Izinkonzo Zokufaneleka

Nawe Zonke Izinyathelo Zendlela

Ukuze uhambisane ne-EN 1422 – I-EN ISO 11135, ISO 13485 Amazinga, kanye nemihlahlandlela ye-GMP, izimiso nezinqubo zethu zenzelwe ukukusiza ukuthi uthobele izidingo zokuqinisekisa futhi uhlangabezane nezidingo zakho ezibekiwe.

I-URS (Izicaciso Zezidingo Zomsebenzisi)

Incazelo yezidingo zokufeza izimfuno zenqubo. Ngokuvamile, i-URS iyadingeka emshinini we-eto sterilizer ngaphambi kokwenza umklamo.
Ukuze kuhlangatshezwane nemfuneko yomsebenzisi, sinaka ngokukhethekile i-URS (Izicaciso Zezimfuneko Zomsebenzisi) (njengosayizi wegumbi, umkhiqizo, iphakheji, iphesenti le-EO, njll.)
Ikhishwe ngu: Umsebenzisi

I-FDS (Izicaciso Zomklamo Osebenzayo)

Ukucaciswa lapho izimfuno zomthengi zidluliselwa kusixazululo sezobuchwepheshe (kusuka kumbono womkhiqizi)
Ikhishwe ngu: Umkhiqizi

INKCAZO YOKWENZIWA (DS)

Ukucaciswa kwesisekelo sobuchwepheshe kanye nokucaciswa kwezinto ezinomkhawulo okufanele zicatshangelwe ngesikhathi sokuthuthukiswa, ukwakhiwa nokuhlanganisa. I-DS iqinisekisa ukuthi zonke izidingo zamakhasimende kanye nezindinganiso zamanje ezisebenzayo ezivela ku-CGMP, EU, EN ISO kanye ne-FDA zanelisekile.

I-FAT / SAT (Isivivinyo Sokwamukelwa Kwefekthri / Ukuhlolwa Kokwamukelwa Kwesayithi)

Ukuhlolwa kokwamukela okubhalwe phansi kumnikezeli/ikhasimende elinelogi yokuhlola, isifinyezo sokuhlola, uhlu lwezinkinga ezivuliwe, nezitifiketi zokukhishwa.
E-BOCON, ngaphambi kokuthengisa, ifektri ihlinzeka amakhasimende ngedizayini nokubonisana ngayo yonke imishini kanye nezinsiza ze-workshop ye-ETO futhi isiza ekwakhiweni kokuhlela okuphelele nokuhlelwa kwendawo yokusebenzela ye-ETO. Ngokwezici zesayithi lekhasimende kanye nomkhiqizo, izinto ezibonakalayo, ukupakishwa, ezokuthutha, kanye nentuthuko yesikhathi esizayo, sikhetha impahla, ukumisa, imodi yokulawula, ivolumu, kanye nenani le-sterilizer. Ukusiza ekulungiseleleni inqubo ye-ethylene oxide inzalo, uhlelo lokuqinisekisa, imithetho nemithethonqubo yokuphatha workshop ye-ETO, ukusetshenziswa kwemishini nokugcinwa, njll. Ngesikhathi esifanayo ukunikeza izindinganiso ezifanele, ukushisa kwangaphambili, ukuhlaziya okusele, ukubonisana kobuchwepheshe bokucubungula, nokubambisana.

I-DQ, IQ, OQ, PQ

I-DQ(Design Qualification)
I-IQ (Ukufaneleka Kokufaka)
I-OQ(Ukufaneleka Kokusebenza)
I-PQ(Ukufaneleka Kokusebenza)
Kusukela ekucacisweni komkhiqizo nezimfuneko, ukuhlaziya ubungozi, ukuya ekuhleleni nasekusetshenzisweni kwezinyathelo zomuntu ngamunye zokufaneleka, sinakekela yonke into edingwa ukuqaliswa.

Ukuqinisekisa: I-BOCON izohlinzeka ngokuqinisekiswa kwesofthiwe. I-IQ, umbiko we-OQ, nokusekelwa kwe-PQ ngemva kokufakwa.