Injection Ampoule Filler

Q: What are the available models and production capacities of the Injection Ampoule Filler?

We offer the following standard models: AFS-1 (Single Head) : Up to 25 ampoules per minute (~1,500 per hour) AFS-2 (Two Heads) : Up to 50 ampoules per minute AFS-4 (Four Heads) : Up to 100 ampoules per minute AFS-8 (Eight Heads) : Up to 200 ampoules per minute (~12,000 per hour) Custom higher-speed models are available up to 36,000 ampoules per hour. The machine supports ampoule sizes from 1 ml to 30 ml (model dependent) with filling volumes from 0.5 ml to 25 ml and ±1% filling accuracy.

Q: How does the Injection Ampoule Filler work?

The machine works on the slant traveling principle for gentle ampoule handling and reduced breakage. Sterilized ampoules are loaded into the in-feed hopper and move through the following automated steps: Nitrogen pre-gassing Precise piston pump filling Nitrogen post-gassing Neck pre-heating LPG + Oxygen flame sealing Safety systems like “No Ampoule – No Filling” and “No Ampoule – No Seal” minimize wastage. Filled and sealed ampoules are automatically collected on a tray.

Description

Injection Ampoule Filler is a specialized pharmaceutical machine designed to fill and seal glass ampoules with liquid drugs, primarily for injectable applications. These machines ensure precise, sterile, and efficient filling of ampoules, adhering to stringent industry standards like cGMP and USFDA. Their advanced design, precise filling mechanisms, and compliance with regulatory standards make them indispensable in pharmaceutical manufacturing. Below is a detailed description based on their design, functionality, and features:

Purpose and Application:
- Used to fill and seal glass ampoules (typically 1ml to 30ml) with liquid pharmaceuticals, such as injectables, vaccines, or other sterile solutions.
- Applicable in industries like pharmaceuticals, biotechnology, cosmetics, and chemicals for filling agro-insecticides or veterinary medicines.

Design and Construction:
- Compact and Monobloc Design: Combines filling and sealing in a single unit for streamlined operation and reduced contamination risk.
- Materials: Contact parts are made of high-quality stainless steel 316L to ensure compatibility with sterile drugs and compliance with cGMP standards. Non-contact parts are typically stainless steel 304 or other durable materials.
- Structure: Built on a sturdy stainless steel square pipe frame with a matte finish, often featuring a large bottom opening for easy cleaning and maintenance.
- Safety Features: Includes toughened glass cabinets or isolators for a sterile environment and stainless steel hoods to channel out fumes during sealing.

Salient Features of Injection Ampoule Filler

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 Injection 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.

- Ampoule Loading: Sterilized ampoules are fed automatically via an in-feed hopper or conveyor, often from a sterilizing tunnel, into a transport rack or star wheel in batches (e.g., 1, 2, 4, or 8 ampoules per cycle).
- Nitrogen Purging: Nitrogen gas is flushed before and/or after filling to remove atmospheric air and prevent oxidation or contamination.
- Filling: Precise filling is achieved using volumetric piston pumps, servo-driven systems, or peristaltic pumps, with filling capacities ranging from 0.5ml to 25ml in a single dose. Co-eccentric nozzles ensure quick and accurate filling.
- Sealing: Ampoules are sealed using oxygen and LPG (propane) flames, with pre-heating and sealing stations. Specially designed rollers rotate ampoules for uniform sealing. A cooling system prevents overheating, and flow meters regulate flames.
- Output Collection: Filled and sealed ampoules are automatically collected in an upright position on a tray or conveyor for further processing (e.g., inspection or labeling).
- Pre-Warming Station: Uses low-pressure flames to prepare thick glass ampoules for sealing, ensuring quality.
- Nitrogen Flush Facility: Enhances sterility and prevents contamination.
- Data Acquisition: SCADA systems provide real-time monitoring of process data for batch control and quality assurance.
- Inspection Compatibility: Easily integrates with upstream (washing, sterilization) and downstream (inspection, labeling) equipment.

