10ml Ampoule Filling Machine

Description

10ml Ampoule Filling Machine is a specialized pharmaceutical device designed to fill and seal 10ml Glass Ampoules with liquid drugs or other substances. These machines are widely used in industries such as pharmaceuticals, biotechnology, cosmetics, and chemicals, ensuring precise, sterile, and efficient filling and sealing processes. Below is a detailed description based on industry standards and available information:

- Nitrogen flushing before and after filling to maintain sterility.

- Optional laminar airflow or RABS (Restricted Access Barrier System) for class 100 sterile filling.

- Minimal changeover time for different ampoule sizes, with tool-less format changes in some models.

- Waste tip collection and dead tray for upright ampoule placement during collection.

- Pendant-style electrical control panels for safe and easy operation.

- Stainless steel hoods to channel fumes during sealing and ergonomic designs for operator comfort.
- Machines may require specific gases (oxygen, LPG) and precise pressure settings, increasing operational complexity.
- Initial setup and calibration for 10ml ampoules may need skilled technicians.
- No machine is 100% error-free, so regular maintenance is critical to avoid inefficiencies.

This machine ensures compliance with cGMP standards for sterile injectable filling. If you need details on specific models, pricing, or comparisons with multi-head machines, let me know!

Salient Features of 10ml Ampoule Filling Machine

Minimum change over time, little maintenance, easy cleaning.
Higher production output up to 12000 Ampoules per hour.
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.

Compact model as per cGMP standard.
Possibility of nitrogen gas flushing before, during and after filling.
Full accessibility allows easy maintenance.
Machine equipped with pre-warming station.
Flow Meters for regulating flames easily.
“No Ampoule – No Filling” system.

Working Principle of 10ml 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.

Loading: Sterilized ampoules are loaded into a slant hopper or fed via a conveyor from a sterilizing tunnel. A star wheel transfers ampoules to an eccentric or vertical rack.

Nitrogen Flushing: Pre-flushing with nitrogen to remove air and ensure sterility.

Filling: Liquid is dispensed via filling nozzles with precise volume control, often using piston or peristaltic pumps.

Post-Nitrogen Flushing: Additional nitrogen flush to maintain sterility.

Pre-Warming and Sealing: Ampoules are warmed at a pre-heating station, then sealed by melting the neck with an open flame, with rollers ensuring uniform sealing.

Collection: Filled and sealed ampoules are automatically collected on a tray without manual handling.

Technical Specification of 10ml 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 10ml Ampoule Filling Machine

High precision and minimal product wastage due to advanced filling systems.

Compact, monobloc design integrates filling and sealing, reducing contamination risks.

Fast changeover and easy maintenance minimize downtime.

Compliance with cGMP and CE standards ensures safety and quality.

Key Features of 10ml Ampoule Filling Machine

Capacity and Compatibility:
- Designed to handle 10ml open-mouth or closed glass ampoules, with flexibility to accommodate sizes ranging from 1ml to 30ml in some models.
- Filling capacity typically ranges from 0.5ml to 25ml in a single dose, with precise volumetric control.

Construction:
- Built with high-quality stainless steel to meet cGMP standards, ensuring durability and compliance with sterile production requirements.
- Features a robust stainless steel square pipe frame with a matte finish and large bottom openings for easy cleaning and maintenance.

Filling Mechanism:
- Operates on the principle of slant travel, allowing precise handling of ampoules despite variations in neck dimensions, thickness, or ovality.
- Utilizes volumetric piston pumps, peristaltic pumps, or ceramic pumps for accurate filling with minimal product waste.
- Equipped with a “no ampoule, no fill” system to prevent liquid wastage.

Sealing Process:
- Sealing is performed using combustible gases (oxygen and LPG/propane) at pressures of approximately 1kg/cm² for oxygen and 0.5kg/cm² for LPG.
- Features pre-warming and sealing stations, with rollers to rotate ampoules for uniform sealing and a waste tip clipper for clean ejection of excess glass.
- Some models include pre- and post-nitrogen flushing to ensure sterility and prevent contamination.

