5)
Slow Exhaust Efficiency Test:
-
Load the sterilizer with a full load of capped
Step 1
bottles containing 1.050 cc of water. Suspend a
thermocouple in the center most bottle in the load
and connect the thermocouple lead wire to a recording
potentiometer.
-
Actuate the potentiometer and operate the sterilizer
Step 2
to expose the load of bottles to (120 C - 123 C)
(250 F - 254 F) for 30 minutes, followed by slow
exhaust of the chamber.
-
Measure the time required for the pressure in the
Step 3
sterilizing chamber to drop to zero, as indicated on
the chamber-vacuum-pressure gauge.
The time required to return the chamber to ambient
pressure should not exceed the contract
specifications requirements and/or the manufacturer's
standards. Loss of not more than 5 percent of water
from any bottle in the load should have occurred, and
without blowing any of the bottle caps, or preventing
automatic sealing of the bottles.
4)
Sterilizing and Drying Efficiency Test:
a)
This test should require a surgical pack containing two
paper strips. Each inoculated with dried spore population
of Bacillus stearothermophilus adjusted for predetermined
resistance as follows; to survive 120 C (250 F) for 5
minutes, to be killed within 13 minutes. The two
spore-inoculated strips should be placed in the center of
the test pack which shall contain, freshly laundered and
loosely wrapped in a double thickness of muslin, 3 surgical
gowns, 30 gauze sponges, 5 lap sponges, and 1 drape sheet.
The pack should be approximately 300 mm by 300 mm by 500 mm
(12 by 12 by 20 inches) and should weight 4.5 to 5.5 kg (10
to 12 pounds).
b)
Procedure:
-
Record the weight of the test pack and then
Step 1
place it (on edge) in the sterilizing chamber.
-
Operate the sterilizer to expose the pack at
Step 2
120 C (250 F) for 30 minutes and dry it for 15
minutes.
-
Within 1 minute following completion of the
Step 3
drying phase of the cycle, remove the pack from
the chamber and record it's weight.
-
Remove the spore-inoculated strips from the pack
Step 4
and test for sterility as recommended in the
U.S. Pharmacopoeia.
c)
Results: Sterility of the test pack shall be evidenced by
the killing of all spores on the strips. Moisture retained
by the pack shall cause not more than 3 percent increase in
the weight of the pack prior to the sterilization and the
pack shall exhibit no wet spots.
11710-3
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