ʻO kahi lumi maʻemaʻe kahi kaiapuni i hoʻomalu pono ʻia i nā mea e like me ka helu o nā ʻāpana i ka ea, ka haʻahaʻa, ka mahana a me ka uila static e hiki ke hoʻomalu ʻia e hoʻokō i nā kūlana hoʻomaʻemaʻe kikoʻī. Hoʻohana nui ʻia nā lumi maʻemaʻe i nā ʻoihana kiʻekiʻe e like me semiconductors, electronics, pharmaceuticals, aviation, aerospace a me biomedicine.
I nā kikoʻī hoʻokele hoʻokele lāʻau lapaʻau, ua māhele ʻia ka lumi maʻemaʻe i 4 mau pae: A, B, C a me D.
Papa A: ʻO nā wahi hana kiʻekiʻe, e like me ka hoʻopiha ʻana i nā wahi, nā wahi kahi i hoʻopili pololei ʻia ai nā pahu pahu pahu a me nā pahu pahu hāmama me ka hoʻomākaukau sterile, a me nā wahi i hana ʻia ai ka hui aseptic a i ʻole nā hana pili, pono e hoʻolako ʻia me ka unidirectional flow operating table. e mālama i ke kūlana kaiapuni o ia wahi. Pono ka ʻōnaehana kahe unidirectional e hāʻawi like i ka ea ma kāna wahi hana me ka wikiwiki o ka ea o 0.36-0.54m/s. Pono nā ʻikepili e hōʻoia i ke kūlana o ke kahe unidirectional a hōʻoia ʻia. I loko o kahi mea paʻa, kaʻawale a i ʻole pahu mīkina lima, hiki ke hoʻohana i ka wikiwiki o ka ea haʻahaʻa.
Papa B: e pili ana i ka ʻaoʻao hope kahi i loaʻa ai ka papa A maʻemaʻe no nā hana koʻikoʻi e like me ka hoʻomākaukau aseptic a me ka hoʻopiha ʻana.
Papa C a me D: e nānā i nā wahi maʻemaʻe me nā pae koʻikoʻi liʻiliʻi i ka hana ʻana i nā huahana lāʻau lapaʻau sterile.
Wahi a nā lula GMP, hoʻokaʻawale ka ʻoihana lāʻau lapaʻau o koʻu ʻāina i nā wahi maʻemaʻe i 4 mau pae o ABCD e like me luna ma muli o nā hōʻailona e like me ka maʻemaʻe o ka ea, ke kaomi ea, ka nui o ka ea, ka mahana a me ka haʻahaʻa, ka walaʻau a me ka ʻike microbial.
Hoʻokaʻawale ʻia nā pae o nā wahi maʻemaʻe e like me ka neʻe ʻana o nā mea i hoʻokuʻu ʻia i ka ea. ʻO ka ʻōlelo maʻamau, ʻoi aku ka liʻiliʻi o ka waiwai, ʻoi aku ka kiʻekiʻe o ka pae maʻemaʻe.
1. 'O ka ma'ema'e o ka ea e pili ana i ka nui a me ka heluna o na mea liilii (me na microorganisms) i loko o ka ea no ka nui o ka lewa, 'o ia ka ma'amau no ka 'ike 'ana i ka pae ma'ema'e o kahi hakahaka.
Static e pili ana i ka moku'āina ma hope o ka lumi hoʻomaʻemaʻe ea ea nenoaiu ua hoʻokomo a piha hana, a maʻemaʻe lumi limahana ua haʻalele i ka paena a me ka hoʻomaʻemaʻe iho no 20 minuke.
ʻO Dynamic ke ʻano o ka lumi maʻemaʻe i ke kūlana hana maʻamau, ke hana maʻamau nā mea hana, a ke hana nei nā limahana i koho ʻia e like me nā kikoʻī.
2. No ka GMP i hoʻolaha ʻia e ka World Health Organization (WHO) ka maʻamau helu ABCD, ʻo ia ka mea maʻamau i ka hoʻokele waiwai o ka lāʻau lapaʻau ma ka ʻoihana lāʻau. Hoʻohana ʻia i kēia manawa ma ka hapa nui o nā wahi a puni ka honua, me ka European Union a me Kina.
Ua hahai ka mana kahiko o GMP i nā pae helu ʻAmelika (papa 100, papa 10,000, papa 100,000) a hiki i ka hoʻokō ʻana i ka mana hou o nā kūlana GMP i ka makahiki 2011. pae o na wahi maemae.
