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KUYESA CHIPINDA CHOYERA MUYESO NDI ZAKUDYA

chipinda choyera
kapangidwe ka chipinda choyera

Kawirikawiri, kuyesa koyera m'chipinda kumaphatikizapo: kuwunika kwa malo oyera, kuyesa kuvomerezedwa ndi uinjiniya, kuphatikiza chakudya, zinthu zaumoyo, zodzoladzola, madzi a m'mabotolo, malo ochitira mkaka, malo ochitira zinthu zamagetsi, malo ochitira opaleshoni a GMP, chipinda chochitira opaleshoni kuchipatala, malo ochitira kafukufuku wa ziweto, malo ochitira kafukufuku wa chitetezo cha chilengedwe, makabati oteteza chilengedwe, mabenchi oyera, malo ochitira maphunziro opanda fumbi, malo ochitira maphunziro osawononga chilengedwe, ndi zina zotero.

Kuchuluka kwa mayeso a chipinda choyera: liwiro la mpweya ndi kuchuluka kwa mpweya, kuchuluka kwa kusintha kwa mpweya, kutentha ndi chinyezi, kusiyana kwa kuthamanga kwa mpweya, tinthu ta fumbi tomwe timapachikidwa, mabakiteriya oyandama, mabakiteriya okhazikika, phokoso, kuunikira, ndi zina zotero. Kuti mudziwe zambiri, chonde onani miyezo yoyenera yoyesera chipinda choyera.

Kuzindikira zipinda zoyera kuyenera kuzindikira bwino momwe zilili ndi anthu. Ma status osiyanasiyana amabweretsa zotsatira zosiyana zoyesa. Malinga ndi "Clean Room Design Code" (GB 50073-2001), kuyesa zipinda zoyera kumagawidwa m'magawo atatu: empty state, static state ndi dynamic state.

(1) Mkhalidwe wopanda kanthu: Malo omanga amangidwa, magetsi onse alumikizidwa ndipo akugwira ntchito, koma palibe zida zopangira, zipangizo ndi antchito.

(2) Malo okhazikika amangidwa, zida zopangira zayikidwa, ndipo zikugwira ntchito monga momwe mwiniwake ndi wogulitsa adavomerezera, koma palibe antchito opanga.

(3) Dongosolo lamphamvu limagwira ntchito m'boma linalake, lili ndi antchito enaake omwe alipo, ndipo limagwira ntchito m'boma lomwe lavomerezedwa.

1. Liwiro la mpweya, kuchuluka kwa mpweya ndi kuchuluka kwa kusintha kwa mpweya

Ukhondo wa zipinda zoyera ndi malo oyera umapezeka makamaka potumiza mpweya woyera wokwanira kuti uchotse ndikuchepetsa tinthu tating'onoting'ono tomwe timapangidwa mchipindamo. Chifukwa chake, ndikofunikira kwambiri kuyeza kuchuluka kwa mpweya, liwiro la mphepo, kufanana kwa mpweya, komwe mpweya umalowera komanso momwe zipinda zoyera kapena malo oyera zimayendera.

Kuti ntchito zoyeretsa zipinda zivomerezedwe bwino, "Clean Room Construction and Acceptance Specifications" (JGJ 71-1990) ya dziko langa ikunena momveka bwino kuti kuyesa ndi kusintha kuyenera kuchitika mu empty state kapena static state. Lamuloli likhoza kuwunika bwino momwe polojekitiyi ilili panthawi yake komanso moyenera, komanso lingapewe mikangano yokhudza kutsekedwa kwa polojekiti chifukwa cholephera kupeza zotsatira zomwe zakonzedwa.

Mu kuwunika kwenikweni, zinthu zosasinthasintha zimakhala zofala ndipo zinthu zopanda kanthu zimakhala zochepa. Chifukwa zida zina zogwirira ntchito m'chipinda choyera ziyenera kukhalapo pasadakhale. Kuyesa ukhondo kusanachitike, zida zogwirira ntchito ziyenera kupukutidwa mosamala kuti zisakhudze deta yoyesera. Malamulo omwe ali mu "Clean Room Construction and Acceptance Specifications" (GB50591-2010) omwe adakhazikitsidwa pa February 1, 2011 ndi omveka bwino: "16.1.2 Mkhalidwe wa anthu okhala m'chipinda choyera panthawi yowunikira wagawidwa motere: mayeso osinthira uinjiniya ayenera kukhala opanda kanthu, Kuyang'anira ndi kuyang'anira tsiku ndi tsiku kuti avomerezedwe pulojekiti kuyenera kukhala kopanda kanthu kapena kopanda kanthu, pomwe kuyang'anira ndi kuyang'anira kuti avomerezedwe kuyenera kukhala kosinthasintha. Ngati pakufunika, momwe akuyendera zitha kudziwikiranso kudzera mu zokambirana pakati pa womanga (wogwiritsa ntchito) ndi gulu loyang'anira."

