Pall Stax™ Capsule System Validation Guide

Brand
Pall
Model
Stax™ Capsule System
Type
Validation Guide
USTR 2528a
Validation Guide
Stax™Capsule System
2
Contents
1. Overview .............................................................................................................................4
 "@FDA6G5F;A@ 
 (H7DH;7IA8A@5>GE;A@E
 7F7D?;@3F;A@A8/3F7D>AI:3D35F7D;EF;5EE77+75F;A@ 
 7F7D?;@3F;A@A83BEG>7/7;9:F3@6>G;6!A>6-BE77+75F;A@ 
 *7E;EF3@57FAGFA5>3H7A@6;F;A@EE77+75F;A@ 
 GDEF)D7EEGD7E3FSM3@6ME77+75F;A@ 
 D77B*GBFGD7,7EF;@9E77+75F;A@
 JFD35F34>7E,7EF;@9A83BEG>7&A>6;@9EGE;@9/3F7D3@6F:3@A>
E77+75F;A@
 ;A>A9;53>*735F;H;FK,7EFEA8+F3J3BEG>7EE77+75F;A@ 
2. Determination of Water Flow Characteristics...................................................................7
 "@FDA6G5F;A@ 
 +G??3DKA8&7F:A6E 
 *7EG>FE 
 A@5>GE;A@E 
3. Determination of Capsule Weight and Fluid Hold-Up Volume ......................................11
 "@FDA6G5F;A@ 
 +G??3DKA8&7F:A6E 
 *7EG>FE 
 A@5>GE;A@E 
4. Resistance to Autoclave (125 °C) Conditions.................................................................13
 "@FDA6G5F;A@ 
 +G??3DKA8&7F:A6E 
 *7EG>FE 
 A@5>GE;A@E 
5. Burst Testing.....................................................................................................................16
 "@FDA6G5F;A@ 
 +G??3DKA8&7F:A6E 
 *7EG>FE 
 A@5>GE;A@E 
6. Creep-Rupture Testing.....................................................................................................18
 "@FDA6G5F;A@ 
 +G??3DKA8&7F:A6E 
 *7EG>FE 
 A@5>GE;A@E 
7. Extractables Testing Using Water and Ethanol 96% .....................................................19
 "@FDA6G5F;A@ 
 +G??3DKA8&7F:A6E 
 )D7B3D3F;A@A8F:7+F3J3BEG>7+KEF7?&A>6+3?B>7E 
 JFD35F;A@)DA576GD7A8F:7+F3J+KEF7?3BEG>7&A>6+3?B>7E 
 )D7B3D3F;A@A8+3?B>7E8AD@3>KE;E
 *7EG>FE 
 *7EG>FEA8'.*3@6,(7F7D?;@3F;A@ 
 *7EG>FEA8,"*@3>KE;E 
 *7EG>FEA8")@3>KE;E 
 3>5G>3F;A@A8'.*8AD+F3J3BEG>7+KEF7?&A>6;@9E43E76A@D73*3F;AE 
 A@5>GE;A@E 
8. Biological Reactivity Tests on the Materials of Construction........................................25
 "@FDA6G5F;A@ 
 +G??3DKA8&7F:A6E 
 ;A>A9;53>*735F;H;FK,7EFin vivo 8AD>3EE.")>3EF;5EM 
 !7?A>KE;E,7EFE+3>;@7JFD35F;A@&7F:A6 
 &;@;?G?EE7@F;3>&76;G?&&>GF;A@KFAFAJ;5;FK,7EFE
 *7EG>FE 
 A@5>GE;A@E
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1. Overview
1.1 Introduction
,:;E9G;675A@F3;@EH3>;63F;A@63F33BB>;534>7FAF:7+F3J,& 6;EBAE34>767BF:8;>F7D53BEG>7E3@6
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1.2 Overview of Conclusions
1.2.1 Determination of Water Flow Characteristics (see Section 2)
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1.2.2 Determination of Capsule Weight and Fluid Hold-Up (see Section 3)
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1.2.3 Resistance to Autoclave Conditions (see Section 4)
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Table 1
Product Claims for Autoclave Resistance of Stax Depth Filter Capsules, Part
Numbers SXL***, SXM***, and SXS***
Maximum Recommended
Pall Filter Autoclave Conditions Autoclave Claim
SXL***, SXM***, SXS*** Autoclaving at 125 °C 1 x 1-hour cycle
The claim in Table 1: Product Claims for Autoclave Resistance of Stax Depth Filter Capsules, Part Numbers
SXL***, SXM***, and SXS*** is supported by data with a 100 % safety margin. A second autoclaving cycle
might be performed for sanitization purpose post use prior to disposal. Pall autoclave resistance testing is
conducted under laboratory conditions intended to demonstrate robustness under typical user autoclaving
conditions. Pall recommends that structural integrity be confirmed under user autoclave conditions during
process qualification validation.
1.2.4 Burst Pressures at 25 °C and 60 °C (see Section 5)
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Table 2
Maximum Operating Pressures of Stax Depth Filter Capsules
Pall Filter Part Number Maximum Operating Pressure (bar/psi)
SXL***, SXM***, SXS*** 3.5 bar (50.8 psi) at up to 25 °C
1.0 bar (14.5 psi) at up to 60 °C
1.2.5 Creep-Rupture Testing (see Section 6)
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1.2.6 Extractables Testing of Capsule Moldings using Water and Ethanol 96%
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53BEG>7EKEF7?E;ED75A??7@676
1.2.7 Biological Reactivity Tests of Stax Capsules (see Section 8)
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A8F:7-+);A>A9;53>S*735F;H;FK,7EFE(in vivo) 8AD>3EE."MB>3EF;5EI:;5:
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2. Determination of Water Flow Characteristics
2.1 Introduction
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2.2 Summary of Methods
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GE;@93@3GFA?3F76F7EFD;98F7D3@;@;F;3>I3F7D8>GE:3F38>GJA8S%?W:8ADS?;@GF7EF:7
8>AII3ED3?B76GB3@6BD7EEGD7D736;@9E8DA?FD3@E6G57DEA@F:7GBEFD73?3@66AI@EFD73?
