.
- Combination machines that handle both ampoules and vials for increased flexibility.

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 Manufacturer of 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.

The operation of an ampoule filling machine follows a systematic, automated process to ensure sterility, precision, and efficiency:

Sterilization and Loading:
- Empty ampoules are washed, sterilized (often in a depyrogenation tunnel), and loaded into the machine’s hopper or infeed system.
- A starwheel or conveyor belt aligns and transports ampoules (1, 2, 4, 6, or 8 at a time, depending on the machine’s head configuration) to the processing stations.

Pre-Gassing (Optional):
- Ampoules are flushed with nitrogen to displace atmospheric air, reducing the risk of oxidation or contamination.

Filling:
- The filling station dispenses a precise volume of liquid or powder into each ampoule using piston or peristaltic pumps.
- Neck centering ensures accurate filling, and diving nozzles minimize foaming.
- In-process control (IPC) systems may weigh ampoules before and after filling to verify accuracy.

Post-Gassing (Optional):
- Additional nitrogen flushing after filling to further protect the contents.

Pre-Warming and Sealing:
- Ampoules move to a pre-warming station where a low-pressure flame warms the glass neck.
- At the sealing station, a high-temperature flame (using oxygen and LPG) melts the thin glass top to create a hermetic seal.
- Rollers rotate the ampoules during sealing for uniform closure, and waste glass tips are clipped and ejected.

Collection:
- Sealed ampoules are collected on a tray, while defective units are rejected.
- The process is continuous, with minimal manual intervention, ensuring high throughput and sterility.

The machine operates on the principle of slant traveling, where ampoules move at an inclined angle during filling and sealing to accommodate variations in neck size, thickness, and shape, ensuring consistent results.

Technical Specification of Manufacturer of 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 Manufacturer of Ampoule Filling Machine

Sterility and Protection: Ampoules protect contents from environmental dust, microorganisms, and air, ensuring product purity.

High Efficiency: Automated systems produce thousands of ampoules per hour, meeting high demand.

Precision: Accurate dosing eliminates wastage and ensures consistent drug delivery.

Ease of Maintenance: Accessible parts and CIP/SIP systems simplify cleaning and upkeep.

Regulatory Compliance: Designed to meet FDA, CE, ISO, and cGMP standards for pharmaceutical production.

Versatility: Suitable for a wide range of ampoule sizes, product types, and industries.

Long-Term Investment: Robust construction and efficient cooling systems extend machine lifespan.

Key Features of Manufacturer of Ampoule Filling Machine

High Precision: Utilizes volumetric piston pumps or servo-driven systems for accurate dosing, with fill accuracy up to ±0.5%.

Versatility: Handles open or closed-mouth ampoules (1ml to 30ml) with adjustable settings for various neck dimensions, thicknesses, and ovalities.

Sterility Compliance: Built with stainless steel 316L for contact parts and 304 for non-contact parts, adhering to cGMP and FDA standards.

Automation: Offers PLC-based controls, touch-screen interfaces, and features like “No Ampoule – No Filling” to minimize waste and ensure safety.

Production Capacity: Ranges from 15 to 400 ampoules per minute, with models like single, two, four, six, or eight-head fillers to suit small to large-scale production.

Additional Features: Includes pre- and post-nitrogen flushing, laminar airflow options, and integration with washing, sterilization, and labeling systems for complete production lines.

Durability: Constructed with robust stainless steel frames, designed for easy maintenance and long-term reliability.

FAQ for Manufacturer of Ampoule Filling Machine

Who is the leading manufacturer of Ampoule Filling Machine in India?

Adinath International (under the Injectable Machines brand) is a trusted and experienced manufacturer of high-quality Ampoule Filling Machines in India. Located in Ahmedabad, Gujarat, we specialize in designing and producing fully automatic ampoule filling and sealing machines that meet stringent international standards. With a strong focus on precision, sterility, and reliability, we supply machines to pharmaceutical companies across India and export to over 60 countries worldwide.

What types of Ampoule Filling Machines do you manufacture?

We manufacture a wide range of Ampoule Filling Machines, including:

Automatic Ampoule Filling and Sealing Machine
Single Head, Two Head, Four Head, and Eight Head models
Laboratory scale and high-speed production models
Machines for open mouth, closed mouth, and onion skin ampoules
Compact and custom-designed variants

All models support ampoule sizes from 1ml to 30ml and are available in different output capacities to suit small, medium, and large-scale production needs.

What is the production capacity of your Ampoule Filling Machines?

Our standard models offer the following capacities:

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

Higher custom models can achieve up to 36,000 ampoules per hour. Filling accuracy is maintained at ±1% with a filling range of 0.5ml to 25ml.

What key features and compliance standards do your Ampoule Filling Machines have?

Our machines are built with advanced features such as:

Nitrogen flushing before, during, and after filling
Slant traveling principle for gentle handling and reduced glass breakage
“No Ampoule – No Filling/Seal” safety system
SS 316L product contact parts
Tool-less quick changeover and easy cleaning
PLC/HMI control with optional 21 CFR Part 11 compliance
Pre-warming station and precise flame sealing

They fully comply with cGMP, USFDA, WHO, CE, ISO, and ISO 9187-1:2010 standards, making them suitable for sterile injectable production.

Which industries benefit from your Ampoule Filling Machines and why choose Adinath International?

Our Ampoule Filling Machines are widely used in:

Pharmaceuticals (injectables, vaccines, and parenterals)
Biotechnology
Veterinary medicines
Cosmetics
Chemical and agro-insecticide industries

Why choose us?

Proven manufacturer with robust, low-maintenance machines
High sterility and minimal product wastage
Fast format changeover and compact footprint
Complete line integration (washing, sterilization, inspection, labeling)
Reliable after-sales support and easy validation
Cost-effective solutions with global export experience

Is Manufacturer of Ampoule Filling Machine cGMP, MHRA, FDA and WHO-GMP Compliant?

Yes — Adinath International Manufacturer of Ampoule Filling Machine 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 Manufacturer of Ampoule Filling Machine?

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 Manufacturer of Ampoule Filling Machine internationally?

Yes, Adinath International Manufacturer of Ampoule Filling Machine 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 Manufacturer of Ampoule Filling Machine?

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 Manufacturer of Ampoule Filling Machine stocked at our premises in Ahmedabad and shipped immediately after ordering. Standard 12 months manufacturing warranty included with supplied equipment.