High Containment Granulation Suite for GlaxoSmithKline

Feasibility and Design

Epsilon was initially engaged to conduct a feasibility study identifying potential locations within the facility, assessing operational impact, and outlining a route to implementation. Following this, Epsilon produced a full detailed design package that was issued for competitive tender.

Epsilon was then contracted to deliver the full design, upgrades, and installation of the new granulation suite.

Scope of Work

• Feasibility and detailed design studies
• Location analysis, site impact analysis, and operational risk assessment
• Utility assessment and civil modifications planning, in collaboration with GSK and their M&E/civils partner
• Legacy equipment upgrades to improve longevity and performance
• Retrofitting for full ATEX compliance, including Notified Body involvement and CE marking
• Design of safe, contained product transfer systems compliant with OEB3 standards
• Controls upgraded to GAMP5 standards, including WinCC HMI and data acquisition for future-proofing and recipe handling
• Comprehensive validation and commissioning plans
• Construction and turnkey installation

Project Integration and Execution

A low-humidity environment was achieved through the integration of a new dehumidifier and re-humidification system. Civil works, utility upgrades, and electro-mechanical installation were coordinated under Epsilon’s project management, ensuring full integration across disciplines.

Close collaboration with GSK’s internal engineering and validation teams ensured all works met regulatory and quality expectations, delivered in the shortest possible time and within budget.

Outcome

The project was completed on time and within budget, with a final delivery cost of £1,100,000. This contributed to an estimated cost saving of approximately £1 million for GSK by reusing and upgrading existing assets instead of procuring new equipment.

The newly commissioned suite met all GMP, ATEX, and containment standards. The finished installation reflected the client’s vision of an “as-new” facility, fully CE marked and ready for high-containment granulation trials and pilot-scale production.