Mu nganda zimiti, buri musaruro ujyanye numutekano wubuzima bwabarwayi. Kuva guhitamo ibikoresho fatizo kugeza kubikorwa, kuva isuku yibikoresho kugeza kugenzura ibidukikije, umwanda uwo ariwo wose urashobora gutera ingaruka mbi kumiti. Muri aya masano y'ingenzi ,.imashini itanga imitiyabaye kimwe mu bikoresho by'ibanze bigamije kurinda umutekano w'ibiyobyabwenge kubera uruhare rwayo rudasubirwaho. Ntabwo itanga gusa garanti yizewe yumusaruro wa aseptike, ahubwo inatanga urufatiro rukomeye rwinganda zimiti igezweho kugirango igere ku bipimo bihanitse kandi bifite ireme.

Umwuka mwiza: umurongo wubuzima bwibikorwa bya farumasi

Ibisabwa kugira isuku mubikorwa bya farumasi birakomeye. Yaba inshinge, ibinyabuzima, inkingo, cyangwa imiti ya gene, ibikoresho, imiyoboro, kontineri, ndetse n’ibidukikije byo mu kirere bigira uruhare mu bikorwa byayo bigomba guhagarikwa neza. Umwuka mwiza (uzwi kandi ku izina rya "farumasi yo mu rwego rwa farumasi") wahindutse uburyo bwa sterisizione mu nganda zimiti kubera ubushyuhe bwinshi no kutagira ibisigazwa by’imiti.

Intandaro yibanze yo kuboneza urubyaro

Umwuka mwiza urashobora kwinjira vuba murukuta rwa mikorobe hanyuma ukica rwose bagiteri, virusi, na spore binyuze mubushyuhe bwinshi (mubisanzwe hejuru ya 121 ℃) hamwe numuvuduko mwinshi. Ugereranije n’imiti yica udukoko, kwanduza amavuta meza nta ngaruka zisigaranye, cyane cyane bikwiriye ibikoresho n’ibikoresho bihura n’ibiyobyabwenge. Kurugero, guhagarika ibikoresho byingenzi nkumurongo wuzuza inshinge, imashini zumisha-gukonjesha, hamwe na bioreactors zishingiye ku kwinjiza neza kwamazi meza.

Gukomera k'ubuziranenge

Ukurikije ibisabwa na GMP, amavuta meza yimiti agomba kuba yujuje ibintu bitatu byingenzi:

Nta nkomoko yubushyuhe: Inkomoko yubushyuhe ni umwanda wica ushobora gutera umuriro mubarwayi kandi ugomba kuvaho burundu.

Amazi afunitse yujuje ubuziranenge: Ubwiza bwamazi nyuma yubushyuhe bwamazi bugomba kuba bujuje amazi yo gutera inshinge (WFI), hamwe nubushobozi bwa ≤ 1.3 μ S / cm.

Agaciro keza ko gukama: Kuma yumye bigomba kuba ≥ 95% kugirango wirinde amazi y’amazi agira ingaruka kuri sterilisation.

Gahunda yuzuye yo gusaba

Kuva kuri sterisizasiya kumurongo (SIP) yibikoresho bitanga umusaruro kugeza ubuhehere bwikirere mubyumba bisukuye, kuva kumesa imyenda itanduye kugeza kwanduza imiyoboro itunganijwe, umwuka mwiza unyura mubuzima bwose bwibikorwa bya farumasi. By'umwihariko mu mahugurwa yo gutegura aseptic, amashanyarazi meza ni "intandaro yimbaraga" ikora amasaha 24 kumunsi nta nkomyi

Guhanga udushya mu buhanga bwa farumasi nziza

Hamwe n’ubwiyongere bukenewe ku bwiza, gukora neza, no kurengera ibidukikije mu nganda zikora imiti, tekinoroji y’amashanyarazi meza nayo ihora icika. Ibikoresho bigezweho byageze kumutekano mwinshi no gukoresha ingufu binyuze muburyo bwubwenge kandi bwubusa.

