GMP Production Freeze Dryers for Aseptic Fill-Finish Integration

The Hull LyoConstellation™ S80/S100/S130 Production Lyophilizers are engineered for large-scale pharmaceutical lyophilization, delivering cleanroom-ready, GMP-compliant freeze drying that integrates seamlessly into fill-finish workflows.

Designed for commercial manufacturing, these production lyophilizers provide a scalable, ready-to-order solution for pharmaceutical and biotech facilities requiring high performance, regulatory compliance, and advanced Process Analytical Technology (PAT) integration.

Developed by SP Scientific, the LyoConstellation™ production range ensures smooth scale-up from pilot to full aseptic manufacturing — reducing risk, simplifying validation, and protecting high-value products.

Scalable Pharmaceutical Lyophilization for Commercial Production

The S80, S100, and S130 production freeze dryers are built to support:

• Commercial-scale aseptic manufacturing

• Clinical-to-commercial scale-up

• High-value biologics and sterile injectables

• Aggressive freeze-drying cycle development

• Technology transfer from pilot to production

Each system is equipped and controlled as a fully integrated production platform, ensuring reliable, repeatable freeze-drying performance at scale.

Key Features & Benefits

✔ Designed for End-to-End Production

Supports scale-up from development and pilot batches through full aseptic production, minimizing process variability.

✔ Advanced PAT-Enabled Quality Assurance

Compatible with SP’s Line of Sight™ Lyophilization approach to enable real-time process monitoring, simplified tech transfer, and improved product quality.

✔ Validation & Compliance Made Simple

• Standard validation ports in the chamber and condenser

• Comprehensive documentation packages

• Designed to meet global GMP and regulatory standards

✔ Accurate Endpoint Determination

• Pirani gauge (standard)

• Capacitance manometer (standard)
  Ensures precise control of primary and secondary drying phases.

✔ Built for Demanding Production Needs

• Accommodates vials up to 100 mL

• Designed for aggressive freeze-drying cycles

• Engineered for high-throughput pharmaceutical manufacturing

✔ Full CIP & SIP Capability

• Steam-In-Place (SIP)

• Clean-In-Place (CIP)

• Manual or H₂O₂ decontamination options

✔ Isolator Ready

• Auto-locking doors

• Seamless integration into aseptic fill-finish lines

Line of Sight™ Lyophilization & PAT Tools

The LyoConstellation™ production lyophilizers integrate with advanced Process Analytical Technologies (PAT) to optimize freeze-drying performance and ensure consistent product quality:

• LyoFlux® TDLAS – Accurate water vapor mass flow measurement during freeze-drying

• SMART™ Freeze Dryer Technology – Real-time data on product resistance, heat flow, and mass transfer

• TEMPRIS® Wireless Sensors – Advanced wireless temperature monitoring for high-value pharmaceuticals

• ControLyo® Nucleation Technology – Precise freezing point control for consistent product structure and reduced variability

These tools reduce development time, enhance scale-up efficiency, and ensure product safety in commercial production environments.

Applications

Hull LyoConstellation™ S80/S100/S130 Production Lyophilizers are ideal for:

• Vaccines

• Antibody Drug Conjugates (ADCs)

• Highly potent compounds

• Biologics

• Sterile injectable pharmaceuticals

Why Choose Hull LyoConstellation™ Production Lyophilizers?

• GMP-compliant commercial freeze dryers

• Fill-finish line integration

• Advanced PAT-enabled lyophilization control

• High-capacity vial handling up to 100 mL

• CIP/SIP-capable and isolator-ready design

• Proven scalability from pilot to production

For pharmaceutical manufacturers scaling lyophilization to full commercial production, Hull LyoConstellation™ production freeze dryers deliver performance, compliance, and confidence.