10ml Ampoule Filler

A 10ml ampoule filler is a specialized machine designed for filling and sealing 10ml glass ampoules, commonly used in pharmaceutical, biotech, cosmetic, and chemical industries. Below is a detailed description based on the latest information available:

Automatic Ampoule Filler Videos

Description of a 10ml Ampoule Filler Machine

Overview:

A 10ml ampoule filler is a precision-engineered, automated machine designed to fill and seal 10ml glass ampoules with liquid, powder, or other injectable substances. These machines are built to meet stringent cGMP (current Good Manufacturing Practices) standards, ensuring high accuracy, sterility, and efficiency in sterile environments. They are typically used for filling pharmaceuticals, veterinary medicines, cosmetics, or agrochemicals, with a focus on preventing contamination and ensuring precise dosing.

Key Features:

1. Filling Capacity:

   • Capable of filling 0.5ml to 10ml in a single dose, with some models supporting up to 30ml for flexibility. For 10ml ampoules, output ranges from 80 to 280 ampoules per minute, depending on the machine’s configuration (e.g., number of filling heads). For instance, an eight-head filler can process up to 150 ampoules per minute for 10ml sizes.

2. Filling Mechanism:

   • Utilizes advanced filling technologies such as:

     • Volumetric Piston Pumps: Ensures precise dosing with a fill accuracy of ±0.5%.

     • Peristaltic Pumps: Ideal for sensitive liquids, as the liquid only contacts the hose, reducing contamination risks.

     • Servo-Driven Systems: Allows for adjustable fill volumes via a touchscreen interface for enhanced precision.

   • Features like “no ampoule, no fill” minimize liquid wastage.
3. Construction and Materials:

   • Contact parts are made of high-quality Stainless Steel 316L to ensure compatibility with sterile liquids and compliance with cGMP standards. Non-contact parts are typically Stainless Steel 304.

   • Monoblock design integrates filling and sealing operations on a single platform, reducing footprint and contamination risks.

4. Operational Process:

   • Loading: Empty, pre-sterilized 10ml ampoules are loaded into an infeed hopper and transferred via a starwheel or cassette to a traveling rack.

   • Nitrogen Purging: Inert gas (nitrogen) is flushed before and after filling to prevent oxidation and contamination.

   • Filling: Filling nozzles deliver a precise 10ml dose, with neck-centering mechanisms ensuring accuracy.

   • Pre-Heating and Sealing: Ampoules are pre-warmed with a low-pressure flame, then sealed using oxygen and LPG (propane) with specially designed rollers for uniform sealing.

   • Collection: Filled and sealed ampoules are collected upright in a tray for further processing.

5. Sealing Mechanism:

   • Uses combustible gases (oxygen and LPG) for sealing, with flow meters to regulate flame intensity.

   • Some models include a stainless steel hood to channel fumes during heating, enhancing safety and cleanliness.

   • Safety valves and pressure reducers ensure safe operation of gas circuits.

6. Automation and Control:

   • Equipped with PLC systems and touchscreen interfaces for real-time parameter adjustments and error monitoring.

   • Features like SCADA (Supervisory Control and Data Acquisition) and SODA (Single Object Data Acquisition) provide real-time process data and supply chain security.

   • Minimal changeover parts for switching between 1ml to 10ml ampoules, reducing downtime.

7. Production Capacity:
   • Varies by model and number of heads:

     • Single Head: ~1,500 ampoules/hour (lab-scale).

     • Four Head: ~6,000–7,200 ampoules/hour (medium-scale).

     • Eight Head: ~12,000 ampoules/hour (high-speed, large-scale).

   • For 10ml ampoules, output is typically lower (e.g., 150 ampoules/min for eight-head models) due to larger volume handling.

8. Additional Features:

   • Nitrogen Flushing: Pre- and post-filling nitrogen flush to ensure product stability.

   • Pre-Warming Station: Ensures proper sealing by warming ampoule necks.

   • Cooling System: Prevents overheating, extending machine lifespan.

   • Minimal Changeover: Quick adjustments for different ampoule sizes (1ml to 10ml) with minimal parts.

   • Optional Features: Laminar Air Flow, isolators, or safety cabinets for enhanced sterility.

Applications:

• Pharmaceuticals: Filling injectable drugs, vaccines, and sterile solutions.

• Biotech: Handling sensitive biologics and biochemicals.

• Cosmetics: Filling serums, essential oils, and other beauty products.

• Chemicals: Filling agro-insecticides, veterinary medicines, and other liquid chemicals.

Advantages:

• High accuracy (±0.5% fill precision) ensures consistent dosing.

• Compact, monoblock design saves space and simplifies cleaning.

• Stainless steel construction ensures durability and compliance with hygiene standards.

• Automated processes reduce labor and human error.

• Nitrogen flushing and sealed designs minimize contamination risks.

• Fast changeover times improve production efficiency.

Models and Configurations:

• Single Head: Ideal for lab-scale or small-batch production (e.g., 1,500 ampoules/hour).

• Four Head: Suitable for medium-scale production (e.g., 6,000–7,200 ampoules/hour).

• Eight Head: High-speed models for large-scale production (up to 12,000 ampoules/hour).

• Closed Ampoule Fillers: Designed for pre-sterilized, closed-mouth ampoules (Type D), with opening, filling, and sealing on one platform.

• Customizable Options: Servo-driven or peristaltic pump systems, laminar flow cabinets, or integration with upstream/downstream equipment (e.g., washing or labeling machines).

Critical Considerations:

• Sterility: Machines must integrate with sterilizing tunnels or isolators to maintain aseptic conditions.

• Maintenance: Easy access for cleaning and minimal changeover parts reduce downtime.

• Customization: Ensure the machine supports both open and closed 10ml ampoules, as requirements vary.

• Regulatory Compliance: Verify compliance with local regulations (e.g., USFDA, WHO, GMP) for pharmaceutical use.

Types of Ampoule Fillers

• Small Ampoule Filler
• Ampoule Filler and Sealer
• Onion Skin Ampoule Filler
• Servo Driven Ampoule Filler
• Peristaltic Pump type Ampoule Filler
• Closed Ampoule Filler
• Single Head Ampoule Filler
• Two Head Ampoule Filler
• Four Head Ampoule Filler
• Six Head Ampoule Filler
• Eight Head Ampoule Filler

Salient Features of Automatic Ampoule Filler

• Compact model as per cGMP standard.

• Higher production output up to 12000 Ampoules per hour.

• 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.

• “No Ampoule – No Filling” system.

• Ampoule neck centering during gas flushing and filling operations.

• Possibility of nitrogen gas flushing before, during and after filling.

• Full accessibility allows easy maintenance.

• Machine equipped with pre-warming station.

• Flow Meters for regulating flames easily.

• Minimum change over time, little maintenance, easy cleaning.

Process Operation of Automatic Ampoule Filler Machine

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 Machine

* 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.