Case Study: Ingenus Pharmaceuticals achieves operational excellence with flexible isolator technology

Challenges with the Fixed Isolator System
Ingenus faced significant challenges with its previous fixed isolator system. Cleaning procedures required extensive effort and precision to ensure no trace of Active Pharmaceutical Ingredients (APIs) remained, preventing cross-contamination during the preparation of a solution bulk by dissolving the API and excipients and filling it into vials. This process consumed significant time, resources, and required dedicated personnel. Moreover, the rigid nature of the fixed system lacked adaptability, making it difficult to tailor operations to specific production needs.
Initial setup with the fixed isolator

A tailored Solution: The Flexible Isolator
Ingenus decided to transition to Lugaia’s flexible isolator system to address these challenges. Unlike fixed systems, the flexible isolator leverages a single-use design, eliminating the need for extensive cleaning and verification processes. This decision was motivated by the desire to maximize flexibility, optimize time and resources, and ensure the highest levels of safety for both employees and products.

Measurable Results
Since implementing the flexible isolator, Ingenus has observed measurable improvements in productivity and efficiency. Process times have been significantly shortened, and resources previously allocated to cleaning operations are now available for other value-adding tasks. Despite initial concerns about potential cost differences, Ingenus found that the operational benefits of the flexible system outweigh any financial parity with the fixed system.

Smooth Installation Process
The installation process was a testament to successful collaboration between Ingenus and Lugaia’s engineering team. „The entire project ran smoothly, and the new system was installed without requiring any special modifications,“ notes the Ingenus production team.

Industry Recommendation
Ingenus Pharmaceuticals recommends the flexible isolator to other companies in the industry. „The complete customizability, safety enhancements, and operational efficiencies of this system are game-changing. For any company handling cytotoxic or hazardous compounds, this solution is a must-consider,“ advises the Ingenus leadership team.

Conclusion
The adoption of Lugaia’s flexible isolator has allowed Ingenus Pharmaceuticals to overcome the limitations of their fixed system. The improvements in flexibility, safety, and resource optimization have strengthened their operations, setting a practical example for other pharmaceutical manufacturers to follow.

Key Benefits Realized

1. Enhanced Flexibility and Customization: The flexible isolator allows full customization to meet specific production requirements. This adaptability ensures a streamlined workflow tailored to Ingenus’ operations.
2. Time and Resource Optimization: By eliminating cleaning and verification tasks, Ingenus has significantly reduced processing times. The system also cuts down on the consumption of Water for Injection (WFI) and cleaning accessories.
3. Improved Safety Standards: The flexible isolator‘s OEB 5 containment ensures the safe handling of potentially toxic powders, prioritizing the well-being of operators, the integrity of the working environment and the final products.
4. Ease of Maintenance: Maintenance has become remarkably straightforward. The disposable bag can be replaced quickly and safely, eliminating the need for complex cleaning processes.

Interested to get to know more? Download the PDF here or contact us directly: anfrage@lugaia.ch