Single Syringe Ampoule Filling Machine

Q: What is a Single Syringe Ampoule Filling Machine?

The Single Syringe Ampoule Filling Machine (Model AFS-30) is a compact, single-head automatic ampoule filling and sealing machine designed for small-scale and pilot/R&D production. It precisely fills and hermetically seals sterile liquid injectables into glass ampoules using a single volumetric syringe (piston pump). Manufactured by Adinath International , this cGMP-compliant machine is ideal for laboratories, research facilities, and low-volume pharmaceutical production where high accuracy and sterility are critical.

Q: What is the production capacity and ampoule size range of the Single Syringe Ampoule Filling Machine?

This single-head model delivers an output of up to 25 ampoules per minute (approximately 1,500 ampoules per hour). It can handle ampoule sizes from 1 ml to 30 ml with a filling accuracy of ±1% . The machine is best suited for small batch and pilot-scale operations in injectable manufacturing.

Q: How does the Single Syringe Ampoule Filling Machine work?

The machine operates on the slant travel (walking beam) principle : Pre-sterilized ampoules are loaded into the infeed hopper. Ampoules move through pre-gassing (nitrogen flushing). Precise filling is done using a single volumetric syringe. Optional post-gassing with nitrogen follows. Pre-heating and gas flame sealing (LPG + Oxygen) hermetically seals the ampoule neck. Filled and sealed ampoules are automatically collected in an upright position on the outfeed tray without human contact. It includes No Ampoule – No Fill and neck centering systems for zero wastage and perfect sealing.

Q: What industries and products is the Single Syringe Ampoule Filling Machine suitable for?

This machine is widely used in: Pharmaceuticals — Small-batch injectables, vaccines, antibiotics, analgesics, and insulin Biotechnology — Sterile biological products and R&D batches Veterinary — Animal health injectables Cosmetics — High-value serums and sterile liquids Chemical & Research Labs — Precise small-volume liquid filling It is perfect for any application requiring single-dose sterile packaging with long shelf life and zero contamination risk, especially for pilot-scale or laboratory production.

Q: Is Single Syringe Ampoule Filling Machine cGMP, MHRA, FDA and WHO-GMP Compliant?

Yes — Adinath International Single Syringe Ampoule Filling Machine 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.

Q: Does Adinath International provide Single Syringe Ampoule Filling Machine internationally?

Yes, Adinath International Single Syringe Ampoule Filling Machine 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 .

Description

Single Syringe Ampoule Filling Machine is a specialized piece of equipment designed for the precise and sterile filling of liquid pharmaceuticals into single-use syringes or ampoules, primarily used in the pharmaceutical, biotech, and medical industries. These machines are engineered to ensure high accuracy, hygiene, and efficiency while minimizing contamination risks and maintaining compliance with stringent regulatory standards such as cGMP.

Loading: Empty, pre-sterilized syringes or ampoules are loaded into a hopper or conveyor.

Filling: A precise volume of liquid is dispensed via a pump or piston system, often with nitrogen flushing to maintain sterility.

Sealing: Syringes are stoppered, or ampoules are sealed using gas flames or vacuum systems, with pre-warming to ensure quality seals.

Inspection: Automated checks for fill accuracy, particle presence, and container integrity.

Ejection: Filled and sealed containers are collected in trays for further processing or packaging.

Salient Features of Single Syringe Ampoule Filling Machine

Compact cGMP model.
Production output up to 1800 ampoules/hour.
Full accessibility allows easy maintenance.
Flow Meters for regulating flames easily.
“No Ampoule – No Filling” system.
Equipped with pre-warming station for perfect sealing operations.

Ampoule neck centering during gas flushing and filling operations.
Possibility of nitrogen gas flushing before, during and after filling.
All contact parts made from high quality Stainless Steel 316 & other Non-contact parts made from Stainless Steel 304.
Suitable to fill 1ml to 20ml ampoule size and minimum change over parts from one size to another.
Minimum change over time, little maintenance, easy cleaning.

