Lo mbhalo uqinisekisa umkhiqizo owenziwe yi-TS Filter ngokuhambisana nezindinganiso ze-Current Good Manufacturing Practice.
Lo mkhiqizo uthuthukiswa, ukhiqizwa futhi usatshalaliswa ngokwesistimu yokuphatha eqinisekiswe yi-ISO9001:2015.
Izindlela Zokuqinisekisa Ikhwalithi
Ukuhlanzeka
Lo mkhiqizo wokuhlunga uhambisana nesihloko 21 CFR, isigaba 210.3 (b)(5)(6) kanye no-211.72
❖ I-TOC kanye Nokuqhuba
Ngemva kokuhlanza ngamanzi okulawulwayo, amasampula anekhabhoni engaphansi kuka-0.5mg (500 ppb) ngelitha, kanti ukuhanjiswa komoya kungaphansi kuka-5.1 S/cm ku-25°c.
❖ Ama-Endotoxin ebhaktheriya
Ukukhishwa kwamanzi kwe-capsule kuqukethe okungaphansi kuka-0.25EU/ml
❖ Ukuphepha Kwezinto Eziphilayo
Zonke izinto zalesi sakhi sesihlungi zihlangabezana nezidingo ze-USP yamanje yeklasi yepulasitiki i-VI-121°c.
❖ Isengezo Sokudla Okungaqondile
Zonke izinto zokwakha zihlangabezana nezidingo ze-FDA zokungezelela ukudla okungaqondile ezishiwo ku-21CFR. Zonke izinto zokwakha zihlangabezana nezidingo zomthethonqubo we-EU 1935/2004/EC. Xhumana nabaphakeli ukuthola ulwazi olwengeziwe mayelana nezinto zokwakha.
❖ Isitatimende Somsuka Wezilwane
Ngokusekelwe olwazini lwamanje oluvela kubaphakeli bethu, zonke izinto ezisetshenziswa kulo mkhiqizo azinazo izilwane.
❖ Ukugcinwa Kwamagciwane
Lo mkhiqizo uhlolwe ngempumelelo ukuze kutholakale ukuthi awusakwazi yini ukugcina izinto ezincane ezingaba yingozi, kusetshenziswa izinqubo ezichazwe ku-TS Filter Validation Guides futhi zihlobene ne-ASTM Standard Test Methos ASTM F838, ngokuhambisana nezidingo ezisebenzayo ze-FDA Guideline Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice (Septhemba 2004).
❖ Izindlela Zokukhishwa Kwelothi
Le ndawo yokukhiqiza yathathwa amasampula, yahlolwa futhi yakhishwa yi-TS Filter Quality Assurance.
❖ Ukuhlolwa Kobuqotho
Ingxenye ngayinye yesihlungi ihlolwe ngokuqinisekiswa kwekhwalithi ye-TS Filter ngokusekelwe ezindinganisweni ezingezansi, bese ikhishwa.
Izinga Lokuhlola Ubuqotho (20°c):
Iphuzu Lebhamuza (BP)
Ukugeleza Kokusabalalisa (DF)
Noma Ukungena Kwamanzi (WI)
Qaphela: I-BP ne-DF kufanele zihlolwe ngemva kokuba i-element yesihlungi imanzisiwe.
Kulesi sihlungi, lezi zindinganiso zokuhlola ubuqotho zihlotshaniswe ngokugcwele nokuhlolwa kwe-ASTM F838 bacterial Challenge, ngokuhambisana nezidingo ezisebenzayo ze-FDA Guideline Sterile Drug Products Productions Produced by Aseptic Processing-Current Good Manufacturing Practice (Julayi 2019).
❖ Ukuhlolwa Kokuvuza
Ingxenye ngayinye yesihlungi ihlolwe ngokuqinisekiswa kwekhwalithi ye-TS Filter ngokusekelwe kumazinga angezansi, bese ikhishwa: