TechTips

This TechTip reviews why qualifying a 2x ethylene oxide process could be beneficial for your medical device.

Introduction The packaging of sterile medical and pharmaceutical devices needs to ensure that the product shall function as intended and remain sterile to the point of use, from both a patient safety and regulatory requirement perspective. As part of p

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

This TechTip provides basic information on how the ethylene oxide sterilization process works, including each step of the process and items for consideration

Learn about the equipment used throughout the ethylene oxide sterilization process.

In an industry requiring the transportation and storage of millions of biologics every year, how do we avoid spoilage?

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

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

This TechTip reviews dose auditing, while a companion document will look at dose setting in this same format

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