Muindasitiri yemishonga, maitiro ese ekugadzira ane chekuita nekuchengetedzwa kwehupenyu hwevarwere. Kubva pakusarudzwa kwezvinhu zvakasvibirira kusvika kumagadzirirwo ekugadzira, kubva pakuchenesa michina kusvika pakudzora kwezvakatipoteredza, chero kusvibiswa kudiki kunogona kukonzera njodzi dzemhando yezvinodhaka. Pakati peaya makiyi link, themishonga yakachena steam jenaretayave imwe yemidziyo yakakosha yekuona kuchengetedzwa kwezvinodhaka nekuda kwebasa rayo risingadzoreki. Iyo haingope zvivimbiso zvakavimbika zvekugadzirwa kweaseptic, asi inoshandawo seyakakosha yekona yemazuva ano indasitiri yemishonga kuti ienderere kumhando yepamusoro uye yemhando yepamusoro.

Pure steam: mararamiro ekugadzirwa kwemishonga

Zvinodiwa zvehutsanana mukugadzirwa kwemishonga zvinenge zvakaoma. Angave majekiseni, biologics, jekiseni, kana mishonga yemajini, midziyo, mapaipi, midziyo, uye kunyange mhepo yemhepo inosanganisirwa mukugadzira kwavo kunofanirwa kunyatso itwa sterilized. Pure steam (inozivikanwawo se "pharmaceutical giredhi steam") yave iyo inosarudzirwa sterilization muindasitiri yemishonga nekuda kwekupisa kwayo kwakanyanya uye kusavapo kwemasara emakemikari.

Iyo yakakosha mutakuri we sterilization

Pure yakachena inogona kukurumidza kupinda mukati me microbial cell madziro uye kuuraya zvachose mabhakitiriya, mavhairasi, uye spores kuburikidza nekushisa kwakanyanya (kazhinji pamusoro pe121 ℃) uye yakanyanya kudzvanywa. Kuenzaniswa nemakemikari ekuuraya utachiona, yakachena sterilization haina njodzi inosara, kunyanya yakakodzera michina uye midziyo inosangana yakananga nemishonga. Semuenzaniso, kuomeswa kwemidziyo yakakosha senge mitsara yekuzadza jekiseni, michina yekuomesa nechando, uye mabioreactors anovimba nekupinda kwakanaka kweutsi hwakachena.

Kuomarara kwemaitiro emhando

Zvinoenderana nezvinodiwa neGMP, mushonga wakachena mupfu unofanirwa kusangana nezviratidzo zvitatu zvakakosha:

Hapana kunobva kupisa: Heat sosi inosvibisa inouraya inogona kukonzera kuita kwefivha muvarwere uye inofanira kubviswa zvachose.

Mvura yakanyungudutswa inosangana nechiyero: Hunhu hwemvura mushure mehupfu hwakachena hunoda kusangana nemvura yejekiseni (WFI) chiyero, ine conductivity ye ≤ 1.3 μ S/cm.

Yakakodzera kuoma kukosha: Kuoma kweupfu kunofanirwa kunge kuri ≥ 95% kudzivirira mvura yemvura inokanganisa maitiro ekuita sterilization.

Full process application coverage

Kubva pamhepo sterilization (SIP) yemidziyo yekugadzira kusvika pakunyorovesa mhepo mumakamuri akachena, kubva pakuchenesa mbatya dzisina utachiona kusvika pakubvisa utachiona hwemapombi, chiutsi chakachena chinopinda mukati mehupenyu hwese hwekugadzirwa kwemishonga. Kunyanya mumusangano wekugadzirira weaseptic, iyo yakachena steam jenareta ndiyo "musimboti simba sosi" inomhanya maawa angangoita makumi maviri nemana pazuva pasina kukanganisa.

Tekinoroji Innovation yePharmaceutical Pure Steam Jenareta

Nekuwedzera kuri kuita kudiwa kwemhando, kushanda zvakanaka, uye kuchengetedzwa kwezvakatipoteredza muindasitiri yemishonga, tekinoroji yeakachena steam jenareta iri kugara ichipaza. Zvishandiso zvemazuva ano zvakawana kuchengetedzwa kwepamusoro uye kugona kwesimba kuburikidza nehungwaru uye modular dhizaini.

