Nhanganyaya
Mupfungwa yemishonga, imba yakachena inoreva imba inosangana nezvinodiwa neGMP zvisina utachiona. Nekuda kwezvinodiwa zvakanyanya zvekuvandudza tekinoroji yekugadzira munzvimbo yekugadzira, imba yakachena murabhoritari inozivikanwawo se "muchengeti wekugadzira kwepamusoro-soro."
1. Chii chinonzi imba yakachena
Kamuri rakachena, iro rinozivikanwawo sekamuri risina guruva, rinowanzo shandiswa sechikamu chekugadzirwa kwehunyanzvi mumaindasitiri kana kutsvagisa kwesainzi, kusanganisira kugadzirwa kwemishonga, macircuits akabatanidzwa, CRT, LCD, OLED uye micro LED displays, nezvimwewo.
Kamuri rakachena rakagadzirirwa kuchengetedza huwandu hwakaderera hwezvinhu zvakaita seguruva, zvinhu zvinobhururuka, kana zvinhu zvakapwanywa nemhepo. Zvikuru, imba yakachena ine huwandu hwakagadziriswa hwekusvibiswa, hunotsanangurwa nehuwandu hwezvinhu pa cubic mita imwe neimwe pahukuru hwakatarwa hwezvinhu.
Kamuri yakachena inogona zvakare kureva chero nzvimbo yekuchengetera zvinhu umo matanho ekuderedza kusvibiswa kwezvikamu uye kudzora zvimwe zvinhu zvakaita sekupisa, hunyoro uye kumanikidzwa. Mupfungwa yemishonga, imba yakachena ikamuri inosangana nezvinodiwa neGMP specifications zvakatsanangurwa muGMP aseptic specifications. Imusanganiswa wekugadzira engineering, kugadzira, kupedzisa uye kutonga kwekushanda (control strategy) zvinodiwa kushandura imba yakajairika kuita imba yakachena. Makamuri akachena anoshandiswa mumaindasitiri mazhinji, chero kupi uko zvidimbu zvidiki zvinogona kukanganisa maitiro ekugadzira.
Makamuri akachena akasiyana muhukuru uye kuoma uye anoshandiswa zvakanyanya mumaindasitiri akadai sekugadzira semiconductor, mishonga, biotechnology, zvishandiso zvekurapa nesainzi yehupenyu, pamwe nekugadzira maitiro akakosha anowanikwa mundege, optics, mauto neDhipatimendi reSimba.
2. Kugadzirwa kwekamuri rakachena
Kamuri remazuva ano rekuchenesa rakagadzirwa nenyanzvi yefizikisi yekuAmerica Willis Whitfield. Whitfield, semushandi weSandia National Laboratories, akagadzira dhizaini yekutanga yekamuri rakachena muna 1966. Whitfield asati atanga, imba yekutanga yekuchenesa yaiwanzosangana nematambudziko ezvimedu uye mhepo isingatarisirwi.
Whitfield akagadzira imba yakachena ine mhepo inoyerera nguva dzose uye yakasefa zvakasimba kuti nzvimbo yacho igare yakachena. Zvizhinji zvezvivako zvekugadzira macircuit akabatanidzwa muSilicon Valley zvakavakwa nemakambani matatu: MicroAire, PureAire, neKey Plastics. Vakagadzira mayuniti ekuyerera kwemvura, mabhokisi emagirovhosi, makamuri akachena uye mashawa emhepo, pamwe chete nematangi emakemikari nemabhenji ekushandira pakuvaka macircuit akabatanidzwa "nemvura". Makambani matatu aya aivewo mapiyona mukushandiswa kweTeflon papfuti dzemhepo, mapombi emakemikari, mascrubbers, pfuti dzemvura, nezvimwe zvishandiso zvinodiwa pakugadzira macircuit akabatanidzwa. William (Bill) C. McElroy Jr. akashanda semaneja weinjiniya, mutariri wemakamuri ekudhirowa, QA/QC, uye mugadziri wemakambani matatu, uye magadzirirwo ake akawedzera mapatenti ekutanga makumi mana nemashanu kune tekinoroji yenguva iyoyo.
