5ml Ampoule Filler

Q: Can the 5ml Ampoule Filler handle only 5ml ampoules or other sizes as well?

While optimized for 5ml ampoules , the machine is versatile and can handle ampoule sizes from 2ml to 10ml (and up to 30ml with suitable change parts). The filling range is flexible from 1ml to 25ml , allowing easy switching between different small-to-medium volume injectable products with quick tool-less changeover.

Description

5ml Ampoule Filler is a specialized machine designed for the precise filling and sealing of 5ml glass ampoules, commonly used in pharmaceutical, biotech, cosmetic, and chemical industries. Below is a detailed description based on advanced technology and industry standards:

- Designed to meet cGMP and US FDA requirements.

- Optional safety cabinets, laminar airflow, or isolator systems for Class 100 cleanroom compatibility.

- CE-certified models available with robust safety features like pressure reducers and stainless steel hoods to channel fumes.

- Available in single, two, four, six, or eight-head configurations to suit small, medium, or large-scale production.

- Options for handling both open and closed ampoules, with specific models for pre-sterilized (closed) ampoules.

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 5ml 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 5ml Ampoule Filler

Closed mouth/pre 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 sequentially below operations performed:

Pre-gassing with Nitrogen
Filling the product
Post Gassing with Nitrogen
Pre-heating with LPG & Oxygen combination
Sealing with LPG & Oxygen combination

At the end duly filled and sealed ampoules get collected automatically onto collection tray of the machine. Ampoules now can be collected for further inspection and/or sticker labeling operations.

Technical Specification of Automatic Ampoule Filling Sealing Machine

Model	AFS-1C	AFS-2C	AFS-4C	AFS-8C
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 Precison	± 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 Arranegment	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	1050mm (L) x 610mm (W) x 965mm (H) approx.	1150mm (L) x 760mm (W) x 965mm (H) approx.	1400mm (L) x 1070mm (W) x 965mm (H) approx.	2700mm (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

Benefits of 5ml Ampoule Filler

High Accuracy: Ensures precise dosing, critical for pharmaceuticals.

Efficiency: High-speed models minimize production time for large batches.

Versatility: Handles a range of ampoule sizes and liquid viscosities.

Ease of Use: Automated processes and minimal changeover time reduce operator effort.

Hygiene: Stainless steel construction and nitrogen flushing prevent contamination.

Key Features of 5ml Ampoule Filler

Design and Construction:
- Monobloc Design: Combines filling and sealing operations on a single platform for efficiency and reduced contamination risk.
- Material: Contact parts are made of high-quality stainless steel for compatibility with sterile liquids, while non-contact parts are typically stainless steel, meeting cGMP standards.
- Compact Structure: Built on a sturdy stainless steel frame with a matte finish, often with a large bottom opening for easy cleaning and maintenance.

Filling Mechanism:
- Filling Capacity: Capable of filling 0.5ml to 5ml in a single dose with high precision (±0.5% fill accuracy).
- Filling Options:
  - Piston pump (volumetric) for consistent dosing.
  - Peristaltic pump for gentle handling of sensitive liquids.
  - Servo-driven systems for precise, adjustable fill volumes via touch-screen controls.
- No Ampoule, No Fill: Feature to minimize liquid wastage by preventing dispensing when no ampoule is present.

Process Flow:
- Ampoule Loading: Sterilized 5ml ampoules are loaded into an infeed hopper and transferred via a starwheel or cassette to a slanted rack for smooth handling.
- Nitrogen Purging: Pre- and post-filling nitrogen flushing to remove atmospheric air and prevent oxidation of sensitive products.
- Filling: Filling nozzles, centered on the ampoule neck, dispense the exact volume. Diving nozzles may be used to avoid foaming.
- Pre-Heating and Sealing:
  - A pre-warming station uses a low-pressure flame to prepare the ampoule neck.
  - Sealing is performed using oxygen and LPG (propane) with specially designed rollers to ensure uniform, airtight seals.
- Collection: Filled and sealed ampoules are automatically collected in an upright position on a tray for further processing.

Production Capacity:
- Varies by model:
  - Single-head fillers: ~1,500 ampoules/hour (lab-scale).
  - Two-head fillers: ~3,300–4,500 ampoules/hour.
  - Four-head fillers: ~6,000–7,200 ampoules/hour.
  - Six-head fillers: ~9,000 ampoules/hour.
  - Eight-head fillers: ~12,000–15,000 ampoules/hour.
- High-speed models can reach up to 240–300 ampoules/minute (14,400–18,000/hour) for 5ml ampoules, depending on machine configuration.

Advanced Features:
- PLC and HMI Control: Programmable logic controllers with human-machine interfaces for real-time monitoring, error detection, and auto-fill volume adjustments.
- Nitrogen Flushing: Ensures product stability by reducing oxygen exposure.
- Flow Meters and Safety Valves: Regulate combustible gases for safe and consistent sealing.
- Cooling System: Prevents overheating, extending machine lifespan.
- Quick Changeover: Minimal parts change for different ampoule sizes (1ml to 10ml or up to 30ml in some models).
- Integration: Can be linked with upstream sterilizing tunnels and downstream inspection or labeling machines.

FAQ for 5ml Ampoule Filler

What is a 5ml Ampoule Filler?

A 5ml Ampoule Filler is a high-precision automatic monobloc machine designed specifically for filling and flame sealing sterile liquid injectables into 5ml glass ampoules. It integrates nitrogen flushing (pre- and post-filling), accurate volumetric piston filling, neck pre-heating, and LPG + Oxygen flame sealing in one compact unit. This machine is widely used in pharmaceutical production for medium-volume parenterals such as antibiotics, analgesics, and other injectable formulations. It fully complies with cGMP, USFDA, and WHO standards.

What is the production capacity of the 5ml Ampoule Filler?

The 5ml Ampoule Filler is available in multiple head configurations:

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

Custom high-speed models can reach up to 36,000 ampoules per hour. It delivers excellent filling accuracy of ±1% for 5ml ampoules.

Can the 5ml Ampoule Filler handle only 5ml ampoules or other sizes as well?

While optimized for 5ml ampoules, the machine is versatile and can handle ampoule sizes from 2ml to 10ml (and up to 30ml with suitable change parts). The filling range is flexible from 1ml to 25ml, allowing easy switching between different small-to-medium volume injectable products with quick tool-less changeover.

What are the key features of the 5ml Ampoule Filler?

Key features include:

Precise filling optimized for 5ml volume with ±1% accuracy
Nitrogen flushing before, during, and after filling to prevent oxidation
Neck centering system for accurate dosing and sealing
Slant traveling principle for gentle handling and reduced glass breakage
Tool-less quick changeover with minimal parts
All product contact parts made of SS 316L
Pre-heating station and precise flame control
“No Ampoule – No Fill/Seal” safety system
Compact monobloc design with easy cleaning and maintenance

What are the main benefits of the 5ml Ampoule Filler?

Main benefits include:

High filling accuracy and repeatability specifically for 5ml ampoules with minimal wastage
Excellent sterility assurance through nitrogen flushing and full automation
Gentle handling that reduces glass particle generation and breakage
Fast format changeover for different ampoule sizes
Compact footprint ideal for cleanroom environments
High production efficiency with low maintenance
Full cGMP compliance making it suitable for regulated markets

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