Production Capacity:
- Output varies by model and number of filling heads (single, two, four, six, or eight heads). For 10ml ampoules, high-speed models like the eight-head vertical machines can process 80–280 ampoules per minute (approximately 4,800–16,800 per hour).
- Specific output for 10ml ampoules is around 150–200 ampoules per minute, depending on machine configuration and ampoule diameter.

Automation and Control:
- Equipped with PLC (Programmable Logic Control) and HMI (Human-Machine Interface) systems for real-time monitoring, error detection, and automated fill volume adjustments.
- Servo-driven systems or brushless motors ensure precise and gentle movements.
- Features like flow meters for flame regulation and safety valves in gas circuits enhance operational safety.

FAQ for 10ml Ampoule Filling Machine

What is a 10ml Ampoule Filling Machine and what does it do?

The 10ml Ampoule Filling Machine is a fully automatic monoblock system designed to fill and hermetically seal 10ml glass ampoules with sterile liquid injectables, vaccines, serums, or other pharmaceutical solutions. It performs nitrogen flushing (before and after filling), precise volumetric piston filling, neck pre-heating, and flame sealing in a single continuous operation. Built on the slant travel principle for gentle ampoule handling, it ensures high sterility, minimal breakage, and full compliance with cGMP standards for pharmaceutical and biotech production.

What is the production capacity of the 10ml Ampoule Filling Machine?

Our 10ml Ampoule Filling Machine is available in four models with the following outputs:

AFS-1 (Single Head): Up to 25 ampoules per minute (~1,500/hour)
AFS-2 (Two Heads): Up to 50 ampoules per minute (~3,000/hour)
AFS-4 (Four Heads): Up to 100 ampoules per minute (~6,000/hour)
AFS-8 (Eight Heads): Up to 200 ampoules per minute (~12,000/hour)

The actual speed depends on liquid viscosity and ampoule quality. All models deliver consistent filling accuracy of ±1% using high-precision piston pumps.

Which ampoule sizes can the 10ml Ampoule Filling Machine handle, and how easy is changeover?

The machine is optimized for 10ml ampoules but supports a wide range:

AFS-1: 1ml to 30ml
AFS-2, AFS-4 & AFS-8: 1ml to 20ml

It handles both open-mouth and closed-mouth ampoules (Type B, C, or D). Changeover between sizes is fast with minimum changeover parts and tool-less adjustments in most cases, resulting in very low downtime. The “No Ampoule – No Filling” system prevents product wastage during operation.

How does the 10ml Ampoule Filling Machine ensure sterility and product quality?

Sterility is maintained through:

Nitrogen gas flushing before, during, and after filling to remove oxygen and prevent oxidation.
Precise ampoule neck centering during flushing and filling.
Pre-warming station before flame sealing using LPG + Oxygen burners.
All product contact parts made from Stainless Steel 316L.
Optional Laminar Air Flow (LAF) cabinet for Class 100 aseptic conditions.

The compact monoblock design and slant travel mechanism minimize contamination risks and glass breakage, making it ideal for sterile injectable production as per USFDA and WHO guidelines.

What are the power requirements and key safety features of the 10ml Ampoule Filling Machine?

Power requirements are model-specific and energy-efficient:

AFS-1: 0.5 HP
AFS-2 & AFS-4: 1 HP
AFS-8: 2 HP

(All models operate on 230 Volts, Single Phase, 50 Hz, 4 Wire System – customizable as per your country’s voltage.)

Key safety and operational features include safety clutches, pressure regulators, stainless steel fume extraction hoods, full accessibility for easy cleaning, PLC + HMI controls, and the “No Ampoule – No Filling” system. The machine integrates seamlessly with washing, sterilizing, inspection, and labeling equipment for a complete production line.

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