Chii chinonzi imba yakachena?
Makamuri akachena, anozivikanwawo semakamuri asina guruva, anowanzo shandiswa sechikamu chehunyanzvi hwekugadzira maindasitiri kana tsvagiridzo yesainzi, kusanganisira kugadzirwa kwemishonga, chikafu, CRTs, maLCD, OLED, uye microLED kuratidza.Makamuri akachena akagadzirirwa kuchengetedza akanyanya kuderera mazinga ezvimedu, senge huruva, zvipenyu zvinofambiswa nemhepo, kana mhute.
Kuti zvive zvakanyatsojeka, imba yakachena ine chiyero chetsvina inodzorwa, iyo inotsanangurwa nenhamba yezvimedu pa cubic mita / pa cubic tsoka pane yakatsanangurwa particle size.Imba yakachena inogona zvakare kureva chero yakapihwa nzvimbo yekugara umo kusvibiswa kwemukati kunoderedzwa uye mamwe maparamendi ezvakatipoteredza senge tembiricha, humidity, uye kudzvanywa kunodzorwa.
Chii chinonzi GMP yakachena kamuri?
Mupfungwa yemishonga, imba yakachena inoreva kamuri inosangana nezvinodiwa neGMP zvinotsanangurwa muGMP sterility yakatarwa (kureva, Annex 1 yeEU uye PIC/S GMP Mirayiridzo, pamwe chete nemimwe mwero uye nhungamiro inodiwa nevakuru vehutano munharaunda. )Musanganiswa weinjiniya, kugadzira, kupedzisa, uye kudzora kwekuita (mano ekudzora) anodiwa kushandura kamuri yakajairika kuita imba yakachena.
Zvinoenderana nemayero akakodzera emasangano eFDA, ivo vakaisa mirau yakasimba uye chaiyo yevagadziri vemishonga muindasitiri yemishonga.Yakanaka Manufacturing Practices (GMP) yekugadzira zvigadzirwa zvemishonga zvisingabatsiri zvakagadzirirwa kuve nechokwadi kuti mishonga yakachengeteka uye ine zvavanenge vanzi zvinosanganisa uye huwandu.Aya mazinga anovavarira kudzikisa njodzi yekusvibiswa kwemicrobial, particulate, uye pyrogen.Uyu murairo, unozivikanwawo seazvino maitiro akanaka ekugadzira (cGMP), unovhara maitiro ekugadzira, kutonga kwemhando, kurongedza, vashandi, uye GMP zvivakwa.
Mukugadzirwa kwemishonga isina utachiona nemidziyo yekurapa, kazhinji hapadiwe dzimba dzakachena dzepamusoro-soro, nepo kugadzirwa kwemishonga inouraya, yakaita semishonga yemamolecular nemishonga yekugadzira, panodiwa zvisingadzivisiki makamuri akachena epamusoro-soro. - GMP makamuri akachena.Isu tinokwanisa kutsanangura nharaunda yekugadzirwa kwemishonga isina hutachiona uye zvigadzirwa zvebiological zvichibva paiyo GMP yakachena mweya mwero uye kupatsanura.
Zvinoenderana nezvinodiwa zvinoenderana nemirairo yeGMP, kugadzirwa kwemishonga isina hutachiona kana zvigadzirwa zvebiological zvinonyanya kukamurwa kuita mazinga mana: A, B, C, uye D.
Masangano aripo anodzora anosanganisira: ISO, USP 800, uye US Federal Standard 209E (yaimbova, ichiri kushandiswa).The Drug Quality and Safety Act (DQSA) yakadzikwa muna Mbudzi 2013 kugadzirisa kufa kwezvinodhaka uye zviitiko zvakakomba.Iyo Federal Chikafu, Mushonga, uye Cosmetic Act (FD&C Act) inogadza yakatarwa nhungamiro uye marongero eforoma yemunhu.503A inogadzirwa nehurumende kana yemubatanidzwa yakatenderwa agency iri pasi pekutariswa kwevashandi vane mvumo (vemishonga / vanachiremba) 503B ine hukama nezvivakwa zvekunze uye inoda kutariswa zvakananga nevane marezinesi emishonga, kwete marezinesi emishonga.Fekitori iyi inopihwa rezinesi kuburikidza neFood and Drug Administration (FDA).
DERSION Modular Yakachena Kamuri
1. KUKURUMIDZA UYE ZVINOKOSHA KUISA
Mukana wakajeka wemodular yakachena makamuri ndeyekuti ari nyore uye anokurumidza kuisa.Izvo hazvifanirwe kuvakwa kubva pakutanga uye hazvizokanganisa mashandiro ako nemavhiki kana mwedzi yenguva yekuvaka.Iwo akagadzirwa kubva kune akasimirirwa mapaneru uye framing, saka anogona kumisikidzwa mukati memazuva kana mavhiki.Nekusarudza DERSION modular yakachena kamuri, sangano rako rinogona kudzivirira kunonoka uye kutanga kushandisa yako yekuchenesa imba nekukurumidza.
Zvakare, DERSION patent dhizaini inoita kuti zvive nyore kuunganidza kana kupatsanura modular yedu yakachena makamuri uye ine mari kuwedzera pairi.Izvi zvinoreva kuti vatengi vedu vane shanduko yekuwedzera kune, kana kubvisa kubva, yavo yakachena yekumisikidzwa sezvo zvinodiwa nesangano ravo zvinoshanduka.Nekuti makamuri edu akachena haasi zvimiro zvechigarire, anodhura zvishoma kutenga uye nemutengo wakaderera wekugadzirisa.
2. QUALITY PERFORMANCE
Modular cleanrooms inoshandisa HEPA uye ULPA fan mafirita mayuniti kubvisa tunhu kubva mumhepo uye kuchengetedza kusvibiswa kune hushoma hunodiwa.DERSION inopa akasiyana siyana emakamuri ekuchenesa nemidziyo yekuchenesa iyo inogona kubatsira sangano rako kutevedzera ISO, FDA, kana EU zviyero.Ose ari maviri maSoftwall uye rigidwall cleanrooms edu anosangana neISO 8 kusvika ISO 3 kana Giredhi A kusvika Giredhi D hutsanana hwemhepo.Yedu rigidwall cleanrooms imhinduro yakaderera yekusangana neUSP797 zvinodiwa.
Mabhenefiti emakamuri akachena modular pamusoro pemakamuri echinyakare akachena akawanda.Kukwanisa kwavo, kuisirwa nyore uye kugadzirisa, uye kuita nekufamba kwenguva kunoita kuti ive sarudzo yakanaka kumakambani kana masangano anoda nzvimbo yekuchenesa kuti ashande ipapo.PaDERSION tinotenda mumhando yezvigadzirwa zvedu zvemumba uye kuchinjika kwavanopa kune vatengi vedu.Kuti uwane rumwe ruzivo rwekuti zvigadzirwa izvi zvingabatsira sei sangano rako kuita zvarinoda, tarisa yedu softwall uye rigidwall modular yakachena kamuri mapeji.
