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GMP PHARMACEUTICAL CLEAN ROOM HVAC SYSTEM KUSANKHA NDI KUPANGA

chipinda choyera
gmp chipinda choyera

Pokongoletsa chipinda choyera chamankhwala cha GMP, dongosolo la HVAC ndilofunika kwambiri. Titha kunena kuti ngati kuwongolera kwachilengedwe mchipinda choyera kumatha kukwaniritsa zofunikira makamaka zimadalira dongosolo la HVAC. Dongosolo la Heating ventilation and air conditioning (HVAC) limatchedwanso purification air conditioning system mu pharmaceutical GMP clean room. Dongosolo la HVAC makamaka limayendetsa mpweya wolowa m'chipinda ndikuwongolera kutentha kwa mpweya, chinyezi, tinthu tating'onoting'ono, tizilombo tating'onoting'ono, kusiyana kwapakatikati ndi zizindikiro zina za malo opangira mankhwala kuti zitsimikizire kuti magawo achilengedwe amakwaniritsa zofunikira zamtundu wamankhwala ndikupewa kuchitika kwa kuipitsidwa kwa mpweya ndi kuipitsidwa kwapakati pomwe akupereka malo abwino kwa ogwira ntchito. Kuphatikiza apo, makina a HVAC oyeretsa m'chipinda chamankhwala amathanso kuchepetsa ndikuletsa zotsatira zoyipa za mankhwala kwa anthu panthawi yopanga, ndikuteteza chilengedwe.

Mapangidwe onse a makina oyeretsera mpweya

Chigawo chonse cha makina oyeretsera mpweya ndi zigawo zake ziyenera kupangidwa molingana ndi zofunikira za chilengedwe. Chigawochi chimaphatikizapo zigawo zogwira ntchito monga kutentha, kuzizira, humidification, dehumidification, ndi kusefera. Zigawo zina zimaphatikizapo mafani otulutsa mpweya, mafani obwezeretsa mpweya, machitidwe obwezeretsa mphamvu za kutentha, ndi zina zotero. Pasakhale zinthu zogwera mkati mwa dongosolo la HVAC, ndipo mipata iyenera kukhala yaying'ono momwe zingathere kuti zisawonongeke fumbi. Makina a HVAC akuyenera kukhala osavuta kuyeretsa ndi kupirira pakufunika kufukiza ndi kupha tizilombo toyambitsa matenda.

1. Mtundu wa dongosolo la HVAC

Makina oyeretsera mpweya amatha kugawidwa m'makina owongolera mpweya a DC ndi makina owongolera mpweya. Dongosolo lamagetsi la DC limatumiza mpweya wakunja womwe umatha kukwaniritsa zofunikira m'chipinda, kenako ndikutulutsa mpweya wonse. Dongosololi limagwiritsa ntchito mpweya wabwino wakunja. Recirculation air conditioning system, ndiko kuti, mpweya wabwino wa chipindacho umasakanizidwa ndi gawo la mpweya wabwino wakunja ndi gawo la mpweya wobwerera kuchokera ku chipinda choyera. Popeza makina obwezeretsanso mpweya ali ndi zabwino zake zotsika mtengo zoyambira komanso zotsika mtengo, makina owongolera mpweya ayenera kugwiritsidwa ntchito moyenera momwe angathere popanga makina owongolera mpweya. Mpweya womwe uli m'malo ena apadera opangira zinthu sungathe kubwezeretsedwanso, monga chipinda choyera (malo) pomwe fumbi limatuluka panthawi yopanga, ndipo kuipitsidwa kwapakatikati sikungapewedwe ngati mpweya wamkati ukuthandizidwa; zosungunulira organic amagwiritsidwa ntchito popanga, ndipo kudzikundikira mpweya kungayambitse kuphulika kapena moto ndi njira zoopsa; malo opangira tizilombo toyambitsa matenda; madera opanga mankhwala a radioactive; njira zopangira zomwe zimapanga kuchuluka kwa zinthu zovulaza, zonunkhiza kapena mpweya wosakhazikika panthawi yopanga.

