10ml Ampoule Filler

Description

10ml Ampoule Filler is a specialized machine designed for filling and sealing 10ml glass ampoules, commonly used in pharmaceutical, biotech, cosmetic, and chemical industries. 10ml Ampoule Filler is a precision-engineered, automated machine designed to fill and seal 10ml glass ampoules with liquid, powder, or other injectable substances. These machines are built to meet stringent cGMP (current Good Manufacturing Practices) standards, ensuring high accuracy, sterility, and efficiency in sterile environments. They are typically used for filling pharmaceuticals, veterinary medicines, cosmetics, or agrochemicals, with a focus on preventing contamination and ensuring precise dosing. Below is a detailed description based on the latest information available:

Sterility: Machines must integrate with sterilizing tunnels or isolators to maintain aseptic conditions.

Maintenance: Easy access for cleaning and minimal changeover parts reduce downtime.

Customization: Ensure the machine supports both open and closed 10ml ampoules, as requirements vary.

Regulatory Compliance: Verify compliance with local regulations (e.g., USFDA, WHO, GMP) for pharmaceutical use.

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 Filler

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 Filler

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.

Technical Specification of 10ml Ampoule Filler

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 Filler

High accuracy (±0.5% fill precision) ensures consistent dosing.

Compact, monoblock design saves space and simplifies cleaning.

Stainless steel construction ensures durability and compliance with hygiene standards.

Automated processes reduce labor and human error.

Nitrogen flushing and sealed designs minimize contamination risks.

Fast changeover times improve production efficiency.

Key Features of 10ml Ampoule Filler

Filling Capacity:
- Capable of filling 0.5ml to 10ml in a single dose, with some models supporting up to 30ml for flexibility. For 10ml ampoules, output ranges from 80 to 280 ampoules per minute, depending on the machine’s configuration (e.g., number of filling heads). For instance, an eight-head filler can process up to 150 ampoules per minute for 10ml sizes.

Filling Mechanism:
- Utilizes advanced filling technologies such as:
  - Volumetric Piston Pumps: Ensures precise dosing with a fill accuracy of ±0.5%.
  - Peristaltic Pumps: Ideal for sensitive liquids, as the liquid only contacts the hose, reducing contamination risks.
  - Servo-Driven Systems: Allows for adjustable fill volumes via a touchscreen interface for enhanced precision.
- Features like “no ampoule, no fill” minimize liquid wastage.

Construction and Materials:
- Contact parts are made of high-quality Stainless Steel 316L to ensure compatibility with sterile liquids and compliance with cGMP standards. Non-contact parts are typically Stainless Steel 304.
- Monoblock design integrates filling and sealing operations on a single platform, reducing footprint and contamination risks.

Operational Process:
- Loading: Empty, pre-sterilized 10ml ampoules are loaded into an infeed hopper and transferred via a starwheel or cassette to a traveling rack.
- Nitrogen Purging: Inert gas (nitrogen) is flushed before and after filling to prevent oxidation and contamination.
- Filling: Filling nozzles deliver a precise 10ml dose, with neck-centering mechanisms ensuring accuracy.
- Pre-Heating and Sealing: Ampoules are pre-warmed with a low-pressure flame, then sealed using oxygen and LPG (propane) with specially designed rollers for uniform sealing.
- Collection: Filled and sealed ampoules are collected upright in a tray for further processing.

Sealing Mechanism:
- Uses combustible gases (oxygen and LPG) for sealing, with flow meters to regulate flame intensity.
- Some models include a stainless steel hood to channel fumes during heating, enhancing safety and cleanliness.
- Safety valves and pressure reducers ensure safe operation of gas circuits.

Automation and Control:
- Equipped with PLC systems and touchscreen interfaces for real-time parameter adjustments and error monitoring.
- Features like SCADA (Supervisory Control and Data Acquisition) and SODA (Single Object Data Acquisition) provide real-time process data and supply chain security.
- Minimal changeover parts for switching between 1ml to 10ml ampoules, reducing downtime.

Production Capacity:
- Varies by model and number of heads:
  - Single Head: ~1,500 ampoules/hour (lab-scale).
  - Four Head: ~6,000–7,200 ampoules/hour (medium-scale).
  - Eight Head: ~12,000 ampoules/hour (high-speed, large-scale).
- For 10ml ampoules, output is typically lower (e.g., 150 ampoules/min for eight-head models) due to larger volume handling.

Additional Features:
- Nitrogen Flushing: Pre- and post-filling nitrogen flush to ensure product stability.
- Pre-Warming Station: Ensures proper sealing by warming ampoule necks.
- Cooling System: Prevents overheating, extending machine lifespan.
- Minimal Changeover: Quick adjustments for different ampoule sizes (1ml to 10ml) with minimal parts.
- Optional Features: Laminar Air Flow, isolators, or safety cabinets for enhanced sterility.

FAQ for 10ml Ampoule Filler

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

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

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

Our 10ml Ampoule Filler is available in multiple models with the following outputs:

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

The actual speed for 10ml ampoules 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 Filler handle, and how easy is size changeover?

The machine is optimized for 10ml ampoules but can handle a wide range from 1ml to 30ml (1ml to 20ml on multi-head models). It supports both open-mouth and closed-mouth ampoules (Type B, C, or D). Changeover between different sizes is quick and requires minimal parts replacement. Most adjustments are tool-less, resulting in very low downtime. A “No Ampoule – No Filling” system prevents product wastage during operation.

How does the 10ml Ampoule Filler maintain sterility and product quality?

Sterility is ensured through several advanced features:

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 are made of Stainless Steel 316L.
Optional Laminar Air Flow (LAF) cabinet for Class 100 aseptic conditions.

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

What are the power requirements and key safety features of the machine?

Power consumption is low and model-dependent:

AFS-1: 0.5 HP
AFS-2 & AFS-4: 1 HP
AFS-8: 2 HP (All operate on 230 Volts, Single Phase, 50 Hz – 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 cleaning, and easy maintenance. The machine integrates seamlessly with upstream washing/sterilizing tunnels and downstream inspection/labeling equipment to form a complete production line.

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