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SED-20FDG-B(CIP)
Consultar
SED-20FDG-B(CIP)
SED · SED-20FDG-B(CIP) · Destacado
SED-20FDG-B(CIP) — rectangular vacuum freeze drying machine with CIP
La descripción completa de este modelo aún se está traduciendo. Consulte los detalles en inglés o solicite información a nuestro equipo. English
PD-20(CIP) pharmaceutical-grade rectangular vacuum freeze dryer with in-place cleaning (CIP) and hydraulic stoppering system. Integral rectangular drying chamber + rectangular condenser, CGMP/GB150-2010 standard. Shelf t
Plazo de entrega
Consultar
Capacidad de producción
42000–84000 unidades/h
Funcionamiento
Pharmaceutical freeze-drying: product is frozen on temperature-controlled shelves (≤-55°C), then water is sublimated under vacuum (ultimate ≤1.0 Pa) to condenser (≤-75°C). Refrigeration uses two BITZER two-stage compressors with R404A refrigerant. Shelf heating/cooling circuit uses 10 cst silicone oil circulated by WILO pump with PID-controlled U-shaped electric heating pipes. Hydraulic system (REXROTH) drives stoppering at 0–1.0 bar and mushroom valve (DN500) between chamber and condenser. CIP system uses USA Flowserve water ring pump and USA SSC rotating + wide-angle nozzles for in-place cleaning of chamber and shelves. PLC controls the entire automated freeze-drying cycle including defrost and CIP sequences.
Proceso de funcionamiento
1Pharmaceutical freeze-drying: product is frozen on temperature-controlled shelves (≤-55°C), then water is sublimated under vacuum (ultimate ≤1.0 Pa) to condenser (≤-75°C).
2Refrigeration uses two BITZER two-stage compressors with R404A refrigerant.
3Shelf heating/cooling circuit uses 10 cst silicone oil circulated by WILO pump with PID-controlled U-shaped electric heating pipes.
4Hydraulic system (REXROTH) drives stoppering at 0–1.0 bar and mushroom valve (DN500) between chamber and condenser.
5CIP system uses USA Flowserve water ring pump and USA SSC rotating + wide-angle nozzles for in-place cleaning of chamber and shelves.
6PLC controls the entire automated freeze-drying cycle including defrost and CIP sequences.
Especificaciones técnicas
Especificaciones de la variante: SED-20FDG-B(CIP)
Especificaciones
Modelo
SED-20FDG-B(CIP)
Capacidad de producción
42000–84000 unidades/h
Tensión
380V/50Hz
Suministros
Cooling water ≥30 m³/h (T≤30°C, P=0.15–0.2 MPa); compressed air ≥0.1 m³/min (0.5–0.8 MPa); defrost water ≤800 kg (T=60°C, P≥0.2 MPa)
Detalles de conformidad
Designed to CGMP and GB150-2010 (pressure vessel) standards. FDA 21 CFR Part 11 compliant control system. Validation documentation: IQ/OQ/PQ/FAT/SAT, operating manual, maintenance manual, installation manual, floorplan, P&ID, electrical circuit diagram, main parts manual, pressure vessel quality certificate, calibration report, material report.
