Chiyambi
Mu lingaliro la mankhwala, chipinda choyera chimatanthauza chipinda chomwe chimakwaniritsa zofunikira za GMP zosakhudzana ndi majeremusi. Chifukwa cha zofunikira zolimba pakukweza ukadaulo wopanga zinthu pa malo opangira zinthu, chipinda choyera cha labotale chimadziwikanso kuti "mtetezi wa kupanga zinthu zapamwamba."
1. Kodi chipinda choyera n'chiyani?
Chipinda choyera, chomwe chimadziwikanso kuti chipinda chopanda fumbi, nthawi zambiri chimagwiritsidwa ntchito ngati gawo la kupanga mafakitale kapena kafukufuku wasayansi, kuphatikizapo kupanga mankhwala, ma circuits ophatikizidwa, CRT, LCD, OLED ndi ma micro LED displays, ndi zina zotero.
Chipinda choyera chimapangidwa kuti chisunge tinthu tating'onoting'ono tochepa kwambiri, monga fumbi, zamoyo zouluka, kapena tinthu tomwe timatenthedwa ndi nthunzi. Makamaka, chipinda choyera chimakhala ndi mlingo woyeretsedwa wolamulidwa, womwe umafotokozedwa ndi chiwerengero cha tinthu tating'onoting'ono pa mita imodzi ya kiyubiki pa kukula kwa tinthu tating'onoting'ono tomwe tatchulidwa.
Chipinda choyera chingatanthauzenso malo aliwonse osungiramo zinthu omwe njira zochepetsera kuipitsidwa kwa tinthu tating'onoting'ono ndikuwongolera zinthu zina zachilengedwe monga kutentha, chinyezi ndi kupanikizika. M'lingaliro la mankhwala, chipinda choyera ndi chipinda chomwe chimakwaniritsa zofunikira za GMP zomwe zafotokozedwa mu GMP aseptic specifications. Ndi kuphatikiza kwa kapangidwe ka uinjiniya, kupanga, kumaliza ndi kuwongolera magwiridwe antchito (njira yowongolera) komwe kumafunika kuti chipinda wamba chikhale chipinda choyera. Zipinda zoyera zimagwiritsidwa ntchito m'mafakitale ambiri, kulikonse komwe tinthu tating'onoting'ono tingakhale ndi zotsatira zoyipa pakupanga.
Zipinda zoyera zimasiyana kukula ndi zovuta ndipo zimagwiritsidwa ntchito kwambiri m'mafakitale monga kupanga zinthu za semiconductor, mankhwala, biotechnology, zipangizo zachipatala ndi sayansi ya moyo, komanso kupanga zinthu zofunika kwambiri zomwe zimapezeka m'mabwalo a ndege, kuwala, asilikali ndi Dipatimenti ya Mphamvu.
2. Kupanga chipinda choyera
Chipinda choyera chamakono chinapangidwa ndi katswiri wa sayansi ya zaku America Willis Whitfield. Whitfield, monga wantchito wa Sandia National Laboratories, adapanga kapangidwe koyambirira ka chipinda choyera mu 1966. Whitfield asanapange, chipinda choyera choyambirira nthawi zambiri chinkakumana ndi mavuto ndi tinthu tating'onoting'ono komanso mpweya wosayembekezereka.
Whitfield adapanga chipinda choyera chokhala ndi mpweya woyenda mosalekeza komanso wosefedwa bwino kuti malowo akhale oyera. Malo ambiri opangira zinthu zozungulira ku Silicon Valley adamangidwa ndi makampani atatu: MicroAire, PureAire, ndi Key Plastics. Adapanga mayunitsi oyenda pansi, mabokosi a magolovesi, zipinda zoyera ndi mashawa a mpweya, komanso matanki a mankhwala ndi mabenchi ogwirira ntchito pomanga mabwalo ozungulira "onyowa". Makampani atatuwa analinso oyambitsa kugwiritsa ntchito Teflon popanga mfuti zamlengalenga, mapampu a mankhwala, zotsukira, mfuti zamadzi, ndi zida zina zofunika popanga mabwalo ozungulira. William (Bill) C. McElroy Jr. anali manejala wa uinjiniya, woyang'anira chipinda cholembera, QA/QC, komanso wopanga makampani atatuwa, ndipo mapangidwe ake adawonjezera ma patent 45 oyambirira kuukadaulo wa nthawiyo.
