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SED-30FDG-B(CIP)

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SED-30FDG-B(CIP)

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SED-30FDG-B(CIP) — Vacuum Freeze Dryer with CIP

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SED-30FDG-B（CIP）vacuum freeze dryer — a CGMP-compliant pharmaceutical freeze dryer with in-place cleaning (CIP). Integral rectangular drying chamber plus rectangular cold trap; 30 m² total shelf area (10+1 layers, 1200×2

CGMPGB150-2010FDA 21CFR Part 11

Délai de livraison

Sur devis

Cadence

150–450 kg/batch

Fonctionnement

Vacuum freeze drying: product is first frozen below its eutectic or glass transition temperature, then placed in a vacuum chamber where pressure is reduced below the triple point of water. Shelf heating (electric, PID-controlled, ±1°C precision) sublimes ice directly to vapor without liquid phase; sublimed vapor is captured by the cold condenser (≤-55°C). A BITZER screw compressor cools both shelves and condenser via silicone oil circulation and refrigerant circuits. The Leybold vacuum pump + Cuiman Roots pump maintains chamber vacuum to ≤1.0 Pa. The CIP system cleans the drying chamber and shelves in place using SSC rotating and wide-angle spray nozzles.

Processus de fonctionnement

1Vacuum freeze drying: product is first frozen below its eutectic or glass transition temperature, then placed in a vacuum chamber where pressure is reduced below the triple point of water.

2Shelf heating (electric, PID-controlled, ±1°C precision) sublimes ice directly to vapor without liquid phase; sublimed vapor is captured by the cold condenser (≤-55°C).

3A BITZER screw compressor cools both shelves and condenser via silicone oil circulation and refrigerant circuits.

4The Leybold vacuum pump + Cuiman Roots pump maintains chamber vacuum to ≤1.0 Pa.

5The CIP system cleans the drying chamber and shelves in place using SSC rotating and wide-angle spray nozzles.

Caractéristiques techniques

Caractéristiques de la variante : SED-30FDG-B(CIP)

Caractéristiques

Modèle

SED-30FDG-B(CIP)

Cadence

150–450 kg/batch

Tension

380V/50Hz

Fluides et énergie

Cooling water ≥50 m³/h (T≤30°C, P=0.15–0.2 MPa); compressed air ≥0.1 m³/min (P=0.5–0.8 MPa); clean water ≥200 L/min (T=80°C, P≥0.4–0.5 MPa); defrost water 1500 kg/batch (T=60°C); electrical supply 380V/50Hz, 107 kW

Détails de conformité

Drying chamber and condenser designed and manufactured per GB150-2010 pressure vessel standard. Control software compliant with FDA 21CFR Part 11 (electronic signatures, audit trail, 3-level user management). CGMP compliant design.

Puissance

107 kW

Pression d’air

0.5-0.8Mpa

Dimensions

Longueur

8000 mm

Largeur

2200 mm

Hauteur

3500 mm

Poids

15000 kg

Emprise au sol

8000×2200×3500 mm (L×W×H), weight ~15000 kg

Matériaux

Matériaux en contact

SUS304 Ra≤0.4 μm (chamber interior, shelves, condenser, all piping)

Matériaux du bâti

SUS304 (chamber, condenser, door); SUS304 brushed panels (exterior); polyurethane foam insulation

Caractéristiques principales

CGMP 3D design with complete sterilization compliance

SUS304 Ra≤0.4 μm inner surface, precision polished

30 m² shelf area; 10+1 layers at 1200×2500 mm; 80 mm spacing; ≥450 kg/batch

Shelf temperature -50 to +80°C; uniformity ±1°C (PID)

Shelf heating rate -40°C → 20°C ≤60 min

Shelf flatness ≤±0.5 mm/m (precision machined)

Anti-bottle/tray fall protection rack on shelves

4 × OMEGA USA thermocouple product temperature probes

Condenser minimum ≤-55°C; cooling rate 20°C→-40°C ≤30 min

S-type coil condenser; mist spray + immersion defrosting

BITZER HSN7471-7 single-stage screw compressor 55 kW (Germany)

