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.El equipo a ser utilizado en el proceso de esterilización, incluyendo cualquier elemento auxiliar, deberá cumplir con sus especificaciones de diseño. Los documentos correspondientes incluyen especificaciones de diseño funcional, especificaciones de requisitos del usuario, planos de diseño, etc. (diagrama esquemático del equipo, diagrama de suministro de energía, diagrama esquemático eléctrico, diagrama esquemático del sistema, 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

SI QUIERES SABER MÁS SOBRE IQ EN EL PROCESO DE ESTERILIZACIÓN ETO

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