Injectable Ampoule Filler Sealer

An Injectable Ampoule Filler Sealer is a specialized machine designed for the precise filling and sealing of glass ampoules, primarily used in the pharmaceutical, biotech, cosmetic, and chemical industries. These machines ensure sterile, accurate, and efficient packaging of liquid or powder injectables in glass ampoules, adhering to stringent cGMP standards. Below is a detailed description based on available information:

Injectable Ampoule Filler Sealer Video

Key Features and Functionality:

1. Purpose and Applications:

   • Used to fill and seal glass ampoules (open-mouth or closed-mouth, typically 1ml to 30ml) with injectable liquids, powders, or other sterile products.

   • Common applications include pharmaceuticals (e.g., parenteral drugs), veterinary medicines, agro-insecticides, and cosmetics.

2. Design and Construction:

   • Built on a stainless steel (SS 316L for contact parts, SS 304 for non-contact parts) frame with a matt finish for durability and compliance with cGMP standards.

   • Monobloc design integrates filling and sealing operations in a single unit, ensuring compactness and efficiency.

   • Features large openings at the bottom for easy cleaning and maintenance, with a pendant-type electrical control panel for safe and user-friendly operation.

3. Operational Process:

   • Ampoule Loading: Sterilized ampoules are loaded into an in-feed hopper and transferred via a star wheel or cassette to a transport rack, handling 1, 2, 4, 6, or 8 ampoules per cycle depending on the machine’s head configuration.

   • Pre-Gassing: Nitrogen flushing occurs before filling to ensure an inert environment and minimize contamination.

   • Filling: Precise filling of liquids or powders (0.5ml to 25ml per dose) using mechanisms like piston pumps, servo-driven systems, or peristaltic pumps. Neck centering ensures accuracy during filling.

   • Post-Gassing: Additional nitrogen flushing after filling to further protect the product.

   • Pre-Heating and Sealing: Ampoules are warmed at a pre-heating station with low-pressure flames, followed by sealing using oxygen and LPG (propane) flames. Specially designed rollers rotate ampoules for uniform sealing.

   • Collection: Filled and sealed ampoules are automatically collected on a tray or dead-tray system for further processing, with rejected ampoule tips ejected into a separate container.

4. Filling Mechanisms:

   • Piston Pump: Common for high precision and volumetric dosing, suitable for various liquid viscosities.

   • Servo-Driven: Offers adjustable filling volumes via PLC for enhanced accuracy.

   • Peristaltic Pump: Ideal for sterile applications, minimizing cross-contamination.

   • “No Ampoule, No Fill” and “No Ampoule, Machine Stop” systems prevent wastage and ensure operational safety.

5. Sealing Process:

   • Utilizes controlled heat sealing technology with oxygen and LPG flames to create airtight seals, preventing contamination and ensuring product sterility.

   • Safety valves and pressure reducers regulate gas flow, while a stainless steel hood channels fumes during heating.

6. Capacity and Speed:

   • Available in single, two, four, six, eight, or twelve-head models, with production speeds ranging from 25 to 400 ampoules per minute, depending on the model (e.g., 1500 ampoules/hour for single-head lab-scale machines, up to 12,000 ampoules/hour for eight-head high-speed models).

   • Suitable for small, medium, and large-scale production.

7. Special Features:

   • Nitrogen Flushing: Pre- and post-filling nitrogen injection to maintain sterility and prevent oxidation.

   • Minimal Changeover: Quick format changes for ampoule sizes (1ml to 30ml) with minimal parts replacement, reducing downtime.

   • Cooling System: Prevents overheating, extending machine lifespan.

   • Safety and Hygiene: Equipped with laminar airflow, isolators, or safety cabinets to meet US FDA and EU GMP standards.

   • Dead-Tray System: Ensures proper diversion of filled and sealed ampoules, reducing manual handling.

8. Closed Ampoule Capability:

   • Some models are designed for pre-sterile Type D closed-mouth ampoules, featuring an additional station to open the ampoule before filling and sealing.

9. Customization and Compliance:

   • Customizable for specific ampoule sizes, filling volumes, and production needs.

   • Designed to handle variations in ampoule neck dimensions, thickness, and ovality.

   • Complies with cGMP, US FDA, and WHO standards, ensuring suitability for sterile injectable production.

10. Additional Features:

    • Flow meters for flame regulation.

    • Tool-less format changes for ease of operation.

    • Optional integration with upstream (e.g., washing, sterilization tunnels) and downstream (e.g., inspection, labeling) equipment for a complete production line.

    • High-speed models can process up to 36,000 ampoules or vials per hour and handle both open and closed ampoules.

Benefits:

• High Precision: Ensures accurate dosing and sealing, critical for injectable pharmaceuticals.

• Sterility: Nitrogen flushing and hygienic design minimize contamination risks.

• Efficiency: High-speed models and automation reduce labor and increase output.

• Versatility: Suitable for various ampoule types, sizes, and product forms (liquid, powder, gel).

• Low Maintenance: Robust SS construction and easy-access design reduce downtime and maintenance costs.

• Scalability: Models range from lab-scale (single-head) to high-speed production (eight- or twelve-head).

Critical Considerations:

• Material Quality: Contact parts must be SS 316L to ensure compatibility with sterile injectables.

• Regulatory Compliance: Machines must meet cGMP, US FDA, or EU GMP standards for pharmaceutical use.

• Customization Needs: Ensure the machine supports the specific ampoule sizes and filling volumes required.

• Safety Features: Look for safety valves, pressure reducers, and automation controls to minimize errors and ensure operator safety.

Types of Injectable Ampoule Filler Sealer

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

Salient Features of Injectable Ampoule Filler Sealer

• 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 Injectable Ampoule Filler Sealer

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 Injectable Ampoule Filler Sealer

* 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.