Turabizi ko muruganda rwa farumasi muri iki gihe, hari byinshi biganisha ku bipimo nganda bibisi.Nukuzamura ubuziranenge, kubungabunga ingufu, umusaruro usukuye, kurwanya umwanda, gutunganya ibidukikije no kurengera ibidukikije nkibyingenzi.Igishushanyo nogushushanya amahugurwa asukuye mubikorwa bya farumasi bisaba gusobanukirwa neza ninganda zimiti na GMP, gusobanukirwa bimwe mubyiciro bijyanye, nurufatiro rukomeye rwa HVAC nandi masomo.Byongeye kandi, birakenewe gukurikiza ibisabwa n’amabwiriza y’igihugu abigenga (nka GMP) hamwe n’ibisobanuro bisanzwe, bidashobora kurenga ariko ntibisobanurwe cyane.Hariho ibintu bitanu byingenzi mugucunga ibidukikije ibyumba byubuvuzi bisukuye, aribyo isuku, urwego rwa mikorobe, ubushyuhe nubushuhe, itandukaniro ryumuvuduko no gukwirakwiza umwuka.Ibi bintu bitanu byingenzi nibintu byingenzi kugirango habeho imikorere ihamye kandi ihamye yicyumba gisukuye cya farumasi, kandi nibintu twibandaho mugushushanya kwa HVAC mubyumba byubuvuzi bya farumasi.
Amahugurwa meza asukuye yinganda zimiti ntagomba gusa kuzuza ibisabwa byumusaruro, ahubwo agomba no kuzirikana ibikubiye mubiro, mububiko no kubungabunga ibidukikije (igikoresho cyibikoresho).Kubaka aya mahugurwa akenshi bishingiye ku kigo cyashushanyijemo cyangwa inganda zumwuga zifite ibyangombwa byo gushushanya, zitanga ibishushanyo mbonera, kugirango ibishushanyo mbonera byubakwe nkibisanzwe, kugirango hubakwe imitako na gahunda yo gutera inkunga tekinike imbere.Ibipimo by’ibidukikije by’ahantu hakorerwa umusaruro bigomba gutegurwa hakurikijwe ibisabwa muri iki gihe “Uruganda rwa farumasi rugizwe n’amahugurwa asanzwe ya GB 50457-2019 ″ hamwe n’ibindi bipimo.Icyumba gisukuye cyubuvuzi kigomba gufata ibice na mikorobe nkibintu nyamukuru bigenzura, kandi bigashyiraho ibipimo bya tekiniki yubushyuhe, ubushuhe, itandukaniro ryumuvuduko, kumurika, urusaku nibindi mubyumba bitandukanye.Kugirango huzuzwe ibisabwa mubipimo byibidukikije, CEIDI XIDI EPC itanga serivise zoguhuza serivise zishaje ntizikora gusa kubaka urwego rwimitako yimbere, ahubwo izahuza no kubaka imiterere imwe ihuriweho na HVAC, gutanga amazi n'amazi, gutunganya inzira, kugenzura byikora, kurinda umuriro nubundi buryo bwa tekiniki bushyigikira ubuhanga.
Muri rusange, igishushanyo mbonera cy’amahugurwa asukuye mu nganda z’imiti kigomba kwibanda ku bintu bibiri: kuzuza ibisabwa mu gutunganya imiti;Kuzuza ibisabwa kurwego rwisuku yikirere.Ukurikije ibikenewe mubikorwa byo gutunganya umusaruro, urujya n'uruza rw'abantu n'inzira yo kohereza ibintu byateguwe kuba bigufi, byihuse kandi byoroshye.Muri icyo gihe, ni ngombwa gushyiraho ibyumba byo kweza n'ibikoresho mbere yuko abakozi n'ibikoresho byinjira mu cyumba gisukuye.Hagomba kwitabwaho ingamba zo kurwanya umwanda kugira ngo abakozi babone uburyo bwo kohereza no gukwirakwiza ibikoresho hagati y’ibyumba by’ubuvuzi bifite urwego rutandukanye rw’isuku ry’ikirere.
Kugenzura tekinike yubushyuhe nubushuhe muri buri gace kamahugurwa asukuye yinganda zimiti CEIDI:
Umusaruro:
Ibikorwa byo kubyaza umusaruro nibicuruzwa ntabwo bisabwa bidasanzwe kubushyuhe nubushuhe.Isuku y’ikirere yo mu cyiciro cya A, B na C isuku y’icyumba cy’ubuvuzi yashyizwe kuri 20 ℃ ~ 24 ℃, naho ubuhehere bugereranije bushyirwa kuri 45% ~ 60%.Ubushyuhe busanzwe bwo mu cyiciro D buva kuri 18 ° C kugeza kuri 26 ° C, naho ubuhehere bugereranije buri hagati ya 45% na 65%.
Agace kafasha:
Ubushyuhe bwo guhumeka abakozi basukura nicyumba cyo kubamo bishyirwa kuri 16 ℃ ~ 20 ℃ mu gihe cyitumba na 26 ℃ ~ 30 ℃ mu cyi.
Ahantu ho kubika:
1 Ubushyuhe bwibidukikije, ubushyuhe bugomba kuba 10 ℃ ~ 30 ℃;
2 Mu bidukikije bikonje, ubushyuhe bugomba kuba munsi cyangwa bingana na 20 ℃;
3. Mugihe gikonje kandi cyijimye, ubushyuhe bugomba kuba munsi cyangwa bingana na 20 and, kandi hagomba kwirindwa urumuri rutaziguye;
4 Ibidukikije bya Cryogenic, ubushyuhe bugomba kuba 2 ℃ kugeza 10 ℃;
5 Ubushuhe bugereranije bwibidukikije bugomba kuva kuri 35% kugeza 75%.
6. Niba ibintu bibitswe bifite ibisabwa byihariye, ubushyuhe nubushuhe bwibidukikije bigomba kugenwa ukurikije imiterere yibintu.
