Hull LyoStar® 4.0 R&D/Process Development Freeze Dryer

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Hull LyoStar® 4.0 R&D/Process Development Freeze Dryer

Ideal for rapid lyophilization cycle development, optimization, and scale-up, the Hull LyoStar® 4.0 R&D/Process Development Freeze Dryer incorporates the very latest innovations in freeze-drying technology.

Based on a full-scale production freeze dryer to support rapid scale-up, the LyoStar 4.0 is a pilot-scale lyophilizer offering superior shelf mapping and rapid shelf freezing for unmatched process accuracy and reliability. Ensure precise process control and protect your valuable product, with us!

Features & Benefits

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
Unparalleled uniformity — superior shelf temperature mapping and rapid shelf freezing
Ecologically sound — reduced carbon footprint with eco-friendlier refrigerant gas
Clean room or isolator integrable — with optional 21 CFR Part 11 compliance ready software
Decreases cycle development time and conserves valuable API
Accessories and consumables for all your lyophilization needs — sample extractor, MVP probes, leveling feet, 21 CFR Part 11

Line of Sight™ Lyophilization & PAT Tools

To help you overcome the mounting challenges when scaling up your lyophilization processes, LyoStar® 4.0 is compatible with our state-of-the-art Line of Sight™ Lyophilization and Process Analytical Technologies (PAT) suite of scalable tools:

LyoFlux® TDLAS — measure water vapor mass flow with accuracy during freeze-drying
SMART™ Freeze Dryer Technology — get instant feedback on important product data including resistance, heat flow, and mass transfer
TEMPRIS® Wireless Sensors — advanced wireless temperature monitoring for the highest quality product, on budget and on time
ControLyo® Nucleation Technology — take control of your freeze-drying with cutting-edge nucleation technology for precise control of the freezing point

Applications

Specifications

Condenser Capacity

30 L
Lowest Condenser Temperature

-85 °C
Number of Shelves

up to 4
Materials

316L stainless steel
Integration

isolator
Configuration

standard or clean room
Dimensions (W x D x H)

994 x 1209 x 2144 mm
Weight

680 kg

Resources

Industries

Frequently Asked Questions

What process controls does the LyoStar 4.0 offer?

The LyoStar 4.0 comes standard with the LyoS 2.0 control system, which retains complete control of temperature and pressure using best-practice instrumentation and primary drying endpoint detection methods, including Pirani-capacitance manometer convergence and pressure rise testing.

Is the LyoStar 4.0 suitable for GMP and regulated environments?

Yes. The LyoS 2.0 control system is 21 CFR Part 11 compliance ready and comes with extensive documentation, onsite Site Acceptance Testing, and IQ/OQ validation support. A more comprehensive factory-initiated System Integration Test and Factory Acceptance Testing is also available.

Is stoppering available on the LyoStar 4.0?

Yes. Automatic bottom-up hydraulic stoppering with backfill and adjustable stoppering pressure is included as standard.

What cooling configurations does the LyoStar 4.0 support?

The LyoStar 4.0 is available in either an air-cooled or a water-cooled configuration. Air-cooled units generate approximately 21,000 BTU/h of peak heat directly into the room. Water-cooled units route heat into a facility cooling water supply (15 to 22 Lpm) instead, generating about 4,200 BTU/h in the room.

What type of refrigeration does the LyoStar 4.0 use?

The LyoStar 4.0 uses a two-stage cascade refrigerant system with two CFC-free gases: R449A, with a lower GWP of 1,397, and R508B, with a higher GWP of 13,396. Total CO2 equivalent is 14.402 tonnes.

What is the Sample Extractor?

The optional Sample Extractor allows an operator to select and remove a serum bottle or vial from the product chamber at any time during a run with virtually no interruption to the drying process, making it particularly useful for periodic sampling during product development or stability studies.

What kind of training is available for operators?

We offer Remote Freeze-Drying Training and Hands-On Training Opportunities to ensure operators can effectively and sustainably utilize the LyoStar 4.0. These programs help maximize cycle efficiency and optimize system performance.

Can the LyoStar 4.0 handle a variety of applications?

Absolutely! The LyoStar 4.0 is designed for versatility, making it suitable for a wide range of industries and applications including but not limited to: