This presentation will review various sterilization processes and their general compatibility to various types of challenging medical products as well as some of the challenges that each of the various sterilization processes might present. In addition the methods that are available for validation will be addressed demonstrating how they may be applied to reduce the effects of the sterilization process.
Other methods such as aseptic processing and reduction of SAL will also be discussed along with their regulatory acceptance both in the United States and internationally.
Areas Covered in the Seminar: - What makes a medical product challenging for sterilization?
- Challenges of radiation sterilization.
- Challenges of ethylene oxide sterilization.
- Challenges of moist or dry heat sterilization.
- Challenges of novel sterilization methods.
- Validation methods that are available.
- Aseptic processing/reduction of SAL - is it an option?