Iterambere mu ikoranabuhanga ryibanze

Ikoreshwa rya tekinoroji ya tekinoroji: Binyuze mubyiciro byinshi byo kugarura ingufu, amazi mbisi (ubusanzwe amazi asukuye) ahinduka amavuta meza, bigabanya gukoresha ingufu zirenga 30% ugereranije nibikoresho gakondo.

Igenzura ryubwenge: rifite ibikoresho byo kugenzura byikora, kumenya igihe nyacyo cyo gukama kwamazi, ubushyuhe, nigitutu, gutabaza byikora no guhindura ibintu bidasanzwe, kugirango wirinde amakosa yimikorere yabantu.

Igishushanyo mbonera cya karubone: gukoresha ibikoresho byo kugarura ubushyuhe kugirango bigabanye imyanda yingufu, bijyanye nicyatsi kibisi cyinganda zimiti.

'Ubwishingizi bubiri' bw'ubwishingizi bufite ireme

Amashanyarazi agezweho ya kijyambere asanzwe afite ibikoresho byuburyo bubiri:

Sisitemu yo gukurikirana kumurongo: Igihe nyacyo cyo kugenzura isuku ikoresheje ibikoresho nka metero zitwara abantu hamwe nisesengura rya TOC.
Igishushanyo mbonera: gusubiramo pompe ebyiri, kuyungurura ibyiciro byinshi nibindi bishushanyo byerekana imikorere ihamye yibikoresho mugihe byananiranye bitunguranye.

Guhinduka mugusubiza ibyifuzo bigoye

Amashanyarazi meza arashobora gutegurwa kumirima igaragara nka biofarmaceuticals hamwe nubuvuzi bwakagari. Kurugero, ibikoresho bikoreshwa mugukora urukingo rwa mRNA bigomba kuba byujuje ibyangombwa bisabwa, kandi ibigo bimwe byashyizeho uburyo bwa "ultra pure steam" bwo kugenzura urwego rwa endotoxine mumazi yegeranye munsi ya 0.001 EU / mL.
Hamwe niterambere ryihuse ryibinyabuzima, ibisabwa byashyizwe hejuru kugirango ubwiza bwamazi meza. Gukora imiti mishya nk'imiti ya gene na antibodiyite za monoclonal bisaba ibidukikije byiza. Ibi birerekana ikibazo gishya cyikoranabuhanga kumashanyarazi meza.

Igitekerezo cyumusaruro wicyatsi uhindura igishushanyo mbonera cya moteri ikora neza. Gukoresha ibikoresho bizigama ingufu, ibikoresho bitangiza ibidukikije, hamwe niterambere rya sisitemu yo gucunga ubwenge byose bitera inganda kugana ku cyerekezo kirambye.

Ikoreshwa rya tekinoroji yubwenge ni uguhindura uburyo bwo gukora amashanyarazi meza. Ishyirwa mu bikorwa rya kure, kurebera hamwe, gutunganya ubwenge hamwe nindi mirimo ntabwo byongera imikorere yimikorere yibikoresho gusa, ahubwo binatanga ubwishingizi bwizewe bwo gukora ibiyobyabwenge.

Uyu munsi, nkuko umutekano wibiyobyabwenge ugenda uhabwa agaciro, akamaro kaimiti itanga amashanyarazi mezabigenda bigaragara cyane. Ntabwo ari ibikoresho by'ingenzi byo gukora ibiyobyabwenge gusa, ahubwo ni n'inzitizi ikomeye yo kurinda umutekano w'imiti rusange. Hamwe nogukomeza gutera imbere kwikoranabuhanga, amashanyarazi meza nta gushidikanya azagira uruhare runini mu nganda zimiti kandi azagira uruhare runini mubuzima bwabantu.