Sterile API
Sterile API ke motheo le mohloli oa likhoebo tsa ho lokisa meriana, 'me boemo ba eona ba netefatso ea boleng ba tlhahiso bo amana ka kotloloho le polokeho ea lithethefatsi.Mokelikeli oa lintho tse bonahalang ts'ebetsong ea tlhahiso le boholo ba lihlapolli tse amehang, haholo-holo filthara e senyang ea solvent, e fana ka litlhoko tse tiileng bakeng sa ho lumellana le lik'hemik'hale tsa karolo ea sefe.Hammoho le lits'ebeletso tsa netefatso ea ts'ebetso ea laboratori, Dali e fana ka tlhahiso e sa khaotseng ea lihlahisoa tsa filthara tse fihlelang litekanyetso tse reriloeng esale pele le litšobotsi tsa boleng bakeng sa likhoebo tsa meriana.
Tokisetso
Tokisetso e hloka ho "kopanya" lisebelisoa tse tala ho li-excipients tse ling kapa li-solvents ho fihlela mahloriso a hlokahalang, 'me qetellong li ka fanoa ho ntho ea phepelo ea lithethefatsi hore e sebelisoe.Mefuta e fapaneng ea ho itokisa e rarolla bothata ba tšebeliso ea lithethefatsi le litekanyetso, empa hape e beha litlhoko tse phahameng tsa polokeho.E le ho boloka junifomo ea ho itokisa le ho tsitsisa, metsoako e sebetsang e finyella litlhoko tsa meriana, le ho laola likotsi tse ka 'nang tsa e-ba teng, mokhoa ona o hloka ho ba le litharollo tse nepahetseng tsa ho hloekisa ho netefatsa hore ho latela melao le polokeho ea litokisetso le ho finyella litlhoko tsa GMP.
Likokoana-hloko
Biotechnology e ntse e tsoela pele ka potlako Chaena.E le karolo ea bohlokoa ea meriana ea sejoale-joale le theknoloji ea baeloji, lihlahisoa tsa baeloji li phetha karolo ea bohlokoa haholo ho thibeleng le ho alafang mafu le ho sireletsa le ho ntlafatsa bophelo ba batho.Lihlahisoa tsa baeloji li hloka mekhoa e mengata ea tlhaho le mekhoa ea tlhoekiso le tlhahlobo ho fumana sepheo.Filtration ea 'mele e na le melemo ea tlhaho mme e ka phethela mesebetsi ka boqhetseke.Ke ts'ebetso ea bohlokoa ea lihlahisoa tsa baeloji.
Tsamaiso ea Sechaba
Tsamaiso ea sechaba e hloka ho fana ka tikoloho e tsitsitseng le e hloekileng bakeng sa tlhahiso.Metsi, khase, moea o hatelitsoeng le khase ea inert li tla fihlela litlhoko tsa bohloeki tsa mekhoa e lumellanang ea meriana, GMP le litataiso le melaoana e tsamaellanang.Metsi a hlokahalang bakeng sa tlhahiso indastering ea meriana a phekoloa ka ho khetheha.E le ho netefatsa bohloeki ba semela kapa ho se be le tšilafalo nakong ea ho belisoa, khase e hloka ho hloekisoa le ho sefshoa.
Sesebelisoa sa Teko
Botšepehi ke taba ea bohlokoa tlhahisong le ts'ebelisong ea likarolo tsa sefa.Lits'ebetsong tse ngata tsa ho hloekisa mokelikeli (khase kapa metsi), ho hlokahala ho eketsa botšepehi ba filthara karolong ea ho qetela ea tlhahiso le ka mor'a tšebeliso ea sebele.Ka hona, filthara ea sterilization ea lijo le lithethefatsi e tlameha ho ba le tlhahlobo e tiileng ea botšepehi, litokomane tsa tlhahlobo le lirekoto.