Isingeniso
Ukuvala inzalo kwe-Ethylene Oxide (EO) kusalokhu kuyindlela ekhethwayo yamathuluzi ezokwelapha engahambelani nemisebe noma ukushisa okumanzi. Nokho, umthombo ophezulu weukushiyeka kwesistimu yokuphatha ikhwalithi ngesikhathi sokuhlolwa kwe-FDA/ISO. Ukubhekana ngqo nalokhu kungqubuzana kubalulekileukubhaliswa kwedivayisi yezokwelapha oyinyumba nokuhambisana.

I. Ukuhluleka Kokuqinisekisa Ukuvala Inzalo

Izikhala ezibalulekile zokufakazela ukusebenza kahle kwenqubo:

  • ?Izinqubo ezingachazwanga: Imingcele yokuvala inzalo engekho embhalweni wokuklama.
  • ?Ukweqiwa kwe-SAL: Izinga Lokuqinisekisa Ukuzala (SAL) alicacisiwe emibikweni.
  • ?Imibiko engagunyaziwe/engaphelele: Ukuntula iziphetho zokuhlola noma idatha yokuhlola eluhlaza.
  • ?Izikhala zokuqinisekisa isoftware: Ayikho idatha yezinhlelo zesofthiwe yokubulala amagciwane.
  • ?Izinkinga zokuqinisekisa: Izibangeli/imijikelezo engachazwanga; izinguquko ezenziwe ngaphandle kokuqinisekiswa kabusha.
  • ?Ipharamitha ayifani: Ukungqubuzana phakathi kwamaphrothokholi, amarekhodi, noma ama-ID wezinto ezibonakalayo.
  • ?Amaphutha e-aeration: Izimo ezingacacile/ubude besikhathi ekubhalweni.

?Lungisa: Qondanisa ne-ISO 11135. Qinisekisa YONKE imingcele ebalulekile (izilungiselelo zokulayisha, ukubekwa kwe-BI, umthamo wegesi).

II. Inqolobane & Izingozi Zesitoreji

Ukwephulwa kokuphepha kwe-EO nokulawulwa kwezinto ezibonakalayo:

  • ?Izilawuli zezinsiza ezingezinhle: Ukhula, amanzi amile, noma imfucumfucu ezindaweni zokukhiqiza.
  • ?Ukungena komoya okwanele: Amakamelo angekho/angaphansi; ukungena komoya okungalungile noma ukukhipha umoya.
  • ??Isitoreji se-EO esingaphephile: Izindawo ezingazinikele; amasilinda agcinwe ngokungahleliwe ngaphandle:
    • Ukuqapha izinga lokushisa/umswakama
    • Izilawuli zomlilo noma ukutholwa kokuvuza
  • ?Izikhala zokuphatha impahla: Izinto eziyinyumba ezingenamalebula; abekho abaqaphi bemvelo.

III. Amaphutha Okulawula Inqubo Yenzalo

Iziphambeko ngesikhathi sokubulawa:

  • ?Ukulandeleka okungekuhle: Izinombolo zeqoqo ezingaqondakali; ama-ID/amalogi edivayisi angekho.
  • ??Amapharamitha abalulekile angekho kulogi:
    • Isikhathi sokujova igesi, umthamo we-EO, imijikelezo ye-vacuum
    • Izinombolo ze-BI, idatha yezinga lokushisa/umswakama
  • ?Ukuchezuka okungalawuleki: Amapharamitha awafani nemininingwane eqinisekisiwe noma imiyalelo yomsebenzi.
  • ?Izinhlelo zokuphepha ezingekho: Azikho izitholi zokuvuza kwegesi noma imidwebo yokulayisha kuma-SOP.

IV. Ukubheka Okusele Kokulawula

Izingozi zokuphepha kwesiguli ezinsalela ze-EO:

  • ?Ukuqinisekisa akukho: Ayikho idatha esekela izindlela zokususa izinsalela.
  • ?Amarekhodi angaphelele: Idatha yokuhlolwa okungahluziwe noma ama-ID wempahla abekho.
  • ??Imikhawulo engahambisani: Imikhawulo yensalela ye-EO engaqinisekisiwe.

V. Amadokhumenti & Izikhala Zabasebenzi

Ubuthakathaka bokuhambisana nesistimu:

  • ?Amadokhumenti angalawulwa: Ama-SOP aphelelwe yisikhathi; amafomu angenazinombolo; amarekhodi angasayiniwe.
  • ???Ukunganakwa kwemishini: Ukusebenzisa izibulala-magciwane ezingalungile; amapayipi angabhaliwe; ukulinganisa okuphelelwe yisikhathi.
  • ???Abasebenzi abangaqeqeshiwe: Akukho ukuhlolwa kokufaneleka kwabaqhubi abavala inzalo.

VI. Supply Chain & Izinkinga Zokuthengisa

Ukuhlukaniswa kokulandeleka:

  • ?Amarekhodi okuthengisa angaphelele: Ama-ID enqwaba awekho, amadethi okuphelelwa yisikhathi, noma imininingwane yeklayenti.
  • ?Izinkontileka eziphelelwe yisikhathi: Izivumelwano zesevisi ye-EO azivuselelwa.
  • ?Ukuchezuka kwesampula: Amanani esampula agciniwe awafani nezinqubo.

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