Ampoule Filler Sealer for Liquid Injection

Description

Ampoule Filler Sealer for Liquid Injection is a specialized pharmaceutical machine designed to fill and seal glass ampoules with liquid drugs, primarily for injectable use. These machines ensure high precision, sterility, and efficiency in the packaging process, adhering to cGMP standards. Below is a detailed description based on their typical features and functionality:

Loading: Pre-sterilized ampoules are loaded into a hopper and transferred to a transport rack via a starwheel or cassette.

Nitrogen Purging: Inert gas (nitrogen) is flushed to remove oxygen from the ampoule.

Filling: Liquid is precisely dispensed using piston or peristaltic pumps, with neck centering for accuracy.

Post-Nitrogen Flushing: Additional nitrogen is flushed to ensure sterility.

Pre-Heating and Sealing: Ampoules are warmed at a pre-heating station, then sealed using flames and rollers for a uniform, hermetic seal.

Collection: Filled and sealed ampoules are automatically collected in an upright position on a tray for further processing.

Ampoule Size: Ensure compatibility with desired ampoule sizes (1ml to 30ml).

Production Scale: Choose single-head for lab-scale or multi-head (e.g., eight-head) for high-volume production.

Sterility Requirements: Opt for models with isolators or laminar airflow for enhanced sterility.

Customization: Look for machines with adjustable filling volumes and tool-less changeovers for flexibility.

Salient Features of 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 Ampoule Filler Sealer for Liquid Injection

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 Ampoule Filler Sealer for Liquid Injection

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 Ampoule Filler Sealer for Liquid Injection

High Accuracy: Ensures precise dosing (±0.5% fill accuracy) for liquids, minimizing wastage.

Sterility: Hermetic sealing and nitrogen flushing protect contents from contamination and oxidation.

Versatility: Suitable for open-mouth (Type B/C) or closed-mouth (Type D) ampoules, with flexibility for various liquid viscosities.

Efficiency: High-speed models and minimal changeover time boost productivity.

Ease of Maintenance: Accessible design with minimal parts for cleaning and upkeep.

Key Features of Ampoule Filler Sealer for Liquid Injection

Purpose and Application:
- Used to fill and seal glass ampoules (1ml to 30ml) with liquid injectable, such as pharmaceuticals, biotech products, veterinary medicines, or cosmetics.
- Ensures the contents remain sterile, non-reactive, and free from contaminants due to the hermetic sealing of glass ampoules.

Construction:
- Built with a stainless steel (SS 316L) frame and contact parts to ensure durability, corrosion resistance, and compliance with cGMP standards.
- Compact, monoblock design integrating filling and sealing operations on a single platform for efficiency.
- Often includes a stainless steel hood to channel out fumes during sealing.

Filling Mechanism:
- Utilizes volumetric piston pumps, servo-driven systems, or peristaltic pumps for precise filling (0.5ml to 25ml per dose).
- Features like “No Ampoule – No Fill” and “No Ampoule – Machine Stop” prevent wastage and ensure accuracy.
- Supports nitrogen purging before and after filling to minimize oxidation and maintain sterility.

Sealing Process:
- Employs oxygen and LPG (propane) flames for hermetic sealing, with pre-heating and sealing stations to ensure a secure seal.
- Uses tip sealing (for liquid-filled ampoules) or pull sealing (for powder-filled ampoules) methods, with rollers to rotate ampoules for uniform sealing.
- Includes safety valves and pressure reducers for safe handling of combustible gases.

Operation and Automation:
- Automatic loading of pre-sterilized ampoules via hoppers or conveyors, with slant travel to accommodate variations in ampoule neck dimensions.
- Features neck centering during filling, gas flushing, and sealing for precision.
- Waste ampoule tips are clipped and collected separately to maintain cleanliness.

Production Capacity:
- Available in single-head, two-head, four-head, six-head, or eight-head models, with outputs ranging from 1,500 to 30,000 ampoules per hour, depending on the model and scale (lab, medium, or large-scale production).
- High-speed models can handle up to 500 ampoules per minute.

Additional Features:
- Tool-less format changes for quick adaptation to different ampoule sizes (1ml to 30ml).
- Optional laminar airflow or isolator systems for enhanced sterility in Class 100 environments.
- Servo-controlled filling volume adjustments via PLC for precision and ease of use.
- Toughened glass cabinets for safety and visibility.

FAQ for Ampoule Filler Sealer for Liquid Injection

What is an Ampoule Filler Sealer for Liquid Injection?