R404A refrigerant (Montreal Protocol compliant)

Alfa Laval plate heat exchanger (Sweden)

Danfoss expansion valves ×5, solenoid valves ×5, pressure protection ×3 (Denmark)

EMERSON refrigerant filter; CASTEL safety valve (USA)

ARMAFLEX closed-cell flame-retardant pipe insulation (USA)

Leybold SV-300 vacuum pump + Cuiman RTO-300 Roots pump (8.5 kW combined)

ULVAC vacuum sensors ×2; ultimate vacuum ≤1.0 Pa; system leak rate 5×10⁻³ Pa·m³/s

SUS304 mushroom valve DN500mm main vacuum valve

German FV pneumatic stainless steel butterfly/ball valves

WILO TOP-65 circulating pump (Germany, 1 kW); silicone oil 10 cst

Electric heating via U-shaped 6 kW heating pipes (×6) with PID control

Hydraulic pressing system: REXROTH solenoid/relief/decompression valves (Germany), 2.2 kW

CIP: SSC SUS304 rotating + wide-angle nozzles; Flowserve LEM125 water-ring vacuum pump 4 kW

SIEMENS WINCC + S7-1200 PLC + 7-inch touch screen; DELL PC + 20-inch monitor

FDA 21CFR Part 11 compliant; electronic signature; 3-level user management

Multi-stage vacuum setpoint; recipe management for freeze-drying curves

Manual/automatic switching at any process node; interlock protection

Emergency hydraulic stop in sterile room

Power failure recovery: auto-resume at process point

UPS (20 min) for PLC and sensors

Validation docs: IQ/OQ/PQ, FAT/SAT, operating/maintenance/installation manuals, P&ID, electrical diagrams

Design pressure 0/−0.1 MPa; design temperature 90°C; GB150-2010 standard

Overall 8000×2200×3500 mm; ~15000 kg; 107 kW; 380V/50Hz; compressed air 0.5–0.8 MPa

CGMP compliant with full in-place CIP cleaning

High-precision ±1°C shelf temperature control (PID)

World-class components: BITZER, Alfa Laval, Danfoss, Leybold, SIEMENS

FDA 21CFR Part 11 compliant with electronic signature and audit trail

Comprehensive validation documentation package (IQ/OQ/PQ/FAT/SAT)

Power failure recovery and multi-level safety interlocks

Flexible manual/automatic operation switchable at any node

Applications

Heat-sensitive API / pharmaceutical freeze drying

Biological products (biologics, vaccines)

Collagen and protein freeze drying

Secteurs

Pharmaceutique

Biotechnology

Vaccine manufacturing

Marques des composants

Compressor

BITZER

Product temperature probes

OMEGA

Temperature sensors

OMEGA

Plate heat exchanger

Alfa Laval

Expansion valve

DANFOSS

Solenoid valve

DANFOSS

Pressure protection

DANFOSS

Refrigerant sight glass

DANFOSS

Pressure gauge

Rosenberg

Refrigerant filter

EMERSON

Safety valve

CASTEL

Pipe insulation

ARMAFLEX

Vacuum pump (SV-300)

Leybold

Roots pump (RTO-300)

Cuiman

Vacuum sensor (SWI-N1)

ULVAC

Control software (WINCC)

SIEMENS

PLC (S7-1200)

SIEMENS

Touch screen

SIEMENS

PC + Monitor

DELL

Circulating pump (TOP-65)

WILO

CIP water ring vacuum pump (LEM125)

Flowserve

SED

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Conformité

CGMP

GB150-2010

FDA 21CFR Part 11

Nettoyage et entretien

CIP in-place cleaning using SSC rotating spray nozzles (SUS304) and wide-angle spray nozzles inside the drying chamber and shelf area. Cleaning, defrosting automatic drain valves prevent positive pressure buildup. Drain outlet has sampling port and filter screen. Cleaning time freely settable.