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.

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:

過程挑戰設備（PCD）是用於評估選定過程參數的殺戮率的微生物挑戰系統。它通常是包含生物學指標的設備或測試套件（例如，具有已知孢子計數的芽孢桿菌孢子）。 PCD對滅菌過程的電阻應大於或等於產品最難殺傷區域的天然微生物載荷的電阻。 PCD的數量應滿足GB18279.1-2015中附錄C的表C.3中概述的要求。 PCD分為內部PCD（IPCD）和外部PCD（EPCD）。

Industry Eto Sterilizer Installation Verification The installation of Industry Eto Sterilizer and all associated services should comply with the requirements

The humidification water used in the ETO Sterilization Equipment should be free from contaminants, should not weaken the ETO sterilization process, and should not damage the sterilizer, sterilized products, or the load. Humidification should be done by injecting steam, not by directly injecting atomized water.

杭州博康機電設備有限公司，俗稱HZBOCON，是一家專業的環氧乙烷（EO/ETO）滅菌器製造商。 HZBOCON成立於2006年，致力於環氧乙烷滅菌設備的設計、開發與製造，滿足各產業需要有效熱敏產品滅菌解決方案的需求。

PQ is the stage of validation that uses Ethylene oxide sterilization chamber to demonstrate that the Ethylene oxide sterilization equipment consistently operates in accordance with predetermined acceptance criteria and the process yields a product that is sterile and meets the specified requirements.

In OQ, the performance of the relevant auxiliary system should be determined and the software system should be tested by simulating the fault conditions.

a.Equipment to be used in the sterilization process, including any ancillary items, shall comply with its design specifications.The corresponding documents include functional design specifications, user requirements specifications, design drawings, etc. (Equipment schematic diagram, energy supply diagram, electrical schematic diagram, system schematic diagram, etc.)

Ethylene oxide sterilizer operate at low temperatures, making them ideal for sterilizing heat-sensitive medical devices and instruments. This characteristic allows for the preservation of the integrity and functionality of complex medical devices that might be damaged by heat.