Ethylene Oxide Sterilization Validation of Medical Devices

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Ethylene Oxide Sterilization Validation of Medical DevicesValidation of Sterilization of health-care products – Ethylene oxide

Conducted by: Ms. Sally Bercovich

Categories: Analytical R&D, Manufacturing, Quality, Sterilization, Validation

SKU: 221087

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Validation of Ethylene Oxide (EO) Sterilization process is considered high-risk and critical step. EO Sterilization Validation can be challenging; there are many aspects and variables to consider, and certain decisions should be made prior to commencing the validation activities.
Ethylene Oxide (EO) Sterilization is a commen and wide used process at the medical device industry and reusers of medical devices, mainly hospitals and outpatient clinics.
Proper planning of EO sterilization validation is beneficial to the process, ensuring delivery of safe product in timely manner, while improper decisions could lead to delays and increased costs, or even compromised Sterility Assurance Level or unsafe EO residuals levels, causing serious harm to patients’ health.
In order to ensure the safety and the efficiency of the process , it is crucial to understand principles and critical parameters of EO Sterilization validation method and routine process, per requirements of ISO 11135:2014, for any medical device manufacturer and reusers.

Dates:

27/10/2022
02/11/2022

Course location: Zoom Course

Duration: 1-Day Course

Hours: 09:00 - 12:30

Credits:

Course Language: עברית

Course price: ₪1,700 + VAT

Early registration is Closed

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Issues to be covered

Introduction to EO sterilization process;
Product/Process definition according to ISO 11135:2014;
EO Sterilization Validation proper planning;
EO Validation Major process steps (IQ/OQ, PPQ, MPQ);
Aspects needed to be addressed in validation protocol/report;
EO Sterilization Requalification.

Who should attend

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
Sterilization Contractors staff
Lab technicians

Benefits to the Participants

At the end of the course, participants will be able to

Understand regulatory framework and applicable standards relevant to EO sterilization of medical devices;
Understand principles and critical parameters of validation of EO sterilization process;
Plan, execute and document EO sterilization validation and requalification.

About The Lecturer

Sally Bercovich

Sally is AAMI Certified Industrial Sterilization Specialist (CISS-EO) and a