Chipinda choyera ndi malo olamulidwa mwapadera momwe zinthu monga kuchuluka kwa tinthu tating'onoting'ono mumlengalenga, chinyezi, kutentha ndi magetsi osasinthasintha zimatha kuyendetsedwa kuti zikwaniritse miyezo yoyeretsera yeniyeni. Zipinda zoyera zimagwiritsidwa ntchito kwambiri m'mafakitale apamwamba monga ma semiconductors, zamagetsi, mankhwala, ndege, ndege ndi biomedicine.
Mu malangizo okhudza kupanga mankhwala, chipinda choyera chimagawidwa m'magawo anayi: A, B, C ndi D.
Gulu A: Malo ogwirira ntchito omwe ali pachiwopsezo chachikulu, monga malo odzaza madzi, malo omwe migolo ya rabara ndi zotengera zotseguka zimakumana mwachindunji ndi zinthu zoyeretsera, ndi malo omwe ntchito zosonkhanitsira kapena zolumikizira zimachitikira, ziyenera kukhala ndi tebulo logwirira ntchito loyenda molunjika kuti malowo azikhala otetezeka. Dongosolo loyenda molunjika liyenera kupereka mpweya mofanana m'malo ake ogwirira ntchito ndi liwiro la mpweya la 0.36-0.54m/s. Payenera kukhala deta yotsimikizira momwe kayendedwe ka mpweya kakuyendera molunjika ndikutsimikiziridwa. Mu bokosi lotsekedwa, lokhala ndi woyendetsa kapena magolovesi, liwiro lotsika la mpweya lingagwiritsidwe ntchito.
Kalasi B: ikutanthauza malo akumbuyo komwe kuli malo oyera a kalasi A omwe amagwiritsidwa ntchito pochita zinthu zoopsa monga kukonzekera ndi kudzaza zinthu zopanda poizoni.
Kalasi C ndi D: amatanthauza madera oyera omwe alibe njira zofunika kwambiri popanga mankhwala osagwiritsidwa ntchito.
Malinga ndi malamulo a GMP, makampani opanga mankhwala m'dziko langa amagawa madera oyera m'magawo anayi a ABCD monga momwe zilili pamwambapa kutengera zizindikiro monga ukhondo wa mpweya, kuthamanga kwa mpweya, kuchuluka kwa mpweya, kutentha ndi chinyezi, phokoso ndi kuchuluka kwa tizilombo toyambitsa matenda.
Magawo a malo oyera amagawidwa malinga ndi kuchuluka kwa tinthu tomwe timapachikidwa mumlengalenga. Kawirikawiri, mtengo wake ukakhala wochepa, ukhondo wake umakhala wokwera.
1. Ukhondo wa mpweya umatanthauza kukula ndi chiwerengero cha tinthu tating'onoting'ono (kuphatikizapo tizilombo toyambitsa matenda) tomwe tili mu mpweya pa unit iliyonse ya malo, yomwe ndi muyezo wodziwira kuchuluka kwa ukhondo wa malo.
Mawu oti Static amatanthauza boma pambuyo poti makina oziziritsira mpweya m'chipinda choyera ayikidwa ndipo akugwira ntchito bwino, ndipo ogwira ntchito m'chipinda choyera achotsa malowo ndikudziyeretsa okha kwa mphindi 20.
Mphamvu imatanthauza kuti chipinda choyera chili bwino, zida zikugwira ntchito bwino, ndipo antchito osankhidwa akugwira ntchito motsatira malangizo.
2. Muyezo wa ABCD wowerengera umachokera ku GMP yolengezedwa ndi World Health Organization (WHO), yomwe ndi njira yodziwika bwino yoyendetsera khalidwe la mankhwala mumakampani opanga mankhwala. Pakadali pano ikugwiritsidwa ntchito m'madera ambiri padziko lonse lapansi, kuphatikiza European Union ndi China.
