Nhanganyaya
Mune pfungwa yemishonga, imba yakachena inoreva kamuri inosangana neGMP aseptic yakatarwa. Nekuda kwezvakaomesesa zvinodiwa zvekugadzira tekinoroji kukwidziridzwa panzvimbo yekugadzira, rabhoritari yakachena imba inozivikanwawo se "muchengeti wepamusoro-yekupedzisira kugadzira."
1. Chii chinonzi imba yakachena
Imba yakachena, inozivikanwawo sekamuri isina guruva, inowanzo shandiswa sechikamu chehunyanzvi hwekugadzira maindasitiri kana tsvagiridzo yesainzi, kusanganisira kugadzirwa kwemishonga, maseketi akabatanidzwa, CRT, LCD, OLED uye micro LED kuratidza, nezvimwe.
Imba yakachena inogadzirirwa kuchengetedza yakaderera zvakanyanya mazinga ezvimedu, senge huruva, zvipenyu zvinofambiswa nemhepo, kana mhute. Kunyanya, kamuri yakachena ine inodzorwa kusvibiswa nhanho, iyo inotsanangurwa nenhamba yezvimedu pa cubic mita pane yakatsanangurwa particle size.
Imba yakachena inogona zvakare kureva chero yakapihwa nzvimbo yekuchengetera umo matanho akaiswa kudzikisa kusvibiswa kwechikamu uye kudzora mamwe maparamendi ezvakatipoteredza senge tembiricha, humidity uye kudzvanywa. Mune pfungwa yemishonga, kamuri yakachena ikamuri inosangana nezvinodiwa zveGMP zvakatsanangurwa muGMP aseptic yakatarwa. Iko kusanganiswa kweinjiniya dhizaini, kugadzira, kupedzisa uye kushanda kwekutonga (control strategy) inodiwa kushandura kamuri yakajairika kuita imba yakachena. Makamuri akachena anoshandiswa mumaindasitiri mazhinji, chero kupi zvidiki zvidiki zvinogona kukanganisa maitiro ekugadzira.
Makamuri akachena anosiyana muhukuru uye kuoma uye anoshandiswa zvakanyanya mumaindasitiri akadai semiconductor kugadzira, mishonga, biotechnology, midziyo yekurapa uye sainzi yehupenyu, pamwe neyakaomarara maitiro ekugadzira akajairika mumhepo, optics, mauto uye Dhipatimendi reMagetsi.
2. Kuvandudzwa kwekamuri rakachena
Imba yemazuva ano yakachena yakagadzirwa neAmerican physics Willis Whitfield. Whitfield, semushandi weSandia National Laboratories, akagadzira dhizaini yepakutanga yekamuri rakachena muna 1966. Pamberi pekugadzirwa kwaWhitfield, imba yakachena yepakutanga yaiwanzosangana nematambudziko ane zvimedu uye zvisingatarisirwi mhepo inoyerera.
Whitfield akagadzira imba yakachena ine inogara uye yakanyatso kusefa mhepo inoyerera kuchengetedza nzvimbo yakachena. Zvizhinji zvezvivakwa zvakabatanidzwa zvekugadzira dunhu muSilicon Valley zvakavakwa nemakambani matatu: MicroAire, PureAire, uye Key Plastics. Vakagadzira laminar kuyerera mayuniti, mabhokisi egirovhosi, makamuri akachena uye mvura yekugezera, pamwe chete nemakemikari matangi uye mabhenji ebasa re "wet process" kuvaka kwemasekete akabatanidzwa. Makambani matatu aya aivewo mapiyona mukushandiswa kweTeflon kwepfuti dzemhepo, pombi dzemakemikari, scrubbers, pfuti dzemvura, uye zvimwe midziyo inodiwa pakugadzira dunhu rakabatanidzwa. William (Bill) C. McElroy Jr. akashanda semaneja weinjiniya, mutariri wekamuri rekunyora, QA/QC, uye mugadziri wemakambani matatu, uye magadzirirwo ake akawedzera makumi mana neshanu patents kune tekinoroji yenguva iyoyo.
