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Data Sheet

Sterilizing-grade Aervent® Filters


Superior filters for the sterile filtration of gases

The 0.2 µm hydrophobic Aervent® polyte-


trafluoroethylene (PTFE) membrane pro-
vides 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 Certifi- Benefits
cate of Quality. Each Opticap® XL and cartridge filter is
• 
Ideal membrane for removing particles and
integrity tested during manufacturing and is supported
microorganisms from gases
with a comprehensive Validation Guide for compliance
• Unparalleled thermal and hydraulic stress resistance
with regulatory requirements. For traceability and easy
• Validated to withstand multiple sterilization cycles
identification, each filter is labeled with the product
name, lot number and serial number.

Multiple Formats Available Membrane Types


Hydrophobic Aervent® membranes are available in two • Aervent® 0.2 µm hydrophobic
polyte­trafluoroethylene (PTFE)
device formats, one pore size, and multiple configura-
tions that vary by filtration area and type of inlet/outlet
connection. 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.

The Right Size


A wide range of filtration areas is available to fit all of your application needs, and to
Opticap® XL Filters 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
Nominal Dimensions
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.)
Filtration Area 0.10 m2 (1.1 ft2) 0.21 m2 (2.3 ft2) 0.32 m2 (3.5 ft2) 0.65 m2 (7.0 ft2)
Materials of Construction
Filter media: Hydrophobic PTFE
Supports: Polypropylene
Structural components: Polypropylene
Vent O-rings: Silicone
Vent/Drain ¼ 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:
- ≤ 9 cc/min ≤ 12 cc/min ≤ 24 cc/min
HydroCorr™ Test At 2620 mbar (38 psig):
≤ 0.12 mL/min ≤ 0.25 mL/min ≤ 0.38 mL/min ≤ 0.75 mL/min
Gravimetric Extractables 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 We certify that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has
Directive 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 108–1010 plaque forming units of φX–174 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
Nominal Dimensions
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.)
Filtration Area 0.32 m2 (3.5 ft2) 0.65 m2 (7.0 ft2)
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 ≤ 24 cc/min
HydroCorr™ Test At 2620 mbar (38 psig):
≤ 0.38 mL/min ≤ 0.75 mL/min
Gravimetric Extractables After autoclaving and a 24 hour soak in 70/30 IPA water at controlled room temperature:
≤ 18 mg ≤ 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 108–1010 plaque forming units of φX–174 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.

4
Air Flow Rate and Pressure Drop - Opticap® XL Capsule Filters

Opticap® XL 2 Capsule with 0.2 μm Opticap® XL 2 Capsule with 0.2 μm Opticap® XL 2 Capsule with 0.2 μm
Aervent® Membrane — FF Fitting* Aervent® Membrane — HH Fitting* Aervent® Membrane — TT Fitting*
scfm scfm scfm
0 4 8 12 16 0 4 8 12 16 0 4 8 12 16
0.25 0.40 0.25
3.5 3.5
0 PSIG Outlet 0.35 0 PSIG Outlet 5 0 PSIG Outlet
15 PSIG Inlet 3.0 15 PSIG Inlet 15 PSIG Inlet 3.0
0.20 0.20
30 PSIG Inlet 0.30 30 PSIG Inlet 30 PSIG Inlet
2.5 4 2.5
Pressure Drop (bar)

Pressure Drop (bar)


Pressure Drop (bar)
0.15 0.25 0.15
2.0 2.0
0.20 3

0.10 1.5 0.10 1.5


0.15
2
1.0 1.0
0.10
0.05 0.05
1
0.5 0.05 0.5
psid

psid

psid
0.00 0.0 0.00 0 0.00 0.0
0 5 10 15 20 25 30 0 5 10 15 20 25 30 0 5 10 15 20 25 30
Flow Rate (Nm3/h) Flow Rate (Nm3/h) Flow Rate (Nm3/h)

