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:

A Process Challenge Device (PCD) is a microbiological challenge system used to evaluate the kill rate of selected process parameters. It is typically a device or test package containing biological indicators (e.g., Bacillus atrophaeus spores with known spore count). The resistance of the PCD to the sterilization process should be greater than or equal to the resistance of the natural microbial load in the most difficult-to-sterilize area of the product. The quantity of PCDs should meet the requirements outlined in Table C.3 of Appendix C in GB18279.1-2015. PCDs are classified into Internal PCDs (IPCD) and External PCDs (EPCD).

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

L'eau d'humidification utilisée dans l'équipement de stérilisation ETO doit être exempte de contaminants, ne doit pas affaiblir le processus de stérilisation ETO et ne doit pas endommager le stérilisateur, les produits stérilisés ou la charge. L'humidification doit être effectuée par injection de vapeur et non par injection directe d'eau atomisée.

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.

Dans OQ, les performances du système auxiliaire pertinent doivent être déterminées et le système logiciel doit être testé en simulant les conditions de défaut.

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