Pharmaceutical companies develop, produce, and package drugs in a sterile environment to ensure products are free of contamination to safeguard against harm or life-threatening health risks to the patient. A cleanroom is a controlled environment where aerosol particles and airborne microbes, such as bacteria and viruses are filtered out to reduce the risk of contamination. The level of air cleanliness in the pharmaceutical cleanroom is regulated by standards like ISO 14644 so that the concentration of airborne particles in the manufacturing environment is controlled to specified limits.

Pharmaceutical cleanrooms use either High-Efficiency Particulate Air (HEPA) or Ultra-Low Particulate Air (ULPA) filters to trap and remove air contaminants. HEPA filters remove at least 99.97% of particles at the most penetrating particle size of 0.3 μm in diameter, while higher rated ULPA filters, similar in function and construction to HEPA filters, remove 99.999% of particles at the most penetrating particle size of 0.12 μm in diameter.

Why is it important to test HEPA filters for leaks?

With the high costs of developing and producing pharmaceuticals, the impact of filter leaks can be staggering:

• Disruption to expensive drug R&D
• FDA violations
• Complete loss of production
• Catastrophic recall

How are ATI’s products used?

In-situ filter integrity testing, also known as dispersed oil particulate (DOP) scan testing, is required once or twice a year, depending on the ISO class of the cleanroom. The filter integrity test requires portable test equipment to generate and measure the concentration of a challenge aerosol, and then detect the amount of aerosol that leaks through the filtration system.