Mtundu wakale wa GMP waku China unatsatira miyezo yaku America yowunikira (kalasi 100, kalasi 10,000, kalasi 100,000) mpaka pomwe mtundu watsopano wa miyezo ya GMP unakhazikitsidwa mu 2011. Makampani opanga mankhwala aku China ayamba kugwiritsa ntchito miyezo ya WHO yogawa ndikugwiritsa ntchito ABCD kusiyanitsa milingo ya madera oyera.
Miyezo ina yogawa zipinda zoyera
Zipinda zoyera zili ndi miyezo yosiyanasiyana ya magiredi m'madera ndi m'mafakitale osiyanasiyana. Miyezo ya GMP idayambitsidwa kale, ndipo apa tikuwonetsa makamaka miyezo ya ku America ndi miyezo ya ISO.
(1). American Standard
Lingaliro loyesa malo oyera linaperekedwa koyamba ndi United States. Mu 1963, muyezo woyamba wa boma wa gawo la asilikali la chipinda choyera unayambitsidwa: FS-209. Miyezo yodziwika bwino ya kalasi 100, kalasi 10000 ndi kalasi 100000 yonse imachokera ku muyezo uwu. Mu 2001, United States inasiya kugwiritsa ntchito muyezo wa FS-209E ndipo inayamba kugwiritsa ntchito muyezo wa ISO.
(2). Miyezo ya ISO
Miyezo ya ISO yaperekedwa ndi International Organization for Standardization ISO ndipo imakhudza mafakitale ambiri, osati makampani opanga mankhwala okha. Pali magawo asanu ndi anayi kuyambira kalasi 1 mpaka kalasi 9. Pakati pawo, kalasi 5 ndi yofanana ndi kalasi B, kalasi 7 ndi yofanana ndi kalasi C, ndipo kalasi 8 ndi yofanana ndi kalasi D.
(3). Kuti mutsimikizire mulingo wa malo oyera a Class A, kuchuluka kwa zitsanzo za malo aliwonse oyesera kuyenera kukhala osachepera mita imodzi ya kiyubiki. Mulingo wa tinthu touluka m'malo oyera a class A ndi ISO 5, ndipo tinthu tomwe timapachikidwa ≥5.0μm ndiye muyezo wokhazikika. Mulingo wa tinthu touluka m'malo oyera a class B (static) ndi ISO 5, ndipo umaphatikizapo tinthu tomwe timapachikidwa tokhala ndi kukula kawiri patebulo. Pa malo oyera a class C (static ndi dynamic), mulingo wa tinthu touluka ndi ISO 7 ndi ISO 8 motsatana. Pa malo oyera a class D (static) mulingo wa tinthu touluka ndi ISO 8.
(4). Potsimikizira mulingo, chotsukira fumbi chonyamulika chokhala ndi chubu chachifupi choyezera zitsanzo chiyenera kugwiritsidwa ntchito kuti tinthu tating'onoting'ono tomwe timapachikidwa pa ≥5.0μm tisakhazikike mu chubu chachitali choyezera zitsanzo cha dongosolo lakutali. Mu machitidwe oyenda molunjika, mitu ya zitsanzo ya isokinetic iyenera kugwiritsidwa ntchito.
(5) Kuyesa kwamphamvu kungachitike panthawi ya ntchito zachizolowezi komanso njira zodzazira zoyezera njira yodzazira kuti zitsimikizire kuti ukhondo wamphamvu wapezeka, koma mayeso odzazira oyezera njira yodzazira amafunika mayeso amphamvu pansi pa "mkhalidwe woipa kwambiri".
