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Amazwi okuphatha amandla nokubalwa kwezinhlelo zokulawula izimo zezindawo zokusebenza ngokuphepha
Kusukela kubakhiyana nezibhizinisi zezinkampani zokuphakamisa amadragu nezibhizinisi zokusebenza ngemithambo yezinhlanzi, isikhumba sokuhlanzekwa kuyisibuko sezinsimbi sokusebenza ngokwesikhathi sokuphakamisa izinto ezingahlanzeki. Ubukhulu nobunzima bezinto ezihlanzeki ziyaphendula ngokuphelele ekuthambekeni kwesikhathi sokuhlanzekwa kwezinye izinto ezilungileyo, ukugcina nokulandela kwezinye izinto ezilungileyo, nokuzimela kwezinye izinto ezilungileyo. Ukukhanya kwenye yalezi zinto ziyakubeka ubunzima bezinto ezihlanzeki kumkhawulo, okuzokubangela ukungafanele kwezinye izinto ezihlanzeki futhi ukuthi kubhekwe ngokwesibonelo ngokwesifundo sokuvikela izinto ezihlanzeki. Ngaphandle kokwesibonelo sokusebenza ngokwesikhathi sokuphakamisa izinto ezihlanzeki, ukulandela kwezinye izinto ezihlanzeki kuyasebenzisa izindlela eziningi zokulandela izinto ezilungileyo, kufuneka kubhalwe ngezinye izinto ezilungileyo ezilungileyo, kufuneka kubhalwe ngezinye izinto ezilungileyo ezilungileyo, kufuneka kubhalwe ngezinye izinto ezilungileyo ezilungileyo. Lezi zinto zilungileyo azizange zibe yizinto ezilungileyo; ziyabukeka ngokwesibonelo sokuvikela izinto ezihlanzeki. Ukuzwa lezi zinto zilungileyo, izindlela zokusebenza zokufundwa ngokwesibonelo sokuvikela izinto ezihlanzeki, nokuzwa kwezindlela zokuvikela izinto ezihlanzeki ziyakudinga ngokuphelele kubantu abasebenza ngokwesibonelo sokuvikela izinto ezihlanzeki.
Isibonelo Sokuvikela Izinto Ezilungileyo Sokuhlanzekwa Kwezinye Izinto Ezilungileyo
Isisekelo sokulawulwa kwemvelo egumbini elihlanzekile sisungulwa yizinhlangano ezilawula umhlaba wonke ezifuna isu eliphelele lokulawulwa kokungcola. Lolu hlelo ludingeka abakhiqizi ukuba bachaze futhi balawule wonke amapharamitha abalulekile angangenisa ingozi yamagciwane noma izinhlayiya. Ukwehluka kwezinga lokushisa nengcindezi kuphakathi kwamapharamitha abaluleke kakhulu. I-EU GMP Annex 1 icela ngokucacile ukuqapha okuqhubekayo kwemingcele yengcindezi phakathi kwezindawo ezihlukanisiwe ukuqinisekisa ukuthi umoya ugeleza usuka endaweni ehlanzeke kakhulu uye endaweni engcolile kakhulu. I-FDA, ngeseluleko sayo sokucubungula i-aseptic, igcizelela ukuthi uhlelo lwe-HVAC kumelwe lugcine izinga lokushisa nomswakama ngaphakathi kobubanzi obuqinisekisiwe obungathinti kabi umkhiqizo. Ukulindela okuyinhloko kwalaba balawuli akuyona ukunamathela ezinombolweni ezingahleliwe, kodwa kunesisekelo sesayensi sokuqonda iphuzu ngalinye lokulawula. Umkhawulo ovamile wendawo ehlanzekile ye-GMP ungase ube yizinga lokushisa lama-degree Celsius angamashumi amabili kuya kwamashumi amabili nane, kanye nengcindezi ephakathi kwama-pascals ayishumi kuya kwangu-15 phakathi kwezindawo ezakhelene. Isizathu salokhu kulinganiselwa siwukugwema ukuqina, ukunciphisa ukwanda kwamagciwane nokuqinisekisa ukuthi ukugeleza komoya okuqondiswa ngenye indlela kuyaqhubeka kusuka endaweni ephakeme yokuhlukanisa kuya endaweni ephansi yokuhlukanisa.
