Intshayelelo
Kwimeko yoxubo mayeza, igumbi elicocekileyo libhekisa kwigumbi elidibana neempawu ze-GMP ze-aseptic. Ngenxa yeemfuno ezingqongqo zokuphuculwa kweteknoloji yokuvelisa kwindawo yemveliso, igumbi elicocekileyo lebhubhoratri likwabizwa ngokuba "ngumlindi wemveliso ephezulu."
1. Yintoni igumbi elicocekileyo
Igumbi elicocekileyo, elikwabizwa ngokuba ligumbi elingenathuli, lidla ngokusetyenziswa njengenxalenye yemveliso yezobuchwephesha okanye uphando lwezenzululwazi, kubandakanywa ukuveliswa kwamayeza, iisekethe ezidibeneyo, i-CRT, i-LCD, i-OLED kunye ne-micro LED displays, njl.
Igumbi elicocekileyo lenzelwe ukugcina amanqanaba asezantsi kakhulu amasuntswana, afana nothuli, izinto eziphilayo ezihamba nomoya, okanye amasuntswana aphuhliswe ngumphunga. Ngokukodwa, igumbi elicocekileyo linenqanaba lokungcola elilawulwayo, elichazwe ngenani leengqungquthela kwi-cubic meter kwi-particle echaziweyo.
Igumbi elicocekileyo linokuthi libhekiselele kuyo nayiphi na indawo enikiweyo yokuqulatha apho amanyathelo amiselwe ukunciphisa ukungcoliseka kwamasuntswana kunye nokulawula ezinye iiparamitha zokusingqongileyo ezifana nobushushu, ukufuma kunye noxinzelelo. Kwingqiqo yamachiza, igumbi elicocekileyo ligumbi elihlangabezana neemfuno zeempawu ze-GMP ezichazwe kwiimpawu ze-aseptic ze-GMP. Kukudityaniswa koyilo lobunjineli, ukuvelisa, ukugqiba kunye nokulawula ukusebenza (isicwangciso sokulawula) esifunekayo ukuguqula igumbi eliqhelekileyo libe yindawo ecocekileyo. Amagumbi acocekileyo asetyenziswa kumashishini amaninzi, naphi na apho amaqhekeza amancinci angaba nefuthe elibi kwinkqubo yokuvelisa.
Amagumbi acocekileyo ahluka ngobukhulu kunye nobunzima kwaye asetyenziswa ngokubanzi kumashishini afana nokuveliswa kwe-semiconductor, amayeza, i-biotechnology, izixhobo zonyango kunye nesayensi yobomi, kunye nenkqubo ebalulekileyo yokuvelisa eziqhelekileyo kwi-aerospace, optics, umkhosi kunye neSebe lezaMandla.
2. Ukuphuhliswa kwegumbi elicocekileyo
Igumbi elicocekileyo langoku laqanjwa yingcali yefiziksi yaseMelika uWillis Whitfield. UWhitfield, njengomsebenzi weSandia National Laboratories, wayila uyilo loqobo lwegumbi elicocekileyo ngo-1966. Phambi kokuqanjwa kukaWhitfield, igumbi elicocekileyo lakwangoko lihlala lidibana neengxaki ngamasuntswana kunye nokuhamba komoya okungalindelekanga.
UWhitfield wayila igumbi elicocekileyo elinomoya ongaguqukiyo kwaye ucociweyo ngokungqongqo ukugcina indawo icocekile. Uninzi lwezixhobo ezidibeneyo zokuvelisa isekethe eSilicon Valley zakhiwe ziinkampani ezintathu: iMicroAire, iPureAire, kunye nePlastiki ePhambili. Baye benza iiyunithi zokuhamba kwe-laminar, iibhokisi zeglavu, amagumbi acocekileyo kunye neeshawa zomoya, kunye neitanki zekhemikhali kunye neebhentshi zokusebenza "inkqubo emanzi" yokwakhiwa kweesekethe ezidibeneyo. Iinkampani ezintathu nazo zazingoovulindlela ekusebenziseni iTeflon kwimipu yomoya, iimpompo zamachiza, i-scrubbers, izibhamu zamanzi kunye nezinye izixhobo eziyimfuneko kwimveliso yesekethe edibeneyo. UWilliam (uBill) C. McElroy Jr. wakhonza njengomphathi wezobunjineli, umphathi woyilo lwegumbi, i-QA / QC, kunye nomyili weenkampani ezintathu, kunye noyilo lwakhe longeza i-patent ye-45 yokuqala kwi-teknoloji yelo xesha.
