Two Needle Ampoule Filling Machine

Q: What is a Two Needle Ampoule Filling Machine?

A Two Needle Ampoule Filling Machine (also known as Two Head Ampoule Filler Sealer) is a fully automatic monobloc machine designed for precise filling and flame sealing of sterile liquid injectables into glass ampoules. It uses two filling needles working simultaneously and integrates nitrogen flushing (pre- and post-filling), volumetric piston filling, neck pre-heating, and LPG + Oxygen flame sealing in one compact unit. This model is ideal for medium-scale production and offers a good balance between output and cost while meeting cGMP, USFDA, and WHO standards.

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

The machine operates on the slant traveling principle for gentle ampoule handling and reduced breakage. The automated process includes: Automatic loading of sterilized ampoules from the hopper Nitrogen pre-flushing to remove oxygen Simultaneous filling through two needles 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: Is Two Needle Ampoule Filling Machine cGMP, MHRA, FDA and WHO-GMP Compliant?

Yes — Adinath International Two Needle 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 Two Needle Ampoule Filling Machine internationally?

Yes, Adinath International Two Needle 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

Two Needle Ampoule Filling Machine is a specialized pharmaceutical device designed for precise filling and sealing of glass ampoules, typically used for injectable liquids, cosmetics, or chemicals. It operates on the principle of slant traveling, where ampoules move at an angle through various stations for efficient processing.

- Optional laminar airflow for sterile Class 100 filling conditions.

- Adjustable ampoule loading tray to accommodate various ampoule sizes.

- Energy-saving technology with automatic shut-off when idle to reduce power consumption (typically 1 H.P., 220V, single-phase, 50 Hz).

- Safety valves and pressure reducers for oxygen (1 kg/cm²) and LPG (0.5 kg/cm²) circuits, with flow meters to regulate flames.

- Optional nitrogen flushing before and after filling for enhanced product purity.

If you need details on specific models, pricing, or comparisons with multi-head machines, let me know!

Salient Features of Two Needle Ampoule Filling Machine

Compact cGMP model.
Higher output up to 3000 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 316 & other 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 Two Needle Ampoule Filling Machine

Empty washed & sterilized ampoules receive automatically on wire mesh conveyor belt from outfeed of sterilizing tunnel. Ampoule fed automatically into in-feed hopper from the left hand side of the machine and feed to receiving rack through cassette. The moving rack which moves horizontally collect two ampoules 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 station.

Technical Specification of Two Needle Ampoule Filling Machine

Model Name	AFS-2
Production Speed	Up to 50 ampules/minute
Ampoule Sizes	1 ml to 30 ml
Filling Error	± 1%
Sealing Gas	LPG and Oxygen (O₂)
Nitrogen Gas	Pre & Post Nitrogen
Power Load	0.5 H. P.
Power Voltage	230 Volts, Single Phase, 50 Hertz
Contact Parts	Made from Stainless Steel 316L
Non-Contact Parts	Made from Stainless Steel 304
Machine Size	915mm (L) x 760mm (W) x 965mm (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 Two Needle Ampoule Filling Machine

High Precision: Ensures accurate filling and sealing with minimal errors.

Efficiency: Doubles production capacity with two heads without increasing the machine’s footprint.

Durability: Stainless steel construction enhances longevity and hygiene.

Flexibility: Handles various ampoule sizes and liquid types with customizable settings.

Low Maintenance: Requires only basic cleaning and lubrication, with tool-less format changes for quick setup.

Key Features of Two Needle Ampoule Filling Machine

Capacity and Output: The machine can fill 1ml to 20ml ampoules with a production output of 30 to 55 ampoules per minute (approximately 1,800 to 3,300 ampoules per hour), making it suitable for small to medium-scale production.

Filling Mechanism: Utilizes two filling needles for simultaneous filling, ensuring high precision with an accuracy of ±0.5% to 1%. It supports various filling systems, such as volumetric piston pumps, servo-driven pumps, or peristaltic pumps, allowing flexibility for different liquid viscosities.

