Production freeze dryer for pharmaceutical manufacturing

Achieve precise lyophilization for sensitive products with customizable freeze drying solutions, maintaining critical product stability and potency throughout production.

Customizes Freeze Drying for Diverse Product Needs

The VirTis Benchmark Production Freeze Dryer from SP Industries is engineered for pharmaceutical and nutraceutical applications, providing a tailored approach to freeze drying. Utilizing customizable configurations, it ensures precise control over moisture removal across diverse product lines, including APIs and diagnostic kits. The system supports pilot and production scale operations with advanced Lyos 2.0™ control, offering both 21 CFR Part 11 compliant and straightforward control packages. Its robust design features 316L stainless steel construction, with options for optimized shelf and condenser configurations. Energy efficiency is enhanced with redundant refrigeration components for seamless operation. The dryer integrates clean-in-place (CIP) solutions, ensuring fast and efficient maintenance while meeting stringent industry regulations.

Benefits

  • Ensures precise moisture removal to maintain product integrity and quality.
  • Reduces operational downtime with hot swappable and redundant refrigeration components.
  • Adapts to diverse product requirements with customizable configurations.
  • Simplifies regulatory compliance with 21 CFR Part 11 software and validation packages.
  • Minimizes cleaning time with an optional clean-in-place (CIP) system.

General


Applications
Tissue products,Active pharmaceutical ingredients (api),Nutraceuticals,Bulk collagen,Test kits,Diagnostic,Veterinary health products
End products
Immunoglobulin supplements,Insulin,Canine joint health supplements,Diagnostic kits,Hydrolyzed collagen powder,Biologic scaffolds,Elisa test kits
Steps before
Purification,Emulsification,Filling
Steps after
Packing,Sterilization,Quality Control,Tablet Pressing
Input ingredients
diagnostic kits,test kits,active pharmaceutical ingredients,nutraceuticals,veterinary health products,bulk collagen,tissue products
Output ingredients
freeze-dried diagnostic kits,lyophilized test kits,lyophilized active pharmaceutical ingredients,freeze-dried nutraceuticals,lyophilized veterinary health products,freeze-dried collagen,lyophilized tissue products
Market info

Technical Specifications


Material
316L stainless steel
Compliance
21 CFR Part 11
Shelf temperature
To -70ºC
Condenser temperature
To -75ºC
Condensers types
Internal/External,Plate/Coil
Control System
Lyos 2.0™
Configuration options
Custom-built configurations
Refrigeration
Hot swappable and redundant components
Validation packages
IQ/OQ validation
Control packages
21CFR compliant to simple applications

Operating Characteristics


Batch vs. continuous operation
Batch
Automation level
PLC/SCADA
CIP/SIP
CIP solutions available
Control system
Lyos 2.0™ control system
Compliance
21 CFR Part 11 compliant
Refrigeration components
Hot swappable and redundant

Material Compatibility


Density/particle size
0.5–2.5 g/cm³ / 50–1000 µm

Physical Characteristics


Material
316L stainless steel
Condenser temperature range
To -75ºC
Shelf temperature range
To -70ºC
Shelf design
Varied shelf sizes and inter-shelf distances
Customization
Available in various configurations with optional features
Discharge method
Internal/external and plate/coil condensers

Custom Options


Shelf designs
Varied sizes and inter-shelf distances
Condenser orientation
Internal/external and plate/coil
Control packages
21CFR compliant to simple applications
Clean-in-place (CIP) solutions
Optional
Control system
Lyos 2.0™ control system
Refrigeration components
Hot swappable and redundant
Installation
Cleanroom wall installation
Validation assistance
Optional