This article looks at DOP filter tests, which are carried out on HEPA filters in cleanrooms and other associated controlled environments.
There’s a brief rundown of the tests themselves, and an examination of why they are so important for patients, staff, operators and facility owners.
We also look at the advantages of having the work carried by Tecomak Environmental Services’ fully-trained and experienced staff.
(This article is a three- to four-minute read).
DOP filter testing is one of the most important specialist tasks we carry out at Tecomak Environmental Services. Here we look briefly at what it involves, and why it’s so important in the areas of healthcare, scientific research and some production facilities.
DOP Filter Testing from Tecomak Environmental Services
Specialist ventilation systems are installed in many high-risk environments, particularly cleanrooms in the pharmaceutical and biotech sectors, and surgical theatres in hospitals. These systems are fitted with high-efficiency particulate air (HEPA) filters, which require regular maintenance and validation.
The principal way of achieving this is via DOP (dispersed oil particulate) filter testing. This will determine if the filters are working properly. The testing process involves releasing a cloud of the particulate into the system’s airstream, upstream of the filter, in the form of an aerosol.
For more information on the DOP test for HEPA filters, check out our previous post on the subject here. But why is the testing process so important?
1. It Ensures the Integrity of the Environment
DOP testing is crucial for maintaining the cleanliness and particulate-free environment of the target environment. It’s vital for cleanrooms and other high-risk areas to have as few airborne pollutants as possible, to protect the product (in the case of production facilities), the patient (who may be immunocompromised if they are about to undergo surgery), any staff who are working there, and any research or experiments which are being carried out.
2. It Ensures Regulatory Compliance
The testing process confirms that HEPA filters are functioning according to their specifications and regulatory requirements. The relevant British Standard is BS EN ISO 14644-3, which deals with cleanrooms and other controlled environments.
If the testing is taking place in a production facility, then GMP (Good Manufacturing Practice) regulations also apply. PD6609:2007 provides guidance on how the tests should be carried out.
3. It Ensures Better Performance
The DOP test for HEPA filters will detect leaks in the system, any poorly installed filters, or any damage to the seals and housing. Specifically, the test will establish whether all the air is passing successfully through the filter; if not, it will identify any ‘dead spots’ where contamination could build up.
This allows for timely repairs or replacements, preventing costly downtime and ensures the ventilation system operates at peak efficiency.
4. It Provides Peace of Mind
Knowing the filter system has been tested and confirmed to be performing to specification should offer confidence – for owners, operators, patients and staff – in the integrity of the cleanroom or critical environment.
DOP Filter Testing from Tecomak Environmental Services
At Tecomak, we test all grades of cleanroom facilities and other sensitive environments with a specialist ventilation system. The testing can be carried out either at the same time as your cleanroom validation or as and when you need it. We carry most types of air filters and spares for them in the event of a DOP test failure.
We keep detailed records of all of your equipment and carry a full set of replacement HEPA filters, ensuring they can be replaced quickly.
And, in a further bid to ensure your facility is out of action for the minimum amount of time, our test reports can be written, quality checked and printed for approval, all before leaving your site. If you have any questions, you can contact us by calling 01732 852250 or by clicking filling in the online form on the right-hand side of this page.
FAQS:
What could happen if you don’t get your HEPA filters tested regularly?
Failure to check on the condition of your filters could result in fines, penalties, or even facility closures. If a problem with a product, or a patient falling ill, can be linked to ineffective HEPA filtration, it could lead to lawsuits and damage the facility’s reputation. Equally, if a problem is detected in a filter which is fitted in a research environment, then any results could be called into question.
How often should DOP filter testing be carried out?
Normally, HEPA filters are built to last between one and four years, but various faults can occur which mean they are no longer providing the intended protection.
Systems which come under the Control of Substances Hazardous to Health (COSHH) regulations, providing protection to people from hazardous airborne particles, will require testing at least once a year.
Some systems need to be tested more frequently, in some cases every six months, with the frequency depending on factors such as the application and the level of risk. Tecomak can advise you on how frequently testing needs to be for your specific cleanroom or high-risk environment.
What else does cleanroom validation involve, apart from DOP filter testing?
Cleanroom validation also involves tests to ensure air purity and environmental control, including airborne particle counts, airflow measurements, air pressure differentials, temperature and humidity monitoring and microbiological contamination.
At Tecomak, we also offer comprehensive cleanroom validation services. For more details, click here.
