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Indima Yokuphatha Kwemithambo Yomoya We-AHU Kukuzimisela Kwezindawo Zokusebenza Ngokupheleleyo Ye-GMP
Kubasebenzisi bokuphatha amadragi nezintshwela empilweni, ubukhulu bekukhanya okuthunyiselwa ekhaya lokuchitha kuyisisekelo sokuvikela isimo sesikhathi sokuphatha. I-Air Handling Unit (AHU) iyakwenza lokhu kukhanya. Lokhu khanya okuthunyiselwa ngaphandle kwe-AHU akuyiyo kuphela indlela yokusebenza; kuyinto ebalulekile kumthwalo wokuvikela ukungatholakali kwamanqindi. Kufanele kube nempilo yokugcina, ukungatholakali kwamadragi, nokungatholakali kwamakhemikhali okuthunyiselwa ngokushesha. Umkhondo wokulawula lokhu khanya uyisikhundla esikhulu futhi asinakukhetha. Izinhlanganiso zokulinganisa njenge-ISO 14644-1, EU GMP Annex 1, nezinhlanganiso zokulawula kwe-FDA cGMP zihlala ziqiniseka ukuthi isistimu yekhanya we-AHU ibhalwe, ibalwe, nabhalwe ngokuphelele ukuze isebenze ngokuphelele ngokuphakanyiswa kokukhanya. Ukungafaneli kwe-sistimu yekhanya we-AHU kungahlela ukuthi wonke umkhakha uphulukwe, ukuthi izinkambo ziphulukwe, ukuthi kubonakaliswe izinkinga zokulawula, nokuthi abantu abasemthwini abavikela abangaboni ukuthi baphila ngokuphelele. Ukuzwa izinhlanganiso zokulawula, izindlela zokugcina, nezindlela zokubhalwa kwe-AHU eyisikhundla sokulawula kuyisisekelo sokuthi wonke umkhakha ushada ukuthi ubukhulu nobuvikeli kuyisisekelo.
Ukuqonda Indima Yomoya Wama-AHU Ekulawulweni Kokungcola
Umoya ovela ku-AHU uyindlela eyinhloko yokuzivikela ekungcolisweni. Siyisithiyo sokuqala esivimba ukungcola ngaphambi kokuba kube nethuba lokusakazeka kuyo yonke indawo. Lokhu kuhlasela kufanele kubhekane nezigaba ezintathu ezihlukene zezinsongo. Esokuqala yizinhlayiya eziqinile. Lezi izinhlayiya eziqinile ezingaba khona emoyeni ongaphandle, imisebenzi yangaphakathi noma ukugqokwa kwemishini. Izinhlayiya zingadala ukulimala komkhiqizo namaphutha okubona. Usongo lwesibili ukungcoliswa amagciwane. Amabhaktheriya, isikhunta nezinye izinto ezincane zingangena ngemithombo yamanzi, umoya ongaphandle noma abasebenzi. Ukuqhuma kwamagciwane kungaholela ekuhlulekeni kokuzala nasekukhangisweni kwemikhiqizo ebizayo. Ingozi yesithathu yizinto eziphilayo eziguquguqukayo, noma ama-VOC. Lezi zingcolisi ezingama-molecule ezingase ziphume ezintweni ezibonakalayo noma zingene emkhathini ophuma ezimotweni. Ama-VOC angabangela ukungcola kokudla nokungcoliswa okuphambene kwezidakamizwa. Uhlelo lomoya lwe-AHU kumelwe lwenziwe ukuze kususwe zonke izinhlobo ezintathu zezingozi ngokuphumelelayo.
