Single Needle Ampoule Filling Machine

Q: How does the Single Needle Ampoule Filling Machine work?

The machine operates on the slant traveling principle for gentle and smooth ampoule movement with minimal breakage. The process includes: Automatic loading of sterilized ampoules from the hopper Nitrogen pre-flushing to remove oxygen Precise volumetric filling through a single needle with neck centering Nitrogen post-flushing Neck pre-warming Accurate flame sealing using LPG + Oxygen burners It is equipped with “No Ampoule – No Filling” and “No Ampoule – No Seal” safety systems to eliminate wastage and ensure high sterility.

Q: What are the key features of the Single Needle Ampoule Filling Machine?

Key features include: Single needle / single head monobloc design Nitrogen flushing before, during, and after filling Precision piston pump for high filling accuracy Tool-less quick changeover with minimal parts All product contact parts made of SS 316L Slant design for reduced glass particle generation Pre-heating station and precise flame control Compact footprint ideal for cleanrooms and R&D setups Easy cleaning, low maintenance, and optional PLC/HMI control

Description

Single Needle Ampoule Filling Machine is a specialized piece of equipment designed for the precise filling and sealing of glass ampoules, primarily used in pharmaceutical, biotech, cosmetic, and chemical industries. It is typically employed for small-scale or laboratory production, offering a compact and efficient solution for filling sterile liquids or powders into ampoules with high accuracy. This machine is recommended for its simplicity, precision, and suitability for small-scale operations. It ensures sterile, accurate filling and sealing with minimal operator intervention, making it ideal for laboratories, startups, or facilities with lower production demands. Its compact design and compliance with cGMP standards make it a reliable choice for producing high-quality ampoules.

Inbuilt laminar airflow for sterile filling.

PLC systems for real-time monitoring and parameter adjustments.

Salient Features of Single Needle Ampoule Filling Machine

Compact cGMP model.
Production output up to 1800 ampoules/hour.
Full accessibility allows easy maintenance.
Flow Meters for regulating flames easily.
“No Ampoule – No Filling” system.
Equipped with pre-warming station for perfect sealing operations.

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 316 & other Non-contact parts made from Stainless Steel 304.
Suitable to fill 1ml to 20ml ampoule size and minimum change over parts from one size to another.
Minimum change over time, little maintenance, easy cleaning.

Working Principle of Single Needle Ampoule Filling Machine

Empty washed & sterilized ampoules fed into in-feed hopper from the left hand side of the machine to receiving rack. The moving rack which moves horizontally collect one ampoule from the receiving rack and transfer the ampoule to the machine in left to right in an inclined position through pre-gassing. Pre-gassing, Filling, Post Gassing, Pre-heating & sealing stations completes filling & sealing operations. Filled & sealed ampoules are collected automatically in SS tray in upright position without hand touch.

The machine performs the following operations:

Ampoule feeding by in-feed hopper, cassettes and ampoule transfer into transport rack.

One ampoule advanced per machine stroke.

Centering of ampoules necks during pre-heating, post heating, gas flushing and liquid filling.

Rotation of ampoules neck in the pre- heating and heating station.

Elimination of burdened-off ampoule tips by clippers and ejection into a separate container.

Technical Specification of Single Needle Ampoule Filling Machine

Model	AFS-30
Production Output	Up to 25 ampules/minute
Ampoule Size	1ml to 30ml
Filling Accuracy	± 1%
Require Gas for Sealing	LPG & Oxygen (O₂)
Nitrogen Flushing	Pre & Post Nitrogen Flushing Available
Power Specification	0.5 H. P.
Electrical Characteristics	230 Volts, Single Phase, 50 Hertz
Contact Parts	Made from Stainless Steel 316L
Non Contact Parts	Made from Stainless Steel 304
Overall Dimension	915mm (L) x 610mm (W) x 965mm (H) approx.
Net Weight	150 Kgs. approx.
Gross Weight	225 Kgs. 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 Single Needle Ampoule Filling Machine

Precision and Sterility: Provides high accuracy in filling and sealing, critical for pharmaceutical applications.

Flexibility: Accommodates various ampoule sizes with minimal changeover time.

Ease of Use: Manual settings allow operators to adjust filling volumes, and the machine supports quick integration with existing production lines.

Safety and Hygiene: Stainless steel construction and nitrogen flushing ensure compliance with stringent safety standards.