3. Mfundo Zokhudza Kuyenda kwa Mpweya M'chipinda Choyera
Zipinda zoyera zimalamulira tinthu tomwe timauluka pogwiritsa ntchito zosefera za HEPA kapena ULPA, pogwiritsa ntchito njira ya laminar (kuyenda kwa njira imodzi) kapena njira yozungulira mpweya yozungulira (kugwedezeka, kosakhala njira imodzi).
Mayendedwe a mpweya a Laminar kapena njira imodzi amatsogolera mpweya wosefedwa mosasunthika pansi kapena mopingasa ku zosefera zomwe zili pakhoma pafupi ndi pansi pa chipinda choyera, kapena kuzunguliridwanso kudzera m'mapanelo okwera pansi okhala ndi mabowo.
Machitidwe oyendera mpweya wa Laminar nthawi zambiri amagwiritsidwa ntchito pa denga loyera la chipinda kuti mpweya ukhale wosasunthika. Chitsulo chosapanga dzimbiri kapena zinthu zina zosataya mpweya zimagwiritsidwa ntchito popanga zosefera ndi ma hood a laminar air flow kuti tinthu tambiri tisalowe mumlengalenga. Kuyenda kwa mpweya wosasunthika, kapena wosakhala wa mbali imodzi kumagwiritsa ntchito ma hood a laminar air flow ndi ma filters osakhala a liwiro kuti mpweya ukhale wosasunthika mu chipinda choyera, ngakhale kuti si onse omwe ali mbali imodzi.
Mpweya woipa umayesetsa kugwira tinthu tating'onoting'ono tomwe tingakhale mumlengalenga ndikukankhira pansi, komwe timalowa mu fyuluta ndikutuluka m'chipinda choyera. Malo ena amawonjezeranso zipinda zoyera: mpweya umaperekedwa m'makona apamwamba a chipindacho, zosefera za hepa zooneka ngati fan zimagwiritsidwa ntchito, ndipo zosefera za hepa wamba zingagwiritsidwenso ntchito ndi zotulutsira mpweya zooneka ngati fan. Zotulutsira mpweya wobwerera zimayikidwa pansi pa mbali inayo. Chiŵerengero cha kutalika ndi kutalika kwa chipinda nthawi zambiri chimakhala pakati pa 0.5 ndi 1. Mtundu uwu wa chipinda choyera ukhozanso kukwaniritsa ukhondo wa Class 5 (Class 100).
Zipinda zoyera zimafuna mpweya wambiri ndipo nthawi zambiri zimakhala pa kutentha koyenera komanso chinyezi cholamulidwa. Kuti muchepetse mtengo wosintha kutentha kapena chinyezi chozungulira, pafupifupi 80% ya mpweya imazunguliranso (ngati mawonekedwe a chinthucho amalola), ndipo mpweya wozunguliranso umasefedwa kaye kuti uchotse tinthu tating'onoting'ono pamene ukusunga kutentha ndi chinyezi choyenera musanadutse m'chipinda choyera.
Tinthu tomwe timauluka m'mlengalenga (zodetsa) zimayandama pang'onopang'ono. Tinthu tambiri tomwe timauluka m'mlengalenga timakhazikika pang'onopang'ono, ndipo kuchuluka kwa mpweya womwe umakhazikika kumadalira kukula kwake. Dongosolo loyendetsera mpweya lopangidwa bwino liyenera kupereka mpweya wabwino watsopano komanso wosefedwa womwe umazungulira m'chipinda choyera pamodzi, ndikunyamula tinthu kuchokera m'chipinda choyera pamodzi. Kutengera ndi momwe ntchito ikuyendera, mpweya wotengedwa m'chipindacho nthawi zambiri umazunguliranso kudzera mu dongosolo loyendetsera mpweya, komwe zosefera zimachotsa tinthu tating'onoting'ono.
Ngati njira, zipangizo zopangira kapena zinthu zili ndi chinyezi chambiri, nthunzi yoipa kapena mpweya, mpweyawu sungabwererenso mchipindamo. Mpweyawu nthawi zambiri umatha mumlengalenga, kenako mpweya wabwino 100% umalowa m'chipinda choyera ndikukonzedwa musanalowe m'chipinda choyera.
