2x Processing for Ethylene Oxide Sterilization
This TechTip reviews why qualifying a 2x ethylene oxide process could be beneficial for your medical device.
Activation Assessment (X-ray and electron beam)
Background Radioactive material of natural origin is abundant and varies widely in both type and amount. The energy from these materials, plus that of cosmic or cosmogenic origin, is called background radiation. Artificial radioactivity is the result o
Anatomy of an Ethylene Oxide Sterilization Process
This TechTip provides basic information on how the ethylene oxide sterilization process works, including each step of the process and items for consideration
Anatomy of an Ethylene Oxide Sterilizer
Learn about the equipment used throughout the ethylene oxide sterilization process.
Avoiding Medicine Spoilage During Transportation and Storage
In an industry requiring the transportation and storage of millions of biologics every year, how do we avoid spoilage?
Bacterial Endotoxin Testing
Pyrogens are substances that can induce a fever response in the body, and sources can be either microbial or non-microbial. The focus of this TechTip is the testing associated with a microbial pyrogen, bacterial endotoxin. Bacterial endotoxins are memb
Biological Indicator Population Verification Test
Purpose In a sterilization process where biological indicator (BI) sterility results are used as part of product release criteria, the BIs shall be procured from an approved supplier with a minimum population of test organisms defined. The population o
Comparison of AAMI Methods for Dose Audits to Substantiate Irradiation Dose
This TechTip reviews dose auditing, while a companion document will look at dose setting in this same format
Comparison of AAMI Methods for Setting of Minimum Sterilization Dose with Irradiation
View a comparison of the methods available as starting point when preparing to review standards and guidelines as they apply to your specific product needs or requirements
Comparison of Alanine and Red 4034 Dosimetry Systems
This TechTip compares various attributes of the Alanine and Red 4034 dosimetry systems