Hull LyoStar 4.0 R&D/Process Development Freeze Dryer

The Hull LyoStar 4.0 R&D and Process Development Freeze Dryer is designed and built to speed your biologic to market, with significant advancements in freeze dryer engineering. Based on a full-scale production freeze dryer to support rapid-scale-up, the Hull LyoStar 4.0 is a pilot-scale lyophilizer offering superior shelf mapping and rapid shelf freezing for unmatched process accuracy and reliability.

Including a cutting-edge suite of Process Analytical Technology (PAT) tools, SP’s Line of Sight™ suite of technologies helps you overcome critical lyophilization challenges during development, scale-up, and manufacture of a biologic.

These technologies include:

• LyoFlux® TDLAS Sensors for vapor mass flow measurement
• AutoMTM/SMART™ Freeze Dryer Technology, a primary drying cycle optimization tool
• ControLyo® Nucleation Technology giving pinpoint control of freezing point
• Tempris® Wireless Sensors for real-time product temperature measurement

• Formulation Development & Stability Studies
• Cycle Optimization & Scale-up
• Lyophilization of Product with Organic Solvents in Addition to Water
• Laboratory Research & Development Freeze-Drying
• Diagnostic Kits
• 96-Well Plates
• Serum Bottles & Vials

• Get to market faster – sophisticated instrumentation set, advanced cycle development, and optimization features decrease cycle development time and conserve valuable API
• You can never be too informed – LyoStar 4.0 provides more product and process information such as dried layer resistance, heat flow, mass transfer, and how different freezing protocols impact cake resistance
• Easily scalable – advanced, reliable, and scalable lyophilization technologies, along with Process Analytical Technology (PAT) tools, support smooth scale-up from process development through to manufacturing
• Cleanroom or isolator integrable – with optional 21 CFR Part 11 compatible software
• Decreases cycle development time and conserves valuable API

Accessories: Sample Extractor, MVP probes, Leveling Feet, 21 CFR Part 11

Consumable Parts Kit and Critical Components Spare Parts.

Optional ControLyo®, LyoFlux* TDLAS and Tempris* Wireless Probes

• Hull LyoStar 4.0 R&D/Process Development Freeze Dryer
• http://LyoStar-4.0_SP-Hull-Product-Bulletin
• http://SP-Tech-Note-Basic-Principles-of-Freeze-Drying-6
• http://White-Paper-Technologies-PAT-Tools-To-Overcome-Lyo-Challenges