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ZVISIMBO ZEVASHANDI UYE ZVINHU ZVINOTEVEDZERA KURONGWA MUCHIDYA GMP CLEAN ROOM.

Paunenge uchigadzira chikafu cheGMP chakachena kamuri, kuyerera kwevanhu uye zvinhu kunofanirwa kuparadzaniswa, kuitira kuti kunyangwe paine kusvibiswa pamuviri, haizopfuudzwa kune chigadzirwa, uye zvakafanana kune chigadzirwa.

Misimboti yekucherechedza

1. Vashandi uye zvinhu zvinopinda munzvimbo yakachena hazvigone kugovera mukova wakafanana.Operator uye zvinhu zvekupinda zviteshi zvinofanirwa kupihwa zvakasiyana.Kana zvinhu zvakasvibirira uye zvigadzirwa zvekubatsira uye zvekurongedza zvinosangana zvakananga nechikafu zvakaputirwa zvakavimbika, hazvizokonzeresa kusvibiswa kune mumwe nemumwe, uye kuyerera kwemaitiro kunonzwisisika, musimboti, musuwo mumwe unogona kushandiswa.Zvemidziyo nemarara zvinogona kusvibisa nharaunda, senge activated kabhoni uye zvisaririra zvinoshandiswa kana kugadzirwa panguva yekugadzira, mapindiro akakosha uye ekubuda anofanirwa kumisikidzwa kudzivirira kusvibiswa kwezvinhu zvakabikwa, zvekubatsira kana zvemukati zvekurongedza zvinhu.Zvakanakisa kumisa masuo akaparadzana uye ekubuda kunze kwezvinhu zvinopinda munzvimbo yakachena uye zvigadzirwa zvakapedzwa zvinotumirwa kunze kwakachena.

2. Vashandi uye zvinhu zvinopinda munzvimbo yakachena vanofanira kumisa makamuri avo ekuchenesa kana kutora matanho anoenderana ekuchenesa.Semuenzaniso, vashandi vanogona kupinda munzvimbo yekugadzira yakachena kuburikidza nemhepo inovhara mushure mekugeza, vakapfeka mbatya dzebasa dzakachena (kusanganisira makepisi ebasa, shangu dzebasa, magirovhosi, masiki, nezvimwewo), kugezesa mhepo, kugeza maoko, uye kuuraya utachiona hwemaoko.Zvishandiso zvinogona kupinda munzvimbo yakachena kuburikidza nekiyi yemhepo kana bhokisi rekupfuura mushure mekubvisa kurongedza kwekunze, kugezesa mhepo, kuchenesa pamusoro, uye disinfection.

3. Kuti udzivise kusvibiswa kwezvokudya nezvinhu zvekunze, paunenge uchigadzira marongerwo ezvigadzirwa zvekugadzira, chete zvigadzirwa zvine chokuita nekugadzirwa, zvivako uye makamuri ekuchengetedza zvinhu zvinofanira kuiswa munzvimbo yakachena yekugadzira.Zvivakwa zveruzhinji zvekubatsira senge compressors, silinda, vacuum pombi, guruva rekubvisa midziyo, dehumidification michina, exhaust mafeni egasi akadzvanywa anofanirwa kurongeka munzvimbo yekugadzira yakawanda sekureba sekunge zvinodiwa maitiro zvichibvumidza.Kuti unyatso dzivirira kusvibiswa kwepakati pakati pezvikafu, zvikafu zvemhando dzakasiyana uye zvakasiyana hazvigone kugadzirwa mukamuri imwechete yakachena panguva imwe chete.Nechikonzero ichi, midziyo yayo yekugadzira inofanirwa kurongeka mune imwe imba yakachena.

4. Paunenge uchigadzira ndima munzvimbo yakachena, ita shuwa kuti ndima yacho inosvika pane imwe neimwe nzvimbo yekugadzira, yepakati kana yekurongedza zvinhu zvekuchengetedza.Makamuri ekuvhiya kana makamuri ekuchengetera mamwe maposvo haagone kushandiswa semigero yezvishandiso uye vashandisi kupinda iyi positi, uye midziyo yakaita seovheni haigone kushandiswa semigero yevashandi.Izvi zvinogona kudzivirira zvinobudirira kusvibiswa kwemarudzi akasiyana-siyana ezvokudya zvinokonzerwa nekutakura zvinhu uye kuyerera kwevashandi.

