Abdi Ibrahim Hadimkoy, Bilim Ilac Gebze, Sanofi Luleburgaz Turkiye ilac sanayinin 12 milyar USD cirosunu yaratir. Granulasyon, FBD (Fluid Bed Drier), coater solvent bazli; etanol, IPA, aseton kullanir. NFPA 497 solvent alanlarini Class I Div 1-2 olarak siniflandirir; ATEX Zone 0-1-2 esdegerdir.
Solvent Kimyasi
- Etanol: Flash 13 C, LEL 3.3 percent
- IPA: Flash 12 C, LEL 2 percent
- Aseton: Flash -20 C, LEL 2.5 percent
- Metanol: Flash 11 C, LEL 6 percent
- DCM: Halojenli, non-flammable
FBD ve Granulasyon
- FBD sicaklik: 60-80 C giris
- Havalandirma: 30 ACH oda
- Nitrogen inertion: O2 <8 percent
- Toz: MIE 10 mJ stearate
- Kst: 100 bar m/s Class St1
NFPA 497 Zonlama
- Solvent tank: Zone 0 ic, 1 dis
- Granulator: Zone 1
- Tablet press: Zone 2 toz
- Coating room: Zone 1
- Loading dock: Zone 2
Sprinkler Farma
- Solvent depo: Foam deluge 12.2
- Granulation: Inerting + CO2
- Tablet area: Tavan 8.1 L/min/m2
- Clean room: Pre-action
- Warehouse: ESFR K25
Turkiye Ornekleri
- Abdi Ibrahim Hadimkoy: 300.000 m2
- Bilim Ilac Gebze: 100.000 m2
- Sanofi Luleburgaz: Insulin
- West Pharma 2013 ABD: Toz patlama - 1 oldu
- GMP EU Annex 1: Steril ilac guncel
Ilac SprinkCalc ile
SprinkCalc ilac solvent foam deluge 12.2 L/min/m2, FBD inerting, toz Kst 100 bar m/s ve NFPA 497 Class I Div 1 zonlama hesabi yapar.
SprinkCalc'i App Store'dan indir
Kaynaklar & İleri Okuma
NFPA 497, NFPA 77, EU GMP Annex 1, ATEX 2014/34/EU, FDA 21 CFR 211. NFPA 497 Classification of Flammable Liquids.