Pilot lyophilizers for pharmaceutical development
For precision freeze-drying in clinical trial production, these pilot lyophilizers offer advanced control over nucleation and temperature, ensuring the stability and quality of delicate pharmaceutical products.
Performs Precise Freeze-Drying for Pharmaceuticals and Diagnostics
The Hull LyoConstellation S10/S20/S30 from SP Scientific Products offers precision and efficiency in lyophilization for pharmaceutical and biotech applications. These pilot lyophilizers excel in controlled ice nucleation and temperature monitoring, enabling accurate moisture removal for monoclonal antibodies, ADCs, and compounded medications. With scalable capacity and aseptic production readiness, they effortlessly integrate into your fill-finish workflow, meeting GMP standards and supporting Process Analytical Technologies (PAT) for enhanced process control. Engineered for flexibility, these units come equipped with 5 to 8 shelves, accommodating vials up to 30 mL and maintaining 100 mTorr at +40⁰C. The Hull LyoConstellation ensures reliable cycle development through to full clinical and pilot-scale production, leveraging automation, remote monitoring, and efficient sterilization and cleaning (SIP/CIP execution).
Benefits
- Enhances precision with controlled ice nucleation, ensuring consistent product quality.
- Supports cycle scalability, allowing seamless transition from pilot to full-scale production.
- Reduces production time with efficient process monitoring tools like wireless temperature sensors.
- Ensures compliance and safety in pharmaceutical applications with GMP-ready design.
- Simplifies cleaning and reduces contamination risk with integrated SIP/CIP systems.
- Applications
- Compounding pharmaceuticals,Antibody drug conjugates (adcs),Small to medium batch pharmaceuticals,Diagnostics,Therapeutic proteins
- End products
- Small molecule drugs,Diagnostic assay kits,Trastuzumab adc,Mab (monoclonal antibodies),Custom compounded medications
- Steps before
- Formulation,Pre-treatment,Dispensing,Compounding
- Steps after
- Inspection,Sterilization,Packing,Quality Control
- Input ingredients
- therapeutic proteins,ADC,compounding pharmacies products,pharmaceuticals,diagnostics
- Output ingredients
- lyophilized therapeutic proteins,lyophilized ADC,lyophilized small to medium batches,lyophilized diagnostics
- Market info
- Model Options
- S10,S20,S30
- Ice Nucleation Control
- Controlled
- Condenser Cooling
- Fluid
- Vapor Ports Diameter
- Large Diameter for High Flow
- Capacity per Vial
- Up to 30 mL
- Vacuum Pressure
- 100 mTorr
- Temperature of Shelves
- +40⁰C when Fully Loaded
- Number of Shelves
- 5,6,and 8
- Automation Technology
- PAT (Process Analytical Technology)
- Temperature Monitoring
- TEMPRIS® Wireless Sensors
- End Point Detection
- Pirani Gauge and Capacitance Manometer
- SIP,CIP
- Full Steam in Place,Clean in Place,Manual/H2O2
- Integration
- Full Line Integration Ready
- Nucleation Technology
- ControLyo®
- Flexible Model Options
- S10,S20,S30
- Scalability
- Consistent software across systems
- Process Integration
- Fill-finish workflow
- CIP/SIP Capability
- Full Steam in Place,Clean in Place
- Automation Level
- LINE of SIGHT suite,PAT tools
- Nucleation Control
- ControLyo® technology
- Temperature Control
- Shelves at +40°C fully loaded
- Pressure Holding
- 100 mTorr
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Machine Footprint
- N/A
- Number of Shelves
- 5,6,8
- Shelf Temperature Range
- +40°C
- Vial Size Accommodation
- up to 30 mL
- Vapor Port Diameter
- Large
- Condenser Cooling
- Fluid
- Control Panel Type
- N/A
- Compact Footprint
- N/A
- Throughput Capacity
- High
- Control panel type
- Automated/HMI
- Integration Possibilities
- Full line integration/Process Analytical Technologies (PAT)
- Shelf Customization
- 5,6,or 8 shelves
- Software and Technology
- Line of Sight™ suite
- Cleaning Method
- Full Steam in Place (SIP),Clean in Place (CIP)
- Validation Ports
- Standard in chamber and condenser
- Isolator Ready
- Auto locking doors