Chipinda choyera ndi malo olamulidwa mwapadera momwe zinthu monga kuchuluka kwa tinthu tating'onoting'ono mumpweya, chinyezi, kutentha ndi magetsi osasunthika zimatha kuwongoleredwa kuti zikwaniritse miyezo yoyeretsera. Zipinda zoyera zimagwiritsidwa ntchito kwambiri m'mafakitale apamwamba kwambiri monga ma semiconductors, zamagetsi, zamankhwala, zandege, zakuthambo ndi biomedicine.
M'mafotokozedwe a kasamalidwe ka mankhwala, chipinda choyera chimagawidwa m'magulu anayi: A, B, C ndi D.
Kalasi A: Malo omwe ali pachiwopsezo chachikulu, monga malo odzaza, malo omwe mipiringidzo yoyimitsa mphira ndi zotengera zotsegula zimalumikizana mwachindunji ndi zokonzekera zosabala, ndi madera omwe ntchito za aseptic kapena zolumikizira zimachitikira, ziyenera kukhala ndi tebulo logwiritsira ntchito unidirectional flow. kusunga chikhalidwe cha dera. Dongosolo la unidirectional flow liyenera kupereka mpweya wofanana m'malo ake ogwirira ntchito ndi liwiro la mpweya wa 0.36-0.54m/s. Payenera kukhala deta yotsimikizira momwe kayendetsedwe ka kayendetsedwe ka kayendetsedwe kake kakuyendera ndi kutsimikiziridwa. Pamalo otsekedwa, odzipatula okha kapena bokosi la glove, kuthamanga kwa mpweya kungagwiritsidwe ntchito.
Kalasi B: imatanthawuza malo akumbuyo komwe kalasi A yoyera imakhalapo kuti anthu azikhala pachiwopsezo chachikulu monga kukonzekera ndi kudzaza kwa aseptic.
Kalasi C ndi D: amatchula madera aukhondo omwe ali ndi njira zosafunikira kwambiri popanga mankhwala osabala.
Malingana ndi malamulo a GMP, makampani opanga mankhwala a dziko langa amagawaniza madera oyera kukhala 4 magawo a ABCD monga pamwambapa potengera zizindikiro monga ukhondo wa mpweya, kuthamanga kwa mpweya, kuchuluka kwa mpweya, kutentha ndi chinyezi, phokoso ndi tizilombo toyambitsa matenda.
Miyezo ya madera oyera imagawidwa molingana ndi kuchuluka kwa tinthu tating'onoting'ono ta mpweya. Nthawi zambiri, mtengo wocheperako, umakhala wokwera kwambiri.
1. Ukhondo wa mumlengalenga umatanthawuza kukula ndi kuchuluka kwa tinthu ting'onoting'ono (kuphatikiza tizilombo tating'onoting'ono) tomwe timakhala mumlengalenga pamlingo wa danga, womwe ndi mulingo wosiyanitsa ukhondo wa danga.
Static imatanthawuza boma pambuyo pa kukhazikitsa makina oziziritsa mpweya m'chipinda choyera ndikugwira ntchito mokwanira, ndipo ogwira ntchito m'chipinda chaukhondo achoka pamalopo ndikudziyeretsa kwa mphindi 20.
Mphamvu imatanthauza kuti chipinda chaukhondo chili m'malo ogwirira ntchito, zida zimagwira ntchito bwino, ndipo ogwira ntchito omwe asankhidwa akugwira ntchito molingana ndi zomwe zanenedwa.
2. Muyezo wa ABCD umachokera ku GMP yolengezedwa ndi World Health Organization (WHO), yomwe ndi yodziwika bwino yopangira mankhwala pamakampani opanga mankhwala. Ikugwiritsidwa ntchito m'madera ambiri padziko lonse lapansi, kuphatikizapo European Union ndi China.
