作者名稱：博康技術團隊

工藝挑戰裝置（ PCD ）係一種微生物挑戰系統，用嚟評估所選工藝參數嘅殺滅率。佢通常係一個包含生物指標（例如已知孢子數量嘅萎縮桿菌孢子）嘅裝置或者測試包。 PCD 對殺菌過程嘅抵抗力應該大於或等於產品最難殺菌嘅區域嘅天然微生物負荷嘅抵抗力。 PCD 嘅數量應該符合 GB18279.1-2015嘅附錄 C 表 C.3所概述嘅要求。 PCD 分為內部 PCD （ IPCD ）同外部 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.

Hangzhou Bocon Mechanical and Electrical Equipment Co., Ltd., commonly referred to as HZBOCON, stands out as a dedicated Ethylene Oxide (EO/ETO) sterilizer manufacturer. Established in 2006, HZBOCON has committed itself to the design, development, and manufacturing of EO sterilization equipment, catering to a wide array of industries that require effective sterilization solutions for thermosensitive products.

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.

在OQ中，應確定相關輔助系統嘅性能，並透過模擬故障條件嚟測試軟件系統。

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.

Protection mechanism and explanation OF ETO Sterilizer System 2. By default, the system will perform the leak detection test before

1.Purpose for validation eto sterilization 1.1.the obtain of eto sterilization validation evidence that the equipment used for ETO sterilization has been