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.निर्जंतुकीकरण प्रक्रियेत वापरण्यात येणारी उपकरणे, कोणत्याही सहायक वस्तूंसह, त्याच्या डिझाइन वैशिष्ट्यांचे पालन करणे आवश्यक आहे. संबंधित दस्तऐवजांमध्ये कार्यात्मक डिझाइन तपशील, वापरकर्ता आवश्यकता तपशील, डिझाइन रेखाचित्रे इ. (उपकरणे योजनाबद्ध आकृती, ऊर्जा पुरवठा आकृती, विद्युत योजनाबद्ध आकृती, सिस्टम योजनाबद्ध आकृती, इ.) समाविष्ट आहेत.

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

तुम्हाला ETO नसबंदी प्रक्रियेतील IQ बद्दल अधिक जाणून घ्यायचे असल्यास

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ईमेल:hayley@hzbocon.com

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