Iyi nyandiko yemeza ibicuruzwa byakozwe na TS Filter hakurikijwe amahame ngenderwaho agenga ikorwa ry’ibicuruzwa.
Iki gicuruzwa cyakozwe, kigakorwa kandi kigakwirakwizwa hakurikijwe uburyo bw’imicungire bwemewe na ISO9001: 2015.
Ibipimo ngenderwaho byo kugenzura ubuziranenge
Isuku
Iki gicuruzwa cy’urufunguzo cyujuje ibisabwa n’ingingo ya 21 CFR, ingingo ya 210.3 (b) (5) (6) na 211.72
❖ TOC & Ubushobozi bwo gutwara ibintu
Nyuma yo gukaraba amazi mu buryo bugenzuwe, ingero ziba zifite munsi ya 0.5mg (500 ppb) ya karuboni kuri litiro, kandi ubushobozi bwo gutwara amazi buri munsi ya 5.1 S/cm kuri 25°C.
❖ Uburozi bwa Bagiteri
Igikoresho cyo gukuramo amazi kiri munsi ya 0.25EU/ml
❖ Uburinganire bw'ibinyabuzima
Ibikoresho byose by'iki gice cy'urufunguzo byujuje ibisabwa na USP kuri pulasitiki yo mu bwoko bwa VI-121°c.
❖ Inyongeramusaruro ku biribwa bitaziguye
Ibikoresho byose bigize ibiryo byujuje ibisabwa na FDA mu buryo butaziguye nk'inyongera ku biribwa byavuzwe muri 21CFR. Ibikoresho byose bigize ibi bikubiyemo byujuje ibisabwa n'amabwiriza y'Umuryango w'Ubumwe bw'u Burayi 1935/2004/EC. Hamagara abatanga serivisi kugira ngo ubone amakuru arambuye ku bijyanye n'ibikoresho by'ubwubatsi.
❖ Itangazo ry'inkomoko y'inyamaswa
Dukurikije amakuru agezweho aturuka ku bacuruzi bacu, ibikoresho byose bikoreshwa muri iki gicuruzwa nta nyamaswa bikoreshwa.
❖ Kubika bagiteri
Iki gicuruzwa cyageragejwe neza kugira ngo kimenyekane niba gifite uturemangingo tw’ingufu twakwifashishwa mu gupima, hakoreshejwe uburyo bwasobanuwe muri TS Filter Validation Guides kandi bufitanye isano na ASTM Standard Test Methos ASTM F838, hakurikijwe ibisabwa n’amabwiriza ya FDA Guideline Sterile Drug Products yakozwe na Aseptic Processing-Current Good Manufacturing Practice (Nzeri 2004).
❖ Ibipimo ngenderwaho byo kurekura Lot
Iyi nyubako yapimwe, igeragezwa kandi irekurwa na TS Filter Quality Assurance.
❖ Isuzuma ry'ubunyangamugayo
Buri gice cy’urufunguzo cyageragejwe hifashishijwe ubwiza bwa TS Filter hashingiwe ku bipimo biri hepfo, hanyuma kikarekurwa.
Igipimo ngenderwaho cy'isuzuma ry'ubunyangamugayo (20°C):
Ingingo y'urubura (BP)
Urujya n'uruza rw'amazi (DF)
Cyangwa Kwinjira mu Mazi (WI)
Icyitonderwa: BP na DF bigomba gupimwa nyuma yuko icyuma gifunguye kimaze gutoserwa.
Kuri iyi filtre, ibi bipimo ngenderwaho by’ibizamini by’ubunyangamugayo byahujwe neza n’ikizamini cya ASTM F838 bacteries Challenge, hakurikijwe ibisabwa n’amabwiriza ya FDA agenga imiti itera indwara yangiza yakozwe na Aseptic Processing-Current Good Manufacturing Practice (Nyakanga 2019).
❖ Ikizamini cyo gusohoka kw'amazi
Buri gice cy’urufunguzo cyageragejwe hakoreshejwe uburyo bwo kugenzura ubuziranenge bwa TS Filter hashingiwe ku mahame ari hepfo, hanyuma kikarekurwa: