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Instrumental Color Measurement in Biotech and Pharmaceutical Manufacturing

 

WarningImportant Notes:

Color is a critical quality attribute (CQA) used across R&D, formulation, scale-up, QC, and stability for both biotech (biologics, gene/cell therapies) and pharmaceutical (small-molecule) products. Even slight changes in color or turbidity can indicate impurities, degradation, formulation inconsistencies, or microbial contamination.

 

Why Color Measurement Matters

  • Color is a critical quality attribute (CQA) used across R&D, formulation, scale-up, QC, and stability for both biotech (biologics, gene/cell therapies) and pharmaceutical (small-molecule) products.
  • Even slight changes in color or turbidity can indicate impurities, degradation, formulation inconsistencies, or microbial contamination.

Traditional Visual Methods Are Obsolete

  • Visual color checks (EP/USP comparators) are subjective, coarse, and fail modern data integrity standards.
  • They require high sample volumes, offer poor reproducibility, and cannot be electronically recorded or validated.

Instrumental Color Measurement Advantages

  • Objective, repeatable data using CIELab values, ΔE*, NTU, and pharmacopeial indices (e.g., EP Y2, USP A–T).
  • Detects subtle changes before human eye can see them—vital for early corrective action.
  • Fully compliant with USP <1061>, EP 2.2.2, JP, CP, and 21 CFR Part 11.
  • Supports very small sample volumes and provides complete audit trails.

Applications

  • Liquids: Injectables, syrups, biologics – measure color/transparency (EP/USP indices) and turbidity (NTU).
  • Solids: Tablets, capsules, powder blends – ensure uniformity and API coating via reflectance.
  • Raw Materials/Excipients: Spot off-spec lots before use in production.
  • Semi-solids/OTC/Cosmeceuticals: Ensure consistent branding and batch uniformity.

Standards and Methods

  • EP 2.2.2 & USP <1061> allow direct replacement of visual tests with instrumental methods.
  • ASTM D7315/D1003 support turbidity and haze reporting.
  • Global harmonization among EP, USP, JP, CP enables cross-market compliance.

HunterLab: Best-in-Class Solutions

  • UltraScan PRO: Research-grade, full-spectrum (350–1050 nm), multi-mode with UV/Vis/turbidity.
  • UltraScan VIS: High-accuracy visible-range (360–780 nm), preloaded with pharma methods.
  • Vista™: Compact benchtop, validated for EP Method III, ideal for QC throughput.

HunterLab Key Benefits

  • Turnkey pharma compliance: Preloaded EP/USP/JP/CP indices.
  • Multi-mode versatility: Reflectance, transmission, turbidity in one instrument.
  • Validated protocols & software: EZMQC & Essentials with FDA 21 CFR Part 11 compliance.
  • Sample efficiency: Requires low volume, non-destructive testing.

Competitive Edge

  • Unlike generic UV-Vis (Agilent, Shimadzu) or water-centric devices (Hach, Lovibond), HunterLab systems are purpose-built for pharma color QC.
  • Offer faster, more sensitive color analysis with fully validated methods, optimized sample handling, and industry-specific software.

Conclusion

Switching from visual to instrumental color measurement significantly enhances product quality, reduces rework, ensures regulatory compliance, and improves manufacturing efficiency across pharma and biotech production

Download the attached white paper to learn more!

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Keywords: Biotech Color Measurement, Pharmaceutical Color Measurement, EP, USP, Pharmacopeia

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