Validation & Process Engineering Support for a High-Potency OSD Manufacturing Facility

Accelerating Facility Startup for OSD Manufacturing

As part of a highly visible greenfield project, the client undertook the development of a new oral solid dosage manufacturing facility designed to support high-potency compounds. The program required rapid progression from construction through qualification and into clinical manufacturing readiness.

To meet aggressive timelines while maintaining GMP compliance, they required a large, experienced validation and process engineering team capable of integrating seamlessly with internal stakeholders and construction partners.

Comprehensive Commissioning, Qualification, & Process Development

Ellab was selected as the sole-source partner to support validation, qualification, and commissioning, as well as process development activities for the greenfield project.

The scope of work for the project included:

• Commissioning and validation project management.
• Validation strategy and master plan development.
• Development and execution of URS, FS, DS, SAT, IQ, OQ, and PQ protocols as applicable and authored validation summary reports in alignment with site and regulatory expectations.

We worked directly with the construction management firm to ensure a seamless turnover of documentation, systems, and milestone deliverables.

We were integrated closely with the project team, working under contract with the construction management firm to assemble Engineering Turnover Packages (ETOPs) to maintain aggressive schedule commitments.

The project scope was later extended to also cover:

• SOP development
• Process engineering
• Clinical manufacturing support
• Computer systems validation

Equipment, Facility, & Manufacturing Systems Qualification

Ellab supported qualification of a broad range of manufacturing, packaging, and facility systems, including:

• Process and manufacturing equipment
• Facilities and material handling systems
• Utilities and building systems qualification
• Computer systems validation

Key equipment included:

• Glatt Fluid Bed Granulator GCPG 300 with WIP system
• Glatt Fluid Bed Granulator GCPG 60 with WIP system
• Glatt Large-Scale and Small-Scale IBC Blenders
• Courtoy MODUL S Tablet Press
• Thomas Engineering 48-inch and 60-inch Accela-Cota Compu-Coat 6S Coaters
• Control Micro Systems Laser Drill with integrated vision system
• IMA Bottle Packaging Line
• Tablet Printer and Proditec Vision Inspection System
• Glatt IBC Washer
• Cold Storage Units and Stability Rooms
• Coating solution preparation systems
• ABB Building Management System
• Trane and custom air handling units
• Clean compressed air and nitrogen systems
• Chilled water, heating hot water, and steam generation systems
• Emergency power, UPS, and cooling tower systems

SOP Development & Operational Readiness

We developed and implemented operational and maintenance SOPs to support startup and sustained operations, including:

• Operational, cleaning, and preventive maintenance SOPs for more than 25 processing equipment systems.
• Operational and maintenance SOPs for 11 utility systems.

Process Engineering, Scale-Up, & Clinical Manufacturing Support

Following completion of commissioning and qualification activities, we supported the product development organization with process scale-up and optimization efforts. This enabled our client to transfer manufacturing from an external contract manufacturing organization to their new facility.

This phase of work included:

• FMEA development.
• Process optimization planning.
• Design of Experiments (DOE) execution using Response Surface Methodology (RSM) supported by Design Expert and Minitab.

And execution of:

• DOE protocols.
• Sampling plans.
• Deviation troubleshooting.
• Final reports summarizing individual studies and overall process performance.

We further supported clinical manufacturing and stability batch execution, including deviation investigations and root cause analysis. Additional process engineering studies were completed to optimize granule moisture content, improve coating weight gain consistency, define maximum in-process material holding times, and evaluate intra-batch tablet weight gain variation and its impact on dissolution performance.

Streamlined Validation Execution & Accelerated Manufacturing Ramp-Up

By deploying a sizable and versatile on-site team, we provided the client with a single, cohesive resource capable of addressing multiple project needs in parallel. This approach shortened timelines, reduced execution risk, and enabled a smooth transition from facility qualification into clinical manufacturing operations.

Successful Transition from CDMO to New Facility

Through meticulous project management and close collaboration, we succeeded in helping the client transition the manufacturing process from a contract manufacturing organization site to the new facility.

The success of the transition demonstrated the value of an integrated validation and process engineering partner with a wealth of subject matter expertise.