Accueil / Équipements / Lyophilisateur à bouchage automatique — grand (FDG) / Vacuum Freeze Dryer (Lyophilizer)

SED-50FDG-B

Sur devis

SED-50FDG-B

SED · SED-50FDG-B · En vedette

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

CGMPFDA 21 CFR Part 11

Délai de livraison

Sur devis

Cadence

1000 kg/batch

Fonctionnement

Vacuum freeze drying (lyophilization): the product is first frozen, then water is removed by sublimation under vacuum, preserving product stability and biological activity.

Processus de fonctionnement

1Vacuum freeze drying (lyophilization): the product is first frozen, then water is removed by sublimation under vacuum, preserving product stability and biological activity.

Caractéristiques techniques

Caractéristiques de la variante : SED-50FDG-B

Caractéristiques

Modèle

SED-50FDG-B

Cadence

1000 kg/batch

Tension

380V/50Hz

Fluides et énergie

Cooling water, Compressed air (0.5-0.8 MPa), Clean water, Defrost water

Puissance

226 kW

Pression d’air

0.5-0.8Mpa

Dimensions

Longueur

8500 mm

Largeur

2700 mm

Hauteur

5000 mm

Poids

25000 kg

Matériaux

Matériaux en contact

SUS304 acier inoxydable

Matériaux du bâti

SUS304 acier inoxydable

Caractéristiques 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

Applications

Pharmaceutical lyophilization

Freeze-dried injectables

Freeze-dried powder for injection

Biological product lyophilization

Secteurs

Pharmaceutique

Marques des composants

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

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Conformité

CGMP

FDA 21 CFR Part 11

Nettoyage et entretien

CIP system used for in-place cleaning of drying chamber and shelves; automatic and manual modes available.