All the package materials shall be suitable for sterilization process. The inner package shall have excellent air-tightness and ensure the product free of Bacterium within its shelf life.
The results of sterilization process validation shall be recorded together with the process data. Every year the sterilization process data shall require a re-validation.
Laparoscopic silicone rubber tube attachment of cap of medical instruments, laparoscopic in the high-temperature sterilization process, still can maintain good performance.
This guideline presents a pragmatic approach to the judicious selection and proper use of disinfection and sterilization processes;
Since the earliest days of parenteral manufacturing it has been recognized that many drugs and biologics would not withstand a physical sterilization process in their final container.
The company shall establish documented procedure for the validation of sterilization process, which shall be earlier than the initial use.
Several novel disinfectant and sterilization processes are under development.
The manufacturer shall subject the medical device to a validated sterilization process and record all the control parameters of the sterilization process.