Umshini Wokumboza Omusha Osebenza Kakhulu we-BGB-250F Onamapani Okumboza Angashintshaniswayo
Umklamo ovulekile ophelele ohlangothini olungaphambili
Ukuhlanza okulula, akukho ndawo evulekile
Indawo yokufaka ebanzi kanye nendawo yokulungisa kanye namapani kungashintshwa
Isakhiwo sokuvala isikhwama somoya esiyingqayizivele, igumbi elivalekile ngokuphelele
Yamukela uhlelo lokulawula oluzenzakalelayo lwe-HM land PLC, ingalandela ngokuzithandela izidingo ze-21 CFR Part 11
Isekela ukushintshaniswa kwamapani okumboza ukuze kukhiqizwe izinhlobo ezahlukene zokukhiqiza, okuvumela ukusebenza kwezinhloso eziningi kanye nokuhlangabezana nezidingo zokukhiqiza eziguquguqukayo.
Umklamo wesakhiwo sokukhipha umoya ophumayo ophezulu kanye nowomoya ophansi, okwandisa ukusetshenziswa kwesisombululo sokumboza ngo-5-10%.
Isekela indlela yokuqoqa amasampula avaliwe ku-inthanethi.
I-feeder yokuphakamisa enikeza ama-tips iyatholakala, evumela ukudluliselwa kwamaphilisi epanini ngokushelela ukuvimbela ukuqhekeka noma ukuphuka okubangelwa ukushayisana kokuphakama, ngokusebenza okulula.
Ukukhipha ngokuzenzakalelayo ukujikeleza okujiyile, akukho ukuchotshozwa kwethebhulethi, izinga lokukhipha elingu-100%, kanye nokunciphisa umsebenzi wezandla.
Ukushintshana kwe-arc okubushelelezi phakathi kwekhoni yesigubhu nepuleti le-mesh, kuvimbela ukulimala kwamaphilisi.
Ukulawula okuvaliwe okungeziwe kwesivinini sokujikeleza kwepani lokumboza: kuthola isivinini sangempela somshafti (esiboniswa esikrinini), kuqinisekisa isivinini esinembile esingathinteki ukuphambuka kwesivinini somthwalo noma semoto; futhi kunikeza ukutholwa kokwehluleka kokuxhumanisa kanye nomsebenzi we-alamu yesivinini ongajwayelekile.
Ukulawulwa kwesixazululo sokumboza kungafinyelela ingcindezi engaguquki kanye nesimo sokugeleza okungaguquki.
Izinga lokuhlunga uthuli i-F9, ehlangabezana nezindinganiso zokukhishwa zikazwelonke ezinenani lokuhlanza elingaphansi kuka-20mg/m³ (isihlungi se-F9+H13 esingakhethwa ukuze sihlanzwe
Ukusebenza kohlelo lokulawula (lapho izinzwa ezingakhethwa zilungiselelwe): ukunemba kokulawula ivolumu yomoya kuze kufike ku-±5%, ukunemba kokulawula ingcindezi okungekuhle kuze kufike ku-±15Pa, kanye nokunikeza ukunemba kokulawula izinga lokushisa lomoya kuze kufike ku-±1.5℃.
Imisebenzi yesistimu yokulawula (ngephaneli yokunethezeka noma iphaneli yezimboni): umkhondo wokuhlola, ukuqoshwa kwedatha, igrafu yezitayela, njll.
Izindlela zokupheka zokukhiqiza okuzenzakalelayo kanye nokuhlanza okuzenzakalelayo zemishini zisekela ukulawulwa kwenqubo eguquguqukayo; amapharamitha enqubo yesigaba ngasinye angasethwa ngokuzimela ukuze ahlangabezane nezidingo zenqubo ezenziwe ngokwezifiso zamakhasimende.
Uhlelo luhlonyiswe ngomshini wokuhlanza ukuze kungabikho zinsalela futhi kugwenywe ukungcola kwamagciwane.
Kuhambisana nezindinganiso zesitifiketi se-EU CE, kanye nezidingo zenguqulo entsha yemithethonqubo ye-GMP, CGMP, kanye ne-FDA.