Ethylene Oxide Sterilization Validation

A sterile medical device is a device that does not contain living microorganisms. Medical devices manufactured under standard manufacturing conditions in accordance with ISO 13485 requirements may contain a small number of microorganisms before sterilization. Such medical devices are not sterile. The purpose of sterilization is to deactivate microbiological contaminants and thus sterilize the non-sterile medical device. 

ISO 11135 specifies the requirements that ensure the ethylene oxide sterilization process with appropriate microbicidal activity to sterilize medical devices. In addition, compliance with the specification allows this activity to be both reliable and reproducible, thus predicting with acceptable confidence that the probability of a microorganism present in the product after sterilization is low. 

While ISO 11135 includes validation activities for tubular systems, ISO 14937 standard is based on for cartridge systems. 

In this context, the reproducibility of sterilization efficiency is shown depending on the bioload of the products. Variables are controlled with physical, microbiological and chemical tests. Physical factors such as temperature, humidity, pressure should be monitored and their contribution on the sterilization process should be determined. 

It should not be forgotten that the following factors directly affect the effectiveness of sterilization before the sterilization process. Therefore, it should be considered, 

Microbiological status of raw materials and / or components, 

Validation and routine control of cleaning and disinfection procedures applied on the product, 

Control of the environment in which the product is manufactured or re-processed, assembled and packaged, 

Control of hardware and processes, 

Control of personnel and personnel hygiene, 

Packaging form and packaging material of the product, 

The conditions in which the product was stored. 

 

For our validation activities, TS EN ISO / IEC 17020 quality system creation work continues. Our company is a inspection company accredited by TÜRKAK.