Isitatega Sokhulu Somkakha
Ukufikwa kwezilingo zokuhlanganisa amafiltara emkhawulo yokuphatha amasiko akhethekile kuzodingeka ukuthi kwenziwe ngendlela yezinkambo eziningi. Akukho mfiltara oyedwa ongakwazi ukuthintela izinto zokungavumelekile zonke ngaphandle kokuthi kubhekwe phambili. Indlela yokufiltara iyadlula ngemfiltara yokuqala. Lokhu mfiltara kusetshezwa kwindawo yokungena kwe-AHU futhi kuyathakelwa ukuthi kubhale amasiko amakhulu. Ngokususa lezi zinto ezingamakhulu, imfiltara yokuqala isihlombele izinkambo eziningi zokuphatha okuphelele ekugcineni ukuthi zizwe ngokushesha. Emva kwalokho, amagazi ayadlula ngemfiltara enenhle. Lokhu mfiltara ithakela amasiko amancane angakwenzela ukuthi abantu bakhululekile bakwazi ukuthi baphathe amasiko amakhulu. Isikhathi sesiphetho nokubalulekile kakhulu kukumfiltara we-HEPA noma we-ULPA. Lokhu mfiltara yisibhali sokugcina. Kuyathakelwa ukuthi kubhale isilingo esikhulu samasiko kusilingo esithile, ukunika umkhawulo wokuhlanganisa amasiko okufanele kwi-ISO 5 kuya kwi-ISO 8. Imfiltara ye-HEPA kufanele ikhulwe kusilingo sesiphetho, na kwindawo yokuphuma kwe-AHU na kwindawo yokuphuma kwesiqulethi sokuhlangothi. Lokhu kucindezela ukuthi akukho yisiphepho esingaphambili singabuyisela ukungavumelekile kumkhawulo wokuhlangothi okuphelele.
Ukuvikela Ubukhulu Bekhophi Yokugcina
Ukusebenza kwe-HEPA filter kuyiphakathi yobukhulu bekuphakanyiswa kwakho. Noma yimiphi lezinye izinkinga zokugcina, isikhumba, noma isikhumba sokugcina singasiza ukuthi umoya ongagcinwa ushaye isikhumba futhi ngene emkhambini yamaphakade. Ukubonisa ubukhulu bekuphakanyiswa kwakho, kufakwa umthwalo wokugcina. Lokhu kuchazwa ngokufaka umthwalo wokugcina phambi kokugcina. Kusetshenziswa i-photometer ukuskena isikhumba sokugcina futhi nokugcina kwezinye izindawo. I-photometer iyavala ukuthi kungakanani umthwalo wokugcina. Uma kutholakala ukuthi kunezinkinga, kufanele isikhumba sifakwe kabusha noma sishayelwe. Lokhu kufanele kwenziwe ngokuzimisayo ngemithombo yase-EU GMP Annex 1 futhi kubonisa ukuthi isistimu yomoya yase-AHU iyathumela umoya ongagcinwa.
Ukubakwa Kwamaphakade Ngokuhle
Izinto ezisetshenziswayo nokuklanywa kwe-AHU ngokwayo kubalulekile ekugcineni umoya uhlanzekile. I-AHU kufanele yakhiwe ngezinto ezingakhiqizi izinhlayiya noma ezisekela ukukhula kwamagciwane. Ingaphakathi le-AHU ngokuvamile lenziwe ngensimbi engagqwali eshiselwe ngokuqhubekayo, e-electropolished. Le nto iqeda imifantu lapho amagciwane noma izinhlayiya zingase ziqoqeke khona. Izimbiza zokukhipha amanzi zikhothama ukuze kuqinisekiswe ukuthi i-condensate iyachitheka ngokuphelele, kuvimbele amanzi angemi futhi kuvimbele ukwakheka kwe-biofilm. Zonke izingxenye zangaphakathi, kuhlanganise amakhoyili, abalandeli, nama-damper, zikhethwa ngenxa yezimfanelo zazo zokungachitheki nezingamelana nokugqwala. Noma yimaphi ama-gasket noma ama-sealants asetshenziswayo ekwakheni kufanele abe nama-outgassing aphansi ukuze kugwenywe ukungeniswa kwama-VOC emkhathini. Lezi zinto ezisetshenziswayo nokuklanywa kwazo kuqinisekisa ukuthi i-AHU ngokwayo ihlala ingenamsebenzi, igcine umoya uhlanzekile kunokuba uwonakalise.