3. Imigaqo yokuCoceka koMoya weGumbi
Amagumbi acocekileyo alawula amaqhekeza ahamba emoyeni ngokusebenzisa i-HEPA okanye i-ULPA filters, usebenzisa i-laminar (indlela enye yokuhamba) okanye i-turbulent (i-turbulent, non-way flow flow) imigaqo yokuhamba komoya.
I-Laminar okanye i-airflow yendlela enye iqondisa umoya ohluziweyo ngokuqhubekayo ukuhla okanye ngokuthe tye kwizihluzo ezikudonga olukufutshane nomgangatho wegumbi elicocekileyo, okanye zijikelezwe ngokutsha ngeepaneli zomgangatho ophakanyisiweyo.
Iinkqubo zokuqukuqela kwe-laminar zidla ngokusetyenziswa ngaphezulu kwe-80% yesilingi yegumbi elicocekileyo ukugcina umoya ongatshintshiyo. Insimbi engenasici okanye ezinye izinto ezingezizo zokuchitha zisetyenziselwa ukwakha izihlungi zokuhamba komoya ze-laminar kunye neehoods ukuthintela amasuntswana angaphezulu ukuba angangeni emoyeni. I-Turbulent, okanye i-non-unidirectional air flow isebenzisa i-laminar air flow hoods kunye nezihlungi zesantya ezingabonakaliyo ukugcina umoya kwindawo ecocekileyo kwintshukumo eqhubekayo, nangona zonke zingekho kwicala elifanayo.
Umoya orhabaxa uzama ukubamba amasuntswana anokuba semoyeni kwaye uwaqhubele emgangathweni, apho angena khona kwisihluzi kwaye ashiye indawo ecocekileyo yegumbi. Ezinye iindawo ziya kongeza amagumbi acocekileyo e-vector: umoya unikezelwa kwiikona eziphezulu zegumbi, izihluzo ze-hepa ezimise okwefeni zisetyenziswa, kwaye izihluzo ze-hepa eziqhelekileyo zinokusetyenziswa kunye neendawo zokuhambisa umoya ezimile. Izixhobo zomoya zokubuyiswa zibekwe kwindawo engezantsi kwelinye icala. Umlinganiselo wobude ukuya kubude begumbi ngokuqhelekileyo phakathi kwe-0.5 kunye ne-1. Olu hlobo lwegumbi elicocekileyo lunokufikelela kwakhona kwiKlasi 5 (iKlasi ye-100) yokucoceka.
Amagumbi acocekileyo afuna umoya omninzi kwaye ahlala ebushushu obulawulwayo kunye nokufuma. Ukunciphisa iindleko zokutshintsha ubushushu be-ambient okanye ukufuma, malunga ne-80% yomoya iphinda ijikelezwe (ukuba iimpawu zemveliso zivumela), kwaye umoya ojikeleziweyo uqala ukuhluzwa ukuze ususe ukungcoliswa kwe-particle ngelixa ugcina ubushushu obufanelekileyo kunye nomswakama ngaphambi kokudlula kwigumbi elicocekileyo.
Amasuntswana omoya (izingcolisi) mhlawumbi adada ngapha nangapha. Uninzi lwamasuntswana omoya luhlala kancinci, kwaye izinga lokumisa lixhomekeke kubungakanani bawo. Inkqubo yokuphatha umoya eyilwe kakuhle kufuneka ihambise umoya ococekileyo nococekileyo ococekileyo ukuze ucoce igumbi kunye, kwaye uthwale amasuntswana kude negumbi elicocekileyo kunye. Ngokuxhomekeke ekusebenzeni, umoya othathwe kwigumbi udla ngokuphinda ujikelezwe ngenkqubo yokuphatha umoya, apho izihlungi zisusa iinxalenye.
Ukuba inkqubo, izinto eziluhlaza okanye iimveliso ziqulethe ubuninzi bokufuma, umphunga onobungozi okanye iigesi, lo moya awukwazi ukuphinda uphinde ubuyele kwigumbi. Lo moya udla ngokuphela emoyeni, kwaye ke i-100% umoya omtsha ufunxelwa kwinkqubo yegumbi elicocekileyo kwaye uphathwe ngaphambi kokungena kwigumbi elicocekileyo.
