Ampoules
Washing and Sterilization
Ampoules are washed (automatically or manually), depyrogenated (typically by dry heat in a depyrogenation tunnel), and transferred to a sterile area.
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.).
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
Washing and Depyrogenation
Vials are washed in specialized machines and often depyrogenated by high-temperature dry heat (e.g., 250°C for 30 minutes).
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).
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)
Container Preparation
Bottles or flexible bags (e.g., PVC, non-PVC) are washed and sterilized (if not assembled in a blow-fill-seal process).
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.
Sealing
For plastic bags: heat-sealed.
For glass bottles: rubber stopper plus aluminum crimp, or specialized cap systems.
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.