Maonekedwe athunthu aukadaulo waukhondo ndi zomwe timazitcha kuti chipinda choyera cha fakitale yamankhwala, yomwe imagawidwa m'magulu awiri: chipinda choyera cha mafakitale ndi chipinda choyera chachilengedwe. Ntchito yayikulu ya chipinda choyera cha mafakitale ndikuwongolera kuipitsidwa kwa omwe si- tinthu tating'onoting'ono, pomwe ntchito yayikulu ya chipinda choyera chachilengedwe ndikuwongolera kuipitsidwa kwa tinthu tating'onoting'ono.GMP ndiye muyeso wa kupanga mankhwala ndi kasamalidwe kabwino, zomwe zimatsimikizira bwino chitetezo ndi mtundu wamankhwala. Popanga, kumanga ndi kugwiritsa ntchito zipinda zoyera m'makampani opanga mankhwala, miyezo yoyenera ya zipinda zoyera komanso zofunikira za kasamalidwe kabwino kazinthu zopanga mankhwala ziyenera kutsatiridwa. Kenako, tikambirana za kapangidwe ka chipinda choyera cha fakitale yoyera yamankhwala molingana ndi malamulo okongoletsa mkati mu "Design Specifications for the Clean Factory of the Pharmaceutical Industry", kuphatikiza ndi zomwe Shanghai IVEN adakumana nazo popanga uinjiniya. mafakitale opanga mankhwala ophatikizika.

Industrial Cleanroom Design
M'zipinda zoyera zamafakitale, zopangira mankhwala ndizomwe timapanga timakumana nazo. Malinga ndi zofunikira za GMP pazipinda zoyera, pali magawo angapo ofunikira omwe ayenera kutsatiridwa.

1. Ukhondo
Vuto la momwe mungasankhire moyenera magawo mumisonkhano yopangira zaluso. Malingana ndi zipangizo zamakono zosiyanasiyana, momwe mungasankhire magawo opangira moyenera ndilo vuto lalikulu pakupanga. Chizindikiro chofunikira chikuperekedwa mu GMP, ndiye kuti, mulingo waukhondo wa mpweya. Mulingo waukhondo wa mpweya ndiye chizindikiro chachikulu chowunika ukhondo wa mpweya. Ngati mulingo waukhondo wa mumlengalenga uli wolakwika, chodabwitsa cha akavalo akulu amakoka ngolo yaying'ono, zomwe sizowononga ndalama kapena kupulumutsa mphamvu. Mwachitsanzo, tsatanetsatane watsopano wapaketi wa 300,000-level standard zomwe sizoyenera kuzigwiritsa ntchito popanga zinthu zazikulu pakadali pano, koma ndizothandiza kwambiri pazipinda zina zothandizira.

Choncho, kusankha kwa mlingo womwe umagwirizana mwachindunji ndi ubwino ndi chuma cha mankhwala. Magwero a fumbi omwe amakhudza ukhondo makamaka amachokera ku fumbi la zinthu zomwe zimagwiritsidwa ntchito popanga, kuyenda kwa ogwira ntchito ndi tinthu tating'onoting'ono ta mlengalenga zomwe zimabweretsedwa ndi mpweya wabwino wakunja. Kuphatikiza pa kugwiritsa ntchito zida zotsekera zotsekeka komanso zochotsa fumbi zopangira zida zopangira fumbi, njira yabwino yothanirana ndi kulowa kwa magwero a fumbi mchipindamo ndikugwiritsa ntchito kusefera koyambirira, kwapakatikati komanso kopambana kwamagawo atatu kwatsopano. kubweza mpweya wa air-conditioning system ndi chipinda chosambira cha anthu ogwira ntchito.

2. Mtengo wosinthira mpweya
Nthawi zambiri, kuchuluka kwa kusintha kwa mpweya mu makina owongolera mpweya kumakhala 8 mpaka 10 kokha pa ola, pomwe mpweya wotsika kwambiri m'chipinda choyera m'mafakitale ndi nthawi 12, ndipo mulingo wapamwamba kwambiri ndi kambirimbiri. Mwachiwonekere, kusiyana kwa kusintha kwa mpweya kumayambitsa kusiyana kwakukulu kwa mpweya ndi mphamvu yogwiritsira ntchito mphamvu. Kupanda kutero, mndandanda wamavuto ungawonekere, monga momwe zotsatira za opareshoni sizili zoyenera, mphamvu zotsutsana ndi kusokoneza chipinda choyera ndizovuta.

3. Kusiyanasiyana kwapakati pa static
Kusiyana kwapakati pakati pa zipinda zoyera ndi zipinda zopanda ukhondo pamiyezo yosiyana sikudzakhala kuchepera 5pa, ndipo kupanikizika pakati pa zipinda zoyera ndi zipinda zakunja sikudzakhala kuchepera 10Pa. Njira yowongolerera kusiyana kwa kuthamanga kwa static ndikupereka voliyumu ya mpweya wabwino. Zida zokakamiza zabwino zomwe nthawi zambiri zimagwiritsidwa ntchito pamapangidwewo ndi valavu yotsalira yamagetsi, chowongolera chamagetsi chamagetsi chamagetsi ndi chowongolera mpweya chomwe chimayikidwa potengera mpweya wobwerera. M'zaka zaposachedwa, nthawi zambiri amatengera mapangidwe kuti voliyumu yoperekera mpweya ndi yayikulu kuposa voliyumu yobwerera komanso kuchuluka kwa mpweya wotulutsa pakutumiza koyambirira popanda chipangizo chokakamiza, ndipo makina owongolera ogwirizana amatha kukwaniritsa zomwezi.