3. Nheyo dzeKufamba Kwemhepo Mukamuri Rakachena
Makamuri akachena anodzora zvidimbu zvinofamba nemhepo nekushandisa mafirita eHEPA kana ULPA, achishandisa nzira yekufamba kwemhepo ine laminar (kuyerera kwenzira imwe chete) kana nzira yekufamba kwemhepo ine turbulent (kutenderera, kwete kwenzira imwe chete).
Masisitimu emhepo anofambisa mhepo nenzira imwe chete anotungamira mhepo yakaseferwa ichiyerera nguva dzose ichidzika pasi kana kuti yakatwasuka kumafirita ari pamadziro ari pedyo nepasi pekamuri rakachena, kana kutenderedzwa kuburikidza nemapaneru epasi akasimudzwa.
Masisitimu emhepo ine laminar anowanzo shandiswa pamusoro pe80% yedenga rekamuri rakachena kuchengetedza mhepo isingaperi. Simbi isina ngura kana zvimwe zvinhu zvisingadonhe zvinoshandiswa kugadzira mafirita emhepo ine laminar uye mahood kudzivirira zvidimbu zvakawandisa kuti zvisapinde mumhepo. Kuyerera kwemhepo ine nyonganyonga, kana kuti isina divi rimwe chete inoshandisa mahood emhepo ane laminar uye mafilter ekukurumidza asina kutsanangurwa kuti achengetedze mhepo iri mukamuri rakachena ichifamba nguva dzose, kunyangwe isiri yese iri munzira imwe chete.
Mhepo isina kugadzikana inoedza kubata zvidimbu zvingangove zviri mumhepo zvozviendesa pasi, uko zvinopinda mufirita zvobva munzvimbo yakachena yekamuri. Dzimwe nzvimbo dzinowedzerawo makamuri akachena evector: mhepo inopihwa mumakona epamusoro ekamuri, mafirita ehepa akafanana nefeni anoshandiswa, uye mafirita ehepa akajairwa anogona kushandiswawo nemagetsi emhepo akafanana nefeni. Mafirita emhepo anodzoka akaiswa pasi perimwe divi. Chiyero chekukwirira nehurefu hwekamuri chinowanzova pakati pe0.5 ne1. Rudzi urwu rwekamuri rakachena runogonawo kuwana kuchena kweKirasi 5 (Kirasi 100).
Makamuri akachena anoda mhepo yakawanda uye anowanzo kuve patembiricha yakarongwa uye hunyoro. Kuti kuderedza mutengo wekuchinja tembiricha yemhepo kana hunyoro, inenge 80% yemhepo inodzokororwa (kana hunhu hwechigadzirwa huchibvumira), uye mhepo inodzokororwa inotanga yaseferwa kuti ibvise kusvibiswa kwezvimedu uku ichichengetedza tembiricha uye hunyoro hwakakodzera usati wapfuura nemukamuri rakachena.
Zvidimbu zvinofamba nemhepo (zvinosvibisa) zvinofamba-famba. Zvidimbu zvakawanda zvinofamba nemhepo zvinodzika zvishoma nezvishoma, uye mwero wekudzika kwemhepo unoenderana nehukuru hwazvo. Sisitimu yekubata mhepo yakagadzirwa zvakanaka inofanira kuendesa mweya wakachena wakaseferwa wakacheneswa mukamuri rakachena pamwe chete, uye kutakura zvidimbu kubva mukamuri rakachena pamwe chete. Zvichienderana nekushanda, mweya unotorwa mukamuri unowanzo tenderera kuburikidza nesisitimu yekubata mhepo, uko mafirita anobvisa tunhu.
Kana nzira yacho, zvinhu zvakagadziriswa kana zvigadzirwa zvine hunyoro hwakawanda, utsi hunokuvadza kana magasi, mweya uyu haugone kudzoserwa mukamuri. Mhepo iyi inowanzo donhedzwa mumhepo, uye mweya mutsva 100% unosvetwa muhurongwa hwekamuri rakachena worapwa usati wapinda mukamuri rakachena.
