Mu nganda za farumasi, buri gikorwa gikora umusaruro ujyanye numutekano wubuzima bwabarwayi. Kuva guhitamo ibintu fatizo kubikorwa byumusaruro, nibikoresho byogusukura ibikoresho byo kugenzura ibidukikije, umwanda wose urashobora kuganisha ku ngaruka zibiyobyabwenge. Muri aya mahuza yingenzi, thefarumasi ya farumanyabaye kimwe mu bikoresho by'ibanze yo kwemeza umutekano w'ibiyobyabwenge kubera uruhare rwayo adasubirwaho. Ntabwo itanga ingwate zizewe gusa umusaruro ugenda wingeri, ariko nanone ukora nk'imfura y'ingenzi mu nganda zigezweho zigenda zigana mu buryo bwo hejuru ndetse n'ubuziranenge.

Steam: Ubuzima bwumusaruro wa farumasi

Ibisabwa kugirango isuku mumusaruro wa farumasi uri hafi. Yaba inshinge, ibinyabuzima, inkingo, cyangwa ibiyobyabwenge, ibikoresho, imiyoboro, ibikoresho, ndetse nibikoresho byo mu kirere bigira uruhare mu kugandumo umusaruro. Ihuriro ryiza (rizwi kandi nka "PlargaceUtical Pries") yabaye uburyo bwo kwerekana uburyo bwa fateri mu miti kubera ubushyuhe bwo hejuru no kubura ibisigazwa bya shimi.

Umutwara neza

Imashini nziza irashobora gucengera byihuse urukuta rwa mikorobe kandi wice bagiteri rwose, virusi, na sposs ukoresheje ubushyuhe bwinshi (mubisanzwe hejuru ya 121 ℃) no guhatira cyane. Ugereranije n'imiti yuzuye imiti, stoam nziza ntabwo ifite ibyago bisigaye, bikwiranye cyane nibikoresho nibikoresho bihura nibiyobyabwenge. Kurugero, gukonya ibitekerezo byingenzi nko gutera inyonge imirongo, imashini zumisha.

Ubunini bwibipimo byiza

Dukurikije ibisabwa GMP, imashini nziza ya farumasi igomba kuba yujuje ibipimo bitatu byingenzi:

Nta soko yubushyuhe: Inkomoko yubushyuhe ni umwanda wica ushobora gutera imiriro yitabira abarwayi kandi igomba kuvaho burundu.

Amazi yegeranye yujuje ubuziranenge: Ubwiza bwamazi nyuma yo kugereranya amababi akeneye kubahiriza amazi yo gutera inshinge (WFI), hamwe na ≤ 1.3 μ SM.

Agaciro kwuzuza ibisabwa: Kuma gutemagurika bigomba kuba ≥ 95% kugirango birinde amazi meza bigira ingaruka kumugaragaro.

Inzira yuzuye

Kuva kuri sterilisation kumurongo (sip) yibikoresho byo kubyaza umusaruro mubyumba mubyumba bisukuye kugirango bindure ibintu byangiza ibintu, inyamanswa nziza inyura kumikorere ya faruce. Cyane cyane mu mahugurwa yo gutegura aseptic, generator nziza ni "isoko y'ingufu" ikora amasaha 24 kumunsi nta nkomyi

Guhanga mu ikoranabuhanga muri farumasi ya faruman

Hamwe no gukenera kwiyongera ku bwiza, gukora neza, no kurengera ibidukikije mu nganda za farumasi, tekinoroji y'amana meza ya Steam nayo ahora acika. Ibikoresho bigezweho byageze kubwumutekano wo hejuru ningufu binyuze muburyo bwubwenge kandi bwa modular.

Kwirukana mukoranabuhanga

Ingero nyinshi Ikoranabuhanga rya Trillow: Binyuze mu kugarura imbaraga, amazi mbisi (mubisanzwe amazi meza) ashyirwa mu mbaho ​​nziza, agabanya ibiciro birenga 30% ugereranije nibikoresho gakondo.

Igenzura ryubwenge: zifite ibikoresho byo gukurikirana byikora, kumenya igihe cyihuse cyumye igicucu, ubushyuhe, impuruza no guhinduka byikora no kwirinda amakosa yabantu.

Igishushanyo mbonera cya karubone: Kwemera ibikoresho byubushyuhe bwo kugarura ubushyuhe kugirango ugabanye imyanda, bijyanye no guhindura icyatsi cyicyatsi cyo guhindura imiti.

'Ubwishingizi bubiri' bwicyizere cyiza

Ikora rya kijyambere rya kijyambere rifite uburyo bukoreshwa neza:

Sisitemu yo gukurikirana kumurongo: Igihe nyacyo cyo gukurikirana isuku binyuze mubikorwa nkibikoresho byo kuyobora no gusesengura toc.
Igishushanyo mbonera: Gusubira inyuma, filt-stade-statution ibice byemeza imikorere ihamye mugihe habaye kunanirwa gutunguranye.

Guhinduka mugusubiza ibyifuzo bigoye

Amashanyarazi meza ya Steam arashobora kuba yihariye imirima igaragara nka kitari ya kitari hamwe nubuvuzi bwa selire. Kurugero, ibikoresho bikoreshwa mu misaruro ya MRNA bigomba kubahiriza ibisabwa byinshi bikabije, kandi ibigo bimwe byashyizeho tekinoroji ya steam "kugirango igenzure urwego rwa endotoxine mu mazi ateganijwe munsi ya 0.001 EU / ML.
Hamwe niterambere ryihuse ryabinyabuzima, ibisabwa byinshi byashyizwe imbere kubwiza bwimyororono. Gukora ibiyobyabwenge bishya nkibiyobyabwenge bya gene na antibodiyani monoclonal bisaba ibidukikije byera. Ibi birerekana ikibazo gishya cyikoranabuhanga ku mashanyarazi meza.

Igitekerezo cyumusaruro wicyatsi kirimo guhindura ibishushanyo mbonera byakozwe na Steam. Gushyira mu bikorwa ibikoresho byo kuzigama ingufu, ibikoresho byinshuti zishingiye ku bidukikije, hamwe n'iterambere ry'imicungire y'ubwenge byose bitwara inganda ku cyerekezo kirambye.

Gushyira mu bikorwa ikoranabuhanga ryubwenge birimo guhindura uburyo bwo gukora bwibinyage byateje. Ishyirwa mu bikorwa ry'igenzura rya kure, kubungabunga ibi byahanuwe, guhinduka ubwenge hamwe nindi mirimo idangiza gusa imikorere yibikoresho, ariko kandi itanga ibyiringiro byizewe kugirango umusaruro wibiyobyabwenge.

Uyu munsi, kubera ko umutekano w'ibiyobyabwenge uhabwa agaciro, akamaro kafarumasi yubutaka bwa faruamni IBINSHI. Ntabwo ari ibikoresho byingenzi byo gukora ibiyobyabwenge, ahubwo ni inzitizi ikomeye kugirango umutekano rusange wubukungu. Hamwe no gutera imbere ikoranabuhanga, amashanyarazi meza ya Steam azagira uruhare runini mu nganda za farumasi kandi itanga umusanzu munini mubuzima bwabantu.