Umthamo womoya ongena kwigumbi elicocekileyo ulawulwa ngokungqongqo, kwaye umthamo womoya ophelileyo ulawulwa ngokungqongqo. Uninzi lwamagumbi acocekileyo axinzelelwe, aphunyezwa ngokungena kwigumbi elicocekileyo elinomoya ophezulu kunomoya ophuma kwigumbi elicocekileyo. Uxinzelelo oluphezulu lunokubangela ukuba umoya uphume phantsi kweengcango okanye ngeentanda ezincinci okanye izikhewu ezingenakuthintelwa kulo naliphi na igumbi elicocekileyo. Isitshixo soyilo olucocekileyo lwegumbi yindawo efanelekileyo yokungenisa umoya (ukubonelela) kunye nokukhupha (ukukhupha).
Xa ubeka igumbi elicocekileyo, indawo yokubonelela kunye nokukhupha (ukubuyisela) i-grilles kufuneka ibe yinto ephambili. I-inlet (i-ceiling) kunye ne-grilles yokubuyisela (kwizinga eliphantsi) kufuneka ibekwe kumacala ahlukeneyo kwigumbi elicocekileyo. Ukuba umqhubi ufuna ukukhuselwa kwimveliso, ukuhamba komoya kufuneka kube kude nomsebenzi. I-US FDA kunye ne-EU zinezikhokelo ezingqongqo kunye nemida yongcoliseko lwemicrobial, kwaye iiplenum phakathi kwesiphathi somoya kunye neyunithi yesihluzo sefeni kunye neemethi ezincangathi nazo zingasetyenziswa. Kumagumbi angenazintsholongwane afuna umoya weKlasi A, ukuhamba komoya ukusuka phezulu ukuya ngasezantsi kwaye ku-unidirectional okanye i-laminar, ukuqinisekisa ukuba umoya awungcoliswanga ngaphambi kokuba uqhagamshelane nemveliso.
4. Ukungcoliswa kwegumbi elicocekileyo
Esona sisongelo esikhulu sokungcoliseka kwegumbi sivela kubasebenzisi ngokwabo. Kumashishini ezonyango kunye namachiza, ukulawulwa kwee-microorganisms kubaluleke kakhulu, ngakumbi i-microorganisms enokuthi ikhutshwe esikhumbeni kwaye ifakwe kwi-airflow. Ukufunda iintyatyambo zemicrobial kumagumbi acocekileyo kubaluleke kakhulu kwii-microbiologists kunye nabasebenzi bolawulo lomgangatho ukuba baphonononge iindlela eziguqukayo, ngakumbi uhlolo lweentlobo zokunganyangeki ngamachiza kunye nophando lokucoca kunye neendlela zokubulala iintsholongwane. Iintyatyambo eziqhelekileyo zegumbi elicocekileyo zinxulumene kakhulu nolusu lomntu, kwaye kuya kubakho iintsholongwane ezivela kweminye imithombo, njengokuvela kokusingqongileyo kunye namanzi, kodwa ngamanani amancinci. Ijenari yebhaktiriya eqhelekileyo ibandakanya iMicrococcus, iStaphylococcus, iCorynebacterium kunye neBacillus, kunye nohlobo lomngundo lubandakanya iAspergillus kunye nePenicillium.
Kukho iinkalo ezintathu ezibalulekileyo zokugcina igumbi licocekile.
