Terminal Sterilisation is the process of Sterilisation of a product after the Manufacturing and Filling process has been completed, Syringes or Vials are then typically passed through Autoclave sterilising the product in place. This means that the sterile boundary is never open to the environment as it is sterilised in place. This is a similar process to how tinned food is cooked after being placed in the can.
As bacteria can enter the product downstream, Terminal sterilisation has strict BioBurden requirements to ensure Sterilisation and breakdown of Endotoxins.
Terminal Sterilisation is a practice used where possible for Sterilisation of product due to the simplicity and intrinsic safety.