Ahantu ho kubika imbeho idasanzwe:
Banki y'inkingo: -5 ~ 8 ℃ irashobora gukoreshwa mukubika inkingo, ibiyobyabwenge, nibindi
Ububiko bukonje bwibiyobyabwenge: 2 ~ 8 ℃ kubika ibiyobyabwenge nibinyabuzima.
Kubika ubukonje bwamaraso: 2 ~ 8 ℃ irashobora kubika amaraso, ibiyobyabwenge nibinyabuzima, nibindi
Ububiko bukonje bwa plasma Ububiko bukonje bukabije: -20 ~ -30 ℃ kubika plasma, ibikoresho biologiya, inkingo, reagent, nibindi.
Isomero rya Cryopreservation: -30 ~ -80 ℃ rirashobora gukoreshwa mukubungabunga insina, amasohoro, ingirangingo, plasma, igufwa ryamagufa, ingero zibinyabuzima, nibindi.
Ibicuruzwa bidasanzwe byamaraso: Utugingo ngengabuzima dutukura dukonje tugomba kubikwa munsi ya -120 ° C kuri selile yumutuku wumukonje urimo glycerine 20% na munsi ya -65 ° C kuri selile yumutuku wumukonje urimo glycerine 40%.
Mu mahugurwa ya farumasi, usibye umwanya usukuye usabwa nuburyo bwo gutunganya ibicuruzwa, icyumba cy’isuku, icyumba cyo kumeseramo, icyumba cyo kubikamo by'agateganyo, icyumba cyo gukoreramo ibikoresho byo gukoreramo n’ibindi byumba nabyo bigomba kwigenga hagati yabyo.Ubwubatsi bwigenga bwa sisitemu zimwe na zimwe zifasha tekinike ntabwo bigoye gusa, ariko kandi ibyiza nibibi byurwego rwubwubatsi, urugero:
1. Gushyira imiyoboro y'amazi yatunganijwe bigomba kunyura mu gisenge hanyuma bikinjira mu mazi kugira ngo amazi atunganijwe mu muyoboro.Umwanya wo kwishyiriraho uruziga hamwe nu muyoboro winjira ntugomba kuba muke cyane, bitabaye ibyo bizatera ibyago byo kwanduza ibyerekezo byombi;
2. Gushushanya no gushyiraho imiyoboro bigomba kwirinda inguni zapfuye n'imiyoboro ihumye;Imiyoboro itambitse igomba gutegurwa kuri Angle runaka kugirango yorohereze amazi no kubika.
3. Buri murongo wo gukwirakwiza ahantu hasukuye ugomba kuba ufite ibikoresho byo guca;Ibikoresho byo gukwirakwiza ahantu hasukuye birashobora kuba bifite urukuta ruto rwo mu bwoko bwa rukuta rwamashanyarazi muri buri cyumba cyo kubyaza umusaruro.Kugabura amashanyarazi kuva mu gasanduku gato ko gukwirakwiza ibikoresho bitandukanye by'amashanyarazi mu cyumba cyo kubyaza umusaruro.Ibi biroroshye kubungabunga, kandi birashobora guteza imbere umutekano wamashanyarazi.
4. Icyumba cyo kugabura kigomba kuba kiri ahantu hatari hasukuye, kandi akabati gashinzwe gukwirakwiza ingufu nkeya, kabili XL-21 yo gukwirakwiza amashanyarazi cyangwa ecran ya PGL igomba kuba mucyumba cyo kugabura.Imbaraga zitangwa kuva mucyumba cyo kugabura kugeza ku dusanduku duto two gukwirakwiza muri buri cyumba cyo kubyaza umusaruro.Ibisanduku bibiri cyangwa bitatu byegeranye byegeranye birashobora gutangwa numurongo umwe wo kugabura, ariko ntibirenze bitatu.Ibikoresho by'amashanyarazi bifite ingufu nini, nk'imashini itwikiriye capsule, imashini itunganya granulation hamwe nicyuma gikonjesha, ifite ibikoresho byo gukata amashanyarazi, bishobora gukoreshwa nicyumba cyo gukwirakwiza amashanyarazi.
5. Agasanduku gato ko gukwirakwiza gashyizwe muri plaque 50mm yibyuma bizasohoka kuva kurukuta, kugirango bigere ku ngaruka zitagira umukungugu, udusanduku duto two kugabura dushyiramo urukuta rwa convex kumpande enye zo kuvura beveri.
6. Witondere imikorere yo gutwika ibikoresho byo gushariza, kandi ugerageze kugabanya ikoreshwa ryibikoresho bimwe na bimwe bya polymer synthique kugirango wirinde umwotsi mwinshi mugihe umuriro ubaye, bidakwiye guhunga abakozi.Imiyoboro y'amashanyarazi igomba gusabwa cyane, kandi imiyoboro y'ibyuma igomba gukoreshwa hashoboka aho bishoboka kugirango imirongo y'amashanyarazi idahinduka inzira yumuriro.
Ubwiza bwamahugurwa asukuye munganda zimiti ntishobora gushingira gusa kumpera yanyuma kugirango yizere.Nkimiti yibinyabuzima, imiti mito ya molekile ubushakashatsi nimbogamizi ziterambere ni byinshi, inzira yumusaruro iragoye, ireme
Igihe cyo kohereza: Ukwakira-20-2022