Nā kūlana hoʻohālikelike lumi maʻemaʻe ʻē aʻe
He ʻokoʻa ko ka lumi maʻemaʻe ma nā wahi a me nā ʻoihana like ʻole. Ua hoʻokomo mua ʻia nā kūlana GMP, a ma ʻaneʻi mākou e hoʻolauna nui i nā kūlana ʻAmelika a me nā kūlana ISO.
(1). ʻAmelika Hui Pū ʻIa
ʻO ka manaʻo o ka helu ʻana i ka lumi maʻemaʻe i hoʻokumu mua ʻia e ʻAmelika Hui Pū ʻIa. I ka makahiki 1963, ua hoʻokumu ʻia ke kūlana federal mua no ka ʻāpana koa o ka lumi maʻemaʻe: FS-209. ʻO ka papa maʻamau 100, ka papa 10000 a me ka papa 100000 maʻamau i loaʻa mai kēia maʻamau. I ka makahiki 2001, ua kāpae ʻo ʻAmelika i ka hoʻohana ʻana i ka maʻamau FS-209E a hoʻomaka e hoʻohana i ka maʻamau ISO.
(2). Nā kūlana ISO
Hoʻolālā ʻia nā kūlana ISO e International Organization for Standardization ISO a uhi i nā ʻoihana he nui, ʻaʻole wale ka ʻoihana lāʻau. He ʻeiwa pae mai ka papa 1 a i ka papa 9. Ma waena o lākou, ua like ka papa 5 me ka papa B, ua like ka papa 7 me ka papa C, a ua like ka papa 8 me ka papa D.
(3). No ka hōʻoia ʻana i ke kiʻekiʻe o ka papa A maʻemaʻe, ʻaʻole e emi ka nui o ka laʻana o kēlā me kēia wahi laʻana ma lalo o 1 mika cubic. ʻO ke kiʻekiʻe o nā ʻāpana ea i ka papa A maʻemaʻe ʻo ISO 5, me nā mea i hoʻokuʻu ʻia ≥5.0μm e like me ka palena palena. ʻO ke kiʻekiʻe o nā mea ea ea ma ka papa B maʻemaʻe (static) ʻo ISO 5, a loaʻa nā ʻāpana i hoʻokuʻu ʻia o ʻelua nui i ka papaʻaina. No nā wahi maʻemaʻe o ka papa C (static a me ka ikaika), ʻo ka pae o nā mea ea ea he ISO 7 a me ISO 8. No nā wahi maʻemaʻe papa D (static) ʻo ke kiʻekiʻe o nā ʻāpana ea he ISO 8.
(4). I ka hōʻoia ʻana i ke kiʻekiʻe, pono e hoʻohana ʻia kahi pākuʻi lepo lepo me kahi puʻupuʻu hōʻailona pōkole e pale aku i ka ≥5.0μm i hoʻokuʻu ʻia mai ka noho ʻana i loko o ka puʻu laʻa lōʻihi o ka ʻōnaehana sampling mamao. I nā ʻōnaehana kahe unidirectional, pono e hoʻohana i nā poʻo sampling isokinetic.
(5) Hiki ke hoʻokō ʻia ka hoʻāʻo ʻana i ka wā o ka hana maʻamau a me ka moʻomeheu medium simulated filling process e hōʻoia i ka loaʻa ʻana o ka pae hoʻomaʻemaʻe hoʻomaʻemaʻe, akā pono ka hoʻāʻo ʻana o ka moʻomeheu medium simulated filling ma lalo o ke "kūlana ʻino loa".
