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MAYANKHO NDI MAFUNSO OGWIRITSA NTCHITO CHIPINDA CHAKHALIDWE

chipinda choyera
gmp chipinda choyera

Mawu Oyamba

M'lingaliro lazamankhwala, chipinda choyera chimayimira chipinda chomwe chimakwaniritsa zofunikira za GMP. Chifukwa cha zofunikira kwambiri za kukweza kwa teknoloji pakupanga malo opangira, chipinda choyera cha labotale chimadziwikanso kuti "woyang'anira mafakitale apamwamba."

1. Kodi chipinda choyera ndi chiyani?

Chipinda choyera, chomwe chimadziwikanso kuti chipinda chopanda fumbi, nthawi zambiri chimagwiritsidwa ntchito ngati gawo la akatswiri opanga mafakitale kapena kafukufuku wasayansi, kuphatikiza kupanga mankhwala, mabwalo ophatikizika, CRT, LCD, OLED ndi zowonetsera zazing'ono za LED, ndi zina zambiri.

Chipinda chaukhondo chimapangidwa kuti chizikhala ndi tinthu tating'ono tochepa, monga fumbi, zamoyo zoyendetsedwa ndi mpweya, kapena tinthu tating'onoting'ono ta vaporized. Mwachindunji, chipinda choyera chimakhala ndi mlingo woipitsidwa wolamulidwa, womwe umatchulidwa ndi chiwerengero cha particles pa cubic mita pa kukula kwake kwa tinthu.

Chipinda choyera chitha kutanthauzanso malo aliwonse osungiramo momwe njira zochepetsera kuipitsidwa ndi kuwongolera zinthu zina zachilengedwe monga kutentha, chinyezi ndi kuthamanga. M'lingaliro lazamankhwala, chipinda choyera ndi chipinda chomwe chimakwaniritsa zofunikira za GMP zomwe zimafotokozedwa mumayendedwe a GMP aseptic. Ndi kuphatikiza kwa kapangidwe ka uinjiniya, kupanga, kumaliza ndi kuwongolera magwiridwe antchito (njira yowongolera) yofunika kusinthira chipinda wamba kukhala chipinda choyera. Zipinda zoyera zimagwiritsidwa ntchito m'mafakitale ambiri, kulikonse komwe tinthu tating'onoting'ono tingakhale ndi zotsatira zoyipa pakupanga.

Zipinda zoyera zimasiyana kukula kwake komanso zovuta zake ndipo zimagwiritsidwa ntchito kwambiri m'mafakitale monga kupanga semiconductor, mankhwala, biotechnology, zida zamankhwala ndi sayansi ya moyo, komanso njira zovuta kupanga zodziwika bwino muzamlengalenga, optics, asitikali ndi dipatimenti yamagetsi.

2. Kukula kwa chipinda choyera

Chipinda choyera chamakono chinapangidwa ndi wasayansi waku America Willis Whitfield. Whitfield, monga wogwira ntchito ku Sandia National Laboratories, adapanga mapangidwe oyambirira a chipinda choyera mu 1966. Asanayambe kupangidwa ndi Whitfield, chipinda choyambirira choyera nthawi zambiri chinkakumana ndi mavuto ndi tinthu tating'ono komanso mpweya wosadziwika bwino.

Whitfield adapanga chipinda choyera chokhala ndi mpweya wokhazikika komanso wosasunthika kuti malo azikhala oyera. Malo ambiri ophatikizika opangira madera ku Silicon Valley adamangidwa ndi makampani atatu: MicroAire, PureAire, ndi Key Plastics. Anapanga ma laminar otaya mayunitsi, mabokosi magolovesi, zipinda zoyera ndi shawa mpweya, komanso akasinja mankhwala ndi workbenches kwa "yonyowa ndondomeko" yomanga madera Integrated. Makampani atatuwa analinso apainiya pakugwiritsa ntchito Teflon pamfuti zamlengalenga, mapampu amadzimadzi, zotsukira, mfuti zamadzi, ndi zida zina zofunika pakupangira dera lophatikizika. William (Bill) C. McElroy Jr. adatumikira monga woyang'anira zomangamanga, woyang'anira chipinda chojambula, QA / QC, ndi wopanga makampani atatuwa, ndipo mapangidwe ake anawonjezera ma patent oyambirira a 45 ku teknoloji ya nthawiyo.

