Biopharmaceuticals inoreva mishonga inogadzirwa pachishandiswa biotechnology, senge biological gadziriro, biological products, biological drugs, etc. Sezvo kuchena, kuita uye kugadzikana kwechigadzirwa kuchida kuve nechokwadi panguva yekugadzirwa kwebiopharmaceuticals, yakachena kamuri tekinoroji inoda kushandiswa mukugadzira. nzira yekuvimbisa kunaka kwechigadzirwa uye kuchengeteka.Dhizaini, kuvaka uye kushanda kweiyo biopharmaceutical GMP yakachena kamuri inoda kuteedzerwa kwakasimba neGMP zvakatemwa, kusanganisira kutonga kwemukamuri yakachena kuchena kwemhepo, tembiricha, hunyoro, mutsauko wekumanikidza uye mamwe ma paramita, pamwe nekutonga kwevashandi, zvishandiso, zvinhu uye marara. muimba yakachena.Panguva imwecheteyo, matekinoroji emakamuri akachena epamberi nemidziyo, senge hepa sefa, shawa yemhepo, bhenji rakachena, nezvimwe zvinodikanwa kuve nechokwadi chekuti mhando yemhepo uye hutachiona hwehutachiona mukamuri yakachena zvinosangana nezvinodiwa.
Dhizaini yegmp yemishonga yakachena kamuri
1. Yakachena kamuri dhizaini haigone kusangana nezvinodiwa chaizvo zvekugadzira.Kune mapurojekiti matsva emakamuri akachena kana mapurojekiti akakura akachena ekugadzirisa makamuri, varidzi vanowanzohaya masangano edhizaini ekugadzira.Pamapurojekiti emakamuri madiki uye epakati nepakati, tichifunga nezve mutengo, Muridzi anowanzo kusaina kondirakiti nekambani yeinjiniya, uye kambani yeinjiniya ichava nebasa rekugadzira.
2. Kuvhiringa chinangwa chekuyedzwa kwekamuri yakachena, kuyedza kuita kwekamuri yakachena uye basa rekuongorora inhanho inodiwa kuti uone kana zvinodiwa zvekugadzira zvazadzikiswa (yekubvunzurudza bvunzo) uye kuve nechokwadi chenguva yekushanda yekamuri yakachena (yenguva dzose kuyedza) apo kuvakwa kwekamuri rakachena kunopedzwa.Muedzo wekugamuchirwa unosanganisira matanho maviri: kupedzisa kutumwa uye kuongororwa kwakadzama kwekuita kwekamuri yakachena kuita kwemukati.
3. Matambudziko mukushanda kwekamuri yakachena
①Hunhu hwemhepo hausi kusvika pachiyero
②Kushanda kwevashandi kusiri nguva
③Kugadziriswa kwemidziyo hakuna nguva
④Kucheneswa kusina kukwana
⑤Kurasa tsvina zvisina kunaka
⑥Kupesvedzera kwezvakatipoteredza zvinhu
Pane akati wandei akakosha ma paramita ekuteerera kana uchigadzira GMP yemishonga yakachena imba.
1. Kuchena kwemhepo
Dambudziko rekuti unganyatso sarudza sei ma parameter mumusangano wezvigadzirwa zvemhizha.Zvinoenderana neakasiyana zvigadzirwa zvekugadzira, maitiro ekusarudza nemazvo dhizaini paramita inyaya yakakosha mukugadzira.GMP inoisa pamberi zvakakosha zviratidzo, kureva, mazinga ehutsanana hwemhepo.Tafura inotevera inoratidza huwandu hwehutsanana hwemhepo hwakatsanangurwa munyika yangu 1998 GMP: Panguva imwecheteyo, WHO (World Health Organisation) neEU (European Union) zvese zvine zvinodiwa zvakasiyana zvehutsanana..Aya mazinga ari pamusoro akanyatsoratidza nhamba, saizi, uye mamiriro ezvimedu.
Zvinogona kuonekwa kuti kuchena kwehupfu hwepamusoro hwakaderera, uye hutsanana hwehupfu hwehupfu hwakaderera hwakakwirira.Mhepo yehutsanana nhanho ndiyo yakakosha chiratidzo chekuongorora yakachena mhepo nharaunda.Semuenzaniso, iyo 300,000-level standard inobva kune nyowani yekurongedza yakapihwa neMedical Bureau.Parizvino haina kufanira kushandiswa mumutambo mukuru wechigadzirwa, asi inoshanda zvakanaka kana ichishandiswa mune mamwe makamuri ekubatsira.
2. Kutsinhana kwemhepo
Huwandu hwekuchinja kwemhepo mune yakajairika air-conditioning system ingori kasere kusvika gumi paawa, nepo huwandu hwekuchinja kwemhepo mukamuri yakachena yeindasitiri ka12 padanho rakaderera uye mazana akati wandei padanho repamusoro.Zviripachena, mutsauko wehuwandu hwekuchinja kwemhepo unokonzera huwandu hwemhepo Musiyano mukuru mukushandiswa kwesimba.Mukugadzira, pahwaro hwekumisikidzwa kwakaringana kwehutsanana, nguva dzakakwana dzekutsinhana kwemhepo dzinofanirwa kuve nechokwadi.Zvikasadaro, mhedzisiro yekuvhiya haizove yakaenzana, kugona kwekamuri yakachena yekudzivirira kupindira kuchave kwakashata, kugona kwekuzvinatsa kuchawedzerwa zvakafanana, uye nhevedzano yezvinetso ichapfuura zvakawanikwa.
3. Static pressure musiyano
Pane zvakatevedzana zvinodiwa senge chinhambwe pakati pemakamuri akachena emazinga akasiyana uye asina-akachena makamuri haagone kuve asingasviki 5Pa, uye chinhambwe pakati pemakamuri akachena uye kunze hachigone kuve pasi pe10Pa.Iyo nzira yekudzora iyo static pressure mutsauko ndeyekunyanya kupa imwe yakanaka yekumanikidza mweya vhoriyamu.Iyo yakanaka yekumanikidza midziyo inowanzoshandiswa mukugadzira mavharuvhu anosara, anosiyanisa kumanikidza emagetsi emhepo vhoriyamu regulators uye mhepo inonyorovesa maseru akaiswa painodzoka mhepo.Mumakore achangopfuura, nzira yekusaisa yakanaka yekumanikidza mudziyo asi ichiita kuti mhepo yekugovera vhoriyamu ive yakakura kupfuura yekudzoka mhepo vhoriyamu uye kupera kwemhepo vhoriyamu panguva yekutanga yekumisikidzwa inowanzo shandiswa mukugadzira, uye inoenderana otomatiki control system inogona zvakare kuwana zvakafanana maitiro.
4. Sangano remhepo
Maitiro ekufambisa kwemhepo yekamuri yakachena chinhu chakakosha pakuita kuti pave nehutsanana.Iyo fomu yesangano rekuyerera kwemhepo inowanzo gamuchirwa mune yazvino dhizaini inotarwa zvichienderana nehutsanana.Semuyenzaniso, kirasi 300,000 yakachena kamuri inowanzoshandisa yepamusoro-yekudya uye yepamusoro-inodzosa mhepo, kirasi 100000 uye kirasi 10000 yekuchenesa dhizaini inowanzo shandisa yekumusoro-kurutivi mhepo inoyerera uye yakaderera-parutivi kudzoka kwemhepo, uye yepamusoro-yepamusoro-inochenesa makamuri anoshandisa yakachinjika kana yakatwasuka unidirectional kuyerera. .
5. Tembiricha uye mwando
Kuwedzera kune yakakosha tekinoroji, kubva pakuona kwekudziya, kufefetedza uye mhepo yekumisikidza, inonyanya kuchengetedza mushandisi kunyaradza, ndiko kuti, tembiricha yakakodzera uye humidity.Pamusoro pezvo, kune akati wandei zviratidzo zvinofanirwa kukwezva kutarisa kwedu, senge muchinjika-chikamu mhepo kumhanya kweiyo tuyere duct, ruzha, muchinjika-chikamu mhepo kumhanya kweiyo tuyere duct, ruzha, kuvhenekera, uye chiyero chemhepo nyowani, etc. Izvi zvinhu hazvigone kufuratirwa mukugadzira.funga.
Biopharmaceutical yakachena kamuri dhizaini
Biological clean rooms anonyanya kukamurwa kuita mapoka maviri;general biological yakachena makamuri uye biological kuchengetedza akachena makamuri.HVAC mainjiniya madhizaini anowanzo kuoneswa kune yekare, ayo anonyanya kudzora kusvibiswa kweanoshanda nezvikamu zvipenyu.Kusvika kumwero, ikamuri rakachena reindasitiri rinowedzera maitiro ekuita sterilization.Kumakamuri akachena maindasitiri, mukugadzirwa kwehunyanzvi kweHVAC system, nzira yakakosha yekudzora nhanho yehutsanana ndeyekusefa uye kudzvanywa kwakanaka.Kumakamuri akachena ebhayoloji, pamusoro pekushandisa nzira dzakafanana nemakamuri akachena maindasitiri, zvinodikanwawo kufunga nezvekuchengetedzwa kwebiology.Dzimwe nguva zvakakosha kushandisa dzvinyiriro isina kunaka kudzivirira zvigadzirwa kubva pakusvibisa nharaunda.
Nguva yekutumira: Zvita-25-2023