R&d and process development freeze dryer

Speed up your biologic development with precise lyophilization control, ensuring rapid cycle optimization and scale-up for high-value biopharmaceuticals and diagnostics.

Optimizes Freeze-Drying for Biologics

The Hull LyoStar 4.0 R&D Freeze Dryer from SP Industries is designed to accelerate your biopharmaceutical process development. It excels in the precise control of freeze-drying cycles, enhancing the stability and integrity of sensitive biologic materials. Utilizing advanced Process Analytical Technology (PAT) tools, it offers unparalleled uniformity in shelf temperature mapping and rapid shelf freezing, making it ideal for applications such as developing monoclonal antibodies and mRNA vaccines. This pilot-scale lyophilizer supports seamless scale-up from development to production, while its eco-friendly refrigerant systems reduce the carbon footprint. The LyoStar 4.0 is 21 CFR Part 11 compatible, ensuring compliance with stringent regulatory standards, and integrates smoothly into cleanroom environments with available CIP systems for efficient maintenance. It can be customized with accessories like ControLyo® nucleation technology to meet specific operational needs, delivering consistent results in high-quality biologic freeze-drying.

Benefits

  • Speeds up time-to-market by reducing cycle development time with advanced process control.
  • Conserves valuable biological materials with precise temperature control and optimized drying cycles.
  • Ensures compliance with 21 CFR Part 11 standards for reliable data integrity and regulatory readiness.
  • Integrates seamlessly into various production environments, maintaining product quality and safety.
  • Minimizes environmental impact through energy-efficient operation and eco-friendly refrigerants.

General


Applications
Organic solvent products,Vials,Biopharmaceuticals,Serum bottles,Diagnostic kits
End products
Protein-based therapeutics,Injectable biomolecules,Monoclonal antibodies,Covid-19 diagnostic kits,Liposomal formulations,Enzyme formulations,Mrna vaccines,Liquid biopsy test kits,Bacteriophages,Peptide therapeutics
Steps before
Formulation,Mixing,Sample Preparation
Steps after
Stability Testing,Quality Control,Packaging
Input ingredients
biologic materials,organic solvents,water,diagnostic samples,formulation samples,serum,96-well plates,bottles,vials
Output ingredients
lyophilized products,freeze-dried samples,stabilized formulations,cake with controlled resistance
Market info

Technical Specifications


Shelf temperature mapping
Superior
Shelf freezing rate
Rapid
Process control
Precise
Refrigerant gas
Eco-friendlier
Cycle development time
Decreased
API conservation
Conserves valuable API
Process Analytical Technology (PAT) tools
Included
Freezing point control
Pinpoint
Product temperature measurement
Real-time

Operating Characteristics


Cycle development speed
Rapid
Process control precision
High reliability
Batch Operation
Yes
Shelf freezing rate
Rapid
Environmental impact
Eco-friendly refrigerant
Scale-up capability
Pilot-scale to full production
Process Analytical Technology (PAT) tools
Included

Material Compatibility


Density/particle size
0.5–2.5 g/cm³


21 CFR Part 11
Compatible

Physical Characteristics


Compact footprint
Designed for pilot-scale
Compact structure
Shelf temperature mapping
Superior uniformity
Shelf freezing
Rapid shelf freezing capability
Control panel type
Integrated with advanced PAT tools
Discharge method
Contains extraction and leveling accessories
Eco-friendliness
Reduced carbon footprint with eco-friendlier refrigerant gas
Cleanroom compatibility
Optional integration into cleanroom or isolator environments

Custom Options


Control panel type
Optional 21 CFR Part 11 compatible software