Pilot lyophilizers for therapeutic proteins and clinical trials
Optimize your freeze-drying process with advanced lyophilization technology that ensures precise control, scalability, and consistent product quality for critical biopharmaceutical applications.
The Hull LyoConstellation S10, S20, and S30 Pilot Lyophilizers from SP Industries are engineered to enhance lyophilization processes through state-of-the-art technologies. This equipment specializes in controlled freeze-drying, crucial for biopharmaceuticals and diagnostics. It integrates controlled ice nucleation and fluid condenser cooling, ensuring efficient and scalable moisture removal. Ideal for therapeutic proteins and ADC formulations, it operates under demanding conditions, accommodating vials up to 30 mL in size, and supports high-throughput production with up to 8 shelves. Automation is facilitated through a suite of tools providing accurate process control, including the use of PI-based sensors and wireless monitoring. These models are built to GMP standards, offering seamless integration in cleanroom environments with features like automatic locking doors and full SIP/CIP capabilities. Customizations are available to meet specific process requirements, backed by comprehensive engineering support for hassle-free validation and maintenance.
Benefits
- Enhances production efficiency by integrating controlled nucleation for precise freeze-drying.
- Ensures product quality and consistency with advanced PAT tools for real-time monitoring.
- Supports diverse biopharmaceutical applications with scalable, GMP-compliant design.
- Simplifies cleaning and validation, reducing downtime with SIP/CIP features.
- Offers flexibility and scalability, accommodating a range of batch sizes and product types.
- Applications
- Antibody-drug conjugates (adc),Compounding pharmacies,Biopharmaceuticals,Diagnostics,Therapeutic proteins
- End products
- Personalized medication dosages,Lateral flow test kits,Monoclonal antibodies,Insulin formulations,Adc formulations
- Steps before
- Purification,Formulation,Compounding,Filling
- Steps after
- Stability Testing,Quality Control,Packing,Sterilization
- Input ingredients
- therapeutic proteins,ADC for clinical trials,small- to medium batch production,compounding pharmacies materials,pharmaceutical ingredients,diagnostics
- Output ingredients
- processed therapeutic proteins,ADC products,compounded pharmaceuticals,freeze-dried diagnostics
- Market info
- Model Types
- S10,S20,S30
- Vial Capacity
- up to 30 mL
- Pressure Capacity
- 100 mTorr
- Shelf Temperature
- +40°C fully loaded
- Number of Shelves
- 5,6,8 shelves
- Process Analytical Technologies
- LyoFlux® 200 TDLAS Sensors,SMART™ Freeze Dryer Technology,TEMPRIS® Wireless Sensors
- Control System
- ControLyo® Nucleation Technology
- Steam in Place (SIP),Clean in Place (CIP)
- Yes,with manual/H2O2 option
- Validation Ports
- In chamber and condenser as standard
- Software,Technology Options
- Same as smaller systems
- Nucleation Control
- Controlled ice nucleation
- Automation Level
- PLC-controlled
- CIP/SIP
- CIP/SIP with H2O2
- Batch Operation
- Batch
- Scale Flexibility
- Model options S10/S20/S30
- Cleanroom Compatibility
- Cleanroom ready
- Throughput Capacity
- Accommodates up to 8 shelves
- Batch production capacity
- Small to Medium Batch Production
- Application examples
- Therapeutic Proteins,ADC Production,Diagnostic
- Machine Model
- S10 / S20 / S30
- Chamber Shelves
- 5 / 6 / 8 shelves
- Vial Capacity
- Up to 30 mL
- Temperature Range
- +40°C shelf temperature
- Pressure Holding Capability
- Up to 100 mTorr
- Aseptic Compatibility
- Isolator ready with auto locking doors
- Integration
- Full line integration ready
- Footprint
- Compact for cleanroom use
- Heating/Cooling Method
- Fluid condenser cooling
- Shelf Configuration
- 5,6,or 8 shelves
- Scalability
- S10,S20,S30 models
- Vial accommodation
- Up to 30 mL
- Isolator readiness
- Auto locking doors
- Integration possibilities
- Full line integration