Kuzuza capsules yubusa ninzira yibanze mugukora dosiye zifatika, kandi ubwiza bwibicuruzwa byayo bigena neza umutekano, umutekano, ningaruka zibiyobyabwenge. Kuberako capsules yubusa ari hygroscopique, ikunda kwanduzwa, kandi igahura neza nubuvuzi mugihe cyo kuzuza, ibidukikije byabyaye ibisabwa cyane. Igomba kugenzurwa mubice byose hakurikijwe neza uburyo bwiza bwo gukora (GMP), harimo isuku, ubushyuhe nubushuhe, itandukaniro ryumuvuduko, ibikoresho byikigo, hamwe nubuyobozi bwabakozi.
1. Kugenzura Isuku: Guhagarika Microbial na Particulite Yanduye
Isuku nicyo kimenyetso cyambere kubusa capsule yuzuye ibidukikije. Ukurikije ibipimo bya GMP, kuzuza capsule yubusa idafite - isanzwe ikorerwa ahantu hasukuye mu cyiciro cya D, bisaba ko bitarenze uduce 3,520.000 duhumeka ikirere kirenze cyangwa kingana na 0.5μm kuri m³ no gutuza mikorobe zitarenze 200 CFU / isahani. Kuri capsules sterile, kuzuza bigomba gukorwa mucyiciro cya A cyerekezo cyerekezo cyerekezo cyicyiciro cya mbere cyicyiciro cya D, hamwe nuduce duto two mu kirere tutarenze 3.500 kuri m³ no gutuza mikorobe zitarenze 1 CFU / isahani. Ahantu hasukuye hagomba kwezwa na sisitemu eshatu - sisitemu yo kuyungurura ikirere (pre {13}
2. Kugenzura Ubushyuhe nubushuhe bwuzuye: Kugenzura niba Capsules ihagaze neza
Ikintu nyamukuru kigizwe na capsules yubusa ni gelatine, yunvikana cyane nubushyuhe nubushuhe. Ubushuhe bwinshi burashobora gutuma capsules ihinduka yoroshe, igafatana, canke mbere igahinduka, mugihe ubuhehere buke burashobora gutuma bucika kandi bikongera umuvuduko. Muri icyo gihe, ubushyuhe n'ubushuhe nabyo bigira ingaruka ku gutembera kw'ibikoresho no kuzuza neza. Kubwibyo, ubushyuhe mubidukikije bwuzuye bugomba kugenzurwa cyane hagati ya dogere 18 - 26 nubushyuhe buri hagati ya 45% -65%. Kugira ngo ibyo bigerweho, ahantu hasukuye hagomba kuba hashyizweho uburyo bunoze bwo guhumeka neza bugenzura kandi bugahindura ubushyuhe n’ubushuhe mu gihe gikwiye, bigatuma umusaruro uhagaze neza kandi ukirinda ibibazo by’ubuziranenge cyangwa dosiye idahwitse iterwa n’imihindagurikire y’ibidukikije.
3. Itandukaniro ryumuvuduko nishyirahamwe ryikirere: Kurinda umusaraba - Kwanduza
Kugirango wirinde gusubira inyuma kwumwuka uturutse hasi - ahantu hashobora gutera kwanduza - kwanduza, hagomba kubaho itandukaniro ryumuvuduko ushimishije hagati yinzego zitandukanye z’isuku. Ubusanzwe, itandukaniro ryumuvuduko hagati yisuku n’ahantu hasukuye -, no hagati yibyumba byegeranye by’urwego rw’isuku zitandukanye, bigomba kuba binini kuruta cyangwa bingana na 10 Pa, mu gihe itandukaniro ry’umuvuduko w’ahantu hasukuye hamwe n’imbere rigomba kuba rinini cyangwa rihwanye na 15 Pa. n'impande zapfuye. Ibi bikuraho neza umukungugu na mikorobe byakozwe mugihe cyo kubyara kandi bikarinda ubwiza bwikirere bwakarere.