Potencia
84 kW
Presión de aire
0.5-0.8Mpa
Dimensiones
Longitud
5800 mm
Anchura
2200 mm
Altura
3600 mm
Peso
12000 kg
Superficie de instalación
5800×2200 mm footprint (plus access clearance per layout drawing)
Materiales
Materiales en contacto
SUS304 (chamber, shelves, condenser, piping); SUS316L (freeze-drying trays)
Materiales del cuerpo
SUS304
Características principales
Total usable shelf area 20 m²
Maximum shelf load 400 kg
Ф22 mm vials ~42,000 pcs; Ф16 mm vials ~84,000 pcs
Shelf layers: 11+1 (compensation board)
Shelf dimensions 1200×1500×20 mm, spacing 90 mm
Shelf temperature ≤-55°C to +80°C; uniformity ±1°C (after stabilization)
Shelf flatness ≤±0.5 mm/m
Condenser lowest temperature (no load) ≤-75°C
Condenser maximum water capacity 400 kg
Overall dimensions 5800×2200×3600 mm
Total weight ~12,000 kg
Total power 84 kW (380V/50Hz, 3-phase 5-wire)
Cooling water ≥30 m³/h (T≤30°C, P=0.15–0.2 MPa)
Compressed air ≥0.1 m³/min (0.5–0.8 MPa)
Defrost water ≤800 kg (T=60°C, P≥0.2 MPa)
Shelf cooling rate 20°C→-40°C ≤60 min; heating rate -40°C→20°C ≤60 min
Condenser cooling rate 20°C→-40°C ≤30 min
Ultimate vacuum ≤1.0 Pa; system leakage ≤5×10⁻³ Pa·m³/s
Mushroom valve DN500 hydraulic SUS304 between chamber and condenser
CIP: USA Flowserve water ring pump + USA SSC rotating & wide-angle nozzles
Hydraulic stoppering 0–1.0 bar adjustable (REXROTH)
Control: Siemens S7-1200 PLC + DELL 20" LCD; FDA 21 CFR Part 11 compliant
Chamber roughness Ra≤0.4 μm; shelf surface roughness Ra≤0.4 μm
100 pcs SUS316L freeze-drying trays (400×500×30 mm) included
CGMP/GB150-2010 certified design
FDA 21 CFR Part 11 compliant electronic signatures and multi-password management
CIP with USA SSC nozzles — first-class in-place cleaning of chamber and shelves
Hydraulic stoppering with anti-slip device; mushroom valve for airtight chamber isolation
Two BITZER two-stage compressors for high reliability and redundancy
ULVAC top-brand vacuum pumps for stable operation guarantee
Multi-stage vacuum setting; process recipe management; real-time data/curve recording
WILO circulation pump: leak-free, noise-free, stable operation
IQ/OQ/PQ/FAT/SAT validation file package provided
USA Omega T-type thermocouple temperature sensors
Aplicaciones
Pharmaceutical vial freeze-drying (Ф16 mm and Ф22 mm vials)
Pharmaceutical product preservation
Sectores
Farmacéutico
Marcas de componentes
Compressor
BITZER
Oil separator
Emerson
Vapor-liquid separator
AIRMENDER/AIRMANDER
High/low pressure protection
DANFOSS
Vacuum pump
ULVAC
Roots pump
CUIMAN
Circulation pump
WILO
PLC
Siemens
PC display
DELL
Circuit breakers / contactors
Schneider
Temperature sensor
USA Omega
Hydraulic valves
REXROTH
CIP nozzles
SSC (Spray Systems Co.)
CIP water ring pump
Flowserve
Pneumatic valves
FV
Pipe insulation
ARMAFLEX
SED
Hable con SED Sales Team
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Conformidad
CGMP
GB150-2010
Limpieza y mantenimiento
In-place cleaning (CIP) via USA Flowserve water ring vacuum pump and USA SSC high-efficiency rotating + wide-angle nozzles. Combined chamber and shelf cleaning for first-class results. Cleaning and defrost with automatic vacuum valve to prevent positive pressure in chamber. Chamber drain has sampling port and filter screen. CIP filters steam-sterilizable in place.
Documentación
Ficha técnica (PDF)
Resumen del equipo, especificaciones y dimensiones · Documento original (inglés)
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Manual del operador
Instalación, funcionamiento y diagnóstico · Documento original (inglés)
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Ficha comparativa (Estándar y Económica)
Comparación de configuraciones · Documento original (inglés)
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Protocolos IQ / OQ / PQ
Documentación de validación para conformidad GMP · Documento original (inglés)
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Protocolos FAT / SAT
Pruebas de aceptación en fábrica y en sitio · Documento original (inglés)
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Planos CAD (STEP / IGES / DWG)
Planos de ingeniería para la instalación · Documento original (inglés)
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Certificados de calibración
Nivel sonoro, resistencia de tierra, rigidez dieléctrica y rugosidad · Documento original (inglés)
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DQ (cualificación del diseño)
Protocolo completo de cualificación del diseño · Documento original (inglés)
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Certificados de materiales
Composición del acero inoxidable 316L · Documento original (inglés)
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