MM Pf2100en00

Data Sheet
Sterilizing-grade Aervent Filters

Superior filters for the sterile filtration of gases
The 0.2 m hydrophobic Aervent polytetrafluoroethylene (PTFE) membrane provides sterility assurance, high flow rates,
and throughput. The Aervent membrane
contributes to clean processes due its
non-fiber releasing properties.
Regulatory Compliance
Filters with hydrophobic Aervent membrane are
designed, developed, and manufactured in accordance
with a Quality Management System approved by an
accredited registering body to an ISO 9001 Quality
Systems Standard. Each filter is shipped with a Certificate of Quality. Each Opticap XL and 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, lot number and serial number.
Multiple Formats Available

Hydrophobic Aervent membranes are available in two
device formats, one pore size, and multiple configurations that vary by filtration area and type of inlet/outlet
connection.
Benefits

Ideal membrane for removing particles and
microorganisms from gases
Unparalleled thermal and hydraulic stress resistance
Validated to withstand multiple sterilization cycles
Membrane Types
Aervent 0.2 m hydrophobic
polytetrafluoroethylene (PTFE)
Filter Formats

Opticap XL disposable capsule filters

Cartridge filters
Opticap XL Disposable Capsule Filters

Opticap XL disposable capsule filters with hydrophobic Aervent 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 patented Opticap XL capsule design allows unparalleled thermal and hydraulic
stress resistance in a disposable filter, resulting in reliability, high confidence in the
sterility process and improved cleanliness.
Convenient and Easy to Use

Opticap XL capsule filters eliminate the time and the expense associated with
assembling, cleaning, and validating stainless steel housings. Adjustable, easy-to-turn,
upstream vents and drain valves with O-ring seals and hose barb connections allow
for easy process control. Other ease-of-use features include flow directional arrows
and ribbed edges for easy gripping even with gloved hands.
Opticap XL Filters
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 and disposable, Opticap XL capsule filters are supplied with a choice
of inlet and outlet connections to optimize your filtration process, including fractional
sanitary flange, hose barb, and sanitary flanges which provide a higher flow rate.
Cartridge Filters
Hydrophobic Aervent cartridge filters provide high flow
rate and minimal differential pressure. Cartridges are
robust, strong, and resilient and are designed to withstand
multiple steam-in-place cycles. Each Aervent cartridge
filter is integrity tested during the manufacturing process.
A full range of filtration areas is available to suit varying
applications and a variety of connection options are
offered for easy adaptation to existing housings.
Cartridge Filters
Specifications
Opticap XL 2
Opticap XL 4
Opticap XL 5
Opticap XL 10
Maximum length:
14.3 cm (5.6 in.)
19.6 cm (7.7 in.)
21.6 cm (8.5 in.)
33.5 cm (13.2 in.)
Body diameter:
8.4 cm (3.3 in.)
8.4 cm (3.3 in.)
10.7 cm (4.2 in.)
10.7 cm (4.2 in.)
Vent to vent diameter:
12.5 cm (4.9 in.)
12.5 cm (4.9 in.)
14.5 cm (5.7 in.)
14.5 cm (5.7 in.)
0.10 m2 (1.1 ft2)
0.21 m2 (2.3 ft2)
0.32 m2 (3.5 ft2)
0.65 m2 (7.0 ft2)
Nominal Dimensions
Filtration Area
Materials of Construction
Filter media:
Hydrophobic PTFE
Supports:
Polypropylene
Structural components:
Polypropylene
Vent O-rings:
Silicone
Vent/Drain
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:
4.1 bar (60 psid) intermittent
Bubble Point at 23 C
1100 mbar (16 psig) in 70/30 IPA/water
Air Diffusion
Through a 70/30 IPA/water wet membrane at ambient room at 965 mbar (14 psig) nitrogen:
-
HydroCorr Test
12 cc/min
24 cc/min
0.25 mL/min
0.38 mL/min
0.75 mL/min
At 2620 mbar (38 psig):

