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SED-30FDG-B(CIP)
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SED-30FDG-B(CIP)
SED · SED-30FDG-B(CIP) · Destacado
SED-30FDG-B(CIP) — Vacuum Freeze Dryer with CIP
La descripción completa de este modelo aún se está traduciendo. Consulte los detalles en inglés o solicite información a nuestro equipo. English
SED-30FDG-B（CIP）vacuum freeze dryer — a CGMP-compliant pharmaceutical freeze dryer with in-place cleaning (CIP). Integral rectangular drying chamber plus rectangular cold trap; 30 m² total shelf area (10+1 layers, 1200×2
Plazo de entrega
Consultar
Capacidad de producción
150–450 kg/batch
Funcionamiento
Vacuum freeze drying: product is first frozen below its eutectic or glass transition temperature, then placed in a vacuum chamber where pressure is reduced below the triple point of water. Shelf heating (electric, PID-controlled, ±1°C precision) sublimes ice directly to vapor without liquid phase; sublimed vapor is captured by the cold condenser (≤-55°C). A BITZER screw compressor cools both shelves and condenser via silicone oil circulation and refrigerant circuits. The Leybold vacuum pump + Cuiman Roots pump maintains chamber vacuum to ≤1.0 Pa. The CIP system cleans the drying chamber and shelves in place using SSC rotating and wide-angle spray nozzles.
Proceso de funcionamiento
1Vacuum freeze drying: product is first frozen below its eutectic or glass transition temperature, then placed in a vacuum chamber where pressure is reduced below the triple point of water.
2Shelf heating (electric, PID-controlled, ±1°C precision) sublimes ice directly to vapor without liquid phase; sublimed vapor is captured by the cold condenser (≤-55°C).
3A BITZER screw compressor cools both shelves and condenser via silicone oil circulation and refrigerant circuits.
4The Leybold vacuum pump + Cuiman Roots pump maintains chamber vacuum to ≤1.0 Pa.
5The CIP system cleans the drying chamber and shelves in place using SSC rotating and wide-angle spray nozzles.
Especificaciones técnicas
Especificaciones de la variante: SED-30FDG-B(CIP)
Especificaciones
Modelo
SED-30FDG-B(CIP)
Capacidad de producción
150–450 kg/batch
Tensión
380V/50Hz
Suministros
Cooling water ≥50 m³/h (T≤30°C, P=0.15–0.2 MPa); compressed air ≥0.1 m³/min (P=0.5–0.8 MPa); clean water ≥200 L/min (T=80°C, P≥0.4–0.5 MPa); defrost water 1500 kg/batch (T=60°C); electrical supply 380V/50Hz, 107 kW
Detalles de conformidad
Drying chamber and condenser designed and manufactured per GB150-2010 pressure vessel standard. Control software compliant with FDA 21CFR Part 11 (electronic signatures, audit trail, 3-level user management). CGMP compliant design.