E;67EA8F:7F7EF3EE7?4>KI7D7?A@;FAD76FA53>5G>3F7F:76;887D7@F;3>BD7EEGD73FE7FI3F7D
8>GJ7E3@6%?W:,:7F7EFI3ED7B73F76F:D77F;?7E
8AD735:?A6G>7E3?B>7F7EF76
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www.pall.com/biopharm 7
8
2.3 Results
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35:A8F:79D3B:E;@;9GD7ET 5A?4;@7EF:7I3F7D8>AIF7EFD7EG>FEA8A@7A8F:7E;J
E:77F8;>F7DFKB7EF7EF76$)$)$+))$);A;@5ADBAD3F76;@F:7F:D77
6;887D7@F53BEG>7E;L7E>3D9753BEG>7+0%?76;G?53BEG>7+0&E?3>>53BEG>7+0+
35:>;@7D7BD7E7@FEF:73H7D397A8F:7F:D77F7EFD7B>;53F7EB7D53BEG>7E3?B>7F7EF76
;9GD7E:AIEF:73H7D397I3F7D8>AIF7EFD7EG>FEA8F:7E;JE:77F8;>F7DFKB7EF7EF76;@F:7
+F3J7BF:;>F7D3BEG>7E
Figure 1
Water Flow Test Results of Sheet Type K900P in SXL, SXM, and SXS Capsules
Figure 2
Water Flow Test Results of Sheet Type K100P in SXL, SXM, and SXS Capsules
Large (SXL) Medium (SXM) Small (SXS)
Differential pressure
(mbar)
10
9
8
7
6
5
4
3
2
1
0
Flux (L/m2*h)
0 50 100 150 200 250 300 350 400 450 500 550 600 650 700 750 800
Large (SXL) Medium (SXM) Small (SXS)
Differential pressure
(mbar)
100
90
80
70
60
50
40
30
20
10
0
Flux (L/m2*h)
0 50 100 150 200 250 300 350 400 450 500 550 600 650 700 750 800
Figure 3
Water Flow Test Results of Sheet Type EKSP in SXL, SXM, and SXS Capsules
Figure 4
Water Flow Test Results of Sheet Type PDK5 in SXL, SXM, and SXS Capsules
www.pall.com/biopharm 9
Large (SXL) Medium (SXM) Small (SXS)
Differential pressure
(mbar)
500
450
400
350
300
250
200
150
100
50
0
Flux (L/m2*h)
0 50 100 150 200 250 300 350 400 450 500 550 600 650 700 750 800
Large (SXL) Medium (SXM) Small (SXS)
Differential pressure
(mbar)
120
110
100
90
80
70
60
50
40
30
20
10
0
Flux (L/m2*h)
0 50 100 150 200 250 300 350 400 450 500 550 600 650 700 750 800
10
Figure 5
Water Flow Test Results of Sheet Type PDD1 in SXL, SXM, and SXS Capsules
Figure 6
Water Flow Test Results of Sheet Type Bio 10 in SXL, SXM, and SXS Capsules
Large (SXL) Medium (SXM) Small (SXS)
Differential pressure
(mbar)
700
600
500
400
300
200
100
0
Flux (L/m2*h)
0 50 100 150 200 250 300 350 400 450 500 550 600 650 700 750 800
Large (SXL) Medium (SXM) Small (SXS)
Differential pressure
(mbar)
500
450
400
350
300
250
200
150
100
50
0
Flux (L/m2*h)
0 50 100 150 200 250 300 350 400 450 500 550 600 650 700 750 800
Figure 7
Average Water Flow Test Results of All Sheets Types Tested in SX Capsules
2.4 Conclusions
/3F7D8>AID3F7EA86;887D7@F+7;FLE:77F8;>F7DFKB7E;@3>>F:D77+F3J53BEG>7E;L7E:3H7477@
67F7D?;@763FE7FI3F7D8>AID3F7E,:7D7EG>FE67?A@EFD3F7F:3FF:7I3F7D8>AI5:3D35F7D;EF;5
A8F:78;>F7DE:77FE;@5ADBAD3F76;@F:7F:D77+F3J53BEG>7FKB7E6A7E@AFE;9@;8;53@F>KH3DKI;F:
53BEG>7E;L7F:GE67?A@EFD3F;@97J57>>7@F>;@73DE53>34;>;FKA8F:7+F3J53BEG>7E8DA?>3D97
+0%FA?76;G?+0&FAE?3>>+0+53BEG>7E;L7E
3. Determination of Capsule Weight and Fluid Hold-Up Volume
3.1 Introduction
,:7BGDBAE7A8F:7E7F7EFEI3EFA67F7D?;@7F:7I7;9:FA8+F3J53BEG>7E;@5ADBAD3F;@9H3D;AGE
FKB7EA88;>F7DE:77FE6DK3E?3673@6I3F7DI7F8A>>AI;@9F:73BB>;53F;A@A83678;@763;D
BD7EEGD7FA6;EB>3573@6?;@;?;L78>G;6:A>6GB,:7F7EFEE7DH7FA;@6;53F7F:7+F3J53BEG>7
I7;9:F3E?3673@6I;F:F:78>G;6:A>6GBHA>G?7;@F:753BEG>7E38F7D3BDA6G5F8;>FD3F;A@
8A>>AI;@93EG;F34>74>AI6AI@BDA576GD7I;F:BD7EEGD;L763;D
3.2 Summary of Methods
,:7F:D773H3;>34>7+F3J53BEG>7E;L7E>3D9753BEG>7+0%?76;G?53BEG>7+0&E?3>>
