SED-0.5FDG1-O
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SED-0.5FDG1-O
SED · SED-0.5FDG1-O · En vedette
SED-0.5FDG1-O — Freeze Dryer - Lyophilizer
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
The SED-0.5FDG1-O is a pharmaceutical-grade vacuum freeze dryer with 0.5 m2 of effective shelf area (3+1 shelves, 410x410 mm), air-cooled refrigeration using two France TECUMSEH full-closure compressors, and PLC-based au
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Fonctionnement
The machine freezes materials and then sublimes moisture under high vacuum (<= 5 Pa) to achieve drying without thermal damage. Two France TECUMSEH full-closure compressors provide redundant refrigeration — one dedicated to shelf indirect refrigeration and one to condenser direct refrigeration. Silicon oil circulates through shelves for precise temperature control (-50 degC to +70 degC). The cold trap (<= -75 degC no load) captures sublimated vapor (>= 8 kg capacity). High-pressure defrosting is used for condenser regeneration. The fan-cooled system requires no external cooling water.
Processus de fonctionnement
1The machine freezes materials and then sublimes moisture under high vacuum (<= 5 Pa) to achieve drying without thermal damage.
2Two France TECUMSEH full-closure compressors provide redundant refrigeration — one dedicated to shelf indirect refrigeration and one to condenser direct refrigeration.
3Silicon oil circulates through shelves for precise temperature control (-50 degC to +70 degC).
4The cold trap (<= -75 degC no load) captures sublimated vapor (>= 8 kg capacity).
5High-pressure defrosting is used for condenser regeneration.
6The fan-cooled system requires no external cooling water.
Caractéristiques techniques
Caractéristiques de la variante : SED-0.5FDG1-O
Caractéristiques
Modèle
SED-0.5FDG1-O
Fluides et énergie
6.5 kW power supply; air-cooled (no cooling water required)
Détails de conformité
Designed and manufactured per GMP, GMP Implementation Guide, and GB/T5226.1-1996; full validation documentation: IQ/OQ/PQ, FAT, SAT, OM, MM, IM, P&ID, wiring diagrams, material reports, calibration reports
Matériaux
Matériaux en contact
AISI 304 stainless steel (shelves, chamber)
Matériaux du bâti
AISI 304 acier inoxydable
Caractéristiques principales
Shelf effective area: 0.5 m2; layers: 3+1 (top as temperature compensating/radiation plate); shelf size: 410x410 mm; shelf spacing: 100 mm (max)
Shelf temperature range: -50 degC to +70 degC (no load); shelf temperature error: <= +-1 degC (in balance)
Shelf flatness: <= +-0.5 mm/m; shelf surface roughness: Ra <= 0.6 um; top/bottom panel thickness: 5 mm
Shelf cooling rate: +20 degC to -40 degC within 60 min (no load, silicon oil inlet); heating rate: -40 degC to +20 degC within 60 min
Shelf min temperature: <= -50 degC (no load); shelf max temperature: >= +70 degC (no load)
Condenser min temperature: <= -75 degC (no load); water capture: >= 8 kg; cooling rate: +20 degC to -40 degC within 30 min
Condenser shape: cylindrical (vertical) — compact, good water capture, easy defrost and cleaning
High-pressure defrosting; air cooling (fan) — no external cooling water required
Ultimate vacuum: <= 5 Pa; chamber roughness: Ra <= 0.6 um; polyurethane foam insulation
Chamber material: AISI 304 stainless steel; door: Acrylic; clockwise door opening
Shelf material: AISI 304 SS; proprietary internal-welding patent technology
Refrigeration: 2 x France imported TECUMSEH full-closure compressors (1 shelf indirect, 1 condenser direct)
Installed power: 6.5 kW (installation power, not running power)
Vial capacity: >= 3,538 phi12 (2 mL), >= 1,990 phi16 (5 mL), >= 1,052 phi22 (10 mL)
Liquid material capacity: 6 L (10 mm material depth)
Dimensions (W x D x H): ~980 x 1,570 x 1,970 mm; weight: ~800 kg; noise: <= 80 dB
Control: Manual + Automatic modes; sensor calibration; intelligent temperature control; drying termination reminder
GMP and GB/T5226.1-1996 design/manufacturing standards; grounding protection electrical system
Air-cooled design — no external cooling water needed, simplified installation
Proprietary internal-welding shelf technology for superior flatness and cleanliness
Dual-compressor redundant refrigeration (separate shelf and condenser circuits) for reliability
Handles phi12/phi16/phi22 vials — versatile for multiple vial sizes
Manual + automatic control with sensor calibration and intelligent temperature management
Applications
Pharmaceutical vial lyophilization
Pilot and production freeze-drying of heat-sensitive biologics and pharmaceuticals
Secteurs
Pharmaceutique
Biotechnology
SED
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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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