Huwandu hwemhepo inopinda mukamuri rakachena hunodzorwa zvakasimba, uye huwandu hwemhepo inobuda hunodzorwawo zvakasimba. Makamuri mazhinji akachena ane pressure, izvo zvinowanikwa nekupinda mukamuri rakachena rine mweya wakawanda kupfuura mweya unobuda mukamuri rakachena. Kumanikidzwa kwakanyanya kunogona kukonzera kuti mhepo ibude kubva pasi pemasuo kana kuburikidza nematombo madiki kana maburi mukamuri rakachena. Chinhu chikuru chekugadzira imba yakachena inzvimbo yakakodzera yemhepo inopindwa (inopa) uye inobuda (exhaust).
Pakuisa imba yakachena, nzvimbo yekuisa magetsi nemagetsi (return grilles) inofanira kuva chinhu chinokosha. Nzvimbo yekupinda (ceiling) nemagetsi ekudzorera (padanho rakaderera) inofanira kunge iri kumativi akatarisana eimba yakachena. Kana mushandi achida kudzivirirwa kubva kuchinhu, kuyerera kwemhepo kunofanira kunge kuri kure nemushandi. US FDA neEU vane mitemo yakasimba uye miganhu yekusvibiswa kwehutachiona, uye plenums pakati pemubati wemhepo nefeni filter unit nema sticky mats zvinogonawo kushandiswa. Kumakamuri asina utachiona anoda mhepo yeClass A, kuyerera kwemhepo kunobva kumusoro kusvika pasi uye kwakanangana kana kuti kwakabatana, zvichiita kuti mhepo isasvibiswe isati yasvika pachigadzirwa.
4. Kusvibiswa kwekamuri rakachena
Dambudziko guru rekusvibiswa kwemakamuri akachena rinobva kune vashandisi pachavo. Mumaindasitiri ekurapa nemishonga, kudzora tupukanana twakakosha zvikuru, kunyanya tupukanana tunogona kudonhedzwa kubva paganda toiswa mumhepo. Kudzidza nezvezvirimwa zvemakamuri akachena kwakakosha zvikuru kune vanoongorora tupukanana tudiki nevashandi vekuongorora mhando kuti vaongorore mafambiro ari kuchinja, kunyanya pakuongorora mhando dzisingarapike nemishonga uye kutsvagisa nzira dzekuchenesa nekuuraya utachiona. Miti yemakamuri akachena inowanzo shandiswa inobatanidzwa neganda revanhu, uye pachavawo netupukanana tunobva kune dzimwe nzvimbo, senge kubva munzvimbo yakakomberedza nemvura, asi muhuwandu hushoma. Mabhakitiriya akajairika anosanganisira Micrococcus, Staphylococcus, Corynebacterium naBacillus, uye fungi dzinosanganisira Aspergillus naPenicillium.
Pane zvinhu zvitatu zvikuru zvinoita kuti imba igare yakachena.
(1). Nzvimbo yemukati meimba yakachena nemidziyo yayo yemukati
Nheyo yacho ndeyekuti kusarudza zvinhu kwakakosha, uye kuchenesa nekuuraya utachiona zuva nezuva kwakakosha. Kuti zvienderane neGMP uye kuwana zvinodiwa zvehutsanana, nzvimbo dzese dzekamuri rakachena dzinofanira kunge dzakatsetseka uye dzisina mhepo, uye dzisingaburitse kusvibiswa kwadzo, kureva kuti, dzisina guruva, kana marara, dzisingakanganise ngura, dziri nyore kuchenesa, zvikasadaro dzichapa nzvimbo yekubereka utachiona, uye pamusoro pacho panofanira kunge pakasimba uye pakasimba, uye panofanira kunge pasina kutsemuka, kutyoka kana kubooka. Kune zvinhu zvakasiyana-siyana zvekusarudza kubva, kusanganisira dagad paneling inodhura, girazi, nezvimwewo. Sarudzo yakanakisisa uye yakanaka kwazvo igirazi. Kuchenesa nekuuraya utachiona nguva dzose kunofanirwa kuitwa zvichienderana nezvinodiwa nemakamuri akachena pamatanho ese. Kuwanda kunogona kuitika mushure mekushanda kwega kwega, kakawanda pazuva, zuva rega rega, mazuva mashoma ega ega, kamwe chete pasvondo, nezvimwewo. Zvinokurudzirwa kuti tafura yekushandisa icheneswe uye iuraye mushure mekushanda kwega kwega, pasi panofanira kunge paine utachiona zuva rega rega, madziro anofanira kuuraye vhiki rega rega, uye nzvimbo yacho inofanira kucheneswa uye iuraye hutachiona mwedzi wega wega zvichienderana nemazinga ekamuri akachena uye zviyero zvakatarwa uye zvinodiwa, uye zvinyorwa zvinofanira kuchengetwa.
(2). Kudzora mhepo muimba yakachena
Kazhinji, zvakakosha kusarudza dhizaini yekamuri yakachena yakakodzera, kuita kugadzirisa nguva dzose, uye kuita ongororo yezuva nezuva. Kunyanya kunofanira kutariswa pakutarisa mabhakitiriya anoyangarara mumakamuri akachena emishonga. Mabhakitiriya anoyangarara ari munzvimbo iyi anotorwa nemuchina wekuongorora mabhakitiriya anoyangarara kuti abudise huwandu hwakati hwemhepo munzvimbo iyi. Kuyerera kwemhepo kunopfuura nemudhishi rekuonana rakazadzwa nechinhu chakasiyana chekukura. Dhishi rekuonana richabata mabhakitiriya, uye ndiro yacho inoiswa mu incubator kuti iverenge huwandu hwemakoroni uye kuverenga huwandu hwemabhakitiriya ari munzvimbo iyi. Mabhakitiriya ari mu laminar layer anofanirawo kuonekwa, uchishandisa laminar layer floating bacteria sampler inoenderana. Nheyo yekushanda yakafanana neyekutora sampler yenzvimbo, kunze kwekuti nzvimbo yekutora sampler inofanira kuiswa mu laminar layer. Kana mhepo yakamanikidzwa ichidiwa mukamuri isina tsvina, zvakakoshawo kuita bvunzo dzemabhakitiriya pamhepo yakamanikidzwa. Uchishandisa muchina wekuongorora mweya wakamanikidzwa unoenderana, kumanikidzwa kwemhepo kwakamanikidzwa kunofanirwa kugadziriswa kusvika padanho rakakodzera kudzivirira kuparadzwa kwezvipembenene nemidziyo yekurima.
(3). Zvinodiwa kuvashandi vari mukamuri rakachena
Vashandi vanoshanda mumakamuri akachena vanofanirwa kudzidziswa nguva dzose nezvedzidziso yekudzora kusvibiswa. Vanopinda nekubuda mukamuri rakachena kuburikidza nemagetsi anovharwa, mashawa emhepo uye/kana makamuri ekuchinjira, uye vanofanirwa kupfeka mbatya dzakagadzirirwa kufukidza ganda nezvinhu zvinosvibisa mumuviri. Zvichienderana nekurongwa kana mashandiro ekamuri rakachena, mbatya dzevashandi dzinogona kungoda dziviriro iri nyore senge majasi emurabhoritari nemahood, kana kuti dzinogona kuvharwa zvizere uye dzisingaburitse ganda pachena. Mbatya dzemukamuri dzakachena dzinoshandiswa kudzivirira zvidimbu uye/kana tupukanana kuti tisaburitswe mumuviri wemunhu akapfeka uye kusvibisa nharaunda.
