1.Inhloso yokuqinisekisa i-eto inzalo
1.1.ukutholwa kobufakazi bokuqinisekisa bokuqinisekisa ukuthi i-eto inzalo iqinisekisa ukuthi okokusebenza okusetshenziselwa ukuvalwa kwe-ETO kuhlinzekiwe futhi kwafakwa ngokuvumelana nencazelo yayo futhi ingasebenza ngokuzinza ngaphakathi kwemikhawulo enqunywe kusengaphambili futhi yenze ngokungaguquki ngokuvumelana nemibandela enqunywe kusengaphambili futhi ngaleyo ndlela ikhiqize umkhiqizo uhlangabezana nokucaciswa kwawo.
1.2
Le ngxenye icacisa izidingo zokuthuthukiswa, ukuqinisekiswa kanye nokulawulwa okujwayelekile kwenqubo yokuvala inzalo ye-ETO futhi inikeze umhlahlandlela wokuthi ihambisane nezidingo zokulawula ezifanele ezifana ne-ISO 11135.
2. Ububanzi
2.1.Izinto ezisetshenziswayo ezifanele ezisetshenziswa e-ETO inzalo(Igumbi le-Precondition?I-Sterilizer?Igumbi lokungenisa umoya?I-Incubator, njll.).
3. Imigomo Nezincazelo
3.1.?IQ
Installation qualification:IQ
3.2.?OQ
Operation qualification:OQ
3.3.?PQ(MPQ/PPQ)
Performance qualification:PQ(Microbiological PQ/Physical PQ )
3.4.:Requalification
3.5.:Bioburden
3.6.:Biological indicator
3.7.:Fractional cycle
3.8.:Half cycle
3.9.:Full cycle
3.10.PCD: process challenge device
3.11.:Product and product family
3.12.?: Usable volume/Product load volume
3.13.:Sterility
3.14.SAL: Sterility assurance level
4. Responsibilities
4.1 The eto sterilization validation engineer is responsible for drafting the validation protocol, and the trained personnel and the uses are responsible for performing the validation and collecting relevant data to assist in the completion of the validation.
5. Procedure
5.1.IQ is undertaken to demonstrate that the sterilization equipment and any ancillary items have been supplied and installed in accordance with their specification. Before performing IQ, the equipment manufacturer will conduct FAT and SAT to ensure that the equipment has been delivered normally.