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.
Agenda
- Types of sterilization methods.
- Predominant uses of sterilization within the Medical Device and Pharmaceutical/Biotech industries.
- Product interactions with Various Modes of Sterilization.
- When to Use one Sterilization Mode vs. Another.
- Parametric Release - What is it?
- How to Use Parametric Methods
- Development of the Techniques - Issues and Answers.
- Considerations of cost of sterilization.
- Use of contract sterilization vs. in-house
Speakers
Carl Patterson,
Who Should Attend
- Manufacturing companies
- Quality system auditors
- Microbiology analysts and technicians
- Consultants
- Regulatory and Compliance Management
- Quality Assurance personnel
- Quality Control personnel
- Research & Development
- Regulatory Affairs Professionals
- Validation
- Auditing Professionals
- Microbiology Professionals
- Auditors
