Overview
Flow Sciences has developed a state-of-the-art containment enclosure designed to interface with the Lyostar IV lyophilizer, ensuring personnel and product safety during critical lyophilization processes. This enclosure builds upon more than a decade of proven success with a similar solution for the Lyostar II, offering advanced features tailored for the updated system while maintaining the same high level of protection at exposure levels as low as 50 ng/m³.
Challenge
The client, a large pharmaceutical manufacturer providing clinical trial samples, needed a solution to transfer vials of active pharmaceutical ingredients (APIs) between a biological safety cabinet (BSC) and the Lyostar IV lyophilizer. The existing enclosure, used with the Lyostar II, needed to be upgraded to accommodate the new equipment while ensuring operator safety and maintaining a clean processing environment.
A key challenge was designing an ergonomic interface to allow operators to access and secure the Lyostar IV’s eight locking bolts during lyophilization. Additionally, the new enclosure needed to integrate seamlessly with the existing BSC and scissor lift while utilizing the current exhaust setup.
Solution
Flow Sciences partnered with SP Scientific and the client to deliver a custom solution that addressed these requirements. The enclosure featured:
- Ergonomic Design: A gimbal door reduced the distance between operators and the Lyostar IV locking bolts, enabling safe and efficient operation.
- Seamless Integration: Custom flanges were designed to create a tight seal between the enclosure and the lyophilizer while maintaining compatibility with the BSC and scissor lift.
- Advanced Containment: HEPA-filtered inlet air and a Bag-In/Bag-Out (BIBO) primary exhaust HEPA filter system ensured clean airflow and optimal containment during processes.
- Durable Construction: The enclosure was supported by a custom table to provide stability and ergonomic convenience.
Implementation
Using Inventor™ 3D modeling software, Flow Sciences created a precision-engineered enclosure validated through simulations with the Lyostar IV model provided by SP Scientific. During the validation phase, the Lyostar IV was shipped to the Flow Sciences facility to test its integration with the enclosure, ensuring containment, cleanliness, and airflow compliance.
Results
In May 2024, the system was successfully installed at the client’s site, where it was validated for performance and safety. The new Lyostar IV containment system has been fully validated both at the factory and on-site, ensuring optimal safety for operators and maintaining the cleanliness required for pharmaceutical manufacturing processes.
Conclusion
Flow Sciences continues to deliver advanced containment solutions tailored to meet the evolving needs of the pharmaceutical industry. The Lyostar IV enclosure exemplifies this commitment, combining innovative design with precision engineering to support critical lyophilization operations.
For more information on containment systems for lyophilizers, contact your local Flow Sciences representative.
