USP <787> Particulate testing solutions for contamination control

Excessive particulate contamination in protein-based drug products may lead to adverse health outcomes. Particle counting and analysis techniques are used to measure particle contamination and ensure adherence to specified limits.

Beckman Coulter specializes in characterizing and quantifying subvisible particles in accordance with USP <787>, USP <788> (Particulate Matter in Injections) and USP <789> (Particulate Matter in Ophthalmic Solutions).

The introduction of USP <787> with the option of testing samples down to 0.2 mL requires an instrument capable of accurately measuring, dispensing and counting at these small volumes. Tests carried out for the HIAC 9703+ report more than 90% sample accuracy for test volumes down to 0.2 mL.

HIAC 9703+ Light Obscuration Liquid Particle Counting System
  • Small vial clamp platform & unique sample probe for very small sample volumes
  • Detection of usual conditions (e.g., bubbles/contamination)
  • Fully automated pass/fail to pharmacopoeia requirements
  • SVI and LVI sampling
  • Selectable flow rate and interchangeable sensors (0.5 – 600 μm)
  • Secure sample handling for protein-based therapeutics

PharmSpec Software

  • USP, EP, JP, KP integrated compendial tests
  • Designed for use in 21 CFR Part 11 lab environments

The Multisizer 4e particle counting & characterization system may be considered an ‘alternative technology’ based on USP <1787>.

With proven technology, the Multisizer 4e is ideal for detecting & counting a wide variety of particles.
  • Electrical zone testing eliminates transparency issues
    • Detects particles independent of refractive index, color or composition
  • Counts particle density & determines particle volume and shape
  • 0.2 – 1,600 μm size range (based on aperture size: 10 μM – 2 mm)
  • Reduced noise for small particle detection
  • Fully automated routines
  • Designed for use in 21 CFR Part 11 lab environments

The QbD1200 TOC Analyzer can help simplify your validation and analysis and ensure regulatory compliance in 21 CFR Part 11 lab environments.

QbD1200 TOC Analyzer

QbD1200 TOC Analyzer

  • Compliant with all global pharmacopeia regulations (USP, JP, EP, IP, KP, ICH )
  • Fastest calibration time available (90 mins)
  • Only one reagent for any analysis
  • Proprietary technology oxidizes organic carbon to carbon dioxide to determine organic carbon concentration.
  • Strict adherence to discrimination requirements for inorganic and organic carbons.
  • Designed for use in 21 CFR Part 11 lab environments