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. Обладнання, яке буде використовуватися в процесі стерилізації, включно з будь-якими допоміжними елементами, повинно відповідати його специфікаціям конструкції. Відповідні документи включають специфікації функціонального дизайну, специфікації вимог користувача, креслення конструкції тощо (схема обладнання, схема енергопостачання, електрична схема, принципова схема системи тощо)
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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