Kuchuluka kwa mpweya wolowa m'chipinda choyera kumayendetsedwa bwino, ndipo kuchuluka kwa mpweya wotuluka kumayendetsedwanso bwino. Zipinda zambiri zoyera zimakhala ndi mpweya wopanikizika, zomwe zimachitika polowa m'chipinda choyera chokhala ndi mpweya wochuluka kuposa mpweya wotuluka m'chipinda choyera. Kupanikizika kwakukulu kungayambitse mpweya kutuluka pansi pa zitseko kapena kudzera m'ming'alu kapena mipata yosapeŵeka m'chipinda chilichonse choyera. Chinsinsi cha kapangidwe kabwino ka chipinda choyera ndi malo oyenera olowera mpweya (kutulutsa) ndi utsi (utsi).
Mukayika chipinda choyera, malo omwe pali ma grille operekera mpweya ndi utsi (wobwezera) ayenera kukhala patsogolo. Malo olowera (denga) ndi ma grille obwezera (pamlingo wotsika) ayenera kukhala mbali zosiyana za chipinda choyera. Ngati wogwiritsa ntchitoyo akufunika kutetezedwa ku chinthucho, mpweya uyenera kuyenda kutali ndi wogwiritsa ntchitoyo. US FDA ndi EU ali ndi malangizo okhwima kwambiri komanso malire a kuipitsidwa kwa tizilombo toyambitsa matenda, ndipo ma plenum pakati pa chogwirira mpweya ndi chipangizo chosefera cha fan ndi ma sticky mat angagwiritsidwenso ntchito. Pazipinda zoyera zomwe zimafuna mpweya wa Class A, mpweya umayenda kuchokera pamwamba mpaka pansi ndipo umakhala wolunjika mbali imodzi kapena wopingasa, kuonetsetsa kuti mpweya sunaipitsidwe usanakhudze chinthucho.
4. Kuipitsidwa kwa chipinda choyera
Chiwopsezo chachikulu cha kuipitsidwa kwa zipinda zoyera chimachokera kwa ogwiritsa ntchito okha. M'mafakitale azachipatala ndi mankhwala, kuwongolera tizilombo toyambitsa matenda ndikofunikira kwambiri, makamaka tizilombo toyambitsa matenda tomwe tingatuluke pakhungu ndikuyikidwa mu mpweya. Kuphunzira za zomera za tizilombo toyambitsa matenda m'zipinda zoyera ndikofunikira kwambiri kwa akatswiri a tizilombo toyambitsa matenda ndi ogwira ntchito yoyang'anira khalidwe kuti aone momwe zinthu zikuyendera, makamaka pofufuza mitundu yosamva mankhwala komanso kafukufuku wa njira zoyeretsera ndi kupha tizilombo toyambitsa matenda. Zomera zoyera m'zipinda zoyera zimagwirizana kwambiri ndi khungu la munthu, ndipo padzakhalanso tizilombo toyambitsa matenda kuchokera kuzinthu zina, monga zachilengedwe ndi madzi, koma pang'ono. Mitundu yodziwika bwino ya mabakiteriya ndi Micrococcus, Staphylococcus, Corynebacterium ndi Bacillus, ndipo mitundu ya bowa ndi Aspergillus ndi Penicillium.
Pali zinthu zitatu zazikulu zomwe zimapangitsa kuti chipinda chikhale choyera.
(1). Pamwamba pa chipinda choyera ndi zida zake zamkati
Mfundo yaikulu ndi yakuti kusankha zinthu n'kofunika, ndipo kuyeretsa tsiku ndi tsiku ndi kuyeretsa ndi kuyeretsa ndikofunika kwambiri. Kuti mutsatire GMP ndikukwaniritsa zofunikira za ukhondo, malo onse a chipinda choyera ayenera kukhala osalala komanso osalowa mpweya, osapanga kuipitsa kwawo, kutanthauza kuti, palibe fumbi, kapena zinyalala, osagwira dzimbiri, osavuta kuyeretsa, apo ayi apereka malo oberekera tizilombo toyambitsa matenda, ndipo pamwamba pake payenera kukhala wolimba komanso wolimba, ndipo sungasweke, kusweka kapena kusweka. Pali zinthu zosiyanasiyana zomwe mungasankhe, kuphatikizapo ma panels okwera mtengo, magalasi, ndi zina zotero. Chosankha chabwino komanso chokongola kwambiri ndi galasi. Kuyeretsa ndi kuyeretsa nthawi zonse kuyenera kuchitika mogwirizana ndi zofunikira za zipinda zoyera pamlingo uliwonse. Kuchuluka kwa nthawi kungakhale pambuyo pa ntchito iliyonse, kangapo patsiku, tsiku lililonse, masiku angapo, kamodzi pa sabata, ndi zina zotero. Ndikofunikira kuti tebulo logwirira ntchito liyeretsedwe ndi kutsukidwa pambuyo pa ntchito iliyonse, pansi pake payenera kutsukidwa tsiku lililonse, khoma liyenera kutsukidwa sabata iliyonse, ndipo malowo ayeretsedwe ndi kutsukidwa mwezi uliwonse malinga ndi mulingo wa chipinda choyera ndi miyezo ndi zofunikira zomwe zakhazikitsidwa, ndipo zolemba ziyenera kusungidwa.
