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.Equipment to be used in the sterilization process, including any ancillary items, shall comply with its design specifications.The corresponding documents include functional design specifications, user requirements specifications, design drawings, etc. (Equipment schematic diagram, energy supply diagram, electrical schematic diagram, system schematic diagram, etc.)
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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