Qhov ntsuas kub teeb tau tshwm sim ntau ntawm cov eto sterilization chamber yuav tsum yog ntawm 30-60 ° C. Nws raug nquahu kom ua qhov ntsuas kub thiab kub thiab kub thiab kub thiab kub thiab kub thiab kub thiab sov thiab sov thiab huab cua sov thiab huab cua sov thiab huab cua sov thiab huab cua sov thiab huab cua sov thiab huab cua sov thiab av sov.

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:

Lub Txheej Txheem Sib Tw Ntaus Ntaus (PCD) yog qhov kev sib tw microbiological siv los ntsuas qhov tua tus nqi ntawm cov txheej txheem xaiv. Nws feem ntau yog ib lub cuab yeej lossis cov ntawv xeem uas muaj cov cim qhia txog kev lom neeg (xws li, Bacillus atrophaeus spores nrog paub suav suav). Kev ua haujlwm ntawm PCD rau cov txheej txheem kom tsis muaj menyuam yuav tsum muaj ntau dua lossis sib npaug ntawm qhov tsis kam ntawm cov khoom siv microbial nyob rau hauv qhov nyuaj tshaj plaws-rau-sterilize cheeb tsam ntawm cov khoom. Qhov ntau ntawm PCDs yuav tsum ua kom tau raws li qhov yuav tsum tau teev tseg hauv Table C.3 ntawm Cov Ntawv Ntxiv C hauv GB18279.1-2015. PCDs raug faib ua Internal PCDs (IPCD) thiab External PCDs (EPCDs).

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.

Hauv OQ, kev ua yeeb yam ntawm cov txheej txheem cuam tshuam yuav tsum txiav txim siab thiab software system yuav tsum tau sim los ntawm kev sim ua txhaum cov kev txhaum.

a.Equipment los siv rau hauv cov txheej txheem tsis muaj menyuam, yuav tsum ua raws cov ntaub ntawv tshwj xeeb, cov ntaub ntawv tsim qauv, hluav taws xob schematic daim duab, system schematic daim duab, thiab lwm yam)

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.