Technical Specification of Injection 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 Injection Ampoule Filler

High production capacity to meet growing demand for injectables.

Hygienic and sterile operations to ensure patient safety.

Minimal downtime due to quick changeovers and robust construction.

Reduced risk of glass particle contamination when paired with filter needles during administration.

Cost-effective for small, medium, and large-scale production due to customizable configurations.

Key Features of Injection Ampoule Filler

- High Precision and Accuracy: Ensures exact dosing for liquid, powder, or solid drugs, minimizing waste and ensuring patient safety.
- High Output: Depending on the model, output ranges from 1,500 to 36,000 ampoules per hour (e.g., single-head for lab-scale, eight-head for high-speed production).
- Flexibility: Supports a wide range of ampoule sizes (1ml to 30ml) with minimal changeover parts, allowing quick adjustments via servo motors and PLC controls.
- Safety and Automation: Features like “No Ampoule, No Fill” and “No Ampoule, Machine Stop” systems prevent errors. Nitrogen flushing and laminar airflow cabinets ensure sterility.
- Ease of Maintenance: Tool-less format changes, easy-to-clean designs, and comprehensive manufacturer documentation simplify operation and troubleshooting.
- Compliance: Built to meet cGMP and USFDA standards, often with CE certification and options for laminar airflow or isolator-based systems for Class 100 environments.

FAQ for Injection Ampoule Filler

What is an Injection Ampoule Filler?

An Injection Ampoule Filler is a compact, automatic monobloc machine designed for filling and sealing sterile liquid injectables into glass ampoules. It performs nitrogen flushing (pre- and post-filling), precise volumetric filling, neck pre-heating, and flame sealing in one unit. Built with SS 316L product contact parts, it ensures high sterility and complies with cGMP, USFDA, and WHO standards. It is ideal for pharmaceutical parenteral products, vaccines, and other injectable formulations.

What are the available models and production capacities of the Injection Ampoule Filler?

We offer the following standard models:

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

Custom higher-speed models are available up to 36,000 ampoules per hour. The machine supports ampoule sizes from 1 ml to 30 ml (model dependent) with filling volumes from 0.5 ml to 25 ml and ±1% filling accuracy.

How does the Injection Ampoule Filler work?

The machine works on the slant traveling principle for gentle ampoule handling and reduced breakage. Sterilized ampoules are loaded into the in-feed hopper and move through the following automated steps:

Nitrogen pre-gassing
Precise piston pump filling
Nitrogen post-gassing
Neck pre-heating
LPG + Oxygen flame sealing

Safety systems like “No Ampoule – No Filling” and “No Ampoule – No Seal” minimize wastage. Filled and sealed ampoules are automatically collected on a tray.

What are the key features of the Injection Ampoule Filler?

Key features include:

Nitrogen flushing before, during, and after filling to prevent oxidation
Ampoule neck centering for accurate filling and sealing
“No Ampoule – No Fill/Seal” system
Tool-less quick changeover with minimal parts
SS 316L contact parts and SS 304 non-contact parts
Pre-warming station and flow meters for flame control
SCADA/PLC options for advanced monitoring
Compatibility with laminar airflow and isolators for cleanroom use

These features ensure high sterility, low contamination risk, and consistent product quality.

Which industries use the Injection Ampoule Filler and what are its main benefits?

It is widely used in:

Pharmaceuticals (injectables, vaccines, parenterals)
Biotechnology
Veterinary medicines
Cosmetics
Chemical and agro-insecticide industries

Main benefits:

High filling accuracy (±1%) with minimal product wastage
Reduced human intervention for better sterility
Fast and easy format changeover
Compact footprint with robust construction
Full cGMP compliance and easy validation
Lower risk of glass particle contamination due to slant design

The machine can be integrated into complete injectable production lines including washing, sterilization, and labeling.

Countries We Export to

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