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SED-40SDG-B
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SED-40SDG-B
SED · SED-40SDG-B · En vedette

SED-40SDG-B — Vacuum Freeze Dryer

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

SED-40SDG-B large-capacity pharmaceutical vacuum freeze dryer with split horizontal drum-type chamber. Capacity 600 kg/batch; designed and built to CGMP standards with FDA-compliant electronic records. Includes cold stor

CGMPFDA
Délai de livraison
Sur devis
Cadence
200–600 kg/batch

Fonctionnement

Product is loaded onto shelves inside the horizontal drum-type vacuum chamber. In the freezing phase, shelf temperature is reduced to freeze the product solid. The chamber is then evacuated to below the triple point of water; shelf temperature is raised gradually to supply sublimation energy. Ice sublimes directly to vapour, which is captured by the condenser (cooled by BITZER compressor system). Condenser pressure is monitored by ULVAC vacuum sensors. Product temperature is tracked by Omega PT probes on the shelves. After primary drying (sublimation) and secondary drying (desorption), the chamber is backfilled and the product is discharged. The system may be operated from either the machine room or the freeze-drying control room; both stations have mutual interlock to prevent misoperation.

Processus de fonctionnement
1Product is loaded onto shelves inside the horizontal drum-type vacuum chamber.
2In the freezing phase, shelf temperature is reduced to freeze the product solid.
3The chamber is then evacuated to below the triple point of water; shelf temperature is raised gradually to supply sublimation energy.
4Ice sublimes directly to vapour, which is captured by the condenser (cooled by BITZER compressor system).
5Condenser pressure is monitored by ULVAC vacuum sensors.
6Product temperature is tracked by Omega PT probes on the shelves.
7After primary drying (sublimation) and secondary drying (desorption), the chamber is backfilled and the product is discharged.
8The system may be operated from either the machine room or the freeze-drying control room; both stations have mutual interlock to prevent misoperation.

Caractéristiques techniques

Caractéristiques de la variante : SED-40SDG-B

Caractéristiques

Modèle
SED-40SDG-B
Cadence
200–600 kg/batch
Tension
380V/50Hz
Fluides et énergie
Compressed air (0.5–0.8 MPa), Cooling water, Defrost water
Puissance
108.5 kW
Pression d’air
0.5-0.8Mpa

Dimensions

Longueur
7000 mm
Largeur
2200 mm
Hauteur
3200 mm
Poids
10000 kg
Emprise au sol
7000 × 2200 mm (L × W); height 3200 mm

Matériaux

Matériaux en contact
SUS304 acier inoxydable
Matériaux du bâti
SUS304 acier inoxydable

Caractéristiques principales

600 kg/batch high-capacity horizontal drum-type vacuum chamber (split structure)
CGMP-compliant: all stainless steel chamber, shelves and flexible hoses; precision-polished interior surface for sterility
Chamber bottom free of all internal components — easy to clean and maintain
Chamber, shelves and flexible hoses all multi-stage leak-tested to ensure zero leakage
Entire cold-storage structure in stainless steel
FDA/EU-standard electronic signatures and multi-level password management
Automatic and manual modes switchable at any point in the process
Dual-station control (machine room + freeze-dry control room) with mutual interlock against misoperation
HMI displays real-time status of all components, key subsystem states, temperature and vacuum parameters
Meets FDA and EU CGMP standards with electronic signatures and multi-level password protection
Seamless auto/manual mode switching at any process step for maximum operational flexibility
Dual-station control with mutual interlock for safe GMP operation
User-friendly HMI with full component status, temperature and vacuum display

Applications

Large-scale pharmaceutical freeze drying (APIs, biologics, injectables)
Pharmaceutical bulk production freeze drying

Secteurs

Pharmaceutique

Marques des composants

Product Temperature Probe
Omega
Vacuum Sensor
ULVAC
Compressor
BITZER
Oil Separator
Hangzhou Safety Equipment Co., Ltd.
Economiser Plate Heat Exchanger
ALFA LAVAL
Pressure Protection Device
DANFOSS
Refrigerant Filter
EMERSON
PLC
SIEMENS
SED
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Conformité

CGMP
FDA

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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