Cleanroom Particle Count Testing for GMP Compliance

Why Particulate Testing Matters

Particulate matter can compromise API purity, product safety, and compliance with ISO 14644 and EU GMP Annex 1.

Microchem’s Monitoring Procedures

We conduct:

  • Non-viable particle counts (≥0.5µm and ≥5µm)
  • Routine monitoring and requalification
  • Data trending and deviation analysis

Integrated Quality Oversight

All results are archived in GMP-compliant systems and reviewed by QA for change control or CAPA if needed.

Keep your cleanrooms within ISO standards with Microchem’s testing services.