ʻO ka papahana Cleanroom e pili ana i ka hoʻokuʻu ʻana o nā mea haumia e like me microparticles, ea ʻino, bacteria, etc. Kapa mākou i ke kaʻina hana kaiapuni e like me ka papahana lumi maʻemaʻe. ʻO kahi papahana lumi hoʻomaʻemaʻe piha e pili ana i nā ʻano ʻē aʻe, me nā ʻāpana ʻewalu: ʻōnaehana hoʻonaninani a mālama ʻia, ʻōnaehana HVAC, ventilation a me nā ʻōnaehana hoʻopau, ʻōnaehana pale ahi, ʻōnaehana uila, ʻōnaehana pipeline kaʻina, ʻōnaehana hoʻokele aunoa a me ka lako wai a me ka ʻōnaehana wai. Hoʻohui ʻia kēia mau ʻāpana i ka ʻōnaehana piha o ka papahana lumi maʻemaʻe e hōʻoia i kāna hana a me ka hopena.
1. Pūnaehana Clenroom
(1). ʻōnaehana hale hoʻonani a mālama
ʻO ka loulou hoʻonaninani a me nā mea hoʻonaninani o ka papahana lumi maʻemaʻe e pili ana i ka hoʻonaninani kikoʻī o ka ʻōnaehana o ka hale paʻa e like me ka lepo, ke kaupaku a me ka pā. ʻO ka pōkole, uhi kēia mau ʻāpana i nā ʻāpana ʻeono o ke ākea ākea ʻekolu, ʻo ia hoʻi ka luna, ka paia a me ka lepo. Eia kekahi, komo pū kekahi i nā puka, nā puka makani a me nā mea hoʻonaninani ʻē aʻe. ʻOkoʻa mai ka hoʻonaninani hale maʻamau a me ka hoʻonaninani ʻoihana, ʻoi aku ka nānā ʻana o ka papahana maʻemaʻe i nā kūlana hoʻonaninani kikoʻī a me nā kikoʻī e hōʻoia i ka hoʻokō ʻana o ka lumi i nā kūlana maʻemaʻe a me ka maʻemaʻe.
(2). Pūnaehana HVAC
Uhi ia i ka chiller (wai wela) wae (me ka pauma wai, hale hooluolu, etc.) a me ka ea-cooled pipe machine level a me na mea hana e ae, air conditioning pipeline, hui hoomaemae ea pahu pahu (me ka hui kahe ana, ka mahele hopena mua, ka pauku wela, ka pauku pahu hau, ka pauku dehumidification, ka pauku pressurization, ka pauku hopena waena, ka pauku kaomi static, etc.)
(3). Pūnaehana hoʻoheheʻe a me ka hoʻopau
ʻO ka ʻōnaehana ventila he hoʻonohonoho piha o nā mea e pili ana i ka ea inlet, exhaust outlet, air supply duct, fan, cooling and heat equipment, filter, control system and other auxiliary. ʻO ka ʻōnaehana hoʻopau he ʻōnaehana holoʻokoʻa i loaʻa i ka puʻu exhaust a i ʻole ke komo ʻana o ka ea, nā lako lumi maʻemaʻe a me ka peʻahi.
(4). ʻōnaehana pale ahi
ʻO ke ala ulia pōpilikia, nā kukui pilikia, ka sprinkler, ka mea kinai ahi, ka paipu ahi, nā keʻena hoʻokiʻekiʻe ʻakomi, ka pahu pahu pahu ahi, etc.
(5). Pūnaehana uila
Aia i loko o ʻekolu mau ʻāpana: nā kukui, ka mana a me ke au palupalu, e uhi pono ana i nā kukui hoʻomaʻemaʻe, nā kumu, nā keʻena uila, nā laina, ka nānā ʻana a me ke kelepona a me nā ʻōnaehana ikaika a nāwaliwali o kēia manawa.
(6). ʻōnaehana paipu kaʻina
I loko o ka lumi lumi hoʻomaʻemaʻe, ʻo ia ka mea nui: nā pipeline gas, pipelines material, pipelines wai hoʻomaʻemaʻe, pipelines wai injection, steam, pipelines mahu maʻemaʻe, pipelines wai mua, circulating wai pipelines, hoʻokaʻawale a hoʻoheheʻe i nā paipu wai, condensate, nā paipu wai hoʻomaha, etc.