Cost-Effective: Suitable for small-scale production, reducing the need for large, expensive machinery.

Key Features of Single Needle Ampoule Filling Machine

Purpose and Application:
- Used for filling and sealing open-mouth glass ampoules with liquid or powder products, such as injectable drugs, veterinary medicines, or cosmetics.
- Ideal for small-scale injectable companies, research labs, and parenteral production units requiring low to medium output.

Construction and Materials:
- Built with high-grade stainless steel 316Lfor filling contact parts to meet cGMP (Current Good Manufacturing Practice) standards, ensuring hygiene and durability.
- Features a compact, monoblock design where the filler and sealer are integrated on a single platform, optimizing space and operation.

Design and Construction:
- Compact cGMP Model: Built to comply with Current Good Manufacturing Practices (cGMP) standards, ensuring hygiene and quality.
- Material: Contact parts are made of high-quality Stainless Steel 316(for filling nozzles and syringes), while non-contact parts are made of Stainless Steel 304, ensuring durability and resistance to corrosion.
- Ergonomic Design: Features a compact footprint with easy-to-clean surfaces and minimal changeover parts for different ampoule sizes, reducing downtime.

Filling Mechanism:
- Operates on a volumetric piston-pumpprinciple or, in some cases, a peristaltic pump for precise dosing.
- Features in-process control (IPC)to monitor filling weight and ensure accuracy.
- Non-contact filling reduces the risk of particulate contamination.

Additional Features:
- Neck Centering: Ensures accurate alignment of the ampoule neck during gas flushing, filling, and sealing operations for consistent results.
- Waste Elimination: Burned-off ampoule tips are clipped and ejected into a separate container to maintain cleanliness.
- Optional Laminar Air Flow: Can be integrated for Class 100 sterile filling, ensuring a contamination-free environment.

FAQ for Single Needle Ampoule Filling Machine

What is a Single Needle Ampoule Filling Machine?

A Single Needle Ampoule Filling Machine (also known as Single Head Ampoule Filler Sealer) is a compact, fully automatic monobloc machine designed for precise filling and flame sealing of sterile liquid injectables into glass ampoules. It uses a single filling needle for accurate dosing and integrates nitrogen flushing (pre- and post-filling), volumetric piston filling, neck pre-heating, and LPG + Oxygen flame sealing in one unit. This model is ideal for small to medium batch production, R&D labs, pilot plants, and low-volume pharmaceutical manufacturing while meeting cGMP, USFDA, and WHO standards.

What is the production capacity of the Single Needle Ampoule Filling Machine?

The Single Needle Ampoule Filling Machine (Model AFS-1) delivers a production capacity of up to 25 ampoules per minute, which is approximately 1,500 ampoules per hour. It supports ampoule sizes from 1ml to 30ml with a filling range of 0.5ml to 25ml and maintains excellent filling accuracy of ±1%. This makes it the perfect choice for low to medium output requirements.

How does the Single Needle Ampoule Filling Machine work?

The machine operates on the slant traveling principle for gentle and smooth ampoule movement with minimal breakage. The process includes:

Automatic loading of sterilized ampoules from the hopper
Nitrogen pre-flushing to remove oxygen
Precise volumetric filling through a single needle with neck centering
Nitrogen post-flushing
Neck pre-warming
Accurate flame sealing using LPG + Oxygen burners

It is equipped with “No Ampoule – No Filling” and “No Ampoule – No Seal” safety systems to eliminate wastage and ensure high sterility.

What are the key features of the Single Needle Ampoule Filling Machine?

Key features include:

- Single needle / single head monobloc design
- Nitrogen flushing before, during, and after filling
- Precision piston pump for high filling accuracy
- Tool-less quick changeover with minimal parts
- All product contact parts made of SS 316L
- Slant design for reduced glass particle generation
- Pre-heating station and precise flame control
- Compact footprint ideal for cleanrooms and R&D setups
- Easy cleaning, low maintenance, and optional PLC/HMI control

What are the main benefits of the Single Needle Ampoule Filling Machine?

Main benefits include:

Ideal for R&D, pilot scale, and small-batch production
Lower investment cost compared to multi-head machines
High filling accuracy (±1%) with minimal product wastage
Gentle handling that reduces glass breakage and contamination risk
Compact design that saves valuable cleanroom space
Fast format changeover and easy validation
Full cGMP compliance with reliable performance

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