Does The Ophthalmic Viscoelastic Device Have To Be Terminally Sterilized, Or Can Aseptic Processing Instead Of Terminal Sterilization Be Acceptable?

It is recommended to use terminal sterilization as a preferred sterilization method for such products. If the product cannot be terminally sterilized indeed, it can be considered to adopt the aseptic processing related process control method, such as filtration sterilization. However, supporting data should be provided to prove the rationality of selecting aseptic processing for such products, and the administrative counterpart should also describe the quality management system and sterilization method used to ensure the sterility of the product and provide the corresponding verification data.