Hull LyoConstellation® Small-Scale Aseptic Freeze Dryers

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Description

Hull LyoConstellation® Small-Scale Aseptic Freeze Dryers

Hull LyoConstellation® Small-Scale Aseptic Freeze Dryers are a range of aseptic freeze-drying systems designed for pharmaceutical development, clinical manufacturing and small-scale commercial production where sterility, process control and regulatory compliance are critical.

The systems are available in S20-A, S30-A and S50-A models and are designed for seamless integration with automated loading systems, isolators and oRABS environments. Their compact design allows installation in existing cleanrooms without compromising production capacity or sterility requirements.

Automated vial handling minimises manual intervention and contributes to a safer and more reproducible freeze-drying process. The innovative bellows-free loading mechanism eliminates several potential contamination risks while simplifying cleaning and validation.

The freeze dryers are designed to meet modern regulatory requirements and support cGMP, FDA, EU Annex 1, 21 CFR Part 11, GAMP5 and ASME-BPE requirements.

For advanced process development, the systems can be equipped with Hull’s Line of Sight™ Lyophilization technology and Process Analytical Technology (PAT) tools, enabling enhanced monitoring, analysis and optimisation of the freeze-drying process.

Features and Benefits

Fully automated vial handling for consistent and reproducible loading and unloading

Reduced risk of human error and contamination

Bellows-free loading mechanism for improved sterility and easier cleaning

Optimised sub-door design to improve decontamination and sterility control

Compact design that saves valuable cleanroom space

Designed for integration with isolators, oRABS and filling lines

Support for advanced PAT tools and process control

Designed to meet leading international regulatory requirements

Compatible Process Technologies

LyoFlux® TDLAS

Accurate measurement of water vapour mass flow during the freeze-drying process for improved process monitoring and control.

TEMPRIS® Wireless Sensors

Wireless temperature monitoring providing reliable product temperature data throughout the freeze-drying process.

ControLyo® Nucleation Technology

Advanced controlled nucleation technology designed to improve product quality and process reproducibility.

Typical Applications

Pharmaceutical development

Vaccines

Antibody Drug Conjugates (ADCs)

Potent pharmaceutical substances

Clinical manufacturing

Biotechnology

CRO/CDMO operations

Diagnostics

Animal health

Research and development

Technical Specifications

Shelf area: 2, 3 or 5 m²

Minimum shelf temperature: -60 °C

Shelf temperature range: -55 °C to +65 °C

Material: 316L stainless steel

Hull LyoConstellation® Small-Scale Aseptic Freeze Dryers are designed to meet demanding requirements for quality, safety, sterility and regulatory compliance within the pharmaceutical and biotechnology industries.

Please contact CIAB for more information, a quotation or assistance in selecting the right freeze-drying solution for your application.