Ukuze kuhlangatyezwane nemigaqo ye-GMP, amagumbi acocekileyo asetyenziselwa imveliso yamayeza kufuneka ahlangabezane neemfuno zebakala elihambelanayo.Ke ngoko, ezi ndawo zokuvelisa i-aseptic zifuna ukubekwa esweni okungqongqo ukuqinisekisa ukulawulwa kwenkqubo yokuvelisa.Imimandla efuna ukubeka iliso eliphambili ngokubanzi ukufaka isethi yenkqubo yokubeka iliso ye-particle particle, ebandakanya: ujongano lolawulo, izixhobo zokulawula, i-particle counter, umbhobho womoya, inkqubo ye-vacuum kunye nesofthiwe, njl.
I-counter particle ye-laser yokulinganisa okuqhubekayo ifakwe kwindawo nganye engundoqo, kwaye indawo nganye ijongwa ngokuqhubekayo kwaye isampuli ngokusebenzisa umyalelo wokuvuselela ikhompyutha, kwaye idatha esweni idluliselwa kwikhompyutheni yokusebenzela, kwaye ikhompyutha ingabonisa kwaye ikhuphe ingxelo. emva kokufumana idatha kumsebenzisi.Ukukhethwa kwendawo kunye nobuninzi be-intanethi yokuhlola okuguquguqukayo kwamasuntswana othuli kufuneka kusekelwe kuphando lovavanyo lomngcipheko, olufuna ukugubungela zonke iindawo eziphambili.
Ukumiselwa kwendawo yesampulu yekhawunta yothuli lwelaser kubhekiselele kule migaqo mithandathu ilandelayo:
1. Inkcazo ye-ISO14644-1: Kwigumbi elicocekileyo elihamba ngokulinganayo, izibuko lesampulu kufuneka lijongane necala lokuhamba komoya;kwigumbi elicocekileyo elihambayo elingeyo-unidirectional, izibuko lesampulu kufuneka lijonge phezulu, kwaye isantya sesampulu kwizibuko lesampulu kufuneka sisondele kangangoko kwisantya sokuhamba komoya sangaphakathi;
2. Umgaqo we-GMP: intloko yesampuli kufuneka ifakwe kufuphi nobude bokusebenza kunye nendawo apho imveliso ibonakaliswe khona;
3. Indawo yesampula ayiyi kuchaphazela ukusebenza okuqhelekileyo kwezixhobo zokuvelisa, kwaye ayiyi kuchaphazela ukusebenza okuqhelekileyo kwabasebenzi kwinkqubo yokuvelisa, ukwenzela ukuba ugweme ukuchaphazela umjelo we-logistics;
4. Isikhundla sesampula asiyi kubangela iimpazamo ezinkulu zokubala ngenxa yeengqungquthela okanye amaconsi awenziwe ngumkhiqizo ngokwawo, obangela ukuba idatha yokulinganisa idlule ixabiso lomda, kwaye ayiyi kubangela umonakalo kwi-particle sensor;
5. Isikhundla sesampula sikhethwe ngaphezu kwendiza enqamlekileyo yenqaku eliphambili, kwaye umgama osuka kwindawo ephambili akufanele udlule i-30cm.Ukuba kukho i-splash yolwelo okanye ukuphuphuma kwisithuba esikhethekileyo, okubangela ukuba iziphumo zedatha yokulinganisa zigqithise umgangatho wommandla wale nqanaba phantsi kweemeko zokuvelisa ezifanisiweyo, umgama kwicala elithe nkqo unokunqunyulwa Ukuphumla ngokufanelekileyo, kodwa akufanele kudlule i-50cm;
6. Zama ukunqanda ukubeka indawo yesampulu ngokuthe ngqo ngaphezu kwepaseji yesingxobo, ukuze ungabangi umoya ongonelanga phezu kwesikhongozeli kunye nesiphithiphithi.
Emva kokuba zonke iingongoma zomgqatswa zichongiwe, phantsi kweemeko zendawo yokuvelisa imveliso, sebenzisa i-laser dust particle counter kunye ne-sampling flow rate ye-100L ngomzuzu ukuvavanya indawo nganye yomviwa kwindawo nganye engundoqo kwimizuzu eyi-10, kwaye uhlalutye uthuli lwazo zonke. amanqaku amasuntswana esampula ukuloga kwedatha.
Iziphumo zesampulu zamanqaku omviwa amaninzi kwindawo enye ziyathelekiswa kwaye zihlalutywe ukufumanisa indawo yokubeka iliso esemngciphekweni omkhulu, ukuze kuqinisekiswe ukuba eli nqaku yindawo efanelekileyo yokubeka iliso ye-particle particles isampula yokufakela intloko.
Ixesha lokuposa: Aug-09-2023