Sterilizing-grade Durapore® 0.22 µm Hydrophobic Filters - Millipore

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Sterilizing-grade
Durapore ® 0.22 µm
Hydrophobic Filters
DAT A SHEET
Ideal for particle and
microorganism removal
Excellent resistance to
thermal and hydraulic stress
Validated to withstand multiple
sterilization cycles
Scalable — from bench-top
to full-scale production
Wide selection of
configurations to meet
your process needs
Reliable filters for the sterile filtration
of gases and liquids
Durapore hydrophobic membrane cartridges and capsules are sterilizing-grade
filters that provide sterility assurance, high flow rates and high throughput. They
are used for sterile tank and gas venting, as well as for the filtration of liquids in
small and large volume systems. Durapore 0.22 µm hydrophobic polyvinylidene
fluoride (PVDF) membrane reliably eliminates contaminants and microorganisms
in sterilizing applications, even at high pH.
Broad Chemical Compatibility,
Low Extractables
Contributing to clean manufacturing
processes, Durapore filters are made
of just two materials—PVDF membrane
and polypropylene support structure
—this ensures broad chemical
compatibility and low gravimetric
extractables.
Regulatory Compliance
Filters with hydrophobic Durapore
0.22 µm membrane are designed,
developed, and manufactured in
accordance with a Quality Management
System approved by an accredited
registering body to an ISO ® 9000
Quality Systems Standard and are
shipped with a Certificate of Quality.
Each Opticap ® XL capsule and
Durapore cartridge filter is integrity
tested during manufacturing and is
supported with a comprehensive
Validation Guide for compliance
with regulatory requirements.
For traceability and easy identification,
each filter is labeled with the
product name and identifying
characteristics.
Multiple Formats Available
Sterilizing-grade hydrophobic
Durapore membranes are available
in three formats and multiple configurations
that vary by filtration surface
area and type of inlet/outlet
connection.
Membrane Types
• Durapore 0.22 µm hydrophobic
Filter Formats
• Opticap XL disposable capsule filters
• Optiseal ® cartridge filters
• Cartridge filters

From process
development
to full-scale
production,
Millipore
has the right
solution for you!
Table of Contents
Opticap XL Capsule Filters
Specifications . . . . . . . . . . . .4
Typical Flow Rate and
Pressure Drop . . . . . . . . . . .6
Ordering Information . . . . . . .7
Opticap XL Disposable Capsule Filters
Opticap XL Filters
Opticap XL disposable capsule filters
with hydrophobic Durapore membrane
are available in multiple filtration
areas, providing an optimal choice for
every application. Each Opticap XL
capsule is integrity tested during the
manufacturing process. The Opticap
XL capsule patented design allows
unparalleled thermal and hydraulic
stress resistance in a disposable filter,
resulting in reliability, high confidence
in the sterility process, and improved
cleanliness. The unique capsule
design with pleated hydrophobic
Durapore membrane minimizes hold-up
volume and reduces production losses.
Convenient and Easy to Use
Opticap XL capsule filters eliminate the
time and expense associated with
assembling, cleaning, and validating
stainless steel housings. Adjustable,
easy-to-turn
upstream vents
and drain valves
with O-ring seals
allow easy process
control. Other easeof-use
features include flow direction
arrows and ribbed housing for easy
gripping, even with gloved-hands.
The Right Size
A wide range of filtration areas is
available to fit all of your application
needs, and to allow easy scale-up of
your small volume filtration steps to
larger, full-scale filtration processes.
The Right Connections
Self-contained, disposable Opticap XL
capsule filters are supplied with a
choice of inlet and outlet connections
to optimize your filtration process.
Connections include hose barb,
fractional sanitary flange, and
sanitary flange, which provide the
highest flow rate.
Optiseal Cartridge Filters
Specifications . . . . . . . . . . . .5
Typical Flow Rate and
Pressure Drop . . . . . . . . . . .6
Ordering Information . . . . . . .7
Cartridge Filters
Specifications . . . . . . . . . . . .5
Typical Flow Rate and
Pressure Drop . . . . . . . . . . .6
Ordering Information . . . . . . .7
2

