November 2024

Preparation Work Before eo Sterilization

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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Request For Eto Gas Sterilizer Manufacturer

2.1.1 The overall shape should be precise, with smooth, clean surfaces and uniform color. There should be no burrs, sharp edges, cracks, visible scratches, or unevenness.
2.1.2 All external text, graphics, and symbols must be printed clearly, with precise and durable markings.
2.1.3 Fasteners must be securely installed. All control switches and adjustment knobs (or buttons) should operate smoothly and reliably without obstructions.

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ETO 멸균 챔버 테스트

The temperature setting range of the ETO Sterilization Chamber should be between 30-60°C. It is recommended to perform temperature distribution testing of the sterilizer’s internal surface and temperature and humidity distribution testing inside the sterilization chamber to ensure the effectiveness of the heating and humidifying systems.

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Routine Monitoring, Control, and Release of Ethylene Oxide Sterilization

The purpose of routine monitoring and control of EO (Ethylene Oxide) sterilization is to demonstrate that the confirmed and specified sterilization process has been applied to the product. Data from each sterilization cycle should be recorded and retained to prove that the confirmed sterilization process specifications have been met. This should include at least the following content:

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EO 멸균 공정 챌린지 장치 생산

프로세스 챌린지 장치(PCD)는 선택된 프로세스 매개변수의 사멸률을 평가하는 데 사용되는 미생물학적 챌린지 시스템입니다. 일반적으로 생물학적 지표(예: 포자 수를 알고 있는 Bacillus atrophaeus 포자)가 포함된 장치 또는 테스트 패키지입니다. 멸균 공정에 대한 PCD의 저항성은 제품의 가장 멸균하기 어려운 영역의 자연 미생물 부하 저항보다 크거나 같아야 합니다. PCD의 수량은 GB18279.1-2015 부록 C의 표 C.3에 설명된 요구 사항을 충족해야 합니다. PCD는 내부 PCD(IPCD)와 외부 PCD(EPCD)로 분류됩니다.

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