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Indasitiri yeParmaceutical

Mishonga inorwisa mabhakitiriya

Mishonga inorwisa mabhakitiriya imhando yemishonga inorwisa utachiona inoshandiswa mukurapa nekudzivirira kutapukira kwebhakitiriya.Dzinogona kuuraya kana kutadzisa kukura kwebhakitiriya.

Chinangwa chekusefa:
Prefilter: bvisa zvimedu, colloid, uye wedzera hupenyu hwekushanda hwemasefa akanaka anoteverwa.
Fine filter: bvisa mabhakitiriya, mycoplasma.

Mafirita maitiro:
1. Bvisa zvimedu, colloid, mabhakitiriya, mycoplasma.
2. Kuyerera kwemahara kuburikidza nechinhu chikuru mumhinduro yezvinovaka muviri (kunyanya kuenderana kwemakemikari.)
3. Yakagadzikana filtration flow rate.

Sefa sarudzo:

Sefa maitiro Sefa sarudzo
Prefilter GF
Mhepo IPF
Sterile IPS

Kusefa

VQV12

Hombe Volume Parenteral

LVP imvura yejekiseni isina utachiona mumuviri wemunhu netsinga, uye inokwira isiri pasi pe50ml.

Chinhu chikuru cheLVP:

Mvura, glucose, amino acid, munyu, uye viscous zvinovaka muviri mhinduro.
Ikozvino inowanikwa mumusika kunyanya mana akasiyana eLVP:
Glucose, NaCl, Glucose/NaCl, Metronidazole

Chinangwa chekusefa:

Prefilter: bvisa zvimedu, colloid, uye wedzera hupenyu hwekushanda hwemasefa akanaka anoteverwa.
Fine filter: bvisa low biological load;sterile filtration

Mafirita maitiro:
Chengetedzo: Mafirita anofanirwa kunge ane simba remuchina, sekubhota pasi pekumanikidzwa kukuru uye kumhanya kwakanyanya
Kugadzikana: Mafirita anofanirwa kupa yakagadzikana kusefa kumhanya uye kusefa kunyatsoita
Bhakitiriya Yemahara: Hapana bhakitiriya mhenyu muLVP

Sefa System Configuration:

EGQF12

Filtration System Diagram:

qgq121v

Diki Volume Parenteral

Diki volume parenterals (SVP) inosanganisira akasiyana echinyakare uye bioengineered mishonga.Mishonga iyi inowanzoiswa mumabhodhoro maduku (pasi pe20 ml), majekiseni akazadzwa kare uye ampoules, kana kuti yakagadzirwa mu lyophilized powder.Mazhinji eSVP anoda aseptic kugadzirisa nekuda kwekushaya kwekupisa-kugadzikana.
Sterilizing filtration inoshandiswa mushure mekugadzirisa kana isati yazadza.Uye inogona kuwedzera sterility vimbiso kana sterilizing kusefa ikashandiswa munzvimbo mbiri idzi.Prefilters dzinofanirwa kushandiswa kuderedza bioburden uye zvimedu, izvo zvaizovhara mafirita ekupedzisira nguva isati yakwana.

Zvinangwa Zvekuparadzana
● Prefiltration
Bvisa colloidal uye chidimbu zvinosvibisa kuti uwedzere hupenyu hwesevhisi yekudzika kwemvura inouraya mafirita.
● Kusefa kwekupedzisira
Ipa sterile filtrate inosangana nezvinodiwa zvezvino zvinodzorwa

Zvinodiwa Zvekushandisa

● Masefa ekupedzisira ekuita sterilizing anofanira kubvisa utachiona pasina kuchinja zvinogadzirwa nemishonga.Naizvozvo, mafirita aya anofanirwa kuve neakaderera adsorption yeanoshanda mishonga yemishonga (API), yakaderera inotorwa, isingaite-pyrogenic uye kuvimbika kunoyedzeka, uye kuve isina mbereko kana inogona kuomeswa.
● Prefilters uye mafirita ekupedzisira anofanira kuva nemazinga akakwana ekuyerera.Mafirita ekupedzisira mumushini wekuzadza anofanirwa kunge aine zvimiro zvakasimba zvekudzivirira midhiya kuchinjika panguva yepulsed kuyerera kwekuzadza kugadzirisa, izvo zvinozoguma nekuburitswa kwechidimbu, kudonhedza kana mamwe matambudziko ekuparadzira.

Kurudziro

Kusefa Danho Kurudziro
Prefiltration PP
Sterile venting IPF
Final filtration IMBWA
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