53BEG>7+0+7CG;BB76I;F:3D3@97A86;887D7@FE:77F8;>F7DFKB7EI7D7GE768ADF:7F7EFE
,:7E:77F8;>F7DFKB7EI7D75:AE7@FAD7BD7E7@FF:78G>>D3@97A8I3F7DB7D?734;>;FKA8+7;FL
8;>F7DE:77FE;@)9D367;@E;@9>73@66AG4>7>3K7D5A@8;9GD3F;A@3@6A@79D367A8F:7;AE7D;7E
,KB;53>>K735:E:77FFKB7I3EF7EF76;@5ADBAD3F76;@F:D77>3D97+0%F:D77?76;G?+0&
3@6F:D77E?3>>+0+53BEG>7EF:GEFKB;53>>KD7BD7E7@F;@9FD;B>7E3?B>7EB7D?A6G>7E;L73@6
E:77FFKB7
)9D367E;@9>7>3K7DE:77FEGE768AD67F7D?;@3F;A@A8I7;9:F3@68>G;6:A>6GBHA>G?7E
N$):;9:I3F7DB7D?734;>;FK
N$)?76;G?I3F7DB7D?734;>;FK
N$+)>AII3F7DB7D?734;>;FK
www.pall.com/biopharm 11
K 900P PDK5 BIO 10
K100P EKSP PDD1
Differential pressure
(mbar)
650
600
550
500
450
400
350
300
250
200
150
100
50
0
Flux (L/m2*h)
0 50 100 150 200 250 300 350 400 450 500 550 600 650 700 750 800
12
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N)$:;9:I3F7DB7D?734;>;FK
N)>AII3F7DB7D?734;>;FK
+:77FE8DA?F:7;AE7D;7EGE768ADF:767F7D?;@3F;A@A8I7;9:F3@68>G;6:A>6GBHA>G?7
N;A>AII3F7DB7D?734;>;FK
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I7D7F:ADAG9:>KI7FF76678;@763;DBD7EEGD7I3E3BB>;76A@F:7GBEFD73?E;678AD
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67B7@6;@9A@F:7E:77F8;>F7DFKB7;@5ADBAD3F76;@FAF:753BEG>73@6D7?3;@7647>AIF:7
BD7EEGD7D7CG;D76FA7JB7>F:78>G;68DA?F:7>3D97EFBAD7@A4>AIF:DAG9:,:7BD7EEGD76753K
;@F:753BEG>7I3E?A@;FAD76FA5A@FDA>F:3F@A4>AIF:DAG9:A55GDD763@6FA5A@8;D?F:7
EFDG5FGD3>;@F79D;FKA8F:753BEG>78F7D?;@GF7EA8BD7EEGD77JBAEGD7F:7I7F53BEG>7EI7D7
393;@B>3576A@3@7>75FDA@;5E53>7FA67F7D?;@7F:7;DI7FI7;9:F,:78>G;6:A>6GBI3E
53>5G>3F768DA?F:76;887D7@5747FI77@F:76DK3@6I7FI7;9:F
3.3 Results
,:7D7EG>FEA8F:7I7;9:F67F7D?;@3F;A@3D7E:AI@;@,34>7H7D3973BEG>7/7;9:FE
3@6>G;6!A>6GB.A>G?7EA8+F3J3BEG>7ECG;BB76I;F:.3D;AGE+7;FL7BF:;>F7D,KB7E
,:7H3>G7EBD7E7@F763D7F:73H7D397EA8F:7;@6;H;6G3>H3>G7EA4F3;@768AD735:A8F:7
E;JE:77F8;>F7DFKB7E;@5ADBAD3F76;@FAF:7F:D77+F3J53BEG>7E;L7E
Table 3
Average Capsule Weights and Fluid Hold-up Volumes of Stax Capsules Equipped with
Various Seitz Depth Filter Types
Average Wet
Weight After
Sheet Air Pressure Average Dry 20 minutes Air Average Water
Sheet Type Capsule Size Lot Number Applied (mbar) Weight (kg) Pressure (kg) Hold-up (kg)
K900P Large R446 50 7.42 13.55 6.13
K900P Medium R446 50 4.85 8.28 3.43
K900P Small R446 50 3.50 5.13 1.63
K100P Large S287 100 7.85 13.13 5.28
K100P Medium S287 100 5.03 7.65 2.62
K100P Small S287 100 3.60 5.10 1.50
EKSP Large S250 500 8.08 13.6 5.52
EKSP Medium S250 500 5.15 7.95 2.80
EKSP Small S250 500 3.70 5.20 1.50
PDK5 Large R446 75 7.12 12.62 5.50
S287
PDK5 Medium R446 75 4.75 8.02 3.27
S287
PDK5 Small R446 75 3.48 4.91 1.43
S287
PDD1 Large S158 600 7.41 12.26 4.85
S309
Table 3 Continued
Average Capsule Weights and Fluid Hold-up Volumes of Stax Capsules Equipped with Various
Seitz Depth Filter Types
Average Wet
Weight After
Sheet Air Pressure Average Dry 20 minutes Air Average Water
Sheet Type Capsule Size Lot Number Applied (mbar) Weight (kg) Pressure (kg) Hold-up (kg)
PDD1 Medium S158 600 4.83 7.26 2.43
S309
PDD1 Small S158 600 3.55 4.85 1.30
S309
Bio 10 Large R841 500 8.23 12.58 4.35
Bio 10 Medium R841 500 5.25 7.65 2.40
Bio 10 Small R841 500 3.75 5.00 1.25
3.4 Conclusions
,:73H7D39753BEG>7I7;9:FE3E?3673@638F7D8>G;68;>FD3F;A@8A>>AI;@9F:73BB>;53F;A@A8
