How To Calculate Allowable Limits For Ethylene Oxide Sterilization
Learn what ethylene oxide residuals are and how to calculate allowable limits for EtO-sterilization of medical devices and products.
Learn what ethylene oxide residuals are and how to calculate allowable limits for EtO-sterilization of medical devices and products.
Learn about ethylene oxide residuals and how to calculate tolerable exposure limits for EtO-sterilized medical devices and products.
Learn about USP regulations regarding non-sterile and aseptic processes, and sterility assurance and how these relate to regulatory testing requirements.
Learn what ethylene oxide residuals are and how to calculate tolerable contact limits for EtO-sterilized medical devices and products.
Learn what isolators and RABS are, and if they can be useful in the manufacturing, filling, testing, or packaging processes for medical devices.
Learn what restricted access barrier systems (RABS) are and how are they useful in manufacturing or packaging processes for medical products.
Learn the differences between electron beam (e-beam) and gamma radiation sterilization processes and which to use for medical device sterilizations.
Learn about electron beam (e-beam) processes and when to use it to sterilize medical devices and products.
Learn the differences between microbial aerosol challenge testing and microbiology testing for parenteral products and combination products.
Learn the differences between microbial aerosol challenge testing and bioburden testing for combination products as well as parenteral products.