Streamline particle counting, turbidity, and color measurement into one automated platform with Big Kahuna VIS

Significance of the topic

Ensuring accurate and reproducible visual inspection of biopharmaceutical formulations for particle count, color, and turbidity is essential for product safety and process efficiency. Automated approaches reduce subjectivity, save time, and enable high-throughput analysis.

Objectives and study overview

The study demonstrates the integration of Unchained Labs Big Kahuna formulation system with a Visual Inspection Station and LEA software to automate particle counting, color assessment, and turbidity measurement in 3 mL and 20 mL vials.

Instrumentation used

• Big Kahuna automated formulation platform configured for biologics
• Visual Inspection Station (VIS) module for imaging
• Lab Execution and Analysis (LEA) software for control and data analysis
• Standard vials (3 mL and 20 mL) and vial/plate gripper
• NIST-certified glass and polystyrene beads for particle tests
• Nephelometric turbidity standards (1–100 NTU) and color standards (including BY4 and blue)

Methodology

• Particle counting: Vials containing 8–9 polystyrene beads in water or ~55 glass beads in 65% glycerol were spun to resuspend particles, imaged at up to 8 fps, and static features removed by image subtraction. Binary conversion and ROI analysis yielded particle counts over four replicates.
• Color assessment: Unknown samples were compared to a library of standards using digital image capture and match scoring. A BY4 standard was tested 30 times and additional blue standards were evaluated.
• Turbidity measurement: Calibration curves for 3 mL and 20 mL vials were generated using NTU standards. Normalized luminance was calculated by comparing sample images to blank images over multiple replicates and two consecutive days.

Key results and discussion

• Particle counting achieved reproducible counts (50–59 beads in glycerol, 8–9 in water), with variations attributed to particle overlap and ROI limits.
• Color matching yielded scores of 99.99–100% for BY4 over 30 repeats, and successfully distinguished additional blue standards.
• Turbidity measurements exhibited linear calibration curves and reproducibility within 5% across 1–100 NTU and between days for 3 mL vials.

These results confirm that the VIS provides accurate, quantitative, and traceable measurements, significantly improving throughput and consistency compared to manual inspection.

Benefits and practical applications

• Non-destructive, automated testing conserves sample and reduces labor.
• High-throughput capability accelerates formulation development.
• Image storage enables retrospective analysis and regulatory compliance.

Future trends and potential applications

Integration of advanced image analysis and machine learning could extend capabilities to sub-visible particles and multi-wavelength colorimetry. Expanding to in-line process monitoring and real-time quality control will further streamline biopharmaceutical manufacturing.

Conclusion

The Big Kahuna VIS platform enables robust, reproducible, and automated measurement of visible particles, color, and turbidity, enhancing efficiency and data reliability in biologics formulation.

References

1. Rathore et al. Challenges and Strategies for Implementing Automated Visual Inspection for Biopharmaceuticals, Pharmaceutical Technology, Nov 1, 2009.