Process Flow:
1. Loading: Sterilized ampoules are loaded into a hopper and fed onto a traveling rack via a starwheel or cassette, typically in groups of two.
2. Nitrogen Purging: Inert gas (nitrogen) is flushed into the ampoules before and after filling to prevent contamination and ensure sterility.
3. Filling: Two needles dispense a preset volume of liquid (0.5ml to 25ml in a single dose) with neck-centering for accuracy. No liquid is dispensed if an ampoule is absent, reducing waste.
4. Pre-Warming: A low-pressure flame warms the ampoule necks to prepare them for sealing, removing any residual droplets.
5. Sealing: Rollers rotate ampoules under a high-precision flame (using oxygen and LPG/propane) for uniform, 360-degree sealing. Waste tips are clipped and collected separately.
6. Collection: Sealed ampoules are automatically collected upright on a tray for further processing.

Construction: Built with a stainless steel 316L frame and contact parts for corrosion resistance and compliance with cGMP standards. The compact, monobloc design minimizes floor space and includes large openings for easy cleaning and maintenance.

Automation and Controls: Fully automatic with minimal human intervention, featuring a user-friendly touchscreen interface for adjusting speed, fill volume, and sealing temperature. It includes an automatic stop function to prevent accidents and reduce wastage, with alerts for malfunctions.

FAQ for Two Needle Ampoule Filling Machine

What is a Two Needle Ampoule Filling Machine?

A Two Needle Ampoule Filling Machine (also known as Two Head Ampoule Filler Sealer) is a fully automatic monobloc machine designed for precise filling and flame sealing of sterile liquid injectables into glass ampoules. It uses two filling needles working simultaneously and integrates nitrogen flushing (pre- and post-filling), volumetric piston filling, neck pre-heating, and LPG + Oxygen flame sealing in one compact unit. This model is ideal for medium-scale production and offers a good balance between output and cost while meeting cGMP, USFDA, and WHO standards.

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

The Two Needle Ampoule Filling Machine (Model AFS-2) has a production capacity of up to 50 ampoules per minute (approximately 3,000 ampoules per hour). It supports ampoule sizes from 1ml to 30ml with a filling range of 0.5ml to 25ml and maintains high filling accuracy of ±1%. This makes it suitable for medium-volume pharmaceutical injectable production.

How does the Two Needle Ampoule Filling Machine work?

The machine operates on the slant traveling principle for gentle ampoule handling and reduced breakage. The automated process includes:

Automatic loading of sterilized ampoules from the hopper
Nitrogen pre-flushing to remove oxygen
Simultaneous filling through two needles 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 Two Needle Ampoule Filling Machine?

Key features include:

Two needle / two head monobloc design for higher output
Nitrogen flushing before, during, and after filling
Precision piston pumps for accurate dosing
Tool-less quick changeover with minimal parts
All product contact parts made of SS 316L
Slant design for smooth movement and low glass particle generation
Pre-heating station and precise flame control
Compact footprint with easy cleaning and maintenance
Optional PLC/HMI with SCADA compatibility

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

Main benefits include:

Double the output compared to single needle machines (up to 50 ampoules/min)
Excellent filling accuracy (±1%) with minimal product wastage
Gentle handling that reduces glass breakage and contamination risk
Faster production with balanced cost-efficiency for medium batches
Fast format changeover and easy validation
Compact design suitable for cleanroom environments
Full cGMP compliance and reliable performance

Is Two Needle Ampoule Filling Machine cGMP, MHRA, FDA and WHO-GMP Compliant?

Yes — Adinath International Two Needle 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 Two Needle 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 Two Needle Ampoule Filling Machine internationally?

Yes, Adinath International Two Needle 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 Two Needle 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 Two Needle Ampoule Filling Machine stocked at our premises in Ahmedabad and shipped immediately after ordering. Standard 12 months manufacturing warranty included with supplied equipment.