5. Pasina kukanganisa kuyerera kwemaitiro, mashandiro ehurongwa, uye dhizaini dhizaini, kana iyo air-conditioning system maparameter epadhuze akachena emakamuri ekushandisa akafanana, mikova inogona kuvhurwa pamadziro emadziro, mabhokisi ekupfuura anogona kuvhurwa, kana mabhandi ekutakura anogona. kugadzirwa kuendesa zvinhu.Edza kushandisa nzira shoma kana isina yakagovaniswa kunze kwekamuri yekuvhiya yakachena.

6. Kana kupwanya, sieving, tableting, kuzadza, API kuomeswa uye zvimwe zvinzvimbo zvinobudisa guruva rakawanda hazvigoni kuvharwa zvakakwana, kunze kwehupfu hunodiwa hwekutora uye kubvisa guruva, imba yepamberi yekushanda inofanirawo kugadzirwa.Kudzivirira kusvibiswa kwemakamuri ari padyo kana nzira dzekufamba dzakagoverwa.Uye zvakare, kune zvinzvimbo zvine huwandu hukuru hwekupisa uye kunyungudika kwehunyoro, sekunge kwakasimba kugadzirira slurry kugadzirira uye jekiseni rekugadzirisa, mukuwedzera pakugadzira mudziyo wekubvisa unyoro, imba yekumberi inogona zvakare kugadzirwa kuti isakanganisa kushanda kweiyo yakatarisana. kamuri yakachena nekuda kwekuwanda kwehunyoro uye kupisa kupisa uye ambient air conditioning parameters.

7. Zvakanakisisa kuparadzanisa ma elevator ekutakura zvinhu uye elevator mumafekitari emakamuri akawanda.Inogona kufambisa marongerwo ekuyerera kwevashandi uye kuyerera kwezvinhu.Nemhaka yokuti marifiti nemigodhi ndiyo manyuko makuru okusvibisa, uye mhepo iri muzvikwiriso nemigodhi yakaoma kuchenesa.Naizvozvo, hazvina kukodzera kuisa elevator munzvimbo dzakachena.Kana nekuda kwezvinodiwa zvakakosha zvemaitiro kana zvipimo zvechimiro chekuvaka fekitori, michina yekugadzira inoda kurongedzerwa-mativi matatu, uye zvinhu zvacho zvinoda kutakurwa kubva kumusoro zvichienda pasi kana pasi kuenda kumusoro munzvimbo yakachena neelevator, airlock. inofanira kuiswa pakati peelevator nenzvimbo yakachena yekugadzira.Kana gadzira mamwe matanho ekuona kuchena kwemhepo munzvimbo yekugadzira.

8. Mushure mekunge vanhu vapinda muwekishopu nemukamuri yekutanga yekuchinjisa neyechipiri yekuchinjisa, uye zvinhu zvinopinda muwekishopu nemukoto wekuyerera kwezvinhu uye nzira yekuyerera kwevashandi muGMP yakachena imba hazvipatsanuriki.Zvese zvinhu zvinogadziriswa nevanhu.Kuvhiya hakuna kunyanya kuoma mushure mekupinda.

9. Mufambiro wekuyerera kwevashandi unofanirwawo kugadzirwa uchifunga nezvenzvimbo yese uye kushandiswa kwezvinhu.Mamwe makamuri ekuchinja evashandi vekambani, makamuri e-buffer, nezvimwe zvakagadzirirwa mashoma masikwe mita, uye nzvimbo chaiyo yekuchinja zvipfeko idiki.

10. Izvo zvinodiwa kuti unyatso kudzivirira kupindirana kwekuyerera kwevashandi, kuyerera kwezvinhu, kuyerera kwemidziyo, uye kuyerera kwemarara.Izvo hazvibviri kuve nechokwadi chakakwana rationality mune chaiyo dhizaini maitiro.Pachave neakawanda marudzi emacollinear ekugadzira maworkshop, uye akasiyana maitiro ekushandisa emidziyo.

11. Izvi zvakafanana kune logistics.Pachava nenjodzi dzakasiyana-siyana.Maitirwo ekuchinja haana kuomeswa, kuwanikwa kwezvinhu hakuna kuomeswa, uye mamwe anogona kunge asina kugadzirwa zvakanaka nzira dzekutiza.Kana njodzi dzakadai sekudengenyeka kwenyika nemoto zvikaitika, paunenge uri munzvimbo yekugadzira canning kana nzvimbo iri pedyo iwe unofanirwa kuchinja zvipfeko kakawanda, chaizvoizvo ine ngozi zvikuru nokuti nzvimbo yakagadzirwa neGMP yakachena imba yakamanikana uye hapana kupukunyuka kwakakosha. hwindo kana chikamu chinoputsika.

imba yakachena
gmp imba yakachena

Nguva yekutumira: Sep-26-2023