3. Mfundo za Ukhondo wa Mpweya m'chipinda

Zipinda zoyera zimayang'anira tinthu tating'onoting'ono ta mpweya pogwiritsa ntchito zosefera za HEPA kapena ULPA, pogwiritsa ntchito laminar (njira imodzi) kapena chipwirikiti (mopanda chipwirikiti, osayenda njira imodzi).

Makina oyendera mpweya kapena njira imodzi amawongolera mpweya wosefedwa mosalekeza kupita pansi kapena mopingasa kupita ku zosefera zomwe zili pakhoma pafupi ndi chipinda choyera, kapena kuzunguliridwanso kudzera pa mapanelo apansi okwera.

Makina oyendetsa mpweya wa Laminar amagwiritsidwa ntchito kupitilira 80% ya denga lachipinda choyera kuti mpweya usasunthike. Chitsulo chosapanga dzimbiri kapena zinthu zina zomwe sizimakhetsa zimagwiritsidwa ntchito popanga zosefera za mpweya wa laminar ndi ma hood kuti tinthu tambiri tisalowe mumlengalenga. Kuthamanga kwa mpweya, kapena kusakhala kwa unidirectional kumagwiritsa ntchito ma laminar air flow hoods ndi zosefera zomwe sizili zenizeni zenizeni kuti mpweya ukhale m'chipinda choyera nthawi zonse, ngakhale kuti sizikuyenda mofanana.

Mpweya woipa umayesa kulanda tinthu tating'onoting'ono tomwe tingakhale mumlengalenga ndikuwathamangitsira pansi, pomwe amalowa mu fyuluta ndikusiya malo oyera. Malo ena adzawonjezeranso zipinda zoyera vekitala: mpweya umaperekedwa m'makona apamwamba a chipindacho, zosefera za hepa zooneka ngati fan zimagwiritsidwa ntchito, ndipo zosefera wamba za hepa zitha kugwiritsidwanso ntchito ndi malo opangira mpweya wooneka ngati fan. Zotulutsa mpweya zobwerera zimayikidwa kumunsi kwa mbali inayo. Kutalika ndi kutalika kwa chipinda nthawi zambiri kumakhala pakati pa 0.5 ndi 1. Mtundu uwu wa chipinda choyera ukhozanso kukwaniritsa ukhondo wa M'kalasi 5 (Kalasi 100).

Zipinda zoyera zimafuna mpweya wochuluka ndipo nthawi zambiri zimakhala pa kutentha ndi chinyezi. Kuti achepetse mtengo wosinthira kutentha kapena chinyezi, pafupifupi 80% ya mpweya umabwerezedwanso (ngati mawonekedwe azinthu amalola), ndipo mpweya wobwereza umasefedwa kuti uchotse kuipitsidwa ndi tinthu tating'ono pomwe ukusunga kutentha koyenera ndi chinyezi musanadutse chipinda choyera.

Tinthu tating'onoting'ono (zowononga) zimayandama mozungulira. Tinthu tating'onoting'ono tokhala ndi mpweya timakhazikika pang'onopang'ono, ndipo kuchuluka kwake kumadalira kukula kwake. Dongosolo lopangidwa bwino lothandizira mpweya liyenera kubweretsa mpweya wabwino komanso wosefedwa kuti uyeretse chipinda pamodzi, ndikunyamula tinthu tating'ono m'chipinda choyera pamodzi. Malingana ndi ntchitoyo, mpweya wotengedwa m'chipindacho umasinthidwanso kupyolera mu kayendedwe ka mpweya, kumene zosefera zimachotsa ma particulates.

Ngati ndondomekoyi, zipangizo kapena mankhwala ali ndi chinyezi chambiri, nthunzi kapena mpweya woipa, mpweya uwu sungathe kubwezeretsedwanso m'chipindamo. Mpweya uwu nthawi zambiri umatha kumlengalenga, ndiyeno 100% mpweya wabwino umalowetsedwa m'chipinda choyera ndikuchiritsidwa musanalowe m'chipinda choyera.