4. Ibikoresho, ibikoresho, no gucunga ibikoresho: Kugabanya ingaruka zanduye
Igorofa, inkuta, hamwe nigisenge ahantu hasukuye bigomba kuba byubatswe bidafite kashe, byangirika - birwanya, kandi byoroshye - kugeza - ibikoresho bisukuye (nka epoxy resin cyangwa plaque yamabara) bifite ubuso bworoshye, buringaniye budashobora kwegeranya umukungugu byoroshye. Ibikoresho byo hejuru bigomba kuba byoroshye kandi bitarimo inguni zapfuye. Ibigize bihuye neza nibikoresho bigomba kuba bikozwe muburozi -, uburozi - bwihanganira 316L ibyuma bitagira umwanda kandi bigahora bisukurwa kandi bikanduzwa. Ibikoresho nkimashini zuzuza imashini zogosha bigomba kuba byateguwe nka sisitemu zifunze kugirango hagabanuke ivumbi, kandi bigizwe nibikoresho bikuramo ivumbi. Mbere yo kwinjira ahantu hasukuye, ibikoresho bigomba kunyura muri airlock cyangwa idirishya ryimurwa, kandi ibyo bapakira hanze bigomba gusukurwa no kwanduzwa kugirango birinde kwanduza hanze.
5. Gucunga abakozi n’isuku: Guca abantu - Byakozwe Inkomoko Yanduye
Abakozi nisoko nini yo kwanduza. Kwinjira ahantu hasukuye bisaba uburyo bukomeye bwo kwambara: guhindura inkweto, gukaraba intoki, no kwambara imyenda yisuku (harimo ingofero, mask, gants, ninkweto zo mu isuku) kugirango hatagira umusatsi cyangwa uruhu rugaragara. Abakoresha bagomba guhabwa amahugurwa yumwuga kugirango bamenyere amabwiriza ya GMP nuburyo bukoreshwa. Amavuta yo kwisiga n'imitako birabujijwe, kandi kugenda no kuganira bitari ngombwa bigomba kugabanywa. Byongeye kandi, ahantu hasukuye hagomba kugira uburyo bukomeye bwo gukora isuku no kuyanduza mugusukura buri munsi no kwanduza buri gihe amagorofa, ibikoresho, nibikoresho byo kwirinda mikorobe.
6. Gukurikirana Ibidukikije no Kubungabunga: Gukomeza Kwubahiriza
Isosiyete igomba gushyiraho gahunda yuzuye yo gukurikirana ibidukikije kugirango isuzume buri gihe ibipimo nkibice byo mu kirere, mikorobe, ubushyuhe, ubushuhe, n’itandukaniro ry’umuvuduko ahantu hasukuye. Amakuru agomba kwandikwa no gusesengurwa kugirango ahite amenya kandi akemure ibintu bidasanzwe. Sisitemu yo kweza ikirere isaba kubungabungwa buri gihe, harimo no kuyungurura, kugirango ikore neza. Byongeye kandi, gukomeza gukora neza no kwizerwa bya sisitemu yo kugenzura ibidukikije bigomba kwemezwa binyuze mu kwemeza no re - kwemeza, bigatanga umusaruro uhamye kandi wujuje ibisabwa kugirango wuzuze capsule yubusa.
Mu gusoza, kugenzura ibidukikije byuzuza capsule yubusa ni umushinga utunganijwe usaba kwitabwaho cyane mubice byinshi, birimo isuku, ubushyuhe nubushuhe, itandukaniro ryumuvuduko, ibikoresho byikigo, hamwe nubuyobozi bwabakozi. Gusa hashyizweho uburyo bwa siyansi yubuyobozi bushingiye kubidukikije bushobora kwemezwa neza ubwiza bwa capsules yubusa, kurinda umutekano wibiyobyabwenge no guha abarwayi imiti yizewe. Niba hari ikibazo kijyanye na capsules yubusa, ikaze kuri contactKornnacCaps.