Chipinda choyera cha Kalasi A
Chipinda choyera cha Kalasi A, chomwe chimadziwikanso kuti chipinda choyera cha kalasi 100 kapena chipinda choyera kwambiri, ndi chimodzi mwa zipinda zoyera kwambiri zomwe zili ndi ukhondo wapamwamba kwambiri. Chimatha kuwongolera kuchuluka kwa tinthu tating'onoting'ono pa futi imodzi mumlengalenga mpaka pansi pa 35.5, kutanthauza kuti, chiwerengero cha tinthu tating'onoting'ono toposa kapena tofanana ndi 0.5um mu mita iliyonse ya kyubiki ya mpweya sichingapitirire 3,520 (chosasunthika komanso chosinthasintha). Chipinda choyera cha Kalasi A chili ndi zofunikira kwambiri ndipo chimafuna kugwiritsa ntchito zosefera za hepa, kuwongolera kuthamanga kwa mpweya, machitidwe oyendera mpweya ndi machitidwe owongolera kutentha ndi chinyezi nthawi zonse kuti akwaniritse zofunikira zawo zaukhondo wapamwamba. Zipinda zoyera za Kalasi A zimagwiritsidwa ntchito makamaka pokonza ma microelectronics, biopharmaceuticals, kupanga zida zolondola, ndege ndi zina.
Chipinda choyera cha kalasi B
Zipinda zoyera za Class B zimatchedwanso zipinda zoyera za kalasi 1000. Ukhondo wawo ndi wochepa, zomwe zimapangitsa kuti chiwerengero cha tinthu tating'onoting'ono toposa kapena tofanana ndi 0.5um pa mita imodzi ya mpweya chifike pa 3520 (static) ndi 352000 (dynamic). Zipinda zoyera za Class B nthawi zambiri zimagwiritsa ntchito zosefera zogwira ntchito bwino komanso makina otulutsa utsi kuti ziwongolere kusiyana kwa chinyezi, kutentha ndi kuthamanga kwa mpweya m'nyumba. Zipinda zoyera za Class B zimagwiritsidwa ntchito makamaka mu biomedicine, kupanga mankhwala, makina olondola komanso kupanga zida ndi zina.
Chipinda choyera cha kalasi C
Zipinda zoyera za Class C zimatchedwanso zipinda zoyera za kalasi 10,000. Ukhondo wawo ndi wochepa, zomwe zimapangitsa kuti chiwerengero cha tinthu tating'onoting'ono toposa kapena tofanana ndi 0.5um pa mita imodzi ya mpweya chifike pa 352,000 (static) ndi 352,0000 (dynamic). Zipinda zoyera za Class C nthawi zambiri zimagwiritsa ntchito zosefera za hepa, kulamulira kuthamanga kwa mpweya, kuyendayenda kwa mpweya, kulamulira kutentha ndi chinyezi ndi ukadaulo wina kuti zikwaniritse miyezo yawo yeniyeni ya ukhondo. Zipinda zoyera za Class C zimagwiritsidwa ntchito makamaka mu mankhwala, kupanga zida zamankhwala, makina olondola komanso kupanga zida zamagetsi ndi madera ena.
Chipinda choyera cha kalasi D
Zipinda zoyera za Class D zimatchedwanso zipinda zoyera za kalasi 100,000. Ukhondo wawo ndi wochepa, zomwe zimapangitsa kuti chiwerengero cha tinthu tating'onoting'ono toposa kapena tofanana ndi 0.5um pa mita imodzi ya mpweya chifike pa 3,520,000 (static). Zipinda zoyera za Class D nthawi zambiri zimagwiritsa ntchito zosefera za hepa wamba komanso njira zowongolera kuthamanga kwa mpweya komanso njira zoyendetsera mpweya kuti ziwongolere malo okhala mkati. Zipinda zoyera za Class D zimagwiritsidwa ntchito makamaka popanga mafakitale, kukonza chakudya ndi kulongedza, kusindikiza, kusunga zinthu ndi zina.
Magawo osiyanasiyana a zipinda zoyera ali ndi ntchito zawozawo, zomwe ziyenera kusankhidwa malinga ndi zosowa zenizeni. Pa ntchito zenizeni, kuwongolera chilengedwe cha zipinda zoyera ndi ntchito yofunika kwambiri, yomwe imaphatikizapo kuganizira zinthu zambiri. Kapangidwe ndi ntchito zasayansi komanso zomveka zokha ndi zomwe zingatsimikizire ubwino ndi kukhazikika kwa malo oyera m'chipindacho.
Nthawi yotumizira: Marichi-07-2024