Kuchuluka kwa mpweya wolowa m'chipinda choyera kumayendetsedwa mosamalitsa, ndipo kuchuluka kwa mpweya wotopa kumayendetsedwanso mosamalitsa. Zipinda zambiri zoyera zimakhala zopanikizidwa, zomwe zimatheka mwa kulowa m'chipinda choyera ndi mpweya wochuluka kuposa mpweya wotopa kuchokera kuchipinda choyera. Kupanikizika kwakukulu kungapangitse mpweya kutuluka pansi pa zitseko kapena kudzera muming'alu yaing'ono kapena mipata ya chipinda chilichonse choyera. Chinsinsi cha mapangidwe abwino a chipinda choyera ndi malo oyenera a mpweya (operekera) ndi utsi (utsi).

Poyala chipinda choyera, malo operekera ndi kutulutsa (kubwerera) grilles ayenera kukhala patsogolo. Malo olowera (denga) ndi ma grilles obwerera (pansi pamunsi) ayenera kukhala mbali zina za chipinda choyera. Ngati wogwiritsa ntchitoyo akuyenera kutetezedwa ku mankhwalawo, mpweya uyenera kukhala kutali ndi woyendetsa. A US FDA ndi EU ali ndi malangizo okhwima kwambiri okhudzana ndi kuipitsidwa ndi tizilombo tating'onoting'ono, ndipo ma plenum pakati pa chothandizira mpweya ndi unit fyuluta ya fan ndi mphasa zomata zitha kugwiritsidwanso ntchito. Pazipinda zosabala zomwe zimafuna mpweya wa Gulu A, mpweya umatuluka kuchokera pamwamba mpaka pansi ndipo umakhala waunidirectional kapena laminar, kuwonetsetsa kuti mpweyawo sunaipitsidwe usanakhudze mankhwala.

4. Kuipitsidwa kwa chipinda choyera

Chiwopsezo chachikulu cha kuipitsidwa kwa zipinda zimachokera kwa ogwiritsa ntchito okha. M'makampani azachipatala ndi opanga mankhwala, kuwongolera tizilombo toyambitsa matenda ndikofunikira kwambiri, makamaka tizilombo tating'onoting'ono tomwe titha kukhetsedwa pakhungu ndikuyikidwa mumlengalenga. Kuphunzira za tizilombo toyambitsa matenda m'zipinda zaukhondo ndikofunikira kwambiri kwa akatswiri azachilengedwe komanso ogwira ntchito yoyang'anira zinthu kuti awone momwe akusintha, makamaka pakuwunika mitundu yosamva mankhwala komanso kufufuza njira zoyeretsera ndi zopha tizilombo. Zomera zoyera za m'chipinda choyera zimagwirizana kwambiri ndi khungu la munthu, ndipo padzakhalanso tizilombo toyambitsa matenda kuchokera kumadera ena, monga chilengedwe ndi madzi, koma mocheperapo. Mitundu yodziwika bwino ya bakiteriya imaphatikizapo Micrococcus, Staphylococcus, Corynebacterium ndi Bacillus, ndipo mitundu ya mafangasi imaphatikizapo Aspergillus ndi Penicillium.

Pali zinthu zitatu zofunika kwambiri kuti chipindacho chizikhala chaukhondo.