Optiseal Cartridge Filters
Cartridge Filters
Optiseal Filters
Featuring a unique cartridge-to-housing
sealing mechanism and pleated membrane
configuration, these Durapore
0.22 µm hydrophobic cartridges offer
maximum sterility assurance. Each
cartridge filter is integrity tested during
the manufacturing process.
Cartridge Filters
Hydrophobic Durapore cartridge filters
provide high throughput and minimal
differential pressure. Cartridges are
robust, resilient, and designed to
withstand multiple steam-in-place
cycles. Each cartridge filter is integrity
tested during the manufacturing
process.
Durapore cartridge filters are
available in five cartridge lengths,
from five to thirty inches, and provide
a full range of filtration areas to suit
every size system. Three connection
options are offered for easy adaptation
to existing housings.
3

Specifications
Opticap XL 5 Opticap XL 10
Nominal Dimensions
Maximum length: 21.6 cm (8.5 in.) 33.5 cm (13.2 in.)
Body diameter: 10.7 cm (4.2 in.) 10.7 cm (4.2 in.)
Vent to vent diameter: 14.5 cm (5.7 in.) 14.5 cm (5.7 in.)
Filtration Area 0.35 m 2 (3.7 ft 2 ) 0.69 m 2 (7.4 ft 2 )
Materials of Construction
Filter membrane:
Film edge:
Supports:
Structural components*:
Vent O-rings:
Vent/Drain
Hydrophobic PVDF
Polypropylene
Polypropylene
Polypropylene
Silicone
ª in. hose barb with double O-ring seal
Maximum Inlet Pressure 5.5 bar (80 psi) at 23 °C
2.8 bar (40 psi) at 60 °C
1.0 bar (15 psi) at 80 °C
Maximum Differential Pressure
Forward: 5.5 bar (80 psid) at ambient temperature, 1.0 bar (15 psid) at 80 °C
Reverse:
3.4 bar (50 psid) at ambient temperature
Bubble Point at 23 °C ≥ 1170 mbar (17.0 psig) nitrogen > 1240 mbar (18.0 psig) nitrogen
with 70/30 IPA/water
with 60/40 IPA/water
Nitrogen Diffusion
Bacterial Endotoxin
Bacterial Retention
Sterilization
Good Manufacturing Practices
Through a water wet membrane at ambient room temperature at 1720 mbar (25 psig) nitrogen:
≤ 5 cc/min
≤ 10 cc/min
Aqueous extraction contains < 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test.
Quantitative retention of 10 7 CFU/cm 2 Brevundimonas diminuta ATCC ® 19146 per ASTM ® methodology.
May be autoclaved for 20 cycles of 30 minutes at 126 °C.
These products are manufactured in a Millipore facility which adheres to FDA Good Manufacturing Practices.
Non-Fiber Releasing Durapore membrane meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6).
Component Material Toxicity
European Pressure Equipment
Directive
*Cage, core, end caps, and capsule housing
Component materials were tested and meet the criteria of USP Reactivity Tests for Class VI Plastics.
Durapore filters meet the requirements of the USP Safety Test.
Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive,
97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel
Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe
use. In compliance with Article 3 § 3 of this Pressure Equipment Directive, this product does not bear the CE mark.
4

Specifications
Optiseal Filters 5-inch Cartridge Per 10-inch Cartridge
Nominal Dimensions
Maximum length: 12.0 cm (4.7 in.) 12.5 cm (5 in.) 25 cm (10 in.)
Outside diameter: 6.9 cm (2.7 in.) 6.9 cm (2.7 in.) 6.9 cm (2.7 in.)
Filtration Area 0.18 m 2 (1.9 ft 2 ) — 0.7 m 2 (7.4 ft 2 )
Materials of Construction
Filter membrane: Hydrophobic PVDF Hydrophobic PVDF
Supports: Polypropylene Polypropylene
O-rings: Silicone Silicone
Connections Double 2-123 O-ring Code 7 (2-226) O-ring with locking tab and spear
Code 5 (2-222) O-ring with spear
Code 0 (2-222) O-ring
Maximum Differential Pressure
Forward: 5.5 bar (80 psid) at 25 °C; 3.5 bar (50 psid) at 80 °C; 0.35 bar (5 psid) at 135 °C
Reverse: 3.4 bar (50 psid) at 25 °C
Bubble Point at 23 °C ≥ 2000 mbar (29 psig) in water ≥ 2000 mbar (29 psig) in water
≥ 1240 mbar (18 psig) in 60/40 IPA/water
≥ 1240 mbar (18 psig) in 60/40 IPA/water
≥ 1170 mbar (17 psig) in 70/30 IPA/water
≥ 1170 mbar (17 psig) in 70/30 IPA/water
≥ 1170 mbar (17 psig) in 100 IPA
Nitrogen Diffusion At 1.0 bar (15 psig) in 60/40 IPA/water at 23 °C: At 1.7 bar (25 psig) in water at 23 °C:
≤ 2 cc/min ≤ 5.0 mL/min ≤ 10.0 mL/min
At 1.7 bar (25 psig) in water at 23 °C:
≤ 5.0 cc/min
Bacterial Endotoxin
Bacterial Retention
< 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test.
Quantitative retention of Brevundimonas diminuta (ATCC 19146) following ASTM F838-83 methodology
at a minimum challenge level of 10 7 CFU/cm 2 .
Sterilization 30 steam-in-place cycles of 30 min at 135 °C; 30 steam-in-place cycles at 30 min at 126 °C;
10 autoclave cycles of 30 min at 126 °C. 30 autoclave cycles of 60 min at 126 °C.
5