Kuyenda kwa mpweya kolunjika kumadalira kwambiri mpweya woyera kuti ukankhire ndikuchotsa mpweya wodetsedwa m'chipinda ndi malo kuti chipinda ndi malo azikhala oyera. Chifukwa chake, liwiro la mphepo ndi kufanana kwa mpweya ndi zinthu zofunika kwambiri zomwe zimakhudza ukhondo. Kuthamanga kwa mphepo kokwera komanso kofanana kumatha kuchotsa zinthu zodetsa zomwe zimapangidwa ndi njira zamkati mwachangu komanso moyenera, kotero ndi zinthu zoyesera chipinda choyera zomwe timayang'ana kwambiri.

Kuyenda kosalunjika mbali imodzi kumadalira kwambiri mpweya woyera womwe ukubwera kuti uchepetse ndikuchepetsa zodetsa zomwe zili mchipindamo ndi malo kuti ukhalebe waukhondo. Zotsatira zake zikusonyeza kuti kuchuluka kwa mpweya kumasintha komanso kayendedwe ka mpweya koyenera, kumachepetsanso kumakhala bwino. Chifukwa chake, kuchuluka kwa mpweya ndi kusintha kwa mpweya kofanana m'zipinda zoyera zoyenda mbali imodzi ndi malo oyera ndi zinthu zoyesera kuyenda kwa mpweya zomwe zakopa chidwi cha anthu ambiri.

2. Kutentha ndi chinyezi

Kuyeza kutentha ndi chinyezi m'zipinda zoyera kapena malo ochitira masewera oyera nthawi zambiri kumatha kugawidwa m'magawo awiri: mayeso wamba ndi mayeso athunthu. Mayeso ovomereza kumaliza mu state yopanda kanthu ndi oyenera giredi yotsatira; mayeso athunthu a magwiridwe antchito mu static kapena dynamic state ndi oyenera giredi yotsatira. Mayeso amtunduwu ndi oyenera nthawi zomwe zimakhala ndi zofunikira kwambiri pa kutentha ndi chinyezi.

Kuyesa kumeneku kumachitika pambuyo pa mayeso ofanana a kayendedwe ka mpweya ndi kusintha kwa makina oziziritsira mpweya. Munthawi yoyeserayi, makina oziziritsira mpweya adagwira ntchito bwino ndipo zinthu zosiyanasiyana zakhazikika. Ndikofunikira kuyika sensa ya chinyezi m'dera lililonse lolamulira chinyezi, ndikupatsa sensa nthawi yokwanira yokhazikika. Muyeso uyenera kukhala woyenera kugwiritsidwa ntchito mpaka sensa itakhazikika musanayambe kuyeza. Nthawi yoyezera iyenera kukhala yoposa mphindi 5. 

3. Kusiyana kwa kuthamanga

Kuyesa kwamtunduwu ndiko kutsimikizira kuthekera kosunga kusiyana kwa kuthamanga pakati pa malo omalizidwa ndi malo ozungulira, komanso pakati pa malo aliwonse omwe ali m'chipindacho. Kuzindikira kumeneku kumagwira ntchito m'malo onse atatu okhalamo. Kuyesa kumeneku n'kofunika kwambiri. Kuzindikira kusiyana kwa kuthamanga kuyenera kuchitika ndi zitseko zonse zotsekedwa, kuyambira ku kuthamanga kwambiri mpaka ku kuthamanga kochepa, kuyambira chipinda chamkati chomwe chili kutali ndi kunja malinga ndi kapangidwe kake, kenako kuyesa kunja motsatizana. Zipinda zoyera zamitundu yosiyanasiyana zokhala ndi mabowo olumikizidwa zimakhala ndi malangizo oyenera a mpweya pakhomo.

Zofunikira pakuyesa kusiyana kwa kuthamanga:

(1) Zitseko zonse zomwe zili pamalo oyera ziyenera kutsekedwa, kusiyana kwa kuthamanga kwa mpweya kumayesedwa.

(2) Mu chipinda choyera, pitirizani motsatira dongosolo kuyambira paukhondo wapamwamba mpaka wotsika mpaka chipinda chomwe chili ndi njira yolowera mwachindunji kunja chizindikirike.

(3) Ngati palibe mpweya m'chipindamo, pakamwa pa chubu choyezera payenera kuyikidwa pamalo aliwonse, ndipo pamwamba pa pakamwa pa chubu choyezera payenera kukhala molingana ndi kulondola kwa mpweya.

(4) Deta yoyezedwa ndi yolembedwa iyenera kukhala yolondola mpaka 1.0Pa.

Njira zodziwira kusiyana kwa kuthamanga kwa magazi:

(1) Tsekani zitseko zonse.

(2) Gwiritsani ntchito choyezera kuthamanga kwa mpweya kuti muyese kusiyana kwa kuthamanga kwa mpweya pakati pa chipinda chilichonse choyera, pakati pa makonde oyera a chipinda, komanso pakati pa konde ndi dziko lakunja.

(3) Deta yonse iyenera kulembedwa.

