Chipinda choyera ndi malo olamulidwa mwapadera monga kuchuluka kwa tinthu tambiri, chinyezi, kutentha ndi magetsi okhazikika kungayendetsedwe kuti akwaniritse miyezo yapadera. Zipinda zoyera zimagwiritsidwa ntchito kwambiri makampani apamwamba monga semicondectors, zamagetsi, mankhwala osokoneza bongo, ndege, Aerodecine ndi biomedicine.
Mu zojambula zamagulu oyang'anira mankhwala, chipinda choyera chimagawidwa m'magawo anayi: A, B, C ndi D.
Kalasi A: Madera ogwiritsira ntchito zowopsa, monga zokhala ndi zoopsa, madera omwe mabulogu olema ndi otseguka amakumana ndi kusinthika kwamisonkhano ya Aseptic kukhalabe ndi malo okhala m'deralo. Dongosolo lopanda tanthauzo lopanda kanthu liyenera kupatsa mpweya pomwe ali m'malo mwake ndi mpweya wa mpweya wa 0.36-0.54m / s. Payenera kukhala deta kuti itsimikizire mawonekedwe osasunthika ndikutsimikiziridwa. Mu wotsekedwa, wowoneka bwino kapena bokosi la magololo, otsika mpweya velocity angagwiritsidwe ntchito.
Kalasi B: Kutanthauza malo okhala komwe kalasi yoyera imapezeka kuti ikhale yoyendetsa bwino monga kukonzekera kwa Aseptic ndi kudzazidwa.
CLUCLE C ndi D: tchulani madera oyera osafunikira pakupanga zinthu zosabala zofananira.
Malinga ndi GMS Malamulowa, malo opangira ma prermaceutical amagawika malo oyera m'magawo anayi a ABCD monga pamwambapa, kuthamanga kwa mpweya, kutentha ndi chinyezi chambiri.
Miyezo ya madera oyera imagawidwa malinga ndi kuchuluka kwa tinthu tating'onoting'ono tomwe timayimilira. Nthawi zambiri, ang'onoang'ono mtengo, mulingo wapamwamba.
1. Ukhondo wa Air amatanthauza kukula ndi kuchuluka kwa tinthu (kuphatikizapo tizilombo tating'onoting'ono) omwe ali mu mpweya pa voliyumu ya danga, yomwe ndi muyezo wosiyanitsa malo aukhondo.
Static amatanthauza boma pambuyo poti chipinda chowongolera chipinda chakhazikitsidwa ndikugwira ntchito mokwanira, ndipo oyenda m'chipinda choyera atuluka malowo ndikudziyeretsa kwa mphindi 20.
Mphamvuyo imatanthawuza kuti chipinda choyera chili bwinobwino, zida zikugwira ntchito mwachizolowezi, ndipo ogwira ntchito osankhidwa akugwira ntchito molingana ndi zigawo.
2. Wolemba ntchito ya Abcd amachokera ku GMP wolonjezedwa ndi dziko la World Health Organisation (ndani), yomwe ndi yodziwika bwino yopanga magwiridwe antchito ogulitsa m'mafashoni. Pakadali pano pamadera ambiri padziko lonse lapansi, kuphatikiza ku European Union ndi China.
Chitchachiro cha GMS Gwar adatsatira miyezo yaku America (kalasi 100, kalasi 10,000, kalasi 100,000) mpaka kukhazikitsa mtundu wa gulu la GPMS mu 2011. magawo oyera.
Miyezo ina yopanga chipinda choyera
Chipinda choyera chimakhala ndi miyezo yosiyanasiyana yamakampani osiyanasiyana ndi mafakitale. Malamulo a GP a GPM adayambitsa kale, ndipo apa timayambitsa miyezo yaku America ndi mfundo za ISO.
(1). Muyezo waku America
Lingaliro la chipinda choyera choyera lidafunsidwa koyamba ndi United States. Mu 1963, muyezo woyamba feduro kuti gulu lankhondo loyera la chipinda choyera liyambitsidwe: FS-209. Gulu lodziwika bwino 100, kalasi la 10000 ndi kalasi 100000 onse amachokera muyezo uno. Mu 2001, United States idasiya kugwiritsa ntchito FS-209E Standard ndikuyamba kugwiritsa ntchito ISO Standa.
(2). ISO Miyezo
Miyezo ya ISO imafunsidwa ndi bungwe lapadziko lonse lapansi kuti lizilowetsanso iso ndikuphimba mafakitale angapo, osati mafakitale opangira mankhwala. Pali magawo asanu ndi anayi kuchokera kwa kalasi1 mpaka kalasi 9. Pakati pawo, kalasi 5 ndi yofanana ndi kalasi B, kalasi 7 ndi yofanana ndi kalasi C, ndi kalasi 8 ndi yofanana ndi kalasi D.
