Sterile Ampoule Filler Sealer

Description

Sterile Ampoule Filler Sealer is a specialized machine used in pharmaceutical, biotech, cosmetic, and chemical industries to fill and seal glass ampoules under sterile conditions. These machines ensure precise filling of liquids or powders into ampoules, followed by sealing to maintain sterility and prevent contamination. When selecting a sterile ampoule filler sealer, consider:

- Production Scale: Choose single-head for labs, four/six-head for medium-scale, or eight-head for large-scale production.
- Ampoule Type: Ensure compatibility with open or closed (Type D) ampoules.
- Regulatory Compliance: Verify cGMP, USFDA, or WHO standards for pharmaceutical use.
- Integration Needs: Opt for machines that integrate with washing, sterilization, and labeling for streamlined production.
- Sterility and Contamination: Automated systems and laminar airflow minimize human contact, ensuring sterile conditions.
- Customization: Machines can be tailored for specific ampoule types, sizes, and production needs.
- Maintenance: Designed for easy cleaning and minimal downtime, with large access panels and tool-less changeovers.
- Safety: Equipped with safety valves, pressure reducers, and exhaust systems for gas circuits.

Salient Features of Sterile Ampoule Filler Sealer

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 Sterile Ampoule Filler Sealer

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 Sterile Ampoule Filler Sealer

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 Sterile Ampoule Filler Sealer

Highest Level of Sterility Assurance

Advanced “No Ampoule – No Fill/Seal” System

Gentle Handling with Minimal Glass Breakage

Superior Filling Accuracy

Immediate Flame Sealing for Enhanced Protection

Compact Monobloc Design with Cleanroom Compatibility

Reduced Human Intervention

Key Features of Sterile Ampoule Filler Sealer

Purpose: Designed for filling and sealing glass ampoules (open or closed, typically 1ml to 30ml) with sterile liquids or powders, ensuring compliance with cGMP standards.

Operation:
- Filling: Uses volumetric piston pumps or peristaltic pumps for precise dosing (0.5ml to 25ml in a single dose). Some models feature “no ampoule, no fill” systems to minimize waste.
- Sealing: Involves pre-heating and sealing stations using oxygen and LPG (propane) flames. Ampoules are rotated during sealing for uniform closure.
- Sterility: Incorporates nitrogen flushing (pre- and post-filling) and optional laminar airflow (Class 100) to maintain sterile conditions.
- Construction: Made with stainless steel 316L for contact parts and 304 for non-contact parts, ensuring durability and compliance with cGMP requirements.

Automation: Fully automated systems reduce human intervention, enhancing sterility and efficiency. PLC-based controls with touch-screen interfaces allow real-time monitoring and adjustments.

Output: Varies by model:
- Single-head: ~1,500 ampoules/hour (lab-scale).
- Four-head: ~6,000–7,200 ampoules/hour (medium-scale).
- Eight-head: Up to 12,000–36,000 ampoules/hour (high-speed).
- Some advanced lines reach 400 ampoules/minute.

Flexibility: Handles various ampoule sizes (1ml to 30ml) with minimal changeover time. Some machines support both open and closed (Type D) ampoules, with additional stations for opening closed ampoules.

Additional Features:
- Pre-warming stations for thick glass ampoules.
- In-process control (IPC) for fill weight and seal quality.
- Optional integration with washing, sterilization tunnels, and labeling machines for complete production lines.

FAQ for Sterile Ampoule Filler Sealer

What is a Sterile Ampoule Filler Sealer?

A Sterile Ampoule Filler Sealer is a high-precision automatic monobloc machine designed for aseptic filling and flame sealing of sterile liquid injectables into glass ampoules. It integrates nitrogen flushing (pre-, during, and post-filling), accurate volumetric piston filling, neck pre-heating, and LPG + Oxygen flame sealing in one compact unit. Built with strict sterility focus using SS 316L product contact parts, it ensures maximum product protection and complies with cGMP, USFDA, WHO, and EU GMP standards. It is ideal for pharmaceutical parenteral drugs, vaccines, and other critical sterile formulations.

What models and production capacities are available for the Sterile Ampoule Filler Sealer?

We offer four standard models to match different production requirements:

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 (~6,000 per hour)
AFS-8 (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. The machine supports ampoule sizes from 1ml to 30ml with filling volumes from 0.5ml to 25ml and filling accuracy of ±1%.

How does the Sterile Ampoule Filler Sealer maintain sterility during the process?

The machine ensures high sterility through several advanced features:

Nitrogen flushing before, during, and after filling to remove oxygen and prevent oxidation
Slant traveling principle with neck centering for gentle ampoule handling and reduced glass particle generation
“No Ampoule – No Filling” and “No Ampoule – No Seal” safety systems
Immediate pre-heating and flame sealing after filling
All product contact parts made of SS 316L
Full compatibility with laminar airflow and isolator systems for Grade A cleanroom operation

These features minimize human intervention and contamination risks.

What are the key features of the Sterile Ampoule Filler Sealer?

Key features include:

Triple nitrogen flushing system for superior product protection
Precision piston pumps with ±1% filling accuracy
Tool-less quick changeover with minimal parts
Pre-warming station and accurate flame control
Slant design for smooth movement and low breakage
SS 316L contact parts and SS 304 non-contact parts
“No Ampoule – No Fill/Seal” intelligent sensors
Compact monobloc design with easy cleaning and validation
Optional PLC/HMI with 21 CFR Part 11 compliance

What are the main benefits of using a Sterile Ampoule Filler Sealer?

Main benefits include:

Highest sterility assurance for critical injectable products
Excellent filling accuracy with minimal product wastage
Reduced glass breakage and particle contamination
Fast format changeover and low maintenance
Compact footprint ideal for cleanroom environments
Full regulatory compliance and easy validation
Seamless integration into complete sterile injectable production lines

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