Izitsha ze-Endotoxin Challenge (Inkomba ye-Endotoxin)

 Izitsha ze-Endotoxin Challenge (Inkomba ye-Endotoxin)

1. Ulwazi Lomkhiqizo

II-Endotoxin Challenge Vial(ECV，Endotoxin Indicator) isetshenziswa ekuqinisekiseni ukushisa okomile depyrogenation imijikelezo.I-Endotoxin Challenge Vials ibekwa ezindaweni ezibandayo kuhhavini wokushisa owomile.Ngemva kokuphothulwa komjikelezo, ukuncipha kwelogi kumazinga e-endotoxin kunganqunywa ngokuqhathanisa amazinga e-endotoxin kuzikhombisi ze-Endotoxin ezibhakiwe vs ezingaphekiwe.Izitsha ze-Endotoxin Challenge zenzelwe ukukhombisa ukuncishiswa kwamalogi angu-3 kokuqukethwe kwe-endotoxin lapho ihlolwa kusetshenziswa ikhithi yokuhlola ye-gel clot endotoxin, ikhinetic turbidimetric endotoxin assay kit noma ikhithi yokuhlola ye-chromogenic Lyophilized Amebocyte Lysate.I-Endotoxin Challenge Vial iqukethe izinga le-Endotoxins le-1000 kuya ku-10000EU kubhodlela lengilazi.I-ECV1250V kanye ne-ECV2500V zivalwe ezitsheni ezilungisa izivalo ezimelana nokushisa namalebula amelana nokushisa, ezingafakwa kuhhavini oshisayo noma emhubheni wokushisa owomile ngaphandle kokususwa kwezivalo namakepisi (isivalo).

Ukuqinisekiswa komjikelezo wokushisa omisiwe (imijikelezo)kudingwa yimithethonqubo ye-ANSI, AAMI, ISO, USP kanye ne-FDA ukuqinisekisa ukuthi zonke izinto ezidingeka ukuthi zingabi namagciwane noma zingabi ne-endotoxin ziyakwazi ukuvalwa inzalo ngokungaguquki nangokuthembekile ukuze kuncishiswe ithuba lokwethula noma lokusabalalisa i-micro-organism ethathelwanayo. noma ama-pyrogens.

Landela imfuneko yeMithetho, sebenzisa i-Bioendo ECV iyakwazi ukusebenzisa ukuqinisekiswa kwamahhala kwe-endotoxin noma ukuqinisekiswa kwamahhala kwe-pyrogen.Ulwazi olubaluleke kakhulu ukuthi i-Bioendo ECV ayidingi ukususwa kwesivalo senjoloba emsebenzini wokushisisa.

2. Ipharamitha yomkhiqizo

Amandla: 1000 kuya ku-10000 EU ngevial ​​ngayinye kanye ne-2000 kuya ku-10000 EU ku-vial.

3. Izici Zomkhiqizo kanye Nokusebenza

Ku-vial enesivalo esimelana nokushisa(izinga lokushisa eliphakeme elibekezelelekayo lifika ku-360 degrees Celsius)kanye nelebula elikwazi ukumelana nokushisa.

Enkambweni yokubhaka noma yomiswe, isivalo se-ECV vial asikho isidingo sokusikhipha.

Ngaphandle kwe-excipient.

I-Endotoxin inselele i-vial, ezinqubweni zokusebenza, i-reagent ye-lysate kufanele ihambisane nekhithi ye-ECV, futhi asikho isidingo sokususa ukukhanya ngesikhathi sokubhaka.