From Lab to Pilot Scale: Core Configurations for ODF Pilot Lines

ODF (oral dissolvable film) has strong market momentum, but moving from lab formulations to commercial production requires a critical pilot stage. Beyond “small-batch output,” the pilot line is the window for process validation, cost control, and registration data generation. A well-planned pilot configuration is the key to successful scale-up.

1) Role and Value of an ODF Pilot Line

• Process validation: Evaluate scale-up readiness and parameter windows.
• Data generation: Produce registration-oriented batch data and reports.
• Customer sampling: Support CDMO work and export sample programs.
• Efficiency assessment: Verify that the workflow can sustain industrial throughput.

For teams targeting the pharmaceutical pathway, the pilot stage is an essential step before submission of registration dossiers.

2) Recommended Pilot-Scale ODF Configuration

The following compact and modular setup covers coating, drying, cutting/packaging, and QC integration.

1) MJ150-L Coating System

View MJ150-L ODF Film Coating Machine

• Compatible with aqueous or solvent-based formulations.
• Precision tension control to suit pharma-grade substrates.
• Adjustable coating width for different product formats.
• Hot-air gradient drying to minimize stress and warpage.

2) MJF180 Strip Cutting & Packaging

View MJF180 ODF Strip Cutting & Packaging Machine

• Cutting accuracy up to ±0.2 mm; supports multiple unit-dose sizes.
• Seals paper, PE, aluminum foil, and multilayer laminates.
• Optional modules: inline coding, rejection, and vision tracking.

3) Integrated Pharmaceutical Testing Instruments

Pharmaceutical Testing Instruments

• Key QC points for dissolution, disintegration, and content uniformity.
• Data architecture designed to support FDA 21 CFR Part 11 requirements.
• Sample report templates for registration-oriented documentation.

3) Who Benefits Most from a Pilot ODF Line?

• Pharma R&D teams: Translate innovation into scalable, manufacturable processes.
• CDMOs: Deliver pilot production, dossier data, and market-ready samples.
• Nutraceutical brands: Launch small batches to test market fit and customization.
• Universities/Research centers: Build standardized platforms for grants and tech transfer.

Conclusion

The pilot stage is the indispensable bridge from R&D to full-scale manufacturing. Choosing a GMP-aligned pilot configuration—covering coating, packaging, and integrated QC—reduces risk, accelerates time to production, and elevates data quality for registrations and global commercialization.