0.12 mL/min
Gravimetric Extractables
9 cc/min
After autoclaving and a 24 hour soak in 70/30 IPA/water at controlled room temperature:
15 mg
15 mg
28 mg
45 mg
Bacterial Endotoxin
Aqueous extraction contains < 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test.
Bacterial Retention
Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC 19146 per ASTM methodology.
Sterilization
May be autoclaved for 30 cycles of 30 minutes at 135 C.
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Non-Fiber Releasing
Aervent membrane meets the criteria for a non-fiber releasing filter as defined in 21 CFR 210.3 (b) (6).
Component Material Toxicity
Component materials were tested and meet the criteria of USP <88> Reactivity Tests for Class VI Plastics.
Aervent filters are non-toxic per the USP <88> Safety Test.
European Pressure Equipment

Directive
We certify 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.
Viral Retention
Rated for aerosol retention of a total challenge of 1081010 plaque forming units of X174 virus particles
at 50 SCFM per cartridge.
Bacterial Aerosol Growth
Retains B. diminuta liquid aerosol for 21 days at a minimum challenge of 107 CFU/cm2.
Specifications (continued)
5-inch Cartridge
Per 10-inch Cartridge
Maximum length:
12.5 cm (5 in.)
25 cm (10 in.)
Outside diameter:
6.9 cm (2.7 in.)
6.9 cm (2.7 in.)
0.32 m2 (3.5 ft2)
0.65 m2 (7.0 ft2)
Nominal Dimensions
Filtration Area
Materials of Construction
Filter media:
Hydrophobic PTFE
Supports:
Polypropylene
Structural components:
Polypropylene
O-rings:
Silicone
Outer support ring:
Stainless Steel
Maximum Differential Pressure

Forward:
5.5 bar (80 psid) at ambient temperature, 1.8 bar (25 psid) at 80 C
Reverse:
4.1 bar (60 psid) intermittent
Bubble Point at 23 C
1100 mbar (16 psig) in 70/30 IPA/water
Air Diffusion
Through a 70/30 IPA/water wet membrane at ambient room at 965 mbar (14 psig) nitrogen:
12 cc/min
HydroCorr Test
At 2620 mbar (38 psig):

0.38 mL/min
Gravimetric Extractables
0.75 mL/min
After autoclaving and a 24 hour soak in 70/30 IPA water at controlled room temperature:
18 mg
24 cc/min
35 mg
Bacterial Endotoxin
Aqueous extraction contains < 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Bacterial Retention
Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC 19146 per ASTM methodology
Sterilization
May be steam sterilized 100 times (forward) and 50 times (reverse) for 30 minutes at 145 C.
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Non-Fiber Releasing
Aervent membrane meets the criteria for a non-fiber releasing filter as defined in 21 CFR 210.3 (b) (6).
Component Material Toxicity
Component materials were tested and meet the criteria of USP <88> Reactivity Tests for Class VI Plastics.
Aervent filters are non-toxic per the USP <88> Safety Test.
Viral Retention
Rated for aerosol retention of a total challenge of 1081010 plaque forming units of X174 virus particles
at 50 SCFM per 10-inch cartridge.
Bacterial Aerosol Growth
Retains B. diminuta liquid aerosol for 21 days at a minimum challenge of 107 CFU/cm2.
Air Flow Rate and Pressure Drop - Opticap XL Capsule Filters

Opticap XL 2 Capsule with 0.2 m
Aervent Membrane HH Fitting*
scfm
3.5
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
Pressure Drop (bar)
2.0
1.5
0.10
1.0
0.05
0.5
0
10
15
25
20
0.0
30
0.15
0.10
10
12
16
25
30
1.2
Pressure Drop (bar)
0.8
0.6
0.04
0.4
10
15
25
20
30
0.0
12
16
10
2.0
1.5
1.0
0.5
0
10
15
25
20
30
0.0
50
10
Pressure Drop (bar)
0.15
0.10
0.6
0.4
0.02
0.2
0.00
10
15
20
25
30
20
30
40
50
1.2
15
0.8
10
0.6
40
60
80
100
7
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
0.4
20
1.0
20
0.5
6
5
0.3
4
3
0.2
2
0.1
10
20
30
40
50
60
70
80
90
0.0
10
20
Flow Rate (Nm3/h)
30
40
50
60
70
80
90
psid
psid
0.2
Opticap XLOpticap
10 Capsule
with 0.2 m
XL 5 Capsule W ith 0.2 m
Aervent Membrane
FF
Aer vent Membrane
FFFitting*
Fitting
20
30
40
50
10
20
30
40
50
1.8
4
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
1.4
3
0.15
0.10
1
0.05
20
30
40
50
60
70
80
90
20
15
1.0
0.8
10
0.6
120
140
10
20
30
40
50
60
70
80
90
80
120
180
4
3
0.20
0.15
0.10
1
0.00
50
100
150
200
Flow Rate (Nm /h)
Flow Rate (Nm /h)
Opticap XL 10 Capsule W ith 0.2 m
160
5
Flow Rate (Nm /h)

