SED-2XDG-B
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SED · SED-2XDG-B · 1 unidades vendidas
SED-2XDG-B — Vacuum Freeze Dryer
A descrição completa deste modelo ainda está sendo traduzida. Consulte os detalhes em inglês ou solicite informações à nossa equipe. English
SED-2XDG-B is a large-scale pharmaceutical vacuum freeze dryer with 8+1 SUS304 shelves (500 × 500 mm each, 2 m² total), built-in hydraulic stoppering system, and SIEMENS PLC+DELL PC control. Shelf temperature range: -55
Prazo de entrega
Consultar
Capacidade de produção
10–30 kg/batch
Como funciona
Product loaded on SUS304 shelves is frozen by silicon-oil (Dow Corning USA) circulation cooled by a 2-stage cascade refrigeration system (DANFOSS MTZ-050 + NTZ-068, France). The condenser (min ≤-75 °C) captures sublimated water vapor from the rectangular SUS304 drying chamber under vacuum (ultimate ≤1 Pa) maintained by a Japan ULVAC rotary-vane vacuum pump (18 m³/h). Shelf heating uses PID-controlled electric heating (3 kW) for precise temperature ramping. A Germany FV butterfly valve isolates the drying chamber from the condenser. Built-in REXROTH (Germany) hydraulic system enables in-situ stoppering of vials under vacuum. SIEMENS PLC + DELL PC with WINCC software supports automatic and full manual emergency operation, recipe management, and remote diagnostics.
Processo de funcionamento
1Product loaded on SUS304 shelves is frozen by silicon-oil (Dow Corning USA) circulation cooled by a 2-stage cascade refrigeration system (DANFOSS MTZ-050 + NTZ-068, France).
2The condenser (min ≤-75 °C) captures sublimated water vapor from the rectangular SUS304 drying chamber under vacuum (ultimate ≤1 Pa) maintained by a Japan ULVAC rotary-vane vacuum pump (18 m³/h).
3Shelf heating uses PID-controlled electric heating (3 kW) for precise temperature ramping.
4A Germany FV butterfly valve isolates the drying chamber from the condenser.
5Built-in REXROTH (Germany) hydraulic system enables in-situ stoppering of vials under vacuum.
6SIEMENS PLC + DELL PC with WINCC software supports automatic and full manual emergency operation, recipe management, and remote diagnostics.
Especificações técnicas
Especificações da variante: SED-2XDG-B
Especificações
Modelo
SED-2XDG-B
Capacidade de produção
10–30 kg/batch
Tensão
380V±10%,50Hz,3Phase,5Wire
Utilidades
Total power 8.65 kW, 380 V±10%, 50 Hz, 3-phase, 5-wire. Compressed air: ≥20 L/min at 0.5–0.8 MPa. Cooling water: ≥5 m³/h at ≤30 °C, 0.2–0.3 MPa.
Detalhes de conformidade
FDA and EU/CE compliant. Supports electronic signature and multiple password levels. IQ/OQ/FAT/SAT documentation packages available. Vacuum vessel design per standard.
Potência
8.65 kW
Pressão de ar
0.5~0.8Mpa
Dimensões
Comprimento
1500 mm
Largura
1500 mm
Altura
2300 mm
Peso
1500 kg
Área de instalação
1500 × 1500 × 2300 mm (L × W × H), approx. 1500 kg
Materiais
Materiais de contato
SUS304
Materiais do corpo
SUS304
Características principais
Total power: 8.65 kW (380 V±10%, 50 Hz, 3-phase, 5-wire)
Overall dimensions: 1500 × 1500 × 2300 mm
Machine weight: approx. 1500 kg
Shelf count: 8 + 1 (compensation shelf)
Shelf dimensions: 500 × 500 mm / δ20 mm
Total shelf area: 2 m²
Shelf spacing: 80 mm
Shelf material: SUS304, surface Ra ≤0.4 μm
Shelf temperature range: -55 °C to +80 °C
Shelf temperature uniformity: ≤±1 °C
Shelf flatness: ≤0.5 mm/m
Max water capture: ≥40 kg/batch
Condenser minimum temperature: ≤-75 °C
Condenser: horizontal cylinder, SUS304, external coil, Ra ≤0.8 μm
Ultimate vacuum: ≤1 Pa
Vacuum pump: Japan ULVAC rotary-vane, 18 m³/h, 0.75 kW
Vacuum degree: auto-controlled, 0–200 Pa adjustable
Refrigeration: DANFOSS MTZ-050 (3 kW, R404a) + NTZ-068 (1.5 kW, R23), cascade
Circulation pump: WILO TOP32 (Germany), 0.4 kW
Heat transfer medium: Dow Corning silicon oil (USA)
Shelf heating rate (no load): ≥1 °C/min
Shelf cooling rate (no load): 20 °C → -40 °C ≤60 min
Condenser cooling rate (no load): 20 °C → -40 °C ≤30 min
Hydraulic stoppering: REXROTH (Germany), 0–1.0 bar adjustable
Control: SIEMENS PLC + DELL PC, WINCC software
FDA/EU compliant, electronic signature, multi-password, multilingual interface
Remote diagnostics and control
Compressed air: ≥20 L/min at 0.5–0.8 MPa
Cooling water: ≥5 m³/h at T ≤30 °C, 0.2–0.3 MPa
FDA and CE certified — ready for regulated pharmaceutical markets
SIEMENS PLC + DELL PC with WINCC: recipe management, data logging, electronic signature, remote diagnostics
In-situ hydraulic stoppering (REXROTH Germany) for aseptic vial sealing under vacuum
Cascade DANFOSS (France) refrigeration to ≤-75 °C condenser and ≤1 Pa ultimate vacuum
±1 °C shelf uniformity and ≤0.5 mm/m flatness for consistent lyophilization results
Multi-language one-button interface switch for global operators
PID electric heating — energy-efficient, stable temperature control
WILO (Germany) leak-free, low-noise circulation pump
Aplicações
Large-scale pharmaceutical freeze-drying (vials, ampoules, bulk)
Biological products and vaccines lyophilization
API and formulation freeze-drying
GMP-compliant production freeze-drying
Setores
Farmacêutico
Biotechnology
Vaccines
Marcas dos componentes
1st-stage compressor
DANFOSS MTZ-050
2nd-stage compressor
DANFOSS NTZ-068
Oil separator
EMERSON
Pressure protection relay
Danfoss
Refrigerant sight glass
Danfoss
Dry filter
Danfoss
Expansion valve
Danfoss
Solenoid valve
Danfoss
1st water condenser
WEIYI
2nd evaporative condenser
WEIYI
Safety valve
CASTEL
Vacuum pump
ULVAC
Vacuum sensor
ULVAC SW1-N1
Vacuum pipeline valve
FV DN25
Chamber isolation valve
FV DN150
Vacuum check valve
SIEGV GYC-JQ40
Condenser drain valve
SIEGV GDC-10
Vacuum adjust valve
SIEGV GDC-8
Circulation pump
WILO TOP32
Hydraulic units
REXROTH
PLC
SIEMENS
PC
DELL
Circuit breaker
SIEMENS
AC contactor
SIEMENS
Pipe insulation
ARMAFLEX
SED
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Conformidade
FDA
CE
Limpeza e manutenção
SUS304 surfaces polished to Ra ≤0.4 μm (shelves) and Ra ≤0.8 μm (condenser). Chamber, shelves, and hoses tested through multiple procedures to ensure no leakage. Condenser interior cleaned by special method to ensure no dirt. Hot refrigerant defrost for condenser.
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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