(1). Pakatikati pa chipinda choyera ndi zida zake zamkati

Mfundo yake ndi yakuti kusankha zinthu n’kofunika, ndipo kuyeretsa tsiku ndi tsiku ndi kupha tizilombo toyambitsa matenda n’kofunika kwambiri. Kuti agwirizane ndi GMP ndi kukwaniritsa mfundo zaukhondo, malo onse a chipinda choyera ayenera kukhala osalala komanso opanda mpweya, osatulutsa zoipitsa zawo, ndiye kuti, palibe fumbi, kapena zinyalala, zosagwira dzimbiri, zosavuta kuyeretsa, mwinamwake zidzapereka malo opangira tizilombo toyambitsa matenda, ndipo pamwamba pake ayenera kukhala amphamvu komanso olimba, ndipo sangathe kusweka, kuswa kapena kuphulika. Pali zinthu zosiyanasiyana zomwe mungasankhe, kuphatikizapo dagad panelling yamtengo wapatali, galasi, ndi zina zotero. Chosankha chabwino kwambiri ndi galasi. Kuyeretsa nthawi zonse ndi kupha tizilombo toyambitsa matenda kumayenera kuchitika mogwirizana ndi zofunikira za zipinda zoyera pamagulu onse. Kuchulukiraku kungakhale pambuyo pa opaleshoni iliyonse, kangapo patsiku, tsiku lililonse, masiku angapo, kamodzi pa sabata, ndi zina zotero. Ndibwino kuti tebulo la opaleshoni litsukidwe ndi kupha tizilombo toyambitsa matenda pambuyo pa opaleshoni iliyonse, pansi payenera kutetezedwa tsiku ndi tsiku, khoma liyenera kutsukidwa ndi kupha tizilombo mwezi uliwonse malinga ndi msinkhu wa chipinda choyera ndi zolemba ndi zolemba ziyenera kusungidwa.

(2). Kuwongolera mpweya m'chipinda choyera

Nthawi zambiri, ndikofunikira kusankha kamangidwe koyenera kachipinda, kukonza nthawi zonse, ndikuwunika tsiku ndi tsiku. Chisamaliro chapadera chiyenera kuperekedwa pakuwunika mabakiteriya oyandama m'zipinda zoyera zamankhwala. Mabakiteriya oyandama mumlengalenga amatengedwa ndi sampler ya mabakiteriya oyandama kuti atenge mpweya wina mumlengalenga. Kuyenda kwa mpweya kumadutsa m'mbale yolumikizana yodzazidwa ndi chikhalidwe china. The kukhudzana mbale adzagwira tizilombo, ndiyeno mbale anayikidwa chofungatira kuwerengera chiwerengero cha madera ndi kuwerengera chiwerengero cha tizilombo mu danga. Tizilombo tating'onoting'ono mu laminar wosanjikiza ayenera wapezeka, ntchito lolingana laminar wosanjikiza akuyandama mabakiteriya sampler. Mfundo yogwira ntchito ndi yofanana ndi ya sampuli ya danga, kupatulapo kuti sampuli iyenera kuikidwa mu laminar layer. Ngati wothinikizidwa mpweya chofunika mu wosabala chipinda, m'pofunikanso kuchita tizilombo toyambitsa matenda pa wothinikizidwa mpweya. Pogwiritsa ntchito chowunikira chofananira cholumikizira mpweya, kuthamanga kwa mpweya wa mpweya woponderezedwa kuyenera kusinthidwa kukhala koyenera kuti tipewe kuwonongeka kwa tizilombo tating'onoting'ono ndi media media.

(3). Zofunikira kwa ogwira ntchito m'chipinda choyera

Ogwira ntchito m'zipinda zaukhondo ayenera kuphunzitsidwa nthawi zonse za chiphunzitso chowongolera kuipitsidwa. Amalowa ndikutuluka m'chipinda choyera kudzera m'ma airlock, ma air shower ndi / kapena zipinda zosinthira, ndipo ayenera kuvala zovala zopangidwa mwapadera kuti aphimbe khungu ndi zonyansa zomwe zimachitika mwachilengedwe pathupi. Kutengera ndi gulu kapena ntchito ya chipinda choyera, zovala za ogwira ntchito zimangofunikira chitetezo chosavuta monga malaya a labotale ndi ma hood, kapena zitha kukhala zophimbidwa bwino komanso zosawonetsa khungu lililonse. Zovala zoyera za m'chipinda zimagwiritsidwa ntchito kuteteza tinthu tating'onoting'ono ndi/kapena tizilombo toyambitsa matenda kuti tituluke m'thupi la wovalayo ndikuwononga chilengedwe.