(2). Kulamulira mpweya m'chipinda choyera
Kawirikawiri, ndikofunikira kusankha kapangidwe koyenera ka chipinda choyera, kukonza nthawi zonse, ndikuyang'anira tsiku ndi tsiku. Chisamaliro chapadera chiyenera kuperekedwa pakuyang'anira mabakiteriya oyandama m'zipinda zoyera za mankhwala. Mabakiteriya oyandama m'malowa amachotsedwa ndi choyezera mabakiteriya oyandama kuti atulutse mpweya winawake m'malowa. Mpweya umadutsa m'mbale yolumikizirana yodzazidwa ndi malo enaake okulira. Mbale yolumikizirana idzagwira tizilombo toyambitsa matenda, kenako mbaleyo imayikidwa mu chosungira kuti iwerengere kuchuluka kwa madera ndikuwerengera kuchuluka kwa tizilombo toyambitsa matenda m'malowa. Tizilombo toyambitsa matenda mu laminar layer tiyeneranso kuzindikirika, pogwiritsa ntchito choyezera mabakiteriya oyandama cha laminar layer. Mfundo yogwirira ntchito ndi yofanana ndi ya mlengalenga, kupatula kuti malo oyezera ayenera kuyikidwa mu laminar layer. Ngati mpweya wokakamizidwa ukufunika m'chipinda chopanda tizilombo, ndikofunikiranso kuchita mayeso a tizilombo pa mpweya wokakamizidwa. Pogwiritsa ntchito choyezera mpweya wokakamizidwa chofanana, kuthamanga kwa mpweya wokakamizidwa kuyenera kusinthidwa kuti kukhale koyenera kuti tipewe kuwonongeka kwa tizilombo toyambitsa matenda ndi malo osungira zomera.
(3). Zofunikira kwa ogwira ntchito m'chipinda choyera
Ogwira ntchito m'zipinda zoyera ayenera kuphunzitsidwa nthawi zonse za chiphunzitso choletsa kuipitsidwa. Amalowa ndi kutuluka m'chipinda choyera kudzera m'malo otsekeredwa ndi mpweya, shawa ndi/kapena zipinda zosinthira zovala, ndipo ayenera kuvala zovala zapadera zophimba khungu ndi zinthu zodetsa thupi zomwe zimapezeka mwachibadwa. Kutengera ndi gulu kapena ntchito ya chipinda choyera, zovala za ogwira ntchito zingafunike chitetezo chosavuta monga malaya ndi ma hood a labotale, kapena zitha kuphimbidwa kwathunthu osawonetsa khungu lililonse. Zovala zoyera za m'chipinda zimagwiritsidwa ntchito poletsa tinthu tating'onoting'ono ndi/kapena tizilombo toyambitsa matenda kuti tisatuluke m'thupi la wovala ndikuipitsa chilengedwe.
Zovala zoyera za chipinda zokha siziyenera kutulutsa tinthu tating'onoting'ono kapena ulusi kuti zisawononge chilengedwe. Kuipitsidwa kwa anthu ogwira ntchito kumeneku kungachepetse magwiridwe antchito a mankhwala m'mafakitale a semiconductor ndi mankhwala, ndipo kungayambitse matenda osiyanasiyana pakati pa ogwira ntchito zachipatala ndi odwala omwe ali mumakampani azaumoyo, mwachitsanzo. Zipangizo zodzitetezera ku chipinda choyera zimaphatikizapo zovala zodzitetezera, nsapato, nsapato, ma apuloni, zophimba ndevu, zipewa zozungulira, zophimba nkhope, zovala zogwirira ntchito/zovala za labu, magawuni, magolovesi ndi machira a zala, manja ndi zophimba nsapato ndi nsapato. Mtundu wa zovala zoyera za chipinda zomwe zimagwiritsidwa ntchito uyenera kuwonetsa chipinda choyera ndi gulu la zinthu. Zipinda zoyera zochepa zingafunike nsapato zapadera zokhala ndi zofunda zosalala zomwe sizingayime pa fumbi kapena dothi. Komabe, pazifukwa zachitetezo, zophimba nkhope za nsapato sizingayambitse ngozi yotsetsereka. Zovala zoyera za chipinda nthawi zambiri zimafunika kuti mulowe m'chipinda choyera. Zovala zosavuta za labu, zophimba mutu ndi zophimba nsapato zingagwiritsidwe ntchito m'chipinda choyera cha Class 10,000. Pa chipinda choyera cha Class 100, zophimba thupi lonse, zovala zoteteza zokhala ndi zipu, magalasi a maso, zophimba nkhope, magolovesi ndi zophimba nsapato ndizofunikira. Kuphatikiza apo, chiwerengero cha anthu omwe ali m'chipinda choyera chiyenera kulamulidwa, ndi avareji ya 4 mpaka 6 m2/munthu, ndipo ntchitoyi iyenera kukhala yofatsa, kupewa mayendedwe akuluakulu komanso ofulumira.
5. Njira zodziwika bwino zophera tizilombo toyambitsa matenda m'chipinda choyera
(1). Kuchotsa majeremusi ku UV
(2). Kupha tizilombo toyambitsa matenda ku ozoni
(3). Kuyeretsa mpweya Mankhwala ophera tizilombo toyambitsa matenda ndi monga formaldehyde, epoxyothane, peroxyacetic acid, carbolic acid ndi lactic acid mixtures, ndi zina zotero.
(4) Mankhwala ophera tizilombo toyambitsa matenda
Mankhwala ophera tizilombo toyambitsa matenda omwe amagwiritsidwa ntchito kwambiri ndi isopropyl alcohol (75%), ethanol (75%), glutaraldehyde, Chlorhexidine, ndi zina zotero. Njira yachikhalidwe yophera tizilombo m'zipinda zoyera m'mafakitale opanga mankhwala aku China ndi kugwiritsa ntchito formaldehyde fumigation. Mafakitale opanga mankhwala akunja amakhulupirira kuti formaldehyde ili ndi vuto lalikulu pa thupi la munthu. Tsopano nthawi zambiri amagwiritsa ntchito kupopera glutaraldehyde. Mankhwala ophera tizilombo omwe amagwiritsidwa ntchito m'zipinda zoyera ayenera kutsukidwa ndi kusefedwa kudzera mu nembanemba ya 0.22μm mu kabati yotetezeka ya zamoyo.
6. Kugawa chipinda choyera
Chipinda choyera chimagawidwa malinga ndi kuchuluka ndi kukula kwa tinthu tomwe timaloledwa pa voliyumu ya mpweya. Manambala akuluakulu monga "Class 100" kapena "Class 1000" amatanthauza FED-STD-209E, zomwe zimasonyeza kuchuluka kwa tinthu tating'onoting'ono tomwe timaloledwa pa cubic foot ya mpweya. Muyezowu umalolanso kulowetsedwa; mwachitsanzo, SNOLAB imasungidwa pa chipinda choyera cha Class 2000. Ma counter a tinthu tating'onoting'ono tomwe timafalikira mumlengalenga amagwiritsidwa ntchito kudziwa kuchuluka kwa tinthu tating'onoting'ono tomwe timauluka mofanana kapena kuposa kukula komwe kwatchulidwa pamalo enaake osankhidwa.
