3 . R e p a i r I n s t r u c t i o n s
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SW 9.xx
3.3.9
Integrity Test HDF Online
Simultaneous pressure build-up of DF
filter and HDF filter
Objective
Detection of safety relevant ruptures, pressure test of the substitution system in the
machine, pressure test of VBE/VSAE/VSAA.
Air can not pass the semipermeable filter membrane at negative pressure of > -500
mmHg. To detect ruptures: One side of the filter is filled with air; On the other side a
negative pressure < -270 mmHg is built up. If the pressure drop is < 20 mmHg in 3 min,
safety relevant ruptures are not present. The final opening of VBP must be detected by
LLS via PDA. Thus it is guaranteed that the filters were filled with air and VBE was
opened.
Test code
15
Repeats until error message
1
ID error message
1151: HDF online filter test failed!
Actions after error
Rinse, repeat all tests
LLC Test
Code
LLC Test Steps
LLS Test Steps
LLS Test
Code
1.
1502x
Prerequisites for Test:
Upline tank must be filled,
PSAUS, PSABF and BPV cover must be closed.
Timeout 2 min
2.
Test code = 15 to LLS
Test code = 15 back to LLC
3.
1510x
Pressure Reduction for VBE Test with FPA:
Pressure reduction with FPA until PDA < -300
mmHg
Valve Status:
VDEBK1/2, VEBK1/2 -------------------- closed
VDABK1/2, VABK1/2------------------- opened
VBE, VDFF, VDE, VSB-------------------- closed
VBP, VDA, VSAE, VSAA----------------- opened
Timeout 1 min
4.
1515x
VBE Pressure Test
Valve Status:
VDEBK1/2, VEBK1/2 -------------------- closed
VDABK1/2, VABK1/2-------------------- closed
VBE, VDFF, VDE, VSB-------------------- closed
VBP, VDA, VSAE, VSAA----------------- opened
Test timeout 1 min or wait for switch-off VGD
from LLS
Start condition for the test (5 s):
4.
Correct valve position
5.
UFP stopped (UF rate < 500 ml/h)
6.
-450 mmHg < PDA < -150 mmHg
Test 10 s,
max. deviation
∆
PDA < 50 mmHg,
PDA < -100 mmHg,
Acknowledge with switch-off of VGD
15001 –
15010
15011
15012 –
15018
5.
1520x
Pressure Reduction for VSAE Test with UFP:
Pressure reduction with UFP until PDA < -300
mmHg
Valve Status:
VDEBK1/2, VEBK1/2 ------------------- opened
VDABK1/2, VABK1/2-------------------- closed
VBE, VDFF, VDE, VSB, VBP, VSAE--------- closed
VDA, VSAA---------------------------- opened
Timeout 1 min
6.
1525x
VSAE Pressure Test and OSP Test
FPE = 1000 ml/min
Valve Status:
VDEBK1/2, VEBK1/2 ------------------- opened
VDABK1/2, VABK1/2-------------------- closed
VBE, VDFF, VDE, VSB, VBP, VSAE--------- closed
VDA, VSAA---------------------------- opened
Test timeout 1 min or wait for switch-off VGD
from LLS
Start condition for the test (5 s):
1.
Correct valve position
2.
UFP stopped (UF rate < 500 ml/h)
3.
PDA < -150 mmHg
Test 10 s,
max. deviation
∆
PDA < 50 mmHg,
PDA < -100 mmHg,
Test delivery rate OSP at 200 ±15 ml/min
Acknowledge with switch-off of VGD
15021 –
15030
15031,
15032
15033
15034 –
15039
