Ukuzaliswa kwee-capsules ezingenanto yinkqubo engundoqo ekuveliseni iifom zedosi eqinile, kwaye umgangatho wendawo yokuvelisa ichaza ngokuthe ngqo ukhuseleko, uzinzo kunye nokusebenza kakuhle kwechiza. Ngenxa yokuba ii-capsules ezingenanto ziyi-hygroscopic, zivame ukusuleleka, kwaye zidibana ngokuthe ngqo namayeza ngexesha lokuzaliswa, indawo yemveliso ixhomekeke kwiimfuno ezingqongqo kakhulu. Kufuneka ilawulwe kuzo zonke iinkalo ngokuhambelana ngokuthe ngqo neMisebenzi yoMveliso eLungileyo (GMP), kubandakanywa nokucoceka, ubushushu kunye nomswakama, ukuhlukana koxinzelelo, izixhobo zokusebenza, kunye nolawulo lwabasebenzi.
1. ULawulo lokucoceka: Ukuvala iMicrobial kunye neParticulate Contamination
Ucoceko luphawu oluphambili lwendawo yokuzalisa i-capsule engenanto. Ngokwemigangatho ye-GMP, ukugcwaliswa kwe-capsule engenanto -engenazintsholongwane ngokuqhelekileyo kuqhutyelwa kwindawo ecocekileyo yeBanga D, ayifuni ngaphezulu kwe-3,520,000 yamasuntswana emoyeni Omkhulu okanye olingana ne-0.5μm ngem³ kunye nokulungisa ii-microbes ezingekho ngaphezulu kwe-200 CFU/ipleyiti. Kwii-capsules eziziintsholongwane, ukugcwaliswa kufuneka kwenziwe kwindawo yokuhambahamba yeBakala A kunye ne-unidirectional ngaphakathi kweBanga D, kunye namasuntswana emoyeni angekho ngaphezu kwe-3,500 nge-m³ kunye nokuhlalisa ii-microbes ezingekho ngaphezu kwe-1 CFU/ipleyiti. Iindawo ezicocekileyo kufuneka zicocwe ngenqanaba lesithathu inkqubo yokucoca umoya (ngaphambili{13}}, eliphakathi{14}}, kunye{15}}nokusebenza kakuhle) kwaye zivavanyelwe rhoqo izikhombisi ezifana namasuntswana omoya, ii-microbes ezidadayo, kunye nokuhlalisa ii-microbes ukuqinisekisa ukuthotyelwa okuqhubekayo, ukuthintela i-microbial contamination kunye neziyobisi.
2. Ubushushu obuchanekileyo kunye noLawulo lokufuma: Ukuqinisekisa ukuzinza kweeCapsules kunye neMathiriyeli
Inxalenye ephambili yee-capsules ezingenanto yi-gelatin, evakalelwa kakhulu kwiqondo lokushisa kunye nomswakama. Ukufuma okuphezulu kunokubangela ukuba ii-capsules zithambile, zincangathi, okanye zide zibeneziphene, ngelixa ukufuma okuphantsi kunokuzenza zibe brittle kwaye zonyuse izinga lokwaphuka. Ngexesha elifanayo, ukushisa kunye nomswakama kuchaphazela ukuhamba kwezinto kunye nokuchaneka kokuzalisa. Ngoko ke, iqondo lobushushu kwindawo yokuzalisa kufuneka ilawulwe ngokungqongqo phakathi kwe-18{7}}iqondo le-26 kunye nokufuma okuphakathi kwe-45% -65%. Ukufezekisa oku, iindawo ezicocekileyo kufuneka zixhotyiswe ngeenkqubo zomoya ezichanekileyo ezibeka iliso kwaye zilungelelanise ubushushu kunye nomswakama ngexesha langempela, ukuqinisekisa indawo yokuvelisa ezinzile kunye nokuthintela imiba yomgangatho okanye ukungachaneki kwedosi okubangelwa ukuguquguquka kokusingqongileyo.
3. Iiyantlukwano zoxinzelelo kunye noMbutho wokuHamba komoya: Ukunqanda uKunqamleza{1}}Ungcoliseko
Ukuthintela ukuphuma komoya ngasemva -kwindawo ezisezantsi ezinokubangela-ungcoliseko olunqamlezayo, umahluko ofanelekileyo woxinzelelo kufuneka ugcinwe phakathi kweendawo zamanqanaba ahlukeneyo ococeko. Ngokuqhelekileyo, ukuhlukana koxinzelelo phakathi kwendawo ecocekileyo kunye- nommandla ongeyena ococekileyo, kwaye phakathi kwamagumbi akufutshane amanqanaba ahlukeneyo okucoceka, kufuneka abe mkhulu kunokuba okanye alingane ne-10 Pa, ngelixa ukuhlukana koxinzelelo lwendawo ecocekileyo ngokuchasene nangaphandle kufuneka ibe Mkhulu okanye ilingane ne-15 Pa. ukucoceka kwiindawo zokucoceka okuphantsi, ukuphepha i-eddies kunye neekona ezifile. Oku kususa ngokufanelekileyo uthuli kunye nee-microbes ezenziwe ngexesha lokuvelisa kunye nokukhusela umgangatho womoya wendawo yokusebenza.