Mtengo wa decimal umatanthauza muyezo wa ISO 14644-1, womwe umatchula logarithm ya decimal ya chiwerengero cha tinthu tating'onoting'ono tomwe tili 0.1μm kapena kuposerapo chololedwa pa mita imodzi ya mpweya. Mwachitsanzo, chipinda choyera cha ISO Class 5 chili ndi tinthu tating'onoting'ono tosakwana 105/m3. FS 209E ndi ISO 14644-1 zonse zimaganiza kuti pali ubale wa logarithmic pakati pa kukula kwa tinthu tating'onoting'ono ndi kuchuluka kwa tinthu tating'onoting'ono. Chifukwa chake, kuchuluka kwa tinthu tating'onoting'ono kulibe. Magulu ena safuna kuyesedwa kwa kukula kwa tinthu tating'onoting'ono chifukwa kuchuluka kwake ndi kochepa kwambiri kapena kokwera kwambiri kuti kukhale kothandiza, koma malo otere sayenera kuonedwa ngati zero. Popeza 1m3 ndi pafupifupi 35 cubic feet, miyezo iwiriyi ndi yofanana poyesa tinthu tating'onoting'ono ta 0.5μm. Mpweya wamba wamkati ndi pafupifupi Class 1,000,000 kapena ISO 9.
ISO 14644-1 ndi ISO 14698 ndi miyezo yomwe si ya boma yomwe idapangidwa ndi International Organization for Standardization (ISO). Yoyamba imagwira ntchito pa chipinda choyera nthawi zambiri; yachiwiri imagwira ntchito pa chipinda choyera chomwe chingakhale vuto ndi kuipitsidwa kwa zinthu zachilengedwe.
Mabungwe olamulira omwe alipo pano ndi awa: ISO, USP 800, US Federal Standard 209E (muyezo wakale, womwe ukugwiritsidwabe ntchito) Drug Quality and Safety Act (DQSA) idakhazikitsidwa mu Novembala 2013 kuti ithetse imfa zomwe zimayambitsa mankhwala osokoneza bongo komanso zochitika zoyipa kwambiri. Federal Food, Drug, and Cosmetic Act (FD&C Act) imakhazikitsa malangizo ndi mfundo zinazake za mankhwala opangidwa ndi anthu. 503A imayang'aniridwa ndi ogwira ntchito ovomerezeka (amankhwala/madokotala) ndi mabungwe ovomerezeka aboma kapena aboma. 503B imagwirizana ndi kupereka ntchito kwa anthu ena ndipo imafuna kuyang'aniridwa mwachindunji ndi wamankhwala wovomerezeka ndipo sikuyenera kukhala pharmacy yovomerezeka. Maofesiwa amapeza zilolezo kudzera mu Food and Drug Administration (FDA).
Malangizo a EU GMP ndi okhwima kuposa malangizo ena ndipo amafuna malo oyera kuti apeze kuchuluka kwa tinthu timene timagwira ntchito (panthawi yopanga) komanso pamene akupuma (pamene palibe kupanga komwe kukuchitika koma chipinda cha AHU chilipo).
8. Mafunso ochokera kwa oyamba kumene mu labu
(1). Kodi mumalowa ndi kutuluka bwanji m'chipinda choyera? Anthu ndi katundu amalowa ndi kutuluka kudzera m'makhomo ndi m'makhomo osiyanasiyana. Anthu amalowa ndi kutuluka kudzera m'makhomo otseguka (ena ali ndi mashawa a mpweya) kapena opanda makhomo otseguka ndipo amavala zida zodzitetezera monga ma hood, masks, magolovesi, nsapato ndi zovala zodzitetezera. Izi ndi kuchepetsa ndikuletsa tinthu tating'onoting'ono tomwe anthu amalowa m'chipinda choyera. Katundu amalowa ndi kutuluka m'chipinda choyera kudzera mu njira yonyamula katundu.
(2). Kodi pali chilichonse chapadera pa kapangidwe ka chipinda choyera? Kusankha zipangizo zomangira chipinda choyera sikuyenera kupanga tinthu tating'onoting'ono, kotero chophimba cha pansi cha epoxy kapena polyurethane chimakondedwa. Mapanelo ogawa sandwichi ndi denga opukutidwa ndi chitsulo chosapanga dzimbiri kapena opakidwa ufa amagwiritsidwa ntchito. Makona opingasa kumanja amapewa ndi malo opindika. Mapazi onse kuyambira pakona mpaka pansi ndi pakona mpaka padenga ayenera kutsekedwa ndi epoxy sealant kuti tipewe kuyika tinthu tating'onoting'ono kapena kupanga tinthu tating'onoting'ono m'malo olumikizirana. Zipangizo zomwe zili m'chipinda choyera zimapangidwa kuti zipange mpweya wochepa. Gwiritsani ntchito ma mops ndi mabaketi opangidwa mwapadera okha. Mipando yoyera ya chipinda iyeneranso kupangidwa kuti ipange tinthu tating'onoting'ono komanso yosavuta kuyeretsa.
