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Controlled Environment Testing

We test and certify controlled environments to ensure that your facilities are compliant with the required standards and customer specifications. Our services are designed to meet regulatory, industry, and certification requirements according to various standards including: ISO, cGMP, CNBT, NSF, FDA, IEST, among others.

Cleanroom Services

Primary Services

Ensures unidirectional and non-unidirectional flow areas are properly balanced and zones are maintaining adequate air patterns.
Documents leakage or defects and ensures HEPA filters for cleanroom provide the required filtration.
Conducted per ISO14644, reports the amount of airborne particulate of a specified size in the clean environment.
Verifies that the room differential pressures meet regulatory requirements.

Additional Services

Verifies airflow direction using a source of visible fog.
Confirms whether HVAC controls are functioning properly and uniformly.
Performed to design specifications for worker comfort.
Performed to design specifications for worker comfort.
Ensures gauges are calibrated to regulatory standards.
Replace any faulty / non-fixable HEPA filters.
Performed to determine whether an area is capable of returning to a specified cleanliness level after non-routine exposure events.
Ensures compressed air and gas systems meet the requirements of the cleanroom.
Determines if any bacterial and fungal contamination is present.
Ensures mag gauges are functioning according to equipment and regulatory standards.

Fume Hoods

Primary Services

  • Room conditions
  • Face velocity tests
  • Sash operation test
  • Verification of proper air flow and patterns
  • Evaluation of low air flow

Additional Services

  • General Repairs

Biosafety Cabinets

Primary Services

Ensures proper inflow is maintained for operator protection and environmental protection.
Documents the air in the work area is unidirectional and functioning as designed, preventing cross contamination, and providing product protection from the environment.
Documents leakage or defects and ensures HEPA filters provide required filtration to prevent both product and environmental contamination.
Qualitatively verifies airflow directions using a small source of visible fog.
Confirms alarm performance and assesses installation of units for NSF and OSHA compliance.

Additional Services

Performed in accordance with ISO 14644-1 or EC Annex 1, and provides a quantitative evaluation of air quality in terms of particulate in the work area.
Verifies hood operation/usage will not contribute to worker fatigue/stress and may be performed in association with troubleshooting.
Ensures product is not subject to damage due to vibration and may be performed in association with troubleshooting.
Ensures fluorescent lighting levels are sufficient to prevent operator fatigue.
Decontamination ensures the unit is non-infectious and compliant with regulatory standards.

Isolator

Primary Services

  • Supply and exhaust airflow
  • Chamber pressure test
  • Site installation tests
  • HEPA filter integrity testing
  • Particle containment integrity and enclosure leak test (CACI only)
  • Smoke pattern test
  • Ingress/Egress test
  • Particle counting at-rest and operational
  • Viable air and surface sampling

Additional Services

  • General Repairs
  • Filter replacements

Laminar Flow Hood

Primary Services

Ensures that the air in the work area is unidirectional and performing as intended, preventing contamination incidents.
Documents leakage or defects and ensures HEPA filters for cleanroom provide the required filtration.

Additional Services

We can repair any faulty equipment
Replace any faulty / non-fixable HEPA filters.
Performed in accordance with ISO14644-1 and reports the amount of particulate, if any, in the workzone.
Determines if any bacterial and fungal contamination is present.
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