Zofunikira pa muyezo wa kusiyana kwa kuthamanga:

(1) Kusiyana kwa mphamvu yosasunthika pakati pa zipinda zoyera kapena madera oyera a milingo yosiyanasiyana ndi zipinda zosayera (madera) kuyenera kukhala kopitilira 5Pa.

(2) Kusiyana kwa mphamvu yosasunthika pakati pa chipinda choyera (malo) ndi chakunja kumafunika kupitirira 10Pa.

(3) Pa zipinda zoyera zoyenda mbali imodzi zokhala ndi mpweya wochepa kuposa ISO 5 (Class 100), chitseko chikatsegulidwa, kuchuluka kwa fumbi pamalo ogwirira ntchito mkati mwa chitseko kuyenera kukhala kochepera kuposa malire a kuchuluka kwa fumbi la mulingo woyenera.

(4) Ngati zofunikira zomwe zili pamwambapa sizikukwaniritsidwa, kuchuluka kwa mpweya wabwino ndi kuchuluka kwa mpweya wotulutsa ziyenera kusinthidwa mpaka zitakwanira.

4. Tinthu tomwe timapachikidwa

(1) Oyesa m'nyumba ayenera kuvala zovala zoyera ndipo ayenera kukhala ochepa kuposa anthu awiri. Ayenera kukhala kumbali ya mphepo yamkuntho ya malo oyesera komanso kutali ndi malo oyesera. Ayenera kusuntha pang'ono akamasintha malo kuti apewe kusokoneza antchito pa ukhondo wa m'nyumba.

(2) Zipangizozi ziyenera kugwiritsidwa ntchito mkati mwa nthawi yowerengera.

(3) Zipangizo ziyenera kutsukidwa musanayesedwe komanso mutayesa.

(4) Mu dera loyenda molunjika mbali imodzi, choyezera zitsanzo chosankhidwa chiyenera kukhala pafupi ndi chitsanzo chosinthasintha, ndipo kupotoka kwa liwiro la mpweya kulowa mu choyezera zitsanzo ndi liwiro la mpweya lomwe likuyesedwa kuyenera kukhala kochepera 20%. Ngati izi sizichitika, choyezera zitsanzo chiyenera kuyang'ana mbali yaikulu ya kayendedwe ka mpweya. Pamalo oyezera zotsatira za kayendedwe ka mpweya osalunjika mbali imodzi, choyezera zitsanzo chiyenera kukhala choyimirira mmwamba.

(5) Chitoliro cholumikizira kuchokera ku doko losankhira zitsanzo kupita ku sensa yotsutsana ndi fumbi chiyenera kukhala chachifupi momwe zingathere.

5. Mabakiteriya oyandama

Chiwerengero cha malo otsika oyesera zitsanzo chikugwirizana ndi chiwerengero cha malo oyesera tinthu tomwe tapachikidwa. Malo oyesera pamalo ogwirira ntchito ali pafupifupi 0.8-1.2m kuchokera pansi. Malo oyesera pamalo operekera mpweya ali pafupifupi 30cm kutali ndi pamwamba pa malo operekera mpweya. Malo oyesera akhoza kuwonjezedwa pazida zofunika kapena pazigawo zofunikira zogwirira ntchito. , malo aliwonse oyesera zitsanzo nthawi zambiri amayesedwa kamodzi.

6. Mabakiteriya okhazikika

Gwirani ntchito pa mtunda wa 0.8-1.2m kuchokera pansi. Ikani mbale ya Petri yokonzedwa pamalo oyesera. Tsegulani chivundikiro cha mbale ya Petri. Pambuyo pa nthawi yomwe yatchulidwa, phimbaninso mbale ya Petri. Ikani mbale ya Petri mu chosungiramo kutentha kosasintha kuti mulimidwe. Nthawi yofunikira kwa maola opitilira 48, gulu lililonse liyenera kuyesedwa kuti liwone ngati pali kuipitsidwa kwa malo osungiramo mbewu.

7. Phokoso

Ngati kutalika kwa muyeso kuli pafupifupi mamita 1.2 kuchokera pansi ndipo malo a chipinda choyera ali mkati mwa mamita 15, mfundo imodzi yokha pakati pa chipindacho ingayesedwe; ngati malowo ali oposa mamita 15, mfundo zinayi zopingasa ziyeneranso kuyezedwa, mfundo imodzi kuchokera pakhoma lam'mbali, mfundo zoyezera zikuyang'ana ngodya iliyonse.

8. Kuunikira

Malo oyezera ali pamtunda wa mamita 0.8 kuchokera pansi, ndipo malo oyezera ali pamtunda wa mamita awiri. Pa zipinda zomwe zili mkati mwa mamita 30, malo oyezera ali pamtunda wa mamita 0.5 kuchokera pakhoma lam'mbali. Pa zipinda zazikulu kuposa mamita 30, malo oyezera ali pamtunda wa mita imodzi kuchokera pakhoma.


Nthawi yotumizidwa: Sep-14-2023