Particle Counting

Concentration of particles in liquid samples

Particle Counting in Pharmaceuticals

Particle counting is critical in ensuring the cleanliness and quality of drug products, especially in injectable formulations and sterile environments.

At Particle Analytical, we provide particle counting services using the Particle Measuring System APSS-2000

This system measures particle count, size and volume distribution through light obscuration. It covers a measurement range of subvisible particle sizes 2-125 μm and complies with Ph. Eur. 2.9.19 The system supports both quality control and contamination monitoring, ensuring products meet the highest standards of purity and safety.

How Particle Analytical can assist with Particle Counting

  • Contamination Monitoring
    Detects and quantifies subvisible particles in injectable drugs and sterile products, ensuring compliance with standards such as USP <788>.
  • Cleanroom Certification
    Verifies the cleanliness of manufacturing areas by counting airborne and liquid-borne particles, essential for maintaining sterile conditions.
  • Injectable Formulation Quality Control
    Ensures injectable formulations are free from particulate contamination, safeguarding product safety and efficacy.
  • Process Monitoring
    Monitors critical processes in sterile pharmaceutical production to ensure consistent particle control and product quality.
  • Regulatory Compliance
    Provides particle size and count data to support compliance with FDA, EU guidelines, and cleanroom validation.
  • Data Integrity and Reporting
    Ensures reliable data collection and reporting to meet regulatory requirements for audits and inspections.