Imvelo engokwenyama namakhemikhali, iziqukathi zemisoco kanye nesiko yizici ezintathu ezibalulekile zesiko lamaseli.Kunezici eziningi ezithinta ukukhula kwamaseli, phakathi kwazo ukuthi izinto zokusetshenziswa zeimboni yamaseliaqukethe izingxenye ezingalungile ekukhuleni kwamaseli nakho kuyisici esibaluleke kakhulu.
Ukuhlukaniswa kwe-United States Pharmacopeia Medical Materials kuyikilasi lesi-6, kusukela ku-USP isigaba I kuya ku-USP isigaba VI, ne-USP yekilasi VI iyibanga eliphakeme kakhulu.Ngokuhambisana nemithetho evamile ye-USP-NF, amapulasitiki angaphansi kokuhlolwa kokusabela kwebhayoloji ye-vivo azohlukaniswa abe amamaki epulasitiki ezokwelapha amisiwe.Inhloso yokuhlolwa ukuthola ukuthi i-biocompatibility yemikhiqizo yepulasitiki ifaneleka yini kumishini yezokwelapha, izimila nezinye izinhlelo.
Izinto zokusetshenziswa zemboni yeseli yi-polystyrene futhi i-API ihlangabezana nezinga le-USP Class VI.Ipulasitiki elinganiselwe njengepulasitiki yesithupha yezokwelapha e-United States isho ukuthi sekusungulwe ukuhlolwa okuphelele nokuqinile.I-Us Medical Materials Level 6 manje isiyindinganiso eyigolide yazo zonke izinhlobo zezinto ezingavuthiwe ezisezingeni lezokwelapha kanye nekhwalithi ephezulu kakhulu yokukhetha kubakhiqizi bemishini yezokwelapha.Izinto zokuhlola zazihlanganisa ukuhlolwa kobuthi obuhlelekile (amagundane), ukuhlolwa kokusabela kwe-intradermal (onogwaja) kanye nokuhlolwa kokufakelwa (onogwaja).
I-polystyrene kuphela impahla eluhlaza ehlolwe ukuhlangabezana nezidingo ze-USP class VI engasetshenziswa kuyoimboni yamaseliukukhiqizwa.Ngaphezu kwalokho, iziqukathi zesiko lamaseli zidinga ukukhiqizwa endaweni yokusebenzela yokuhlanzwa kwesigaba C, ngokuhambisana nezidingo zesistimu yokuphathwa kwekhwalithi ye-ISO13485, ukulawula ngokuqinile ikhwalithi yomkhiqizo kusuka kunqubo yokukhiqiza, ukuze kuqinisekiswe izinga elifanelekile lemikhiqizo eqediwe.
Isikhathi sokuthumela: Dec-30-2022