EG;F34>73;DBD7EEGD7EFA?;@;?;L7>;CG;6:A>6GBHA>G?7E:3H7477@67F7D?;@768AD3>>F:D77
+F3J53BEG>7E;L7E8DA?>3D97+0%FAE?3>>+0+I;F:3D3@97A86;887D7@F+7;FLE:77F8;>F7D
FKB7E,:7D7EG>FE53@3EE;EFFA67F7D?;@7F:7I7;9:FA839;H7@+F3J53BEG>7EKEF7?3@6
;@6;53F7F:7FKB;53>8>G;6:A>6GBHA>G?7;@F:7+F3J53BEG>7EKEF7?38F7DBDA6G5F8;>FD3F;A@
8A>>AI;@93EG;F34>74>AI6AI@BDA576GD7I;F:BD7EEGD;L763;D
4. Resistance to Autoclave (125 °C) Conditions
4.1 Introduction
,:7BGDBAE7A8F:7E7F7EFEI3EFA67F7D?;@7F:778875FEA87JBAEGD7FA3GFA5>3H;@95K5>7EA@
+F3J67BF:8;>F7D53BEG>7E,:7F7EFD7EG>FEE7DH7FA67?A@EFD3F7F:734;>;FKA8+F3J67BF:8;>F7D
53BEG>7EFAI;F:EF3@63GFA5>3H;@9I:;>7?3;@F3;@;@9F:7EFDG5FGD3>;@F79D;FKA8F:7;@5ADBAD3F76
8;>F7D?A6G>73@6EFDG5FGD3>;@F79D;FK3@6AB7D3F;@9E387FKA8F:753BEG>7E:7>>8ADF:7>3FF7DE77
3>EA+75F;A@GDEF,7EF;@93@6+75F;A@D77B*GBFGD7,7EF;@9
4.2 Summary of Methods
,:7F:D773H3;>34>753BEG>7E;L7E>3D9753BEG>7+0%?76;G?53BEG>7+0&E?3>>53BEG>7
+0+7CG;BB76I;F:FIA6;887D7@FE:77F8;>F7DFKB7EI7D7GE768ADF:7F7EFE,:7E:77F8;>F7DFKB7E
I7D75:AE7@FAD7BD7E7@F+7;FL8;>F7DE:77FE;@)9D367;@E;@9>73@66AG4>7>3K7D5A@8;9GD3F;A@
3@6FA3>>AI3EE7EE?7@FA8F:7EFDG5FGD3>;@F79D;FKA8F:7;@5ADBAD3F76?A6G>7E4K36;88GE;H73;D
F7EFBD7EEGD76753K?7F:A635:E:77FFKB7I3EF7EF76;@5ADBAD3F76;@E7H7D3>>3D97+0%
?76;G?+0&3@6E?3>>+0+53BEG>7E3@6EG4<75F76FAFIAADF:D773GFA5>3H75K5>7E
)9D367E;@9>7>3K7DE:77FEGE768AD67F7D?;@3F;A@A8D7E;EF3@57FA3GFA5>3H;@9
N$+)>AII3F7DB7D?734;>;FK
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N)>AII3F7DB7D?734;>;FK
)D78;>F7D76I3F7DI3EBG?B76F:DAG9:F:78;>F7D53BEG>7E;@F:7@AD?3>8>AI6;D75F;A@AGFFA;@
3F38>GJA8S%?W:8AD8;H7?;@GF7E678;@763;DBD7EEGD7I3E3BB>;76A@F:7GBEFD73?
E;67FA3EE7EEF:7EFDG5FGD3>;@F79D;FKA8F:753BEG>7E3@6F:7;@5ADBAD3F76E:77F8;>F7D?A6G>7E
4K?A@;FAD;@9F:7BD7EEGD76753KI:;5:;E3D7EG>FA8F:793EFD3@EBADF35DAEEF:7I7FF768;>F7D
E:77FE,:7;@F79D3F76?A6G>73@653BEG>7E:7>>I3E677?76;@F79D3>I:7@F:73BB>;76F7EF
BD7EEGD7:366753K764K@AF?AD7F:3@;@A@7?;@GF7F7EFF;?7,:753BEG>7EI7D7
F:7@3GFA5>3H76;@5K5>7EA8A@7:AGD3FSMGE;@93EG;F34>73GFA5>3H7BDA9D3?
8D35F;A@3F76BD7H35GG?6D3IA8 J?43D8F7D735:3GFA5>3H75K5>7F:753BEG>7E
I7D7I3F7D8>GE:763@6F:7EFDG5FGD3>;@F79D;FK3EE7EE763E67E5D;47634AH7
www.pall.com/biopharm 13
14
,:734AH7F7EFE7CG7@57I:7D7F:7E:77F8;>F7DEI7D7I7FF76BD;ADFAF:78;DEF3GFA5>3H75K5>7
BD7E7@FE3IADEF53E7E57@3D;A8ADF:73GFA5>3H;@9A8E:77F8;>F7DE!AI7H7DF:;E;E@AF8G>>K
D7BD7E7@F3F;H7A8FKB;53>3GFA5>3H;@95A@6;F;A@E3F35GEFA?7DE;F7,:7D78AD7EA?7F7EFEI7D7
3>EAB7D8AD?76I:7D7F:7E:77F8;>F7DEI7D76DKBD;ADFAF:78;DEF3GFA5>3H75K5>7I:;5:;E?AD7
D7BD7E7@F3F;H7A83FKB;53>GE7DBDA57EEADF:7E7F7EFEF:7I3F7D8>GE:BD;ADFAF:78;DEF
3GFA5>3H75K5>7I3EA?;FF76EAF:3FF:7;@5ADBAD3F76?A6G>7I3E6DKBD;ADFA3GFA5>3H;@9
>>8A>>AI;@9EF7BEI7D7B7D8AD?763E67E5D;47634AH7
4.3 Results
,:7F7EFD7EG>FE8ADF:7+F3J53BEG>7EF7EF763D7E:AI@;@,34>7*7EG>FEA8GFA5>3H;@9
*7E;EF3@57,7EFEA8%3D97&76;G?3@6+?3>>+F3J7BF:;>F7D3BEG>7ECG;BB76I;F:
+;@9>7%3K7D;>F7D+:77FE38F7DGFA5>3H;@9K5>7E3FSSM3@6,34>7*7EG>FEA8
GFA5>3H;@9*7E;EF3@57,7EFEA8%3D97&76;G?3@6+?3>>+F3J7BF:;>F7D3BEG>7ECG;BB76
I;F:AG4>7%3K7D;>F7D+:77FE38F7DGFA5>3H;@9K5>7E3FSSM>>53BEG>7EI7D78AG@6FA
:3H;@9?3;@F3;@76F:7EFDG5FGD3>;@F79D;FKA8F:7;@5ADBAD3F76?A6G>7E38F7DFIA :AGD
3GFA5>3H75K5>7E3FSM
Table 4
Results of Autoclaving Resistance Tests of Large, Medium and Small Stax Depth Filter Capsules
Equipped with Single-Layer Filter Sheets after Autoclaving Cycles at 125 °C
Capsule Structural
Sheet Sample Autoclaving Integrity Test
Sheet Type Capsule Size Lot Number Number Cycles Result
EKSP Large S250 10 Pass
1 Pass
2 Pass
3 Pass
EKSP Large S250 20 Pass
1 Pass
2 Pass
EKSP* Large S250 31 Pass
2 Pass
EKSP* Medium S626 11 Pass
2 Pass
EKSP* Medium S626 21 Pass
2 Pass
EKSP* Medium S626 31 Pass
2 Pass
EKSP Small S250 10 Pass
1 Pass
2 Pass
3 Pass
EKSP Small S250 20 Pass
1 Pass
2 Pass
EKSP Small S250 30 Pass
1 Pass
2 Pass
* Dry prior to the first autoclaving cycle
Table 5
Results of Autoclaving Resistance Tests of Large, Medium and Small Stax Depth Filter Capsules
Equipped with Double-Layer Filter Sheets after Autoclaving Cycles at 125 °C
Capsule Structural
Sheet Sample Autoclaving Integrity Test
Sheet Type Capsule Size Lot Number Number Cycles Result
PDD1* Large S158 11 Pass
S309 2 Pass
PDD1* Large S158 21 Pass
S309 2 Pass
PDD1* Large S158 31 Pass
S309 2 Pass
PDD1* Medium S158 11 Pass
S309 2 Pass
PDD1* Medium S158 21 Pass
S309 2 Pass
PDD1* Medium S158 31 Pass
S309 2 Pass
PDD1 Small S158 10 Pass
S309 1 Pass
2 Pass
3 Pass
PDD1 Small S158 20 Pass
S309 1 Pass
2 Pass
3 Pass
PDD1 Small S158 30 Pass
S309 1 Pass
2 Pass
* Dry prior to the first autoclaving cycle
4.4 Conclusions
+F3J67BF:8;>F7D53BEG>7E:3H767?A@EFD3F76F:734;>;FKFAI;F:EF3@63F>73EFFIA3GFA5>3H7
5K5>7E3FM,:7F7EFEB7D8AD?7667?A@EFD3F7F:3FF:7+-)*6;E5"";@5:8;>F7D?A6G>7E
;@5ADBAD3F76;@F:7+F3J53BEG>7E?3;@F3;@F:7;DEFDG5FGD3>;@F79D;FK,7EFE3>EAE:AI76F:3FF:7
53BEG>7E:7>>E?3;@F3;@F:7;DEFDG5FGD3>;@F79D;FK3@6AB7D3F;@9E387FK?3D9;@38F7DFIA3GFA5>3H7
5K5>7EE773>EA+75F;A@GDEF,7EF;@93@6+75F;A@D77B*GBFGD7,7EF;@9
,:763F3BD7E7@F76;@F:;ED7BADFEGBBADFF:7BDA6G5F5>3;?EE:AI@;@,34>7)DA6G5F>3;?E8AD
GFA5>3H7*7E;EF3@57A8+F3J7BF:;>F7D3BEG>7E)3DF'G?47DE+0%+0&3@6+0+
Table 6
Product Claims for Autoclave Resistance of Stax Depth Filter Capsules,
Part Numbers SXL***, SXM***, and SXS***
Maximum Recommended
Pall Filter Part Number Autoclave Conditions Autoclave Claim
SXL***, SXM***, SXS*** Autoclaving at 125 °C 1 x 1-hour cycle
The claim in Table 6: Product Claims for Autoclave Resistance of Stax Depth Filter Capsules, Part Numbers SXL***,
SXM***, and SXS*** is supported by data with a 100 % safety margin. A second autoclaving cycle might be performed
for sanitization purpose post use prior to disposal. Pall autoclave resistance testing is conducted under laboratory
conditions intended to demonstrate robustness under typical user autoclaving conditions. Pall recommends that
structural integrity be confirmed under user autoclave condition during process qualification validation.
www.pall.com/biopharm 15
16
5. Burst Testing
5.1 Introduction
,:7BGDBAE7A8F:7E7F7EFEI3EFA67?A@EFD3F7F:3F+F3J67BF:8;>F7D53BEG>7EI;F:EF3@6F:7
?3J;?G?EB75;8;76AB7D3F;@9BD7EEGD7E3FSM43D BE;3@63FSM
 43D BE;I:;>7?3;@F3;@;@9EFDG5FGD3>;@F79D;FK3@6AB7D3F;@9E387FKI;F:3@3BBDABD;3F7
E387FK?3D9;@GDEFF7EFEI7D7B7D8AD?76I;F:>3D97?76;G?3@6E?3>>+F3J67BF:8;>F7D
53BEG>7EB3DF@G?47DE+0%+0&+0+D7EB75F;H7>K38F7D7JBAEGD7FAFIA
3GFA5>3H75K5>7E3FM
5.2 Summary of Methods
+F3@63D653BEG>7EA8F:7F:D773H3;>34>753BEG>7E;L7E>3D9753BEG>7+0%?76;G?53BEG>7
+0&E?3>>53BEG>7+0+8DA?8AGD6;887D7@F?76;343F5:7EI7D7GE768ADF:7F7EFE,:7
53BEG>7EI7D77CG;BB76I;F:H3D;AGEE:77F8;>F7DFKB7E,:7E:77F8;>F7DFKB7EI7D75:AE7@FA
