ʻO nā mea hoʻohana ʻole pyrogen he mau mea hoʻohana me ka ʻole o ka endotoxin exogenous, me nā ʻōlelo aʻoaʻo paipu pyrogen-free (tip box), pyrogen-free tube test a i ʻole i kapa ʻia he endotoxin free glass tubes, pyrogen-free glass ampoules, endotoxin-free 96-well microplates, a me endotoxin- wai manuahi (ka hoʻohana ʻana i ka wai depyrogenated i ka hoʻāʻo endotoxin bacterial), endotoxin free buffer a me nā mea ʻē aʻe. ia lakou, ka wai no ka bacterial endotoxintest ma ka gel clot method and quantitative endotoxin test assay in the all related Pharmacopoeia editions (USP, EP, BP, JP and China Pharmaceutica). E pili ana i ka wai maʻemaʻe no ka injection me ka ʻike endotoxin ma lalo o 0.015EU/ml. ʻO kēia ka mana hou loa o Pharmacopoeia, ʻo ka wai BET ma lalo o 0.005EU/ml. ʻO ke kūlana kiʻekiʻe loa ma lalo o 0.001EU / ml hiki ke hana a hoʻolako ʻia e Bioendo.
Hāʻawi ka wehewehe ʻana i kahi kikoʻī kikoʻī o nā mea hoʻohana ʻole pyrogen-free a me kā lākou mau noi, e koʻikoʻi ana i kā lākou kuleana koʻikoʻi i ka hoʻāʻo endotoxin ma waena o nā kūlana pharmacopoeia. Eia kahi hōʻuluʻulu o nā mea nui:
- Wehewehe:
- ʻO nā mea hoʻohana ʻole Pyrogen he mau mea me ka ʻole o nā endotoxins exogenous, me:
- Pyrogen-free pipette tips(pahu pahu).
- ʻO nā paipu hoʻāʻo ʻole Endotoxin a i ʻole nā paipu aniani.
- ʻO nā ampoules aniani ʻole Endotoxin.
- ʻO nā microplates 96-well ʻole Endotoxin.
- ʻO ka wai ʻole Endotoxin (wai depyrogenated).
- Hoʻopaʻa ʻole Endotoxin.
- ʻO nā mea hoʻohana ʻole Pyrogen he mau mea me ka ʻole o nā endotoxins exogenous, me:
- ʻO ka wai no ka hoʻāʻo ʻana i ka Endotoxin Bacterial (BET):
- Hoʻohana ʻia i nā ʻano gel clot a me nā hoʻokolohua endotoxin quantitative e like me nā kūlana USP, EP, BP, JP, a me China Pharmacopeia.
- ʻO ke kūlana mua: ≤0.015 EU / ml no ka wai maʻemaʻe no ka injection.
- Koi o kēia manawa (pharmacopoeia hou loa): ≤0.005 EU/ml no ka wai BET.
- Kūlana kiʻekiʻe: Hiki i ka Bioendo ke hana i ka wai me ≤0.001 EU / ml endotoxin content, e hālāwai ana i nā koi kiʻekiʻe loa.
Manaʻo no ka hoʻomaʻemaʻe:
- Hoʻoikaika i ka laulā noi, e laʻa, nā hale hana, nā lāʻau lapaʻau, a i ʻole biotech.
- E hāʻawi i nā kikoʻī hou aku e pili ana i ka ʻike o Bioendo i ka hana ʻana e hoʻoikaika i kona pae hoʻokūkū.
- E hōʻike i nā pono kikoʻī o nā huahana kūlana kiʻekiʻe a Bioendo, e like me ka hoʻonui ʻana i ka pololei o ka hoʻāʻo ʻana a i ʻole ka hoʻokō hoʻoponopono.
Makemake ʻoe iaʻu e kōkua i ka hana ʻana i kēia i kahi huahana kūlana a i ʻole ka wehewehe ʻenehana?
ʻO nā huaʻōlelo koʻikoʻi e pili ana i nā endotoxins, a me nā endotoxin free consumables, pyrogen a me nā kumu wela ʻelua mau manaʻo like ʻole.Pyrogen: Ua kapa ʻia ʻo pyrogen a i ʻole exothermic factor. nā mea hiki ke hoʻonui i ka wela o ke kino.Puna Wela: He mea e hoopuka ana i ka wela. E like me ka puhi ʻana i nā pāʻani, ka lanahu, a me nā mea ʻē aʻe. ʻO nā mea i kapa ʻia ʻo "non-pyrogenic consumables" a me "pyrogenic pane" o kekahi mau mea hana a me nā mea kūʻai aku, he mau inoa hewa ʻole a hoʻopunipuni. Pono nā mea pololei i "Pyrogen Free" a me "Pyrogen Response".
No ke aha e pono ai ka Pyrogen free consumables i ka ho'āʻo hoʻāʻo endotoxin, ʻelua hoʻāʻo hoʻāʻo ʻana o ka gel clot endotoxin a me quantitative endotoxin test assay?
ʻAe, pono nā mea hoʻohana ʻole pyrogen-free no ka hana ʻana i ka endotoxin test assay me ka pololei a me ka hilinaʻi. hoʻāʻo endotoxin, ʻike mau ʻia ʻo ka hoʻāʻo Limulus amebocyte lysate (LAL) a i kapa ʻia ʻo Lyophilized amebocyte lysate (LAL), hoʻohana ʻia e ʻike a helu i ka loaʻa ʻana o nā endotoxins bacteria i nā lāʻau lapaʻau, nā lāʻau lapaʻau, a me nā huahana ʻē aʻe. Ke hilinaʻi nei ka ho'āʻo LAL i ka hopena ma waena o ka LAL reagent a me nā endotoxins e hana i ka clotting a iʻole ka pane chromogenic. Hiki i nā pyrogens ke hoʻohaumia i nā ʻano mea hoʻokolohua like ʻolenā ipu aniani, nā ʻōlelo aʻoaʻo pipette, nā paipu, a me nā ipu laʻana. Inā hele mai nā mea hoʻohana i hoʻohaumia i ka pyrogen me ka LAL reagent a i ʻole nā mea ho'āʻo, hiki iā lākou ke hoʻoulu i nā hopena maikaʻi ʻole, e alakaʻi ana i nā manaʻo kuhi hewa e pili ana i ka hele ʻana a i ʻole ka pae ʻana o nā endotoxins. ka loaʻa ʻana o nā pyrogens. Hana lākou i nā kaʻina hana hoʻomalu maikaʻi e hōʻoia e hoʻokō lākou i nā kūlana i koi ʻia no ka hoʻāʻo endotoxin. ʻO ka hoʻohana ʻana i kēia mau mea hoʻohana kūikawā e kōkua i ka mālama pono a me ka pololei o ka hoʻāʻo endotoxin test assay, e hōʻoiaʻiʻo ana i nā hopena hilinaʻi a me ka hoʻolaha ʻana i ka palekana maʻi i nā lāʻau lapaʻau a me nā noi biomedical.
Ka manawa hoʻouna: Nov-07-2022