Gamma Irradiation of Medical Devices, Apparatus, and Instruments
One-Day Basic Course
When gamma irradiation is selected as the sterilization method, the dose delivered to the product must be established and validated in accordance with the relevant international standards – ISO 11137-1, ISO 11137-2, ISO 11137-3, and ISO/TR 13004.
These standards and associated guidance documents specify the requirements and recommendations for products intended to be sterilized by irradiation. They define how to validate and maintain a Sterility Assurance Level (SAL) for a product or product family.
The standards provide a framework for process design, enabling the definition of gamma sterilization conditions and allowing either a bioburden-based or a dose-based approach to be followed.
While the energy of gamma radiation effectively destroys biological structures, it may also have adverse effects on certain materials – for example, some plastics tend to discolor or become brittle.
In this course, you will learn about the different validation options, including the advantages and limitations of each approach to dose setting.
- Content
- Process design for sterilization
- Validation in compliance with applicable standards
- Definition of reference load configurations and product families
- Microbiological parameters relevant to irradiation
- Evaluation of process adaptations and changes
- Your Benefits
- Learn the requirements for validation and documentation of sterilization processes for medical devices.
- Gain the ability to interpret microbiological data relevant to sterilization.
- Understand and assess (re)validation reports from sterilization service providers.
- Learn how to evaluate and apply sterilization processes across different products.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Manufacturers of medical devices
- Manufacturers of sterile products
- Professionals in product management
- Personnel from Quality Assurance (QA) and Quality Management (QM)
- Research and Development (R&D) staff
- Regulatory Affairs Managers
