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FD-20L-TP Freeze Dryer

The Vikumer FD-20L-TP pharmaceutical lyophilizer was designed for commercial mass manufacturing of vaccines. Large capacity with 19.8sq.m shelves area for vials loading. The hydraulic stoppering system enable to cap the vials after lyophilization finish, under vacuum environment or after inert gas backfill.

2R

OD16mm *76725Pcs

6R

OD22mm *40392Pcs

10R

OD24mm *34100Pcs

FD-20L-TP Pharmaceutical Stoppering Lyophilizer
FD-20L-TP Pharmaceutical Stoppering Lyophilizer Controller Room View

Parameters

Shelves Area 19.8m2
Shelves Temp. -55C to +70C
Ice Condenser -85C, 400L
Final Vacuum <1Pa
Installed Size 2300*7000*3500mm
Power 85Kw

Main Features

Shelves

11 + 1 Plates, Total area 19.8m2.

Condenser

External condenser with isolator.

Control

PC Software, Meet 21CFR Part11.

Design

Meet cGMP, with super craftsmanship.

Configuration

Customizable based on URS.

Technical Details

FDL-TP Stoppering Freeze Dryer Shelves Arrangement

Designing Applications

The Vikumer pharmaceutical lyophilizers are cost effective freeze drying solutions, which can be addressed to all pharmaceutical lyophilization applications. Include both injectable formulation freeze drying and bulk material freeze drying.

Offer standard configuration as well as customized accessories and functions. Here is the summary of our standard machines.

Machinery Structure

Drying Chamber and Door

Pressure vessel rated rectangular shape drying chamber. Stainless steel 316L made and surface mirror polished. Inner corners are rounded for easy cleaning.

Hinged door is fully Insulated, with viewing port. Door decoration panel for clean room mount is stainless steel 304 made.

External Condenser

Both condenser chamber and condensing coils are S/S316L made, surface mirror polished. Condenser bottom is sloped for water easy draining.

Isolate of the condenser is a butterfly valve, pneumatically operated.

Shelves and Trays

Flexible shelf module, hydraulic stoppering device. All plates are mirror polished roughness better than 0.6um, flatness better than 0.5mm/m.

Construction

Condenser and drying chamber connect can be vertical or horizontal. Drying chamber is rectangular, condenser chamber can be cylindrical or rectangular shape.

System Specifications

Vacuum System

The vacuum pumps installed in pharmaceutical freeze dry system is 2-stage oil sealed pumps and roots pump combination.

Each vacuum pump has individual isolation valve, and is pneumatically operated. Capable of automatic close once electric interrupt.

Refrigeration System

Water cooling method, Bitzer 2-stage compressor system.

Shelves Heating System

Fluid circulates inside sandwich type plates, which can be heated or chilled. Brazed plate heat exchanger and fluid transfer pump is installed to guarantee the evenly temperature of shelves.

Controller and Measuring Apparatus

Temperature Sensors

PT100A probes for fluid, shelves, products and condenser coils temperature measure and control.

Vacuum Gauges

Pirani type vacuum gauges for drying chamber and vacuum system.

Controller

Based on PC, PLC and user friendly HMI. Meet 21 CFR PART 11 guidelines.

  • Users and authorization management.
  • Batch report generate and auto save.
  • Freeze drying recipes management.
  • Graphic display system working status.
  • Real-time freeze drying curve.
  • Automatic and semi-automatic working.
  • Alarms and debug model.
Valves

All the valves that use to isolate air and water are pneumatically operated, which include:

  • Vacuum pumps isolate, vacuum adjust, vacuum break.
  • Condenser isolation valve.
  • CIP and SIP related valves.
  • Condenser defrost water supply/draining/overflow.

Options and Accessories

  • Backup units for key parts (compressor, vacuum pump, fluid pump)
  • Dry type vacuum pumps.
  • PC control and software authorization.
  • CIP, SIP
  • Variable shelves spacing.
  • Pneumatic door lock.
  • Door lock sensor.
  • Capacitive vacuum gauge.
  • Air filters.
  • Lyophilizer documents (Validation package IQ, O/PQ, FAT etc.)