(1). Umphezulu wangaphakathi wegumbi elicocekileyo kunye nezixhobo zayo zangaphakathi
Umgaqo-siseko kukuba ukhetho lwezinto eziphathekayo lubalulekile, kwaye ukucocwa kwansuku zonke kunye nokubulala iintsholongwane kubaluleke kakhulu. Ukuze uthobele i-GMP kwaye ufezekise ukucoceka, zonke iindawo zegumbi elicocekileyo kufuneka zibe zigudileyo kwaye zingabi namoya, kwaye zingavelisi ungcoliseko lwazo, oko kukuthi, akukho thuli, okanye i-debris, i-corrosion-resistant, kulula ukuyicoca, ngaphandle koko iya kubonelela ngendawo yokuveliswa kwe-microbial, kwaye umphezulu kufuneka womelele kwaye uhlale, kwaye awukwazi ukuqhekeka, ukuphuka okanye ukubola. Kukho izinto ezahlukeneyo onokukhetha kuzo, kubandakanywa i-dagad panelling ebiza kakhulu, iglasi, njl. Olona khetho luhle kakhulu yiglasi. Ukucoca rhoqo kunye ne-disinfection kufuneka kuqhutywe ngokuhambelana neemfuno zamagumbi acocekileyo kuwo onke amanqanaba. Ubuninzi bunokuba emva kotyando ngalunye, amaxesha amaninzi ngosuku, yonke imihla, rhoqo emva kweentsuku ezimbalwa, kanye ngeveki, njalo njalo.
(2). Ukulawula umoya kwigumbi elicocekileyo
Ngokuqhelekileyo, kuyimfuneko ukukhetha idizayini efanelekileyo yegumbi elicocekileyo, ukwenza ukugcinwa rhoqo, kwaye wenze ukubeka iliso kwansuku zonke. Ingqwalasela ekhethekileyo kufuneka ihlawulwe ekubekweni esweni kweebhaktheriya ezidadayo kumagumbi acocekileyo amayeza. Iibhaktheriya ezidadayo esithubeni zitsalwa yisampulu yebhaktiriya edadayo ukukhupha umthamo othile womoya esithubeni. Ukuhamba komoya kudlula kwisitya soqhagamshelwano esizaliswe yinkcubeko ethile. Isitya soqhagamshelwano siya kubamba i-microorganisms, kwaye ke isitya sifakwe kwi-incubator ukubala inani lamakholoni kwaye ubale inani le-microorganisms kwindawo. Iimicroorganisms kumaleko welaminar nazo kufuneka zibhaqwe, kusetyenziswa isampler yebhaktheriya ehambelanayo yelaminar edadayo. Umgaqo wokusebenza ufana nowokusampula kwendawo, ngaphandle kokuba indawo yesampulu kufuneka ibekwe kwi-laminar layer. Ukuba umoya oxinyiweyo uyadingeka kwigumbi elinyumba, kuyafuneka kwakhona ukuba kwenziwe uvavanyo lwe-microbial emoyeni oxinyiweyo. Ukusebenzisa i-detector yomoya ohambelanayo ohambelanayo, uxinzelelo lomoya lomoya ocinezelweyo kufuneka lulungiswe kuluhlu olufanelekileyo ukukhusela ukutshatyalaliswa kwe-microorganisms kunye nenkcubeko yenkcubeko.
(3). Iimfuno zabasebenzi kwigumbi elicocekileyo
Abasebenzi abasebenza kumagumbi acocekileyo kufuneka bafumane uqeqesho rhoqo kwithiyori yokulawula ukungcoliseka. Bangena kwaye baphume kwigumbi elicocekileyo ngokusebenzisa i-airlocks, iishawari zomoya kunye / okanye amagumbi okutshintsha, kwaye kufuneka banxibe iimpahla ezilungiselelwe ngokukodwa ukugquma ulusu kunye nokungcola okwenzeka ngokwemvelo emzimbeni. Ngokuxhomekeke kuluhlu okanye umsebenzi wegumbi elicocekileyo, iimpahla zabasebenzi zingafuna kuphela ukhuseleko olulula njengeebhatyi zaselabhoratri kunye neehood, okanye zinokugqunywa ngokupheleleyo kwaye zingavezi naluphi na ulusu. Impahla yegumbi ecocekileyo isetyenziselwa ukuthintela amasuntswana kunye/okanye ii-microorganisms ukuba zikhutshwe kumzimba womntu onxibileyo kwaye zingcolise indalo.
