Gamma Irradiation of Medical Devices, Equipment and Instruments
When gamma irradiation is selected for product sterilization, the dose to which the product is exposed must be determined and validated in accordance with the relevant standards (ISO 11137-1, -2, -3, and ISO TIR 13004). The standards and associated guidelines contain recommendations and requirements for products to be sterilized using irradiation methods, which must validate and maintain a SAL for a product or product group.
The standards provide a framework for process design that allows the conditions for gamma sterilization to be defined and either a bioburden-based or dose-based approach to be followed.
While the energy of gamma radiation destroys biological structures, it can also have a negative effect on other materials; for example, certain plastics are prone to discoloration or embrittlement.
This course explains the differences between the validation options and outlines the advantages and disadvantages of each of these approaches to dose setting.
- Content
- Sterilization Process Design
- Validation in Accordance with Standards
- Definition of Reference Load and Product Families
- Microbiological Parameters
- Evaluation of Adjustments and Changes
- Your Benefits
- You will learn about the requirements for validating sterilization processes and documenting them for medical devices.
- You will be able to interpret microbiological data related to sterilization.
- You will be able to understand and evaluate the (re)validation reports provided by a sterilization service provider.
- You will be able to apply and evaluate sterilization processes across different products.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- Medical device manufacturers
- Manufacturers of sterile products
- Product management professionals
- Quality assurance and quality management professionals
- Research and development
- Regulatory affairs managers