Papa A lumi maemae
ʻO ka lumi maʻemaʻe o ka papa 100 a i ʻole ka lumi hoʻomaʻemaʻe ultra, ʻo ia kekahi o nā lumi maʻemaʻe me ka maʻemaʻe kiʻekiʻe. Hiki iā ia ke hoʻomalu i ka helu o nā ʻāpana i kēlā me kēia kapuaʻi cubic i ka lewa i ka liʻiliʻi ma mua o 35.5, ʻo ia hoʻi, ʻo ka helu o nā ʻāpana i ʻoi aku ka nui a i ʻole like me 0.5um i kēlā me kēia cubic mika o ka ea ʻaʻole hiki ke ʻoi aku ma mua o 3,520 (static and dynamic). He koʻikoʻi koʻikoʻi ko ka lumi maʻemaʻe o ka papa A a koi aku i ka hoʻohana ʻana i nā kānana hepa, ka mana o ke kaomi ʻokoʻa, nā ʻōnaehana ea a me nā ʻōnaehana mālama wela a me ka haʻahaʻa no ka hoʻokō ʻana i kā lākou koi maʻemaʻe kiʻekiʻe. Hoʻohana nui ʻia nā lumi maʻemaʻe papa A i ka hana microelectronics, biopharmaceuticals, precision instrument manufacturing, aerospace a me nā māla ʻē aʻe.
Papa B lumi maemae
Kapa ʻia nā lumi maʻemaʻe papa B he 1000 lumi maʻemaʻe. He haʻahaʻa ko lākou pae hoʻomaʻemaʻe, e ʻae ana i ka helu o nā ʻāpana i ʻoi aku ma mua o a i ʻole like me 0.5um no ka cubic mika o ka ea a hiki i 3520 (static) a me 352000 (dynamic). Hoʻohana maʻamau nā lumi hoʻomaʻemaʻe papa B i nā kānana kiʻekiʻe a me nā ʻōnaehana hoʻopau no ka mālama ʻana i ka haʻahaʻa, ka mahana a me ka ʻokoʻa o ke kaomi o ka kaiapuni o loko. Hoʻohana nui ʻia nā lumi maʻemaʻe papa B i ka biomedicine, ka hana lāʻau lapaʻau, ka mīkini kikoʻī a me ka hana ʻana i nā mea hana a me nā māla ʻē aʻe.
Papa C lumi maemae
Kapa ʻia nā lumi maʻemaʻe papa C he 10,000 lumi maʻemaʻe. He haʻahaʻa ko lākou pae hoʻomaʻemaʻe, e ʻae ana i ka helu o nā ʻāpana i ʻoi aku ma mua o a i ʻole like me 0.5um no ka cubic mika o ka ea a hiki i 352,000 (static) a me 352,0000 (dynamic). Hoʻohana maʻamau nā lumi maʻemaʻe papa C i nā kānana hepa, ka hoʻomalu ʻana i ke kaomi maikaʻi, ke kahe ʻana o ka ea, ka mālama ʻana i ka mahana a me ka haʻahaʻa a me nā ʻenehana ʻē aʻe e hoʻokō i kā lākou mau kūlana maʻemaʻe kikoʻī. Hoʻohana nui ʻia nā lumi maʻemaʻe papa C i nā lāʻau lapaʻau, nā mea hana lāʻau lapaʻau, nā mīkini kikoʻī a me ka hana ʻana o nā mea uila a me nā māla ʻē aʻe.
Papa D lumi maemae
Kapa ʻia nā lumi maʻemaʻe papa D he 100,000 lumi maʻemaʻe. He haʻahaʻa ko lākou pae maʻemaʻe, e ʻae ana i ka nui o nā ʻāpana i ʻoi aʻe ma mua o a i ʻole like me 0.5um no ka cubic mika o ka ea a hiki i 3,520,000 (static). Hoʻohana maʻamau nā lumi maʻemaʻe papa D i nā kānana hepa maʻamau a me ka hoʻomalu ʻana i ke kaomi maikaʻi kumu a me nā ʻōnaehana ea e hoʻokele ai i ka kaiapuni o loko. Hoʻohana nui ʻia nā lumi maʻemaʻe papa D i ka hana ʻoihana maʻamau, ka hoʻoili ʻana i ka meaʻai a me ka hoʻopili ʻana, ka paʻi ʻana, ka hale kūʻai a me nā māla ʻē aʻe.
Loaʻa nā pae like ʻole o nā lumi maʻemaʻe i kā lākou pono ponoʻī o ka noi, pono e koho ʻia e like me nā pono maoli. Ma nā noi kūpono, he hana koʻikoʻi ka mālama kaiapuni o nā lumi maʻemaʻe, e pili ana i ka noʻonoʻo piha ʻana i nā kumu he nui. ʻO ka hoʻolālā a me ka hana ʻepekema wale nō e hiki ke hōʻoia i ka maikaʻi a me ke kūpaʻa o ka lumi lumi maʻemaʻe.
Ka manawa hoʻouna: Mar-07-2024