Impahla yegumbi ecocekileyo ngokwayo akufunekanga ikhuphe amasuntswana okanye imicu ukuthintela ukungcoliseka kwendalo. Olu hlobo longcoliseko lwabasebenzi lunokunciphisa ukusebenza kwemveliso kwi-semiconductor kunye namashishini amayeza, kwaye kunokukhokelela kwi-cross-infection phakathi kwabasebenzi bezonyango kunye nezigulane kwishishini lezempilo, umzekelo. Izixhobo zokukhusela igumbi elicocekileyo ziquka iimpahla ezikhuselayo, iibhuthi, izihlangu, iifaskoti, izigqubuthelo zeentshebe, iminqwazi ejikelezileyo, iimaski, iimpahla zokusebenza / iibhatyi zalebhu, iigawuni, iiglavu kunye neebhedi zeminwe, imikhono kunye nezihlangu kunye nezigqubuthelo zebhuthi. Uhlobo lwempahla yegumbi ecocekileyo esetyenzisiweyo kufuneka lubonise igumbi elicocekileyo kunye necandelo lemveliso. Amagumbi acocekileyo akumgangatho ophantsi anokufuna izihlangu ezikhethekileyo ezineengcambu ezigudileyo ngokupheleleyo ezingayi kuma eluthulini okanye kumdaka. Nangona kunjalo, ngenxa yezizathu zokhuseleko, i-soles yezicathulo ayinakubangela ingozi ye-slip. Impahla yegumbi ecocekileyo idla ngokufuneka ukuba ungene kwigumbi elicocekileyo. Iingubo zelebhu ezilula, izigqubuthelo zentloko kunye nezihlangu zezihlangu zingasetyenziselwa i-Class 10,000 igumbi elicocekileyo. Kwigumbi elicocekileyo leKlasi le-100, iingubo ezipheleleyo zomzimba, iimpahla zokukhusela ezifakwe ziphu, izibuko, iimaski, iiglavu kunye nezigqubuthelo ze-boot ziyafuneka. Ukongezelela, inani labantu kwigumbi elicocekileyo kufuneka lilawulwe, kunye nomyinge we-4 ukuya kwi-6 m2 / umntu, kwaye umsebenzi kufuneka ube mnene, ugweme ukunyakaza okukhulu kunye nokukhawuleza.
5. Iindlela ezisetyenziswa ngokuqhelekileyo zokubulala iintsholongwane kwigumbi elicocekileyo
(1). Ukukhutshwa kweentsholongwane kwi-UV
(2). Ukubulala iintsholongwane kwi-ozone
(3). Ukubulala iintsholongwane ngegesi Izibulali-ntsholongwane ziquka i-formaldehyde, i-epoxyethane, i-peroxyacetic acid, i-carbolic acid kunye nemixube ye-lactic acid, njl.
(4) Izibulali-ntsholongwane
Iintsholongwane eziqhelekileyo ziquka i-isopropyl alcohol (75%), i-ethanol (i-75%), i-glutaraldehyde, i-Chlorhexidine, njl. Indlela yendabuko yokubulala iintsholongwane kumagumbi angenazintsholongwane kwiifektri zamachiza aseShayina kukusebenzisa i-formaldehyde fumigation. Iifektri zamayeza angaphandle zikholelwa ukuba i-formaldehyde inomonakalo othile kumzimba womntu. Ngoku ngokuqhelekileyo basebenzisa i-glutaraldehyde yokutshiza. Isibulali-ntsholongwane esisetyenziswa kumagumbi angenazintsholongwane kufuneka sicocwe kwaye sihluzwe ngenwebu yokucoca i-0.22μm kwikhabhathi yokhuseleko lwebhayoloji.
6. Ukuhlelwa kwegumbi elicocekileyo
Igumbi elicocekileyo lihlelwa ngokwenani kunye nobukhulu bamaqhekeza avunyelwe ngomthamo womoya. Amanani amakhulu afana ne "Class 100" okanye "Class 1000" abhekisela kwi-FED-STD-209E, ebonisa inani le-0.5μm okanye amasuntswana amakhulu avunyelwe kwi-cubic foot of air. Umgangatho ukwavumela ukutolikwa; umzekelo, iSNOLAB igcinelwe igumbi elicocekileyo leKlasi 2000. Izibali zomoya ezisasaza ukukhanya okucacileyo zisetyenziselwa ukumisela ukuxinana kwamasuntswana asemoyeni alingana okanye amakhulu kunobukhulu obuchaziweyo kwindawo ethile yesampulu.