3. Misimboti Yekuchenesa Kamuri Airflow
Makamuri akachena anodzora zvimedu zvemhepo nekushandisa HEPA kana ULPA mafirita, uchishandisa laminar (imwe-nzira inoyerera) kana mhirizhonga (mhirizhonga, isiri-imwe nzira yekuyerera) misimboti yekuyerera kwemhepo.
Laminar kana one-way airflow systems yakanangana nemhepo yakasefa mukugara ichiyerera ichidzika pasi kana kuti yakatwasuka kumasefa ari pamadziro padhuze nekamuri rakachena uriri, kana kutenderedzwa zvakare kuburikidza neakasimudzwa peforated floor panels.
Laminar kuyerera kwemhepo masisitimu anowanzo shandiswa pamusoro pe80% yekamuri yakachena sirin'i kuchengetedza mweya unogara uripo. Simbi isina tsvina kana zvimwe zvisiri zvekudurura zvinoshandiswa kugadzira laminar air flow sefa uye hood kudzivirira zvidimbu zvakawandisa kupinda mumhepo. Mhepo inoputika, kana kuti isiri-unidirectional air flow inoshandisa laminar air flow hoods uye kwete-specific velocity filters kuchengetedza mhepo mukamuri yakachena mukufamba nguva dzose, kunyange zvazvo isiri yose munzira imwe chete.
Mhepo yakakasharara inoedza kutora zvimedu zvinogona kunge zviri mumhepo uye zvidzingire pasi, kwazvinopinda musefa uye zvichisiya nzvimbo yakachena yekamuri. Dzimwe nzvimbo dzinowedzerawo makamuri akachena mavector: mweya unopihwa mumakona ekumusoro ekamuri, mafirita ane shasha-yakaita hepa anoshandiswa, uye akajairwa mafirita ehepa anogona zvakare kushandiswa neakaita fan-yakaita mhepo yekuburitsa mweya. Kudzoka kwemhepo kunobuda kunoiswa kune chikamu chezasi cherumwe rutivi. Kureba-kusvika-kureba kwekamuri kunowanzova pakati pe 0.5 ne 1. Rudzi urwu rwekamuri yakachena runogonawo kuwana Chikoro 5 (Kirasi 100) utsanana.
Dzimba dzakachena dzinoda mhepo yakawanda uye dzinowanzova pane inodzorwa tembiricha uye mwando. Kuti uderedze mutengo wekushandura tembiricha yepakati kana humidity, inenge 80% yemhepo inodzokororwa (kana maitiro echigadzirwa achibvumira), uye mweya wakadzokororwa unotanga kusefa kuti ubvise kusvibiswa kwemukati uchichengetedza tembiricha yakakodzera uye hunyoro usati wapfuura nemukamuri yakachena.
Zvimedu zvinofambiswa nemhepo (zvinosvibisa) zvinoyangarara zvakatenderedza. Zvizhinji zvemhepo zvinogara zvishoma nezvishoma, uye chiyero chekugadzirisa chinoenderana nehukuru hwavo. Iyo yakanyatsogadzirwa mhepo yekubata system inofanirwa kuunza mhepo yakachena uye yakadzokororwa yakasefa yakachena kuchenesa imba pamwe chete, uye kutakura zvimedu kubva mukamuri yakachena pamwechete. Zvichienderana nekushanda, mhepo inotorwa kubva mukamuri inowanzodzokororwa kuburikidza nemhepo inobata hurongwa, apo mafiritsi anobvisa zvikamu.
Kana maitiro, zvigadzirwa kana zvigadzirwa zvine hunyoro hwakawanda, hutsi hunokuvadza kana magasi, mweya uyu haugone kudzokororwa kukamuri. Iyi mhepo inowanzopedzwa kumhepo, uye ipapo 100% mweya mutsva inosvetwa mukamuri yakachena system uye inorapwa isati yapinda mukamuri yakachena.
