4-3
Techniques of Sterilization Operator Manual 129390199
For SFPP sterilizers, if the SFPP cycle is used exclusively, there is no
need to run a daily Dart (Bowie-Dick) test. If prevacuum cycles will
also be run on the same sterilizer, then a daily Dart (Bowie-Dick) test
must be run.
NOTE: The Dart (Bowie-Dick) test cycle is not a test for adequate
exposure to heat in terms of time-at-temperature.
4.3 Vacuum Leak Test The Vacuum Leak Test (see SECTION 6.14.2, VACUUM LEAK TEST ON
PAGE
6-34) measures the integrity of the sealed pressure vessel and
associated piping to assure air is not being admitted to the sterilizer
during the vacuum draw downs.
After running a Leak Test cycle, a value or leak rate will be printed on
the printer tape. This value will help define a trend over a period of
time if the integrity of the system begins to deteriorate (i.e., allowing
air to enter the system). By running a Leak Test cycle daily or weekly,
the operator or maintenance personnel can always monitor the air
tightness of the system and make repairs or adjustments when
necessary.
NOTE: A leak rate of greater than 1.0 mm Hg (1.3 mbar) per minute
indicates a problem with the sterilizer that must be addressed.
WARNING – STERILITY
ASSURANCE HAZARD: Load
sterility may be compromised
if the biological indicator or
vacuum leak test indicates a
potential problem. If these
indicators show a potential
problem, refer the situation to
a qualified service technician
before using the sterilizer
further.