Malo opangira mankhwala amatha kugawidwa m'malo angapo okhala ndi ukhondo wosiyanasiyana. Malo osiyanasiyana aukhondo ayenera kukhala ndi mayunitsi odziyimira pawokha. Dongosolo lililonse lowongolera mpweya limasiyanitsidwa ndi thupi kuti lipewe kuipitsidwa pakati pa zinthu. Zodziyimira pawokha mpweya akugwira mayunitsi Angagwiritsidwenso ntchito m'madera osiyanasiyana mankhwala kapena osiyana madera kudzipatula zinthu zoipa kudzera okhwima mpweya kusefera ndi kuteteza mtanda kuipitsidwa kudzera dongosolo mpweya ngalande, monga madera kupanga, madera owonjezera kupanga, malo osungira, madera utsogoleri, etc. ayenera kukhala okonzeka ndi osiyana mpweya chochitira unit. Kwa madera opangira omwe ali ndi masinthidwe osiyanasiyana ogwirira ntchito kapena nthawi yogwiritsira ntchito komanso kusiyana kwakukulu kwa kutentha ndi zofunikira zowongolera chinyezi, makina oziziritsira mpweya ayeneranso kukhazikitsidwa padera.

2. Ntchito ndi miyeso

(1). Kutentha ndi kuziziritsa

Malo opangira zinthu ayenera kusinthidwa kuti agwirizane ndi zofunikira zopangira. Ngati palibe zofunikira zapadera zopangira mankhwala, kutentha kwa Class C ndi zipinda zoyera za Class D zimatha kuyendetsedwa pa 18 ~ 26 ° C, ndipo kutentha kwa zipinda zoyera za Class A ndi Class B zimatha kuyendetsedwa pa 20 ~ 24 ° C. M'chipinda chaukhondo chowongolera mpweya, zowotcha zotentha ndi zoziziritsa zokhala ndi zipsepse zotengera kutentha, kutentha kwamagetsi a tubular, ndi zina zotere zitha kugwiritsidwa ntchito kutenthetsa ndi kuziziritsa mpweya, ndikuwongolera mpweya ku kutentha komwe kumafunika ndi chipinda choyera. Mpweya wabwino ukakhala waukulu, kutenthetsa mpweya wabwino usanayambike kuyenera kuganiziridwa kuti tipewe kuzizira kozizira kwa mtsinje. Kapena gwiritsani ntchito zosungunulira zotentha ndi zozizira, monga madzi otentha ndi ozizira, nthunzi yodzaza, ethylene glycol, mafiriji osiyanasiyana, ndi zina zotero.

(2). Humidification ndi dehumidification

Chinyezi cham'chipinda choyera chiyenera kukhala chogwirizana ndi zofunikira za kupanga mankhwala, komanso malo opangira mankhwala ndi chitonthozo cha ogwira ntchito ziyenera kutsimikiziridwa. Ngati palibe zofunikira zapadera pakupanga mankhwala, chinyezi chachifupi cha malo oyera a M'kalasi C ndi M'kalasi D chimayendetsedwa pa 45% mpaka 65%, ndipo chinyezi chachifupi cha madera oyera a Gulu A ndi Gulu B chimayendetsedwa pa 45% mpaka 60%.

Zopangidwa ndi ufa wosabala kapena zokometsera zolimba zimafunikira malo opangira chinyezi chochepa. Ma dehumidifiers ndi post-coolers amatha kuganiziridwa kuti achepetse chinyezi. Chifukwa cha kuchuluka kwa ndalama komanso ndalama zogwirira ntchito, kutentha kwa mame kumafunika kutsika kuposa 5°C. Malo opangirako omwe ali ndi chinyezi chambiri amatha kusamalidwa pogwiritsa ntchito nthunzi ya fakitale, nthunzi yoyera yokonzedwa kuchokera kumadzi oyeretsedwa, kapena kudzera mu chonyowa cha nthunzi. Pamene chipinda chaukhondo chili ndi chinyezi chocheperako, mpweya wakunja m'chilimwe uyenera kuziziritsidwa ndi choziziritsa ndikutenthetsa ndi chotenthetsera kuti usinthe chinyezi. Ngati magetsi osasunthika a m'nyumba akufunika kuwongoleredwa, chinyezi chiyenera kuganiziridwa kumalo ozizira kapena owuma.

