At Opira, we’re the trusted experts in controlled environmental testing. HEPA testing is a big part of that and is particularly important for hospitals, healthcare providers, laboratories, pharmaceutical manufacturers and all other classified cleanrooms and controlled environments.
HEPA stands for ‘High Efficiency Particulate Air’ and is crucial for the safe operation of controlled environments throughout Australia. Regular inspection and testing of contamination control equipment, controlled areas and air quality hygiene processes are vital to protecting the health and safety of staff, patients, products and the wider community.
What is HEPA testing?
HEPA testing is part of our broader NATA (National Association of Testing Authorities) accredited controlled environment testing.
HEPA filters are installed in the HVAC systems that supply air to clean rooms, and other controlled environments such as operating theatres and other medical facilities. They are also installed in a variety of laboratory and process manufacturing equipment such as biological safety cabinets, laminar flow cabinets, Pharmaceutical isolators and cytotoxic drug cabinets.
These filters are designed to remove contaminants from the air, hence providing a safe, clean and sterile environment. Their high efficiency at sub-micron particle sizes makes them suitable for applications in areas where cleanroom conditions and contamination control is critical.
HEPA filter testing detects small pinholes or other damage in the filter medium and frame seal, by-pass leaks in the filter frame and gasket seal, and leaks in the filter bank framework. Another important part of this testing is to confirm that the filters are properly installed with no leaks due to manufacturing defects or installation workmanship.
Opira can provide professional, onsite testing and certification services for HEPA filters to AS 1807.6 & 7.
Who needs HEPA testing?
All types of controlled environments require HEPA filters, and therefore also need HEPA testing. Cleanrooms are spaces that need to be free from contaminants such as microbes and particles. These areas need to comply with certain standards that specify the quantity of particles at a certain size that are allowable to be contained within 1m³ of air (the ISO Class rating). Cleanrooms need to meet certain ISO Class ratings depending on their function, and some examples include:
- Operating theatres
- Research laboratories
- Pharmaceutical manufacturing
- Veterinary medicine
HEPA testing may also be one of the requirements for annual certification of contamination control equipment such as:
- Biological safety cabinets and laminar flow cabinets,
- Cytotoxic drug safety cabinets,
- Pharmaceutical isolators
- Downflow booths
In order to comply with standards that apply to these types of cleanrooms and controlled environments, HEPA testing is essential.
The importance of HEPA testing
HEPA testing is all about protection. Whether it’s maintaining a safe surgical environment through to ensuring the integrity of manufacturing operations, HEPA filters play a major role. In fact, without this sort of protection, cleanrooms and controlled environments are unable to meet the standards set out for them. This means they’re not only risking the quality and success of their work and the health and safety of staff, patients and the community, but they may also be in breach of the law.
When should HEPA filters be tested?
- 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 and in some cases more regularly depending on the client’s requirements,
- As required by the organization’s GMP code or regulatory authority.
- In special circumstances, such as a significant change in the work program, or where impaired operation is suspected.
Why choose Opira for HEPA testing?
Opira is NATA accredited for working in controlled environments (Accreditation no: 15597) and we meet ISO 9001:2015 Quality Assurance standards (Certificate AU15/4370). We are also:
- Certified consultants
- Fully insured with professional indemnity, public liability and work cover
- Quality assured practices 3rd party certified to ISO9001.
- Provide professional, friendly service
- Respected specialist in the science industry
So you can be confident in our industry knowledge, management systems and capabilities.
When you choose Opira, you’re gaining access to full accredited professionals with years of experience in controlled environment and HEPA testing. Once our testing is complete, we issue a fully-documented test report and A NATA Certificate of Compliance. This includes details of the test procedures and equipment used (and its calibration reference), analysis of test data and details of any repairs and/or adjustments made to equipment.
Where appropriate, we also report any recommendations we may have for future action. Any replacement parts installed during the testing process are selected to be at least equivalent to those specified for the original installation. We can help design a maintenance and test program specifically designed to ensure that your equipment operates efficiently and safely.
For the very best in HEPA testing, and all other controlled environment assessments, you can trust the specialist at Opira.