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. Oprema koja će se koristiti u procesu sterilizacije, uključujući sve pomoćne stavke, mora biti u skladu sa svojim specifikacijama dizajna. Odgovarajući dokumenti uključuju specifikacije funkcionalnog dizajna, specifikacije korisničkih zahtjeva, crteže dizajna itd. (shematski dijagram opreme, dijagram opskrbe energijom, električni shematski dijagram, shematski dijagram sustava itd.)

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

AKO ŽELITE ZNATI VIŠE O IQ-U U ETO PROCESU STERILIZACIJE

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