3.4.1 eto sterilizer machine Temperature Setting Range
The temperature setting range for the eto sterilizer is: 30 to 70°C
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If a leak is detected in the eto sterilizer dosing pipeline during the administration process, immediately close the medication bottle, switch and the dosing valve on the main unit. Turn on the axial fan to ensure proper ventilation, and then proceed with repairs.
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Note: Regardless of whether the equipment is in normal operation, malfunction, or maintenance state, if personnel need to enter the
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Note 1: The Ethylene Oxide sterilization conditions must be obtained through validation confirmation and should be verified with monitoring and
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The temperature of representative areas on the inner surfaces should be measured and recorded using temperature recording instruments that comply with the requirements of Appendix B.
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Appearance Inspection: Check the main unit, control rack, and electrical control cabinet for any damage on the surface.
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Start cycle phase(Select parameters/sterilization recipe) Serial number Potentially risky content Risk assessment under existing process conditions Risk assessment of the
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9.1 During ETO Sterilization, operators are not allowed to leave the operating area and must continuously observe the ETO Sterilization process. If any abnormal phenomena occur, the machine must be immediately shut down, and the power supply should be cut off for inspection.
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For the purposes of this document, the following terms and definitions apply in ethylene oxide sterilization 3.1 Aeration part of
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Appearance Inspection: Check for any damage on the surfaces of the main machine, control rack, and electrical control cabinet.
Power Supply Check: Ensure the power supply meets the requirements and check the rotation direction of the water pump and vacuum pump.
Turn on the power and observe whether the instrument display values are normal; otherwise, cut off the power, inspect and repair before restarting.
Pipeline Inspection: Check for leaks in the water supply, vacuum, and medication delivery pipelines, and ensure all valves are in standby mode; adjust if necessary.
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