Air Filters for Medical Device Manufacturing Facilities

Cleanrooms, anterooms, clean benches, and pass-through cabinets are the staple of any Medical Device Manufacturing Facility. In these highly specialized and critical spaces making the correct air filter choice is critical. Different manufacturer’s and filter styles within the HEPA and ULPA filter classifications have vast differences in energy consumption and filter life. As a general rule the “pack height” or depth of the filter media cartridge is the most significant factor in determining filter life and energy use – the deeper the pack the longer life and lower energy consumption. Media spacing methods, sealing into the frame, and media manufacturing also plays an important role – not all 70mm packs are created (or perform) equal.

However, the HEPA and ULPA filter is only one part of the filtration equation. Just as important is the housing or module that the filter is installed in. It is easier for manufacturers to cut

corners to offer a cheaper product here because, unlike the filters, there is no standardized testing procedure for the housings/modules/hoods. Make sure your housings are FULLY WELDED, even leaks into intersitial space can creae problems because of hte dynamics of air movement. Also, the housing should be pressure decay tested to make sure that all welds secure. ISO:9001 certification goes without saying, but a facility following NQA-1 quality control guidelines will typically have superior products becuase of the extra quality control procedures that are forced to be followed and are audited more regularly and severly than ISO:9001