3
160
0.05
psid
0.0
100
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
0.25
1.2
0.4
psid
40
0.30
0.2
10
80
0.35
25
1.6
Pressure Drop (bar)
0.20
60
scfm
0.30
0.25
40
20
Opticap XLOpticap
10 Capsule
with 0.2 m
XL 5 Capsule W ith 0.2 m
Aervent Membrane
TT
Aer vent Membrane
TTFitting*
Fitting
scfm
10
Flow Rate (Nm3/h)
Opticap XLOpticap
10 XLCapsule
with 0.2 m
5 Capsule W ith 0.2 m
Aervent Membrane
HH
Fitting*
Aer vent Membrane
HH Fitting
scfm
0
0.0
Flow Rate (Nm3/h)
Pressure Drop (bar)
0.0
Opticap XLOpticap
5 Capsule
0.2
XL 4 Capsulewith
W ith 0.2
m m
Aer vent Membrane
Fitting
Aervent Membrane
TT TTFitting*
0.4
0.05
0.8
Flow Rate (Nm /h)
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
1.4
0.20
1.0
0.03
25
1.6
4
16
scfm
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
12
1.8
0.04
Pressure Drop (bar)
40
0.0
0.05
scfm
30
30
0.01
Aer vent Membrane HH Fitting
scfm
25
20
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
0.06
2.5
0.10
0.07
3.0
0.15
0.00
15
0.08

Opticap XL 4 Capsule
W ithFitting*
0.2 m
Aervent Membrane
HH
0.35
0.25
Flow Rate (Nm /h)
Aer vent Membrane FF Fitting
0.30

W ith
0.2 m
Aervent Membrane
FF
Fitting*
20
0.5
Aer vent Membrane TT Fitting
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
Flow Rate (Nm /h)
10
1.5
1.0
0.00
3.5
2.0
0.10

W ith
0.2 m
Aervent Membrane
TT
Fitting*
0.05
0.2
0
0.20
1.0
0.06
2.5
0.15
scfm
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
3.0
Flow Rate (Nm3/h)
0.25
1.4
psid
Pressure Drop (bar)
20

Aervent Membrane HH Fitting*
0.02
Pressure Drop (bar)
15
Pressure Drop (bar)
16
0.05
psid
0.08
Pressure Drop (bar)
scfm
12
3.5
Flow Rate (Nm3/h)
0.10
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
0.20
0.20
0.00
0.25
scfm
0.00
16
0.05

Aervent Membrane FF Fitting*
0.00
12
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
Flow Rate (Nm3/h)
0.00
0.25
0.30
2.5
0.15
0.35
3.0
psid
Pressure Drop (bar)
0.20
scfm
0
0.40
psid
16
psid
12
Pressure Drop (bar)
psid
psid
scfm
0
0.25
0.00

Aervent Membrane TT Fitting*
250
300
psid

Aervent Membrane FF Fitting*
vent Membrane FF Fitting

Aer vent Membrane TT Fitting
Aer vent Membrane HH Fitting
*Opticap XLAerCapsule
Connection Types
T T = 38 mm (1 in.) Sanitary Flange Inlet & Outlet; FF = 19 mm ( in.) Sanitary Flange Inlet & Outlet; HH = 14 mm (/ in.) Hose Barb Inlet & Outlet
Air Flow Rate and Pressure Drop - Cartridge Filters

10-inch Cartridge with 0.2 m Aervent
Membrane Codes 0 and 5*
scfm
30
40
50
60
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
2.5
2.0
1.5
0.10
1.0
0.05
200
250
300
20
60
40
100
80
psid
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
50 PSIG Inlet
70 PSIG Inlet
0.3
5
4
100
200
400
300
200
150
250
300
350
400
100
2
0.1
150
200
250
300
350
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
50 PSIG Inlet
70 PSIG Inlet
100
200
300
500
400
600
700
0.1
0.0
0
100
200
500
400
600
Pressure Drop (bar)
4
3
2
700
200
300
400
500
600
700
800
900
10
9
8
7
6
5
4
3
0.2
1
0
100
200
0.3
200
500
600
700
3
2
200
300
400
500
600
700
800
900
300
400
0.3
6
5
4
3
0.2
0.0
100
200
300
400
500
600
700
Flow Rate (Nm /h)
30-inch Cartridge with 0.2 m