D7BD7E7@F+7;FL8;>F7DE:77FE;@)9D367;@E;@9>73@66AG4>7>3K7D5A@8;9GD3F;A@)D;ADFAF:7
4GDEFF7EF;@9E3?B>7EA8F:753BEG>7EI7D7BD7FD73F76I;F:FIA3GFA5>3H75K5>7E3FM
35:53BEG>7I3E4GDEFF7EF76;@38;JFGD7FAE;?G>3F7:AI;F;E8;FF76;@F:7EF3;@>7EEEF77>
5:3EE;E,:77@F;D73EE7?4>KI3EB>3576;@3I3F7D43F:3FSM8AD3?;@;?G?A8:AGDAD3F
T SM8AD3?;@;?G?8AD:AGDEFA7@EGD7F:3F;F:367CG;>;4D3F76I;F:F:7I3F7D43F:
F7?B7D3FGD7,:753BEG>7I3EF:7@5A@@75F76FAF:7BD7EEGD7EAGD575A?B>7F7>K8;>>76I;F:
I3F7D8;>>F;?734AGFE75A@6E3FF:7D7EB75F;H7F7EFF7?B7D3FGD7G@F;>I3F7DI3E
A4E7DH76FA7E53B7F:DAG9:F:73;D4>776,:73;D4>776I3EE75GD763@6F:7BD7EEGD7I3E
9D36G3>>K;@5D73E76G@F;>F:78;>>7653BEG>74GDEF,:74GDEFBD7EEGD7I3ED75AD676
5.3 Results
,:7F7EFD7EG>FEA8F:74GDEFBD7EEGD7F7EFE3D7E:AI@;@,34>7ET ,:73H7D3974GDEF
BD7EEGD7A8F:7>3D9753BEG>7EI3E43DBE;3FSM3@643DBE;3F
SM,:73H7D3974GDEFBD7EEGD7A8F:7?76;G?53BEG>7EI3E43DBE;3FSM
3@643D43D3FSM,:73H7D3974GDEFBD7EEGD7A8F:7E?3>>53BEG>7EI3E8AG@6
FA47 43DBE;3FSM3@643DBE;3FSM
Table 7
Burst Pressure of Large Stax Depth Filter Capsules after Two Autoclaving Cycles at 125 °C
Media Test Temperature Burst Pressure
Part Number Batch Number Serial Number (°C) (bar/psi)
SXLPEKS416SP S250 0002 25 9.10 bar/132.0 psi
(containing 0003 25 9.03 bar/131.0 psi
single-layer sheet 0008 25 8.83 bar/128.1 psi
of type EKSP) 0009 25 9.79 bar/142.0 psi
0010 25 8.96 bar/130.0 psi
SXLPDK5408SP R446/S287 0001 25 8.89 bar/128.9 psi
(containing 0002 25 9.17 bar/133.0 psi
double-layer sheet 0003 25 10.00 bar/145.0 psi
configuration of 0009 25 9.03 bar/131.0 psi
type PDK5) 0010 25 9.79 bar/142.0 psi
SXLPEKS416SP S250 0001 63 7.31 bar/106.0 psi
(containing 0004 63 8.14 bar/118.1 psi
single-layer sheet 0005 63 8.20 bar/118.9 psi
of type EKSP) 0006 63 8.27 bar/119.9 psi
SXLPDK5408SP R446/S287 0003 63 8.14 bar/118.1 psi
(containing 0004 63 7.58 bar/109.9 psi
double-layer sheet 0010 60 7.65 bar/111.0 psi
configuration of
type PDK5)
Table 8
Burst Pressure of Medium Stax Depth Filter Capsules after Two Autoclaving Cycles at 125 °C
Media Test Temperature Burst Pressure
Part Number Batch Number Serial Number (°C) (bar/psi)
SXMB010408SP R841 0001 25 10.10 bar/146.5 psi
(containing 0002 25 9.24 bar/134.0 psi
single-layer sheet 0004 25 9.45 bar/137.1 psi
of type Bio 10) 0006 25 9.17 bar/133.0 psi
0010 25 9.58 bar/138.9 psi
SXSPDD1404SP S158/S309 0002 25 9.24 bar/134.0 psi
(containing 0003 25 9.86 bar/143.0 psi
double-layer sheet 0004 25 9.86 bar/143.0 psi
configuration of 0005 25 9.31 bar/135.0 psi
type PDD1) 0006 25 9.51 bar/137.9 psi
SXMB010408SP R841 0005 63 8.55 bar/124.0 psi
(containing 0007 63 9.38 bar/136.0 psi
single-layer sheet 0008 63 10.10 bar/146.5 psi
of type Bio 10) 0009 63 8.55 bar/124.0 psi
SXMPDD1404SP S158/S309 0001 63 9.03 bar/131.0 psi
(containing 0007 63 9.86 bar/143.0 psi
double-layer sheet 0009 60 9.58 bar/138.9 psi
configuration of 0010 60 7.86 bar/114.0 psi
type PDD1)
Table 9
Burst Pressure of Small Stax Depth Filter Capsules after Two Autoclaving Cycles at 125 °C
Media Test Temperature Burst Pressure
Part Number Batch Number Serial Number (°C) (bar/psi)
SXSB010404SP R841 0001 25 10.80 bar/156.6 psi
(containing 0003 25 10.60 bar/153.7 psi
single-layer sheet 0004 25 9.45 bar/137.1 psi
of type Bio 10) 0005 25 9.93 bar/144.0 psi
0010 25 9.24 bar/134.0 psi
SXSPDD1402SP S158/S309 0001 25 9.24 bar/134.0 psi
(containing 0002 25 10.40 bar/150.8 psi
double-layer sheet 0003 25 11.20 bar/162.4 psi
configuration of 0006 25 8.55 bar/124.0 psi
type PDD1) 0007 25 10.30 bar/149.4 psi
SXSB010404SP R841 0002 63 8.20 bar/118.9 psi
(containing 0006 63 8.20 bar/118.9 psi
single-layer sheet 0007 60 8.55 bar/124.0 psi
of type Bio 10) 0009 60 9.31 bar/135.0 psi
SXSPDD1402SP S158/S309 0004 63 8.62 bar/125.0 psi
(containing 0005 63 10.10 bar/146.5 psi
double-layer sheet 0009 63 8.14 bar/118.1 psi
configuration of
type PDD1)
www.pall.com/biopharm 17
18
5.4 Conclusions
+F3J67BF:8;>F7D53BEG>7E:3H767?A@EFD3F76F:734;>;FKFAI;F:EF3@6F:7?3J;?G?EB75;8;76
AB7D3F;@9BD7EEGD7E3FSM3@63FSMI;F:35A@E;67D34>7E387FK?3D9;@38F7D7JBAEGD7
FAFIA3GFA5>3H75K5>7E3FSM,:7D75AD6764GDEFBD7EEGD7E3FSM7J577676
43DBE;I:;>7F:7D75AD6764GDEFBD7EEGD7E3FSM7J57767643DBE;
F:GEEGBBADF;@9F:7?3J;?G?AB7D3F;@9BD7EEGD7E67F3;>76;@,34>7&3J;?G?(B7D3F;@9
)D7EEGD7EA8+F3J7BF:;>F7D3BEG>7E
Table 10
Maximum Operating Pressures of Stax Depth Filter Capsules
Pall Filter Part Number Maximum Operating Pressure
SXL***, SXM***, SXS*** 3.5 bar (50.8 psi) at up to 25 °C
1.0 bar (14.5 psi) at up to 60 °C
6. Creep-Rupture Testing
6.1 Introduction
,:7BGDBAE7A8F:7E7F7EFEI3EFA67?A@EFD3F7F:3F+F3J67BF:8;>F7D53BEG>7E3D7DA4GEF3@6
?3;@F3;@EFDG5FGD3>;@F79D;FK3@6AB7D3F;@9E387FKI:;>7G@67DBD7EEGD78AD7JF7@676B7D;A6EA8
F;?7,7EFEI7D7B7D8AD?763FSM3@63FSMI;F:>3D97?76;G?3@6E?3>>+F3J67BF:
8;>F7D53BEG>7EB3DF@G?47DE+0%+0&+0+D7EB75F;H7>K38F7D7JBAEGD7FAFIA
3GFA5>3H75K5>7E3FM
6.2 Summary of Methods
+F3@63D653BEG>7EA8F:7F:D773H3;>34>753BEG>7E;L7E>3D9753BEG>7+0%?76;G?53BEG>7
+0&E?3>>53BEG>7+0+8DA?8AGD6;887D7@F?76;343F5:7EI7D7GE768ADF:7F7EFE
,:753BEG>7EI7D77CG;BB76I;F:H3D;AGEE:77F8;>F7DFKB7E,:7E:77F8;>F7DFKB7EI7D7
5:AE7@FAD7BD7E7@F+7;FL8;>F7DE:77FE;@)9D367;@E;@9>73@66AG4>7>3K7D5A@8;9GD3F;A@
)D;ADFAF:75D77BDGBFGD7F7EF;@9E3?B>7EA8F:753BEG>7EI7D7BD7FD73F76I;F:FIA
3GFA5>3H75K5>7E3FM
35:53BEG>7I3E5D77BDGBFGD7F7EF76;@38;JFGD7FAE;?G>3F7:AI;F;E8;J76;@F:7EF3;@>7EE
EF77>5:3EE;E,:753BEG>7EI7D78;>>76I;F:I3F7D3FF:7D7EB75F;H7F7EFF7?B7D3FGD7SMAD
SM3@65A@@75F76FA35D77BDGBFGD7F7EFD;967E;9@76FA?3;@F3;@E7FBD7EEGD7EI;F:;@F:7
53BEG>7,:753BEG>73@6F7EF8;JFGD7I7D7F:7@8G>>K;??7DE76;@FA3I3F7DF3@=?3;@F3;@763F
F:7F7EFF7?B7D3FGD73@6F:7;@F7D@3>F7EFBD7EEGD7E?3;@F3;@76G@F;>83;>GD7A8F:753BEG>7
A55GDD76FF:;E7@6BA;@FF:783;>GD7F;?73@6?A67I7D7@AF76
6.3 Results
,:7F7EFD7EG>FEA8F:75D77BDGBFGD7F7EFE3D7E:AI@;@;9GD7D77B*GBFGD7)D7EEGD7,7EF
*7EG>FE8AD+F3J3BEG>7E3FM3@6;9GD7D77B*GBFGD7)D7EEGD7,7EF*7EG>FE8AD+F3J
3BEG>7E3FM,:7FIAFD7@6>;@7E;@735:9D3B:D7BD7E7@FF:763F3BA;@FE8ADF:7E?3>>
3@6?76;G?53BEG>7E3@68ADF:7>3D9753BEG>7E@7JFD3BA>3F;A@A8F:7FD7@6>;@7EBD76;5F3
5D77BDGBFGD7A8E3?B>7E?3;@F3;@763F5A@EF3@F?3J;?G?AB7D3F;@9BD7EEGD743DBE;
3FSM43DBE;3FSM;@7J57EEA8:AGDE63KE
Figure 8
Creep-Rupture Pressure Test Results for Stax Capsules at 25 °C
Figure 9
Creep-Rupture Pressure Test Results for Stax Capsules at 60 – 63 °C
6.4 Conclusions
+F3J67BF:8;>F7D53BEG>7E:3H7477@67E;9@768ADE;@9>75K5>7GE7I:7@AB7D3F763FGBFA
 43DBE;GBFASM3@643DBE;3FGBFASM8AD:AGDE;@5A@F;@GAGE
GE7@7JFD3BA>3F;A@A8F:7FD7@6>;@7EA8F:75D77BDGBFGD763F38DA?>3D97?76;G?3@6
E?3>>+F3J67BF:8;>F7D53BEG>7EB3DF@G?47DE+0%+0&+0+BD7E7@F76;@F:;ED7BADF