Opticap® XL 4 Capsule with 0.2 μm Opticap® XL 4 Capsule with 0.2 μm Opticap® XL 4 Capsule with 0.2 μm
Aervent® Membrane — FF Fitting* Aervent® Membrane — HH Fitting* Aervent® Membrane — TT
Opticap XL 2 Capsule Fitting*
W ith 0.2 µm
Aer vent Membrane — TT Fitting
scfm scfm scfm
0 4 8 12 16 0 4 8 12 16 0 4 8 12 16
0.10 0.25 0.08
1.4 3.5
0 PSIG Outlet 0 PSIG Outlet 0.07 0 PSIG Outlet 1.0
15 PSIG Inlet 1.2 15 PSIG Inlet 3.0 15 PSIG Inlet
0.08 0.20
30 PSIG Inlet 30 PSIG Inlet 0.06 30 PSIG Inlet
1.0 2.5 0.8
Pressure Drop (bar)

Pressure Drop (bar)

Pressure Drop (bar)


0.06 0.15 0.05
0.8 2.0
0.04 0.6

0.04 0.6 0.10 1.5


0.03
0.4
0.4 1.0
0.02
0.02 0.05
0.2
0.2 0.5 0.01
psid

psid

psid
0.00 0.0 0.00 0.0 0.00 0.0
0 5 10 15 20 25 30 0 5 10 15 20 25 30 0 5 10 15 20 25 30
Flow Rate (Nm /h) 3
Flow Rate (Nm /h) 3
Flow Rate (Nm /h) 3

Opticap® XL 5 Capsule with 0.2 μm Opticap® XL 5 Capsule with 0.2 μm Opticap® XLOpticap
5 Capsule
XL 4 Capsulewith 0.2
W ith 0.2 µm μm
Aervent® Membrane — FF
Opticap XL 4 Capsule Fitting*
W ith 0.2 µm Aervent® Membrane — HH
Opticap XL 4 Capsule W ithFitting*
0.2 µm Aervent® Membrane — TT— TTFitting*
Aer vent Membrane Fitting
Aer vent Membrane — FF Fitting Aer vent Membrane — HH Fitting
scfm scfm scfm
0 10 20 30 40 50 0 10 20 30 40 50 0 20 40 60 80 100
0.35 5 1.8 0.5
25 7
0 PSIG Outlet 1.6 0 PSIG Outlet 0 PSIG Outlet
0.30
15 PSIG Inlet 15 PSIG Inlet 15 PSIG Inlet 6
4 1.4 0.4
30 PSIG Inlet 30 PSIG Inlet 20 30 PSIG Inlet
0.25
1.2 5
Pressure Drop (bar)

Pressure Drop (bar)

Pressure Drop (bar)

3 15 0.3
0.20 1.0 4

0.15 0.8
2 10 0.2 3
0.6
0.10 2
0.4 0.1
1 5
0.05 1
0.2
psid

psid

psid
0.00 0 0.0 0 0.0 0
0 10 20 30 40 50 60 70 80 90 0 10 20 30 40 50 60 70 80 90 0 20 40 60 80 100 120 140 160 180
Flow Rate (Nm3/h) Flow Rate (Nm3/h) Flow Rate (Nm3/h)

Opticap® XLOpticap
10 Capsule with 0.2 μm
XL 5 Capsule W ith 0.2 µm
Opticap® XLOpticap
10 XLCapsule with 0.2 μm
5 Capsule W ith 0.2 µm
Opticap® XLOpticap
10 Capsule with 0.2 μm
XL 5 Capsule W ith 0.2 µm
Aervent® Membrane — FF
Aer vent Membrane — FFFitting*
Fitting Aervent® Membrane — HH
Aer vent Membrane Fitting*
— HH Fitting Aervent® Membrane — TT
Aer vent Membrane — TTFitting*
Fitting

scfm scfm scfm


0 10 20 30 40 50 0 10 20 30 40 50 0 40 80 120 160
0.30 1.8 0.35 5
25
4 1.6 0 PSIG Outlet
0 PSIG Outlet 0.30 0 PSIG Outlet
0.25 15 PSIG Inlet
15 PSIG Inlet 15 PSIG Inlet 4
1.4 30 PSIG Inlet 20
30 PSIG Inlet 30 PSIG Inlet
0.25
0.20 3 1.2
Pressure Drop (bar)

Pressure Drop (bar)

Pressure Drop (bar)

15 0.20 3
1.0
0.15
2 0.8 0.15
10 2
0.10 0.6
0.10
1 0.4
5 1
0.05 0.05
0.2
psid

psid
psid

0.00 0 0.0 0 0.00 0


0 10 20 30 40 50 60 70 80 90 0 10 20 30 40 50 60 70 80 90 0 50 100 150 200 250 300
Flow Rate (Nm /h) 3
Flow Rate (Nm /h) 3
Flow Rate (Nm /h) 3

Opticap XL 10 Capsule W ith 0.2 µm Opticap XL 10 Capsule W ith 0.2 µm Opticap XL 10 Capsule W ith 0.2 µm
*Opticap® XLAerCapsule Connection Types
vent Membrane — FF Fitting Aer vent Membrane — HH Fitting Aer vent Membrane — TT Fitting

T T = 38 mm (1½ in.) Sanitary Flange Inlet & Outlet; FF = 19 mm (¾ in.) Sanitary Flange Inlet & Outlet; HH = 14 mm (⁹/₁₆ in.) Hose Barb Inlet & Outlet 5
Air Flow Rate and Pressure Drop - Cartridge Filters

5-inch Cartridge with 0.2 μm Aervent® 10-inch Cartridge with 0.2 μm Aervent® 10-inch Cartridge with 0.2 μm Aervent®
Membrane — Code 7* Membrane — Codes 0 and 5* Membrane — Code 7*
scfm scfm scfm
0 10 20 30 40 50 60 0 50 100 150 200 250 300 0 50 100 150 200 250 300
0.20 0.5 0.5
7 7
0 PSIG Outlet 0 PSIG Outlet 0 PSIG Outlet
2.5
15 PSIG Inlet 15 PSIG Inlet 6 15 PSIG Inlet 6
0.4 0.4
0.15 30 PSIG Inlet 30 PSIG Inlet 30 PSIG Inlet
2.0 50 PSIG Inlet 5 50 PSIG Inlet 5
Pressure Drop (bar)

Pressure Drop (bar)

Pressure Drop (bar)


0.3 70 PSIG Inlet 0.3 70 PSIG Inlet
4 4
0.10 1.5

0.2 3 0.2 3
1.0
2 2
0.05
0.1 0.1
0.5 1 1
psid

psid

psid
0.00 0 0.0 0 0.0 0
0 20 40 60 80 100 0 100 200 300 400 0 100 200 300 400
Flow Rate (Nm3/h) Flow Rate (Nm3/h) Flow Rate (Nm3/h)

20-inch Cartridge with with


5-inch Cartridge 0.20.2μm
µm Aervent® 20-inch Cartridge with with
10-inch Cartridge 0.20.2μm
µm Aervent® 30-inch Cartridge with with
10-inch Cartridge 0.20.2μm
µm Aervent®

Membrane —AerCodes 0 and 5*


vent Membrane — Code 7*
MembraneAer—ventCode 7*
Membrane — Codes 0 and 5
Membrane — Aer vent Membrane — Code 7
Codes 0 and 5*
scfm scfm scfm
0 50 100 150 200 250 300 350 400 0 50 100 150 200 250 300 350 400 0 100 200 300 400 500
0.4 0.4 0.8
11
0 PSIG Outlet 0 PSIG Outlet 0 PSIG Outlet
5 5 10
15 PSIG Inlet 15 PSIG Inlet 15 PSIG Inlet
30 PSIG Inlet 9
0.3 30 PSIG Inlet 0.3 0.6 30 PSIG Inlet
4 50 PSIG Inlet 4 50 PSIG Inlet 8
50 PSIG Inlet
Pressure Drop (bar)

Pressure Drop (bar)

Pressure Drop (bar)


70 PSIG Inlet 70 PSIG Inlet 70 PSIG Inlet 7

0.2 3 0.2 3 0.4 6


5
2 2 4
0.1 0.1 0.2 3
1 1 2
1
psid

psid

psid
0.0 0 0.0 0 0.0 0
0 100 200 300 400 500 600 700 0 100 200 300 400 500 600 700 0 100 200 300 400 500 600 700 800 900
Flow Rate (Nm /h) 3
Flow Rate (Nm /h) 3
Flow Rate (Nm /h) 3

