Delivering Validation Support for a Brand-New Tablet Manufacturing Facility

Managing Validation Across a Complex Multi-System Manufacturing Project

The client required comprehensive validation support for a new oral solid dose manufacturing suite in Zebulon, North Carolina. The project involved multiple process systems, manufacturing technologies, utilities, and cleaning processes that needed to align with strict quality, validation, and production requirements while maintaining aggressive project timelines.

Scope of Validation and Project Support

Ellab provided project management and validation services for a new tablet manufacturing suite for the client in Zebulon, NC consisting of the following equipment. We provided validation project management, equipment factory acceptance test representation, equipment validation, computer systems validation, control system validation, and cleaning validation for all equipment.

Equipment and Systems Included in Scope

• Lancer 4100 Parts Washer
• Centralized Dispensary with automated contained dispensing
• General Dispensary
• GEA/Fielder PMA1200 Granulator
• GEA/Niro MP7 Fluid Bed Dryer and WIP skid
• Quadro® Comil® inline Conical Screen Mil
• Buck Blender with integrated containment/closure valves
• Intermediate Bulk Containers (IBC)
• Fette 3090i Tablet Press
• Safeline Tablet Deduster with integrated Metal Checker
• Glatt CCM500 Tablet Coater and WIP Skid
• Coating Solution Prep area
• USP Water System
• GEA-Niro MP-5 Fluid Bed Dryer and CIP skid
• Quadro® Comil® inline Conical Screen Mill
• Aeromatic-Fielder Pharma Matrix™ PMA 300 High Shear Granulator
• Meto tote lift, Tote blender

Coordinating a Multi-Phase Expansion Project

This project turned into a multi-phase project over several years as the facility required additional expansion and retrofits. The team had to coordinate all the different phases of work to align with the site quality and validation masters plans as well as the manufacturing objectives.

Building a Long-Term Project Partnership

This project came through referral via our close relationship with the Design/Construction team. This has blossomed into a mutually beneficial relationship where we continue to both serve the site together on new projects.

Providing Reliable Validation Support Across Every Project Phase

Project Outcome: Ellab successfully delivered the project on time and on budget for all phases of work at the site.

Success Story: The Ellab team became an extension of the site’s Validation team and now provides all validation services for the site. We currently have 4 people staffed on-site to handle ongoing validation and requalification needs.

Innovative Solutions: To support evolving project requirements, we provided scalable validation support that adapted to multiple facility expansions and retrofit phases over time.

By embedding experienced validation specialists on-site and aligning closely with site quality and manufacturing objectives, the team helped maintain project continuity, streamline validation activities, and support operational readiness across critical manufacturing systems.

Delivering Lasting Value Beyond Project Completion

Having delivered a true white glove service for all phases of the project, the Ellab team established itself as a long-term partner. The client has continued to keep Ellab team members staffed full-time as a permanent extension of their internal validation team, providing subject matter expertise to the local team.