Iq in eto sterilization process is undertaken to demonstrate that the sterilization equipment and any ancillary items have been supplied and installed in accordance with their specification. Before performing IQ, the equipment manufacturer will conduct FAT and SAT to ensure that the equipment has been delivered normally.

During IQ the following events need to be further identified and substantiated.

a. 滅菌過程所用設備,包括任何附屬項目,應符合其設計規格,相應文件包括功能設計規格、用戶需求規格、設計圖等(設備原理圖、供能圖、電氣原理圖、系統原理圖等)

b.Verify that all components (including control software) are functioning properly; Key measuring instruments need to be calibrated; Key component information should be recorded;

c.Ensure the installation and use environment is safe and complies with local regulations. Meet safety and personnel health requirements.

d.Develop safety production and operating procedure documents, including maintenance and exception handling documents; conduct operator training; operators can only start work after they are qualified.

e. IQ may be a one-time exercise for the specific equipment being employed for a sterilization process.

f. Additional IQ needs to be performed in the event of significant component changes or functional changes, as well

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