Pharmaceutical Ampoule Filling Machine

Description

Pharmaceutical Ampoule Filling Machine are available from Adinath International. The pharmaceutical and cosmetic industries utilise an advanced piece of machinery called an Automatic Ampoule Filling 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 Pharmaceutical Ampoule Filling Machine can frequently be altered or adjusted to accommodate a variety of product requirements by handling different ampoule sizes and types.

The machine is designed to accommodate a wide range of ampoule neck dimensions, thicknesses, and ovality of available ampoules by using the principle of slant travel of ampoules during filling and sealing. The unit is completely covered in stainless steel with a beautiful matt surface and is constructed on a square pipe frame made of stainless steel. The machine’s bottom side has large ports for thorough cleaning. For convenience and security, the pendant-style electrical control panel is raised from the machine.

High Precision and Accuracy: Fill accuracy of ±0.5% ensures no over- or under-dosing, critical for pharmaceuticals.

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

High Output: Models range from 10–250 ampoules/min (up to 36,000/hour for high-speed).

Sterility: Operates in sterile class 100 environments with optional LAF or isolator systems to prevent contamination.

Automation: PLC and HMI systems allow easy operation, real-time monitoring, and error correction.

Durability: Stainless steel construction ensures longevity and compliance with cGMP standards.

Quick Changeover: Minimal downtime for format changes, with tool-less adjustments in some models.

Safety: Equipped with safety valves, pressure reducers, and cooling systems to prevent overheating and ensure operator safety.

Flexibility: Can process open-mouth and closed-mouth ampoules, with some models handling vials as well.

Nitrogen Flushing: Ensures product stability by replacing air with inert gas.

Integration: Easily integrates with upstream (washing, sterilization) and downstream (inspection, labeling) equipment.

Salient Features of Ampoule Filling 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 Pharmaceutical 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.

Conveying: Sterilized ampoules are fed via a conveyor belt or hopper to a star wheel or eccentric rack for precise positioning.

Filling: Ampoules are centered, flushed with nitrogen, filled with the precise dose, and flushed again to ensure purity.

Sealing: Pre-warmed ampoules are sealed by melting the glass neck with a flame, with waste tips collected separately.

Collection: Filled and sealed ampoules are automatically collected in trays without manual intervention.

Technical Specification of Pharmaceutical 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 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

Advantages of Pharmaceutical Ampoule Filling Machine

High Precision: Ensures exact dosing, minimizing waste and ensuring patient safety.

Sterility: Maintains a contamination-free process, critical for injectables.

Efficiency: High-speed production reduces labor and operational costs.

Versatility: Adapts to various ampoule sizes, shapes, and materials (glass or plastic).

Safety: Automated processes reduce human contact, ensuring product integrity.

Durability: Stainless steel construction and cooling systems extend machine lifespan.

Key Features of Pharmaceutical Ampoule Filling Machine

Construction and Materials:
- Built with stainless steel for durability, hygiene, and compliance with cGMP standards.
- Compact, ergonomic designs with large openings for easy cleaning and maintenance.
- Often equipped with laminar airflow systems or isolators to maintain a sterile Class 100 environment.

Filling Mechanism:
- Utilizes advanced filling technologies such as:
  - Piston metering pumps for precise volumetric dosing (0.5ml to 25ml in a single dose).
  - Peristaltic pumps, mass-flow, or time-pressure filling for customized, high-precision filling.
  - Servo-based systems for automated fill volume adjustments via PLC and HMI control panels.
- Capable of filling liquids, powders, or pellets with an accuracy of ±0.5%.
- Features like nitrogen purging (pre- and post-filling) prevent contamination and oxidation by flushing inert gas into the ampoule.

Sealing Process:
- Ampoules are sealed using combustible gases (e.g., oxy-hydrogen, coal gas, or liquefied petroleum gas) to melt the glass neck, ensuring a hermetic seal.
- Sealing stations include pre-warming and final sealing, with rollers to rotate ampoules for uniform sealing.
- Options for laser sealing or vacuum stopper insertion for enhanced precision and safety.

