Cleanroom Certification in Boston, MA

The Boston–Cambridge metro is home to one of the world's largest concentrations of biotech and pharmaceutical research, development, and manufacturing facilities. GENTAB certifies cleanrooms and controlled environments across the area to ISO 14644 standards, supporting the aseptic processing suites, cell and gene therapy labs, and GMP-aligned manufacturing spaces that this life-sciences cluster depends on.

Certification work here covers airborne particle classification, filter integrity testing, pressure cascade verification, and recovery performance — the same measured, documented approach GENTAB applies to pharmaceutical cleanrooms nationwide. Because life-sciences facilities in the Boston area frequently operate under tight regulatory and internal quality timelines, we scope certification and requalification programs to keep suites in a continuous, audit-ready state of control.

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.