This topic will discuss the methods of sterilization to be used on medical devices and pharmaceutical products. Understanding the regulations pertaining to sterilization of products will help to decide with method to use for your product. The advantages and disadvantages of each will be discussed. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.
Pharmaceutical products and medical devices are required to be sterile to be used in patients. Sterilization of these crucial products can be done in several ways depending on the characteristics of the product being sterilized. There are four typical ways a product can be sterilized. These are sterilization by Ethylene Oxide, Gamma irradiation, Steam and Pressure, and filtration. Knowing the characteristics of your product will determine what method will be used. This webinar will go over the four methods of sterilization and why one method would be chosen over the other.
- Regulations relating to sterilization of products
- Methods of sterilization
- Why one method is used over another
- Validations of the sterilizations method
- Parametric release
- Quality Assurance Departments
- Quality Control Departments
- Manufacturing Departments
- Regulatory Departments
- Compliance Departments
- Quality system auditors
- Microbiology analysts and technicians