Kuwanda kwemhepo inopinda muimba yakachena inodzorwa zvakasimba, uye huwandu hwemhepo hwakapera hunodzorwawo zvakasimba. Makamuri mazhinji akachena anomanikidzirwa, ayo anowanikwa nekupinda muimba yakachena nepamusoro pemhepo inopa kupfuura mhepo inopera kubva muimba yakachena. Dzvinyiriro dzakakwirira dzinogona kuita kuti mweya ubude kubva pasi pemikova kana kuburikidza nepakatsemuka madiki kana maburi mune chero imba yakachena. Chinokosha chekugadzirwa kwekamuri yakachena inzvimbo yakakodzera yekutora mhepo (kupa) uye kupera (kupera).
Paunenge uchiisa kunze kwekamuri yakachena, nzvimbo yekugovera uye kupera (kudzoka) grilles inofanira kuva yakakosha. Iyo inlet (ceiling) uye kudzoka grilles (padanho rezasi) inofanira kunge iri pamativi akatarisana ekamuri yakachena. Kana mushandisi achida kuchengetedzwa kubva pachigadzirwa, mhepo inoyerera inofanira kunge iri kure nemushandi. Iyo US FDA neEU vane nhungamiro yakasimba uye miganhu yekusvibiswa kwehutachiona, uye plenums pakati pemubati wemhepo uye fan filter unit uye meti anonamira zvinogona kushandiswa zvakare. Kumakamuri asina utachiona anoda mhepo yeKirasi A, mafambiro emhepo anobva kumusoro kusvika pasi uye haana kutungamira kana laminar, kuona kuti mweya hauna kusvibiswa usati wabata chigadzirwa.
4. Kusvibiswa kwekamuri yakachena
Dambudziko guru rekusvibisa kusvibiswa kwekamuri rinobva kune vashandisi pachavo. Mumaindasitiri ekurapa uye emishonga, kutonga kwema microorganisms kwakakosha, kunyanya ma microorganisms anogona kudururwa kubva paganda uye kuiswa mumhepo. Kudzidza maruva ane microbial emakamuri akachena kwakakosha zvikuru kune vanodzidza nezvezvinhu zvipenyu nevashandi vezvemhando yepamusoro kuti vaongorore mafambiro ari kuita, kunyanya kuongororwa kwemhando dzinoramba zvinodhaka uye kutsvagisa nzira dzekuchenesa nekuuraya utachiona. Iyo yakajairwa yakachena mukamuri flora inonyanya kuenderana neganda remunhu, uye pachavawo nehutachiona kubva kune mamwe masosi, senge kubva kunharaunda nemvura, asi muhuwandu hudiki. Mabhakitiriya ejenareta anowanzo sanganisira Micrococcus, Staphylococcus, Corynebacterium uye Bacillus, uye fungal genera inosanganisira Aspergillus uye Penicillium.
Pane zvinhu zvitatu zvakakosha kuchengetedza imba yakachena.
