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...
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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....
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...
Material Consideration Radiation Processing
Each polymer reacts differently to ionizing radiation, making it crucial to verify that the maximum administered dose...
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...
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...
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...
Critical First Steps of an Ethylene Oxide (EO) Validation – Process Definition Process Definition The Critical First Steps in the Validation of an EO Sterilization Process
In this webinar, you will learn about the importance of process definition (fractional) work as a part...
What is a Sterilization Dose Audit and How are they Performed?
The performance of periodic sterilization dose audits is required when a sterilization dose has been established using...