Pharmaceutical Ampoule Filling Machine

Q: What ampoule sizes and production capacities does the Pharmaceutical Ampoule Filling Machine support?

The machine supports ampoule sizes from 1 ml to 30 ml (model dependent). Available models include: AFS-1 (Single Head): Up to 25 ampoules/min AFS-2 (Two Heads): Up to 50 ampoules/min AFS-4 (Four Heads): Up to 100 ampoules/min AFS-8 (Eight Heads): Up to 200 ampoules/min (up to 12,000 ampoules/hour) It delivers ±1% filling accuracy using volumetric piston pumps and offers quick changeover parts for different sizes with minimal downtime.

Q: hich industries is the Pharmaceutical Ampoule Filling Machine suitable for, and what are its main advantages?

It is ideal for the pharmaceutical , biotech , veterinary , cosmetic , and chemical industries. Main advantages include: Superior sterility through nitrogen flushing and immediate sealing High filling precision with minimal product wastage Flexibility to handle a wide volume range and thin-walled ampoules Compact footprint, low maintenance, quick changeover, and easy integration with sterilization tunnels Compliance with stringent regulatory standards (cGMP, FDA, CE, ISO) The machine supports both small-scale and high-speed production while maintaining product integrity.

Description

Pharmaceutical Ampoule Filling Machine is specialized equipment designed for the precise filling and sealing of glass ampoules, which are small, sealed containers used to store sterile liquid or powdered medications, primarily for injections in pharmaceutical, biotech, cosmetic, and chemical industries. These machines ensure high accuracy, sterility, and efficiency while meeting stringent regulatory standards like cGMP, FDA, CE, and ISO.

Oxy-hydrogen sealing: Cleaner and safer sealing technology.

Plastic Ampoules: Gaining popularity for cost-efficiency and break resistance.

Automated Inspection: Uses cameras and sensors for real-time quality control.

Integration: Seamless connection with sterilization tunnels and labeling machines for end-to-end solutions.

Fragility: Glass ampoules require careful handling to avoid breakage.

Risk of Contamination: Requires strict adherence to sterile conditions.

Glass Fragments: Potential for shards during opening, though modern snap-off designs mitigate this.

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 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.

Technical Specification 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 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 monobloc system designed for filling and flame-sealing sterile glass ampoules (including open-mouth/Type B & C onion skin ampoules) with liquid injectables. It is widely used in the pharmaceutical and biotech industries to ensure contamination-free filling of vaccines, injections, and other sterile liquids. The machine combines filling, nitrogen flushing, pre-warming, and sealing in one compact cGMP-compliant unit.

What ampoule sizes and production capacities does the Pharmaceutical Ampoule Filling Machine support?

The machine supports ampoule sizes from 1 ml to 30 ml (model dependent). Available models include:

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

It delivers ±1% filling accuracy using volumetric piston pumps and offers quick changeover parts for different sizes with minimal downtime.

What are the key features of the Pharmaceutical Ampoule Filling Machine?

Key features include:

“No Ampoule – No Filling” and “No Ampoule – No Seal” safety systems
Nitrogen gas flushing before, during, and after filling with neck centering
Pre-warming station and precise flame sealing (LPG + Oxygen or oxy-hydrogen option)
All contact parts in SS 316L and non-contact parts in SS 304
Compact cGMP design with full accessibility for easy cleaning and maintenance
Flow meters for flame regulation and automated inspection options

These ensure high sterility, reliability, and compliance with FDA, CE, and ISO standards.

How does the Pharmaceutical Ampoule Filling Machine work?

Sterilized ampoules are loaded into the infeed hopper and transferred via star wheel to a moving rack that travels in an inclined (slant) position. The process sequence includes:

Pre-gassing with nitrogen
Precise liquid filling
Post-gassing
Pre-heating of the ampoule neck
High-speed rotation and flame sealing

Filled and sealed ampoules are automatically collected upright in a tray. The slant design ensures smooth handling and reduces breakage.

hich industries is the Pharmaceutical Ampoule Filling Machine suitable for, and what are its main advantages?

It is ideal for the pharmaceutical, biotech, veterinary, cosmetic, and chemical industries. Main advantages include:

Superior sterility through nitrogen flushing and immediate sealing
High filling precision with minimal product wastage
Flexibility to handle a wide volume range and thin-walled ampoules
Compact footprint, low maintenance, quick changeover, and easy integration with sterilization tunnels
Compliance with stringent regulatory standards (cGMP, FDA, CE, ISO)

The machine supports both small-scale and high-speed production while maintaining product integrity.

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