2.3.6 Test Methods
2.3.7 General Data
Test method
Type of bags to be tested
Plate holder test
Adapted for testing of
2D or 3D bags restrained
in a plate holder (e.g. FlexAct
for 2D bags), via a sterilizing
grade vent filter, with or
without additional tubings.
The test can also be performed
without any sterilizing grade
vent filter.
Installed bag test
Adapted for testing of
3 dimensional bags (e.g. STR),
installed in an appropriate
holder (e.g. STR holder), via
the sterilizing grade vent filter.
Ambient conditions
Ambient temperature:
Noise level:
Humidity:
The unit should be set up under ambient conditions that produce no negative
effects during operation and processing, e.g. from contaminated airflows,
metallic dust or fluids from leaks, condensation, aerosols or widely changing
temperature conditions.
Test pressure
Min 3 mbar |
Max 300 mbar
Min 3 mbar | Max 50 mbar
+5 up to +35°C
< 70 dB (A)
95% at 25°C
Overview and Proper Use
9