ʻO nā pahu hoʻokūkū Endotoxin (Endotoxin Indicator)

 ʻO nā pahu hoʻokūkū Endotoxin (Endotoxin Indicator)

1. ʻIke huahana

ʻO kaʻO ka pahu hoʻokūkū Endotoxin(ECV，Endotoxin Indicator) hoʻohana ʻia i ka hōʻoia ʻana i nā pōʻai depyrogenation wela maloʻo.Hoʻokomo ʻia nā pahu Endotoxin Challenge ma nā wahi anu o ka umu wela maloʻo.Ma hope o ka pau ʻana o ka pōʻai, hiki ke hoʻoholo ʻia ka emi ʻana o ka lāʻau i nā pae endotoxin ma ka hoʻohālikelike ʻana i nā pae endotoxin i loko o nā mea hōʻike Endotoxin baked vs ʻaʻole baked.Hoʻolālā ʻia nā hue Endotoxin Challenge e hōʻike i kahi hōʻemi liʻiliʻi he 3-log i loko o ka ʻike endotoxin ke hoʻāʻo ʻia me ka hoʻohana ʻana i ka pahu hoʻāʻo ʻana o ka gel clot endotoxin assay kit, kinetic turbidimetric endotoxin assay kit a i ʻole chromogenic Lyophilized Amebocyte Lysate assay kits.Loaʻa iā Endotoxin Challenge Vial he 1000 a 10000EU Endotoxins pae i loko o kahi hue aniani.Hoʻopaʻa ʻia ʻo ECV1250V a me ECV2500V i loko o nā hue e hoʻonohonoho i nā pani pale wela a me nā hōʻailona pale wela, hiki ke waiho ʻia i loko o ka umu wela maloʻo a i ʻole ka lua wela maloʻo me ka wehe ʻole ʻia o nā pani a me nā pāpale (poʻi).

'O ka hō'oia 'ana o ka pō'ai ho'oma'ema'e wela malo'o.koi ʻia e nā lula o ANSI, AAMI, ISO, USP a me FDA e hōʻoia i nā mea āpau i koi ʻia e sterile a i ʻole endotoxin-free hiki ke hoʻopaʻa ʻia a hilinaʻi ʻia e hōʻemi i ka manawa o ka hoʻolauna ʻana a hoʻolaha ʻana i kahi micro-organism infectious. a i ʻole nā ​​pyrogens.

E hahai i nā koi o nā lula, e hoʻohana i ka Bioendo ECV hiki ke hana i ka endotoxin free validation a i ʻole pyrogen free validation.ʻO ka ʻike koʻikoʻi ʻoi aku ka Bioendo ECV ʻaʻole pono e wehe ʻia ke poʻi (kapi) i ka hana hoʻomehana.

2. Lahui Huahana

ʻO ka mana: 1000 a 10000 EU no ka vial a me 2000 a 10000 EU i loko o kahi hue.

3. Nā hiʻohiʻona huahana a me ka noi

I loko o ka hue me ka mea pani pale wela(hiki i ka wela kiʻekiʻe a hiki i 360 Celsius degere)a me ka lepili pale wela.

I ke kaʻina hana o ka kuke ʻana a i ʻole ka hoʻomaloʻo ʻana, ʻaʻole pono e wehe ke poʻi o ECV vial.

Me ka ʻole o ka excipient.

ʻO ka pahu hoʻāʻo Endotoxin, i nā kaʻina hana, pono ka lysate reagent e kūlike me ka pahu ECV, a ʻaʻole pono e wehe i ke kukui i ka wā o ka hana ʻana.