CLEAN ROOM CERTIFICATION
NATA Accredited Cleanroom Testing Services
Airepure NATA certified technicians are accredited to perform various compliance tests to validate cleanrooms, as per the following Australian Standards:
- AS 1807.1 – Determination of air velocity and uniformity in clean work stations, laminar flow safety cabinets and pharmaceutical isolators
- AS 1807.3 – Determination of air velocity and uniformity in laminar flow clean rooms. Air volume change rates
- AS 1807.5 – Determination of work zone integrity
- AS 1807.6 – Determination of integrity for terminally mounted HEPA Filter installations.
- AS 1807.7 – Determination of integrity for non-terminally mounted HEPA Filter installations.
- AS 1807.8 – Particle Counting in work zone
- AS 1807.10 – Determination of air pressure of cleanrooms
- AS 1807.15 – Determination of illuminance
- AS 1807.16 – Determination of Sound level in clean room
- AS 1807.20 – Determination of sound level at installed work stations, safety cabinets and pharmaceutical isolators
- AS 1807.21 – Determination of inward air velocity
- AS 1807.22 – Determination of air barrier containment of laminar flow safety cabinets
- AS 1807.23 – Determination of intensity of radiation from UV lamps
- AS 1807.24 – Determination of recovery times of cleanrooms
- AS/NZS ISO 14644.1 & 14644.3 – Clean rooms and associated controlled environments AS/NZS ISO 14644.1 (Annex B) – Clean room classifications
- AS/NZS ISO 14644.3 – 4.2.2 Airflow test (Procedure B.4)
- AS/NZS ISO 14644.3 – 4.2.3 Air pressure difference test (Procedure B.5)
- AS/NZS ISO 14644.3 – 4.2.4 Installed filter system leakage test (Procedure B.6)
- AS/NZS ISO 14644.3 –Upstream aerosol challenge for installed filter system leakage scan test with an aerosol photometer (Procedure B6.2.2)
- AS/NZS ISO 14644.3 – 4.2.9 Recovery test (Procedure B.12)
Cleanrooms can be positive (or in some instances negative) pressure environments that sweep a specified area with HEPA filtered air, providing a controlled environment.
At the conclusion of our comprehensive testing, you will receive a detailed analysis report and a NATA endorsed Certificate of Compliance to verify that your Clean Room meets Australian Standard specifications, ISO cleanroom classifications and relevant state or industry requirements.
Hospital Cleanroom Validation
Controlled cleanrooms within hospital or healthcare environments may include the following:
- Immune suppressed areas such as cancer wards, positive isolation rooms or low flow burns rooms
- Uni-directional or ultra clean ventilation systems within operating theatres, setup and recovery areas or sterile store stock areas
- Clean spaces such as pharmacy or cytotoxic areas, research / laboratory areas, pathology areas or cyclotron / nuclear medicine areas
We can also help you to meet and maintain compliance to relevant ACHS and state healthcare guidelines.
Pharmacy Cleanroom Certification
Controlled cleanrooms and laminar airflow systems within pharmaceutical environments may include the following:
- Sterile, positive pressure aseptic pharmacy cleanrooms
- Cytotoxic pharmacy cleanrooms (HEPA exhaust filtration systems)
- Pass through boxes and hatches
- Air showers
- Pharmaceutical isolators and laminar flow cabinets
- Safety cabinets, including biological safety cabinets, cytotoxic drug safety cabinets and fume cabinets
We can also help you to meet and maintain compliance to relevant TGA guidelines.