Izidingo zobuchwepheshe zokukhishwa kweParametric ku-EO Sterilization
Imihlahlandlela esekelwe ku-GB/Z 44877-2024 kanye ne-GB 18279-2023
1. Ukulawula Izisetshenziswa kanye Namakhono Okuqapha
Ngokungeziwe kuzimfuneko ze-GB 18279-2023 Isahluko 10, okokusebenza kufanele kube namakhono alandelayo okuqapha ukuze kukhishwe ipharamitha:
- Ukuphathwa kokugeleza komoya: Amakamelo okufaka umoya opholile ngaphambi kwesikhathi, izibulala magciwane, kanye namakamelo okufaka umoya kufanele afakwe izinto zokuhambisa umoya, ama-anemometer, noma ezinye izinyathelo zokuqapha ukugeleza komoya kwangaphakathi.
- Umswakamo: Isilinganiso esiqondile somswakama wegumbi phakathi nesigaba sokwelashwa.
- Ukugxila: Isilinganiso esiqondile sokugxila kwe-Ethylene Oxide (EO) ngezikhathi ezithile phakathi nokuchayeka.
- Izinga lokushisa: Ukuqapha okungenani izindawo ezimbili ezizimele ngaphakathi kwegumbi.
Zonke izinhlelo zokuqapha nokurekhoda kufanele zichazwe, ziphawulwe, futhi zibhalwe phansi. Ukubekwa kwenzwa kufanele kumelele isimo segumbi sangempela.
2. Ukucaciswa Kwepharamitha Ebalulekile
2.1 Ukuqapha Umswakama
Umswakamo ungalinganiswa Njengokuswakama Okuhlobene (RH) noma Umswakamo Ophelele.
- Umswakama Ohlobene: Ikalwa ngokujwayelekile kusetshenziswa ubuchwepheshe befilimu ye-capacitance ukunquma ukuminyana komfutho womhwamuko ezingeni lokushisa elinikeziwe.
- Umswakamo Ophelele: Ikala ukugcwala kwamanzi ngevolumu ethile yomoya, ngokuvamile isebenzisa amasu e-spectroscopic.
- Ukulinganisa: Izinzwa ze-Electronic RH (ifilimu yamandla) kufanele zilinganiswe kusetshenziswa izixazululo zikasawoti ogcwele noma amasistimu okukhiqiza i-RH aqinisekisiwe.
Qaphela: Ukuchayeka kwe-EO kubangela ukunemba ukukhukhuleka. Ukuqinisekisa njalo noma ukulinganisa kuyadingeka. Uma kusetshenziswa izinzwa ezingazodwa, ukushisa noma ukufakwa kwe-insulation kumele kufakwe ukuvimbela ukufiphala kwangaphakathi.
2.2 I-Ethylene Oxide (EO) Ukugxila
Ukunemba nokunemba kwesistimu yokulinganisa ye-EO kufanele kubhalwe phansi. Kusetshenziswa izindlela ezimbili eziyinhloko:
| Ubuchwepheshe | Indlela |
|---|---|
| I-Spectroscopy (IR) | Ikala ukumuncwa kokukhanya kwe-infrared ngama-molecule e-EO. |
| I-Gas Chromatography (GC) | Ihlukanisa i-EO ngekholomu futhi ilinganise ukugxila ngejika elijwayelekile. |
Ngezilinganiso ezithathwe ngaphandle kwegumbi, izici ezengeziwe kufanele zibhekwe:
- Ubude bepayipi nokuhambisana kwezinto (isb., amabanga athile ensimbi engagqwali).
- Ukuvuza okungenzeka ezindaweni zokuxhuma.
- Ukulandelela Ukushisa: Ukufakwa kwamasampula olayini ukuze kuncishiswe ingozi yokufiphala kwe-EO noma umhwamuko wamanzi.
- Ukukhishwa kwemishini (amaphampu noma abalandeli) kusuka ekamelweni.
2.3 Ukuqapha izinga lokushisa
Ukuvumelana kumathuluzi adingekayo kukho kokubili ukukhishwa kwenkomba ye-parametric kanye ne-biological. Ukukhishwa kwepharamethikhi kudinga okungenani izindawo ezimbili ezizimele zokuqapha.
Uma idatha ilinganiselwe, zonke izinzwa kufanele zibe zohlobo olufanayo (isb., Thermocouples, RTDs, noma Pt100) ezinokunemba okufanayo kanye nokunemba kokucaciswa.
3. Incazelo Yenqubo kanye Neziqu Zokusebenza (PQ)
3.1 Ukusungulwa Kwemininingwane
Imininingwane yomswakama kanye nokugxila kwe-EO isungulwa ngokuhlaziywa kwedatha etholwe ngesikhathi sokuthuthukiswa kwenqubo noma i-PQ.
- Ubuncane bokucaciswa: Isungulwe ngezifundo ze-PQ ezincane nezingokwenyama ukuze kuqinisekiswe Izinga Lokuqinisekisa Ukuzala (SAL).
- Ubuningi bokucaciswa: Isungulwe ukuze kuqinisekiswe ukuphepha komkhiqizo, ikhwalithi, nokusebenza kuyilapho kunciphisa izinsalela ze-EO (nge-GB/T 16886.7 ngayinye).
3.2 Imijikelezo ye-PQ eyengeziwe
Ukukhishwa kwepharamethri kungase kudinge imijikelezo yokufaneleka eyengeziwe ukuze kusungulwe amapharamitha enqubo afanelekile nokubekezelelana. Lokhu kuhlanganisa:
- Amabhayisikili at imikhawulo ephansi yamapharamitha wenqubo (umswakama, izinga lokushisa, i-EO) ukuze kuqinisekiswe ubunyumba.
- Amabhayisikili at imikhawulo ephezulu ukuhlola ukusebenza komkhiqizo/ukupakishwa kanye namazinga asala e-EO.