Inicio / Equipos / Liofilizador con taponado automático — grande (FDG) / Vacuum Freeze Dryer (Lyophilizer)
SED-50FDG-B
Consultar
SED-50FDG-B
SED · SED-50FDG-B · Destacado
SED-50FDG-B — Vacuum Freeze Dryer
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SED-50FDG-B CIP Vacuum Freeze Dryer. Industrial-scale pharmaceutical lyophilizer compliant with CGMP and FDA 21 CFR Part 11. Drying capacity 1000 kg/batch. Shelf heating precision ±1°C (PID). Advanced SIEMENS PLC/HMI con
Plazo de entrega
Consultar
Capacidad de producción
1000 kg/batch
Funcionamiento
Vacuum freeze drying (lyophilization): the product is first frozen, then water is removed by sublimation under vacuum, preserving product stability and biological activity.
Proceso de funcionamiento
1Vacuum freeze drying (lyophilization): the product is first frozen, then water is removed by sublimation under vacuum, preserving product stability and biological activity.
Especificaciones técnicas
Especificaciones de la variante: SED-50FDG-B
Especificaciones
Modelo
SED-50FDG-B
Capacidad de producción
1000 kg/batch
Tensión
380V/50Hz
Suministros
Cooling water, Compressed air (0.5-0.8 MPa), Clean water, Defrost water
Potencia
226 kW
Presión de aire
0.5-0.8Mpa
Dimensiones
Longitud
8500 mm
Anchura
2700 mm
Altura
5000 mm
Peso
25000 kg
Materiales
Materiales en contacto
SUS304 acero inoxidable
Materiales del cuerpo
SUS304 acero inoxidable
Características principales
All stainless steel plates from premium brands, precision-polished to specified surface roughness — ensuring sterility requirements
3D design fully compliant with CGMP sterilization requirements
Chamber, shelves, and flexible hoses inspected through multiple quality procedures to guarantee leak-free performance
Shelves of very high strength for long-term use
Shelves precision-machined to guarantee high-requirement flatness
Shelf heating temperature control precision plus/minus 1 degree C (PID regulation)
Compressor: German BITZER single-stage screw refrigeration compressor — more stable, reliable, easy to maintain
Compressor temperature and pressure multi-point protection
Environmentally-friendly refrigerant compliant with Montreal Protocol
World-class brand vacuum pump for reliably stable operation
High-performance vacuum pump check-valve synchronized with vacuum pump — prevents oil back-flow under atmospheric pressure when pump is stopped
Multi-stage vacuum set-point function — multiple variable vacuum control within one freeze-drying cycle
All piping fully auto-welded — clean internal and external surfaces guaranteed
Back-pressure system with interface port enabling in-place manual filter testing
Electric heating uses PID energy-regulation control — energy-saving and temperature-stable
Compliant with FDA / EU standards; electronic signatures; multi-level password management
Seamless switching between automatic and manual operation at any process point
One-touch system health check — provides data assurance for freeze-dryer health
System operable from equipment room or freeze-drying control room, with mutual interlocking to prevent misoperation
Aseptic room fitted with hydraulic emergency-stop button for forced shelf-stop in emergencies
Friendly HMI displays status of all components plus key temperature and vacuum parameters
Process Recipe Management for freely customizable freeze-drying process curves
Freeze Drying automatic process with stage display and free skip-step capability
Recipe can be adjusted at any time during Freeze Drying process
Operation screen shows all fault points
Dual record modes: data and curve; recallable or printable by batch number
Freeze-drying data and curve records storable at will
Each vacuum / temperature curve displayed in multiple colors; individually show/hide settable
Clean-in-Place (CIP) operable in both automatic and manual modes
Sterilize-in-Place (SIP) with safety interlock; pulse pre-heating sterilization
Software functions expandable per customer requirements
Software system compliant with FDA 21 CFR Part 11
Electronic signatures; three-level user permission management; curve reports tamper-proof
Power-failure protection: on power restoration the control system auto-locates the process point at power loss, restores all systems to that state, and resumes the interrupted process
Compliant with CGMP standards
Large-batch drying capacity (1000 kg/batch)
Advanced control system
Precise freeze-drying process
CIP (Clean-in-Place) system
Stainless steel construction
Energy-efficient
Multi-point protection
Compliant with FDA standards
Aplicaciones
Pharmaceutical lyophilization
Freeze-dried injectables
Freeze-dried powder for injection
Biological product lyophilization
Sectores
Farmacéutico
Marcas de componentes
Compressor
BITZER
Plate heat exchanger
Alfa Laval
Expansion valve
DANFOSS
Solenoid valve
DANFOSS
Pressure protection device
DANFOSS
Refrigerant sight glass
DANFOSS
Pressure gauge
Rosenberg
Refrigerant filter
EMERSON
Safety valve
CASTEL
Vacuum pump
ULVAC
Roots pump
Cuiman
Temperature sensor
OMEGA
Circulation pump
WILO
Control software / PLC / HMI touch screen / circuit breaker / AC contactor
SIEMENS
UPS
DELL
SED
Hable con SED Sales Team
Especialistas en equipos · contacto por WhatsApp
Consulte el horario y la disponibilidad del equipo
Conformidad
CGMP
FDA 21 CFR Part 11
Limpieza y mantenimiento
CIP system used for in-place cleaning of drying chamber and shelves; automatic and manual modes available.
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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