Abdi Ibrahim Hadimkoy, Bilim Ilac Gebze and Sanofi Luleburgaz drive Turkey's 12 billion USD pharma sector. Granulation, FBD (Fluid Bed Drier) and coaters use ethanol, IPA and acetone. NFPA 497 classifies solvent areas as Class I Div 1-2 (ATEX Zone 0-1-2 equivalent).
Solvent Chemistry
- Ethanol: Flash 13 C, LEL 3.3 percent
- IPA: Flash 12 C, LEL 2 percent
- Acetone: Flash -20 C, LEL 2.5 percent
- Methanol: Flash 11 C, LEL 6 percent
- DCM: Halogenated, non-flammable
FBD and Granulation
- FBD temp: 60-80 C inlet
- Ventilation: 30 ACH room
- Nitrogen inerting: O2 <8 percent
- Dust: MIE 10 mJ stearate
- Kst: 100 bar m/s Class St1
NFPA 497 Zoning
- Solvent tank: Zone 0 inside, 1 outside
- Granulator: Zone 1
- Tablet press: Zone 2 dust
- Coating room: Zone 1
- Loading dock: Zone 2
Pharma Sprinkler
- Solvent storage: Foam deluge 12.2
- Granulation: Inerting + CO2
- Tablet area: Ceiling 8.1 L/min/m2
- Clean room: Pre-action
- Warehouse: ESFR K25
Turkey Examples
- Abdi Ibrahim Hadimkoy: 300,000 m2
- Bilim Ilac Gebze: 100,000 m2
- Sanofi Luleburgaz: Insulin
- West Pharma 2013 US: Dust blast - 1 dead
- GMP EU Annex 1: Sterile drug update
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Sources & Further Reading
NFPA 497, NFPA 77, EU GMP Annex 1, ATEX 2014/34/EU, FDA 21 CFR 211. NFPA 497 Classification of Flammable Liquids.