Sterile Ampoule Filler Sealer

A sterile ampoule filler sealer is a specialized machine used in pharmaceutical, biotech, cosmetic, and chemical industries to fill and seal glass ampoules under sterile conditions. These machines ensure precise filling of liquids or powders into ampoules, followed by sealing to maintain sterility and prevent contamination. Below is a concise overview based on available information:

Sterile Ampoule Filler Sealer Video

Key Features and Functionality

• Purpose: Designed for filling and sealing glass ampoules (open or closed, typically 1ml to 30ml) with sterile liquids or powders, ensuring compliance with cGMP standards.

• Operation:

  • Filling: Uses volumetric piston pumps or peristaltic pumps for precise dosing (0.5ml to 25ml in a single dose). Some models feature “no ampoule, no fill” systems to minimize waste.

  • Sealing: Involves pre-heating and sealing stations using oxygen and LPG (propane) flames. Ampoules are rotated during sealing for uniform closure.

  • Sterility: Incorporates nitrogen flushing (pre- and post-filling) and optional laminar airflow (Class 100) to maintain sterile conditions.

  • Construction: Made with stainless steel 316L for contact parts and 304 for non-contact parts, ensuring durability and compliance with cGMP requirements.

• Automation: Fully automated systems reduce human intervention, enhancing sterility and efficiency. PLC-based controls with touch-screen interfaces allow real-time monitoring and adjustments.

• Output: Varies by model:

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

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

  • Eight-head: Up to 12,000–36,000 ampoules/hour (high-speed).

  • Some advanced lines reach 400 ampoules/minute.

• Flexibility: Handles various ampoule sizes (1ml to 30ml) with minimal changeover time. Some machines support both open and closed (Type D) ampoules, with additional stations for opening closed ampoules.

• Additional Features:

  • Pre-warming stations for thick glass ampoules.

  • In-process control (IPC) for fill weight and seal quality.

  • Optional integration with washing, sterilization tunnels, and labeling machines for complete production lines.

Applications

• Pharmaceuticals: Filling sterile injectables, vaccines, and biologics.
• Cosmetics: Packaging serums and other liquid products.
• Veterinary and Chemicals: Filling agro-insecticides and veterinary medicines.

Critical Considerations

• Sterility and Contamination: Automated systems and laminar airflow minimize human contact, ensuring sterile conditions.

• Customization: Machines can be tailored for specific ampoule types, sizes, and production needs.

• Maintenance: Designed for easy cleaning and minimal downtime, with large access panels and tool-less changeovers.

• Safety: Equipped with safety valves, pressure reducers, and exhaust systems for gas circuits.

Limitations and Trade-offs

• Cost: High-speed, fully automated systems can be expensive, though manufacturers like Adinath and Shree Bhagwati emphasize cost-effectiveness.

• Complexity: Advanced features (e.g., PLC systems, isolators) may require skilled operators and regular maintenance.

• Energy Use: Flame-based sealing using oxygen and LPG increases operational costs and requires careful gas management.

Recommendations

When selecting a sterile ampoule filler sealer, consider:

• Production Scale: Choose single-head for labs, four/six-head for medium-scale, or eight-head for large-scale production.

• Ampoule Type: Ensure compatibility with open or closed (Type D) ampoules.

• Regulatory Compliance: Verify cGMP, USFDA, or WHO standards for pharmaceutical use.

• Integration Needs: Opt for machines that integrate with washing, sterilization, and labeling for streamlined production.

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 Sterile 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 Sterile 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 Sterile 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.