Ethylene Oxide (EO) Sterilization process is considered high-risk and critical manufacturing step. EO Validation can be challenging; there are many aspects and variables to consider, and certain decisions made prior to commencing the validation activities could be beneficial to the process, ensuring delivery of safe product in timely manner, while others could lead to delays and increased costs, or even compromised Sterility Assurance Level or unsafe EO residuals levels. For that reason, careful planning is crucial to successful validation. Proper validation execution is a key factor to save time, money, and assure required safety level per ISO 11135:2014.
During this webinar, we will discuss Ethylene Oxide’ mode of action as a sterilant, EO Sterilization process’ critical parameters and how they affect process performance and safety. We will go over three key process phases and understand process’ impact on your product.
Proper product design and load configuration shall assure safe product per ISO 11135:2014.