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:

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.

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

ETO 멸균 장비에 사용되는 가습수는 오염 물질이 없어야 하고 ETO 멸균 과정을 약화시키지 않아야 하며 멸균기, 멸균 제품 또는 부하를 손상시키지 않아야 합니다. 가습은 분무수를 직접 주입하는 것이 아니라 증기를 주입하여 가습해야 합니다.

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.

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.

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