Kubudirira mune yakakosha tekinoroji

Multi-effect distillation tekinoroji: Kuburikidza neakawanda-nhanho simba kudzoreredza, mvura mbishi (inowanzo yakacheneswa mvura) inoshandurwa kuita chiutsi chakachena, ichideredza kushandiswa kwesimba neinopfuura 30% zvichienzaniswa nemidziyo yechinyakare.

Intelligent control: yakashongedzerwa neatomatiki yekutarisa sisitimu, chaiyo-nguva yekuona kwekuoma kwemhepo, tembiricha, uye kudzvanywa, otomatiki alarm uye kugadzirisa mamiriro asina kujairika, kudzivirira kukanganisa kwekushanda kwevanhu.

Yakaderera kabhoni dhizaini: kutora marara kupisa kudzoreredza zvishandiso kuderedza simba remarara, zvinoenderana neyakasvibira shanduko maitiro eindasitiri yemishonga.

Iyo 'dual inishuwarenzi' yekusimbisa kunaka

Mazuva ano pure steam jenareta anowanzo kuve akashongedzerwa neaviri emhando yekusimbisa nzira:

Pamhepo yekutarisa sisitimu: Chaiyo nguva yekutarisa yekuchena kweutsi kuburikidza nemidziyo yakaita seye conductivity metres uye TOC analyzer.
Redundant dhizaini: kaviri pombi backup, multi-stage filtration uye mamwe magadzirirwo anovimbisa kushanda kwakagadzikana kwemidziyo kana ikangoerekana yakundikana.

Flexibility mukupindura kune zvakaoma zvinodikanwa

Pure steam jenareta anogona kugadzirwa kune ari kusimukira minda senge biopharmaceuticals uye cell therapy. Semuyenzaniso, midziyo inoshandiswa mukugadzirwa kwemishonga yekudzivirira mRNA inoda kusangana nepamusoro soro zvinodiwa, uye mamwe makambani akaunza tekinoroji ye "ultra pure steam" kudzora mwero we endotoxin mumvura yakapfupikiswa iri pasi pe 0.001 EU/mL.
Nekukurumidza kukura kwebiopharmaceuticals, zvinodiwa zvepamusoro zvakaiswa pamberi pemhando yehutsi hwakachena. Kugadzirwa kwemishonga mitsva yakadai semishonga yemajini uye monoclonal antibodies inoda nzvimbo yakachena yemhepo. Izvi zvinopa dambudziko idzva retekinoroji kune yakachena steam jenareta.

Pfungwa yekugadzira yakasvibirira iri kushandura dhizaini yekufunga yeakachena steam jenareta. Kushandiswa kwemidziyo inochengetedza simba, zvinhu zvine hushamwari kwezvakatipoteredza, uye kuvandudzwa kwehungwaru manejimendi masisitimu zvese zviri kutyaira indasitiri yakanangana negwara rakasimba.

Iko kushandiswa kwehungwaru tekinoroji kuri kugadziridza maitiro ekushanda eakachena steam jenareta. Kuitwa kwekutarisa kure, kufembera kuchengetedza, kugadziridza kwakangwara uye mamwe mabasa kwete kungovandudza kugona kwekushandisa kwemidziyo, asiwo kunopa yakavimbika yemhando vimbiso yekugadzirwa kwezvinodhaka.

Nhasi, sezvo kuchengetedzwa kwezvinodhaka kuri kuwedzera kukosha, kukosha kwemishonga yakachena chiutsi jenaretaari kuwedzera kuva akatanhamara. Haisi chete midziyo yakakosha yekugadzira zvinodhaka, asiwo yakakosha chipingamupinyi chekuvimbisa veruzhinji kuchengetedzwa kwemishonga. Nekuenderera mberi kwekufambira mberi kwetekinoroji, majenareta akachena emhepo pasina mubvunzo achaita basa rakakura muindasitiri yemishonga uye nekupa mipiro yakakura kuhutano hwevanhu.