Potencia
107 kW
Presión de aire
0.5-0.8Mpa
Dimensiones
Longitud
8000 mm
Anchura
2200 mm
Altura
3500 mm
Peso
15000 kg
Superficie de instalación
8000×2200×3500 mm (L×W×H), weight ~15000 kg
Materiales
Materiales en contacto
SUS304 Ra≤0.4 μm (chamber interior, shelves, condenser, all piping)
Materiales del cuerpo
SUS304 (chamber, condenser, door); SUS304 brushed panels (exterior); polyurethane foam insulation
Características principales
CGMP 3D design with complete sterilization compliance
SUS304 Ra≤0.4 μm inner surface, precision polished
30 m² shelf area; 10+1 layers at 1200×2500 mm; 80 mm spacing; ≥450 kg/batch
Shelf temperature -50 to +80°C; uniformity ±1°C (PID)
Shelf heating rate -40°C → 20°C ≤60 min
Shelf flatness ≤±0.5 mm/m (precision machined)
Anti-bottle/tray fall protection rack on shelves
4 × OMEGA USA thermocouple product temperature probes
Condenser minimum ≤-55°C; cooling rate 20°C→-40°C ≤30 min
S-type coil condenser; mist spray + immersion defrosting
BITZER HSN7471-7 single-stage screw compressor 55 kW (Germany)
R404A refrigerant (Montreal Protocol compliant)
Alfa Laval plate heat exchanger (Sweden)
Danfoss expansion valves ×5, solenoid valves ×5, pressure protection ×3 (Denmark)
EMERSON refrigerant filter; CASTEL safety valve (USA)
ARMAFLEX closed-cell flame-retardant pipe insulation (USA)
Leybold SV-300 vacuum pump + Cuiman RTO-300 Roots pump (8.5 kW combined)
ULVAC vacuum sensors ×2; ultimate vacuum ≤1.0 Pa; system leak rate 5×10⁻³ Pa·m³/s
SUS304 mushroom valve DN500mm main vacuum valve
German FV pneumatic stainless steel butterfly/ball valves
WILO TOP-65 circulating pump (Germany, 1 kW); silicone oil 10 cst
Electric heating via U-shaped 6 kW heating pipes (×6) with PID control
Hydraulic pressing system: REXROTH solenoid/relief/decompression valves (Germany), 2.2 kW
CIP: SSC SUS304 rotating + wide-angle nozzles; Flowserve LEM125 water-ring vacuum pump 4 kW
SIEMENS WINCC + S7-1200 PLC + 7-inch touch screen; DELL PC + 20-inch monitor
FDA 21CFR Part 11 compliant; electronic signature; 3-level user management
Multi-stage vacuum setpoint; recipe management for freeze-drying curves
Manual/automatic switching at any process node; interlock protection
Emergency hydraulic stop in sterile room
Power failure recovery: auto-resume at process point
UPS (20 min) for PLC and sensors
Validation docs: IQ/OQ/PQ, FAT/SAT, operating/maintenance/installation manuals, P&ID, electrical diagrams
Design pressure 0/−0.1 MPa; design temperature 90°C; GB150-2010 standard
Overall 8000×2200×3500 mm; ~15000 kg; 107 kW; 380V/50Hz; compressed air 0.5–0.8 MPa
CGMP compliant with full in-place CIP cleaning
High-precision ±1°C shelf temperature control (PID)
World-class components: BITZER, Alfa Laval, Danfoss, Leybold, SIEMENS
FDA 21CFR Part 11 compliant with electronic signature and audit trail
Comprehensive validation documentation package (IQ/OQ/PQ/FAT/SAT)
Power failure recovery and multi-level safety interlocks
Flexible manual/automatic operation switchable at any node
Aplicaciones
Heat-sensitive API / pharmaceutical freeze drying
Biological products (biologics, vaccines)
Collagen and protein freeze drying
Sectores
Farmacéutico
Biotechnology
Vaccine manufacturing
Marcas de componentes
Compressor
BITZER
Product temperature probes
OMEGA
Temperature sensors
OMEGA
Plate heat exchanger
Alfa Laval
Expansion valve
DANFOSS
Solenoid valve
DANFOSS
Pressure protection
DANFOSS
Refrigerant sight glass
DANFOSS
Pressure gauge
Rosenberg
Refrigerant filter
EMERSON
Safety valve
CASTEL
Pipe insulation
ARMAFLEX
Vacuum pump (SV-300)
Leybold
Roots pump (RTO-300)
Cuiman
Vacuum sensor (SWI-N1)
ULVAC
Control software (WINCC)
SIEMENS
PLC (S7-1200)
SIEMENS
Touch screen
SIEMENS
PC + Monitor
DELL
Circulating pump (TOP-65)
WILO
CIP water ring vacuum pump (LEM125)
Flowserve
SED
Hable con SED Sales Team
Especialistas en equipos · contacto por WhatsApp
Consulte el horario y la disponibilidad del equipo
Conformidad
CGMP
GB150-2010
FDA 21CFR Part 11
Limpieza y mantenimiento
CIP in-place cleaning using SSC rotating spray nozzles (SUS304) and wide-angle spray nozzles inside the drying chamber and shelf area. Cleaning, defrosting automatic drain valves prevent positive pressure buildup. Drain outlet has sampling port and filter screen. Cleaning time freely settable.
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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