LimsPulse
Dosage-form testing

Liquid Particle Counter (Light Obscuration)

Counts and sizes sub-visible particles in injections by passing the liquid through a narrow light beam. Each particle casts a shadow whose size gives the particle size. Used for the USP <788> particulate matter test.

  • Pharmaceutical (parenterals)
  • Biotech
  • Medical devices
  • Industrial fluids
CALIBRATION

Liquid particle counter calibration procedures

Sizing calibration with certified spheres

Calibrates the size thresholds of the light obscuration sensor using monodisperse polystyrene spheres of certified diameter, and checks sensor resolution.

Open procedure

Counting accuracy

Runs a reference suspension of known particle concentration and checks that the counter reports the certified count. Sample volume accuracy is checked at the same time.

Open procedure
QUALIFICATION

Instrument qualification (DQ · IQ · OQ · PQ)

  1. 01

    DQ — Design qualification

    Specifies size range, sensor type, sample volumes and 21 CFR Part 11-compliant software.

  2. 02

    IQ — Installation qualification

    Verifies installation, software and certificates for the sensor and calibration standards.

  3. 03

    OQ — Operational qualification

    Checks sample volume accuracy, flow rate, sizing calibration, sensor resolution and count accuracy.

  4. 04

    PQ — Performance qualification

    Runs the reference suspension and product tests to show consistent results.

In LimsPulse · Calibration Management

Keep every Liquid particle counter in control: usage logs, calibration and maintenance schedules, and automatic blocking of overdue instruments.

See how