30-inch Cartridge with with


20-inch Cartridge 0.20.2μm
µm Aervent® 40-inch Cartridge withwith
20-inch Cartridge 0.20.2μm
µm Aervent® 40-inch Cartridge with with
30-inch Cartridge 0.20.2μm
µm Aervent®

MembraneAer—vent
Code 7*
Membrane — Codes 0 and 5
Membrane —AerCodes 0 and 5*
vent Membrane — Code 7
Membrane Aer
—vent Membrane — Codes 0 and 5
Code 7*
scfm scfm scfm
0 100 200 300 400 500 0 100 200 300 Outlet 400
0 PSIG 500 0 100 200 300 400 500
0.5 0.5 15 PSIG Inlet 0.5
7 7 7
0 PSIG Outlet 0 PSIG Outlet 30 PSIG Inlet 0 PSIG Outlet
15 PSIG Inlet 6 15 PSIG Inlet 50 PSIG Inlet 6 15 PSIG Inlet 6
0.4 0.4 0.4
30 PSIG Inlet 30 PSIG Inlet 70 PSIG Inlet 30 PSIG Inlet
50 PSIG Inlet 5 50 PSIG Inlet 5 50 PSIG Inlet 5
70 PSIG Inlet
Pressure Drop (bar)

Pressure Drop (bar)

Pressure Drop (bar)

0.3 70 PSIG Inlet 0.3 0.3 70 PSIG Inlet


4 4 4

0.2 3 0.2 3 0.2 3

2 2 2
0.1 0.1 0.1
1 1 1
psid

psid

psid

0.0 0 0.0 0 0.0 0


0 100 200 300 400 500 600 700 800 900 0 100 200 300 400 500 600 700 800 900 0 100 200 300 400 500 600 700 800 900
Flow Rate (Nm /h) 3
Flow Rate (Nm /h) 3
Flow Rate (Nm /h) 3

30-inch Cartridge with 0.2 µm 40-inch Cartridge with 0.2 µm 40-inch Cartridge with 0.2 µm
Aer vent Membrane — Code 7 Aer vent Membrane — Codes 0 and 5 Aer vent Membrane — Code 7

*Cartridge Codes
0 = (2-222) O-ring
5 = (2-222) O-ring w/spear
7 = (2-226) O-ring w/locking tab spear

6
Ordering Information
Opticap® XL Capsule Filters

K T G R A

Opticap® XL Pore Size May be Autoclaved Length Quantity per Package


Capsule Filter GR = 0.2 μm 10 = Opticap® XL 10 1 = 1/pack (10 and 5 in.)
05 = Opticap® XL 5 3 = 3/pack (4 and 2 in.)
04 = Opticap® XL 4
Membrane Type 02 = Opticap® XL 2
T = Aervent®
Connection Type
T T = 38 mm (1½ in.) Sanitary Flange Inlet & Outlet
FF = 19 mm (¾ in.) Sanitary Flange Inlet & Outlet
HH = 14 mm (⁹/₁₆ in.) Hose Barb Inlet & Outlet
TH = 38 mm (1½ in.) Sanitary Flange Inlet and 14 mm
(⁹/₁₆ in.) Hose Barb Outlet (XL 2 and 4 only)
NN = 6 mm (¼ in.) NPT Inlet and Outlet (XL 2 and 4 only)

Cartridge Filters

C T G R

Cartridge Pore Size Cartridge Length Packaging Code


Filter GR = 0.2 µm 5 = 5 inch S01 = 1/pk (5-inch element only)
(Cartridge code 7 only) TP1 = 1 per package
1 = 10 inch (all other elements)
2 = 20 inch
Membrane Cartridge Code 3 = 30 inch
Type 0 = (2-222) O-ring 4 = 40 inch
T = Aervent® 5 = (2-222) O-ring w/spear
7 = (2-226) O-ring with
locking tab and spear

7
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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