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SED-0.5FDG-Z
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SED-0.5FDG-Z
SED · SED-0.5FDG-Z · Hervorgehoben
SED-0.5FDG-Z — Freeze Dryer - Lyophilizer
Die vollständige Beschreibung dieses Modells wird noch übersetzt. Lesen Sie die englischen Details oder fragen Sie unser Team nach weiteren Informationen. English
The SED-0.5FDG-Z is a GMP/FDA/CE-certified pharmaceutical production vacuum freeze dryer with 0.5 m2 of shelf area (3+1 shelves,410x410 mm),featuring fully integrated CIP (Clean-in-Place) and SIP (Steam-in-Place) systems
Lieferzeit
Auf Anfrage
Durchsatz
10–100 Flaschen/min
Funktionsweise
To reduce material loss risk while lowering operating costs, the freeze dryer vacuum, refrigeration, and circulation systems each employ a dual-system configuration with mutual backup. If one unit fails, the other starts automatically to ensure the freeze-drying program is completed. PID-regulated silicon oil circulation controls shelf temperature. Two BITZER single-machine two-stage refrigeration compressors provide redundant cooling for the shelf (indirect refrigeration) and condenser (direct refrigeration). Two dual-stage rotary vane vacuum pumps (Leybold, Germany) maintain system vacuum. The CIP system uses standard + wide-angle + ball-type spray nozzles for dead-angle-free cleaning. The SIP system achieves sterilization at 121 degC using pulsed negative-pressure steam delivery.
Prozessbeschreibung
1To reduce material loss risk while lowering operating costs, the freeze dryer vacuum, refrigeration, and circulation systems each employ a dual-system configuration with mutual backup.
2If one unit fails, the other starts automatically to ensure the freeze-drying program is completed.
3PID-regulated silicon oil circulation controls shelf temperature.
4Two BITZER single-machine two-stage refrigeration compressors provide redundant cooling for the shelf (indirect refrigeration) and condenser (direct refrigeration).
5Two dual-stage rotary vane vacuum pumps (Leybold, Germany) maintain system vacuum.
6The CIP system uses standard + wide-angle + ball-type spray nozzles for dead-angle-free cleaning.
7The SIP system achieves sterilization at 121 degC using pulsed negative-pressure steam delivery.
Technische Daten
Technische Daten für Variante: SED-0.5FDG-Z
Technische Daten
Modell
SED-0.5FDG-Z
Durchsatz
10–100 Flaschen/min
Spannung
380V
Versorgung
380 V 3-phase 5-wire 10 kW power; compressed air 0.7 MPa 20 L/min; cooling water 5 m3/h; steam 130 degC 0.4 MPa 500 kg/batch; defrost water 500 L/batch at 65 degC; jacket cooling water ~1 m3
Konformitätsangaben
FDA 21 CFR Part 11 compliant control software; IQ/OQ/PQ validation documents; GMP and GB/T5226.1-1996 design/manufacturing standards
Leistung
10 kW
Luftdruck
0.7Mpa
Abmessungen
Länge
1800 mm
Breite
1100 mm
Höhe
2000 mm
Gewicht
1800 kg
Werkstoffe
Kontaktwerkstoffe
316L stainless steel (chamber inner, shelf); AISI 304 SS (condenser, cold trap coil)
Gehäusewerkstoffe
304 stainless steel (outer); 316L stainless steel (chamber, shelf)
Wesentliche Merkmale
Shelf effective area: 0.5 m2; layers: 3+1 (top as radiation/compensating layer); shelf size: 410x410 mm; shelf spacing: 80 mm
Shelf temperature range: -55 degC to +80 degC (no load); condenser minimum temperature: <= -75 degC (no load)
Ultimate vacuum: <= 1 Pa (no load); system leak rate: <= 5x10^-3 Pa.m3/sec
Shelf temperature control accuracy: +-0.5 degC (PID regulated); shelf temperature uniformity: <= +-1 degC (stabilized)
Shelf flatness: <= +-0.5 mm/m; shelf withstands pressure test up to 0.3 MPa
Dual-redundant refrigeration: 2 x BITZER S4T-5.2Y single-machine two-stage compressors; R507/R404A refrigerants; water-cooled condenser (Nanjing Jindian); cooling water 5 m3/h
Dual-redundant vacuum: 2 x dual-stage rotary vane vacuum pumps (Leybold, Germany)
Dual-redundant circulation: 2 x Grundfos (Denmark) wet-rotor canned circulating pumps; silicon oil (25 degC, 10 cst); heating power 3.2 kW; solid-state relay control
Hydraulic stoppering: cylinder at top of chamber; adjustable stoppering pressure 0-1.0 bar; ROKEN hydraulic valves; IFM/HUBA pressure sensors
