EtO Sterilization Validation

Ethylene oxide (EtO) is used to sterilize moisture or heat-sensitive products that cannot be exposed to steam. Featuring both unique benefits and challenges, EtO validation is a multi-staged, meticulous process. 

A low-temperature sterilization technology, EtO sterilization is widely used in the medical industry to treat products that can be damaged by extreme heat, moisture, or radiation. The technology is also characterized by its ability to penetrate packaging made of breathable materials easily.

The validation of product sterilization is an essential regulatory requirement for medical device manufacturers, and following EtO sterilization, a stringent set of tests must be completed to ensure compliance with sterility assurance levels. 

As EtO sterilization involves the use of a potentially harmful gas, the validation process must adhere to strict guidelines, including employing adequate detection and identification measures after ensuring mechanical product aeration for 8 to 12 hours at 50 to 60°Ct.

Before the actual validation can begin, the process methodology and qualifications must first be meticulously designed and approved to ensure it meets the appropriate level of sterility assurance. 

An effective validation for EtO sterilization is primarily focused on the bioburden of the product and packaging, and Bioburden is defined as the population of viable microorganisms on a product and/or a package and is characterized in terms of number, identity, and resistance. A validated sterilization procedure must demonstrate that it can consistently and adequately remove biological contaminants from the product and packaging. 

Generally, the validation process encompasses:

While also offering steam and VHP sterilization, Taryag specializes in EtO sterilization and its validation, leveraging its extensive infrastructure to provide comprehensive validation services and technical support in all phases of the validation process: from protocol design to the final report. 

As part of our integrated approach, Taryag offers its clients complementary services, including sterilization and packaging: helping remove barriers and reduce costs.