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

Die bevogtigingswater wat in die ETO-sterilisasietoerusting gebruik word, moet vry wees van kontaminante, moet nie die ETO-sterilisasieproses verswak nie, en moet nie die sterilisator, gesteriliseerde produkte of die vrag beskadig nie. Bevogtiging moet gedoen word deur stoom in te spuit, nie deur direk vernevelde water in te spuit nie.

Hangzhou Bocon Mechanical and Electrical Equipment Co., Ltd., wat algemeen na verwys word as HZBOCON, staan ​​uit as 'n toegewyde Etileenoksied (EO/ETO) steriliseerder vervaardiger. HZBOCON, wat in 2006 gestig is, het hom verbind tot die ontwerp, ontwikkeling en vervaardiging van EO-sterilisasietoerusting, wat voorsiening maak vir 'n wye verskeidenheid nywerhede wat effektiewe sterilisasie-oplossings vir termosensitiewe produkte benodig.

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 moet die prestasie van die betrokke hulpstelsel bepaal word en die sagtewarestelsel moet getoets word deur die fouttoestande te simuleer.

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