Typical Air Flow Rate and Pressure Drop
Opticap XL 5 Capsule with Hydrophobic
Durapore 0.22 µm Membrane, FF Fitting*
Pressure Drop (bar)
scfm
0 10
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.0
0
20 30 40 50
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
0
10 20 30 40 50 60 70 80 90
Air Flow Rate (Nm 3 /h)
10
8
6
4
2
psid
Opticap XL 5 Capsule with Hydrophobic
Durapore 0.22 µm Membrane, HH Fitting*
Pressure Drop (bar)
scfm
0 10
2.5
2.0
1.5
1.0
0.5
0.0
0
20 30 40 50
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
35
30
25
20
15
10
5
0
10 20 30 40 50 60 70 80 90
Air Flow Rate (Nm 3 /h)
psid
Opticap XL 5 Capsule with Hydrophobic
Durapore 0.22 µm Membrane, TT Fitting*
Pressure Drop (bar)
scfm
0 20 40 60 80 100
0.9
12
0.8
0 PSIG Outlet
0.7
15 PSIG Inlet
30 PSIG Inlet
10
0.6
8
0.5
0.4
6
0.3
4
0.2
2
0.1
0.0
0
0 20 40 60 80 100 120 140 160 180
Air Flow Rate (Nm 3 /h)
psid
Opticap XL 5 Capsule With 0.22 µm
Phobic Durapore Media — FF Fitting
Opticap XL 10 Capsule with Hydrophobic
Durapore 0.22 µm Membrane, FF Fitting*
Pressure Drop (bar)
scfm
0 10
0.5
0.4
0.3
0.2
0.1
0.0
0
20 30 40 50
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
7
6
5
4
3
2
1
0
10 20 30 40 50 60 70 80 90
Air Flow Rate (Nm 3 /h)
psid
Opticap XL Phobic 10 Durapore Capsule Media — with HH Fitting Hydrophobic
Durapore 0.22 µm Membrane, HH Fitting*
Pressure Drop (bar)
scfm
0 10
2.5
2.0
1.5
1.0
0.5
0.0
0
Opticap XL 5 Capsule With 0.22 µm
20 30 40 50
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
0
10 20 30 40 50 60 70 80 90
Air Flow Rate (Nm 3 /h)
35
30
25
20
15
10
5
psid
Opticap XL 10 Capsule with Hydrophobic
Durapore 0.22 µm Membrane, TT Fitting*
Pressure Drop (bar)
scfm
0 20 40 60 80 100
0.45
0.40
0 PSIG Outlet
6
15 PSIG Inlet
0.35
30 PSIG Inlet
5
0.30 Opticap XL 5 Capsule With 0.22 µm
Phobic Durapore Media — TT Fitting 4
0.25
0.20
3
0.15
2
0.10
1
0.05
0.00
0
0
20 40 60 80 100 120 140 160 180
Air Flow Rate (Nm 3 /h)
psid
Opticap XL 10 Capsule With 0.22 µm
Phobic Durapore Media — FF Fitting
Optiseal Cartridge with 0.22 µm
Hydrophobic Durapore Membrane
Pressure Drop (bar)
scfm
0 2 4 6 8 10 12 14 16 18 20
0.28
4.0
0 PSIG Outlet
3.5
15 PSIG Inlet
30 PSIG Inlet
3.0
50 PSIG Inlet
2.5
0.14
2.0
1.5
1.0
0.5
0.0
0.0
0 70 140 210 280 350 420 490 560
Air Flow Rate (L/min)
psid
Opticap XL 10 Capsule With 0.22 µm
Phobic Durapore Media — HH Fitting
10-inch Cartridge with 0.22 µm
Hydrophobic Durapore Membrane
Pressure Drop (bar)
scfm
0 20 40 60 80 100
0.45
0.40
0 PSIG Outlet
6
15 PSIG Inlet
0.35
30 PSIG Inlet
5
0.30
4
0.25
0.20
3
0.15
2
0.10
1
0.05
0.00
0
0 20 40 60 80 100 120 140 160 180
Air Flow Rate (Nm 3 /h)
psid
Opticap XL 10 Capsule With 0.22 µm
Phobic Durapore Media — TT Fitting
Optiseal Cartridges
Typical Liquid Flow Rate and Pressure Drop
Opticap XL 5 Capsule Temperature with Hydrophobic
Durapore 0.22 µm Membrane
Pressure Drop (bar)
gpm
0 5 10 15 20
3.0
2.5
2.0
1.5
1.0
0.5
with Durapore 0.22µm
Hydrophobic Filters (LAGB)
Air Flow Rate at Ambient
TT
FF
HH
0.0
0
0 10 20 30 40 50 60 70 80
Water Flow Rate (L/min)
40
30
20
10
psid
Opticap XL 10 Capsule with Hydrophobic
Durapore 0.22 µm Membrane
Pressure Drop (bar)
gpm
0 5 10 15 20
3.0
2.5
2.0
1.5
1.0
0.5
10-inch Cartridge with 0.22 µm
Phobic Durapore Media
TT
FF
HH
0.0
0
0 10 20 30 40 50 60 70 80
Water Flow Rate (L/min)
40
30
20
10
psid
10-inch Cartridge with 0.22 µm
Hydrophobic Durapore Membrane
Pressure Drop (bar)
gpm
0 4
1.40
1.05
0.70
0.35
0.00
0
8 12 16 20
20
18
16
14
12
10
8
6
4
2
0
10 20 30 40 50 60 70 80
Water Flow Rate (L/min)
psid
6
Opticap XL 5 Capsule with
0.22 µm Phobic Durapore Media (KVGB)
Opticap XL 10 Capsule with
0.22 µm Phobic Durapore Media (KVGB)
CVGB 01T P3 Liquid
*Opticap XL Capsule Connection Types
TT = 38 mm (1∞ in.) sanitary flange inlet and outlet; FF = 19 mm (º in.) sanitary flange inlet and outlet; HH = 14 mm ( 9 /16 in.) hose barb inlet and outlet

