In the design of any Clean Room, HEPA filters are a vital component. GMP regulations dictate their use. In a Pharmaceutical facility, a well-designed HVAC system requires the use of HEPA filters to ensure the cleanliness and classification of specific areas.

GMP regulations and ISO 14644 guidelines mandate the periodic testing of HEPA filters to validate their efficiency and integrity. Over time, HEPA filters can experience a decline in efficiency due to clogging, become ineffective due to improper installation, or sustain damage such as holes or rips during installation or maintenance activities in the plant. To ensure the integrity of HEPA/ULPA filters and comply with relevant standards and governing agency requirements, we recommend conducting filter testing and evaluation at least twice a year. Proper documentation and certification also help predict potential performance issues and increase filter life.