Izinto ezisetshenziswayo ezingena-pyrogen ziwuketshezi ngaphandle kwe-endotoxin yangaphandle, okuhlanganisa namathiphu e-pipette angenayo i-pyrogen (ibhokisi lethiphu), amashubhu okuhlola angenayo i-pyrogen noma abizwa ngamashubhu engilazi angenayo i-endotoxin, ama-ampoule engilazi angenayo i-pyrogen, ama-microplates angenayo i-endotoxin-free 96-well, kanye ne-endotoxin- amanzi amahhala (ukusetshenziswa kwamanzi ane-depyrogenated ekuhlolweni kwe-bacterial endotoxin), I-endotoxin free buffer nokunye. Phakathi kwazo, amanzi e-endotoxintest ye-bacterial by gel clot method kanye ne-quantitative endotoxin test assay kukho konke okuhlobene ne-Pharmacopoeia editions (USP, EP, BP, JP kanye ne-China Pharmaceutica) . Isho amanzi angenalutho omjovo anokuqukethwe kwe-endotoxin ngaphansi kuka-0.015EU/ml. Manje inguqulo yakamuva ye-Pharmacopoeia, amanzi e-BET angaphansi kuka-0.005EU/ml. Ngisho nezinga eliphakeme kakhulu lingaphansi kuka-0.001EU/ml liyakwazi ukukhiqizwa futhi lihlinzekwe yi-Bioendo.
Incazelo ihlinzeka ngemininingwane eningiliziwe yezinto ezisetshenziswayo ezingena-pyrogen nezicelo zazo, ikakhulukazi igcizelela indima yazo ebalulekile ekuhlolweni kwe-endotoxin kuwo wonke amazinga e-pharmacopoeia ahlukahlukene. Nasi isifinyezo samaphuzu abalulekile:
- Incazelo:
- Izinto ezisetshenziswayo ezingena-Pyrogen yizinto ezingenawo ama-endotoxin angaphandle, okuhlanganisa:
- Amathiphu e-pipette angenayo i-Pyrogen(ithiphu ibhokisi).
- Amashubhu okuhlola angenayo i-endotoxin noma amashubhu engilazi.
- Ama-ampoules engilazi angenayo i-endotoxin.
- Ama-microplates angenayo i-Endotoxin-free 96-well.
- Amanzi angenayo i-endotoxin (amanzi ane-depyrogenated).
- Amabhafa angenayo i-endotoxin.
- Izinto ezisetshenziswayo ezingena-Pyrogen yizinto ezingenawo ama-endotoxin angaphandle, okuhlanganisa:
- Amanzi Okuhlola I-Endotoxin Yegciwane (BET):
- Isetshenziswa ezindleleni zehlule lejeli kanye nokuhlolwa komthamo we-endotoxin ngokwamazinga e-USP, EP, BP, JP, kanye ne-China Pharmacopeia.
- Izinga langaphambilini: ≤0.015 EU/ml emanzini angenalutho omjovo.
- Imfuneko yamanje (i-pharmacopoeia yakamuva): ≤0.005 EU/ml yamanzi e-BET.
- Izinga elithuthukisiwe: I-Bioendo ingakhiqiza amanzi anokuqukethwe kwe-endotoxin engu-≤0.001 EU/ml, ehlangabezana nezimfuneko zekhwalithi ephezulu kakhulu.
Iziphakamiso zokucwengisiswa:
- Gcizelela ububanzi bokufaka isicelo, isb, amalabhorethri, imithi, noma i-biotech.
- Nikeza imininingwane eyengeziwe ngobungcweti be-Bioendo kwezokukhiqiza ukuze kuqiniswe umkhawulo wayo wokuncintisana.
- Gqamisa izinzuzo ezithile zemikhiqizo esezingeni eliphezulu ye-Bioendo, njengokunemba okuthuthukisiwe kokuhlolwa noma ukuthobela imithetho.