Zovala zoyera siziyenera kutulutsa tinthu tating'ono kapena ulusi kuti tipewe kuipitsidwa ndi chilengedwe. Kuyipitsidwa kwamtunduwu kwa ogwira ntchito kumatha kuchepetsa magwiridwe antchito m'mafakitale a semiconductor ndi mankhwala, ndipo kungayambitse kufalikira kwapakati pakati pa ogwira ntchito zachipatala ndi odwala omwe ali m'makampani azachipatala, mwachitsanzo. Zida zotetezera zipinda zoyera zimaphatikizapo zovala zotetezera, nsapato, nsapato, ma apuloni, zophimba ndevu, zipewa zozungulira, masks, zovala zogwirira ntchito / malaya a labu, mikanjo, magolovesi ndi machira a zala, manja ndi nsapato ndi nsapato. Mtundu wa zovala zapachipinda zoyera zomwe zimagwiritsidwa ntchito ziyenera kuwonetsa chipinda choyera komanso gulu lazinthu. Zipinda zoyera zotsika zingafunike nsapato zapadera zokhala ndi zosalala bwino zomwe sizingayime pafumbi kapena dothi. Komabe, chifukwa cha chitetezo, nsapato za nsapato sizingayambitse ngozi. Zovala zoyera za m'chipinda nthawi zambiri zimafunikira kulowa m'chipinda choyera. Zovala za labu zosavuta, zophimba kumutu ndi zovundikira nsapato zitha kugwiritsidwa ntchito pachipinda choyera cha Class 10,000. Pachipinda choyera cha Class 100, zofunda zonse, zovala zodzitchinjiriza zokhala ndi zipi, magalasi, masks, magolovesi ndi zovundikira nsapato ndizofunikira. Kuonjezera apo, chiwerengero cha anthu omwe ali m'chipinda choyera chiyenera kuyendetsedwa, ndi pafupifupi 4 mpaka 6 m2 / munthu, ndipo ntchitoyo iyenera kukhala yofatsa, kupewa kuyenda kwakukulu ndi mofulumira.

5. Njira zophera tizilombo toyambitsa matenda m'chipinda chaukhondo

(1). UV disinfection

(2). Ozoni disinfection

(3). Kusakaniza kwa mpweya Mankhwala opha tizilombo monga formaldehyde, epoxyethane, peroxyacetic acid, carbolic acid ndi lactic acid osakaniza, ndi zina zotero.

(4) Mankhwala ophera tizilombo

Mankhwala opha tizilombo toyambitsa matenda akuphatikizapo isopropyl mowa (75%), ethanol (75%), glutaraldehyde, Chlorhexidine, ndi zina zotero. Njira yachikhalidwe yophera tizilombo toyambitsa matenda m'zipinda zopangira mankhwala ku China ndikugwiritsa ntchito fumigation ya formaldehyde. Makampani opanga mankhwala akunja amakhulupirira kuti formaldehyde ili ndi vuto linalake m'thupi la munthu. Tsopano amagwiritsa ntchito kupopera glutaraldehyde. Mankhwala ophera tizilombo omwe amagwiritsidwa ntchito m'zipinda zosabala amayenera kusautsidwa ndikusefedwa kudzera pa nembanemba ya 0.22μm mu kabati yoteteza zachilengedwe.

6. Gulu la chipinda choyera

Chipinda choyera chimayikidwa molingana ndi chiwerengero ndi kukula kwa tinthu tating'onoting'ono tololedwa pa voliyumu ya mpweya. Ziwerengero zazikulu monga "Class 100" kapena "Class 1000" zimatanthawuza FED-STD-209E, zomwe zimasonyeza chiwerengero cha 0.5μm kapena tinthu tating'onoting'ono tololedwa pa phazi limodzi la mpweya. Mulingo umalolanso kutanthauzira; mwachitsanzo, SNOLAB imasungidwa m'chipinda choyera cha Class 2000. Zowerengera za tinthu tating'onoting'ono tomwe timamwazitsa mpweya zimagwiritsidwa ntchito kudziwa kuchuluka kwa tinthu tating'onoting'ono tofanana kapena tokulirapo kuposa kukula kwake komwe kumatchulidwa.

