Government regulations mandate that all bottles of solution complete a rigorous sterilisation process through an autoclave. Bottles of the solution must be sterilised at a temperature of 120°C for at least 10-15 minutes. Consequently, the production process must have strict documentation and control.
If any batch is questioned in terms of having successfully completed the sterilisation process, the entire batch must be discarded. Considering a bottle of the solution may cost around $110 and a tray contains around one hundred and sixty 3 ml bottles, a complete tray that must be discarded because of doubt has a value of $17,600 that is literally thrown away.