Ungathanda ukuthi ngikusize ngenze lokhu kube umkhiqizo osemthethweni noma incazelo yobuchwepheshe?
Amagama angukhiye ahlobene we-endotoxins, kanye ne-endotoxin engasetshenziswa mahhala, imithombo ye-pyrogen neyokushisa imiqondo emibili ehluke ngokuphelele:I-Pyrogen: Ibizwa nangokuthi i-pyrogen noma i-exothermic factor. izinto ezingabangela ukwanda kokushisa komzimba.Umthombo Wokushisa: Into ekhipha ukushisa. Okufana nomentshisi ovuthayo, amalahle, njll.Okubizwa ngokuthi "izinto zokusetshenziswa ezingezona ze-pyrogenic" kanye "nempendulo ye-pyrogenic" yabanye abakhiqizi nabathengisi empeleni amagama angenamsebenzi kakhulu futhi adukisayo. Okufanelekile kufanele kube "I-Pyrogen Free" kanye "Nempendulo Ye-Pyrogen".
Kungani izinto ezisetshenziswayo ezingenaPyrogen zidingekile ekuhlolweni kokuhlolwa kwe-endotoxin, kokubili ukuhlolwa kokuhlolwa kwehlule lejeli endotoxin kanye nokuhlolwa komthamo we-endotoxin?
Yebo, izinto ezisetshenziswayo ezingenayo i-pyrogen zibalulekile ekwenzeni ukuhlolwa kokuhlolwa kwe-endotoxin ngokunembile nangokuthembekile.Ukuba khona kwama-pyrogens, okuyizinto ezibangela umkhuhlane ngokuvamile eziphuma kuma-endotoxin amagciwane, kungaphazamisa imiphumela yokuhlolwa futhi kuholele ekufundweni okungamanga. ukuhlolwa kwe-endotoxin, okuvame ukubizwa ngokuthi yi-Limulus amebocyte lysate (LAL) noma okubizwa nge-Lyophilized i-amebocyte lysate (LAL) test, isetshenziselwa ukuthola kanye nokulinganisa ubukhona be-endotoxin yebhaktheriya kwezemithi, emishinini yezokwelapha, nakweminye imikhiqizo. Ukuhlolwa kwe-LAL kuncike ekuphenduleni phakathi kwe-reagent ye-LAL nama-endotoxins ukuze kukhiqizwe ukujiya noma impendulo ye-chromogenic. Ukuze kuqinisekiswe imiphumela enembile, kubalulekile ukusebenzisa izinto ezidlekayo ezingenawo ama-pyrogens. Ama-pyrogens angangcolisa izinto ezahlukahlukene zaselabhorethri, kufaka phakathii-glassware, amathiphu e-pipette, amashubhu, neziqukathi zesampula. Uma izinto ezisebenzisekayo ezingcoliswe i-pyrogen zithintana ne-reagent ye-LAL noma amasampula okuhlola, zingadala ukusabela okungelona iqiniso, okuholela eziphethweni eziyiphutha mayelana nokuba khona noma ukugcwala kwe-endotoxins. Izinto ezisetshenziswayo ezingena-pyrogen ziyakhiqizwa futhi zihlolwe ngokukhethekile ukuze kuncishiswe noma kuqedwe ukuba khona kwama-pyrogens. Babhekana nezinqubo eziqinile zokulawula ikhwalithi ukuze baqinisekise ukuthi bahlangabezana namazinga adingekayo okuhlolwa kwe-endotoxin. Ukusebenzisa lezi zinto ezisetshenziswayo ezikhethekile kusiza ukugcina ubuqotho nokunemba kokuhlolwa kokuhlolwa kwe-endotoxin, ukuqinisekisa imiphumela enokwethenjelwa kanye nokukhuthaza ukuphepha kwesiguli ekusetshenzisweni kwemithi kanye ne-biomedical.
Isikhathi sokuthumela: Nov-07-2022