Ukulawulwa Kokugeleza Komoya Nokucindezela
Ukudlula kwamandla wehhele kumkhakha kuyisisekelo sokuclean. I-AHU kufanele ikhuphe amandla wehhele ngendlela ekwenza ukuthi akwazi ukuthi kubhekene nezinkinga zokugqibela kwezinye izindawo. Lokhu kufikelela ngokusebenzisa ukudlula kwamandla wehhele okungaphansi kwezinyathelo nokuguquka kwezinhlobo zezindawo zokuzimela. Ukudlula kwamandla wehhele okungaphansi kwezinyathelo kukusho lokudlula okungafana nokudlula kwezinyathelo, okukhuphela amasimu emandla wehhele ezingxenye eziningi kusuka kwezindawo zokuzimela ngendlela eyodwa futhi engeziwe. Lokhu kunciphisa isikhathi sokuhlala kwamandla wehhele okungayikho. Ukuguquka kwezinhlobo zezindawo zokuzimela kufakelwa ngokusebenzisa amasensha okuguquka kwezinhlobo zezindawo. Le masensha akhuluma ukuthi kunezinhlobo zezindawo zokuzimela ezithile, noma kuyizindawo ezinamandla wehhele amakhulu kakhulu, futhi kunezindawo ezinamandla wehhele amancane kakhulu kwezinye izindawo. Lokhu kunciphisa ukuthi amandla wehhele okungayikho ayidliwe kusuka kwezindawo ezinamandla wehhele amancane kusuka kwezindawo ezinamandla wehhele amakhulu. Isistimu kufanele ikhulise isibalance esihlukene phakathi kwamandla wehhele okukhuphwa, amandla wehhele okuvulwa, kanye namandla wehhele okuvulwa ngokwesibonelo sokuzimela.
Ukukhombisa Ngokushesha Kwaye Ukuguquka Ngokushesha
Ukuhlukumezwa kwe-pressure ne- airflow kwi-cleanroom kuyisiqu. Kungalungelwa ngokuvulwa kwezinyango, izinguquko kwezinhloso zokusebenza, noma ukulayishwa kwamafiltara. Ukugcina ubukhane, lokhu kufuneka kubhalwe phakathi kanye nokuthatha iziphakamiso ezilandelwayo. Izinhlangano zesikhulu sezinkampani zezindawo zokusebenza zasezantsi zihlukaniswa ngokusebenzisa i-BMS esenzayo. I-BMS ibona izimboni ezinamandla amaningi futhi isebenza ngalezi zimboni ukuthatha izivululo zezinyango nezizindlela zokuphuma kwezinyango ngokushesha. Uma izinyango ziphula futhi ipressha iphela, i-BMS ingathola ngokushesha ukuthi iphuma kwezinyango ukuze kubonakaliswe. Lokhu kubonakalisa ukuthi umkhumbi wokulinda uyaphila futhi ukuthi umoya owavumelwe kwi-cleanroom uyabona ukuthi uyagcina ubukhane bokuphatha.
Ukuvavanya nokubuyisela ukuthi kuyasemthethweni
Ukuqinisekisa kwempilo kwe-AHU air system kufanele kube ngokwemvelo. Lokhu kufanele kubonise ukuthi isistimu iyakwazi ukwenza ngokuphelele iziphakamiso zayo zokusebenza. Ukuvavanywa kufaka ekhaya ukuvavanya amaqhuba okuhamba kwe-ah, iziphakamiso zokuphinda kabusha, nokuphatha kwe-HEPA filters. Lokhu kufanele kuzwe ngokuphinda kabusha okuphambili. Ukuvavanya ngokuphinda kabusha nokudala kufanele kwenziwe ngokuphinda kabusha ukuze kubekiwe ukuthi isistimu ibuyela ukwenza njengoko kuvavanywe. Lokhu kufanele kwenziwe ngokuphinda kabusha kubaluleke kakhulu ukubeka i-GMP compliance.
Ukuthi ubukhulu bekukhuluma njani kusindisa ukuphila kwe-air kwe-cleanroom
Ukuthi isithunzi se-AHU sikhuluma amafutha okhona kusungulwa ngokuphelele kusungulwa kwakho. Ukuphelele kwezinkambo zokuvimbela, ukuthembeka kwezinkambo zokuphatha iziphakamiso, nokuphelele kwezinkambo zokugcina i-HEPA zonke ziyadonsa ukuthi isithunzi sisebenza ngendlela efanelekileyo ngeminyaka. Abasunguli abayisiza i-ISO 9001 bakhupha izinkambo zabo ngokuphelele phambi kokuthunyelwa kwazo. Kusukela ekhaya lokusebenza lapho umphathi wokusebenza uyasebenzisa i-AHU ukuze akhulame indawo yokusebenza engamafutha, ukubambisana nebasunguli abanobubi bekhona nokuthembeka kwezinkambo zokusebenza kuyabona ukuthi isithunzi sakho sibonakala ngokuphelele ngokwesikhundla sokuziphatha.