Chitchaina chakale cha GMP chinatsatira miyezo yaku America (kalasi 100, kalasi 10,000, kalasi 100,000) mpaka kukhazikitsidwa kwa miyezo yatsopano ya GMP mu 2011. Makampani opanga mankhwala aku China ayamba kugwiritsa ntchito miyezo yamagulu a WHO ndikugwiritsa ntchito ABCD kusiyanitsa milingo ya madera aukhondo.
Miyezo ina ya zipinda zoyera
Zipinda zoyera zimakhala ndi milingo yosiyanasiyana m'magawo ndi mafakitale osiyanasiyana. Miyezo ya GMP idayambitsidwa kale, ndipo apa tikuwonetsa kwambiri miyezo yaku America ndi miyezo ya ISO.
(1). American Standard
Lingaliro lakuyika zipinda zoyera lidaperekedwa koyamba ndi United States. Mu 1963, gawo loyamba la federal la gawo lankhondo la chipinda choyera linakhazikitsidwa: FS-209. Miyezo yodziwika bwino ya kalasi 100, kalasi 10000 ndi kalasi 100000 zonse zimachokera ku muyezo uwu. Mu 2001, United States idasiya kugwiritsa ntchito muyezo wa FS-209E ndipo idayamba kugwiritsa ntchito muyezo wa ISO.
(2). Miyezo ya ISO
Miyezo ya ISO imaperekedwa ndi International Organisation for Standardization ISO ndipo imakhudza mafakitale angapo, osati makampani opanga mankhwala okha. Pali milingo isanu ndi inayi kuyambira kalasi 1 mpaka 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 kuchuluka kwa malo oyera a Gulu A, voliyumu yachitsanzo chilichonse sichiyenera kuchepera 1 kiyubiki mita. Mulingo wa tinthu tating'onoting'ono ta kalasi A malo oyera ndi ISO 5, tinthu tapang'onopang'ono ≥5.0μm ngati malire. Mulingo wa tinthu tating'onoting'ono tating'onoting'ono tating'onoting'ono ta kalasi B (static) ndi ISO 5, ndipo mumaphatikizapo tinthu tating'onoting'ono tokhala ndi miyeso iwiri patebulo. M'malo oyera a kalasi C (okhazikika komanso osunthika), milingo ya tinthu tating'onoting'ono tokhala ndi mpweya ndi ISO 7 ndi ISO 8 motsatana. M'malo oyera a kalasi D (static) mulingo wa tinthu tating'onoting'ono ta mpweya ndi ISO 8.
(4). Mukatsimikizira mulingowo, kauntala ya fumbi yonyamula yokhala ndi chubu chachifupi chachifupi iyenera kugwiritsidwa ntchito kuteteza ≥5.0μm kuyimitsidwa tinthu ting'onoting'ono kuti tisakhazikike muchubu chachitali chotengera chitsanzo chakutali. M'machitidwe a unidirectional flow, mitu yoyeserera ya isokinetic iyenera kugwiritsidwa ntchito.
(5) Kuyesa kwamphamvu kumatha kuchitidwa nthawi zonse komanso njira zotsatsira zikhalidwe zofananira kuti zitsimikizire kuti ukhondo wokhazikika umakwaniritsidwa, koma kuyesa kwapakatikati kofananira kumafunikira kuyesedwa kwamphamvu pansi pa "mkhalidwe woyipa kwambiri".