(3). Kodi mungasankhe bwanji mankhwala ophera tizilombo toyambitsa matenda oyenera? Choyamba, kusanthula kwa chilengedwe kuyenera kuchitika kuti kutsimikizire mtundu wa tizilombo toyambitsa matenda omwe ali ndi kachilombo kudzera mu kuyang'anira chilengedwe. Gawo lotsatira ndikudziwa kuti ndi mankhwala ati omwe angaphe tizilombo toyambitsa matenda omwe amadziwika. Musanayambe kuyesa nthawi yokhudzana ndi kupha tizilombo toyambitsa matenda (njira yoyezera chubu kapena njira yoyezera zinthu pamwamba) kapena kuyesa kwa AOAC, mankhwala ophera tizilombo omwe alipo ayenera kuyesedwa ndikutsimikiziridwa kuti ndi oyenera. Kuti muphe tizilombo toyambitsa matenda m'chipinda choyera, nthawi zambiri pali mitundu iwiri ya njira zozungulira tizilombo toyambitsa matenda: ① Kuzungulira kwa mankhwala ophera tizilombo toyambitsa matenda amodzi ndi sporicide imodzi, ② Kuzungulira kwa mankhwala ophera tizilombo awiri ndi sporicide imodzi. Dongosolo lophera tizilombo litatsimikizika, mayeso ophera tizilombo toyambitsa matenda amatha kuchitika kuti apereke maziko osankha mankhwala ophera tizilombo. Mukamaliza kuyesa kophera tizilombo toyambitsa matenda, mayeso ophunzirira m'munda amafunika. Iyi ndi njira yofunika kutsimikizira ngati SOP yoyeretsa ndi yophera tizilombo komanso mayeso ophera tizilombo toyambitsa matenda a mankhwalawa ndi othandiza. Pakapita nthawi, tizilombo toyambitsa matenda tomwe sitinapezekepo tingaoneke, ndipo njira zopangira, antchito, ndi zina zotero zingasinthe, kotero ma SOP oyeretsera ndi kupha tizilombo toyambitsa matenda ayenera kuunikidwanso nthawi zonse kuti atsimikizire ngati akugwirabe ntchito pa chilengedwe chomwe chilipo.
(4). Makonde oyera kapena makonde odetsedwa? Ufa monga mapiritsi kapena makapisozi ndi makonde oyera, pomwe mankhwala osabala, mankhwala amadzimadzi, ndi zina zotero ndi makonde odetsedwa. Kawirikawiri, mankhwala osabala monga mapiritsi kapena makapisozi ndi ouma komanso afumbi, kotero pali kuthekera kwakukulu kwa kuipitsidwa kwakukulu. Ngati kusiyana kwa kuthamanga pakati pa malo oyera ndi konde kuli kwabwino, ufawo umatuluka m'chipindamo kupita ku konde kenako n'kusunthidwa ku chipinda china choyera. Mwamwayi, zokonzekera zambiri zouma sizimathandizira kukula kwa tizilombo toyambitsa matenda mosavuta, kotero nthawi zambiri, mapiritsi ndi ufa amapangidwa m'malo oyera chifukwa tizilombo toyambitsa matenda omwe amayandama mu konde sitingapeze malo omwe angakulire. Izi zikutanthauza kuti chipindacho chili ndi kupanikizika koyipa ku konde. Pa mankhwala osabala (okonzedwa), osabala kapena otsika a bioburden ndi mankhwala amadzimadzi, tizilombo toyambitsa matenda nthawi zambiri timapeza zomera zothandizira kuti zikulire, kapena pankhani ya mankhwala osabala, kachilombo kamodzi kokha kangakhale koopsa. Chifukwa chake, malo awa nthawi zambiri amapangidwa ndi makonde odetsedwa chifukwa cholinga chake ndikuteteza tizilombo toyambitsa matenda kuti tisalowe m'chipinda choyera.
Nthawi yotumizira: Feb-20-2025