Eight Stroke Ampoule Filler

Q: What does "Eight Stroke" signify in an ampoule filling machine?

The term 'Eight Stroke' refers to the machine's ability to process eight ampoules simultaneously in a single cycle. While a standard filler might handle one or two ampoules at a time, this machine utilizes an eight-head filling and sealing assembly, significantly increasing output (often reaching up to 12,000–15,000 ampoules per hour) without compromising accuracy.

Q: What are the key safety and quality features included?

The Eight Stroke model is built with a 'No Ampoule – No Filling' sensor system to prevent wastage. Additionally, it features: AISI SS 316L contact parts for cGMP compliance. Fine-tuning volume adjustments for high dosing accuracy. Emergency stop buttons and safety acrylic covers to protect operators from high-temperature sealing flames.

Q: How easy is it to maintain and clean the filling assembly?

The machine is engineered with a 'clutter-free' design. Most modern Eight Stroke fillers use a center-filling system that allows for easy removal of the filling pumps and syringes. This facilitates rapid CIP (Clean-In-Place) or SIP (Sterilize-In-Place) procedures, which are vital for preventing cross-contamination in pharmaceutical environments.

Description

As the name implies, the Adinath Eight Stroke Ampoule Filler has eight heads that can fill injection liquids in 1 ml to 10 ml open mouth glass ampoules, increasing the filling capacity from 0.5 ml to 10 ml in a single dose. The components of the ampoule filling and sealing machine are composed of premium stainless steel for long-lasting, low-maintenance operation. The ampoule filling and sealing machine is designed atAdinath for maximum output of 80 to 225 ampoules per minute based on the size. For the sealing procedure, a combination of LPG and oxygen is used. Preheating is an option for both before and post nitrogen purging.

The Vertical Servo Based Ampoule Filler, High Speed Ampoule Filling & Sealing Machine with 8, 12, and 16 nozzle ampoule filling, Eight Head Ampoule Filler, Eight Head Ampoule Filling Sealing Machine is based on a widely used machine principle: slant travel of ampoules during the filling and sealing process. This is done to accommodate a wide range of ampoule neck and thickness dimensions of the current standard ampoules.

provides Combo Ampoule and Ampoule Filling Line. Ampoule machine, eight-head ampoule filling machine, eight-head ampoule sealing machine, ampoule filler sealer, sterilisation and depyrogenation tunnel, and ampoule and vial washing machine. The filling unit is entirely composed of stainless steel covers and was constructed on stainless steel square pipe framing. The stainless steel has a matt finish. Additionally, the Automatic Eight Head Ampoule Filling and Sealing Machine has a large aperture on the bottom side to make cleaning much simpler than with other machines. To make cleaning even easier, the pendant-style electrical control panel is taken out of the machine. These procedures also make it possible for the equipment to operate more effectively.

Salient Features of Eight Stroke Ampoule Filler

Compact cGMP model.
Higher output up to 12000 Ampoules per hour.
Machine equipped with pre-warming station.
“No Ampoule – No Filling” system.
Flow Meters for regulating flames easily.
Full accessibility allows easy maintenance.

All contact parts made from High Quality Stainless Steel 316L & Non-contact parts made from Stainless Steel 304.
Ampoule neck centering during gas flushing and filling operations.
Minimum change over parts from 1ml to 10ml ampoule size.
Possibility of nitrogen gas flushing before, during and after filling.
Minimum change over time, little maintenance, easy cleaning.

Working Principle of Eight Stroke 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 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.

Sterilized ampoules are loaded into the slant hopper.

A synchronized star wheel delivers ampoules (in groups of eight) to a moving eccentric rack.

Ampoules move through stations for:
- Pre-Nitrogen Flushing: Inert gas to maintain sterility.
- Filling: Precise liquid dosing via chosen pump mechanism.
- Post-Nitrogen Flushing: Additional gas flush to prevent contamination.
- Preheating: Warms ampoule necks for sealing.
- Sealing: Uses LPG/oxygen for a clean, secure seal.

Filled and sealed ampoules are automatically collected in an upright position on a tray, with waste tips ejected into a separate container.

Technical Specification of Eight Stroke Ampoule Filler

Model Name	AFS-8
Production Speed	Up to 200 ampules/minute
Ampoule Sizes	1 ml to 20 ml
Filling Error	± 1%
Sealing Gas	LPG and Oxygen (O₂)
Nitrogen Gas	Pre & Post Nitrogen
Power Load	2 H. P.
Power Voltage	230 Volts, Single Phase, 50 Hertz
Contact Parts	Made from Stainless Steel 316L
Non-Contact Parts	Made from Stainless Steel 304
Machine Size	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 Eight Stroke Ampoule Filler

High Precision: Minimal breakage and accurate dosing for high reliability.

Low Maintenance: Quick-change parts and easy cleaning reduce operational costs.

Versatility: Handles a wide range of ampoule sizes and liquid types with customizable filling options.

Sterility: Nitrogen flushing and GMP-compliant materials ensure product safety.

Global Reach: Machines are exported to over 48 countries, with manufacturers like Adinath International offering tailored solutions.

