Endotoxin Challenge Vials (Qhov taw qhia Endotoxin)

 Endotoxin Challenge Vials (Qhov taw qhia Endotoxin)

1. Cov ntaub ntawv khoom

CovEndotoxin Challenge Vial(ECV, Endotoxin Indicator) yog siv nyob rau hauv lub validation ntawm qhuav tshav kub depyrogenation mus.Endotoxin Challenge Vials tau muab tso rau hauv qhov chaw txias ntawm qhov cub qhuav kub.Tom qab lub voj voog ua tiav, cov cav txo qis hauv cov qib endotoxin tuaj yeem txiav txim siab los ntawm kev sib piv cov qib endotoxin hauv cov khoom ci thiab tsis ci Endotoxin Cov Ntsuas.Endotoxin Challenge vials yog tsim los qhia qhov tsawg kawg nkaus 3-log txo qis hauv cov ntsiab lus endotoxin thaum kuaj siv gel clot endotoxin assay kit, kinetic turbidimetric endotoxin assay kits lossis chromogenic Lyophilized Amebocyte Lysate assay kits.Endotoxin Challenge Vial muaj 1000 txog 10000EU Endotoxins qib hauv iav vial.ECV1250V thiab ECV2500V tau ntim rau hauv vials uas teeb tsa cov khoom siv hluav taws xob tiv thaiv hluav taws xob thiab cov ntawv tiv thaiv tshav kub, uas tuaj yeem muab tso rau hauv qhov cub qhuav los yog qhov chaw qhuav cua sov yam tsis muaj kev tshem tawm cov nres thiab lub hau (lub hau).

Validation ntawm qhuav cua sov sterilization voj voogyuav tsum tau ua los ntawm cov kev cai ntawm ANSI, AAMI, ISO, USP thiab FDA los xyuas kom meej tias txhua yam khoom uas yuav tsum tau ua kom tsis muaj menyuam lossis endotoxin tsis muaj peev xwm ua kom tsis tu ncua thiab ntseeg tau kom tsis muaj menyuam kom txo tau txoj hauv kev qhia lossis kis kab mob sib kis. los yog pyrogens.

Ua raws li Txoj Cai Lij Choj, siv Bioendo ECV muaj peev xwm ua haujlwm rau endotoxin dawb validation lossis pyrogen dawb validation.Cov ntaub ntawv tseem ceeb tshaj plaws yog Bioendo ECV tsis tas yuav tshem tawm lub hau roj hmab (cap) hauv kev ua haujlwm cua sov.

2. Khoom Parameter

Lub peev xwm: 1000 txog 10000 EU ib vial thiab 2000 txog 10000 EU hauv ib lub vial.

3. Khoom nta thiab daim ntawv thov

Nyob rau hauv vial nrog kub resistant stopper(siab kub siab txog 360 degrees Celsius)thiab kub resistant daim ntawv lo.

Hauv cov txheej txheem ntawm ci lossis ziab, ECV vial lub hau tsis tas yuav tshem tawm.

Tsis muaj excipient.

Endotoxin kev sib tw vial, hauv cov txheej txheem ua haujlwm, cov lysate reagent yuav tsum ua kom haum rau cov khoom siv ECV, thiab tsis tas yuav tshem lub teeb thaum lub sijhawm ci.