Accueil / Équipements / Lyophilisateur à bouchage automatique — grand (FDG) / Freeze dryer — rectangular vacuum freeze drying machine with CIP (pharmaceutical grade)
SED-20FDG-B(CIP)
Sur devis
SED-20FDG-B(CIP)
SED · SED-20FDG-B(CIP) · En vedette
SED-20FDG-B(CIP) — rectangular vacuum freeze drying machine with CIP
La description complète de ce modèle est encore en cours de traduction. Consultez les détails en anglais ou demandez des informations à notre équipe. 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
Délai de livraison
Sur devis
Cadence
42000–84000 pièces/h
Fonctionnement
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.
Processus de fonctionnement
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.
Caractéristiques techniques
Caractéristiques de la variante : SED-20FDG-B(CIP)
Caractéristiques
Modèle
SED-20FDG-B(CIP)
Cadence
42000–84000 pièces/h
Tension
380V/50Hz
Fluides et énergie
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)
Détails de conformité
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.
Puissance
84 kW
Pression d’air
0.5-0.8Mpa
Dimensions
Longueur
5800 mm
Largeur
2200 mm
Hauteur
3600 mm
Poids
12000 kg
Emprise au sol
5800×2200 mm footprint (plus access clearance per layout drawing)
Matériaux
Matériaux en contact
SUS304 (chamber, shelves, condenser, piping); SUS316L (freeze-drying trays)
Matériaux du bâti
SUS304
Caractéristiques principales
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
Applications
Pharmaceutical vial freeze-drying (Ф16 mm and Ф22 mm vials)
Pharmaceutical product preservation
Secteurs
Pharmaceutique
Marques des composants
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
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Spécialistes des équipements · contact sur WhatsApp
Consultez les horaires et la disponibilité de l’équipe
Conformité
CGMP
GB150-2010
Nettoyage et entretien
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.
Documentation
Fiche technique (PDF)
Aperçu de l’équipement, caractéristiques et dimensions · Document d’origine (anglais)
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Manuel opérateur
Installation, fonctionnement et dépannage · Document d’origine (anglais)
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Fiche comparative (Standard et Économique)
Comparaison des configurations · Document d’origine (anglais)
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Protocoles IQ / OQ / PQ
Documentation de validation pour la conformité GMP · Document d’origine (anglais)
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Protocoles FAT / SAT
Essais de réception en usine et sur site · Document d’origine (anglais)
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Plans CAD (STEP / IGES / DWG)
Plans d’ingénierie pour l’implantation · Document d’origine (anglais)
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Certificats d’étalonnage
Niveau sonore, résistance de terre, rigidité diélectrique et rugosité · Document d’origine (anglais)
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DQ (qualification de la conception)
Protocole complet de qualification de la conception · Document d’origine (anglais)
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Certificats matières
Composition de l’acier inoxydable 316L · Document d’origine (anglais)
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