Aer vent Membrane Code 7

Aer vent Membrane Codes 0 and 5

Aer vent Membrane Code 7
0 = (2-222) O-ring
5 = (2-222) O-ring w/spear
7 = (2-226) O-ring w/locking tab spear
500
0.1
100
200
Flow Rate (Nm /h)
*Cartridge Codes
900
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
50 PSIG Inlet
70 PSIG Inlet
0.4
100
Flow Rate (Nm /h)

3
800
0.5
400
30-inch Cartridge
m Aervent
40-inch Cartridge
with with
0.20.2m
Membrane Codes 0 and 5
Membrane Aer
vent
Code
7*
500
0.2
0.0
300
Flow Rate (Nm /h)
0.1
100
11
300 Outlet 400

0 PSIG
15 PSIG Inlet
0 PSIG Outlet 30 PSIG Inlet
15 PSIG Inlet 50 PSIG Inlet
30 PSIG Inlet 70 PSIG Inlet
50 PSIG Inlet
70 PSIG Inlet
0.4
0.1
500
0.0
Pressure Drop (bar)
0.2
100
0.5
0.3
400
scfm
psid
Pressure Drop (bar)
300
20-inch Cartridge
m Aervent
40-inch Cartridge
withwith
0.20.2m
vent Membrane Code 7
Membrane AerCodes
0 and 5*
500
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
50 PSIG Inlet
70 PSIG Inlet
300
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
50 PSIG Inlet
70 PSIG Inlet
Flow Rate (Nm /h)
0.5
0.4
200
400
psid
300
400
300
0.4
scfm
200
100
0.6
scfm
psid
psid
200
20-inch Cartridge
m Aervent
30-inch Cartridge
with with
0.20.2m
MembraneAervent
Code
7*
100
100
10-inch Cartridge
m Aervent
30-inch Cartridge
with with
0.20.2m
vent Membrane Code 7
Membrane Aer
Codes
0 and 5*
Flow Rate (Nm /h)
0.2
400
Flow Rate (Nm3/h)
Pressure Drop (bar)
0.2
0.8
0.3
4
scfm
50
Pressure Drop (bar)
0.3
300
0.0
0.4
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
50 PSIG Inlet
70 PSIG Inlet
250
0.2
scfm
100
50
0.4
0.0
0.3
10-inch Cartridge
m Aervent
20-inch Cartridge
with with
0.20.2m
MembraneAerventCode
7*
scfm
200
Flow Rate (Nm3/h)
5-inch Cartridge
m Aervent
20-inch Cartridge
with with
0.20.2m
vent Membrane Code 7*
Membrane AerCodes
0 and 5*
0.0
150
0.1
0.0
100
0 PSIG Outlet
15 PSIG Inlet
30 PSIG Inlet
50 PSIG Inlet
70 PSIG Inlet
0.4
Flow Rate (Nm3/h)
0.2
50
0
0.5
0.1
0.5
Pressure Drop (bar)
150
100
0.4
Pressure Drop (bar)
Pressure Drop (bar)
0.15
0.00
scfm
50
0
0.5
psid
20
psid
10
psid
0
0.20
Pressure Drop (bar)
scfm

Membrane Code 7*
800
900
psid

Membrane Code 7*
Ordering Information
Opticap XL Capsule Filters
Opticap XL
Capsule Filter
Pore Size
May be Autoclaved
GR = 0.2 m
Membrane Type
T = Aervent
Length
10 = Opticap XL 10
05 = Opticap XL 5
04 = Opticap XL 4
02 = Opticap XL 2
Quantity per Package

1 = 1/pack (10 and 5 in.)
3 = 3/pack (4 and 2 in.)
Connection Type
T T = 38 mm (1 in.) Sanitary Flange Inlet & Outlet
FF = 19 mm ( in.) Sanitary Flange Inlet & Outlet
HH = 14 mm (/ in.) Hose Barb Inlet & Outlet
TH = 38 mm (1 in.) Sanitary Flange Inlet and 14 mm

