Filling and Sealing of Ampoules, Vials, and Infusion Fluids

• Filling and Sealing of Ampoules, Vials, and Infusion Fluids ensure sterility and accurate dosing by using automated systems under aseptic conditions.
• Filling and Sealing of Ampoules are critical for patient safety and product stability.

Ampoules:

1. Washing and Sterilization

   • Ampoules are washed (automatically or manually), depyrogenated (typically by dry heat in a depyrogenation tunnel), and transferred to a sterile area.

2. Filling

   • Sterile solution (or suspension) is filled into ampoules using sterile filling machines under laminar airflow.
   • The fill volume is carefully controlled by automated equipment (piston pumps, peristaltic pumps, etc.).

3. Sealing (Tip-Seal or Pull-Seal)

   • Ampoule necks are sealed by melting the glass with a flame, either pulling the tip or tipping it off.
   • Ensures an airtight, tamper-evident closure.

Vials:

1. Washing and Depyrogenation

   • Vials are washed in specialized machines and often depyrogenated by high-temperature dry heat (e.g., 250°C for 30 minutes).

2. Filling and Partial Stoppering

   • Sterile product is filled under aseptic conditions using vial-filling machines.
   • Vials are partially stoppered (the rubber stopper is placed but not fully sealed) before or after lyophilization (if applicable).

3. Sealing (Stoppering / Crimping)

   • Fully seated stoppers are then crimped with an aluminum seal (flip-off or tear-off seal).
   • Ensures a secure closure and maintains sterility throughout shelf life.

Infusion Fluids (Large Volume Parenterals):

1. Container Preparation

   • Bottles or flexible bags (e.g., PVC, non-PVC) are washed and sterilized (if not assembled in a blow-fill-seal process).

2. Filling

   • Typically done in a dedicated high-volume filling line.
   • Product (e.g., saline, dextrose solution) is filtered, then filled into containers under controlled conditions.

3. Sealing

   • For plastic bags: heat-sealed.
   • For glass bottles: rubber stopper plus aluminum crimp, or specialized cap systems.

4. Terminal Sterilization (if applicable)

   • Many infusion fluids are steam sterilized in autoclaves at 121°C (or higher), unless the formulation or container is heat-sensitive.

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