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Most current standards and recommended practices require a minimum of 10 micrograms per
liter (ug/l) as an upstream aerosol challenge. While higher concentrations can be used, 10-ug/l
is the minimum that may be used and still have a valid leakage certification test. Modern
aerosol photometers were designed to operate at upstream challenge concentrations between
10 and 100 ug/l.
2) Will using aerosol to test filters cause excessive loading (clogging) and shorten the
filters usable life?
The next calculation is the amount of liquid that will be converted into an aerosol and spread
over the 5,325 square feet of media. This equals 0.00283 grams per cfm (calculate 100
micrograms per liter x 28.3 for one cubic foot per minute). Since the system is a 25,000 cfm
system, we multiply 25,000 x .00283 grams per cfm which totals 70.75 grams of liquid we will
aerosolize to obtain a challenge of 100 micrograms per liter in this 25,000 cfm filtration system.
Because we will run this test for 40 minutes, we will multiply 70.75 x 40 minutes and come up
with a total of 2,830 grams of liquid that we will aerosolize to challenge the in-tegrity of the
25,000 cfm filtration system with 100 micrograms per liter. The 2,830 grams is equal to 99.8
ounces of oil spread over 5,325 square feet of media (equivalent to a 12 inch wide roll of filter
media just under a mile long). How can we clog this filter system? If we decide to only use 36
ounces to test the filter system, we could then challenge it with 36.1 micrograms per liter (equal
to three-12 ounce containers).
3) Where should upstream challenge aerosol be introduced into a filter system that is
being tested?
Adequate aerosol mixing upstream can usually be obtained by introduction at least ten duct
diameters upstream of the filters, or by introducing it upstream of baffles or turning vanes in the
duct. When neither of these methods is practical, a Stairmand disk located four to six duct
diameters upstream will provide satisfactory mixing. A Stairmand disk is a plate with the same
geometric shape as the duct section that blocks the central half of the duct area. Air flowing past
the disk creates vortices on the leeward side that compel turbulent and thorough mixing of the
introduced aerosol and the dilution air stream. The required diameter of the stairmand disk may
be calculated using the following information.
The Stairmand disk diameter equals the pipe (or duct) diameter divided by the square root of
two (1.414213).
4) What type of PAO does the FDA require for filter leakage certification tests?
Several differing opinions on the correct PAO to use have arisen recently. The FDA, in their
original CGMP (Current Good Manufacturing Processes) release was specific in the type that
was approved as a replacement for DOP (DEHP).
"The Chemical Abstracts Service (CAS) number which identifies this product also remained as
68649-12-7. Other reported alternatives used in the industry include DOS (Di-(2-ethylhexyl)
sebacate) and Ondina Oil. However, no manufacturer has yet submitted all the necessary data
to evaluate these alternatives. As such, Emery 3004 PAO with the CAS number 68649-12-7 still
remains an acceptable replacement for DOP."
ATI's position is that PAO with a CAS # 68649-12-7 is acceptable by FDA definition. The full text
of the referenced CGMP document is available at: http://www.fda.gov/cder/hdn/cnotesd6.htm.
5) How much compressed air does a Type III-A Laskin nozzle aerosol generator need?
Each Laskin nozzle being used in a generator consumes approximately 2.64 cfm (75 Liters) of
air at 20 psi (1.4 bars) and total air consumption is proportional to the number of nozzles in use.
Therefore the maximum compressed air requirement for a three nozzle generator is 7.92 cfm at
20 psi and a six nozzle generator would need 15.84 cfm at 20 psi. The applied pressure of 20
psi needs to remain constant to allow calculation of the aerosol generator output. Air
compressor performance specifications that will show output volume (cfm) versus pressure (psi)
are readily available from most vendors and will make selection of an appropriate compressor
less difficult.
median
245 415 528 528
(nm)
mean
281 454 549 549
(nm)
geo.
mean 248 407 503 503
(nm)
mode
233 429 594 594
(nm)
geo. st.
1.65 1.62 1.55 1.55
dev.
7) What is the particle size distribution of a Laskin nozzle generator
using DOP?
geo. mean
259 318 350 350
(nm)
*The TDA-5B aerosol distribution listed above is characteristic of the operating conditions and
settings present at the time of testing. Particle size distributions generated during field usage
will change depending upon the ambient temperature, humidity and equipment settings in use.
9) What is the DOP/DEHS particle size distribution of a Thermal
generator ?
geo. mean
275 346 377 377
(nm)
*The TDA-5B aerosol distribution listed above is characteristic of the operating conditions and
settings present at the time of testing. Particle size distributions generated during field usage will
change depending upon the ambient temperature, humidity and equipment settings in use.
The manufacturer's stated shelf life for PAO (CAS# 68649-12-7) is three (3)
years in the original, sealed and unopened container. The shelf life of an
open container, that is tightly sealed between uses, is one (1) year.
12) What happens if the photometer sample flow drops below its
normal operating range of 28.3 lpm +/- 2.8?