Certifications

TESTING AND CERTIFICATION SERVICES FOR – CLEANROOMS, LAMINAR AIRFLOW PRODUCTS, SAFETY CABINETS AND HEPA FILTER INSTALLATIONS

The need for testing and certification:

Laminar Airflow Products, Cleanrooms, Clean Work Stations and Safety Cabinets are the primary barrier against airborne contamination in many critical applications in health care, science and industry. Manufacturers of pharmaceuticals, electronics, optics components, and other high-technology companies rely on the performance of cleanrooms to ensure that product standards are achieved.

The health and safety of laboratory personnel, and the success of important experiments and research projects depend on the safe and effective operation of biological safety cabinets. The periodic inspection, testing and certification of these controlled environments is vital to their ability to provide specified performance levels.

A proficient, specialized service organization should be engaged for this essential service work.

All test procedures should be performed in accordance with Australian Standard AS1807 using calibrated equipment.

LAMINAR AIR FLOW SERVICES

The need for testing and certification:

Laminar Air Flow Services (a division of Clyde-Apac), provides comprehensive on-site maintenance, testing and certification services for cleanrooms, laminar flow work stations, safety cabinets, HEPA filter installations and fume cabinets. Fully equipped laboratories staffed by highly skilled service technicians are maintained throughout Australia. Clyde-Apac provides factory training for technicians operating in South East Asia.

Laboratories in Australia are registered by NATA. Laminar Air Flow Services provides this service to leading hospitals, research institutions and high-technology manufacturers throughout Australia and South East Asia.

When testing is required:

Cleanrooms, laminar flow work stations and safety cabinets should be inspected, tested and certified as follows:

• On site, prior to use.
• After any electrical or mechanical maintenance.
• After filter replacement.
• After re-location of work stations or safety cabinets.
• At least annually.
• As required by the organization’s GMP code or regulatory authority.

In special circumstances, such as a significant change in the work programme, or where impaired operation is suspected.

LABORATORY ACCREDITATION

In order to achieve and maintain NATA registration, laboratories that provide mechanical testing services for these controlled environments
are required to satisfy stringent requirements. They must demonstrate that they operate strictly in accordance with the terms of registration. This includes:

• The performance of test procedures to Australian Standards.
• The maintenance of records for all testing work, and the supply to equipment users of certificates which detail the results of testing.
• The regular calibration of all test apparatus.
• Technically-competent service engineers and capable administrative personnel.

The laboratories of Clyde-Apac Laminar Air Flow Services meet these rigorous requirements. This is your a assurance that we are able to provide the highest standard of service to your organisation.

AUSTRALIAN STANDARDS

Our testing procedures are conducted in accordance with AS1807.
We certify equipment to comply with specific Standards for performance, which includes:

AS1386 – Cleanrooms and clean workstations
AS2243.8 – Safety in laboratories – fume cupboards
AS2243.9 – Safety in laboratories – fume cabinets
AS2251 – Laminar flow operating theatre enclosures
AS2252.1 – Class I biological safety cabinets
AS2252.2 – Class II biological safety cabinets
AS2567 – Cytotoxic drug safety cabinets

REPLACEMENT PARTS

We use only those replacement parts which are at least equivalent to those specified for the original installation. Our replacement HEPA filters are individually certified in a NATA-accredited laboratory for efficiency, integrity and airflow resistance.

These filters are manufactured in Australia under an accredited Quality Management system developed to comply with ISO-9001.

OTHER SERVICES

In addition to the routine certification of controlled environments, we provide other specialised services as follows:

• Air quality monitoring by particle counts
• Equipment rebuilding and upgrades*
• Installation surveys*
• Maintenance contracts
• Pre-maintenance fumigation of biologically contaminated areas, such as biological safety cabinets and HEPA filter exhaust systems*
• Minor equipment repairs performed at no charge in the course of normal service work*

Please contact us for a free survey and quotation for your application.

* Not all listed services are test procedures to Australian Standards that are covered by laboratory registration.