Key Features of Eight Stroke Ampoule Filler

High-Speed Production:
- Capable of filling and sealing up to 12,000 ampoules per hour (approximately 80–280 ampoules per minute, depending on ampoule size and liquid viscosity). For example, it can process up to 290 ampoules/min for 1ml ampoules, 270 for 2ml, 260 for 3ml, 240 for 5ml, and 150 for 10ml.
- Ideal for medium to large-scale production lines requiring high output with minimal errors.

Filling and Sealing Mechanism:
- Filling Capacity: Handles ampoule sizes from 0.5ml to 25ml in a single dose, with precise volume control. Common models support 1ml to 10ml ampoules, with some offering flexibility up to 20ml.
- Filling Options: Equipped with multiple filling mechanisms, including:
  1. Piston Pump Filling: Ensures consistent dosing for various liquids.
  2. Servo-Driven Filling: Enhances accuracy with programmable control.
  3. Peristaltic Pump Filling: Ideal for sterile operations, minimizing contamination.
- Two-Stage Sealing Process:
  1. Preheating: Removes residual droplets to ensure clean sealing.
  2. Sealing: Uses LPG and oxygen with clippers for precise, defect-free seals.
- Nitrogen Flushing: Pre- and post-filling nitrogen purging to maintain sterility and prevent contamination.

Construction and Compliance:
- Built on a stainless steel square pipe frame with SS 316L contact parts for injectable liquids, ensuring compliance with cGMP standards. Non-contact parts are typically made of SS 304.
- GMP Compliance: Designed for sterility, with contact surfaces ensuring hygiene for injectable liquids.
- Robust Design: Heavy-duty stainless steel piping and anti-rust treatment for durability and jerk-free operation.
- Easy Maintenance: Features a large bottom opening for cleaning and quick-changeover parts to minimize downtime when switching ampoule sizes (1ml to 10ml).

Operational Efficiency:
- Slant Travel Mechanism: Ampoules move in an inclined position through filling and sealing stations, accommodating variations in neck dimensions and thicknesses.
- No Ampoule, No Fill System: Prevents liquid wastage by halting filling when no ampoule is detected.
- Neck Centering: Ensures precise alignment during filling, gas flushing, and sealing for improved accuracy.
- Automated Process: Sterilized ampoules are loaded into a slant hopper, delivered via a synchronized star wheel to an eccentric rack, and processed through pre-gassing, filling, post-gassing, preheating, and sealing stations. Filled ampoules are collected automatically without manual handling.

Advanced Features:

PLC-Based Control: Some models include a PLC with an HMI touch screen for automatic fill volume adjustments, reducing manual intervention.
Servo-Based Vertical Models: High-speed vertical fillers with 8, 12, or 16 nozzles for enhanced precision.
Pre-Warming Unit: Ensures proper heating of ampoule necks for flawless sealing, especially for thicker glass.
Gas Flow Meters: Acrylic body meters for easy flame setting (oxygen and LPG).
Optional Features:
1. Safety cabinet with doors and Class 100 laminar airflowfor sterile filling.
2. Compatibility with both open-mouthand closed-mouth (Type B and C)
3. Dead tray for upright collection of filled ampoules and waste tip collector for easy disposal.
4. CE and ISO 9001:2000 certifications for quality assurance.

FAQ for Eight Stroke Ampoule Filler

What does “Eight Stroke” signify in an ampoule filling machine?

The term “Eight Stroke” refers to the machine’s ability to process eight ampoules simultaneously in a single cycle. While a standard filler might handle one or two ampoules at a time, this machine utilizes an eight-head filling and sealing assembly, significantly increasing output (often reaching up to 12,000–15,000 ampoules per hour) without compromising accuracy.

Can this machine handle different ampoule sizes?

Yes. Most Eight Stroke Ampoule Fillers are designed for versatility. They can typically process ampoules ranging from 1ml to 20ml with minimal changeover parts. However, for the best performance, it is recommended to use “star wheels” and “feed worms” specifically calibrated for each size to ensure smooth container movement.

How does the machine ensure sterile and nitrogen-flushed filling?

To maintain product integrity, the machine follows a rigorous sequence:

Pre-gassing: Displaces oxygen with Nitrogen before filling.
Filling: Precision pumps dispense the liquid.
Post-gassing: A second Nitrogen flush ensures no oxygen is trapped before sealing.
Sealing: The “Draw-off” sealing method is used to create a hermetic, tamper-proof seal.

What are the key safety and quality features included?

The Eight Stroke model is built with a “No Ampoule – No Filling” sensor system to prevent wastage. Additionally, it features:

AISI SS 316L contact parts for cGMP compliance.
Fine-tuning volume adjustments for high dosing accuracy.
Emergency stop buttons and safety acrylic covers to protect operators from high-temperature sealing flames.

How easy is it to maintain and clean the filling assembly?

The machine is engineered with a “clutter-free” design. Most modern Eight Stroke fillers use a center-filling system that allows for easy removal of the filling pumps and syringes. This facilitates rapid CIP (Clean-In-Place) or SIP (Sterilize-In-Place) procedures, which are vital for preventing cross-contamination in pharmaceutical environments.

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