Ikimenyetso cyuzuye cyikoranabuhanga kisukuye nicyo dusanzwe twita icyumba gisukuye cyuruganda rusukuye, mugihe cyicyumba cyinganda cyicyumba cyibinyabuzima, mugihe cyicyumba cyinganda cyicyumba cya farumasi nukuyobora umutekano winganda, kibera neza umutekano n'ubwiza bw'imiti. Muburyo bwo gushushanya, kubaka no gukora ibyumba bisukuye mumiterere yimiti, ibipimo byibyumba bisukuye nibisabwa byihariye imicungire yimiti ya farumasi igomba gukurikizwa. Ibikurikira, tuzavuga kubyerekeye icyumba cyicyumba gisukuye cyuruganda rusukuye cya farumasi hakurikijwe amabwiriza yimbere mu nganda z'imiti ", duhuza uburambe bwo guturika mu nganda z'imiti"

Igishushanyo mbonera cy'inganda
Mubyumba bisukuye mu nganda, ibihingwa bya farumasi nubuhanga busanzwe duhura nabyo. Ukurikije ibisabwa mubyumba bisukuye, hari ibipimo byinshi byingenzi bigomba kwitabwaho.

1.. Isuku
Ikibazo cyuburyo bwo guhitamo neza ibipimo mubitabo byibicuruzwa. Ukurikije ibicuruzwa bitandukanye byikoranabuhanga, uburyo bwo guhitamo ibishushanyo mbonera nibyo ikibazo cyibanze mubishushanyo. Ikimenyetso cyingenzi gisabwa muri GMP, ni ukuvuga, urwego rwisuku rwisuku. Urwego rwisuku rwindege nicyerekezo cyibanze cyo gusuzuma ikirere. Niba urwego rwisuku rwikirere rutari rwo, ibintu by'amafarashi binini bikurura igare rito bizagaragara, bidafite ubukungu cyangwa kuzigama. Kurugero, ibisobanuro bishya byo gupakira byiciro 300.000-urwego rudakwiriye kubikoresha muburyo nyamukuru bwibicuruzwa kuri ubu, ariko bikaba ari byiza cyane mubyumba bifasha.

Kubwibyo, guhitamo urwego rufitanye isano itaziguye nubwiza nubukungu bwibicuruzwa. Inkomoko y'ivumbi igira ingaruka ku isuku ahanini biva mu mukungugu wibintu mubikorwa byo kumusaruro, urujya n'uruza rw'abakora n'umukungugu wo mu kirere hamwe n'umwuka w'ikirere wazanywe n'umwuka mwiza wo hanze. Usibye gukoresha ibikoresho byafunzwe no gukuraho umukungugu kubikoresho bitanga ivumbi, uburyo bukora bwo kugenzura umukungugu winjiye mucyumba nugukoresha imikorere mishya yo gusubiza ikirere hamwe nicyumba cyo kwiyuhagira.

2. Igipimo cy'ivunjisha
Mubisanzwe, umubare wimpinduka zo mu kirere muri sisitemu yo guhuza ikirere ni inshuro 8 kugeza 10 kumasaha, mugihe urwego rwo hasi rwimpinduka zumuyaga mucyumba cyiza cyinganda ni inshuro 12. Biragaragara, itandukaniro mu mukino wo kungurana ikirere ritera itandukaniro rikomeye mu mbuto zo mu kirere no gukoresha ingufu.in Igishushanyo mbonera, ni ngombwa ko ibihe byiza byo guhumeka. Bitabaye ibyo, ibibazo by'ibibazo bishobora kugaragara, nk'ibikorwa bivuye ku bushobozi bwo kurwanya ihohoterwa rikennye.

3. Itandukaniro ryikibazo gihamye
Itandukaniro ry'umuvuduko hagati y'ibyumba bisukuye n'ibyumba bitasukuye mu nzego zitandukanye ntibigomba kuba munsi ya 5PA, hamwe n'umuvuduko hagati y'ibyumba byo gusukura no mu byumba byo hanze ntibishobora kuba munsi ya 10PA. Uburyo bwo kugenzura itandukaniro ryumuvuduko uhagaze ni ugutanga cyane cyane umuvuduko mwiza. Ibikoresho byiza byingutu bikoreshwa mugushushanya ni valve isigaye, igitutu gitandukanye nigitabo cyashyizwe ahagaragara hamwe nimpande zikirere zashyizwe mu kirere cyo gusubiza ikirere. Mu myaka yashize, akenshi byemejwe muburyo bwo gutanga ikirere bunini kuruta kugaruka kw'ikirere hamwe nubunini bwikirere bwikirere butagira umuvuduko wibikorwa, hamwe na sisitemu yo kugenzura byikora irashobora kugera ku ngaruka imwe.