An Ampoule Filler Sealer for Liquid Injection is a compact, monoblock cGMP-compliant machine that automatically fills and seals glass ampoules with sterile liquid injectables. It handles pre-sterilized open-mouth or closed-mouth ampoules, performs nitrogen purging (pre and post-filling), precise volumetric filling, neck pre-heating, and hermetic flame sealing using LPG + Oxygen. The machine ensures high sterility, prevents oxidation, and produces leak-proof sealed ampoules ready for packaging.

What are the main applications of the Ampoule Filler Sealer for Liquid Injection?

This machine is widely used in the pharmaceutical industry for filling and sealing liquid injectables such as vaccines, antibiotics, analgesics, and other parenteral drugs. It is also suitable for:

Biotechnology products
Veterinary medicines
Cosmetic industry (injectable serums)
Chemical industry

It supports both small and medium-scale production of sterile liquid-filled ampoules.

What is the output capacity and ampoule size range of the Ampoule Filler Sealer?

The machine is available in multiple head configurations:

AFS-1 (Single Head): Up to 25 ampoules/min
AFS-2 (Two Heads): Up to 50 ampoules/min
AFS-4 (Four Heads): Up to 100 ampoules/min
AFS-8 (Eight Heads): Up to 200 ampoules/min (approx. 12,000 ampoules/hour)

Filling range: 0.5 ml to 25 ml Ampoule sizes: 1 ml to 30 ml (model-dependent; up to 20 ml on higher-speed models) Changeover is quick with minimum change parts.

What are the key features of the Ampoule Filler Sealer for Liquid Injection?

Volumetric piston pumps with ±1% filling accuracy and neck centering
Nitrogen purging before, during, and after filling to maintain sterility
Pre-heating station + LPG + Oxygen flame sealing with rollers for uniform hermetic seals
“No Ampoule – No Filling” and “No Ampoule – No Seal” safety systems
All contact parts in AISI 316L Stainless Steel
Compact monoblock design with variable speed drive
Easy maintenance, low changeover time, and optional PLC + HMI control
Laminar airflow / isolator compatibility for enhanced sterility

How does the Ampoule Filler Sealer ensure product safety and regulatory compliance?

The machine is built as a complete cGMP model with AISI 316L Stainless Steel contact parts. Nitrogen flushing removes oxygen, while immediate flame sealing creates a perfect hermetic closure, preventing contamination and oxidation. Safety features like “No Ampoule – No Fill/Seal”, gas safety valves, and optional laminar airflow ensure sterile operation. It supports Class 100 environments and comes with full documentation for easy regulatory approval (FDA/cGMP compliance).

Is Ampoule Filler Sealer for Liquid Injection cGMP, MHRA, FDA and WHO-GMP Compliant?

Yes — Adinath International Ampoule Filler Sealer for Liquid Injection complies to cGMP, MHRA, FDA and WHO-GMP standards, with optional CE marked equipments and 21 CFR Part 11 software compliance for the HMI/PLC. Machine contact parts having Stainless Steel 316L grade materials with validation documents having IQ, OQ, DQ validation protocols as optional. Organization is ISO 9001:2015 certified.

What is the lead time for Ampoule Filler Sealer for Liquid Injection?

Manufacturing lead time is generally 7 to 14 weeks from order confirmation. Further it takes 2 to 8 weeks for international shipping depending upon destination. Order can be expediate sooner or later as per specific buying requirements. Destination specific certifications like US FDA, EU, ANVISA, SFDA. CE can add 3 to 6 weeks additionally.

Does Adinath International provide Ampoule Filler Sealer for Liquid Injection internationally?

Yes, Adinath International Ampoule Filler Sealer for Liquid Injection export this machine to more than 48 countries of this world including America, Europe, Asia, Middle East, Africa, CIS and Australia sub continents. Please visit our clientele page for complete list of our customers worldwide. Located at Ahmedabad, India having world class infrastructure.

Does After Sales Support provided for Ampoule Filler Sealer for Liquid Injection?

Service of skilled engineers and technicians provided for technical support of supplied equipments. Installations, commissioning, training and IQ, OQ, DQ validations performed by qualified engineers. Remote support through video call, phone, email and other modes provided for international installations. Spare parts of Ampoule Filler Sealer for Liquid Injection stocked at our premises in Ahmedabad and shipped immediately after ordering. Standard 12 months manufacturing warranty included with supplied equipment.