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SED-30FDG-B(CIP)
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SED-30FDG-B(CIP)
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SED-30FDG-B(CIP) — Vacuum Freeze Dryer with CIP
A descrição completa deste modelo ainda está sendo traduzida. Consulte os detalhes em inglês ou solicite informações à nossa equipe. 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
Prazo de entrega
Consultar
Capacidade de produção
150–450 kg/batch
Como funciona
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.
Processo de funcionamento
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.
Especificações técnicas
Especificações da variante: SED-30FDG-B(CIP)
Especificações
Modelo
SED-30FDG-B(CIP)
Capacidade de produção
150–450 kg/batch
Tensão
380V/50Hz
Utilidades
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
Detalhes de conformidade
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.
Potência
107 kW
Pressão de ar
0.5-0.8Mpa
Dimensões
Comprimento
8000 mm
Largura
2200 mm
Altura
3500 mm
Peso
15000 kg
Área de instalação
8000×2200×3500 mm (L×W×H), weight ~15000 kg
Materiais
Materiais de contato
SUS304 Ra≤0.4 μm (chamber interior, shelves, condenser, all piping)
Materiais do corpo
SUS304 (chamber, condenser, door); SUS304 brushed panels (exterior); polyurethane foam insulation
Características principais
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
Aplicações
Heat-sensitive API / pharmaceutical freeze drying
Biological products (biologics, vaccines)
Collagen and protein freeze drying
Setores
Farmacêutico
Biotechnology
Vaccine manufacturing
Marcas dos 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
Fale com SED Sales Team
Especialistas em equipamentos · contato pelo WhatsApp
Consulte o horário e a disponibilidade da equipe
Conformidade
CGMP
GB150-2010
FDA 21CFR Part 11
Limpeza e manutenção
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.
Documentação
Ficha técnica (PDF)
Visão geral do equipamento, especificações e dimensões · Documento original (inglês)
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Manual do operador
Instalação, operação e diagnóstico · Documento original (inglês)
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Folha comparativa (Padrão e Econômica)
Comparação das configurações · Documento original (inglês)
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Protocolos IQ / OQ / PQ
Documentação de validação para conformidade GMP · Documento original (inglês)
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Protocolos FAT / SAT
Testes de aceitação na fábrica e no local · Documento original (inglês)
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Desenhos CAD (STEP / IGES / DWG)
Desenhos de engenharia para a instalação · Documento original (inglês)
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Certificados de calibração
Nível sonoro, resistência de terra, rigidez dielétrica e rugosidade · Documento original (inglês)
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DQ (qualificação do projeto)
Protocolo completo de qualificação do projeto · Documento original (inglês)
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Certificados de materiais
Composição do aço inoxidável 316L · Documento original (inglês)
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