Ampoule Filler for Biological Indicator

An Ampoule Filler for Biological Indicator is a specialized machine designed for filling and sealing glass ampoules used in biopharmaceutical, biotech, and sterilization validation applications. These machines ensure precise filling of biological indicators, typically containing microorganisms like Geobacillus stearothermophilus spores, into ampoules for monitoring sterilization processes, such as steam or hydrogen peroxide sterilization.

Automatic Ampoule Filler Videos

Key Features and Description:

• Purpose: Fills and seals ampoules with biological indicators, which are used to validate or monitor sterilization processes by confirming the elimination of resistant microorganisms. These ampoules often contain a nutrient broth, pH indicator, and spores, sealed to prevent contamination.

• Design: Typically a monobloc system combining filling and sealing on a single platform, ensuring efficiency and compliance with cGMP standards. Constructed from high-quality stainless steel (e.g., 316L) for durability and hygiene.

• Filling Mechanism: Operates on a volumetric piston-pump principle, delivering precise liquid volumes (0.5ml to 25ml in single dosing) into ampoules ranging from 1ml to 30ml in capacity. Some models handle smaller sizes, like 0.4ml mini spore ampoules, or specialized forms like onion skin ampoules.

• Nitrogen Flushing: Features pre- and post-nitrogen flushing units to purge oxygen, minimizing contamination and ensuring an inert environment inside the ampoule.

• Sealing Process: Includes pre-warming and sealing stations using oxygen and LPG (propane) flames. Specially designed rollers rotate ampoules for uniform sealing, with burners suited for glass thicknesses (e.g., 0.3mm to 0.8mm for onion skin tubes). A dead-tray system ensures upright collection of sealed ampoules.

• Capacity and Speed: Can fill and seal 10 to 250 ampoules per minute, depending on the model (e.g., single, two, four, six, or eight-head configurations). High-speed models can process up to 12,000 ampoules per hour.

• Applications: Used for filling biological indicator ampoules, crushable glass tubes, or onion skin tubes for pharmaceutical, biotech, cosmetic, and chemical applications, including agro-insecticides and veterinary medicines.

• Additional Features:

  • Minimal change-over time for different ampoule sizes.

  • Pre-heating units for thick glass ampoules to ensure proper sealing.

  • Safety features like pressure reducers and stainless steel hoods to vent fumes.

  • Compact cGMP-compliant models with options for laminar airflow or isolators for sterile environments.

• Examples:

  • Machines like those from Adinath or Syntegon offer flexibility for filling 1ml to 30ml ampoules with precise dosing and nitrogen flushing, suitable for biological indicator production.

  • Onion Skin Ampoule Fillers are custom-designed for thinner, crushable tubes used in specific biological indicator applications, with a filling accuracy of 1%.

Operational Process:

1. Loading: Empty, sterilized ampoules are fed from a hopper onto a traveling rack (in formats of 1, 2, 4, or 8).

2. Nitrogen Purging: Inert gas (nitrogen or argon) is flushed to remove oxygen.

3. Filling: Precise liquid volumes (e.g., nutrient broth with spores) are dispensed via filling needles.

4. Post-Nitrogen Flush: Additional nitrogen flushing to ensure an inert environment.

5. Pre-Warming and Sealing: Ampoules are warmed with a low-pressure flame, then sealed using high-precision burners and rollers for uniform closure.

6. Collection: Sealed ampoules are collected upright on a tray for further processing or testing.

Compliance and Standards:

• Designed to meet ANSI/AAMI/ISO EN 11138-1 and USP standards for biological indicators.

• Certified for use in steam, ethylene oxide, or hydrogen peroxide sterilization validation.

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.