Customizable production freeze dryer for pharmaceuticals

Ensure precise moisture control and preservation with a versatile freeze dryer, ideal for transitioning from pilot to full-scale production, maintaining product integrity in advanced processing applications.

Customizes and Optimizes Lyophilization Processes

The VirTis Benchmark Production Freeze Dryer from Scientific Products is a custom-built lyophilizer designed for versatility and precision in pharmaceutical, nutraceutical, diagnostic, and veterinary health applications. Utilizing advanced lyophilization processes, this equipment ensures optimal drying and preservation of products like monoclonal antibodies, dietary supplements, and enzyme-linked immunosorbent assay kits. It offers customizable configurations, with shelf temperatures reaching -70ºC and condenser temperatures to -75ºC, facilitating varied applications and end-product demands. Equipped with the Lyos 2.0™ control system, it integrates seamlessly into production lines, supports 21 CFR Part 11 compliance, and provides robust historical trend analysis and batch record keeping. Constructed from durable 316L stainless steel, it also includes optional clean-in-place solutions and hot swappable, redundant refrigeration components for minimized downtime and simplified maintenance. Perfect for environments demanding precise and efficient lyophilization, this freeze dryer supports varied operations from pilot to full-scale production while maximizing lab space and processing capacity.

Benefits

  • Enhances production flexibility with customizable configurations to meet specific needs.
  • Minimizes operational disruptions with hot swappable and redundant components.
  • Ensures regulatory compliance with 21 CFR Part 11-certified control systems.
  • Optimizes lab and production space with efficient shelf and condenser design.
  • Reduces cleaning time with optional clean-in-place solutions.

General


Applications
Tissue products,Active pharmaceutical ingredients,Nutraceuticals,Bulk collagen,Test kits,Diagnostic kits,Veterinary health products
End products
Regenerative medicine products,Monoclonal antibodies,Pcr test kits,Enzyme-linked immunosorbent assay (elisa) kits,Animal vaccines,Collagen peptides,Herbal extracts,Dietary supplements
Steps before
Solution preparation,Formulation,Pre-freezing
Steps after
Storage,Packaging,Quality control
Input ingredients
diagnostic kits,test kits,active pharmaceutical ingredients,nutraceuticals,veterinary health products,collagen,tissue products
Output ingredients
lyophilized diagnostic kits,lyophilized test kits,lyophilized active pharmaceutical ingredients,lyophilized nutraceuticals,lyophilized veterinary health products,lyophilized collagen,lyophilized tissue products
Market info

Technical Specifications


Material
316L stainless steel
Shelf Temperature
To -70ºC
Condenser Temperature
To -75ºC
Control System
Lyos 2.0™ control system
Software Compliance
21 CFR Part 11 compliant
Validation Packages
IQ/OQ validation available

Operating Characteristics


Automation level
21 CFR Part 11,IQ/OQ
Batch vs. continuous operation
Batch
Cleaning method
CIP Optional
Energy efficiency
Not specified
Custom configuration
Yes
Shelf temperature range
-70ºC
Condenser temperature range
-75ºC
Control systems
Lyos 2.0™

Material Compatibility


Corrosive resistance
316L stainless steel
Cleanability
Optional CIP solutions


21 CFR Part 11
Compliant
IQ/OQ validation
Available

Physical Characteristics


Material of construction
316L stainless steel
Shelf temperature range
Up to -70ºC
Condenser temperature
Up to -75ºC
Configuration options
Internal/external,plate/coil condensers
Footprint
Configurable/customized
Shelf design
Varied sizes/inter-shelf distances

Custom Options


Shelf sizes
Varied
Inter-shelf distances
Varied
Condenser configurations
Internal/External,Plate/Coil
Shelf temperature
To -70ºC
Condenser temperature
To -75ºC
Control packages
21CFR compliant to simple applications
Clean-in-place solutions
Optional
Control systems
Lyos 2.0™