Ethylene oxide, abbreviated as EO or ETO. It is a very important special process in the current industry, especially in the aseptic production of medical devices. What steps does its sterilization process usually include?
As a special processing procedure, sterilization confirmation is required before the product is sterilized. The sterilization confirmation includes the IQ, OQ and PQ of the sterilization equipment, which is what we commonly call the three Qs.
After the process of PQ confirmation, it can be used for corresponding equipment and products for EO sterilization. At the same time, we must note that after confirmation, the product structure, materials, packaging, loading, processing technology, sterilization equipment used, and parameters cannot be changed. Any changes need to be reconfirmed before routine sterilization can be carried out.
When sending sterilization routinely, you should make an appointment with the sterilization supplier in advance to avoid affecting normal production and shipment. When the product is delivered, you should confirm the quantity list with the consignee, and ensure that the product is packaged in good condition and that the list is consistent with the actual content. Any non-compliance or fraudulent behavior shall be subject to corresponding legal responsibilities.
The sterilizer should preheat the product according to the appointment and schedule (if required during confirmation), and ensure that the temperature and humidity of the product reach the predetermined level before entering the sterilizer. It should be noted that the product is sterilized Outside the box, there should be no wrapped items that affect the effect of EO sterilization. The product loading quantity should also refer to the loading method and quantity at the time of confirmation.
After the sterilization cabinet is finished, if the analysis method has been confirmed, the analysis should be carried out according to the specified conditions. And provide relevant records. All process records should be recorded and archived. When the product is released, process records, BI training results, and analytical results or residual test results are what we should confirm.
When all the conditions meet the release requirements, the product can be picked up and used for sale.