(1). Nzvimbo yemukati yekamuri yakachena uye midziyo yayo yemukati
Nheyo yacho ndeyekuti kusarudzwa kwezvinhu kwakakosha, uye kucheneswa kwezuva nezuva nekuuraya hutachiona kwakakosha. Kuti uenderane neGMP uye uwane hutsanana hutsanana, nzvimbo dzese dzemukamuri yakachena dzinofanirwa kunge dzakatsetseka uye dzisina mhepo, uye dzisingaburitse kusvibiswa kwavo, kureva kuti, hapana guruva, kana marara, isingadziviriri, iri nyore kuchenesa, zvikasadaro ichapa nzvimbo yekuberekesa hutachiona, uye pamusoro pacho panofanirwa kuve yakasimba uye yakasimba, uye haigone kutsemuka, kutyora kana kutsemuka. Pane zvinhu zvakasiyana-siyana zvokusarudza kubva, kusanganisira inodhura dagad paneling, girazi, nezvimwewo. Nguva dzose kuchenesa uye disinfection inofanira kuitwa maererano nezvinodiwa zvemakamuri akachena pamatanho ose. Kuwanda kunogona kuva mushure mekuvhiyiwa kwega kwega, kakawanda pazuva, zuva rega rega, mazuva mashoma, kamwe chete pasvondo, zvichingodaro. Zvinokurudzirwa kuti tafura yekushandisa inofanirwa kucheneswa uye kubviswa utachiona mushure mekuvhiyiwa kwega kwega, pasi panofanirwa kuvharirwa utachiona zuva rega rega, madziro anofanirwa kucheneswa nekuuraya utachiona mwedzi woga woga zvichienderana nechiyero chekamuri yakachena uye zviyero zvakatarwa uye zvakatemwa zvinofanirwa kuchengetwa.
(2). Kudzora mhepo muimba yakachena
Kazhinji, zvinodikanwa kusarudza yakakodzera dhizaini yekamuri yakachena, kuita nguva dzose kugadzirisa, uye kuita yekutarisa zuva nezuva. Kunyanya kutarisisa kunofanirwa kubhadharwa pakutariswa kwemabhakitiriya anoyangarara mumakamuri akachena emishonga. Mabhakitiriya anoyangarara ari muchadenga anotorwa nesampler yebhakitiriya inoyangarara kuburitsa imwe vhoriyamu yemhepo munzvimbo. Kuyerera kwemhepo kunopfuura nemudhishi rekusangana rakazadzwa neimwe tsika yepakati. Iyo yekudyira ndiro ichabata ma microorganisms, uye ipapo ndiro inoiswa mune incubator kuverenga nhamba yemakoloni uye kuverenga nhamba ye microorganisms munzvimbo. Zvipembenene zviri mulaminar layer zvinodawo kuwonekwa, uchishandisa inoenderana laminar layer inoyangarara mabhakitiriya sampler. Nheyo yekushanda yakafanana neyeye sampling yenzvimbo, kunze kwekuti iyo sampling point inofanirwa kuiswa mune laminar layer. Kana mhepo yakamanikidzwa ichidikanwa mukamuri isina mbereko, zvinodikanwa zvakare kuita microbial test pamhepo yakamanikidzwa. Uchishandisa inowirirana compressed air detector, mhepo yemhepo yemhepo yakamanikidzwa inofanira kugadziriswa kune iyo yakakodzera yekudzivirira kuparadzwa kwe microorganisms uye tsika media.
(3). Zvinodikanwa zvevashandi mukamuri yakachena
Vashandi vanoshanda mumakamuri akachena vanofanira kuwana dzidziso yenguva dzose mudzidziso yekudzora kusvibiswa. Vanopinda nekubuda mukamuri rakachena kuburikidza neairlocks, air shower uye / kana makamuri ekuchinja, uye vanofanirwa kupfeka zvipfeko zvakagadzirirwa kuvhara ganda uye zvinosvibisa zvinongoitika pamuviri. Zvichienderana nechikamu kana kushanda kwekamuri rakachena, zvipfeko zvevashandi zvingangoda dziviriro yakapfava semajasi emurabhoritari nehodhi, kana kuti zvinogona kuvharwa zvizere uye kusafumura chero ganda. Mbatya dzemukamuri dzakachena dzinoshandiswa kudzivirira zvimedu uye/kana tupukanana kuburitswa kubva mumuviri wemunhu akapfeka uye kusvibisa nharaunda.
