Biosafety Cabinet Testing & Validation
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What is Biological Safety Cabinet Testing?
Biosafety cabinets, also known as BSC’s or MSC’s, are primary barriers of containment used in cleanroom environments or research centres and hospitals, for work with potentially infectious agents. They offer localised environmental protection for the user using hepa filtration and an exhaust system. These units must therefore be reliable as it is a key safety measure. A BSC is an enclosed ventilated work area and the different types that exist are distinguished by the level of necessary biocontainment or operator protection. Biosafety cabinets are predominantly for operator protection, but a class II cabinet also offers product protection. Qualified personnel who are specialised in maintenance and certification of such equipment must certify the equipment at least annually depending on your requirements. A BSC that contains a Grade A or ISO 5 environment should be tested bi-annually. The process leading to the certification is known as biological safety cabinet validation testing, or BCS testing. This is a legal requirement for regular maintenance and examination under COSHH regulations. It’s important to have a validation process to control the routine validation testing of all biosafety cabinet devices and a risk assessment may be necessary.
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References Available
Air Velocities Testing
Air velocity testing is a vital process involved in biosafety cabinet testing and validation. This test is divided into two:
Downflow Velocity Test
The downflow velocity test is used only for a class II biosafety cabinet to determine the average air descent speed and to verify the laminar flow within the work area.
The downflow velocity test is specific to class II safety cabinets as it is created from direct hepa filtration to keep the air uniform. Downflow velocity plays a critical role in product protection and maintaining an ultra low particulate environment. It can also have an effect on the noise level if set up incorrectly. A risk assessment for product entry and exit of the cabinet should always be carried out.
Inflow Velocity Test
The inflow velocity test calculates the average inflow air speed entering the cabinet. The inflow velocity test has different requirements for class I, class II and class III cabinets as they all have slightly different functions. It’s imperative that the inflow velocity is accurate for each type of cabinet as it jeopardises operator protection for the user if it’s incorrect. Inflow velocity plays an important role as it is uniquely linked to the exhaust system of the cabinet. If the cabinet is ducted, it may be linked to the building exhaust system. If it is set up incorrectly, it can also affect the noise level of the cabinet and has other impacts for environmental protection.
A class 1 biosafety cabinet is measured at the aperture, whereas a class II biosafety cabinet is more accurately measured using the exhaust air and calculating the inflow velocity using surface area calculations. For detailed information on biosafety cabinets and velocity testing, contact a Total Clean Air specialist to get specific answers to your project.
HEPA Filter Integrity Leak Testing
HEPA filters are the critical components of any biological safety cabinet, and as such should be regularly tested for performance, safety and filter leak .
HEPA filter integrity testing is extremely important and ISO 14644-3 states the correct method to determine the integrity of the HEPA filters, housings and mounting frames for air supply and exhaust, when the cabinet is operated at nominal speeds. Each cabinet has a specific filter housing or clamping arrangement that’s suitable for exact dimensions and ratings.
The standard HEPA filter media is a single sheet of borosilicate fibres treated with a water-repellent, water-resistant binding agent.
In order to increase the overall surface area inside the filter frames, the filter media is pleated, and the pleats can be separated by layers of aluminium. The separators prevent the pleats in the air stream from collapsing and provide a pathway for air. Careless filter handling may damage the glue medium and cause tears or filter shifts that result in a filter leak to the media. This is the main reason for checking the integrity of the hepa filters when a biological safety cabinet is first mounted, and each time it is transferred or relocated. It’s important to routinely perform a filter integrity leak test to ensure the cabinet is still operating safely.
Hepa filtration is a fundamental part of biological safety testing and looking for a filter leak using best practises for the field certifiers, cannot be underestimated. Airflow smoke at specific micron sized particles should be dispersed within the biological safety cabinet to provide a suitable upstream concentration. This is usually done by injecting the airflow smoke in the work area of the biosafety cabinet.
Airflow Visualisation (Smoke Visualisation)
On a class II biosafety cabinet, airflow smoke patterns tests are done to verify that the air flows down smoothly in the work area without any dead spots and does not escape from the cabinet. It is necessary to verify that no smoke escapes from the cabinet after being drawn in and that no smoke blows or penetrates the work surface.
A class I cabinet will look to see that the airflow smoke is captured at all areas around it’s aperture and that no airflow smoke escapes.
Ultimately, this test verifies that the cabinet window is well sealed. An airflow visualisation test must be conducted using the authorised chemical or smoke generator that is especially developed for the purpose. The current trend is to conduct the test with ultrasound nebulised, distilled or ultra-pure water.
Total Clean Air offers custom-tailored, airflow visualisation studies. To maintain environmental control in a cleanroom, it is necessary to be aware of airflow smoke patterns. It is best to visualise and document the airflow patterns.
Our experts offer airflow visualisation tests that record current airflow patterns with our unique techniques and the process can be recorded for evidence as requested.
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