Ukuqonda Ukuchazwa kwe-ISO 14644-1
Izindlela zokuzimela zezinye izindawo zokusula zihlaziywa ngokwesifundo se-ISO 14644-1. Lokhu kubukhwekwe kwebandla lomthetho wokuphathwa kwezwe, kubeka ubumbano lwemithombo yokuqondisa ukuthi ubumbano lwemithombo yamaphuzu kubonakala ngokwesifundo sokuzimela kwesikhathi esithile. Izigraidi, ezinhlungu kusukela ku-Graidi A kuze kuma-Graidi D, zihlaziywa ngokwesifundo se-EU GMP futhi zibonakalisa ukuthi ukuzimela kwe-HVAC kufanele kube yisikhathi esikhulu. I-Graidi A, eyahlukene nge-ISO 5 uma kusebenza ngokushesha, ibonisa indawo enkulu yokuzimela. Iyasebenza kumisebenzi oyinkulu yokuvikela, njengokufaka amaphuzu ngokushesha, futhi iyadinga ukuzimela okukhulu kwezinhlobo zokugcina kwezinye izinhlobo zokugcina nezinhlobo zokuzimela kwezinye izinhlobo. I-Graidi B, eyasendaweni yokuzimela kwe-Graidi A, kufanele ikhuleke ngokujabula nokuzimela kwezinhlobo zokuzimela kwezinye izinhlobo ukuze ikhuleke ngokujabula kwezinye izinhlobo zokuzimela. Izigraidi C ne-D, ezimbili ziyahlukene nge-ISO 8, zivumela ukusebenza ngokujabula ngokwesifundo sokuzimela kwezinye izinhlobo ngokwesifundo sokuzimela kwezinye izinhlobo ngokwesifundo sokuzimela kwezinye izinhlobo. Kodwa, isiqiniso esingaphansi sibe yilowo: isistimu se-HVAC kufanele isebenzise isifundo sokuzimela kwezinye izinhlobo zokuzimela.
Ukuthatha isikhundla sokukhokha kwemithambo yokuqinisa ukuthi iphakathi lamakhono
Ukufinyelela ukuzimisa kwezindawo zokusebenza eziphakathi kwezindawo ezihlukene zokusebenza kubalulekile kufuneka kwenziwe ngendlela eyodwa, engekhathazekiyo yokusebenza kwezinhlanhla zokuhlanza amadliwane. Kufuneka kwenziwe i-air handling unit eyodwa, nasezinkampani zokuchitha amadliwane nezinkampani zokuphepha amadliwane ziyisize ngokuphelele ukuze zilungiselele izinkinga zokuchitha amadliwane nezinkinga zokuchitha amadliwane okususa. Amadliwane akhulula kuyabhalwa ngamafiltela a-HEPA aphakathi kwezindawo zokusebenza ngokuthi akhulule kumkhulu, okukhuthaza ukungafani kwezindawo zokusebenza. Ukubaluleka kwesibonelo sokugcina isikhundu kubalulekile. Isibonelo sokugcina isikhundu, njengoko kusho ukugcina kwesikompressor, singasika ukuthi isikhundu sifana ngemizuzu eminingi, okuvula isikhundu esisenzeka. Ukuze sikubhekisele lokhu, isistimu kufuneka ibe nezindlela ezimbili zokuchitha amadliwane nezinkompressor ezinamandla. I-d ductwork yena kufuneka ibe nezinkampani ezinkulu futhi izitshikelwe ukuze zilungiselele ukuthi amadliwane ayifane ngokuphelele kwezindawo zokusebenza. Amafan ezinamandla ezinye, abhekiswe ngokuphelele ku-BMS eyodwa, abhekiswe ngokuphelele ku-balance yamadliwane ukuze zilungiselele izinkinga njengezindawo zokuvula noma izinkinga zokusebenza.
Ukukhulisa I-Pressure Control ne-Positive Pressure Cascades
Ukuphepha kwe-clean room kuyasebenza ngokuphepha kokukhula kwesikhathi sokukhula kwe-pressure. Lokhu kusho ukuthi ipressha yamadliwane kufanele ibe ephakeme kakhulu endaweni engcwele kakhulu futhi isiphambano esifanayo sibuye siphambana ngokuphansi njengoba sishaya emizini engasiklasiyisiwe. Lokhu kusiza ukuthi lapho izinyawo zivulwa, amadliwane ayedla ngaphandle kwe-clean room, okungakhuthazela ukuthi amadliwane angafihliwe ayengeze. Ukufikwa kwalokho kufune ukubalwa kahle phakathi kwe-volume yamadliwane okuhamba kumkhumbi ne-volume yamadliwane okubuyela. Isistimu kufanele isakhiwe ukuze indawo yonke ibe ne-differential yepressha enzima ekhona ngaphezu kwezindawo ezibalulekile. I-differential yama-ten kuya ku-ma-fifteen pascals iyatholakala ngokujwayelekile njengokufanele ukukhuthaza ukungabikho kwe-cross-contamination lapho kusebenzisa ngokunormal. Kepha isistimu kufanele ibe nezindlela zokuzisusa kwezinkinga zokuguqula. Lapho izinyawo zivulwa, ipressha endaweni ingathwala ngokushesha, okungakhuthazela ukuphepha.