Mtengo wa decimal umatanthawuza muyeso wa ISO 14644-1, womwe umatchula chiwerengero cha decimal cha chiwerengero cha particles 0.1μm kapena zokulirapo zololedwa pa kiyubiki mita imodzi ya mpweya. Kotero, mwachitsanzo, chipinda choyera cha ISO Class 5 chimakhala ndi ma particles 105 / m3. Onse FS 209E ndi ISO 14644-1 amalingalira kuti pali mgwirizano wa logarithmic pakati pa kukula kwa tinthu ndi kusakanikirana kwa tinthu. Chifukwa chake, zero particle concentration palibe. Makalasi ena safuna kuyesa kukula kwa tinthu tating'ono chifukwa ndende yake ndi yotsika kwambiri kapena yokwera kwambiri kuti ikhale yothandiza, koma zosoweka zotere siziyenera kuganiziridwa kuti ziro. Popeza 1m3 ndi pafupifupi 35 ma kiyubiki mapazi, miyeso iwiriyi imakhala yofanana poyezera tinthu tating'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 yaboma yopangidwa ndi International Organisation for Standardization (ISO). Yoyamba ikugwiritsidwa ntchito ku chipinda choyera; chomalizacho kuyeretsa chipinda chomwe biocontamination ingakhale vuto.

Mabungwe omwe akuyang'anira pano akuphatikizapo: ISO, USP 800, US Federal Standard 209E (muyezo wakale, womwe ukugwiritsidwabe ntchito) The Drug Quality and Safety Act (DQSA) idakhazikitsidwa mu Novembala 2013 kuti ithane ndi imfa zomwe zikuphatikiza mankhwala osokoneza bongo komanso zochitika zoyipa kwambiri. Federal Food, Drug, and Cosmetic Act (FD&C Act) imakhazikitsa zitsogozo ndi ndondomeko za kapangidwe ka anthu. 503A imayang'aniridwa ndi ogwira ntchito ovomerezeka (madokotala/madokotala) ndi mabungwe ovomerezeka aboma kapena aboma 503B imagwirizana ndi malo opangira ntchito ndipo imafuna kuyang'aniridwa ndi katswiri wazamankhwala yemwe ali ndi chilolezo ndipo safunikira kukhala malo ogulitsa mankhwala. Malo amapeza ziphaso kudzera ku Food and Drug Administration (FDA).

Malangizo a EU GMP ndi okhwima kuposa malangizo ena ndipo amafunikira chipinda choyera kuti akwaniritse kuchuluka kwa tinthu tikamagwira ntchito (panthawi yopanga) komanso pakupuma (pamene palibe kupanga koma chipinda cha AHU chili).

8. Mafunso ochokera ku labu novices

(1). Kodi mumalowa bwanji ndikutuluka mchipinda choyera? Anthu ndi katundu amalowa ndikutuluka kudzera m'njira zosiyanasiyana. Anthu amalowa ndikutuluka kudzera m'ma airlock (ena amakhala ndi ma shawa) kapena opanda zotsekera ndege ndipo amavala zida zodzitetezera monga ma hood, masks, magolovesi, nsapato ndi zovala zoteteza. Uku ndikuchepetsa ndi kutsekereza tinthu tating'ono tomwe timabwera ndi anthu olowa mchipinda choyera. Katundu amalowa ndikutuluka mchipinda choyera kudzera munjira yonyamula katundu.

(2). Kodi pali china chapadera pakupanga zipinda zaukhondo? Kusankhidwa kwa zida zomangira zipinda zoyera sikuyenera kupanga tinthu tating'onoting'ono, kotero kuti zokutira pansi za epoxy kapena polyurethane ndizokonda. Chitsulo chosapanga dzimbiri chopukutidwa kapena chitsulo chosapanga dzimbiri chopukutidwa ndi chitsulo chosapanga dzimbiri chimagwiritsidwa ntchito. Makona akumanja amapewa ndi malo opindika. Malumikizidwe onse kuyambira ngodya mpaka pansi ndi ngodya mpaka padenga amayenera kusindikizidwa ndi epoxy sealant kupewa kuyika kwa tinthu tating'ono kapena m'badwo pamalumikizidwe. Zipangizo zomwe zili m'chipinda choyera zidapangidwa kuti zisawononge mpweya wochepa. Gwiritsani ntchito mops ndi ndowa zokha zopangidwa mwapadera. Mipando yoyera yakuchipinda iyeneranso kupangidwa kuti ipange tinthu tating'ono komanso kuti ikhale yosavuta kuyeretsa.