Automation and Control:
- Fully or semi-automatic operation with PLC systems for real-time monitoring, parameter adjustments, and error detection.
- In-process control (IPC) checks filling weight and stopper placement to ensure quality.
- SCADA systems provide real-time data for batch and process control.

Versatility:
- Handles various ampoule types (straight-stem, funnel-type, or sealed) and sizes (1ml to 30ml).
- Supports open and closed ampoules, as well as vials, with combi-platforms for dual processing.
- Tool-less format changes and variable filling heads (1, 2, 4, 6, 8, or 16) allow flexibility for different production needs.

Production Capacity:
- Ranges from 15 to 36,000 ampoules per hour, depending on the model (e.g., single-head to eight-head machines).
- High-speed models, achieve up to 36,000 ampoules/hour.

Sterility and Cleaning:
- Integrated cleaning and sterilization systems (e.g., Clean-in-Place, CIP) maintain a contamination-free environment.
- Pre-treatment includes washing and sterilizing ampoules via autoclaves or sterilization tunnels before filling.
- Post-filling inspection systems (manual, semi-, or fully automated) check for particles, container defects, and fill accuracy using image sensors or cameras.

FAQ for Pharmaceutical Ampoule Filling Machine

What is a Pharmaceutical Ampoule Filling Machine?

A Pharmaceutical Ampoule Filling Machine is a high-precision, automated equipment used in the pharmaceutical industry to fill sterile liquids (such as injectables, vaccines, antibiotics, and serums) into glass ampoules and hermetically seal them. It ensures accurate dosing, maintains sterility, and prevents contamination through processes like nitrogen purging, flame sealing, and operation under laminar airflow. These machines are ideal for high-speed, GMP-compliant production of injectable products.

How does a Pharmaceutical Ampoule Filling Machine work?

The machine typically operates on a slant-travel principle. Sterilized ampoules are loaded into a hopper or conveyor. They then move through synchronized stations where the following occurs sequentially:

Pre-gassing (nitrogen flushing)
Precise liquid filling
Post-gassing
Pre-heating and flame sealing (melting the ampoule neck to create a hermetic seal)

The entire process is designed to handle ampoules in groups (e.g., 2, 4, 6, or 8 at a time) while maintaining sterility and high accuracy. Modern machines often include PLC controls for smooth operation and minimal human intervention.

What are the key features and benefits of your Pharmaceutical Ampoule Filling Machine?

Our machine offers several advanced features, including:

High filling accuracy (±0.5% or better)
Multi-head configurations for higher output
Nitrogen flushing before and after filling
GMP/cGMP compliant design with easy-to-clean contact parts (usually SS 316L)
Flame sealing for perfect hermetic closure
User-friendly PLC/HMI interface and minimal changeover time

Benefits include reduced product waste, ensured sterility, increased production speed, and compliance with stringent pharmaceutical regulations — making it perfect for scalable injectable manufacturing.

Which products and ampoule sizes can the machine handle?

The Pharmaceutical Ampoule Filling Machine is suitable for a wide range of sterile liquid products, including vaccines, antibiotics, biotech injectables, ophthalmic solutions, and other parenteral drugs. It can handle various glass ampoule sizes, commonly from 1 ml to 20 ml (or as per custom requirements). The machine supports open-mouth, closed-mouth, and onion-skin type ampoules with precise volume control for different viscosities.

What maintenance and compliance standards does the machine follow?

The machine is built with high-quality, corrosion-resistant materials and follows cGMP, FDA, and WHO guidelines. It features easy-access design for cleaning and maintenance to ensure zero cross-contamination. Regular maintenance involves checking filling nozzles, gas systems, and sealing burners. We provide detailed manuals, training, and after-sales support, including spare parts availability, to keep downtime minimal and ensure long-term reliable performance.

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