(7). Pūnaehana mana ʻakomi
Hoʻopili i ka mālama ʻana i ka mahana, ka mālama ʻana i ka mahana, ka nui o ka ea a me ka mana kaomi, ke kaʻina wehe a me ka mana manawa, etc.
(8). Hoʻolako wai a me ka ʻōnaehana wai
ʻO ka hoʻonohonoho ʻana o ka ʻōnaehana, ke koho ʻana i ka pipeline, ka hoʻomoe ʻana i ka pipeline, nā mea hoʻoheheʻe wai a me nā ʻōnaehana hoʻoheheʻe liʻiliʻi, ka ʻōnaehana hoʻomaʻemaʻe lumi maʻemaʻe, kēia mau ana, ka hoʻonohonoho ʻana o ka ʻōnaehana a me ka hoʻonohonoho ʻana, etc.
ʻO ka ʻoihana meaʻai, ke keʻena nānā maikaʻi, ʻoihana uila, halemai, ʻoihana mālama olakino, aerospace, ʻepekema noiʻi ʻepekema, hale hana lāʻau lapaʻau, microelectronics, lumi hoʻomaʻemaʻe biological a me nā ʻoihana ʻē aʻe e hāʻawi i nā ʻano like ʻole a me ka papa 100000 maʻemaʻe pae o nā papa hoʻomaʻemaʻe maʻemaʻe a me ka hoʻolālā ʻōnaehana hoʻomaʻemaʻe ea maʻemaʻe, hoʻonohonoho a kūkulu ʻana, hana ʻana, lawelawe ma hope o ke kūʻai aku a me nā hopena holoʻokoʻa. ʻO ka biosafety laboratory i hoʻolālā ʻia e kā mākou hui e hōʻoiaʻiʻo i ka maikaʻi o ke kūkulu ʻana a hoʻokō i nā koi o nā kikoʻī ʻenehana maʻamau maʻamau.
2. Pono lawelawe lumi maʻemaʻe
(1). Nā lawelawe lumi hoʻomaʻemaʻe
① Hoʻolālā a hoʻoponopono hou i nā lumi hoʻomaʻemaʻe ea a me nā hale hana maʻemaʻe, lepo ʻole a sterile o nā pae hoʻomaʻemaʻe like ʻole, nā koi kaʻina hana a me nā hoʻolālā papahele.
② Hoʻoponopono hou i nā lumi hoʻomaʻemaʻe me nā koi kūikawā e like me ke kaomi maikaʻi ʻole, ke kiʻekiʻe kiʻekiʻe, ke ahi a me ka pale ʻana i ka pahū, ke kani ʻana a me ka silencing, ka sterilization kiʻekiʻe, ka detoxification a me ka deodorization, a me ka anti-static.
③ E kūkulu i nā kukui, nā lako uila, nā mana, nā ʻōnaehana hoʻokele uila a me nā ʻōnaehana hoʻokele ea ea e like me ka lumi maʻemaʻe.
3. Nā polokalamu lumi hoʻomaʻemaʻe
(1). Nā lumi olaola halemai
ʻO nā lumi hoʻomaʻemaʻe ola kino o ka haukapila ka nui o nā lumi hana maʻemaʻe a me nā keʻena maʻemaʻe. ʻO nā keʻena maʻemaʻe o nā halemai, ʻo ia nā wahi e hoʻomalu pono ʻia ai nā fungi e pale ai i nā maʻi mai ka maʻi ʻana a i ʻole nā hopena koʻikoʻi.
(2). Nā hale hana moʻo P-level
① ʻO nā laboratories P3 nā hale hana biosafety level 3. Hoʻokaʻawale ʻia nā laboratories biosafety i ʻehā pae e like me ke kiʻekiʻe o ka pōʻino o nā microorganisms a me kā lākou mau toxins, me ka pae 1 he haʻahaʻa a ʻo ka pae 4 ke kiʻekiʻe. Hoʻokaʻawale ʻia lākou i ʻelua mau ʻāpana: ka pae cell a me ka pae holoholona, a ua māhele ʻia ka pae holoholona i ka pae holoholona liʻiliʻi a me ka pae holoholona nui. Ua kūkulu ʻia ka hale hana P3 mua ma koʻu ʻāina i ka makahiki 1987 a ua hoʻohana nui ʻia no ka noiʻi AIDS.
