He aha ke keʻena maʻemaʻe?
Hoʻohana mau ʻia nā lumi maʻemaʻe, ʻike ʻia he lumi lepo ʻole, ma ke ʻano he ʻāpana o ka hana ʻoihana ʻoihana a i ʻole ka noiʻi ʻepekema, me ka hana ʻana i nā lāʻau lapaʻau, meaʻai, CRT, LCD, OLED, a me nā hōʻike microLED.Hoʻolālā ʻia nā lumi maʻemaʻe e mālama i nā haʻahaʻa haʻahaʻa loa o nā ʻāpana, e like me ka lepo, nā mea ea ea, a i ʻole nā particulated vaporized.
ʻO ka pololei, aia kahi lumi maʻemaʻe i ka pae hoʻohaumia i hoʻomalu ʻia, i hōʻike ʻia e ka helu o nā ʻāpana i kēlā me kēia mika cubic / no ka cubic kapuaʻi ma kahi ʻāpana kikoʻī.Hiki i ke keʻena maʻemaʻe ke kuhikuhi i kekahi wahi hoʻokipa i hoʻemi ʻia ka pollution particulate a mālama ʻia nā ʻāpana ʻē aʻe e like me ka mahana, ka haʻahaʻa, a me ke kaomi.
He aha ka lumi maʻemaʻe GMP?
Ma ka manaʻo lāʻau lapaʻau, ʻo kahi lumi maʻemaʻe e pili ana i kahi lumi e kū ana i nā kikoʻī GMP i wehewehe ʻia ma nā kikoʻī sterility GMP (ʻo ia hoʻi, Annex 1 o EU a me PIC/S GMP Guidelines, a me nā kūlana a me nā alakaʻi i koi ʻia e nā luna olakino kūloko. ).He hui ia o ka ʻenekinia, ka hana ʻana, ka hoʻopau ʻana, a me nā mana hana (nā hoʻolālā mana) pono e hoʻololi i kahi lumi maʻamau i lumi maʻemaʻe.
Wahi a nā kūlana kūpono o nā keʻena FDA, ua hoʻokumu lākou i nā kānāwai koʻikoʻi a pololei no nā mea hana lāʻau lapaʻau i ka ʻoihana lāʻau.Hoʻolālā ʻia nā hana hana maikaʻi (GMP) no ka hana ʻana i nā huahana lāʻau lapaʻau sterile e hōʻoia i ka palekana o nā lāʻau a loaʻa i kā lākou mea i koi ʻia a me ka nui.Ke manaʻo nei kēia mau maʻamau e hōʻemi i ka pilikia o ka microbial, particulate, a me ka pyrogen contamination.ʻO kēia hoʻoponopono, i ʻike ʻia ʻo nā hana hana hana maikaʻi o kēia manawa (cGMP), uhi i nā kaʻina hana, ka mālama ʻana i ka maikaʻi, ka ʻeke, nā limahana, a me nā keʻena GMP.
I ka hana ʻana i nā lāʻau lapaʻau non sterile a me nā lāʻau lapaʻau, ʻaʻohe pono o nā lumi maʻemaʻe kiʻekiʻe, ʻoiai no ka hana ʻana i nā lāʻau lapaʻau sterile, e like me nā lāʻau molecular a me nā lāʻau lapaʻau synthetic, pono ʻole ka pono o nā lumi maʻemaʻe kiʻekiʻe. - nā lumi maʻemaʻe GMP.Hiki iā mākou ke wehewehe i ke kaiapuni no ka hana ʻana i nā lāʻau lapaʻau sterile a me nā huahana biological e pili ana i ka pae ea maʻemaʻe GMP a me ka hoʻohālikelike ʻana.
Wahi a nā koi kūpono o nā hoʻoponopono GMP, ʻo ka hana ʻana o nā lāʻau lapaʻau sterile a i ʻole nā huahana olaola e māhele nui ʻia i ʻehā mau pae: A, B, C, a me D.