Ixabiso ledesimali libhekiselele kumgangatho we-ISO 14644-1, ochaza idesimali yelogarithm yenani lamasuntswana 0.1μm okanye amakhulu avumelekileyo kwi-cubic meter nganye yomoya. Ngoko, umzekelo, i-ISO Class 5 igumbi elicocekileyo linobuninzi be-particle 105 / m3. Bobabini i-FS 209E kunye ne-ISO 14644-1 bacinga ukuba kukho ubudlelwane be-logarithmic phakathi kobukhulu be-particle kunye ne-particle concentration. Ngoko ke, i-particle zero concentration ayikho. Ezinye iiklasi azifuni kuvavanywa ubungakanani bamasuntswana athile kuba ugxininiso luphantsi kakhulu okanye luphezulu kakhulu ukuba lungenziwa, kodwa ezo zithuba zingenanto akufuneki zithathwe njengeqanda. Ekubeni i-1m3 imalunga ne-35 cubic feet, imigangatho emibini iphantse ilingane xa ilinganisa amasuntswana angama-0.5μm. Umoya oqhelekileyo wangaphakathi umalunga noKlasi 1,000,000 okanye i-ISO 9.
I-ISO 14644-1 kunye ne-ISO 14698 yimigangatho engekho phantsi kukarhulumente eyenziwe yi-International Organisation for Standardization (ISO). Eyangaphambili isebenza kwigumbi elicocekileyo ngokubanzi; ukucoca igumbi apho i-biocontamination ingaba ngumba.
Ii-arhente ezilawulayo zangoku zibandakanya: ISO, USP 800, US Federal Standard 209E (umgangatho wangaphambili, usasetyenziswa) UMthetho woMgangatho weDrug and Safety Act (DQSA) wasekwa ngoNovemba 2013 ukujongana nokufa okudityaniswa kweziyobisi kunye neziganeko ezimbi kakhulu. Umthetho we-Federal Food, Drug, and Cosmetic Act (FD & C Act) useka izikhokelo ezithile kunye nemigaqo-nkqubo yokuqulunqwa kwabantu. I-503A ilawulwa ngabasebenzi abagunyazisiweyo (oosokhemesti / oogqirha) yi-arhente karhulumente okanye i-federal egunyazisiweyo i-503B inxulumene nezibonelelo zokukhutshwa ngaphandle kwaye ifuna ukulawulwa ngokuthe ngqo ngusokhemesti onelayisensi kwaye ayifuni ukuba yikhemesti enelayisensi. Amaziko afumana iilayisensi ngoLawulo lokuTya kunye neDrugs (FDA).
Izikhokelo ze-EU GMP zingqongqo kunezinye izikhokelo kwaye zifuna igumbi elicocekileyo ukufezekisa ukubalwa kweengqungquthela xa kusebenza (ngexesha lokuvelisa) kunye nokuphumla (xa kungekho mveliso eyenzekayo kodwa igumbi le-AHU likhona).
8. Imibuzo evela kwabaqalayo baselabhu
(1). Ungena kwaye uphume njani kwigumbi elicocekileyo? Abantu kunye nempahla bangena kwaye baphuma ngeendlela ezahlukeneyo zokungena kunye nokuphuma. Abantu bangena kwaye baphume ngee-airlocks (abanye baneshawari zomoya) okanye bengenazo izitshixo zomoya kwaye banxibe izixhobo zokhuseleko ezifana neehood, iimaski, iiglavu, iibhutsi kunye nempahla yokukhusela. Oku kukunciphisa kunye nokuvimbela amaqhekeza angeniswe ngabantu abangena kwigumbi elicocekileyo. Impahla ingena kwaye iphume kwigumbi elicocekileyo ngomjelo wempahla.
(2). Ngaba kukho into ekhethekileyo malunga noyilo lwegumbi elicocekileyo? Ukukhethwa kwezixhobo zokwakha igumbi elicocekileyo akufanele kuvelise nayiphi na i-particle, ngoko ke i-epoxy iyonke okanye i-polyurethane i-coating floor ikhethwayo. Intsimbi ekhazimlisiweyo okanye iipaneli zokwahlula iisangweji zentsimbi ezithambileyo ezifakwe ngumgubo kunye neepaneli zesilingi ziyasetyenziswa. Iikona ze-right-angle ziphetshwa yimigangatho egobileyo. Onke amakhonkco ukusuka kwikona ukuya kumgangatho kunye nekona ukuya kwisilingi kufuneka atywinwe nge-epoxy sealant ukuphepha nakuphi na ukubekwa kwamasuntswana okanye isizukulwana kumalungu. Izixhobo ezikwigumbi elicocekileyo ziyilelwe ukuvelisa ungcoliseko oluncinci lomoya. Sebenzisa kuphela iimops ezenziwe ngokukodwa kunye neebhakethi. Ifenitshala yegumbi ecocekileyo kufuneka nayo iyilwe ukuvelisa amasuntswana amancinci kwaye kube lula ukuyicoca.