Kalasi A chipinda choyera
Chipinda choyera cha Class A, chomwe chimadziwikanso kuti chipinda choyera cha 100 kapena chipinda choyera kwambiri, ndi chimodzi mwazipinda zaukhondo kwambiri. Iwo akhoza kulamulira chiwerengero cha particles pa phazi kiyubiki mu mpweya zosakwana 35.5, kutanthauza kuti, chiwerengero cha particles wamkulu kapena wofanana 0.5um aliyense kiyubiki mita mpweya sangathe upambana 3,520 (malo amodzi ndi zamphamvu). Kalasi A chipinda choyera chimakhala ndi zofunikira kwambiri ndipo zimafunikira kugwiritsa ntchito zosefera za hepa, kuwongolera kusinthasintha kwamphamvu, makina oyendetsa mpweya komanso kutentha kosalekeza ndi machitidwe owongolera chinyezi kuti akwaniritse zofunikira zawo zaukhondo. Zipinda zoyera za Class A zimagwiritsidwa ntchito makamaka pokonza ma microelectronics, biopharmaceuticals, kupanga zida zolondola, zakuthambo ndi zina.
Chipinda choyera cha Class B
Zipinda zoyera za Class B zimatchedwanso zipinda zoyera za kalasi 1000. Mulingo wawo waukhondo ndi wocheperako, zomwe zimalola kuti tinthu tating'onoting'ono tomwe tinthu tating'onoting'ono ting'onoting'ono kapena tofanana ndi 0.5um pa kiyubiki mita ya mpweya kufika 3520 (static) ndi 352000 (zamphamvu). Zipinda zoyera za Gulu B nthawi zambiri zimagwiritsa ntchito zosefera zogwira mtima kwambiri komanso makina otulutsa mpweya kuti azitha kuwongolera chinyezi, kutentha komanso kupanikizika kwa m'nyumba. Zipinda zoyera za Class B zimagwiritsidwa ntchito makamaka mu biomedicine, kupanga mankhwala, makina olondola komanso kupanga zida ndi zina.
Chipinda choyera cha Class C
Zipinda zoyera za Class C zimatchedwanso zipinda zoyera za kalasi 10,000. Ukhondo wawo ndi wochepa kwambiri, zomwe zimapangitsa kuti chiwerengero cha particles chachikulu kuposa kapena chofanana ndi 0.5um pa cubic mita imodzi ya mpweya kufika 352,000 (static) ndi 352,0000 (zamphamvu). Zipinda zoyera za Class C nthawi zambiri zimagwiritsa ntchito zosefera za hepa, kuwongolera kuthamanga kwabwino, kuyenda kwa mpweya, kuwongolera kutentha ndi chinyezi ndi matekinoloje ena kuti akwaniritse miyezo yawo yaukhondo. Zipinda zoyera za Class C zimagwiritsidwa ntchito kwambiri pazamankhwala, kupanga zida zamankhwala, makina olondola komanso kupanga zinthu zamagetsi ndi zina.
Chipinda choyera cha Class D
Zipinda zoyera za Class D zimatchedwanso zipinda zoyera za kalasi 100,000. Mulingo wawo waukhondo ndi wocheperako, zomwe zimapangitsa kuti tinthu tating'onoting'ono tomwe titha kupitilira kapena kufanana ndi 0.5um pa kiyubiki mita ya mpweya kufika 3,520,000 (static). Zipinda zoyera za Class D nthawi zambiri zimagwiritsa ntchito zosefera wamba za hepa komanso zowongolera zoyambira zabwino komanso makina oyendetsa mpweya kuti athe kuwongolera chilengedwe chamkati. Zipinda zoyera za Class D zimagwiritsidwa ntchito kwambiri popanga mafakitale, kukonza chakudya ndikuyika, kusindikiza, kusungirako zinthu ndi zina.
Magawo osiyanasiyana a zipinda zoyera ali ndi mawonekedwe awoawo, omwe ayenera kusankhidwa malinga ndi zosowa zenizeni. M'magwiritsidwe ntchito, kuyang'anira chilengedwe cha zipinda zoyera ndi ntchito yofunika kwambiri, yomwe imaphatikizapo kulingalira mozama pazinthu zambiri. Mapangidwe ndi magwiridwe antchito asayansi ndi omveka okha ndi omwe angatsimikizire kukhazikika ndi kukhazikika kwa malo oyera achipinda.
Nthawi yotumiza: Mar-07-2024