And JWL’s sterilization time is fully validated satisfying the target Fo value (Fo ≥ 8.0). To satisfy the target Fo value (Fo ≥ 8.0) for product, sterilization time should be maintained for 18 minutes for 1440 mL and 23 minutes for 1920 mL in the chamber of sterilization machine.
And the stability of the product with 18 and 23 minutes is confirmed by stability study during the expiry date (You can see the data on the CTD section P3 and P8).
So JWL inform that sterilization time for 23 minutes is a maintaining time in the chamber of sterilization machine satisfying the target Fo value (Fo ≥ 8.0).
The sterilization time in accordance with target Fo value is changing depends on the product size. So the bigger the size of the product, the more time needed to reach the target Fo value that the sterilization time is increased by the product size. Althougt sterilization time of Aminolyte peri 1920 mL is 23 minutes, the Fo value is same with Aminolyte peri 1440 mL. The difference of the sterilization time is originated from product size.
And JWL’s sterilization time is fully validated satisfying the target Fo value (Fo ≥ 8.0). To satisfy the target Fo value (Fo ≥ 8.0) for product, sterilization time should be maintained for 18 minutes for 1440 mL and 23 minutes for 1920 mL in the chamber of sterilization machine.
And the stability of the product with 18 and 23 minutes is confirmed by stability study during the expiration date (You can see the data on the CTD section P3 and P8).
So JWL inform that sterilization time for 23 minutes is a maintaining time in the chamber of sterilization machine satisfying the target Fo value (Fo ≥ 8.0).
