Pharmaceutical companies develop, produce and package drugs in a sterile environment to ensure products are free of contamination. This is essential for safeguarding 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. Such standards ensure 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

* Regulatory violations

* Complete loss of production

* Catastrophic recall

Filter testing Solutions  

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.

OptiCal Sciences offers a range of filter testing solutions from Air Techniques International (ATI). These products perform in-situ filter integrity and leak tests for optimal micro-contamination control for the pharmaceutical manufacturing industry.

To find out more about our range of aerosol photometers and aerosol generators, please contact our expert team: info@optical-sciences.co.uk | Phone +44 (0)1604 493200