4. Kugawa kwa mpweya
Mawonekedwe ogawa mpweya a chipinda choyera ndi chinthu chofunikira kwambiri kuti atsimikizire ukhondo. Fomu yogawa mpweya yomwe nthawi zambiri imatengedwa pamapangidwe amakono imatsimikiziridwa molingana ndi ukhondo. Mwachitsanzo, zipinda zoyera za 300,000 nthawi zambiri zimagwiritsa ntchito njira yotumizira pamwamba ndi kumbuyo, zipinda zoyera za 100,000 ndi 10,000-class nthawi zambiri zimagwiritsa ntchito njira yolowera mpweya yobwerera kumtunda ndi kumunsi, komanso zoyera zapamwamba. chipinda chimatengera njira yopingasa kapena yoyima ya njira imodzi.

5. Kutentha ndi chinyezi
Kuphatikiza pa njira zapadera, pakuwona kutentha, mpweya wabwino ndi mpweya wabwino, makamaka kusunga chitonthozo cha ogwira ntchito, ndiko kuti, kutentha koyenera ndi chinyezi. Kuonjezera apo, pali zizindikiro zingapo zomwe ziyenera kuchititsa chidwi chathu, monga kuthamanga kwa mphepo yam'mbali ya mpweya, phokoso, kuunikira ndi chiŵerengero cha mpweya wabwino wa mpweya ndi zina, zomwe sizinganyalanyazidwe pakupanga.

Kukonza chipinda choyera
Zipinda zoyera zachilengedwe zimagawidwa m'magulu awiri; zipinda zonse zoyera zamoyo komanso zipinda zachitetezo chachilengedwe. Kwa zipinda zoyera zamafakitale, pamapangidwe aukadaulo otenthetsera, mpweya wabwino ndi mpweya, njira zofunika zowongolera ukhondo ndi kusefera ndi kukakamiza kwabwino. Pazipinda zoyera zamoyo, kuphatikiza kugwiritsa ntchito njira zofananira ndi zipinda zoyera za mafakitale, ziyeneranso kuganiziridwa potengera chitetezo chachilengedwe, ndipo nthawi zina pamafunika kugwiritsa ntchito njira zopondereza zoletsa kuwononga chilengedwe.
Kugwira ntchito kwa zinthu zowopsa kwambiri kumakhudzidwa ndi kupanga zinthu zomwe zikugwiritsidwa ntchito, ndipo njira yake yoyeretsera mpweya ndi malo ena ayeneranso kukwaniritsa zofunikira zapadera. Kusiyana pakati pa chipinda choyera cha biosafety ndi chipinda choyera cha mafakitale ndikuwonetsetsa kuti malo ogwirira ntchito amakhalabe ndi vuto loyipa. Ngakhale kuti mlingo wa malo opangira zoterezi siwokwera kwambiri, udzakhala ndi mlingo wapamwamba wa biohazard. Ponena za chiwopsezo chachilengedwe, pali miyezo yofananira ku China, WTO ndi mayiko ena padziko lapansi. Nthawi zambiri, njira zomwe amatengera ndizodzipatula. Choyamba, tizilombo toyambitsa matenda timasiyanitsidwa ndi woyendetsa ndi kabati yachitetezo kapena bokosi lodzipatula, lomwe makamaka ndilolepheretsa kuteteza kuchulukira kwa tizilombo toyambitsa matenda. Kudzipatula kwachiwiri kumatanthawuza kudzipatula kwa labotale kapena malo ogwirira ntchito kuchokera kunja powasandutsa malo oponderezedwa olakwika.Kwa dongosolo loyeretsa mpweya, njira zina zimatengedwanso molingana, monga kusunga kupanikizika koipa kwa 30Pa ~ 10Pa m'nyumba, ndi kukhazikitsa zone yotchinga yoyipa pakati pa malo oyandikana nawo osayera.

Shanghai VEN nthawi zonse amakhala ndi udindo waukulu ndipo amatsatira muyezo uliwonse pamene akuthandiza makasitomala kumanga mafakitale opanga mankhwala. Monga kampani yomwe ili ndi zaka zambiri popereka uinjiniya wamankhwala ophatikizika, IVEN ali ndi chidziwitso chambiri mumgwirizano wapadziko lonse lapansi. Ntchito iliyonse ya Shanghai IVEN ikugwirizana ndi EU GMP/US FDA GMP, WHO GMP, PIC/S GMP ndi mfundo zina. Kuwonjezera pa kupereka makasitomala ndi mautumiki apamwamba, VEN amatsatiranso lingaliro la "kupereka thanzi kwa anthu" .

Shanghai VEN ikuyembekezera kugwira ntchito nanu.