Camfil's NATA accredited facility can perform various compliance tests to validate cleanrooms, as per the following international and Australian Standards:
- AS/ISO 14644.3 - Method B2 - Determination of air velocity and air change rates in clean rooms
- AS/ISO 146443 - Method B7 - Installed filter system leakage test
- AS 1807.7 – Determination of integrity for non-terminally mounted HEPA Filter installations
- AS/ISO 14644.1 – Particle Counting in work zone
- AS/ISO 14644.3 - Method B1 – Determination of air pressure of cleanrooms
- AS 1807.4.5 – Determination of illuminance
- AS 1807.16 – Determination of Sound level in clean room
- AS/ISO 14644.3 - Method B4 – Determination of recovery times of cleanrooms
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 accredited certificate of compliance to verify that your clean room meets 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.
Australia