CIP system: standard + wide-angle + ball-type spray nozzles (316L SS); ~80 L/min water consumption; alternating left/right shelf nozzle; nitrogen charging valve
SIP system: pulsed negative-pressure steam delivery; sterilization at 121 degC; 30 degC to 121 degC within 30 min; jacket water cooling for chamber
Special O-type door seal to prevent water accumulation and ensure sterility
Chamber, shelves, and flexible hoses leak-tested by helium mass spectrometer
Control: SH-HPSC-IV cabinet; MCGS touch screen; Dell computer (Hite software); SANTAK UPS (sustains PLC 20 min after power failure)
FDA 21 CFR Part 11 compliant; electronic signatures; three-tier user access; unmodifiable curve reports
Unlimited recipe management; stage-jump function; real-time recipe adjustment during process
Complete batch record printing (process recipe, data curves, history, operation/alarm logs)
IQ/OQ/PQ, FAT, SAT validation documentation provided
Contact material: 316L stainless steel (chamber, shelf); outer: 304 SS; cold trap: AISI 304 SS
Dimensions (L x W x H): ~1,800 x 1,100 x 2,000 mm; weight: ~1,800 kg; installed power: 10 kW
Power: 3-phase 5-wire 380 V; compressed air: 0.7 MPa 20 L/min; steam: 130 degC 0.4 MPa
Complies with FDA/EU standards; electronic signature; multi-group password protection
System operation from cleanroom, machine room, or freeze-drying control room with mutual interlocking
User-friendly HMI showing all component/valve status, temperature and vacuum parameters
Recipe management for unlimited freeze-drying process curves
Stage display and arbitrary stage-jump function during freeze-drying
Real-time recipe adjustment during freeze-drying process
Alarm display for all fault points on operation screen
Data and curve recording functions; callable and printable by batch number
Multi-color vacuum/temperature curve display with show/hide toggle per channel
Complete batch record printing after freeze-drying completion
Online CIP with fully automatic control
FDA 21 CFR Part 11 compliant software; unmodifiable curve reports
Electronic signatures; three-tier user access management
UPS emergency power sustains PLC and sensors for 20 min after power failure
Anwendungen
Pharmaceutical vial lyophilization
Biopharmaceuticals
Branchen
Pharma
Komponentenhersteller
BITZER
DANFOSS
Castel
DANFOSS
ZOER
DANFOSS
DANFOSS
DANFOSS
DANFOSS
BITZER
DANFOSS
DANFOSS
DANFOSS
LR/REFCO
ZOER
ROKEN
IFM/HUBA
SH-HPSC-IV
MCGS
UPS
SANTAK
CHINT
CHINT
CHINT
SED
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Konformität
GMP
CE
FDA
ISO 9001
Reinigung und Wartung
In-place CIP: standard + wide-angle + ball-type spray nozzles ensure no dead corners inside chamber. Intermittent cleaning mode ensures pressure and effectiveness while reducing cost. Water consumption ~80 L/min.
Dokumentation
Datenblatt (PDF)
Überblick, technische Daten und Abmessungen · Originaldokument (Englisch)
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Bedienhandbuch
Einrichtung, Betrieb und Fehlersuche · Originaldokument (Englisch)
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Vergleichsdatenblatt (Standard und Economy)
Vergleich der Konfigurationen · Originaldokument (Englisch)
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IQ / OQ / PQ-Protokolle
Validierungsunterlagen zur GMP-Konformität · Originaldokument (Englisch)
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FAT / SAT-Protokolle
Abnahmeprüfungen im Werk und vor Ort · Originaldokument (Englisch)
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CAD-Zeichnungen (STEP / IGES / DWG)
Konstruktionszeichnungen für die Aufstellung · Originaldokument (Englisch)
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Kalibrierzertifikate
Schallpegel, Erdungswiderstand, Spannungsfestigkeit und Rauheit · Originaldokument (Englisch)
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DQ (Designqualifizierung)
Vollständiges Designqualifizierungsprotokoll · Originaldokument (Englisch)
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Werkstoffzeugnisse
Zusammensetzung des Edelstahls 316L · Originaldokument (Englisch)
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