High
-
Level Disinfectant/
Sterilizing Solution
Technical Data Sheet
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . .
460 Glennie Circle
•
King of Prussia, PA
19406
•
(610) 755
-
0800
•
Fax (610)
270
-
8905
-
BRIEF DESCRIPTION
-
SporGon is a ready
-
to
-
use hydrogen
peroxide/peracetic acid
-
based high
-
level
disinfectant and sterilant. Its ready
-
to
-
use formula
requires no mixing and no activation. It has broad
spectrum efficacy against bacteria, virus & fungi
including TB, and many other pathogenic
organisms. SporGon also passed the AOAC
Sporicidal Test effectiveness in killing the spores of
Bacillus subtilis and Clostridium sporogenes in
three hours and thus met the FDA established
criteria for chemical steril
ant (FDA 510K
Clearance). SporGon achieves high
-
level
disinfection in 15 minutes and sterilization in 3
hours at room temperature.
SporGon is far less toxic than gluteraldehyde
-
based high
-
level disinfectants and is far less
corrosive than chlorinated dis
infectants. No test
strip is required to test the concentration of active
ingredients and solution can be reused for medical
devices for 14 days when used as directed.
-
USE PROTOCOL
-
Directions for High
-
level Disinfection:
SporGon achieves high
-
level
disinfection
(destroys all pathogenic microorganisms, except
for large numbers of bacterial endospores, but
including
Mycobacterium
strains as represented
by
M. bovis
-
Quantitative TB method) when used
according to the Directions for Use at 68°F (20°
C) wi
th a
contact time of 15 minutes . (
For a
medical device reuse period not to exceed 14
days.)
Directions for Sterilization:
SporGon achieves sterilization (eliminates all
microorganisms including
Clostridium
sporogenes
and
Bacillus subtilis
spores) when
u
sed or reused according to the Directions for
Use at 68° (20° C) with a contact time of 180
minutes (3 hours). (For a medical device reuse
period not to exceed 14 days.)
Directions for Use:
Refer
to package insert
(reprinted at the end of this bulletin
) for more
detailed product usage/data
.
-
ACTIVE INGREDIENTS
-
Hydrogen peroxide ....................7.35 %
Peracetic Acid ..........................0.23%
-
EFFICACY
-
Organism With Spores
Contact Time
Bacillus subtilis
180 minutes
Clostridium sporogenes
180 minutes
