Integrated GMP Compliance Guide: Izisetshenziswa Eziyinzalo & Ukusekela Ukuphathwa Kwama-Post-Sterilization Xhumana Nabo Abakwa-WhatsApp Us Imikhuba Engcono Kakhulu Yezisetshenziswa Nenzalo ku
Izixazululo Ezithuthukisiwe Zokufakwa Kwenzalo Zokufakelwa Kwezokwelapha: Umhlahlandlela Ophelele Othuthukisa Ukuphepha Kwesiguli Nobuqotho Bempahla Ngobuchwepheshe Obuhamba Phambili Embonini. Kwe
Umhlahlandlela ophelele wemikhawulo yakamuva yokulawula ye-Ethylene Oxide (EtO) kumazwe nama-ejensi angama-31, okuhlanganisa amazinga e-OSHA, EU, kanye ne-GBZ. Leli thebula lihlinzeka ngemininingwane yamanani e-TWA yamahora angu-8 kanye nemizuzu engu-15 ye-STEL, kanye namazwi okuphepha abalulekile ekumunceni kwesikhumba nobungozi be-carcinogenic ukusiza indawo yakho ukuthi ihlale ithobela iziyalezo zomhlaba jikelele zokuphepha kwendawo yokusebenza.
Uhlu Lokuhlola Lokuhlolwa Kwenzalo Okubanzi kwe-Ethylene Oxide (EO) olusekelwe ku-ISO 11135 ne-ISO 13485. Hlola ukuqinisekiswa kwe-IQ/OQ/PQ, ukulinganisa imishini, nokuqapha okujwayelekile ukuze uqinisekise ukuthobela idivayisi yezokwelapha.
Uhlu Lokuhlola I-Ethylene Oxide Sterilization Audit (ISO 11135) Funda kabanzi
Umhlahlandlela onguchwepheshe kumakhodi okuphepha e-California ETO. Hlola ukuvala inzalo okujwayelekile kwe-ASME kanye nezinhlelo ze-BOCON's EO Scrubber ukuze uqinisekise ukuthobela okungu-100% kwendawo yakho.
Ukuthobela Ikhodi: I-Ethylene Oxide (ETO) Funda kabanzi
Qhathanisa izindlela ze-ETO vs. Gamma zokuvala inzalo zezihlungi zesirinji. Funda mayelana nokubhujiswa kwe-bacterial metabolism, ukuguqulwa kwe-DNA, kanye nezixazululo ezithuthukisiwe ze-BOCON ze-EO Scrubber zemiphumela engenazinsalela.
Izindlela zokuvala inzalo zezihlungi zesirinji Funda kabanzi
Izindlela Ezintathu Eziyinhloko Zokuhlwanyela Izinongo Ukuqinisekisa ukuphepha kwamagciwane kuyilapho ulondoloza iphunga, umbala, kanye nokunambitheka kwezinongo
Izindlela Ezintathu Zokuvula Inzalo Eziyinhloko Zezinongo Funda kabanzi
Ukuvalwa Kwedivayisi Yezokwelapha: Izindlela Ukuqhathanisa Ukukhetha inqubo efanele yokuvala inzalo kubalulekile ukuze ubuqotho bedivayisi nokuphepha kwesiguli. Ngezansi
Ukuqhathaniswa Kwezindlela Zokuvula Inzalo Yezokwelapha Funda kabanzi
Ukuhambisana kweSterile Barrier Systems Nezinqubo Zokuvala Inzalo Ekukhetheni izinto ezisetshenziswayo zamasistimu okuvimbela inzalo kumishini yezokwelapha, ukuqinisekisa ukuthi
Ukuhambisana kwamasistimu okuvimbela inzalo anezinqubo zokuvala inzalo Funda kabanzi
Ukuvumelana Kokuvala Inzalo Kwezinhlelo Zokuvimbela Inzalo Iphepha Elimhlophe Lobuchwepheshe 1. Isingeniso Ukuhambisana phakathi kwamasistimu okuvimbela inyumba (SBS) nokuvala inzalo
Ukuvumelana Kokuvalwa Kwenzalo Kwezinhlelo Zokuvimbela Inzalo Funda kabanzi