Injection Ampoule Filler

An Injection Ampoule Filler is a specialized pharmaceutical machine designed to fill and seal glass ampoules with liquid drugs, primarily for injectable applications. These machines ensure precise, sterile, and efficient filling of ampoules, adhering to stringent industry standards like cGMP and USFDA. Below is a detailed description based on their design, functionality, and features:

Injection Ampoule Filler Video

Description of Injection Ampoule Filler

1. Purpose and Application:

   • Used to fill and seal glass ampoules (typically 1ml to 30ml) with liquid pharmaceuticals, such as injectables, vaccines, or other sterile solutions.

   • Applicable in industries like pharmaceuticals, biotechnology, cosmetics, and chemicals for filling agro-insecticides or veterinary medicines.

2. Design and Construction:

   • Compact and Monobloc Design: Combines filling and sealing in a single unit for streamlined operation and reduced contamination risk.

   • Materials: Contact parts are made of high-quality stainless steel 316L to ensure compatibility with sterile drugs and compliance with cGMP standards. Non-contact parts are typically stainless steel 304 or other durable materials.

   • Structure: Built on a sturdy stainless steel square pipe frame with a matte finish, often featuring a large bottom opening for easy cleaning and maintenance.

   • Safety Features: Includes toughened glass cabinets or isolators for a sterile environment and stainless steel hoods to channel out fumes during sealing.

3. Operational Process:

   • Ampoule Loading: Sterilized ampoules are fed automatically via an in-feed hopper or conveyor, often from a sterilizing tunnel, into a transport rack or star wheel in batches (e.g., 1, 2, 4, or 8 ampoules per cycle).

   • Nitrogen Purging: Nitrogen gas is flushed before and/or after filling to remove atmospheric air and prevent oxidation or contamination.

   • Filling: Precise filling is achieved using volumetric piston pumps, servo-driven systems, or peristaltic pumps, with filling capacities ranging from 0.5ml to 25ml in a single dose. Co-eccentric nozzles ensure quick and accurate filling.

   • Sealing: Ampoules are sealed using oxygen and LPG (propane) flames, with pre-heating and sealing stations. Specially designed rollers rotate ampoules for uniform sealing. A cooling system prevents overheating, and flow meters regulate flames.

   • Output Collection: Filled and sealed ampoules are automatically collected in an upright position on a tray or conveyor for further processing (e.g., inspection or labeling).

4. Key Features:

   • High Precision and Accuracy: Ensures exact dosing for liquid, powder, or solid drugs, minimizing waste and ensuring patient safety.

   • High Output: Depending on the model, output ranges from 1,500 to 36,000 ampoules per hour (e.g., single-head for lab-scale, eight-head for high-speed production).

   • Flexibility: Supports a wide range of ampoule sizes (1ml to 30ml) with minimal changeover parts, allowing quick adjustments via servo motors and PLC controls.

   • Safety and Automation: Features like “No Ampoule, No Fill” and “No Ampoule, Machine Stop” systems prevent errors. Nitrogen flushing and laminar airflow cabinets ensure sterility.

   • Ease of Maintenance: Tool-less format changes, easy-to-clean designs, and comprehensive manufacturer documentation simplify operation and troubleshooting.

   • Compliance: Built to meet cGMP and USFDA standards, often with CE certification and options for laminar airflow or isolator-based systems for Class 100 environments.

5. Types and Configurations:

   • Single to Multi-Head Fillers: Available in single-head (lab-scale, ~1,500 ampoules/hour), two-head, four-head (~6,000 ampoules/hour), eight-head (~12,000 ampoules/hour), or higher (up to 36,000 ampoules/hour for high-speed models).

   • Servo-Based or Vertical Models: Advanced models use servo motors for precise volume control and vertical configurations for efficient handling.

   • Combination Machines: Some models can process both ampoules and vials, enhancing production flexibility.

6. Additional Features:

   • Pre-Warming Station: Uses low-pressure flames to prepare thick glass ampoules for sealing, ensuring quality.

   • Nitrogen Flush Facility: Enhances sterility and prevents contamination.

   • Data Acquisition: SCADA systems provide real-time monitoring of process data for batch control and quality assurance.

   • Inspection Compatibility: Easily integrates with upstream (washing, sterilization) and downstream (inspection, labeling) equipment.

7. Advantages:

   • High production capacity to meet growing demand for injectables.

   • Hygienic and sterile operations to ensure patient safety.

   • Minimal downtime due to quick changeovers and robust construction.

   • Reduced risk of glass particle contamination when paired with filter needles during administration.

   • Cost-effective for small, medium, and large-scale production due to customizable configurations.

8. Applications:

   • Primarily used for sterile injectable pharmaceuticals, including antibiotics, anesthetics, and vaccines.

   • Suitable for filling air-sensitive or hygroscopic chemicals in industries like biotech and cosmetics.

Conclusion

Injection Ampoule Fillers are critical for the safe and efficient production of sterile injectable drugs. Their advanced design, precise filling mechanisms, and compliance with regulatory standards make them indispensable in pharmaceutical manufacturing.

Types of Injection Ampoule Filler

• 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 Injection 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 Injection Ampoule Filling 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 Injection Ampoule Filler

* 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.