Ordering Information
Device Connections Qty/Pk Catalogue No.
Opticap XL 5 Capsules 38 mm (1∞ in.) sanitary flange inlet and outlet 1/pk KVGB A05 TT1
19 mm (º in.) sanitary flange inlet and outlet 1/pk KVGB A05 FF1
14 mm ( 9 /16 in.) hose barb inlet and outlet 1/pk KVGB A05 HH1
Opticap XL 10 Capsules 38 mm (1∞ in.) sanitary flange inlet and outlet 1/pk KVGB A10 TT1
19 mm (º in.) sanitary flange inlet and outlet 1/pk KVGB A10 FF1
14 mm ( 9 /16 in.) hose barb inlet and outlet 1/pk KVGB A10 HH1
Optiseal Cartridges Double 2-123 O-ring 6/pk LAGB 04T P6
5-inch Cartridges Code 7 (2-226) O-ring with locking tab 1/pk CVGB 75S 01
10-inch Cartridges Code 7 (2-226) O-ring with locking tab and spear 3/pk CVGB 71T P3
Code 5 (2-222) O-ring with spear 3/pk CVGB 51T P3
Code 0 (2-222) O-ring 3/pk CVGB 01T P3
20-inch Cartridges Code 7 (2-226) O-ring with locking tab and spear 3/pk CVGB 72T P3
Code 5 (2-222) O-ring with spear 3/pk CVGB 52T P3
Code 0 (2-222) O-ring 3/pk CVGB 02T P3
30-inch Cartridge Code 7 (2-226) O-ring with locking tab and spear 3/pk CVGB 73T P3
Code 5 (2-222) O-ring with spear 3/pk CVGB 53T P3
Code 0 (2-222) O-ring 3/pk CVGB 03T P3
7

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Millipore, Durapore, Opticap and Optiseal are registered trademarks of Millipore Corporation.
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