Sais 0 Gelatin Kapsul

Wantaim bikpela proses, gutpela stebiliti na bikpela probabiliti, em i nambawan prodak bilong kapsul dos fom long nau. Mitim ol nid bilong planti kastoma.

▶cGMP QUALITY MENAGEMENT STANDARDS

 

Bihainim cGMP long oganaisim prodaksen na kwaliti menesmen, kamapim wanpela kwaliti asurens sistem, na leboretori bai karimaut CNAS setifikesen.

 

▶SMART SOL-GEL

 

Ful-otometik operesen bilong sol gel na viskositi, as teknoloji bilong mekim gutpela kwaliti bilong gel wara. Proses trasebiliti bilong mekim kwaliti i stap gut moa.

 

▶SISTEM BILONG KLINIM WAN

 

Dispela sistem bilong klinim win em ol bikpela kampani olsem Carrier, AL-KO, na Ingersoll i wokim bilong mekim win i kamap klin na i gat wankain tempereja na humiditi bilong envairomen.

 

▶MENESMEN BILONG INFOMATISESEN

 

lBM i bin wokim bilong lukautim infomesen bilong entaprais, we i gat ERP, MES, SCADA, LIMS, WMS na ol narapela sistem.

• Long kamapim ol gutpela, seif, helti emti kapsul, olgeta step bilong prodaksen i gat strongpela operesen prosedur na kwaliti kontrol.

 

• Stat long makim ol 'raw material', i go inap long lukluk long wok bilong kamapim na sekim ol 'capsules' we i pinis, olgeta i bihainim stret ol standet.

Kontrol

 

1. Raw materiel

2. Traim ol 'raw material'

3. Melting

4. Wokim kapsul

5. Printim (ol i mas askim)

6. Sekim long masin

7. Kauntim na bungim

8. Sekim prodak insait long leb

Prodak bilong mipela i bihainim ol standet bilong Chinese Pharmacopoeia na i winim ol intanesenel setifikesen olsem HALAL, Kosher, FDA, ISO9001 na ISO22000.

• PE beg+Aluminium foil beg+Sikspela 'surface foam board+5 ply corrugated Carton

 

• Katon sais 60x73x40cm, volium 0.18 kubik mita, hevi bilong en em olsem 15kgs long wan wan bokis

 

• Stoa Kondisen: Tempereja: 15 digri ~ 25 digri, Humiditi: 35%~65%

 

• 20' Kontena bilong aisbokis: 140 katon emti kapsul.

 

• 40' Kontena bilong aisbokis: 345 katon emti kapsul.

 

I stap bilong stretim bihainim laik bilong kastoma.

Wanem ol gutpela samting bilong sterilisasen we i no gat 'ethylene oxide tech' long ol emti kapsul?

Sefti
Olpela pasin bilong 'ethylene oxide sterilisasen' i gat ol hevi we i stap yet, we inap long bagarapim sefti bilong ol marasin. Nupela proses i yusim 'hydrogen peroxide' na 'coloidal silver ions' long kamapim 'synergistic sterilisation', na i no gat ol samting nogut i stap. Em i bihainim ol ISO na EU setifikesen standet na em inap long abrusim ol bagarap we inap kamap long bodi bilong man bikos long 'residual ethylene oxide'.

Gutpela wok
Dispela nupela kain marasin bilong kilim ol binatang inap long go insait long straksa bilong ol sel bilong ol liklik binatang na kamapim bikpela 'spectrum' bilong kilim ol binatang, na senisim pasin bilong 'ethylene oxide sterilization'. Dispela i mekim na ol kapsul i inapim ol mak bilong 'aseptic' long taim bilong wokim na i no gat wok long mekim moa 'sterilization' tritmen.

Proses Optimaisesen
Ol i ken putim nupela marasin bilong kilim ol binatang i go stret long 'gel stej', na dispela i mekim wok bilong kamapim ol samting i kamap isi, na i holim strong ol 'transparency' na 'mechanical properties' bilong ol 'capsules', na tu i daunim dipens long tempereja na humiditi kondisen na i mekim wok bilong kamapim ol samting i kamap gutpela moa.

Nau yet, ol i yusim dispela teknoloji long wokim ol 'gelatin' emti kapsul na i kamapim ol gutpela samting tru.

Ol salens bilong Ethylene Oxide-Fre Sterilisasen

Taim ol i laikim moa yet 'ethylene oxide' (EO)-fri sterilisasen bikos em i gutpela long sefti na envairomen, wok bilong en i gat planti salens long sait bilong teknikel, materiel, na reguletori.

1. Samting i ken wok gut wantaim:
Planti kain kapsul-espeseli gelatin, pullulan, na ol narapela 'natural polymers-i save pilim hat, wara, o rediesen. Ol rot bilong 'sterilization' olsem 'steam autoclaving', 'dry heat', o 'gamma irradiation' inap long senisim ol samting bilong 'capsule', na mekim 'capsule' i senis, i bruk bruk, o senis long kala bilong en. Wok bilong lukautim gutpela bilong kapsul na tu mekim gut wok bilong en em i wanpela gutpela samting we i nidim bikpela tes na wok bilong stretim gut ol samting.

2. Limited Method Options:
I no olsem EO, we inap long go insait long ol paket na ol kompleks ples long liklik tempereja, ol rot we i no gat EO- i save nidim stretpela eksposesen o bikpela eneji. Olsem, 'steam sterilisation' i nidim bikpela hat, we i no inap long olgeta samting. Gamma na electron-beam sterilization i nidim ol spesel fasiliti na ol i mas givim gut marasin bilong abrusim bagarap long prodak.

3. Ol Ikwipmen na Kost Konstraksen:
Ol gutpela masin bilong kilim ol pikinini olsem ol 'gamma irradiators' o 'dry heat tunnels' i nidim bikpela mani. Ol dispela sistem i gat bikpela pe bilong wok tu, olsem ol sefti protokol, ol wok bilong skelim, na mentenens, we inap long apim pe bilong prodaksen, moa yet long ol liklik kampani.

4. Reguletori Kompliens:
Sapos yu senisim EO na go long ol narapela rot bilong 'sterilization' yu mas gat strongpela wok painimaut long inapim GMP na ol intanesenel standet (olsem, USP, EU, ISO 11137). Pruvim ol mak bilong 'sterility assurance' (SAL) na mekim 'batch-to-batch i stap wankain em i nidim planti risos- na i nidim ol saientifik pepa na planti taim 'third-setifikesen.

5. Proses Kastomaisesen:
Olgeta kain prodak na fom bilong paket i ken nidim ol 'customized sterilization protocols'. Wok bilong kamapim na stretim ol dispela proses bilong ol kain kain kapsul o fomulasen i ken kisim bikpela haptaim na i gat planti wok long en.

Olsem Wanem Mipela i Mekim Ethylene Oxide-fri Sterilisasen?

Fektori bilong mipela i gat wanpela Klas 100,000 klinrum, we i gat wanpela top-tier ea tritmen sistem na ol ful otomatik prodaksen ikwipmen. Long olgeta taim bilong wokim kapsul-kirap long givim ol samting, miksim, putim, i go long trenspotim-ol i no save mekim wok long han tasol long mekim olgeta hap bilong prodaksen i stap klin. Na tu, olgeta wokmanmeri we i wok long sekim na putim ol samting insait long ol paket i save bihainim ol strongpela lo bilong klinim na lukautim ol yet. Olsem na, mipela inap long mekim 'sterilization' na i no yusim 'ethylene oxide'.

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