I-ETO Sterilization Re-qualification Izidingo

1. Imvamisa yokufaneleka kabusha

•Isidingo esincane sonyaka
• Okungenani kanye ngonyaka, idatha yokuqinisekisa, idatha yokuqinisekisa kabusha elandelayo, kanye nedatha yokucubungula okujwayelekile kufanele kubuyekezwe.
• Ububanzi bokufaneleka kabusha kufanele bunqunywe futhi bubhalwe phansi
• Inqubo yokubuyekeza izobhalwa phansi

2. Ingabe Ukufaneleka Kabusha Kuyadingeka Uma Lungekho Ushintsho Lomkhiqizo Olwenzekayo?

•Yebo, ukufaneleka kabusha kusadingeka

3. Izinto zokufaneleka kabusha

•Ngokusekelwe kwimibandela ethile, izinketho ezilandelayo ziyatholakala:

  • Ukufaneleka kabusha okugcwele
  • Asikho isidingo sokuqinisekiswa kabusha ngokomzimba noma kwe-microbial
  • Ukuqinisekiswa kokusebenza kwe-microbial encane

Izimfuneko zokufaneleka kabusha

a) Okulandelayo kufanele kubuyekezwe/kuhlolwe:
b) Noma ngabe ikhonaizinguquko ezibalulekile okuthinta ubunyumba bomkhiqizo kwenzeke ku-:

  • Umklamo womkhiqizo
  • Izinto zokwakha/zokupakisha
  • I-PCD (Process Challenge Device)
  • Abahlinzeki
  • Izindawo/izinsiza zokukhiqiza
  • Layisha ukucushwa noma izinqubo zokukhiqiza
    c)Ukuhlaziywa kwethrendi ye-Bioburden kwemikhiqizo;
    d) Nomaizifundo zokusabalalisa izinga lokushisa kanye nokusebenza kwesibulala-magciwane kukhombisa izinguquko ezibalulekile kusukela ekutholeni iziqu zokugcina;
    e) Nomaukusatshalaliswa kwezinga lokushisa kanye namasheke okubuyisela kabusha emakamelweni e-preconditioning noma ezindaweni zokungenisa umoya abonise izinguquko ezibalulekile kusukela ekutholeni iziqu zokugcina;
    f) Ukuthi i-ETO Sterilization umlando wokucubungula njengoba ukuqinisekiswa kokugcina kukhombisa ukukhiqiza kabusha;
    g) Nomashintsha ukulawula kanye namarekhodi okulondoloza okuvimbela qinisekisa ukuthi akukho ukuguqulwa kwemishini ethinta inqubo;
    h) Nomaazikho izinguquko kunqubo ye-ETO Sterilization okuthinta inzalo kwenzeke;
    i) UmaUkucaciswa kwenqubo ye-ETO Sterilization kushintshile, ukufaneleka kabusha kufanele kubandakanye ukuqinisekiswa kweImikhawulo yensalela ye-EO ukuhambisana nezidingo zokulawula.

Amazinga Okulawula

  • ISO 11135:2014 (Isiqephu 9.2: Imibandela yokufaneleka)
  • I-FDA 21 CFR 211.113 (Izilawuli zenqubo yokuvala inzalo)
  • I-EU GMP Isijobelelo 1:2022 (Isiqephu 8.5: Izidingo zokuqinisekisa)

I-ETO Sterilization Re-qualification Izidingo

Ukufaneleka kabusha kufanelehlanganisa ukubuyekezwa kokusebenza kwegumbi kanye nezinguquko zonyaka zobunjiniyela ukuze uqinisekise ukuthi imiphumela ye-IQ/OQ yasekuqaleni ihlala isebenza. Isibuyekezo kufanele sihlanganise:

  • Amaphrofayli wokushisa/womswakama wezoni preconditioning (uma kusebenza);
  • Amaphrofayela wangempela womswakama wegumbi elingenalutho;
  • Amazinga okushisa endaweni yomoya (uma kusebenza);
  • Ukwengeza, noma ngabe imininingwane yenqubo iyahlangatshezwa, ukuhlolwa kumele kucushwe yilokhu:
    • Imikhuba emibi ekusebenzeni kwemishini,
    • Ukuhluleka kokuzala;
    • Ukunquma ukuthi ukuqinisekiswa kabusha kuyaqinisekiswa yini.
  • Ochwepheshe bokuvala inzalo izochaza ububanzi bokudingekayoukuqinisekiswa kabusha ngokomzimba namagciwane ngokusekelwe emiphumeleni yokubuyekeza.

Ukucatshangelwa Okubalulekile Kokufaneleka Kabusha Kwenzalo

1. Ukusingatha Izinguquko Ezibalulekile

• Umaizinguquko ezinkulu zikhonjwa ngesikhathi sokufaneleka kabusha, kungase kudingeke kwenziwe kabusha i-IQ/OQ/PQ:

  • I-IQ (Ukufaneleka Kokufaka): Qinisekisa ukufakwa kwemishini elungisiwe/ukufakwa kwesofthiwe.
  • I-OQ (Ukufaneleka Kokusebenza): Hlola kabusha amapharamitha wokusebenza athintekile.
  • I-PQ (Ukufaneleka Kokusebenza): Qinisekisa kabusha ukusebenza kokuvala inzalo ngaphansi kwezimo ezintsha.

2. Izidingo Ezengeziwe Zokukhishwa Kwepharamitha

Ngezinsiza ezisetshenziswayoukukhululwa kwe-parametric (kuncike kwidatha yenqubo esikhundleni sokuhlolwa kwe-BI):
a)Imvamisa yokuqinisekisa kabusha: Kumele kwenziweokungenani njalo ngonyaka;
b)Ububanzi bokuqinisekisa kabusha: Kumele ihlanganiseizifundo ze-microbiological ukuqinisekisa:

Izimo Ezidinga Ukufaneleka Okugcwele (IQ/OQ/PQ):

a)Ukugcinwa okuyinhloko kwe-sterilizer;
b)Izinguquko zesakhiwo, indawo, noma imvelo;
c)Ukuhluleka kobunyumba okungachazeki;
d)Izinguquko ku-EO supply/delivery, diluent, noma ukulungiselelwa kokulayisha kwegumbi.

Ukukhululwa ekuqeqesheni kabusha ngokomzimba noma kwe-Microbial

Lapho lezi zimo ezilandelayo zifinyelelwa:

  • Azikho izinguquko emkhiqizweni, emaphaketheni, ezintweni zokusebenza/ezinsizeni, noma ezinqubweni;
  • Ukusebenza kwegumbi nokubuyekezwa kobunjiniyela bafanelekile;
  • Izinqubo zokuvala inzalo njalo asebenze ngokwethembeka phakathi nalesi sikhathi;
    ?Ukwahlulela kochwepheshe ingase inqume ukuthi ukufaneleka kabusha ngokomzimba noma kwe-microbialakudingekile kuze kube yisibuyekezo esilandelayo.

Ukufaneleka Kokusebenza Kwezinto Ezincane Ezilinganiselwe

•Kungase kudingeke ezimweni ezithile, njenge:

  • Ukuqinisekisa ukuqhubeka kokufaneleka kwama-BI ngokuphathelene nomthwalo wezinto eziphilayo zomkhiqizo;
  • Ukunikeza ubufakazi bokuthi chaizinguquko ezingahlosiwe kwenzeke kusukela ocwaningweni lwangaphambilini (kabusha) lweziqu ngemuva kwesikhawu sesikhathi esichaziwe.
    •Izidingo ezijwayelekile (okungenani):
  • Eyodwaukugijima komjikelezo omfushane noma uhhafu womjikelezo;
  • Kuhlanganisaizinga lokushisa kanye nomswakama izilinganiso wezinto ezifakwe inzalo.

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