4. I-Facility, iZixhobo, kunye noLawulo lweMathiriyeli: Ukunciphisa imingcipheko yokuNcitshiswa
Imigangatho, iindonga, kunye neesilingi kwindawo ezicocekileyo kufuneka zakhiwe ngendlela engenamthungo, engadlelekiyo{0}}ekwaziyo ukumelana, kwaye kulula{1}}ukucoca imathiriyeli ({2}}njengeepoxy resin okanye iipleyiti zentsimbi ezinombala) ezigudileyo, umphezulu osicaba ongafumbenanga lula uthuli. Umphezulu wezixhobo kufuneka ugudiswe kwaye ungabi neekona ezifileyo. Izixhobo ezinxibelelana ngokuthe ngqo nemathiriyeli kufuneka zenziwe ngentsimbi engeyiyo{5}eyityhefu, engagqwaliyo{6}}ingakwazi ukumelana ne-316L yentsimbi estainless kwaye icocwe rhoqo kwaye ibulawe iintsholongwane. Izixhobo ezifana noomatshini bokuzalisa kunye noomatshini bokupholisa kufuneka baqulunqwe njengeenkqubo ezivaliweyo zokunciphisa ukusabalalisa uthuli, kwaye zixhotyiswe ngezixhobo zokukhupha uthuli lwendawo. Ngaphambi kokungena kwindawo ecocekileyo, izinto kufuneka zidlule kwi-airlock okanye kwifestile yokudlulisa, kwaye ukupakishwa kwazo kwangaphandle kufuneka kucocwe kwaye kubulawe iintsholongwane ukuze kuthintelwe ukungenisa ukungcola kwangaphandle.
5. ULawulo lwaBasebenzi kunye noCoceko: Ukusika uMntu{1}}Imithombo yoNgcoliseko eyenziweyo
Abasebenzi ngowona mthombo mkhulu wosulelo. Ukungena kwindawo ecocekileyo kufuna inkqubo engqongqo yokunxiba: ukutshintsha izihlangu, ukuhlamba izandla, nokunxiba iimpahla zegumbi elicocekileyo (kuquka umnqwazi, imaski, iiglavu, nezihlangu zegumbi elicocekileyo) ukuqinisekisa ukuba akukho nwele okanye ulusu luvezwayo. Abaqhubi kufuneka bafumane uqeqesho lobuchwephesha ukuze baqhelane nemigaqo ye-GMP kunye neenkqubo zokusebenza. Izithambiso kunye nobucwebe akuvumelekanga, kwaye ukunyakaza okungadingekile kunye nencoko kufuneka kuncitshiswe. Ngaphaya koko, iindawo ezicocekileyo kufuneka zicoceke ngokungqongqo kunye neenkqubo zokubulala iintsholongwane zokucoca imihla ngemihla kunye nokubulawa kweentsholongwane ngamaxesha athile kwimigangatho, izixhobo, kunye nezixhobo zokuthintela ukukhula kweentsholongwane.
6. Ukubekw'esweni nokuLondolozwa kokusiNgqongileyo: Ukuqinisekisa ngokuqhubekayo ukuthotyelwa
Iinkampani kufuneka ziseke isicwangciso esibanzi sokujonga imeko yokusingqongileyo ukuvavanya rhoqo izikhombisi ezinje ngamasuntswana omoya, ii-microbes, ubushushu, ukufuma, kunye nokwahluka koxinzelelo kwindawo ecocekileyo. Idatha kufuneka irekhodwe kwaye ihlalutywe ukuze ikhangele ngokukhawuleza kwaye ilungise naziphi na izinto ezingaqhelekanga. Inkqubo yokucoca umoya idinga ukugcinwa rhoqo, kubandakanywa ukutshintshwa kokucoca, ukuqinisekisa ukusebenza kwayo. Ukongeza, ukusebenza okuqhubekayo kunye nokuthembeka kweenkqubo zolawulo lokusingqongileyo kufuneka kuqinisekiswe ngokuqinisekiswa kunye-nokuqinisekiswa kwakhona, ukubonelela ngemeko yokuvelisa ezinzileyo kunye nethobelayo yokuzaliswa kwe-capsule engenanto.
Ukuqukumbela, ukulawula indawo yokuzaliswa kwe-capsule engenanto yiprojekthi ecwangcisiweyo efuna ingqwalasela engqongqo kwiinkalo ezininzi, kubandakanywa nokucoceka, ubushushu kunye nomswakama, ukuhlukana koxinzelelo, izixhobo zokusebenza, kunye nolawulo lwabasebenzi. Kuphela ngokuseka inkqubo yenzululwazi yolawulo lwendalo esingqongileyo apho umgangatho wee-capsules ezingenanto unokuqinisekiswa ngokufanelekileyo, ukuqinisekisa ukhuseleko lwamachiza kunye nokubonelela izigulane ngamayeza athembekileyo. Ukuba kukho nayiphi na imibuzo malunga nee-capsules ezingenanto, wamkelekile ukuba uqhagamshelaneKornnacCaps.