Chipfeko chemukamuri chakachena pachacho hachifanire kuburitsa zvimedu kana shinda kudzivirira kusvibiswa kwenharaunda. Mhando iyi yekusvibiswa kwevashandi inogona kuderedza kuita kwechigadzirwa mu semiconductor uye maindasitiri emishonga, uye inogona kutungamira mukuyambuka-kutapukira pakati pevashandi vekurapa nevarwere muindasitiri yehutano, semuenzaniso. Midziyo yekudzivirira yekamuri yakachena inosanganisira zvipfeko zvekudzivirira, bhutsu, shangu, maapuroni, zvivharo zvendebvu, ngowani dzakatenderedza, masiki, mbatya dzebasa/majasi erabhoritari, majasi, magurovhosi uye machira eminwe, maoko neshangu uye zvivharo zvebhutsu. Rudzi rwembatya dzemukamuri dzakachena dzinoshandiswa dzinofanirwa kuratidza kamuri yakachena uye chikamu chechigadzirwa. Dzimba dzakachena dzepasi-pasi dzingada bhutsu dzakakwana dzakatsetseka zvachose dzisingamire pahuruva kana tsvina. Nekudaro, nekuda kwezvikonzero zvekuchengetedza, zvigaro zveshangu hazvigone kukonzera njodzi yekutsvedza. Zvipfeko zvemukamuri zvakachena zvinowanzodiwa kuti upinde mukamuri rakachena. Majasi erabhoritari akareruka, mavhavha emusoro uye mavhavha eshangu anogona kushandiswa kuKirasi 10,000 imba yakachena. Kukamuri rakachena reKirasi 100, zvipfeko zvemuviri wakazara, zvipfeko zvekudzivirira zvakaiswa zipi, magirazi, masiki, magurovhosi nemavharo ebhutsu zvinodiwa. Mukuwedzera, nhamba yevanhu vari muimba yakachena inofanira kudzorwa, nevhareji ye4 kusvika ku6 m2 / munhu, uye kushanda kunofanira kuva kwakapfava, kudzivisa kufamba kukuru uye nekukurumidza.
5. Inowanzoshandiswa nzira dzekuuraya utachiona dzekamuri yakachena
(1). UV disinfection
(2). Ozone disinfection
(3). Gasi sterilization Mishonga inouraya utachiona inosanganisira formaldehyde, epoxyethane, peroxyacetic acid, carbolic acid uye lactic acid musanganiswa, nezvimwe.
(4) Mishonga inouraya utachiona
Mishonga inouraya utachiona yakajairika inosanganisira isopropyl alcohol (75%), ethanol (75%), glutaraldehyde, Chlorhexidine, etc. Nzira yechinyakare yekuuraya utachiona mumakamuri asina utachiona mumafekitari emishonga ekuChina ndeyekushandisa formaldehyde fumigation. Mafekitari emishonga ekunze anotenda kuti formaldehyde ine kumwe kukuvadza kumuviri wemunhu. Iye zvino vanowanzoshandisa glutaraldehyde spraying. Mushonga wekuuraya utachiona unoshandiswa mumakamuri asina hutachiona unofanirwa kuvharirwa uye kusefa kuburikidza ne 0.22μm sefa membrane mune biological kuchengetedza kabati.
6. Kurongwa kwekamuri yakachena
Imba yakachena inokamurwa zvichienderana nenhamba uye saizi yezvimedu zvinotenderwa pavhoriyamu yemhepo. Nhamba huru dzakadai se "Kirasi 100" kana "Kirasi 1000" inoreva FED-STD-209E, iyo inoratidza nhamba ye0.5μm kana zvidimbu zvakakura zvinotenderwa pa cubic foot yemhepo. Chiyero chinobvumirawo kududzira; semuenzaniso, SNOLAB inochengeterwa yeKirasi 2000 yakachena kamuri. Discrete light scattering air particle counters anoshandiswa kuona kuwanda kwezvikamu zvinofambiswa nemhepo zvakaenzana kana kuti zvakakura pane saizi yakatarwa panzvimbo yakatarwa yesampling.