4. Isaranganya ry'ikirere
Imiterere yo gukwirakwiza ikirere ni ikintu cyingenzi kugirango habeho isuku. Ifishi yo gukwirakwiza ikirere akenshi yemejwe muburyo buteganijwe bugenwa hakurikijwe urwego rwisuku. Kurugero, icyumba cya 300.000-cyiciro cyakunze kohereza hejuru-yohereze hamwe nuburyo bwo hejuru, ibyumba bisukuye. Ibyumba bisukuye

5. Ubushyuhe n'ubushuhe
Usibye inzira zidasanzwe, ukurikije uko gushyushya, guhumeka no guhumeka no guhumeka cyane cyane kugirango bikomeze guhumurizwa nabakora, ni ukuvuga, ubushyuhe bukwiye nubushuhe bukwiye nubushuhe. Byongeye kandi, hari ibipimo byinshi byagombye kubyutsa, nkumuvuduko wumuyaga wambukiranya umwuka, urusaku, ihindagurika nigipimo cyijwi ryikirere gishya nibindi, byose ntibishobora kwirengagizwa mubishushanyo.

Igishushanyo mbonera
Ibyumba bisukuye bigabanywa cyane mubyiciro bibiri; Ibyumba rusange bikomoka kubinyabuzima hamwe nibinyabuzima bifite umutekano. Kubyumba bisukuye mu nganda, mu gishushanyo mbonera cy'umwuga cyo gushyushya, guhumeka no guhumeka no guhumeka, uburyo bw'ingenzi bwo kugenzura urwego rw'isuku runyuze mu kayira no gukangurira iciza. For biological clean rooms, in addition to using the same methods as industrial clean rooms, it also should be considered from the perspective of biological safety，and sometimes it is necessary to use negative pressure means to prevent the pollution of the product to the environment.
Igikorwa cyibyago byagize ingaruka kumusaruro mwinshi bigira uruhare mubikorwa byumusaruro wibicuruzwa byakazi, hamwe na sisitemu yo kweza ikirere nibindi bikoresho bigomba no kubahiriza ibisabwa byihariye. Itandukaniro riri hagati yicyumba cyiza cya biosaftef cyerekana nicyumba cyiza ni ukureba ko agace k'imikorere gakomeza leta mbi. Nubwo urwego rwumusaruro nkubu ruri hejuru cyane, ruzaba rufite urwego rwo hejuru rwa biohazard. Ku bijyanye n'ingaruka z'ibinyabuzima, hari ibipimo ngenderwaho mu Bushinwa, WTO n'ibindi bihugu byo ku isi. Mubisanzwe, ingamba zemejwe ni kwigunga kwa kabiri. Ubwa mbere, pathogen yigunze kubakoresha na agasanduku k'umutekano cyangwa agasanduku k'imubazi, ahanini ni inzitizi yo gukumira imishinga iteje akaga. Kwigunga kwa kabiri bivuga kwigunga kwa laboratoire cyangwa agace kakazi uhereye hanze kubihindura ahantu hatashye 30pa ~ 10 10PA mu nzu, no gushyiraho akantu gato ka kaffer hagati y'ahantu hegereye utunganijwe.

Shanghai iven buri gihe ashimangira imbaraga nyinshi kandi yubahiriza ibipimo byose mugihe ufasha abakiriya kubaka impumuro. Nkisosiyete ifite uburambe bwimyaka myinshi mugutanga ubuhanga bwimiti, iven ifite uburambe bwamagana mubufatanye mpuzamahanga ku isi. Umushinga wose wa Shanghai Iven urimo uhuza EU Gmp / US FDA GMP, GMP, pic / s gmp nandi mahame asanzwe. Usibye guha abakiriya serivisi nziza, iven kandi yubahiriza igitekerezo cyo "gutanga ubuzima kubantu".

Shanghai iven ategereje gukorana nawe.