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    Ikhemisi neBhayiloji

    Iinsombululo

    Ikhemisi neBhayiloji

    I-OBAIR yenza iindawo ezihle zokukhiqiza ze-biopharma kanye namabubulo wokukhiqiza ukudla ukuqinisekisa ikhwalithi yomkhiqizo. Njengombana kuneemfuno ezihlukahlukeneko zamazinga womtjhiso, umswakama, nokusabalaliswa komoya eenkambisweni ezihlukahlukeneko, i-OBAIR inikela ngeensombululo ezihlukahlukeneko ze-HVAC. Ngobungcweti ku-GMP ne-GSP, i-OBAIR isekela amaklayenti ukusuka ekucacisweni kweemfuneko zomsebenzisi (URS) ukuya ekuklameni (DQ), ukufakwa (i-IQ), kanye neziqu zokusebenza (PQ), isiza ekutholeni isitifiketi se-GMP.

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    Ukunikela ngeendlela ezinengi ezisebenzako zokupholisa, amahlelo womthombo wokupholisa/wokutjhisa ophakathi ukuya kobukhulu ahlangana nokulawulwa kwamanzi wokupholisa okuthuthukisiweko ukufikelela ukusebenzisana komoya namanzi, ukuthuthukisa okusebenzako, nokonga amandla okukhulu. I-SCOP yegumbi lomtjhini ingafinyelela ku-7.0+, ukuqinisekisa ukusebenza okuhle.

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    Ema-workshop we-pharma, amaqhinga amanengi wokusebenza atlhoga indawo enomswakama ophasi, njengokukhiqizwa kwe-aseptic powder yokujova, amaphilisi avuthako, amakhemikhali, imikhiqizo ethile yezinto eziphilako, njll.

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    Ngokuhambisana ne-Good Supply Practice (GSP), iindawo zokugcina izinto ezipholileko zitlhoga iinsetjenziswa zokulawula amazinga womtjhiso nomswakama, iinkambo zokungenisa umoya, ukutjheja ngokuzenzakalelako, kanye neensetjenziswa zokurekhoda. Izinga lokutjhisa kufanele ligcinwe hlangana kwe-2°C kanye ne-20°C, begodu umswakama ophakathi kwe-35% kanye ne-75%. Iinsombululo ze-OBAIR zifaka hlangana ifreyimu ye-labyrinth enelungelo lobunikazi elinokungangeni komoya okuhle khulu, ukuhlanzeka okuphezulu, nomsindo ophasi wokusebenza, okuhlangabezana neemfuneko ze-GSP zeendawo zokugcina imithi ezipholileko.

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