Production lyophilizer for pharmaceuticals
Ensure precise freeze-drying for high-value pharmaceuticals with cutting-edge technology designed to streamline your fill-finish workflow and enhance product stability.
Freeze-Dries and Monitors Pharmaceutical and Biotech Products
The Hull LyoConstellation S80/S100/S130 from Scientific Products represents a leap forward in lyophilization technology for the pharmaceutical, biotechnology, and diagnostics industries. These production lyophilizers use state-of-the-art techniques such as controlled ice nucleation and fluid condenser cooling to efficiently freeze-dry products like monoclonal antibodies and diagnostic assay kits. With a flexible design, they accommodate vials up to 100 mL, making them ideal for applications ranging from therapeutic proteins to personalized medications. The lyophilizers ensure seamless integration into your fill-finish workflow, featuring robust automation with Process Analytical Technologies (PAT) for real-time monitoring and control. Compliance with GMP standards comes standard, along with options for SIP and CIP systems to maintain hygiene and reduce downtime. Configurations can be tailored to specific process requirements, ensuring reliable operation under various conditions. Additionally, their scalability from pilot to full production systems supports rapid scale-up, meeting the rigorous demands of compounding pharmacies, CMOs, and CROs.
Benefits
- Streamlines production workflows with scalable lyophilization processes from pilot to full-scale applications.
- Enhances product quality and process consistency using integrated Process Analytical Technologies (PAT).
- Reduces operational downtime with Steam in Place (SIP) and Clean in Place (CIP) systems.
- Complies with GMP standards, ensuring regulatory adherence for pharmaceutical manufacturing.
- Optimizes freeze-drying for diverse end-products, accommodating up to 100 mL vials for versatile applications.
- Applications
- Compounding pharmacies,Adc production,Diagnostics,Therapeutic proteins
- End products
- Diagnostic assay kits,Personalized compounded medications,Monoclonal antibodies,Antibody-drug conjugates
- Steps before
- Formulation,Solution Preparation,Dispensing,Filling
- Steps after
- Inspection,Packing,Labeling,Storage
- Input ingredients
- vials,therapeutic proteins,ADC materials,compounding pharmacy materials,diagnostics
- Output ingredients
- freeze-dried therapeutic proteins,lyophilized ADC products,medium batch lyophilized pharmaceuticals,lyophilized diagnostics
- Market info
- Capacity
- Vials up to 100 mL
- Automation
- Controlled via software
- Cooling option
- Fluid condenser cooling
- Nucleation Technology
- Controlled ice nucleation
- Vapor flow
- Large diameter vapor ports
- SIP,CIP execution
- Full Steam in Place,Clean in Place
- Temperature monitoring
- Advanced wireless sensors
- Nucleation Technology
- ControLyo® Nucleation Technology
- Automation level
- PLC / SCADA
- Batch vs. continuous operation
- Batch
- CIP/SIP
- CIP / SIP with manual/H2O2 option
- Cleaning method
- SIP / CIP
- Changeover time
- Fast,scalable setup
- Biological compatibility
- Yes*
- Cleanability
- Full Steam in Place (SIP),Clean in Place (CIP)
- Corrosive resistance
- Yes*
- Density/particle size
- Compatible with vials up to 100 mL
- Container type
- Vials
- Capacity
- Up to 100 mL per vial
- Production Scale
- Therapeutic Proteins,ADC Production
- Machine Footprint
- Compact for cleanroom
- Freeze-Drying Shelf Area
- S80,S100,S130
- Vial Capacity
- Up to 100 mL
- Vapor Ports Diameter
- Large diameter
- Discharge Method
- Manual or Automated
- Control panel type
- Touchscreen / HMI
- Integration possibilities
- SCADA / MES
- Model Options
- S80 / S100 / S130
- Ice Nucleation Technology
- ControLyo® Nucleation Technology