Zvipfeko zvemukamuri zvakachena hazvifanirwe kuburitsa zvidimbu kana fiber kudzivirira kusvibiswa kwezvakatipoteredza. Rudzi urwu rwekusvibiswa kwevashandi runogona kuderedza mashandiro ezvigadzirwa mumaindasitiri e semiconductor uye emishonga, uye zvinogona kukonzera hutachiona pakati pevashandi vekurapa nevarwere vari muindasitiri yehutano, semuenzaniso. Midziyo yekudzivirira mukamuri yakachena inosanganisira zvipfeko zvekudzivirira, bhutsu, shangu, maapuroni, machira ekudzivirira ndebvu, ngowani dzakatenderera, masks, mbatya dzebasa/majasi emurabhoritari, magowns, magirovhosi nemachira eminwe, maoko emaoko uye machira eshangu nebhutsu. Rudzi rwezvipfeko zvemukamuri zvakachena zvinoshandiswa runofanira kuratidza chikamu chekamuri chakachena uye chikamu chechigadzirwa. Makamuri akachena akaderera anogona kuda shangu dzakakosha dzine tsoka dzakatsetseka dzisingamire paguruva kana tsvina. Zvisinei, nekuda kwezvikonzero zvekuchengetedza, pasi peshangu hadzigone kukonzera njodzi yekutsvedza. Zvipfeko zvemukamuri zvakachena zvinowanzodiwa kuti upinde mukamuri rakachena. Majasi akareruka emurabhoritari, machira emusoro uye machira eshangu zvinogona kushandiswa mukamuri rakachena reKirasi 10,000. Mukamuri rakachena reKirasi 100, machira ekudzivirira muviri wese, mbatya dzekudzivirira dzine zipi, magogorosi, masks, magurovhosi uye machira ebhutsu zvinodiwa. Pamusoro pezvo, huwandu hwevanhu vari muimba yakachena hunofanira kudzorwa, neavhareji ye4 kusvika 6 m2 pamunhu, uye mashandiro acho anofanira kuitwa zvinyoro nyoro, kudzivirira kufamba kukuru uye nekukurumidza.
5. Nzira dzinowanzo shandiswa dzekuuraya utachiona mukamuri rakachena
(1). Kuchenesa UV
(2). Kuuraya utachiona muOzone
(3). Kuchenesa gasi Mishonga yekuuraya utachiona inosanganisira formaldehyde, epoxyethane, peroxyacetic acid, carbolic acid uye lactic acid mixes, nezvimwewo.
(4) Mishonga yekuuraya utachiona
Mishonga inouraya utachiona inowanzo sanganisira isopropyl alcohol (75%), ethanol (75%), glutaraldehyde, Chlorhexidine, nezvimwewo. Nzira yechinyakare yekuuraya utachiona mumakamuri asina tsvina mumafekitori emishonga ekuChina ndeyekushandisa formaldehyde fumigation. Mafekitori emishonga ekune dzimwe nyika anotenda kuti formaldehyde ine njodzi chaiyo kumuviri wemunhu. Iye zvino vanowanzo shandisa glutaraldehyde spraying. Mishonga inouraya utachiona inoshandiswa mumakamuri asina tsvina inofanira kucheneswa ne 0.22μm filter membrane mubhokisi rekuchengetedza rehupenyu.
6. Kupatsanura kwekamuri rakachena
Kamuri rakachena rinorongwa zvichienderana nehuwandu nehukuru hwezvidimbu zvinobvumirwa pahuwandu hwemhepo. Nhamba huru dzakadai se "Kirasi 100" kana "Kirasi 1000" dzinoreva FED-STD-209E, iyo inoratidza huwandu hwezvidimbu zvakakura zvinobvumirwa pa cubic foot yemhepo. Mutemo unobvumidzawo kuverengerwa; semuenzaniso, SNOLAB inochengeterwa imba yakachena yeClass 2000. Zviyero zvemhepo zvinopararira nechiedza che discrete zvinoshandiswa kuona huwandu hwezvidimbu zviri mumhepo zvakaenzana kana kuti zvakakura kupfuura saizi yakatarwa panzvimbo yakatarwa yekutora sampu.
