Cleanroom Validation & HEPA Filter Integrity Testing
AirRated® offers a comprehensive range of cleanroom testing services tailored to meet your specific cleanroom requirements, including particle and HEPA filter integrity testing.
Cleanroom Validation
What is a Cleanroom?
A cleanroom is a controlled environment meticulously engineered to maintain a specific concentration of airborne particles. It’s isolated from external contaminants through HEPA filter systems, with applications spanning various industries, including hospitals, nuclear facilities, virology labs, pharmaceuticals, manufacturing, hazardous biology, and research centres.
Maintaining Purity
Cleanrooms adhere to stringent ISO/GMP classification standards, with air changes per hour (ACH) measured and calculated to meet their mechanical design requirements. Differential pressure cascading is a crucial aspect of validation, ensuring that the correct pressure differentials (positive or negative) prevent cross-contamination. Visual differential pressure gauges aid in identifying pressure gradients, while more advanced systems use Building Management Systems (BMS) with temperature/RH sensors and visual/audible alarms for comprehensive control.
Choose AirRated®
AirRated® offers a comprehensive suite of cleanroom testing services tailored to your specific cleanroom requirements. Contact us to ensure your cleanroom consistently meets the highest standards of cleanliness and safety.
AirRated® carry out Cleanroom test methods & procedures in line with ISO 14644.1 - 14644.3 & GMP Annex 1-2015
The use of Light Scattering Airborne Particle Counters (LSAPC) forms the basis for determining the concentration of airborne particles, equal to or greater than specified sizes, at designated sample locations. These classification tests are conducted in compliance with ISO 14644-1 and ISO 14644-2 standards.
Particles ranging from 0.1μm to 5.0μm are used to assess air cleanliness particle concentrations for this classification. The air cleanliness testing is defined in one or more of three occupancy states:
1. The first condition is the ‘as-built’ state, where the cleanroom or clean zone is complete with all services connected and functioning, but without equipment, furniture, materials, or personnel.
2. The second state is the ‘at-rest’ condition, where the cleanroom or clean zone is complete with equipment installed and operating as agreed, but with no personnel present.
3. The third state is referred to as the ‘operational’ state, wherein the cleanroom or clean zone functions in a specified manner, with equipment operational and the specified number of personnel present.
When conducting tests in accordance with Good Manufacturing Practices (GMP), both ‘at-rest’ and ‘operational’ occupancy states are measured.
AirRated® can also provide the following tests:
- Airflow test
- Air pressure difference test
- Installed filter system leakage test
- Airflow direction test and smoke visualisation
- Temperature test
- Humidity test
- Recovery test
At-rest or Operational classification may be carried out periodically based upon risk assessment of the application or process in which the rooms are used for, typically on an annual basis.
HEPA Filter Integrity Testing
To achieve the high-grade results required for ISO/GMP Classification, air must pass through HEPA/ULPA filter media. We rigorously test the filter media and framing assemblies to ensure there is no air leakage bypassing the HEPA/ULPA. This testing detects filter deficiencies such as pinholes, gasket leaks, or sealing issues around the frame. These issues can be quantifiably pinpointed and corrected, ensuring the protection of both products and personnel.
HEPA filters play a crucial role in both supply and exhaust air applications. On the supply side, HEPA filters deliver clean air to environments such as manufacturing clean rooms, hospitals, pharmaceutical, and food processing facilities where there are UCVs or HEPA filtration systems in place. For exhaust systems, HEPA filters prevent contaminants from being discharged externally or spreading to other rooms within a building. HEPA filter Integrity testing can be performed on either the supply or exhaust air. This test employs a photometer to scan for small leak holes that could allow contaminants to penetrate.
- Light Scattering Photometer – Air Techniques
- ATI 4BLite – 3 laskin nozzle Aerosol Generator
- Particle Counter - TSI Inc. AeroTrak 9500 (100L/min)
- TSI 9565-P-NB VelociCalc Multimeter, 964 Hotwire Probe & 995 Vane Anemometer
Installed Filter System Leakage test AS/NZS 14644.3:2009
Prescribed method
For terminally mounted filters the integrity testing was performed in accordance with AS 1807.6-2000
For non-terminally mounted filters the integrity testing was performed in accordance with AS 1807.7-2000
- Installation / Commissioning and before initial use
- Before and after HEPA filter replacement
- After any mechanical maintenance is carried out
- When HEPA's reach their max filter pressure loadings
- When the BMS alarms for maximum fan speed or duct velocity is no longer achieved due to filter loading
- After any movement of clean room stations
- In line with any local regulatory body requirements
- Where impaired operation is suspected
- As per individual infection control plan
- Relocation of HEPA Filter
Why choose AirRated®?
Established in 2020, AirRated® is a 100% NZ owned and operated business with over 20 years of experience in the commercial HVAC industry. We pride ourselves in providing accurate test results, using state-of-the-art instrumentation to meet design engineers specifications.
We are a solutions based commissioning firm with vast technical knowledge in testing & balancing of HVAC systems and cleanroom certification. Our Quality & Procedures are carried out to ISO 17025.2017 standards. See our other services
Contact us about your cleanroom classification
AirRated® provides a full suite of cleanroom testing to meet the specifications of your individual cleanroom requirements.