(3). Kuti mutsimikizire kuchuluka kwa kalasi loyera, kuchuluka kwa kuchuluka kwa mfundo iliyonse sikungakhale kochepera 1 cubic mita. Mulingo wa tinthu tating'onoting'ono tinthu tating'onoting'ono timakhala malo oyera ndi iso 5, ndi tinthu tating'onoting'ono ≥5.0μm monga malire. Mulingo wa tinthu tating'onoting'ono tomwe timakhala m'gulu loyenererana (chikhazikitso) ndi ISO 5, ndipo chimaphatikizapo tinthu tating'onoting'ono tating'onoting'ono. Kwa madera oyera Class Class Class (Static ndi Bodic), magawo a tinthu tating'onoting'ono ndi ISO ndi ISo 8 motsatana. Kwa madera oyera (Static) pamlingo wa tinthu tating'onoting'ono ndi ISO.
(4). Mukamatsimikizira mulingo, thumba la fumbi lotsika ndi chubu cha Sapling iyenera kugwiritsidwa ntchito popewa ≥5.0μm Mu machitidwe osawoneka bwino, mitu ya isokinic Stupling iyenera kugwiritsidwa ntchito.
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Gulu loyera
Kalasi yoyera, yomwe imadziwikanso ngati chipinda choyera cha gulu la 100 kapena chipinda choyera, ndi chimodzi mwazipinda zomveka bwino kwambiri. Itha kuwongolera kuchuluka kwa tinthu tating'onoting'ono tosiyanasiyana mpaka 35.5, ndiye kuti, kuchuluka kwa tinthu tating'ono kapena kofanana ndi 0,520 (wamba komanso zamphamvu). Kalasi yoyera imakhala ndi zofunika kwambiri ndipo zimafunikira kugwiritsa ntchito zosefera za hepa, kuwongolera kosiyanasiyana, njira zotchingira mpweya nthawi zonse ndi njira zowongolera ndi chinyezi chowongolera kuti akwaniritse zofunika zawo zonse kuti akwaniritse zofuna zawo zapamwamba. Kalasi yoyera imagwiritsidwa ntchito makamaka pokonzanso micherelentics, biopharmaceuticals, kupanga chida chowongolera, aerospace ndi minda ina.
Chipinda choyera
Zipinda zoyera zimatchedwanso chipinda choyera 1000. Mulingo wawo waukhondo ndi wotsika kwambiri, kuloleza kuchuluka kwa tinthu tambiri kuposa kapena kofanana ndi 0.5um pa mita imodzi kuti ifike520 (Stax) ndi 352000 (addic). Zipinda za Class B zoyera nthawi zambiri zimagwiritsa ntchito zosefera kwambiri komanso njira zolimbikitsira kuti muchepetse chinyezi, kutentha ndi kusiyana kwapakatikati kwa malo. Zipinda za Class B zoyera zimagwiritsidwa ntchito ku biomedicine, kupanga mankhwala opezeka m'mabuku opezeka m'matchalitchi, makina oyenerera komanso kupanga zida ndi minda ina.
Chipinda choyera C
Zipinda zoyera za Class zimatchedwanso chipinda choyera choyera. Mulingo wawo waukhondo ndi wotsika kwambiri, kulola kuchuluka kwa tinthu tambiri kuposa kapena kofanana ndi 0.5um pa mita imodzi mpaka 352,000 ndi 352,0000 (addic). C Oyera nthawi zambiri amagwiritsa ntchito zosefera a SuP, kuwongolera mphamvu, kufalitsidwa kwa mpweya, kutentha ndi materiyamu komanso matekinolo ena kuti akwaniritse miyezo yawo yapadera. Zipinda za Class C zoyera zimagwiritsidwa ntchito makamaka pamankhwala opanga mankhwala, kupanga zida zamankhwala azachipatala, makina oyenerera ndi magawo ena apakompyuta ndi minda ina.
Chipinda choyera
Zipinda zoyenerera zimatchedwanso chipinda choyera choyera 100,000. Mulingo wawo waukhondo ndi wotsika kwambiri, kuloleza kuchuluka kwa tinthu tambiri kuposa kapena kofanana ndi 0.5um pa mita imodzi kuti ifike 3,520,000 (Static). Class D Oyera nthawi zambiri amagwiritsa ntchito zosefera za hepa ndi njira zowongolera zoyambira komanso njira zomasulira mpweya kuti ziziwongolera malo okhala. Zipinda za Class Class zimagwiritsidwa ntchito makamaka pakupanga mafakitale, kukonza chakudya ndi ma CD, kusindikiza, kuwonzekera minda ina.
Miyezo yosiyanasiyana ya zipinda zoyera zimakhala ndi pulogalamu yawo yogwiritsa ntchito, yomwe iyenera kusankhidwa malinga ndi zosowa zenizeni. Pamapulogalamu othandiza, kuwongolera zachilengedwe kwa zipinda zoyera ndi ntchito yofunika kwambiri, kuphatikizapo kuganizira zonse zomwe zingachitike. Denga lasayansi komanso woyenera ndi opaleshoni imatha kutsimikizira mtundu ndi kukhazikika kwa malo otetezeka chipinda.
Post Nthawi: Mar-07-2024