Kukosha kwedesimali kunoreva ISO 14644-1 mwero, uyo unotsanangura decimal logarithm yenhamba yezvikamu 0.1μm kana kuti hombe inotenderwa pa cubic mita yemhepo. Saka, semuenzaniso, ISO Class 5 kamuri yakachena ine huwandu hwe105 particles/m3. Ose ari maviri FS 209E uye ISO 14644-1 anofungidzira kuti pane hukama hwelogarithmic pakati pehukuru hwechikamu uye chidimbu chemisumbu. Naizvozvo, zero particle concentration haipo. Mamwe makirasi haadi kuyedzwa kwemamwe masaizi nekuti iyo yekumisikidza yakadzikira kana yakawandisa kuti ishande, asi ma blanks akadaro haafanirwe kutariswa zero. Sezvo 1m3 ingangoita 35 cubic tsoka, zviyero zviviri izvi zvakada kuenzana pakuyera 0.5μm zvidimbu. Mhepo yakajairika yemumba ingangoita Kirasi 1,000,000 kana ISO 9.
ISO 14644-1 uye ISO 14698 zviyero zvisiri zvehurumende zvakagadziriswa neInternational Organisation for Standardization (ISO). Iyo yekutanga inoshanda kune yakachena kamuri kazhinji; iyo yekupedzisira kuchenesa kamuri umo biocontamination inogona kunge iri nyaya.
Masangano azvino anodzora anosanganisira: ISO, USP 800, US Federal Standard 209E (yakapfuura mwero, ichiri kushandiswa) The Drug Quality and Safety Act (DQSA) yakavambwa muna Mbudzi 2013 kugadzirisa kufa kwezvinodhaka uye zviitiko zvakakomba. Iyo Federal Chikafu, Mushonga, uye Cosmetic Act (FD&C Act) inogadza yakatarwa nhungamiro uye marongero ekuumbwa kwevanhu. 503A inotariswa nevashandi vane mvumo (vemishonga/vanachiremba) nehurumende kana mubatanidzwa akatenderwa masangano 503B ane hukama nezvivakwa zvekunze uye inoda kutariswa zvakananga nemufemesi ane rezinesi uye haidi kuve chitoro chemishonga. Zvivakwa zvinowana marezinesi kuburikidza neFood and Drug Administration (FDA).
Nhungamiro dzeEU GMP dzakaomarara kupfuura mamwe nhungamiro uye inoda kamuri yakachena kuti uwane maverengero ezvikamu kana uchishanda (panguva yekugadzira) uye pakuzorora (apo pasina kugadzirwa kuri kuitika asi kamuri AHU iripo).
8. Mibvunzo kubva kuLab novices
(1). Unopinda sei nekubuda mukamuri rakachena? Vanhu nezvinhu zvinopinda nekubuda nemumikova nekubuda kwakasiyana. Vanhu vanopinda nekubuda nepama airlocks (vamwe vane mashawa emhepo) kana vasina airlocks uye vanopfeka midziyo yekudzivirira yakadai semahoods, masks, magirovhosi, bhutsu nembatya dzekudzivirira. Uku kudzikisa uye kuvhara zvimedu zvinounzwa nevanhu vanopinda mukamuri rakachena. Zvinhu zvinopinda nekubuda mukamuri rakachena nemugero rekutakura zvinhu.
(2). Pane chimwe chinhu chakakosha pamusoro pekugadzira imba yakachena? Sarudzo yemidziyo yekuvaka yekamuri yakachena haifanirwe kuburitsa chero zvidimbu, saka yakazara epoxy kana polyurethane floor coating inosarudzwa. Simbi yakakwenenzverwa kana poda-yakavharidzirwa simbi sandwich partition panels uye sirin'i mapaneru anoshandiswa. Makona ekurudyi anodziviswa nenzvimbo dzakakombama. Majoini ese kubva pakona kusvika pasi uye pakona kusvika padenga anofanirwa kuvharwa ne epoxy sealant kudzivirira chero chidimbu chekuisa kana chizvarwa pamajoini. Midziyo iri mukamuri yakachena yakagadzirirwa kugadzira kusvibiswa kwemhepo kushoma. Shandisa mops nemabhaketi chete akagadzirwa. Yakachena yekamuri fenicha inofanirwawo kugadzirwa kuti igadzire zvidimbu zvidiki uye zvive nyore kuchenesa.
