High Speed Ampoule Filler

Q: What is the maximum production output of the High Speed Ampoule Filler?

The High Speed Ampoule Filler is designed for medium to large-scale production, capable of filling and sealing between 10 to 250 ampoules per minute (up to 15,000 per hour). This high output is achieved through an eight-head filling system that works simultaneously on a single monoblock platform.

Q: What features are included to maintain product stability and sterility?

The machine is built to strict cGMP standards with all liquid-contact parts made from Stainless Steel 316L . To protect oxygen-sensitive products, it is equipped with both pre- and post-nitrogen flushing units . This replaces atmospheric air with an inert gas before and after the filling process to prevent oxidation and ensure long-term stability.

Q: Is the machine easy to maintain and change over for different batches?

One of the core advantages of this equipment is the minimal changeover time . Most format parts can be adjusted or changed by hand without the need for complex tools. Additionally, the machine is designed with a large opening at the bottom for easy cleaning, and it includes a waste tip collector to keep the production area free of glass debris.

Q: Is High Speed Ampoule Filler cGMP, MHRA, FDA and WHO-GMP Compliant?

Yes — Adinath International High Speed Ampoule Filler 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 High Speed Ampoule Filler internationally?

Yes, Adinath International High Speed Ampoule Filler 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

High Speed Ampoule Filler is an advanced pharmaceutical machine designed for the rapid, precise filling and sealing of glass ampoules, primarily used in the pharmaceutical, biotech, cosmetic, and chemical industries. These machines are engineered to handle medium to large-scale production, offering high output rates while maintaining accuracy, sterility, and compliance with cGMP standards. Below is a detailed description based on the latest available information:

Production Needs: Choose based on required output (e.g., 6,000–12,000 ampoules/hour for medium to large-scale production).

Ampoule Specifications: Ensure compatibility with ampoule size, thickness, and neck dimensions.

Filling Type: Select piston, servo, or peristaltic pump systems based on product viscosity and precision needs.

Regulatory Compliance: Verify adherence to cGMP and FDA standards for pharmaceutical applications.

Maintenance and Support: Opt for models with accessible designs and reliable after-sales service from Our Company.

Salient Features of High Speed 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 High Speed 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.

Technical Specification of High Speed 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 High Speed Ampoule Filler

High Efficiency: Rapid filling and sealing reduce production time, ideal for large-scale operations.

Precision and Sterility: Accurate dosing (±0.5% fill accuracy) and nitrogen flushing ensure product quality and safety.

Ease of Maintenance: Large openings and stainless steel construction simplify cleaning and upkeep.

Flexibility: Accommodates diverse ampoule sizes and product types (liquids, powders, or pellets).

Integration: Easily integrates with upstream (e.g., washing, sterilization tunnels) and downstream (e.g., labeling, inspection) equipment for complete production lines.

Key Features of High Speed Ampoule Filler

High Output Capacity: Capable of filling and sealing up to 200–400 ampoules per minute, depending on the model and configuration (e.g., 200 ampoules/min for an eight-head filler, up to 400 ampoules/min for a twelve-head model).

Ampoule Size Compatibility: Handles a wide range of ampoule sizes, typically from 1ml to 30ml, with filling capacities from 0.5ml to 25ml in a single dose. Suitable for both open-mouth and closed-mouth ampoules.

Filling Mechanism: Operates on volumetric piston-pump principles, with options for servo-driven or peristaltic pump systems for enhanced precision. Some models allow fill volume adjustments via touch-screen interfaces.

Material and Build: Constructed with high-quality stainless steel 316L for contact parts and 304 for non-contact parts, ensuring durability, corrosion resistance, and compliance with cGMP standards.

Nitrogen Flushing: Features pre- and post-nitrogen flushing units to purge atmospheric air, minimizing contamination and preserving the sterility of sensitive products like injectables.

Sealing Process: Utilizes oxygen and LPG (propane) for sealing, with pre-warming and sealing stations equipped with specially designed rollers for uniform heating and sealing of ampoules. Safety valves and pressure reducers regulate gas flow.

Automation and Control: Incorporates PLC systems and touch-screen HMIs for real-time monitoring, error detection, and parameter adjustments. Servo technology minimizes mechanical wear, enhancing reliability.

Monobloc Design: Combines filling and sealing operations on a single platform, reducing footprint and improving efficiency. Some models feature a dead-tray for seamless diversion of filled and sealed ampoules.

Minimal Changeover: Designed for quick format changes, accommodating various ampoule sizes with minimal downtime. Tool-less changeovers are available in advanced models.

Additional Features:
- Pre-heating units for thick glass ampoules to ensure proper sealing.
- Flow meters for precise flame regulation.
- Waste tip collectors made of stainless steel for efficient disposal of glass remnants.
- Optional integration with laminar air flow or isolator systems for sterile class 100 filling.

FAQ for High Speed Ampoule Filler

What is the maximum production output of the High Speed Ampoule Filler?

The High Speed Ampoule Filler is designed for medium to large-scale production, capable of filling and sealing between 10 to 250 ampoules per minute (up to 15,000 per hour). This high output is achieved through an eight-head filling system that works simultaneously on a single monoblock platform.

Can the machine handle different ampoule sizes and fill volumes?

Yes, the machine offers excellent flexibility. It can process glass ampoules ranging from 1ml to 20ml in size. Furthermore, it features a unique single-dosing capacity that allows for fill volumes between 0.5ml and 25ml, making it suitable for a wide variety of injectable formulations.

How does the machine ensure a perfect hermetic seal?

To ensure high-quality sealing, especially for thicker glass, the machine includes an active pre-heating unit. This station warms the ampoule neck before it reaches the final sealing station, where the glass is melted and sealed using a combination of Oxygen and LPG (Propane) gases. A delicate rotation mechanism ensures the seal is uniform and secure all around.

What features are included to maintain product stability and sterility?

The machine is built to strict cGMP standards with all liquid-contact parts made from Stainless Steel 316L. To protect oxygen-sensitive products, it is equipped with both pre- and post-nitrogen flushing units. This replaces atmospheric air with an inert gas before and after the filling process to prevent oxidation and ensure long-term stability.

Is the machine easy to maintain and change over for different batches?

One of the core advantages of this equipment is the minimal changeover time. Most format parts can be adjusted or changed by hand without the need for complex tools. Additionally, the machine is designed with a large opening at the bottom for easy cleaning, and it includes a waste tip collector to keep the production area free of glass debris.

Is High Speed Ampoule Filler cGMP, MHRA, FDA and WHO-GMP Compliant?

Yes — Adinath International High Speed Ampoule Filler 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 High Speed Ampoule Filler?

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 High Speed Ampoule Filler internationally?

Yes, Adinath International High Speed Ampoule Filler 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 High Speed Ampoule Filler?

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 High Speed Ampoule Filler stocked at our premises in Ahmedabad and shipped immediately after ordering. Standard 12 months manufacturing warranty included with supplied equipment.