BD76;5F35D77BDGBFGD7A853BEG>7E?3;@F3;@763F5A@EF3@F?3J;?G?AB7D3F;@9BD7EEGD7
 43D BE;3FSM43DBE;3FSM;@7J57EEA8:AGDE63KE
F:GE67?A@EFD3F;@9F:7H7DK>3D97E387FK?3D9;@EF:3F:3H7477@;@5ADBAD3F76;@FAF:7E7
BD7EEGD75>3;?E)>73E75A@F35F)3>>8AD8GDF:7D36H;57A@>A@97DAB7D3F;@9F;?7E;8D7CG;D76
7. Extractables Testing Using Water and Ethanol 96%
7.1 Introduction
,:7BGDBAE7A8F:;EE7D;7EA8F7EFEI3EFACG3@F;8K3@65:3D35F7D;L7F:7?3F7D;3>F:3F53@47
7JFD35F768DA?F:7?A>6;@9EA8+F3J53BEG>7EKEF7?EGE;@9I3F7D3@67F:3@A>
"@8AD?3F;A@A@F:77JFD35F34>7E3@6D;@E7GB47:3H;ADA8F:7;@5ADBAD3F76+7;FL8;>F7DE:77FE
53@47A4F3;@76;@F:7)3>>6A5G?7@FE-+,*U)3>>O)E7D;7E7BF:;>F7D&76;3V3@6
-+,*U)3>>O+-)*6;E5!)7BF:;>F7D?76;3V
/3F7D;E5A@E;67D763EG;F34>7UIADEF53E7V?A67>EA>H7@F8AD3?3<AD;FKA83CG7AGEEA>GF;A@E
I:;>77F:3@A>;E5A@E;67D763EG;F34>7IADEF53E7?A67>EA>H7@F8AD97@7D3>AD93@;58>G;6E
www.pall.com/biopharm 19
Small and Medium Capsules
Large Capsules
Trend Line Large Capsules
Trend Line Small and Medium Capsules
Pressure (bar)
8
7
6
5
4
3
2
1
0
Time (h)
0.01 0.1 1 10 100 1000 10000
20
7.2 Summary of Methods
,KB;53>+F3J53BEG>7EKEF7??A>6;@9EI7D7GE768ADF:7F7EFE+7>75F76?A>6;@9EI7D75GFFA
3>>AI8ADF:7D7CG;D76:3@6>;@9EG4E7CG7@F>K53>>76U?A>6E3?B>7EV3@6EG4?;FF76FAF:7
7JFD35F;A@F7EFE,AF3>'A@HA>3F;>7*7E;6G7'.*"@6G5F;H7>KAGB>76)>3E?3")
+B75FDAE5ABK,AF3>(D93@;53D4A@,(3@6AGD;7D,D3@E8AD?"@8D3D76+B75FDAE5ABK,"*
7.2.1 Preparation of the Stax Capsule System Mold Samples
)D;ADFAF:77JFD35F;A@F7EFF:7?A>6E3?B>7EI7D73GFA5>3H76FA?3J;?;L7F:7
CG3@F;FKA83@K7JFD35F34>7?3F7D;3>BD7E7@F,:75GF?A>6E3?B>7EI7D7>AAE7>K
ID3BB76;@3>G?;@G?8A;>3@63GFA5>3H768ADFIA:AGD5K5>7E3FSMSQSSM
GE;@93E>AI7J:3GEF5K5>7.;E;4>76DAB>7FEA8I3F7DD7?3;@;@9A@F:7?A>6E3?B>7E
I7D73>>AI76FA7H3BAD3F73FDAA?F7?B7D3FGD7478AD7F:77JFD35F;A@I3EB7D8AD?76
7.2.2 Extraction Procedure of the Stax System Capsule Mold Samples
JFD35F;A@F7EFEI7D7B7D8AD?76;@3=@AI@HA>G?7A867;A@;L76I3F7DAD7F:3@A>
3F3?4;7@FF7?B7D3FGD7,:7?A>6E3?B>7EI7D78G>>K;??7DE76;@F:7
7JFD35F;A@8>G;6;@35>73@9>3EE5A@F3;@7D3@639;F3F766GD;@9F:77JFD35F;A@B7D;A6
4K?73@EA83@AD4;F3>E:3=7D+A?7?A>6E3?B>7EI7D7EG4?;FF76FA3E75A@6
5A@E75GF;H76K@3?;57JFD35F;A@5K5>7G@67DF:7E3?77JFD35F;A@5A@6;F;A@E3E
67E5D;47634AH7
>3@=E3?B>7EI7D767F7D?;@763E3BBDABD;3F78AD?7F:A63@6D7EG>F5A@FDA>E
7.2.3 Preparation of Samples for Analysis
Determination of NVR
A>>AI;@9F:77JFD35F;A@B7D;A63?73EGD76HA>G?7A8F:77JFD35F;A@>;CG;6I3E
7H3BAD3F76FA6DK@7EE3@6F:7'.*I7D767F7D?;@769D3H;?7FD;53>>K5ADD75F;A@
I3E?367FAF:7'.*H3>G7FA355AG@F8ADF:7FAF3>7JFD35F;A@HA>G?7GE76
Analysis by ICP
A>>AI;@9F:77JFD35F;A@B7D;A63E3?B>7HA>G?7A8F:73CG7AGE7JFD35F;A@>;CG;6
I3EF3=7@3@63@3>KL764K")8ADH3D;AGE;@AD93@;5;A@E
Analysis by TOC
A>>AI;@9F:77JFD35F;A@B7D;A63E3?B>7HA>G?7A8F:73CG7AGE7JFD35F;A@>;CG;6
I3EF3=7@3@63@3>KL768AD,(
Analysis by FTIR
(@>KF:77JFD35F;A@I;F:7F:3@A>BDAH;676EG88;5;7@F'.*8AD,"*3@3>KE;EI:;>7
F:7'.*EA8F:73CG7AGE7JFD35FEI7D7FAA?;@GF7FA473@3>KL76,"*3@3>KE;EA8
F:7'.*I3EB7D8AD?76FABDAH;67;@8AD?3F;A@A@F:7@3FGD7A8;FEAD93@;5
5A?BAG@6E
7.3 Results
7.3.1 Results of NVR and TOC Determination
,:7,34>7'A@HA>3F;>7CG7AGE"I3F7DJFD35F34>7E3@6,AF3>(D93@;5
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Pall Stax™ Capsule System Validation Guide

Brand
Pall
Model
Stax™ Capsule System
Type
Validation Guide
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