Pharmaceutical Cleanroom Certification & Testing

GENTAB certifies and tests pharmaceutical cleanrooms where contamination control is inseparable from product quality and patient safety. From aseptic filling suites and sterile compounding areas to formulation, packaging, and quality-control laboratories, we verify that each controlled environment performs to its required ISO 14644 cleanliness classification.

Pharmaceutical environments demand evidence, not assumptions. We measure airborne particle concentrations, scan HEPA and ULPA filtration for leaks, confirm air change rates and recovery performance, and verify the pressure cascades that keep critical zones protected from less-clean adjacencies. Each test is performed with calibrated, traceable instrumentation and documented against defined acceptance criteria so the results stand up to internal quality review and external scrutiny.

We support new-facility certification, post-shutdown requalification, and ongoing recertification programs that keep your suites in a continuous state of control. When a reading falls out of tolerance, our whole-system diagnostic approach helps pinpoint whether the cause is filtration, airflow, pressurization, or recovery — so remediation is precise and requalification is fast. The deliverable is an audit-ready certification package aligned to your specifications and standard operating procedures.

ISO 14644 Classification: Airborne particle classification to confirm aseptic and controlled spaces meet their required cleanliness class at rest and in operation.

Filter Integrity Testing: PAO challenge scanning of HEPA/ULPA filters protecting critical fill, compounding, and processing zones.

Pressure Cascade Verification: Differential pressure mapping that confirms clean-to-dirty cascades safeguard the most critical environments.

Recovery & Air Change Testing: Recovery timing and air change rate measurement to demonstrate rapid return to classification after disturbance.

Airflow Visualization: Smoke studies for unidirectional flow and critical zones, documenting protective airflow over exposed product.

Requalification Programs: Scheduled recertification that keeps suites in a continuous, documented state of control between projects.