LEO required a major upgrade to its semi-solids manufacturing and filling capabilities to meet increasing production demands and regulatory standards. Integrated Life Science Group (ILS Group) was entrusted with delivering a comprehensive, £5.5M turnkey solution, which included the design and construction of a 200m² Class 7 cleanroom and the installation of state-of-the-art processing and filling equipment.

From project inception through to commissioning, ILS Group managed every aspect of the upgrade, ensuring a seamless transition to an advanced, fully validated production environment.

The Project

LEO’s creams manufacturing facility required a significant upgrade to enhance production efficiency and compliance. The project included:

• A new 200m² Class 7 cleanroom to support a controlled manufacturing environment.
• Installation of high-capacity processing and storage vessels, including:
  • A 6-tonne main mixing vessel
  • A 1-tonne side vessel
  • Two 6-tonne storage vessels
• An 80 UPM filling line to optimise production output.

ILS Group was responsible for delivering the entire upgrade as a turnkey project, ensuring that every aspect—from design through to commissioning—met LEO’s stringent quality and operational requirements.

Our Approach

Leveraging extensive experience in pharmaceutical manufacturing, ILS Group took a structured and proactive approach to executing this high-value upgrade. Our scope of work covered:

• Project & Cost Management – Overseeing all aspects of planning, budgeting, and execution to ensure timely and cost-effective delivery.
• Equipment Design Overview – Ensuring the selected equipment met both performance and regulatory requirements.
• Equipment Selection – Identifying and procuring the most suitable vessels and filling lines to optimise production efficiency.
• Vendor Management – Coordinating with multiple suppliers to ensure smooth procurement, delivery, and installation of equipment.
• Full Validation Documentation – Developing comprehensive validation protocols to meet pharmaceutical industry compliance standards.
• Installation & Commissioning – Managing the installation of all new systems and overseeing commissioning to ensure seamless integration into existing operations.

Challenges & Solutions

1. Complex Coordination Across Multiple Vendors
   With several suppliers involved, effective project coordination was essential to prevent delays and maintain quality standards. ILS Group ensured clear communication and strong oversight, keeping the project on track.
2. Compliance with Cleanroom Standards
   The installation of a Class 7 cleanroom required rigorous adherence to regulatory guidelines. Our team implemented a detailed validation and qualification process, ensuring the cleanroom was fully compliant and operational from day one.
3. Integration with Existing Manufacturing Processes
   Introducing large-scale equipment into an active facility required careful planning to avoid disruptions. Through phased implementation and precise scheduling, ILS Group ensured minimal impact on LEO’s ongoing operations.

Results & Client Impact

The successful completion of this project provided LEO with:

• A State-of-the-Art Semi-Solids Manufacturing Facility – Equipped with high-capacity vessels and an advanced filling line to enhance production efficiency.
• Regulatory Compliance & Full Validation – Ensuring seamless adherence to pharmaceutical manufacturing standards.
• Optimised Production Output – The integration of the 80 UPM filling line improved manufacturing speed and capacity.
• A Fully Operational Class 7 Cleanroom – Supporting stringent quality control requirements for semi-solids production.

This upgrade positioned LEO for greater production flexibility and long-term growth, ensuring they can meet increased demand while maintaining the highest industry standards.

Conclusion

The CALVN project exemplifies ILS Group’s ability to deliver complex, high-value pharmaceutical upgrades with precision and efficiency. By managing every stage of the project—from design through to commissioning—we provided LEO with a future-proof, fully validated manufacturing environment that enhances productivity and compliance.

With a commitment to quality and seamless execution, ILS Group continues to be a trusted partner in delivering cutting-edge pharmaceutical manufacturing solutions.