Ty, San. so if I understand the requirements as posted we can still use a .2 ultrafilter rather than a .05? Our technical supervisor claims the new AAMI standards require a .05 post D.I.

"The typical range of micron filter size is .001 to .05 microns."

If "D.I. = True"
Then ".2 = False" then
".001 - .05 = True"
If "D.I. = False"
Then ".2 = True" then
".001 - .2 = True"

Also, if you're an Ultra-Pure dialysis center, you will be using .05 micron filters most likely.

We are not.

ok San it is safe to assume you do not run full time D./I.? We use D.I. tanks ..a worker and a polisher post RO. We used to use .2 ultrafilters post D.I. but were told as of Oct 1st 2008 we would be required to go to the .05. Is this correct?

That would be correct.

Gotcha!

Thank you for your help...it is appreciated!

There is some confusion as to what an ultrafilter is. RD52 says to use an ultrafilter and defines an ultrafilter as having a pore size in the range of 0.001 to 0.05 micron. Ultrafilters are required to be downstream of DI Tanks and UV lights (recommended downstream of RO Water Storage Tanks).

BUT, RD62 was revised after RD52. RD62 changed the language to "endotoxin retentive filter." You can use an "ultrafilter" to remove endotoxins, but there are some "endotoxin retentive filters" with a micron size greater than 0.05. For instance, Minntech Fiberflo filters remove endotoxins by adsorption rathan than by particle size. The endotoxins stick to the hollow fibers. For Minntech's 0.05, 0.1, 0.2 micron filters, their validation testing showed 100% removal of pyrogens for all micron sizes. The Fiberflo 50 showed 100% removal when challenged with 5 EU/ml, the Fiberflo 100 showed 100% removal when challenged with 1 EU/ml, and the Fiberflo 200 showed 100% removal when challenged with 0.5 EU/ml. I don't know why they did not challenge all filtes with 5 EU/ml. 100% removal means the effluent was <0.06 EU/ml.

Therefore, you can use a micron size greater than 0.05 if the filter has been shown to remove endotoxins. Is anyone using something different than the Fiberflo filters that is larger than 0.05 micron?

Do you know how often the ultra-filters must be replaced in CA? I replaced every three months, but I do knot know what the regulations say.
Thanks

Gambro water systems are installed with .2 micron pyrogen filters that use an absorbtion process also, and are 510k

I believe endotoxin filters are suppose to measure 0.05 microns. 0.2 microns will allow 4x as many endotoxins and bacteria not to be filtered. If you are not using diasafe filters as well, I think you might lack sufficient filtration.

when the granuflo mixers first came out the wording did say it is recommended (by manufacturer) that you draw a quarterly AAMI to verify the water mixed was not changing the electrolytic composition of the acid. FMC changed that wording several years ago (more than I care to admit to).
As far as the return loop, that is done to verify that no "additional burden" is put on your system. Basically you are checking to make sure if any loop repairs are done they have been done with proper materials and nothing is leaching into your water system.