I-Parametric Release kanye ne-Sterile Product Release Protocols
Ukunemba okuphezulu kwe-EO Sterilization Chamber for Parametric Release Compliance.
1. Amakhono Okuqapha Okukhishwa KweParametric
Ngokuvumelana ne I-GB/Z 44877-2024 futhi I-GB 18279-2023, okokusebenza okusetshenziselwa ukukhishwa kwepharamitha kufanele kudlule amandla okuqapha ajwayelekile. Lokhu kuhlanganisa:
- Ukuqapha ukugeleza komoya: Ukufakwa okuphoqelekile kwamadivayisi omjikelezo womoya kanye nama-anemometers emakamelweni angaphambi kokupholisa, ukuvala inzalo, kanye nasekamelweni.
- Ukuswakama Okuqondile: Ukulinganisa kwesikhathi sangempela phakathi nesigaba sokwelashwa.
- I-EO Concentration: Ukulinganisa okuqondile kuzo zonke izikhawu ezidingekayo phakathi nokuchayeka.
- Amaphuzu Okushisa Okubili: Okungenani izindawo ezimbili zezinzwa ezizimele ezimele isimo segumbi.
1.1 Ubuchwepheshe Bezinzwa & Ukulinganisa
Ukukala Umswakama
Kukalwa nge Ifilimu ye-Capacitance (Umswakama Ohlobene) noma I-Spectroscopy (Absolute Humidity). Izinzwa kufanele zilinganiswe kusetshenziswa izixazululo zikasawoti ogcwele futhi zivikelwe ekukhukhuleni okubangelwa yi-EO ngokuqinisekiswa njalo noma ukuhlukaniswa okushisayo.
Ukuswakama Okudidiyelwe kanye ne-EO Concentration Monitoring Systems.
I-EO Concentration (Spectroscopy & GC)
Ukunemba nokunemba kufanele kubhalwe phansi. I-IR Spectroscopy (Ukumuncwa kwe-infrared) noma I-Gas Chromatography (GC) izindlela ezijwayelekile. Imigqa yamasampula yangaphandle kufanele isetshenziswe Ukulandelela Ukushisa ukuvimbela ukujiya.
2. Ukukhishwa Okuyinyumba Kwemikhiqizo (Isahluko 11)
2.1 Umbandela Wokukhishwa KweParametric
Ukukhishwa okuyinyumba okujwayelekile kusekelwe kuphela amapharamitha wokucubungula ngokomzimba ukuhlangabezana nezidingo ezimisiwe ngesikhathi sokuqinisekisa. Ngokungafani nezindlela zendabuko, ayincikile emiphumeleni yokuhlola ye-Biological Indicator (BI). Ukubuyekezwa okubhaliwe okwenziwa ngabasebenzi abagunyaziwe kuyisibopho.
Ukubuyekezwa Okubhaliwe kanye Nokulawulwa Kwepharamitha Engokoqobo Yokukhishwa Kweqoqo.
2.2 Ubuqotho benzwa nokunemba
Uma izinzwa zokulawula noma zokuqapha zehluleka ukuhlangabezana nezicaciso, noma uma uphenyo lungakwazi ukuqinisekisa ukunemba kokufundwa kwegumbi, umthwalo kumele uthathwe njengokungathobeli.
3. Ukuchezuka kanye Nophenyo
3.1 Ukuphatha Idatha Engaphandle Kokucaciswa (OOS).
Uma amapharamitha eqa imikhawulo, uphenyo kufanele lunqume umsuka wembangela. Imikhiqizo kufanele ibekwe yodwa kuze kuphothulwe ukuhlolwa kokuphepha.
Layisha izici: Uma i-EO noma idatha yomswakama iyi-OOS kuyilapho izilawuli zivamile, hlola ukulayisha iphethini. Umehluko ekumunceni uma kuqhathaniswa nomthwalo wokuqala we-PQ ungase ube yimbangela.
3.2 Izenzo Zokulungisa Nokukhululwa kabusha
Uma inzwa yehluleka, inqubo ingase ibuyele kuyo okwesikhashana Ukukhishwa Kwesikhombi Sebhayoloji ngesikhathi sokulungiswa. Ukukhishwa kwepharamethri kungaqaliswa kabusha kuphela ngemva kokulungiswa kwemishini nokulinganisa kabusha.
Ukulinganisa Nokugcinwa Ukuqinisekisa Ukunemba Kwenzwa Yokukhishwa Okuqhubekayo KweParametric.
Inothi Elibalulekile: Inqubo eyehluleka ukucaciswa kokukhishwa kwepharamitha akufanele ikhishwe ngokusekelwe emiphumeleni ye-BI eyimpumelelo. Ngaphezu kwalokho, ukukhishwa kwepharamitha akukwazi ukusetshenziselwa ukubhala ngaphezulu ukuhlolwa kwe-BI okuhlulekile.