www.pall.com/biopharm
31
Table 11
Continued
Temperature Correction Factors (TCF) for Normalizing Water Permeability
Temperature Correction Factors (TCF
20 °C
)
T °C
TCF
20 °C
T °C
TCF
20 °C
10
1.31
34
0.73
11
1.27
35
0.72
12
1.24
36
0.70
13
1.20
37
0.69
14
1.17
38
0.68
15
1.14
39
0.66
16
1.11
40
0.65
17
1.08
41
0.64
18
1.05
42
0.63
19
1.03
43
0.62
20
1.00
44
0.61
21
0.98
45
0.60
22
0.95
46
0.59
23
0.93
47
0.58
24
0.91
48
0.57
25
0.89
49
0.56
26
0.87
50
0.55
27
0.85
4.6
System and Membrane Cassette Integrity Test
Air diffusion (or forward flow) is a quantitative test that measures the rate of air diffusing
through the wetted membrane or seal defects at a given pressure differential. Since the
measurements are relative, air diffusion rates can be performed on cassettes wetted with
water or buffer solution.
Before performing a forward flow air integrity test on a membrane cassette, the membrane
must be completely wetted out. Sections 4.2 through 4.4 should be performed before
performing the integrity test.
If the system temperature will be altered from the current value, it is recommended that buffer
conditioning and temperature stabilization (Section 4.7) should be performed before the integrity
test. Refer to Figure 22 for the setup with the Palltronic
®
Flowstar Integrity Test Instrument.
This instrument regulates air and pressure to perform the forward flow air integrity test.
The Palltronic Flowstar Integrity Analyzer measures and displays the rate of air that is diffusing
through the membrane.
There are two important steps to the integrity test protocols:
1.
System Integrity Test (external test)
The System Integrity Test checks the external seals, fittings, plumbing and gasket
assemblies within the pressurized feed/retentate flow path for leaks.
2.
Membrane Cassette Integrity Test (internal test)
The Membrane Cassette Integrity Test checks the membrane and internal seal
assemblies within the cassette for defects.
The System Integrity Test is usually performed first. This assures that any airflow measured
during the Membrane Cassette Integrity Test is not the result of an external leak.
