Establishing Maximum Acceptable Dose for Medical Devices in Radiation Sterilization
Medical device manufacturers using ionizing radiation (gamma, electron beam, or X-ray) for sterilization purposes must establish the...
Browse Content
Validating, Optimizing and Monitoring EO Sterilization Processes – Part 2
Establishing an Ethylene Oxide (EO) sterilization process involves navigating a complex path, as multiple factors influence the...
Validating, Optimizing and Monitoring EO Sterilization Processes – Part 1
Establishing an EO (ethylene oxide) sterilization process can be a complicated path as multiple factors play a...
Materials Qualification of Healthcare Products to Radiation Sterilization
Newer medical products, particularly those that are biological in nature or composed of materials sensitive to traditional...
A Review of Ionizing Radiation Sterilization Modalities
High-energy ionizing radiation is an established and proven method for sterilizing healthcare, food, and general industrial products....
How to Evaluate a New Product Against an Existing Product in a Validated EO Process
Section 12 of ISO 11135:2014 provides a pathway for adding new or modified ("candidate") products to an...
Three Methods to Establish the Sterilization Dose of a Medical Device
In the medical device industry, sterilization processing is performed to obtain a Sterility Assurance Level (SAL) as...
Material Consideration Radiation Processing
Each polymer reacts differently to ionizing radiation, making it crucial to verify that the maximum administered dose...
Gamma: the heart of radiation sterilization past, present and future
The COVID-19 pandemic of 2020 highlighted the pivotal role of the medical device supply chain in delivering...
Establishing Maximum Acceptable Dose in Radiation Sterilization
Manufacturers utilizing ionizing radiation (gamma, electron beam, or X-ray) for sterilization purposes must establish the maximum acceptable...