January 26, 2022-
Get ready for your EO sterilization validation

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.

This course offers a rewarding experience and is particularly relevant to the following key figures:

• CTO
• R&D Manager,
• QA Manager,
• RA Manager,
• Engineering Manager,
• Validation Manager.

Sally Bercovich

Sally is AAMI Certified Industrial Sterilization Specialist (CISS-EO) and a member of ISO/TC 198. She holds M.Sc. degree in Biotechnology from Hebrew University and has extensive experience in EO Sterilization of medical devices. In the past, she has successfully managed quality microbiological testing group for one of the global leaders in its field.  In the last 5 years she leads EO Sterilization projects at Li-Med, helping dozens of customers to overcome the hurdles of building and validating EO Sterilization process.