Kukosha kwedesimali kunoreva chiyero cheISO 14644-1, chinotsanangura decimal logarithm yehuwandu hwezvikamu 0.1μm kana zvakakura zvinobvumirwa pa cubic meter yemhepo. Saka, semuenzaniso, imba yakachena yeISO Class 5 ine huwandu hwezvikamu 105/m3. FS 209E neISO 14644-1 zvese zvinofungidzira kuti pane hukama hwe logarithmic pakati pehukuru hwezvikamu uye huwandu hwezvikamu. Naizvozvo, huwandu hwezvikamu zero hahupo. Mamwe makirasi haadi kuyedzwa kwehukuru hwezvikamu nekuti huwandu hwakaderera zvakanyanya kana kuti hwakakwira zvakanyanya kuti hushande, asi nzvimbo dzisina chinhu dzakadaro hadzifanirwe kunzi zero. Sezvo 1m3 iri inenge 35 cubic feet, zviyero zviviri izvi zvakaenzana pakuyera zvikamu 0.5μm. Mhepo yakajairika yemukati inenge Class 1,000,000 kana ISO 9.
ISO 14644-1 neISO 14698 zviyero zvisiri zvehurumende zvakagadzirwa neInternational Organization for Standardization (ISO). Chekutanga chinoshanda kumakamuri akachena kazhinji; chechipiri chinoshanda kumakamuri akachena uko kusvibiswa kwezvinhu zvipenyu kunogona kuva dambudziko.
Masangano aripo pari zvino anosanganisira: ISO, USP 800, US Federal Standard 209E (mutemo wekare, uchiri kushandiswa) Mutemo weDrug Quality and Safety Act (DQSA) wakagadzwa muna Mbudzi 2013 kugadzirisa kufa kunowedzera mishonga uye zviitiko zvakakomba zvakaipa. Mutemo weFederal Food, Drug, and Cosmetic Act (FD&C Act) unogadza nhungamiro dzakananga uye marongero emishonga yevanhu. 503A inotariswa nevashandi vane mvumo (vemishonga/vanachiremba) nemasangano akatenderwa nehurumende kana nehurumende. 503B ine chekuita nekupa nzvimbo dzekutengesa mishonga kunze kwenyika uye inoda kutariswa zvakananga nemutengesi ane rezinesi uye haifanirwe kunge iri pharmacy ine rezinesi. Nzvimbo dzinowana marezenisi kuburikidza neFood and Drug Administration (FDA).
Gwaro reEU GMP rakaomarara kupfuura mamwe magwaro uye rinoda nzvimbo yakachena kuti uwane huwandu hwezvinhu kana zvichishandiswa (panguva yekugadzira) uye pakuzorora (kana pasina kugadzirwa kuri kuitwa asi imba yeAHU iri kushanda).
8. Mibvunzo kubva kune vanotanga murabhoritari
(1). Unopinda nekubuda sei muimba yakachena? Vanhu nezvinhu zvinopinda nekubuda nenzira dzakasiyana dzekupinda nekubuda. Vanhu vanopinda nekubuda nemidziyo inovhara mhepo (vamwe vane mashawa emhepo) kana vasina mahwindo emhepo uye vanopfeka midziyo yekudzivirira yakaita semahood, mamasiki, magurovhosi, bhutsu nembatya dzekudzivirira. Izvi ndezvekuderedza nekuvhara zvidimbu zvinounzwa nevanhu vanopinda muimba yakachena. Zvinhu zvinopinda nekubuda muimba yakachena nepanzira yekutakura zvinhu.
(2). Pane chimwe chinhu chakakosha here nezvekugadzirwa kwekamuri rakachena? Kusarudzwa kwezvinhu zvekuvaka mukamuri rakachena hakufanirwe kugadzira zvidimbu, saka epoxy kana polyurethane floor coating ndiyo inonyanya kufarirwa. Mapanera esimbi isina tsvina yakaposhwa kana simbi yakaputirwa nehupfu uye mapanera esimbi yakapfava anoshandiswa. Makona akakombama kurudyi haadzivirirwe nepamusoro pakakombama. Mapanera ese kubva pakona kusvika pasi uye pakona kusvika padenga anofanira kuvharwa ne epoxy sealant kudzivirira chero zvidimbu zvakaiswa kana kugadzirwa pamapaneti. Midziyo iri mukamuri rakachena yakagadzirirwa kusvibisa mhepo zvishoma. Shandisai mops nemabhaketi akagadzirwa chete. Fenicha yakachena yemukamuri inofanirawo kugadzirwa kuti igadzire zvidimbu zvishoma uye ive nyore kuchenesa.
