Tests were performed
at an independent laboratory on ErtelAlsop filter media to determine
the concentration of endotoxin units
per ml extracted from the filter media.
A 12.0 gram portion was covered with 240 ml of sterile nonpyrogenic water for injection
and were extracted for 40 to 60 minutes at 37° C to 40° C in a shaker incubator.
One-tenth ml of the test and control
solutions was placed in a sterile microplate well and incubated
at 37± 1° C for ten minutes in the Kinetic-Chromogenic Reader.
One-tenth ml of Lysate, reconstituted per manufacturer’s
current directions, was then added to each well and testing was
engaged. The quantity of endotoxin, determined spectrophotometrically,
and its reaction time, with the LAL/Substrate, was compared to
that of a standard curve to determine endotoxin concentration.
Results
|
Grade
|
Concentration
|
Concentration
using buffer for cellulose
|
|
M-70P
|
0.171 EU/ml
|
<0.05 EU/ml |
|
M-90P
|
0.032 EU/ml
|
0.009 EU/ml
|