Working Principle of Single Syringe Ampoule Filling Machine

Empty washed & sterilized ampoules fed into in-feed hopper from the left hand side of the machine to receiving rack. The moving rack which moves horizontally collect one ampoule from the receiving rack and transfer the ampoule to the machine in left to right in an inclined position through pre-gassing. Pre-gassing, Filling, Post Gassing, Pre-heating & sealing stations completes filling & sealing operations. Filled & sealed ampoules are collected automatically in SS tray in upright position without hand touch.

The machine performs the following operations:

Ampoule feeding by in-feed hopper, cassettes and ampoule transfer into transport rack.

One ampoule advanced per machine stroke.

Centering of ampoules necks during pre-heating, post heating, gas flushing and liquid filling.

Rotation of ampoules neck in the pre- heating and heating station.

Elimination of burdened-off ampoule tips by clippers and ejection into a separate container.

Technical Specification of Single Syringe Ampoule Filling Machine

Model	AFS-30
Production Output	Up to 25 ampules/minute
Ampoule Size	1ml to 30ml
Filling Accuracy	± 1%
Require Gas for Sealing	LPG & Oxygen (O₂)
Nitrogen Flushing	Pre & Post Nitrogen Flushing Available
Power Specification	0.5 H. P.
Electrical Characteristics	230 Volts, Single Phase, 50 Hertz
Contact Parts	Made from Stainless Steel 316L
Non Contact Parts	Made from Stainless Steel 304
Overall Dimension	915mm (L) x 610mm (W) x 965mm (H) approx.
Net Weight	150 Kgs. approx.
Gross Weight	225 Kgs. 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 Single Syringe Ampoule Filling Machine

Precision: Ensures accurate dosing, critical for patient safety and treatment efficacy.

Efficiency: Automates filling and sealing, significantly reducing manual labor and human error.

Sterility: Maintains a contamination-free environment, essential for injectables.

Versatility: Handles various container sizes and liquid types with quick changeovers.

Durability: Stainless steel construction and efficient cooling systems enhance longevity.

Key Features and Description of Single Syringe Ampoule Filling Machine

Functionality: The machine automates the process of filling and sealing single syringes or ampoules with precise doses of liquid medication, ranging from water-thin to medium-viscosity fluids. It is ideal for small to medium-scale production, particularly for lab-scale or low-volume sterile injectable preparations.

Capacity and Output: Depending on the model, it can fill syringes or ampoules with volumes typically ranging from 0.5ml to 25ml. For example, a single-head machine can achieve outputs of approximately 1,500 syringes or ampoules per hour, suitable for small-scale operations.

Filling Mechanism: Utilizes advanced filling technologies such as volumetric piston pumps, peristaltic pumps, or pneumatic systems to ensure accurate dosing. The machine often incorporates a “no syringe/ampoule, no filling” system to prevent wastage.

Sterility and Hygiene: Designed for aseptic processing, these machines often feature stainless steel (316L for contact parts, 304 for non-contact parts) construction for corrosion resistance and easy cleaning. Some models include laminar airflow or isolator options to maintain a sterile Class 100 environment.

Sealing Process: For ampoules, the machine may include pre-warming and sealing stations using oxygen and LPG (propane) flames or vacuum stopper insertion for precise sealing. Syringes are typically sealed with plungers or stoppers, often under vacuum to ensure sterility.

Flexibility: Capable of handling various syringe or ampoule sizes (e.g., 1ml to 30ml) with minimal changeover time due to tool-less format changes. Some models support nitrogen flushing before, during, and after filling to reduce contamination.

Control Systems: Equipped with PLC systems and real-time monitoring for precise control of filling volumes, error detection, and process adjustments. In-process control (IPC) ensures consistent fill weight and stopper placement.

