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SED-20FDG-B(CIP)
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SED-20FDG-B(CIP)
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SED-20FDG-B(CIP) — rectangular vacuum freeze drying machine with CIP
A descrição completa deste modelo ainda está sendo traduzida. Consulte os detalhes em inglês ou solicite informações à nossa equipe. 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
Prazo de entrega
Consultar
Capacidade de produção
42000–84000 unidades/h
Como funciona
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.
Processo de funcionamento
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.
Especificações técnicas
Especificações da variante: SED-20FDG-B(CIP)
Especificações
Modelo
SED-20FDG-B(CIP)
Capacidade de produção
42000–84000 unidades/h
Tensão
380V/50Hz
Utilidades
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)
Detalhes de conformidade
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.
Potência
84 kW
Pressão de ar
0.5-0.8Mpa
Dimensões
Comprimento
5800 mm
Largura
2200 mm
Altura
3600 mm
Peso
12000 kg
Área de instalação
5800×2200 mm footprint (plus access clearance per layout drawing)
Materiais
Materiais de contato
SUS304 (chamber, shelves, condenser, piping); SUS316L (freeze-drying trays)
Materiais do corpo
SUS304
Características principais
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
Aplicações
Pharmaceutical vial freeze-drying (Ф16 mm and Ф22 mm vials)
Pharmaceutical product preservation
Setores
Farmacêutico
Marcas dos 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
Fale com SED Sales Team
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Consulte o horário e a disponibilidade da equipe
Conformidade
CGMP
GB150-2010
Limpeza e manutenção
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.
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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