In Pre-conditioning, products are heated and humidified to aid the effectiveness of the sterilant gas and optimise the sterilisation process. Then, in sterilisation dwell time EO gas is introduced to the products and held for a predefined dwell time validated to deliver a Sterility Assurance Level (SAL) of 10-6.
The aeration or degassing basically uses circulated heated air to remove residual EO from the product to ensure that it meets specified EO residual limits outlined in ISO10993-7. Traditionally, since these processes where carried out in different rooms, they were not controlled as part of the sterilisation cycle.
STERISYS approach is to take as much profit from each cell function and keep the sterilisation chamber focus on the sterilisation phase only, but fully integrated in the validated cycle. Thus, preconditioning and post-conditioning have to be carried out with full control on the parameters. The number of preconditioning and/or degassing cells can be different from the sterilisation chamber and fully adapted to the needs of the different products. The cycle management, and therefore the logistics within the plant, is totally modular allowing to process different loads with different cycle times within the shortest possible time.