②P4 Laboratory pili i ka biosafety level 4 laboratory, kahi i hoʻohana kūikawā ʻia no ka noiʻi ʻana i nā maʻi ʻeha loa. ʻO ia ka pae kiʻekiʻe o ka hale hana biosafety ma ka honua. ʻAʻohe hale hana like ma Kina i kēia manawa. Wahi a nā poʻe loea kūpono, ʻoi aku ka paʻakikī o nā ana palekana o nā laboratories P4 ma mua o nā laboratories P3. ʻAʻole pono ka poʻe noiʻi e ʻaʻahu i nā lole pale paʻa piha akā lawe pū kekahi i nā cylinders oxygen i ke komo ʻana.
(3). ʻEnekinia lumi maʻemaʻe o nā hale hana a me nā hale hana
Hiki ke hoʻokaʻawale ʻia nā ʻano hana i ka ʻenekinia kīwila a me nā ʻano prefabricated.
ʻO ka ʻōnaehana hoʻomaʻemaʻe maʻemaʻe prefabricated ka nui o ka ʻōnaehana hoʻolako ea, hoʻihoʻi ʻana i ka ea, hoʻihoʻi ʻana i ka ea, ʻāpana exhaust, ka hale paʻa, kanaka a me nā mea maʻemaʻe maʻemaʻe, kumu mua, waena a me ke kiʻekiʻe o ka ea kānana, ka ʻea a me ka ʻōnaehana wai, ka mana a me ke kukui, ka nānā ʻana i ke kaiapuni hana a me ka alarm, pale ahi, kamaʻilio a me ka mālama ʻana i ka papahele anti-static.
①GMP hoʻomaʻemaʻe hale hana maʻemaʻe nā ʻāpana:
Nā manawa hoʻololi ea: papa 100000 ≥15 manawa; papa 10000 ≥20 manawa; papa 1000 ≥30 manawa.
ʻOkoʻa ʻokoʻa: ka hale hana nui i kahi lumi pili ≥5Pa;
Awelika ea velocity: papa 100 maʻemaʻe hale hana 03-0.5m/s;
Ka wela: >16 ℃ i ka hoʻoilo; <26 ℃ i ke kauwela; ka loli ± 2 ℃. ʻO ka haʻahaʻa 45-65%; ʻoi aku ka maikaʻi o ka haʻahaʻa ma ka hale hana maʻemaʻe GMP ma kahi o 50%; ʻoi aku ka kiʻekiʻe o ka haʻahaʻa ma ka hale hana uila e pale i ka uila paʻa. Ka leo ≤65dB(A); he 10% -30% ka nui o ka ea ea hou; ka malamalama: 300LX.
②GMP papa hana hale hana:
Hana ʻia ka pā a me ke kaupaku o ka hale hana maʻemaʻe me 50mm mānoanoa o nā papa kila sandwich, nani a paʻa. ʻO nā puka kihi Arc, nā puka makani, a me nā mea ʻē aʻe i hana maʻamau i nā profiles alumini anodized kūikawā;
Hiki ke hana ʻia ka papahele me ka epoxy self-leveling floor a i ʻole ka papa kiʻekiʻe kiʻekiʻe. Inā loaʻa kahi koi anti-static, hiki ke koho ʻia ke ʻano anti-static;
ʻO ka hāʻawi ʻana i ka ea a me ka hoʻihoʻi ʻana i hana ʻia me ka ʻili wela wela, a ua hoʻopaʻa ʻia ka ʻili i hoʻopaʻa ʻia i ka lapalapa ahi PF foam me ka hoʻomaʻemaʻe maikaʻi a me ka hopena mālama wela;
Hoʻohana ka pahu hepa i ke kila kila, nani a maʻemaʻe hoʻi, a ʻo ka pā mesh perforated e hoʻohana ana i kahi pā alumini pena, ʻo ia ka ʻōpala a me ka lepo a maʻalahi ke hoʻomaʻemaʻe.
(4). ʻEnekinia lumi hoʻomaʻemaʻe kino
Hoʻohana maʻamau i nā mea uila, lumi kamepiula, nā hale semiconductor, ʻoihana kaʻa, ʻoihana aerospace, photolithography, microcomputer manufacturing a me nā ʻoihana ʻē aʻe. Ma waho aʻe o ka maʻemaʻe o ka ea, pono e hōʻoia i ka hoʻokō ʻana i nā koi o ka anti-static.
Ka manawa hoʻouna: Feb-28-2025