Rev. 03 / Jan. 2019
Plasmapp Co., Ltd.
STERLINK
®
FPS-15s Plus User Manual
14
3.3. Sterilization cycle
The STERLINK
®
FPS-15s Plus sterilizer is designed to be operated at two different modes, and
each mode is the combined cycle of the Smart Ready (SR
TM
), Sterilization and Smart Complete
(SC
TM
) process. The sterilizer system is designed to operate only with the sterilant cassettes of
STERPACK
®
, STERPACK
®
Plus and STERLOAD
®
. Each cassette has individual barcode which
is scanned by the sterilizer to start the sterilization cycle automatically according to the barcode
identifying the type of the cassettes. This automatic scan step reduces user error and the reliability
of sterilization.
The optimized heating and drying process is provided in the SR
TM
process by measuring volume
of the medical devices and residual water left on the devices in which the pressure of the pouch
and chamber is independently controlled to obtain the venting and pumping pressure curves.
The sterilization process consists of the two consecutive identical phases, and the critical process
parameters are controlled to be identical. The validation of the sterilization process is performed
by using the half-cycle overkill method to demonstrate the 10
-6
SAL. In the SC
TM
process the
sterilizing agent is removed before using the sterilized medical devices to maintain the asepsis. To
ensure user safety we use an independent pressure sensor of the sterilizer to measure the residual
sterilant and perform an optimized completion process. The following table provides a brief
description for each cycle mode.
Sterilization cycle and minimum time by mode
Mode
Sterilant cassette
Cycle and minimum cycle time (unit: min)
SR
TM
/
SC
TM
Sterilization
Total
POUCH
STERPACK
Ⓡ
3
4
7
POUCH Plus
STERPACK
Ⓡ
Plus
6
8
14
CHAMBER
STERLOAD
Ⓡ
21
15
36