(3). Kodi mungasankhe bwanji mankhwala ophera tizilombo? Choyamba, kuwunika kwa chilengedwe kuyenera kuchitidwa pofuna kutsimikizira mtundu wa tizilombo toyambitsa matenda kudzera mu kuyang'anira chilengedwe. Chotsatira ndikuzindikira kuti ndi mankhwala ati omwe angaphe tizilombo todziwika. Musanayambe kuyesa kupha nthawi yolumikizana (njira yoyezera chubu kapena njira yapamtunda) kapena kuyesa kwa AOAC, mankhwala opha tizilombo omwe alipo amayenera kuunika ndikutsimikiziridwa kuti ndi oyenera. Kupha tizilombo m'chipinda choyera, nthawi zambiri pamakhala mitundu iwiri ya njira zophera tizilombo toyambitsa matenda: ① Kuzungulira kwa mankhwala amodzi ndi sporicide imodzi, ② Kuzungulira kwa mankhwala awiri ophera tizilombo ndi sporicide imodzi. Njira yophera tizilombo itatha kutsimikiziridwa, kuyesa kwa bactericidal efficacy kungapangidwe kuti apereke maziko a kusankha mankhwala ophera tizilombo. Mukamaliza mayeso a bactericidal efficacy, kuyesa kwa kumunda kumafunika. Iyi ndi njira yofunikira yotsimikizira ngati kuyeretsa ndi kupha tizilombo toyambitsa matenda SOP komanso kuyesa kwa bactericidal kwa mankhwala opha tizilombo ndi othandiza. Pakapita nthawi, tizilombo toyambitsa matenda tomwe sitinapezekepo tingayambe kuonekera, ndipo njira zopangira zinthu, ogwira ntchito, ndi zina zotero zingasinthenso, choncho ma SOP oyeretsa ndi ophera tizilombo amayenera kuwunikidwa pafupipafupi kuti atsimikizire ngati akugwirabe ntchito pazomwe zikuchitika.

(4). Kuyeretsa makonde kapena makonde akuda? Ufa monga mapiritsi kapena makapisozi ndi makonde oyera, pamene mankhwala osabala, mankhwala amadzimadzi, ndi zina zotero ndi makonde akuda. Nthawi zambiri, mankhwala okhala ndi chinyezi chochepa monga mapiritsi kapena makapisozi amakhala owuma komanso afumbi, kotero pali kuthekera kwakukulu kwachiwopsezo chotenga kachilomboka. Ngati kupsyinjika pakati pa malo aukhondo ndi kopanda bwino, ufawo umatuluka m'chipindamo kupita mukhonde kenako nkusamutsira kuchipinda china choyera. Mwamwayi, kukonzekera kowuma sikumathandiza kukula kwa tizilombo toyambitsa matenda, choncho monga lamulo, mapiritsi ndi ufa amapangidwa m'malo oyeretsera makonde chifukwa tizilombo tomwe timayandama m'njira sitingathe kupeza malo omwe angapindule nawo. Izi zikutanthawuza kuti chipindacho chimakhala ndi zovuta zowonongeka kwa korido. Kwa wosabala (okonzedwa), aseptic kapena otsika kwambiri a bioburden ndi mankhwala amadzimadzi, tizilombo tating'onoting'ono nthawi zambiri timapeza zikhalidwe zomwe zimathandizira kuti zizikhala bwino, kapena ngati zili ndi zinthu zosabala, tizilombo tating'onoting'ono titha kukhala towopsa. Chifukwa chake, malowa nthawi zambiri amapangidwa ndi makonde akuda chifukwa cholinga chake ndikuchotsa tizilombo tomwe titha kukhala m'chipinda choyera.

dongosolo la zipinda zoyera
class 10000 chipinda choyera
kalasi 100 chipinda choyera

Nthawi yotumiza: Feb-20-2025
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