(/ in.) Hose Barb Outlet (XL 2 and 4 only)
NN = 6 mm ( in.) NPT Inlet and Outlet (XL 2 and 4 only)
Cartridge Filters
C
Cartridge
Filter
Membrane
Type
T = Aervent
Pore Size
GR = 0.2 m
Cartridge Code
0 = (2-222) O-ring
5 = (2-222) O-ring w/spear
7 = (2-226) O-ring with
locking tab and spear
Cartridge Length
5 = 5 inch
(Cartridge code 7 only)
1 = 10 inch
2 = 20 inch
3 = 30 inch
4 = 40 inch
Packaging Code
S01 = 1/pk (5-inch element only)
TP1 = 1 per package
(all other elements)
To Place an Order or Receive

Technical Assistance
In Europe, please call Customer Service:
France: 0825 045 645
Germany: 01805 045 645
Italy: 848 845 645
Spain: 901 516 645 Option 1
Switzerland: 0848 645 645
United Kingdom: 0870 900 4645
For other countries across Europe,
please call: +44 (0) 115 943 0840
Or visit: www.merckmillipore.com/offices
For Technical Service visit:
www.merckmillipore.com/techservice
www.millipore.com/offices
Merck Millipore, the M logo and HydroCorr are trademarks of Merck KGaA, Darmstadt, Germany. Aervent and
Opticap are registered trademarks of Merck KGaA, Darmstadt, Germany. ISO is a registered trademark of the
International Organization for Standardization. ASTM is a registered trademark of American Society for Testing
and Materials. ATCC is a registered trademark of American Type Culture Collection. Lit No. PF2100ENEU Rev. A
1/13 DP SBU-12-07589 Printed in the USA. 2013 EMD Millipore Corporation, Billerica, MA, USA.
All rights reserved.

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Data Sheet

Sterilizing-grade Aervent Filters

Multiple Formats Available

Opticap XL Disposable Capsule Filters

Convenient and Easy to Use

The Right Size

14.3 cm (5.6 in.)

19.6 cm (7.7 in.)

21.6 cm (8.5 in.)

33.5 cm (13.2 in.)

8.4 cm (3.3 in.)

8.4 cm (3.3 in.)

10.7 cm (4.2 in.)

10.7 cm (4.2 in.)

Vent to vent diameter:

12.5 cm (4.9 in.)

12.5 cm (4.9 in.)

14.5 cm (5.7 in.)

14.5 cm (5.7 in.)

0.10 m2 (1.1 ft2)

0.21 m2 (2.3 ft2)

0.32 m2 (3.5 ft2)

0.65 m2 (7.0 ft2)

in. hose barb with double O-ring seal

Maximum Inlet Pressure

5.5 bar (80 psi) at 23 C

Maximum Differential Pressure

4.1 bar (60 psid) intermittent

1100 mbar (16 psig) in 70/30 IPA/water

At 2620 mbar (38 psig):

May be autoclaved for 30 cycles of 30 minutes at 135 C.

Good Manufacturing Practices

Component Material Toxicity

European Pressure Equipment

Bacterial Aerosol Growth

Per 10-inch Cartridge

6.9 cm (2.7 in.)

6.9 cm (2.7 in.)

0.32 m2 (3.5 ft2)

0.65 m2 (7.0 ft2)

Outer support ring:

Maximum Differential Pressure

4.1 bar (60 psid) intermittent

1100 mbar (16 psig) in 70/30 IPA/water

At 2620 mbar (38 psig):

Good Manufacturing Practices

Component Material Toxicity

Bacterial Aerosol Growth

Air Flow Rate and Pressure Drop - Opticap XL Capsule Filters

Pressure Drop (bar)

Pressure Drop (bar)

Flow Rate (Nm3/h)

Flow Rate (Nm /h)

Flow Rate (Nm /h)

Opticap XL 10 Capsule W ith 0.2 m

Opticap XL 10 Capsule W ith 0.2 m

Opticap XL 10 Capsule W ith 0.2 m

Flow Rate (Nm /h)

Pressure Drop (bar)

Flow Rate (Nm3/h)

Flow Rate (Nm3/h)

Pressure Drop (bar)

Flow Rate (Nm /h)