(3). Indlela yokukhetha isibulali-ntsholongwane esifanelekileyo? Okokuqala, uhlalutyo lokusingqongileyo kufuneka luqhutywe ukuze kuqinisekiswe uhlobo lwee-microorganisms ezingcolileyo ngokubeka iliso lokusingqongileyo. Inyathelo elilandelayo kukufumanisa ukuba sesiphi isibulali-ntsholongwane esinokubulala inani elaziwayo leentsholongwane. Phambi kokwenza uvavanyo lwexesha lokunxibelelana lokubulala (indlela yokuvavanya i-tube dilution okanye indlela yemathiriyeli engaphezulu) okanye uvavanyo lwe-AOAC, iintsholongwane ezikhoyo kufuneka zivavanywe kwaye ziqinisekiswe ukuba zifanelekile. Ukubulala iimicroorganisms kwigumbi elicocekileyo, kukho ngokubanzi iindidi ezimbini zeendlela zokujikeleziswa kwesibulali-ntsholongwane: ① Ukujikeleziswa kwesibulali-ntsholongwane esinye kunye ne-sporicide enye, ② Ukujikeleziswa kwezibulali-ntsholongwane ezibini kunye ne-sporicide enye. Emva kokuba inkqubo ye-disinfection inqunywe, uvavanyo lwe-bactericidal efficacy lunokwenziwa ukubonelela ngesiseko sokukhethwa kwee-disinfectants. Emva kokugqiba uvavanyo lwe-bactericidal efficacy, uvavanyo lwe-field study luyafuneka. Le yindlela ebalulekileyo yokubonisa ukuba ingaba i-SOP yokucoca kunye nokubulala iintsholongwane kunye novavanyo lwe-bactericidal efficacy ye-disinfectant luyasebenza. Ngokuhamba kwexesha, ii-microorganisms ezingazange zibonwe ngaphambili zingavela, kwaye iinkqubo zokuvelisa, abasebenzi, njl njl.
(4). Coca iipaseji okanye iipaseji ezimdaka? Iipowders ezifana neepilisi okanye ii-capsules ziipaseji ezicocekileyo, ngelixa amachiza angcolileyo, amachiza angamalwelo, njl.njl. ziipaseji ezimdaka. Ngokuqhelekileyo, iimveliso zonyango ezinobumanzi obuphantsi ezifana neepilisi okanye iipilisi zomile kwaye zinothuli, ngoko ke kukho umngcipheko omkhulu wokungcoliswa kwe-cross-contamination. Ukuba umahluko woxinzelelo phakathi kwendawo ecocekileyo kunye nepaseji ulungile, umgubo uya kuphuma kwigumbi ukuya epasejini kwaye kunokwenzeka ukuba udluliselwe kwigumbi elicocekileyo elilandelayo. Ngethamsanqa, uninzi lwamalungiselelo omileyo aluxhasi lula ukukhula kwe-microbial, ngoko ke njengomgaqo jikelele, iipilisi kunye nee powders zenziwa kwiindawo ezicocekileyo zepaseji kuba ii-microorganisms ezidadayo kwi-corridor azikwazi ukufumana indawo ezinokuthi ziphumelele kuyo. Oku kuthetha ukuba igumbi linoxinzelelo olubi kwi-corridor. Kwizinyumba (ezicutshungulwayo), i-aseptic okanye i-bioburden ephantsi kunye neemveliso zamayeza ezingamanzi, ii-microorganisms zihlala zifumana iinkcubeko ezixhasayo apho zikhula khona, okanye kwimeko yeemveliso ezichuliweyo, i-microorganism enye inokuba yintlekele. Ke ngoko, ezi ndawo zihlala ziyilwe zineepaseji ezimdaka kuba injongo kukugcina ii-microorganisms ezinokubakho kwigumbi elicocekileyo.
Ixesha lokuposa: Feb-20-2025