The sterilization process of the products with gamma should be valid.
Validation studies are carried out according to TS EN ISO 11137-1/2 standards. The method that is appropriate from validation methods is selected and studies are carried out according to this selected method. The teleportation of the products to be used for validation is carried out in the company to be served.
The following steps are followed for gamma sterilization validation work;
- Preparation of validation protocol,
- Performing the number of bioburden analyses specified in the standard to determine the amount of dose,
- Performing the dose verification study at the transporter,
- Performing the number of sterility analyses specified in the standard of the irreparse of the irised products,
- The preparation of the validation report tells the whole process along with the results.
- It is recommended that the packaging validation be completed in order to make the relevant work in a healthy manner.