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...
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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...
An Introduction to Radiation Dosimetry and the Mathmatical Model
This webinar offers an in-depth overview of radiation dosimetry, focusing on essential principles and calibration methods required...
Regulatory Landscape for EO Residue Levels in Medical Devices
The global regulatory landscape around Ethylene Oxide (EO) residues is a topic of increasing interest. This webinar...
Ethylene Oxide Sterilization, Revision of Annex E, Single Batch Release
ANSI/AAMI/ISO 11135:2014 Annex E has recently undergone significant revisions, expanding the requirements for the release of products...
Performance Qualification for Gamma Irradiators
Sterilization validation is a critical phase in the lifecycle of sterile products. This webinar will focus on...