October 2024

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.

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

ethylene oxide in sterilization Introduction ETO is a colorless gas that is flammable and explosive. The four essential parameters (operational

The Detail EtO Sterilization Cycle A typical EtO sterilization cycle comprises three main stages: Preconditioning This stage prepares the chamber

Eto Sterilization is conducted using a eto sterilizer located in a dedicated facility.

Ethylene Oxide (EtO lossis EO) sterilization yog cov roj tsis muaj xim uas siv dav hauv kev lag luam sib txawv, suav nrog cov khoom tsim, cov khoom tu tus kheej, thiab eto sterilization ntawm cov cuab yeej kho mob, pleev, thiab tsw. EtO yog lub tswv yim tseem ceeb rau kev ua kom tsis muaj menyuam kho cov khoom siv kho mob, ua si qhov tseem ceeb hauv kev zam kom tsis txhob kis kab mob hauv cov neeg mob uas muaj cov txheej txheem phais thiab lwm yam kev kho mob kho dua tshiab.