(3). Nzira yekusarudza sei disinfectant yakakodzera? Chekutanga, kuongororwa kwezvakatipoteredza kunofanirwa kuitwa kuratidza rudzi rwehutachiona hwakasvibiswa kuburikidza nekutarisa kwezvakatipoteredza. Nhanho inotevera ndeyekuona kuti ndeipi mushonga wekuuraya utachiona unogona kuuraya huwandu hunozivikanwa hwehutachiona. Usati waita bvunzo yekuuraya nguva yekubata (yekuyedza chubhu dilution nzira kana pamusoro pezvinhu nzira) kana yeAOAC bvunzo, ma disinfectants aripo anofanirwa kuongororwa nekusimbiswa kuti akakodzera. Kuuraya tupukanana mukamuri yakachena, panowanzove nemhando mbiri dzemajekiseni ekuuraya utachiona: ① Kutenderedzwa kwemushonga wekuuraya utachiona uye imwe sporicide, ② Kutenderedzwa kwemaviri ekuuraya utachiona uye imwe sporicide. Mushure mekunge chirongwa chekuuraya hutachiona chatemwa, bvunzo yehutachiona hwehutachiona inogona kuitwa kuti ipe hwaro hwekusarudzwa kwemishonga inouraya utachiona. Mushure mekupedza bvunzo yehutachiona hwehutachiona, bvunzo yemunda inodiwa. Iyi inzira yakakosha yekuratidza kana kuchenesa nekuuraya hutachiona SOP uye bvunzo yehutachiona hwehutachiona hwehutachiona hunoshanda. Nekufamba kwenguva, tupukanana tusina kuonekwa hunogona kuoneka, uye maitiro ekugadzira, vashandi, nezvimwewo zvinogonawo kuchinja, saka kuchenesa nekuuraya hutachiona maSOPs anofanirwa kuongororwa nguva nenguva kuti aone kana achiri kushanda kune yazvino nharaunda.
(4). Kuchenesa mikoto kana kuti mikoto ine tsvina? Hupfu hwakaita semapiritsi kana makapisi mikoto yakachena, nepo zvinodhaka zvisina utachiona, zvinodhaka zvinoyerera, nezvimwewo zvine tsvina. Kazhinji, mishonga yemishonga yakaderera-yakadzika senge mahwendefa kana capsules yakaoma uye ine guruva, saka pane mukana mukuru wengozi yakakura yekusvibiswa. Kana mutsauko wekumanikidza pakati penzvimbo yakachena nemukoto uri wakanaka, hupfu hunobuda mukamuri huchipinda mukoridho uye kazhinji hunogona kuendeswa kune imwe inotevera imba yakachena. Sezvineiwo, gadziriro zhinji dzakaoma hadzisi nyore kutsigira kukura kwehutachiona, saka seyakajairwa, mahwendefa uye hupfu zvinogadzirwa munzvimbo dzakachena mukoridho nekuti ma microorganisms anoyangarara mumukoridho haakwanise kuwana nharaunda yaanogona kubudirira. Izvi zvinoreva kuti mukamuri ine dzvinyiriro yakaipa kumukoridho. Kune sterile (yakagadziriswa), aseptic kana yakaderera bioburden uye yemvura mishonga yemishonga, tupukanana kazhinji tinowana tsigiro yetsika umo kuti ibudirire, kana muchiitiko chezvakagadzirwa zvigadzirwa, microorganism imwechete inogona kuva njodzi. Naizvozvo, zvivakwa izvi zvinowanzo gadzirwa zvine mikoto ine tsvina nekuti chinangwa ndechekuchengetedza tupukanana tunogona kubva mukamuri yakachena.
Nguva yekutumira: Feb-20-2025