ULPA vs. HEPA filters
American Cleanrooms
Anthony Chien of American Cleanrooms emphasizes the advantages of ULPA filters
for removing small particles but points also to the disadvantages. He also
points to the correlation between cleanroom class.
So, Class 1 would definitely be using ULPA filters whereas Class 7 would
be using HEPAs.
ULPA filters disadvantages:
Angstrom
Cell and gene therapies are practices that require a high level of control. In
order to fulfill their purpose and work effectively to treat life-threatening
diseases, there can be no disruption in their production process - which is why
they’re usually concerned about removing smaller airborne particles between .1,
.3, and .5 microns. Other cleanroom applications with less stringent
requirements are typically only concerned about .5, 1, and 5 microns. This is
the most important factor in determining which type of filter is best for cell
and gene therapy cleanrooms.
This also implies that most cell and gene therapy cleanrooms must meet
stringent ISO
standards,
which are usually between ISO Class 5-7, but can be higher or lower depending on
the application. For ISO 5, this means that they must have at lea 240
air changes per hour, 35-70% ceiling coverage, 40-80 feet per minute of air
velocity, and no more than 10,200 particles 0.3μm or larger in a cubic meter.
The requirements are a little looser for ISO 7, which requires at least 60 air
changes per hour, 15-20% ceiling coverage, 10-15 feet per minute of air
velocity, and no more than 1,020,000 particles 0.3μm or larger in a cubic meter.
So, which type of filter is right for your cell and gene therapy cleanroom? ULPA
or HEPA?
It depends on what specific tasks you’re hoping to accomplish within your
cleanroom. Currently, in the world of cell and gene therapy, there are four main
types of therapies:
·
Each of these therapies requires a number of different sub-processes, which all
require a different level of control. It’s best to determine which ISO standard
your cleanroom needs to meet first and what size airborne particulates can be
detrimental to your process, then choose your type of filter based on that.
·
But from a broad perspective, ULPA filters are generally recommended for cell
and gene therapy processes, since they offer more stringent control over smaller
airborne particles. HEPA
filters can offer enough control for some cell and gene therapy applications but
aren’t the most commonly recommended.
https://angstromtechnology.com/ulpa-vs-hepa-filters-for-cell-gene-therapy-cleanrooms/