(3). Sefa

Chiwerengero cha particles fumbi ndi tizilombo mu mpweya wabwino ndi kubwerera mpweya akhoza kuchepetsedwa kukhala osachepera kudzera zosefera mu HVAC dongosolo, kulola malo kupanga kukwaniritsa zofunika ukhondo wamba. M'makina oyeretsera mpweya, kusefera kwa mpweya nthawi zambiri kumagawidwa m'magawo atatu: kusefa kusanachitike, kusefera kwapakati ndi kusefera kwa hepa. Gawo lirilonse limagwiritsa ntchito zosefera zazinthu zosiyanasiyana. Chosefera ndichotsika kwambiri ndipo chimayikidwa kumayambiriro kwa gawo lothandizira mpweya. Imatha kugwira tinthu tokulirapo mumlengalenga (kukula kwa tinthu pamwamba pa ma microns atatu). Kusefedwa kwapakatikati kumakhala pansi pa fyuluta ya pre-filter ndipo imayikidwa pakati pa makina oyendetsa mpweya kumene mpweya wobwerera umalowa. Amagwiritsidwa ntchito kujambula tinthu tating'onoting'ono (kukula kwa tinthu pamwamba pa 0,3 microns). Sefa yomaliza imakhala mu gawo lotulutsa mpweya, lomwe limatha kusunga payipi kukhala laukhondo ndikukulitsa moyo wautumiki wa fyuluta ya terminal.

Chipinda chaukhondo chikakhala chapamwamba, fyuluta ya hepa imayikidwa pansi pa kusefera komaliza ngati chipangizo chosefera. Chipangizo chojambulira ma terminal chili kumapeto kwa chogwirira cha mpweya ndipo chimayikidwa padenga kapena khoma la chipindacho. Itha kuwonetsetsa kuti mpweya waukhondo ukupezeka ndipo umagwiritsidwa ntchito kusungunula kapena kutumiza tinthu tating'onoting'ono tomwe timatuluka m'chipinda choyera, monga chipinda choyera cha Gulu B kapena Gulu A m'chipinda cha B choyera.

(4).Kuwongolera kuthamanga

Zipinda zoyera kwambiri zimakhala ndi mphamvu zabwino, pomwe chipinda cholowera kuchipinda choyerachi chimakhala ndi zitseko zotsika motsatizana, mpaka ziro zoyambira malo osalamulirika (nyumba zonse). Kusiyanitsa kwapakati pakati pa malo oyera ndi malo osayera komanso pakati pa malo oyera a magawo osiyanasiyana sayenera kukhala osachepera 10 Pa. Pakafunika, ma gradients oyenerera ayenera kusungidwa pakati pa madera osiyanasiyana ogwira ntchito (zipinda zogwirira ntchito) za ukhondo womwewo. Kuthamanga kwabwino kosungidwa m'chipinda choyera kumatha kutheka ndi kuchuluka kwa mpweya kukhala wamkulu kuposa kuchuluka kwa mpweya wotulutsa mpweya. Kusintha mphamvu ya mpweya kumatha kusintha kusiyana kwapakati pakati pa chipinda chilichonse. Kupanga mankhwala apadera, monga mankhwala a penicillin, malo opangira opaleshoni omwe amatulutsa fumbi lambiri ayenera kukhalabe ndi kukakamiza koyipa.

chipinda choyera chamankhwala
mpweya wogwira unit

Nthawi yotumiza: Dec-19-2023
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