The sterilization process of ethylene oxide was verified according to the standard GB18279--2015,ISO11235-2014. The verification process is divided into three parts: IQ (installation confirmation), OQ (operation confirmation) and PQ (performance confirmation). According to the relevant standards of ethylene oxide sterilization, the company focuses on the confirmation of ethylene oxide sterilizer (IQ,OQ), and assist customers to develop reasonable sterilization process (PQ), guide customer specification verification process and daily control to ensure that the equipment can continuously and steadily produce qualified products.

 1.Installation confirmation(IQ):Confirm that sterilization equipment and auxiliary systems are installed in accordance with the specifications。

2.Operational validation(OQ):Confirm the operation performance of the sterilizer equipment to ensure that the performance parameters of the equipment meet the requirements。

3.Performance evaluation(PQ):Confirm the process parameters to ensure that the sterilization process meets the asepsis requirements under the specified process parameters, loading mode, packaging and other process conditions。