Cleanroom Certification in Chicago, IL

Chicago's metro area carries one of the Midwest's densest concentrations of hospital systems, pharmaceutical and biologics manufacturing, and large-scale industrial production. GENTAB certifies cleanrooms and controlled environments for facilities throughout the Chicago area to ISO 14644 standards, supporting aseptic manufacturing suites, hospital compounding pharmacies, and process cleanrooms embedded within larger industrial plants.

We measure and document airborne particle concentration, HEPA/ULPA filter integrity, air change rate and recovery, and room-to-room pressure relationships, then package the results into audit-ready certification reports mapped to each facility's specifications and standard operating procedures. Our teams support new-space certification, post-shutdown requalification, and ongoing recertification programs for Chicago-area facilities operating under pharmaceutical, healthcare, or industrial quality oversight.

Airborne Particle Classification: Particle count measurement and statistical analysis to determine and document ISO 14644-1 cleanliness classification at rest and in operation.

HEPA / ULPA Filter Integrity Testing: Aerosol challenge (PAO) scanning of installed filters and housings to detect leaks, bypass, and media damage before they compromise the space.

Air Change Rate & Recovery: Supply airflow measurement, air change rate calculation, and recovery testing to confirm the room clears contamination within its required time.

Room Pressurization Verification: Differential pressure mapping across doors and adjacencies to confirm correct cascade and protect critical spaces from cross-contamination.

Airflow Visualization & Uniformity: Smoke studies and velocity uniformity testing for unidirectional flow zones, documenting that airflow patterns sweep contaminants as designed.

Certification Documentation: A complete, audit-ready certification package referencing test methods, instrumentation, acceptance criteria, and pass/fail results per room.