Ukuthi Kuyisiphiwo Sokubaluleka Kwemithombo Yokunqoba
Ukuvumela ukubalwa kwezinkinga zokuphatha kwezindawo eziphakeme, izinhlangano zamakhilimane ezintsha zezindawo eziphakeme zisebenzisa izinkambo zokulinda okwenzekayo. Uma ubomvu buvulwa, umkhawulo wezinye zokuthiwa kungabonakala kakhulu. Izinhlangano eziphezulu zisebenzisa izimodeli ezithiwe ngodatha ukubonakala umkhawulo wezinye zokuthiwa ngekuphathwa kwesikhundla sokubuyisela, kubuyisela umkhawulo wezinye zokubuyisela ngexesha lesibili ukuvumela ukubalwa kokuphatha okudingekayo. Le ndlela ibuyisa ukubalwa nokuba kunezilinganiso ezingaphezulu kwezinye zokuthiwa. EU GMP Annex 1 isho ukuthi lezi zinhlangano kufanele zibe nezinhlangano zokubalwa kokuphatha ngexesha lesibili nezinhlangano zokukhomba ukuthi kunezinkinga ngexesha lesibili. Umthwalo wokuvavanya izindawo eziphakeme kufanele akwazi ukubeka kuphela ukuthi kunezindlela zokuphatha okuphakeme; kufanele kubonise ukuthi isistimu inqubo yokuphatha ngexesha lesibili. Ukubonisa kufanele kubonise ukuthi isistimu yokuphatha inqubo yokuqinisa amadampers kanye nokubuyisela ispeed yamafan ngexesha lesibili ukubuyisela izindlela zokuphatha okudingekayo emva kokuthi kwenziwe izinkinga. Lokhu kuvumela ukuthi isikhumba sezindawo eziphakeme sibuyisele ngexesha lonke.
Ukubhalwa Kweminyaka Nokuphepha Kwedatha
Ukuphepha kwendlela yokwakha kwe-HVAC kuyisikhundla esifanayo nokukhokhela okusindisayo. Ikhonkothi lezinkambo zokuthi izinkambo zokuchaza isikhathi nezinkambo zokuchaza ubungakanani zibekwe ngokuphelele emsebenzini wokuvula. Lezi zinkambo zinakha imininingwane yonke ekhaya lokugcina, okuyinto ebonisa ukuthi yiliphi inqubo yokuqonda i-“setpoint”. Ukuthi kufuneka kubhekwe ngokushesha kumaphuzu okuhamba ngaphezulu komkhondo wokusebenza kuyisisekelo sokubhekwa ngokushesha. Emsebenzini wokuziphatha ngokwesifundo, isistimu yokubhalwa kwedatha kumele ibe yilokho okufanele ngokwesiphumo se-21 CFR Part 11. Lokhu kubiza ukuthi yonke imininingwane yekhompyutha kumele ibe yilokho okungathintiwe, noma yikuphi isikhathi, futhi kumele kubhalwe ngokuphelele. Ukufikelela kulesistimu kumele kubhekwe ngokuphelele ngokwesihloko sesihloko sika-“user ID”, futhi yonke indlela yokuguqula idatha kumele kubhalwa. Lokhu kukhala kakhulu ukuthi umsebenzi wokubhekwa kwenziwe ngokuphelele.
Ukuphatha Okuphelele Ngokwesifundo Nokuphatha
Ukuvavanywa kwe-HVAC yekhlabathi elikhanyile akuyi indlela eyodwa; kukhona indlela eyisisekelo. Ukuvavanywa kwakwesibini kwenza isisekelo, kodwa ukuvavanywa okuphambili kwezinhlayo zokusebenza kudinga ukuthi isistimu isebenza ngaphandle kwesisekelo sakho. Ukulungisa okuphambili, njengoko kufanele kwenziwe ukuzilungisa izinhlayo zokukhomba nokubuyisela amafiltara aye-HEPA, kuyidinga ukususa ukusebenza. Ngaphezu kwalokho, isistimu kufanele ikhombiswe ukuthi iphansi kwezinhlayo zokugcina.
Indlela Yokunikezela Ukuthi Ukuhlanganisa Okuhle Kusinika Isikhundla Sokuhlakanisa
Ukusebenza kahle kwe-cleaning room kuyaphendula kakhulu ekwalithi yamaphakathi e-HVAC. Ukuphepha kwe-damper actuators, ukuthembeka kwe-temperature sensors, nokuphatha kwe-HEPA filter housings konke kusindisa ukuphepha kwe-system ngokudala. Abasemthwakazi abasebenzisa izindlela zokulungisa ezitholakala, njenge-ISO 9001 ne-ISO 13485, bafaka izinkambo zabo kuzo zonke izilinganiso zokubona kwesifundazwe phambi kokuthunywa. Basesicela izinto eziningi zokukhanya nezindlela zokwenza okuphephile ukuze zibe nesiphelo sokusebenza ngokuphephile ngeminyaka. Kuma-facility manager osebenzisa i-cleaning room ukwenza izinto ezinconywa umntu, ukubambisana no-manufacturer ongathembekiyo nokulungisa kunceda ukuthi ubheke isiphelo sokuthembeka sokuthi isistimu yokulungisa izimo ayizokufunda izindlela zokulungisa zezinhlanga.