Cleanroom Services
Cleanrooms, by definition, are designed to control particulate
and environmental conditions. Cleanrooms can be positive or negative
pressure environments that sweep a specified area with HEPA filtered
air. Critical biopharmaceutical, pharmaceutical, and microbiological
areas require adherence to exacting performance requirements. TSS’
certification programs verify that facilities perform to appropriate
international standards and client specifications. All testing is
concluded with a fully documented formal report detailing test procedures,
test results, and offers comprehensive conclusions of the testing
performed. All cleanroom testing is performed in accordance and
compliant with Current Good Manufacturing Practices [cGMP], Institute
of Environmental Sciences Technologies [IEST], and International
Organization for Standardization [ISO].
Our primary cleanroom test battery includes:
- Airflow volume / velocity readings
- assures that both unidirectional and non-unidirectional flow
areas are properly balanced and unidirectional zones are maintaining
proper air patterns
- Room air exchange rates - state
if the area is meeting its design airflow
- HEPA filter integrity testing -
Tests HEPA filters and system for leaks
- Non-viable particle counting - reports
the amount of airborne particulate, of a specified size in the
clean zone
- Temperature / relative humidity testing
- examines whether the air HVAC controls are functioning properly
and uniformly
- Pressure cascade monitoring - verifies
that room differential pressures are operating according to design
Optional tests include:
- Air balancing - adjusts airflow in
the air handling systems to achieve design airflow, room air exchange
rates and pressure cascade
- Airflow visualization testing –
qualitatively verifies airflow direction using a source of visible
fog
- Viable environmental monitoring [EM]
- samples both the air and surface for microbe enumeration and
identification
- Compressed gas testing, [e.g. CDA]
– assures that the compressed gas sources meet the requirements
of the controlled environment for contamination and/or microbes
- Lighting, vibration and sound tests
– assures worker comfort
- All other special tests from the ISO/IEST guidelines
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