(3). Nzira yekusarudza mushonga wekuuraya utachiona wakakodzera? Kutanga, ongororo yezvakatipoteredza inofanira kuitwa kusimbisa rudzi rwetupukanana twakasvibiswa kuburikidza nekutarisa nharaunda. Danho rinotevera nderekuona kuti ndeipi mushonga wekuuraya utachiona unogona kuuraya huwandu hunozivikanwa hwetupukanana. Usati waita bvunzo yekuuraya utachiona panguva yekubata (nzira yekunyungudutsa tube kana nzira yezvinhu zvepamusoro) kana bvunzo yeAOAC, mishonga yekuuraya utachiona iripo inofanira kuongororwa uye kusimbiswa kuti yakakodzera. Kuti uuraye tupukanana mukamuri rakachena, kazhinji kune mhando mbiri dzenzira dzekutenderedza tupukanana: ① Kutenderedza mushonga mumwe wekuuraya utachiona nesporicide imwe, ② Kutenderedza mishonga miviri yekuuraya utachiona nesporicide imwe. Mushure mekunge sisitimu yekuuraya utachiona yaonekwa, bvunzo yekubudirira kwetupukanana inogona kuitwa kuti ipe hwaro hwekusarudzwa kwemishonga yekuuraya utachiona. Mushure mekupedza bvunzo yekubudirira kwetupukanana, bvunzo yekudzidza mumunda inodiwa. Iyi inzira yakakosha yekuratidza kana SOP yekuchenesa nekuuraya utachiona nebvunzo yekubudirira kwetupukanana yetupukanana inoshanda. Nekufamba kwenguva, tupukanana twaisamboonekwa twunogona kuoneka, uye maitiro ekugadzira, vashandi, nezvimwewo zvinogona kuchinjawo, saka maSOP ekuchenesa nekuuraya utachiona anofanira kuongororwa nguva nenguva kuti aone kana achiri kushanda kune nharaunda iripo.
(4). Migwagwa yakachena here kana kuti migwagwa yakasviba? Upfu hwakaita semapiritsi kana makapisi imigwagwa yakachena, nepo mishonga isina utachiona, mishonga yemvura, nezvimwewo imigwagwa yakasviba. Kazhinji, mishonga ine hunyoro hushoma senge mapiritsi kana makapisi yakaoma uye ine guruva, saka pane mukana mukuru wekuti pave nenjodzi huru yekusvibiswa. Kana musiyano wekumanikidzwa pakati penzvimbo yakachena nemugwagwa uri wakanaka, upfu hunobva mukamuri huchipinda mumugwagwa uye hunogona kutamisirwa mukamuri rinotevera rakachena. Nerombo rakanaka, mishonga yakawanda yakaoma haitsigire kukura kwehutachiona zviri nyore, saka kazhinji, mapiritsi neupfu zvinogadzirwa munzvimbo dzakachena dzemumugwagwa nekuti tupukanana twunofamba mumugwagwa hatwugone kuwana nharaunda yatinogona kukura nayo. Izvi zvinoreva kuti imba yacho ine kumanikidzwa kwakaipa kune mugwagwa. Kune mishonga isina utachiona (yakagadziriswa), isina utachiona kana kuti isina bioburden yakawanda uye yemvura, tupukanana tunowanzo tsvaga tsika dzinotsigira kuti dzikure, kana kana paine mishonga isina utachiona, tupukanana kamwe chete kanogona kuva nenjodzi. Nokudaro, nzvimbo idzi dzinowanzo gadzirwa nemigwagwa yakasviba nekuti chinangwa ndechekuchengetedza tupukanana tunogona kubuda mukamuri rakachena.
Nguva yekutumira: Kukadzi-20-2025