Inspection and Safety: Includes features for detecting particles, fill volume accuracy, and container defects, often integrating high-voltage leak detection (HVLD) or headspace analysis (HSA) for quality assurance.

Applications: Widely used for filling syringes or ampoules with pharmaceuticals (e.g., vaccines, insulin, analgesics), veterinary medicines, cosmetics, or agro-insecticides. It supports both open and closed ampoules and can be integrated into larger production lines with washing, sterilization, and labeling systems.

Design: Compact and often tabletop or bench-top for small-scale operations, with ergonomic designs compatible with cleanrooms, bio-safety cabinets, or isolators. The machine may include a material hopper, filling needle, and automated ejection systems for filled containers.

FAQ for Single Syringe Ampoule Filling Machine

What is a Single Syringe Ampoule Filling Machine?

The Single Syringe Ampoule Filling Machine (Model AFS-30) is a compact, single-head automatic ampoule filling and sealing machine designed for small-scale and pilot/R&D production. It precisely fills and hermetically seals sterile liquid injectables into glass ampoules using a single volumetric syringe (piston pump). Manufactured by Adinath International, this cGMP-compliant machine is ideal for laboratories, research facilities, and low-volume pharmaceutical production where high accuracy and sterility are critical.

What is the production capacity and ampoule size range of the Single Syringe Ampoule Filling Machine?

This single-head model delivers an output of up to 25 ampoules per minute (approximately 1,500 ampoules per hour). It can handle ampoule sizes from 1 ml to 30 ml with a filling accuracy of ±1%. The machine is best suited for small batch and pilot-scale operations in injectable manufacturing.

How does the Single Syringe Ampoule Filling Machine work?

The machine operates on the slant travel (walking beam) principle:

Pre-sterilized ampoules are loaded into the infeed hopper.
Ampoules move through pre-gassing (nitrogen flushing).
Precise filling is done using a single volumetric syringe.
Optional post-gassing with nitrogen follows.
Pre-heating and gas flame sealing (LPG + Oxygen) hermetically seals the ampoule neck.
Filled and sealed ampoules are automatically collected in an upright position on the outfeed tray without human contact.

It includes No Ampoule – No Fill and neck centering systems for zero wastage and perfect sealing.

What are the key features of the Single Syringe Ampoule Filling Machine?

Compact cGMP model with easy maintenance and full accessibility
“No Ampoule – No Filling” safety system
Pre & post nitrogen gas flushing facility
Pre-warming station for superior sealing quality
Flow meters for easy flame regulation
All contact parts made of SS 316L and non-contact parts of SS 304
Minimum change-over time and easy cleaning
Low power consumption (0.5 H.P.) and compact footprint
Suitable for open-mouth ampoules with high filling accuracy

These features make it highly reliable for sterile injectable production.

What industries and products is the Single Syringe Ampoule Filling Machine suitable for?

This machine is widely used in:

Pharmaceuticals — Small-batch injectables, vaccines, antibiotics, analgesics, and insulin
Biotechnology — Sterile biological products and R&D batches
Veterinary — Animal health injectables
Cosmetics — High-value serums and sterile liquids
Chemical & Research Labs — Precise small-volume liquid filling

It is perfect for any application requiring single-dose sterile packaging with long shelf life and zero contamination risk, especially for pilot-scale or laboratory production.

Is Single Syringe Ampoule Filling Machine cGMP, MHRA, FDA and WHO-GMP Compliant?

Yes — Adinath International Single Syringe Ampoule Filling Machine 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 Single Syringe Ampoule Filling Machine?

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 Single Syringe Ampoule Filling Machine internationally?

Yes, Adinath International Single Syringe Ampoule Filling Machine 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 Single Syringe Ampoule Filling Machine?

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 Single Syringe Ampoule Filling Machine stocked at our premises in Ahmedabad and shipped immediately after ordering. Standard 12 months manufacturing warranty included with supplied equipment.