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Cleanroom Validation Services

Cleanroom Validation Services

Ensure your cleanroom is compliant, efficient, and audit-ready with our end-to-end validation services. We help pharmaceutical, biotech, healthcare, and manufacturing facilities meet ISO 14644, EU GMP Annex 1, WHO TRS, and cGMP requirements.

Instruments We Validate

  • • Cleanrooms
  • • Laminar Airflow units
  • • Bio Safety Cabinets
  • • Dynamic Pass Boxes
  • • HVAC systems
Cleanroom Validation

On-site cleanroom validation with certified instruments.

Our Services

HEPA Integrity Testing

Detects leaks and validates HEPA/ULPA filters using aerosol-based methods. Ensures compliance with ISO 14644 & GMP.

Airflow & Velocity Testing

Ensures consistent laminar airflow and contamination control. Includes smoke visualisation, velocity mapping, and ACPH determination.

Pressure & Leakage

Verifies pressure cascades, room pressurisation, and envelope integrity to prevent cross-contamination.

Temp, Humidity & Recovery

Performs RH mapping, humidity tests, and recovery validation to confirm HVAC efficiency and stability.

Particle & Microbial

ISO 14644 particle counting, viable monitoring, settle plates, swabs, and deposition tests for compliance.

Cleanroom Classification

Certifies cleanrooms with full audit-ready documentation.

Lux Intensity & UV Testing

Conducts light intensity and UV-A/B/C tests as per standards.

Standards We Follow

  • • ISO 14644-1/2/3
  • • ISO 8995-01
  • • ANSI/NSF-49
  • • EU GMP Annex 1 (2022)
  • • WHO TRS & US FDA cGMP
  • • ISO/IEC 17025 traceability

Industries We Serve

  • • Pharmaceuticals & Biotechnology
  • • API & Sterile Manufacturing
  • • Hospitals & Operation Theatres
  • • Food & Cosmetics
  • • FMCG

Why Choose Us?

Frequently Asked Questions

We validate against ISO 14644-1/2/3, EU GMP Annex 1, WHO TRS, cGMP, and customer URS requirements.

Typically annually or after critical changes such as filter replacement, layout modifications, or HVAC upgrades.

Yes. All our instruments carry ISO/IEC 17025 traceable calibration certificates.

Yes, wherever feasible. We coordinate to minimise downtime and include recovery testing if needed.

Request a Quote

Share your cleanroom classification, area (m²), and number of devices (Laminar Air Flow, Bio Safety Cabinet, and Dynamic & Static pass boxes). Our team will propose a tailored validation plan, timeline, and cost.

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