Aia nā kino hoʻoponopono o kēia manawa: ISO, USP 800, a me US Federal Standard 209E (ma mua, hoʻohana mau ʻia).Ua kau ʻia ka Drug Quality and Safety Act (DQSA) i Nowemapa 2013 e hoʻoponopono i nā make pili i ka lāʻau a me nā hanana ʻino koʻikoʻi.Hoʻokumu ka Federal Food, Drug, and Cosmetic Act (FD&C Act) i nā alakaʻi a me nā kulekele no ke ʻano kanaka.Hoʻopuka ʻia ʻo 503A e kahi mokuʻāina a i ʻole federal i ʻae ʻia ma lalo o ka mākaʻikaʻi ʻana o nā limahana i ʻae ʻia (nā lāʻau lapaʻau/kauka) 503B pili i nā hale i waho a koi pono i ka nānā pono ʻana e nā lāʻau lapaʻau laikini, ʻaʻole nā lāʻau lapaʻau laikini.Ua laikini ʻia ka hale hana ma o ka Food and Drug Administration (FDA).
DERSION lumi hoʻomaʻemaʻe modular
1. KA WIWAI A ME KA MA'alahi
ʻO ka maikaʻi loa o nā lumi maʻemaʻe modular ʻo ia ka maʻalahi a me ka wikiwiki e hoʻokomo.ʻAʻole pono lākou e kūkulu ʻia mai ka wā ʻōpala a ʻaʻole e hoʻopau i kāu hana me nā hebedoma a i ʻole mau mahina o ke kūkulu ʻana.Hana ʻia lākou mai nā panela prefabricated a me ka framing, no laila hiki ke hoʻonohonoho ʻia i loko o nā lā a i ʻole mau pule.Ma ke koho ʻana i ka lumi hoʻomaʻemaʻe modular DERSION, hiki i kāu hui ke pale i ka lohi a hoʻomaka e hoʻohana i kāu lumi hoʻomaʻemaʻe kokoke koke.
ʻO ka mea hou aku, ʻo DERSION patent design ka mea maʻalahi e hōʻuluʻulu a wehe paha i kā mākou lumi maʻemaʻe modular a me ka waiwai e hoʻohui iā lākou.ʻO ia ke ʻano o kā mākou mea kūʻai aku ka hiki ke hoʻohui, a i ʻole ka unuhi ʻana mai, kā lākou lumi hoʻomaʻemaʻe i hoʻonohonoho ʻia e like me ka hoʻololi ʻana o nā pono o kā lākou hui.No ka mea, ʻaʻole hale paʻa ko mākou lumi maʻemaʻe modular, ʻoi aku ka liʻiliʻi o ke kūʻai ʻana a me ka uku mālama haʻahaʻa.
2. KA HANA HANA
Hoʻohana nā lumi hoʻomaʻemaʻe modular i nā ʻāpana kānana fan HEPA a me ULPA no ka wehe ʻana i nā mea ʻala mai ka lewa a mālama i ka haumia i ka liʻiliʻi e pono ai.Hāʻawi ʻo DERSION i nā lumi maʻemaʻe like ʻole a me nā lako lumi maʻemaʻe e hiki ke kōkua i kāu hui e hoʻokō i nā kūlana ISO, FDA, a i ʻole EU.ʻO kā mākou mau lumi hoʻomaʻemaʻe softwall a me nā lumi hoʻomaʻemaʻe rigidwall e hui pū me ISO 8 a ISO 3 a i ʻole Grade A a i ka Papa D i nā helu hoʻomaʻemaʻe ea.ʻO kā mākou lumi hoʻomaʻemaʻe rigidwall kahi hopena haʻahaʻa haʻahaʻa no ka hālāwai ʻana i nā koi USP797.
ʻO nā pōmaikaʻi o nā lumi maʻemaʻe modular ma mua o nā lumi maʻemaʻe kahiko he nui.ʻO kā lākou kūpono, hoʻonohonoho maʻalahi a mālama ʻia, a me ka hana ʻana i ka manawa e lilo lākou i koho maikaʻi loa no nā ʻoihana a i ʻole hui e pono ai kahi lumi maʻemaʻe e hana koke.Ma DERSION ke manaʻoʻiʻo nei mākou i ka maikaʻi o kā mākou huahana lumi maʻemaʻe a me ka maʻalahi a lākou e hāʻawi ai i kā mākou mea kūʻai.No nā kikoʻī hou aʻe e pili ana i kēia mau huahana ke kōkua i kāu hui e hoʻokō i kāna mau pono, e nānā i kā mākou softwall a me rigidwall modular lumi lumi maʻemaʻe.
